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Stephanie Abbott, Clinical Research Program Director, Clinical Trials, Western Washington Medical Group
Dr. Stephanie Abbott has been a clinical investigator for nearly two decades, she is the managing partner for Western Washington Medical Group clinical research center and oversees clinical trials as the director of research. Dr. Abbott and Western Washington Medical Group are dedicated to the continual improvement of the delivery of clinical trials and is a proud partner in the Innovo Research Network, a network of independent medical groups participating in clinical research in support of our population health initiatives.
Omar Abdelsamad, Executive Director, Patient Recruitment, Clinical Trial Services, CVS Health
Omar Abdelsamad leads Patient Recruitment for CVS Health Clinical Trial Services helping to support our sponsors and to engage more than 100 million patients. Prior to recruiting patients for clinical trials, he worked at CVS Health to help develop and deploy the COVID-19 testing strategy and footprint. In addition, he led strategy for the Retail, Pharmacy, and MinuteClinic segments for Enterprise Strategy, enterprise workforce strategy for the Workforce Management department, and Patient Outreach for the Retail Pharmacy Growth section. Prior to CVS Health, Omar worked as an internal consultant at Samsung Electronics in Seoul, South Korea, where he conducted growth and product strategy projects across various businesses in China, India, Europe and the U.S.; product management at Amazon; and due diligence consulting for a private equity firm. He has an MBA from the Tuck School of Business and a BA from Harvard College.
Amy Abernethy, MD, PhD, President, Clinical Studies Platforms at Verily; Former Principal Deputy Commissioner, FDA
Amy P. Abernethy, MD, PhD is the President of Clinical Studies Platforms at Alphabet’s Verily, where she has responsibility for the company’s Baseline program and other initiatives to support clinical trials and real-world evidence (RWE) studies. Before joining Verily, Dr. Abernethy was Principal Deputy Commissioner and Acting Chief Information Officer of the US Food & Drug Administration. Prior roles include serving as CMO/CSO of Flatiron Health and multiple roles at Duke University, where she was Professor of Medicine. Dr. Abernethy went to the University of Pennsylvania and then Duke University Medical School, and received her PhD from Flinders University in Australia.
Blake Adams, Senior Vice President of Marketing, Marketing, Florence Healthcare
I'm a seasoned marketing executive with over 13 years of experience driving predictable revenue growth through long- and short-term strategies and maximizing business value through cross-functional alignment.
In addition to leading high-growth marketing and strategy teams, I have experience as a member of the senior executive team, helping to steer overall corporate strategy, product roadmaps, organizational structure, investor relations and market strategy.
Lokesh Agrawal, PhD, Program Director, Biorepositories & Biospecimen Research, NIH NCI
Dr. Lokesh Agrawal is a Program Director at the Biorepositories and Biospecimen Research Branch (BBRB). Dr. Agrawal leads the Branch’s biobanking and biospecimen science research program. Dr. Agrawal has expertise in biomarker development, clinical laboratory science and regulatory experience to strengthen BBRB programs.Before joining the NCI in 2012, Dr. Agrawal worked at AstraZeneca Inc. (Medimmune Inc.) where he was a team leader on various projects involving pre-clinical/clinical biomarker assay development/validation in oncology and managed several cross functional teams to qualify and validate clinical biomarker assays. Prior to Medimmune he worked at Rapid Pharmaceuticals, Inc., as a Research Director in oncology and infectious diseases/vaccines research. Dr. Agrawal also led several NIH-sponsored projects at Thomas Jefferson University and did his postdoctoral fellowship at Indiana University-Purdue University at Indianapolis (IUPUI). He earned his Ph.D. from All India Institute of Medical Sciences, India and graduated from Delhi University. Dr. Agrawal has authored and co-authored several manuscripts in high impact journals and has presented his work at national and international conferences. Dr. Agrawal’s main interests include biobanking, understanding biospecimen science in a clinical setting, and development and validation of human biospecimen integrity markers using proteomic and molecular approaches and novel biomarkers for cancer treatment and diagnosis.
Murray L. Aitken, Senior Vice President & Executive Director, IQVIA Institute for Human Data Science
Murray Aitken Executive Director, IQVIA Institute for Human Data Science Senior Vice President, IQVIA Visiting Professor in Practice, The London School of Economics and Political Science As head of the IQVIA Institute for Human Data Science, Murray Aitken provides policy setters and decision-makers in the global health sector with evidence, analysis, and insights that contribute to the advancement of Human Data Science to improve human health outcomes. Aitken is tasked with creating and managing a research agenda that leaders in global governments, payers, providers, academia, and the life sciences industry use to accelerate the understanding of global trends in disease patterns, data science, and technology. This research is used to foster innovation critical to evidence-based decision-making and the advancement of human health. A renowned healthcare expert, Aitken addresses the challenges facing the global healthcare industry and prospects for improving patient outcomes, managing costs and maximizing access through the application of Human Data Science-an emerging discipline that combines insights from human science (disease biology, prevention, and treatment), data science (AI, Machine Learning, and predictive analytics), and human health (social, environmental, and behavioral). Throughout his 20+ year tenure at IQVIA, Aitken has served in various roles responsible for healthcare insights, corporate strategy, consulting, and services. Prior to IQVIA, Aitken was a partner at McKinsey & Company in the U.S. and in South Korea, covering a broad range of industries, including life sciences and consumer goods. He holds an MBA, with distinction, from Harvard University and a Master of Commerce from the University of Auckland in New Zealand. A frequent speaker on the international healthcare industry circuit, Aitken’s perspectives are widely covered in the business/financial press, including The Wall Street Journal, The Financial Times, Fortune, Time, The Associated Press, Bloomberg Business, Reuters, CNBC as well as in local market publications across Europe, Asia and Latin America. You can follow him on Twitter @Murray_Aitken.
Daniella Ajib, Executive Director, Vendor Outsourcing, Gilead Global
I have over 20 years of experience in the BioPharma industry focused on Clinical Vendor Outsourcing and Management. In my current role, I am the Global Head of Vendor Outsourcing, responsible for category management, vendor sourcing activities, vendor qualification, onboarding, contract life-cycle management, and vendor management in support of the Global Development organization. In this role, my objective is to deliver strategic, scalable, cost-effective outsourced solutions by leveraging internal collaborations and external partners in order to help drive operational excellence and innovation in response to the evolving clinical trial landscape and Development business needs.
Bardia Akbari, Vice President, Development Operations, Oncology, AbbVie, Inc.
Bardia Akbari is the VP and head of Oncology Clinical Operations at Abbvie. In this role, he is accountable for planning and implementation of clinical studies of late stage Abbvie’s oncology assets for global registration. With more than 20 years of experience in pharmaceutical and biotechnology sector, Dr. Akbari has held a variety of positions in medical affairs, clinical science, clinical operations, alliance management, and business development, at Roche, Genentech, and Science 37. Prior to joining Abbvie Dr. Akbari served as Chief Clinical and Experience officer at Lightship; a decentralized clinical trial company. As a passionate advocate for innovation and data driven decision making in clinical operations throughout his career, Dr. Akbari has championed and led data analytics and business insights teams within clinical operation ecosystem.
Jodi Akin, Founder, Chairman, and CEO, Hawthorne Effect, Inc.
Jodi is a healthcare executive, leader, innovator, advisor and serial entrepreneur. She has more than 20 years experience in clinical development, scientific and regulatory strategy, management and medtech market development from start-ups to S&P 500 companies. Prior to founding Hawthorne Effect, Inc., Jodi was Global VP Clinical Affairs at Edwards Lifesciences, LLC- where she led the seminal clinical trials and regulatory approvals for transcatheter heart valve therapy. Also a humanitarian, Jodi led international healthcare initiatives including Heart To Heart International Children's Medical Alliance, The Nahapetov Friendship Foundation and the China Heart Group, a joint venture with the United Nations Industrial Development Organization. She holds an undergraduate degree in Foreign Service from Georgetown University, Masters in Physiology and Nursing from Pace University, New York and 8 patents with a few more pending.
Rinol Alaj, Director, Head of COA and Patient Innovation, Regeneron
Director, Head of COA and Patient Innovation, Regeneron, Rinol’s professional focus is centered around integrated innovation, design thinking, and clinical operation with 15+ years of experience in startup and pharma industry. Savvy, results-oriented leader with proven success in transforming and building eCOA organizations from the ground up. In his current role, he leads Clinical Outcome Assessment and Patient Innovation team within Regeneron pharmaceutical.
Demissie Alemayehu, PhD, Vice President, Biostatistics, Pfizer Inc.
Demissie Alemayehu is Vice President of Biostatistics at Pfizer. He has over 25 years of leadership experience in the pharmaceutical industry. He has been influential externally, with decades of research and teaching experience at major institutions. He has held important offices at key professional societies and has served on editorial boards of major journals. Demissie has published extensively in refereed journals and has co-authored or edited three monographs. He is a Fellow of the American Statistical Association and holds a Ph.D. degree in Statistics from the University of California at Berkeley.
Morgen Alexander-Young, Associate Director Global Trial Optimization, Global Clinical Trial Operations, Merck & Co.
Morgen Alexander-Young has worked in oncology clinical research for the past 12 years. She currently works with the Global Trials Optimization team at Merck, where she focuses on feasibility and recruitment and retention within the Hematology clinical trials program. Prior to joining Merck, Morgen worked with the Alliance for Clinical Trials in Oncology, in the protocol operations department for NCI-sponsored trials. Morgen received a Master of Public Health from the University of Michigan and worked in public health research before moving into clinical research. Previous public health research projects include health disparities in chronic disease care, multidisciplinary teams addressing child abuse and neglect, and hepatitis B infant vaccinations. Morgen lives in Oak Park, Illinois with her husband, two boys, and their growing home zoo (currently one cat, three snails, one guinea pig, and one fish).
Mohamed "Mo" Ali, Chief Domain Expert, Medable
Focused on the creation and execution of strategic programs which aim to serve the needs of patients, sites and sponsors. Mo has over 21 years of industry experience across multiple pharma organizations and key stakeholders. Mo has led major technological transformations across the industry aiding and leading to the adoption of several e-Initiatives to help facilitate the scalability of DCTs and digital applications. He has a background in pharmacology and currently is serving as a board of trustee member for the ACRP and the Chief Domain Expert for Medable.
Adrelia Allen, PharmD, PMP, Director, Clinical Trial Patient Diversity, Merck
Adrelia Allen is a 22-year veteran of the pharmaceutical industry working in sales and clinical research at Merck. She has held positions of increasing experience as a Clinical Research Associate, Clinical Trial Project Manager, and Clinical Research Manager (CRM). She is currently the Director of Clinical Trial Patient Diversity, where she is responsible for the strategy and execution of activities for the diverse representation of patients in clinical trials. Adrelia has a Doctor of Pharmacy degree from Florida A&M University College of Pharmacy.
Jaime Altamirano, Jr., Staff Clinical Data Systems Analyst, Abbott Labs
My name is Jaime C Altamirano, Jr. I have 21 years in the clinical research industry, gaining experience as a Clinical Research Coordinator for a major medical center, a Clinical Research Associate/Field Monitor (CRA) Clinical Data Manager (CDM) for a contract research organization (CRO), and in my current position as a Staff Clinical Data Systems Analyst for Global Clinical Operations, Abbott's Medical Devices division. The Clinical Data Systems group provides application, reporting, and data processing solutions for the planning, execution, and analysis of clinical studies. My clinical research areas of work include medical devices, pharmaceuticals, and biologics.
Melanie Anderson, Principal Scientist, Translational Medicine, Merck
Melanie Anderson is a principal scientist at Merck, Sharp, and Dohme (NJ, USA) with over 18 years of experience in clinical development. In her current role, she evaluates and implements patient centric sampling approaches for drug level quantitation and biomarker testing in clinical research. She currently co-leads a cross-functional team at Merck working to operationalize digital technology in interventional clinical trials. Melanie currently co-chairs the CPLG/TALG IQ Patient Centric Sampling Group which published an editorial entitled “Will patient-centric sampling become the norm for clinical trials after COVID-19?” in Nature Medicine in November 2020. In addition, she is on the organizing committee for the Land O’ Lakes bioanalytical conference and CPSA-USA. She received her BA in Chemistry from Hasting College (NE, USA), and an MS in Chemistry from Lehigh University (PA, USA).
David Anderson, Ph.D., Principal Scientist, Clinical ink
A Senior Scientist at Clinical ink and a visual cognitive neuroscientist with over 12 years of experience developing hardware and software capabilities to evaluate mechanisms of visual perception, attention, and working memory. He collaborates with engineers and scientists to integrate data from multiple sensors and assessments, implement high-dimensional feature engineering pipelines, and evaluate scalable machine learning algorithms to develop digital biomarkers in remotely monitored clinical trials.
Dawn Anderson, Managing Director, Life Sciences, Deloitte
Dawn is a Managing Director in Deloitte's Life Sciences practice and leader in Deloitte's Clinical Transformation practice. She has 30+ years of industry experience in Global Pharma and CROs across Clinical Development & Operations with an emphasis on enabling her clients to innovate and transform the way they conduct clinical trials. She has a special focus on Clinical Transformation, Decentralized Trials, & enabling better recruitment, retention and diversity in Clinical Trials.
Ardy Arianpour, CEO & Co-Founder, SEQSTER
Ardy Arianpour is CEO & Co-Founder of SEQSTER the leading healthcare technology company that puts the patient at the center of all their health data. He is a visionary health tech executive with 20+ years driving innovation in biotech and digital health. Prior to starting SEQSTER, Ardy launched several clinical and consumer-based genetic tests as CCO of Pathway Genomics, and served as SVP of Ambry Genetics, which sold to Konica in 2017 for $1 Billion.
Derk Arts, Founder & CEO, Castor
Derk Arts MD, PhD has over fifteen years of experience in medicine, research and technology. He founded Castor to solve the biggest issues in clinical research: a lack of inclusivity, patient focus and impact of data. Castor enables sponsors worldwide to run patient-centric trials on a unified platform, that helps them maximize the impact of research data on patient lives. Dr. Derk Arts believes the key to achieving lasting change in the industry is through scalability and standardization. Technology to run better trials and maximize the impact of data should be available to all researchers. Over the past 12 months, Castor provided pro-bono support to over 300 COVID-19 trials, and provided the entire infrastructure for the World Health Organizations’ Solidarity Trials.
Valerie Balosso, Director, Data Management, Infectious Diseases, GSK
Valerie Balosso is Director for Infectious Disease for GlaxoSmithKline with 15 years of experience in pharmaceutical industry and specifically in Data Management. She has a large experience in selection, set up and management of collaboration with CRO in the Data Management and ePRO area. Valerie has a specific interest for new technologies including Artificial Intelligence/Machine Learning, Decentralized Clinical Trail and Team engagement.
Luiz A. Barberini, CQE, CSCP, CPIM, Head, External Manufacturing Operations, Bayer SA
MBA, mechanical engineer, ASQ’s CQE and APICS’ CSCP & CPIM certified, with post-graduations in Marketing, Logistics and Transports, has worked for almost 30 years in activities related to Supply Chain, Production, Procurement, Demand management and Logistics. Ford Motors Co., Rhone-Poulenc, British American Tobacco, Pfizer, Takeda Pharmaceutical and Merck, Sharp & Dohme are some companies where he has worked for and added value through his knowledge and experience. Currently works as Operations Manager for Latin America External Manufacturing Operations Consumer Health at Bayer. Besides this role, teaches and coordinates courses of Negotiation, Supply Chain and Demand Management for some major post-graduation schools in Sao Paulo. Plan is to conclude his Masters in Supply Chain/Production Engineering by March 2022. In his personal life, loves to use his time with his family & dogs, but also traveling. Additionally, he is also an avid target shooter, teaching gun principles at the state Police Association.
Roland Barge, Associate Director, User Experience Research, Regeneron Pharmaceuticals, Inc.
Roland Barge graduated from Loughborough University (UK), with a BSc in industrial design, a MSc in human factors and a PhD in human computer interaction. Since then, he has held positions at BAE Systems Advanced Technology Center, Marshall Aerospace and Defense Group, Rolls-Royce Nuclear, Jaguar Land Rover and now Regeneron Pharmaceuticals as Associate Director of User Experience Research. Roland’s passion is leading global user experience research initiatives, working collaboratively through inclusive human centered design thinking methods to deliver user insights. He is a winner of two Queens Innovation Awards and a Chartered Human Factors Specialist.
West Barnes, Senior Director, Product Analytics Center of Excellence, R&D Solutions, IQVIA
As the head of product in the Applied Data Science Center, a team of over 200 data scientists, engineers and product managers at IQVIA, West Barnes has harnessed and organized game-changing innovations into a compelling product suite focused on propelling trial strategy design into the future. With a strong focus on empowering IQVIA’s customers, West is making many of these solutions available to the market for the first time.
Charlie Barr, MD, MPH, CMO, Adaptic Health
Charlie is Chief Medical Officer, Adaptic Health, accelerating treatments through better clinical trial design. He is also Managing Director, Pivotal Strategic Consulting, advising a portfolio of companies improving healthcare and drug development. Recently as Chief Science Officer, Academy of Managed Care, he led research for a coalition of pharma companies in comparative safety and efficacy of biologics and biosimilars using FDA’s Sentinel Network. Previously Charlie had leadership roles in the biotech and pharmaceutical industry (Pfizer, Roche and Genentech) overseeing therapeutic and cross-portfolio groups in clinical development, medical affairs, clinical trials, health economics and outcomes research, data management, biostatistics, epidemiology and data science. At Genentech he was Group Medical Director and led three groups (Patient Registries, Evidence Science and Innovation, Strategy and External Relationships, Evidence for Access). Charlie Barr is board-certified in Internal Medicine and began his career as an academic faculty doing teaching, clinical practice and research.
Dorothee B. Bartels, PhD, Chief Digital Officer, AETION
Dorothee B. Bartels is Global Head of Real World Evidence and Digital Sciences at UCB after having been Clinical and Real World Data Strategy Lead at X, Moonshot (Alphabet). Before, she used to be Corporate Head of Global Epidemiology at Boehringer Ingelheim (BI) for 10 years and for nearly two years Chief Digital Science Officer in the digital incubator of BI. She holds a Professorship of Epidemiology and Public Health at Hannover Medical School and is Adjunct Professor at McGill University, where she lectures in the course of Advanced Pharmacoepidemiology. Her research is focused on secondary data use and data linkages, on innovative real world data analysis approaches, new strategies for faster drug developments and approvals, and digital epidemiology, in particular combining AI/ML and traditional epidemiological methods.
Daniel Beal, RN, BSN, CCRP, Associate Director, Site Engagement, Dyne Therapeutics
Daniel is a Registered Nurse with 12 years of industry experience, the last 7 of which have been focused in site activation and engagement on both the CRO and sponsor side for small biotech. Having designed site engagement and in-house site activation management models at two companies, Daniel is a subject matter expert on the importance of oversight and appropriate management of critical site activation activities to the health and progress of trials, regardless of company size.
Philip Bedrin, Director of Learning & Technology Solutions, ScienceMedia, Inc.
Philip has over 15 years of experience in the Life Sciences space, and has led various strategic and global initiatives in the healthcare and biopharmaceutical industries supporting clinical, medical, and commercial teams in some of the environment's most recognizable organizations. Philip is an active participant in industry-focused associations and has been a long-standing member of the LTEN association, leading various educational workshops, webinars, and seminars on a variety of industry topics.
Jef Benbanaste, VP of Product, Intelligent Trials, Medidata, a Dassault Systemes company
Jef leads Medidata AI's Intelligent Trials solution area. He has 17+ years of experience improving business processes and decision-making through the use of technology and analytics, including experience at AIG and Deloitte. Jef has an MBA from MIT and a BS in Systems and Information Engineering from the University of Virginia.
Michael Benecky, Senior Director, Regulatory Affairs, UCB
Mike received his B.A. in Biochemistry from the University of Wisconsin-Milwaukee and his Ph.D in Biophysical Chemistry from Princeton University. Mike continued his academic research career as a Post-Doctoral Fellow at Northwestern University and as an Assistant Professor at the University of Wisconsin Medical School-Milwaukee Clinical Campus. Mike then entered the in vitro diagnostic industry where he held product development positions of increasing professional responsibility. Mike gained expertise in the preparation of FDA IDE and PMA medical device submissions for lasers used for vision correction surgery at Bio-Reg Associates. At QIAGEN (formerly Digene), Mike led the Regulatory /Clinical Affairs Group that prepared numerous FDA PMA submissions for the first FDA approved HPV DNA test for cervical cancer screening. Mike Benecky joined GSK in October 2011 as Senior Director, Global Regulatory Affairs in Precision and Digital Medicine located in Research Triangle Park, North Carolina. In the area of Digital Medicine, Mike currently assists GSK Teams in regulatory strategy during use of digital health technology in both clinical trial and commercial settings. Recent projects include the commercial launch of the MyAsthma mobile medical app in the EU and inclusion of digital sensors and mobile apps within GSK clinical development programs.
Kristen Bennett, Director, Client Delivery, WCG Avoca
At WCG Avoca, Kristen Bennett provides consulting services to top pharma, biotech, and CRO clients, and oversees client deliverables, systems, and processes across Avoca. She has 15 years of clinical trial experience, with expertise in clinical trial execution, process development, strategic management, and project, data, and site management. Kristen holds a bachelor’s degree in Biology from Kutztown University of Pennsylvania.
Neil Berger, Vice President, FSP Commercial and Operational Strategy, Parexel
Neil is an operational and commercial strategist for clinical development outsourcing solutions at Parexel. Bringing 20 years of commercial and research operations experience, he is a recognized expert in holistic and cross-functional approaches to talent development - integrating acquisition, development and retention to meet long-term portfolio needs for biopharmaceutical sponsors. Neil earned a master of business administration degree from Schulich School of Business, and holds a master’s and bachelor’s degree in science from McGill University.
Sonali Bhatnagar, Associate Director, Clinical Innovation & Digital Health, R&D Sourcing & Procurement, Merck
Sonali Bhatnagar is currently an Associate Director responsible for all Procurement activities associated with Clinical Innovation and Digital Health and is responsible for executing world class procurement strategies and driving category management for this critical function at Merck. Sonali has previously held roles in the Pre-clinical Procurement as well as held previous roles in Merck Research Labs as a Process engineer and Merck Manufacturing Division as a Specialist engineer in the Commercialization Technology areas. Sonali has a B.S. in Chemical Engineering, minor in Computer Engineering from the New Jersey Institute of Technology and an M.S. in Chemical Engineering from Columbia University. She is a Certified Associate in Project Management (CAPM) from the Project Management Institute.
Joy Bhosai, Founder & CEO, Pluto Health
Joy is inspired by innovations that address gaps in access to high-quality care. She is the CEO of Pluto Health, a company focused on improving patient access and care through a health platform that bridges siloed real world data (RWD). She previously served as Chief of Digital Health and Strategy for the Duke Clinical Research Institute. Through previous public health work in Africa and Asia, she developed innovations focused on improving access to health services that were used for clinical trials, which then lead to her founding ChatrHealth, a health tech organization dedicated to developing patient safety and communication tools deployed across both academic and private health system settings. She has also worked with Health 2.0, directing a program that paired large industry leaders with health tech startups. Joy is an alumni of Pomona College, where she studied anthropology and neuroscience, and a previous Fulbright Scholar. She received a Masters of Public Health from Yale, focusing on global health management, an MD with distinction from UCSF, where she completed the global health pathways concentration, and completed the management and leadership residency program at Duke.
Malachi Bierstein, Vice President of Sales, ScienceMedia
Malachi Bierstein leads global sales and is responsible for driving commercial growth. Malachi brings 20 years of global sales management, major international account strategy, and customer centric product positioning expertise. Malachi has held senior leadership positions responsible for media technology licensing and distribution at Nokia Technologies, Rovi (now Tivo), and DivX (acquired by Rovi). He holds a B.S. in Industrial and Systems Engineering from the University of Florida.
Melissa Bime, Founder & CEO, Infiuss Health, Inc
As a registered nurse in Cameroon, Melissa experienced first-hand the challenges patients faced across diverse health care settings in Africa. She is passionate about addressing these problems and believes that by leveraging technology, we can go a long way to provide solutions to these problems. This inspired Melissa to found Infiuss Health, a startup that connects researchers, research facilities, and pharmaceutical companies to patients and participants for clinical research and clinical trials in Africa. Through her work with Infiuss and her passion for entrepreneurship, Melissa hopes to be able to identify and provide solutions to some of Africa’s ever-growing health care concerns.
Rebecca Blanchard, PhD, President, Blanchard Consulting
Dr. Blanchard has over 30 years of experience in scientific research and drug development. She is currently President of Blanchard Consulting, LLC where she provides expertise across various drug development activities. Her career in academia and industry has spanned basic, translational, and clinical research and development across multiple therapeutic areas. Rebecca was most recently (2021) Vice President of Translational Pharmacology at CRISPR Therapeutics where she was responsible for Animal Pharmacology/Toxicology, Clinical Assay Development and Clinical Pharmacology activities. Rebecca was also the Project Lead on CRISPR Therapeutics’ first CAR T program, CTX110 (anti CD19 CAR T cell). Rebecca’s education includes a B.S. in Pharmacy from Albany College of Pharmacy and a Ph.D. in Pharmaceutical Chemistry from the University of Utah. She completed postdoctoral studies at the Mayo Clinic with a focus on human pharmacogenetics. From 1998 through 2004, Rebecca was an Assistant Professor at Fox Chase Cancer Center in Philadelphia where her research focused on pharmacogenomics as related to anticancer therapies. Prior to joining CRISPR Therapeutics in 2018, Rebecca spent 13 years at Merck, Inc. where she held positions of increasing responsibility across several departments including Clinical Pharmacology, Oncology and Genetics & Pharmacogenomics. These responsibilities spanned research and clinical development. Rebecca’s most recent position at Merck was head of Clinical Pharmacogenomics within the Dept of Genetics & Pharmacogenomics where she was responsible for the scientific strategy and execution of Merck’s Clinical Pharmacogenomics efforts. While also at Merck, she held prior positions as Senior Project Leader in Oncology and Clinical Director in Clinical Pharmacology where led several Drug Development teams across early- and late-stage development. Throughout her career, Rebecca has demonstrated a strong external scientific presence as evidenced by her roles on the ASCPT Board of Directors; ICH E18 Working Group; National Academy of Sciences, Engineering and Medicine Genomics Roundtable, Industry Pharmacogenomics Working Group, and ACPHS Scientific Advisory Board.
Lukasz Bojarski, Head of Centralized Monitoring, AstraZeneca Pharmaceuticals, Inc.
Lukasz has received his PhD in biochemistry from Nencki Institute of Polish Academy of Sciences and after enjoying a career in academia he joined pharma industry in 2009. Initially he was involved in preclinical development programes at Celon Pharma SA, where he led several drug discovery projects in psychiatric and metabolic diseases. Some of these projects are now continued in clinical development phase. Later on Lukasz transitioned to clinical monitoring roles at Quintiles Inc. (now IQVIA) and then at Covance to eventually join Centralized Monitoring Team at AstraZeneca in 2016. Now Lukasz is leading the Centralized Monitoring group, which guides study teams through study de-risking exercise and identification of areas that are critical to study quality. In study execution phase the team led by Lukasz performs continuous central monitoring of study data in search of risk signals at study, country and site levels.
Jen Bolton, Senior Fellow, Regulatory Affairs, Boston Scientific
Jennifer has over 25 years of experience leading key market and clinical regulatory approvals. She's currently working to integrate an acquired company, engaged in ISO standards committees, serves on the MDIC ENRICHMENT Industry Advisory Council, volunteers with a local Medtech Accelerator for early-stage start-ups, and is an Adjunct Instructor for the St. Cloud State University Regulatory Affairs and Services master's program. Jennifer has supported global strategies for integrations of acquired companies, mechanical circulatory support devices, transcatheter aortic valves, left atrial appendage closure devices, drug-eluting stents, abdominal and thoracic aortic stent grafts, peripheral balloons/guidewires, vascular surgery grafts/fabrics, and orthopedic implants and facilitated a Regulatory Strategy Board.
Christopher Boone, PhD, Global Head, Health Economics & Outcomes Research, AbbVie, Inc.
Christopher Boone, PhD has a career-long history as a dynamic, innovative thought leader and a public voice on the power of real-world evidence, health informatics, and big data analytics and its ability to radically transform the global health care system into a learning health system. Chris currently serves as the Vice President, Global Head of Health Economics and Outcomes Research at Abbvie. He is also an adjunct assistant professor of health administration at the New York University's Robert F. Wagner Graduate School of Public Service, an active board member of several influential organizations, and a co-founder of a few start-up companies. Most recently, he served as the vice president and head of global medical epidemiology and big data analysis at Pfizer. Chris has been recognized as a 2019 Top 100 Innovator in Data & Analytics, a 2018 Emerging Pharma Leader by Pharmaceutical Executive, and a 2017 Top 40 Under 40 Leader in Minority Health by the National Minority Quality Forum (NMQF). Boone holds, or has held, appointments to some of the most influential national committees focused on health data and patient centricity, including the Board of Directors for the Stewards of Change Institute, the Executive Board of Directors for the Patient Advocate Foundation, the Executive Board of Directors for the National Patient Advocate Foundation, the Board of Directors for SHARE for Cures, the Robert Wood Johnson Foundation’s Data Across Sectors for Health (DASH) Initiative, the Interoperability Committee for the National Quality Forum, the National Committee on Vital and Health Statistics (NCVHS) Working Group on HHS Data Access and Use, the Health IT Policy Committee (federal advisory committee), and the advisory group for the American Society of Clinical Oncologists’ (ASCO) CancerLinQ initiative. Chris earned a B.S. from the University of Tulsa, a M.H.A. from the University of Texas at Arlington, a Ph.D. from the University of Texas at Dallas, and two executive certificates from the Harvard Kennedy School. He is a Fellow of the American College of Health Executives and a Fellow of the Healthcare Information Management & Systems Society.
Hala Borno, MD, CEO, Trial Library
Hala Borno, MD is a practicing medical oncologist and health equity researcher at the University of California, San Francisco. She spun out and founded Trial Library, a public benefit company committed to improving access to cancer precision medicine. Trial Library deploys software integrated with technology-enabled navigation to advance access to oncology clinical trials.
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Walker Bradham, Product Leader, Clinical Development, Product Management, Merative
Walker Bradham brings 20 years of experience defining, designing and deploying web applications to the marketplace, and leads the product roadmap for all EDC/CDMS and eCOA offerings. Championing user empowerment through SaaS principles and AI, he works to provide intuitive tools to solve complex problems in health IT and clinical research. He holds a BS in Business Management from North Carolina State University. He and his family live in Raleigh, North Carolina.
Chuck Bradley, Senior Vice President, Global Development Operations, Annexon Biosciences
Charles Bradley is SVP Global Development Operations at Annexon Bioscienes. located in South San Francisco, CA. Dr. Bradley is an experienced clinical research professional with an in-depth background in all phases of drug development. He is a seasoned senior manager with knowledge of resource allocation, portfolio management, budgetary processes, outsourcing strategies, and regulatory requirements associated with drug development. He has expertise in driving clinical programs forward in entrepreneurial environments, smaller biotech companies, and large traditional pharmaceutical companies. Chuck received his Ph.D. in bioanalytical chemistry from the University of Delaware, received post-doctoral training in Clinical Pharmacology at Uniformed Services University, and is Board Certified in Applied Pharmacology.
Teri Breedlove, Advisor Clinical Services and Capabilities, Eli Lily and Company
Teri Breedlove is a Clinical Services and Capabilities Senior Director at Eli Lilly & Company. In her 20+ years in clinical research, Teri has implemented global phase 1- 3 trials across multiple therapeutic areas in process, quality, and manager roles. In her current role, Teri is working to broaden patient access to and awareness of clinical trials through use of new site models.
Dan Brenner, CEO, 1nHealth
Prior to starting 1nHealth, Dan served as Chief Growth Officer at Sprim Ventures overseeing its MedTech venture companies' digital strategies where the opportunity to start 1nHealth became apparent; Dan pulled from his eCommerce experience the CEO of various eCommerce, Direct-to-Consumer companies. Dan’s prior start up experience includes the launching of TriNova and leading the brand from inception to Strategic acquisition in 2016.
Jamie Brewer, MD, Clinical Team Lead, Division of Oncology 3, Office of Oncologic Diseases, FDA
Jamie Brewer, MD, is a medical oncologist and Acting Clinical Team Lead in the Division of Oncology 3 (DO3) in the Office of Oncologic Diseases (OOD) at the Food and Drug Administration (FDA). Dr. Brewer joined the FDA in 2018 and previously served as a clinical reviewer on the Genitourinary Cancer team. Dr. Brewer serves as the Oncology Center of Excellence (OCE) Scientific Liaison for Cancer Disparities for which she actively engages with FDA colleagues and external stakeholders to promote inclusion and representation of diverse patient populations in clinical trials. Dr. Brewer is an active contributor to OCE initiatives such as Project Equity and Project Community. She is also a participant in multiple internal and external scientific working groups. Dr. Brewer completed her medical training at The University of Illinois at Chicago. She completed her residency and a joint fellowship in Medical Oncology and Clinical Pharmacology and Pharmacogenomics at The University of Chicago.
Katherine Broecker, Senior Director, Design Hub Data Insights, Eli Lilly & Co.
Katherine Broecker is Senior Director, Design Hub Data Insights, Clinical Innovation & Optimization with Eli Lilly. With a background in both business management and biostatistics, her passion is using data and analytics to make the next business decision to drive clinical trial success and provide medicines to patients. Her current role is focused on global clinical trial allocation and novel ways to identify and reach target patients, including diverse populations.
Jennifer Byrne, CEO, Javara, Inc.
Jennifer Byrne’s career has been devoted to leading organizations, building teams, and cultivating partnerships centered on advancing the clinical research enterprise to better connect patients and providers to clinical trials. Jennifer founded Javara with a vision to revolutionize the industry by accelerating access to research - for patients, biopharma companies and healthcare systems alike. Her passion and commitment to transforming the clinical research landscape into an integrated component of healthcare are at the forefront of Javara’s mission. As the former CEO of PMG Research and Founder of Greater Gift (501(c)3), Jennifer’s involvement in the clinical research enterprise has been vast across collaborations with hundreds of pharma, device, Contract Research Organizations (CROs), technology, site organizations, and other research service providers for the direct execution of over 7,500 Phase I-IV industry sponsored clinical trials. Her stellar track record for consistent and excellent quality in patient, provider and client experiences associated with research trials is but one of many professional accomplishments. As a clinical research thought leader, Jennifer thrives on building high performing teams and partnerships within the evolving healthcare and biopharmaceutical landscapes, leading to better outcomes for all stakeholders. Jennifer has been recognized as a CenterWatch Top 20 Innovator and was included in the 2021 PharmaVOICE Women of Influence. She has been the recipient of both the NC Biotechnology Entrepreneurial Excellence Award as well as ACRP’s 2018 Innovation in Clinical Research Award. Jennifer currently co-chairs the Racial Equity Task Force at Wake Forest Baptist Health, and serves as the Board Chair for Greater Gift, a Trustee for The Association of Clinical Research Professionals (ACRP) and an Advisory Board member to CISCRP. She is also an Advisory Chair for the Masters in Clinical Research Management with Wake Forest University and serves in Advisory roles with the Wake Forest Institute of Regenerative Medicine, the Dioko Fund, and the North Carolina Biotech of the Piedmont Triad. Jennifer sits on the Leadership Advisory Board for the Avoca Quality Consortium and the Workforce Innovation Steering Committee for ACRP and Board Chair for The Summit School. She is a graduate of Texas A&M University.
John Cai, MD, PhD, Executive Director, Real-World Data Analytics and Innovation, Merck
John Cai, MD, PhD, FAMIA, is Executive Director, Real-world Data Analytics and Innovation, in the Merck Center for Observational and Real-World Evidence. He is leading a team of data scientists and outcomes researchers to generate real-world evidence and insights through innovative and advanced analytics. John has more than 20 years of experience in biomedical and clinical research across academic, biotech, and pharmaceutical settings. John received his medical training from China Medical University and his Medical Informatics training from Harvard Medical School. Pursuing a passion for both medicine and computing, John has co-authored peer-reviewed publications in the areas of medical informatics, machine learning, clinical trials, and cancer genomics. John is a Fellow of the American Medical Informatics Association (AMIA), and also serves in the AMIA Industry Advisory Council.
Laurie Callen, Senior Director, Clinical Data Management, Moderna Therapeutics
Over 25 years of experience in leading Clinical Data Management and Statistical Programming teams across multiple therapeutic areas, including vaccine, oncology, infectious disease, rare disease, auto-immune, and cardiovascular. Through experience and the passion of bringing drugs to market faster for patients, Laurie's thought-leadership is focused on modern data management approaches, emphasis on standards, technical innovation, and ensuring the highest quality of data. These strategies have supported multiple drug approvals and many successful regulatory audits.
John Campbell, Head of Decentralized Trials, Walgreen Co.
John is the Head of Decentralized Clinical Trials for Walgreens. In his role, he works with an array of stakeholders including patients and sponsors to build and deliver more accessible and less burdensome trials. Prior to joining Walgreens, he served in positions of increasing responsibility at Casimir, a patient-centric decentralized CRO, with his last position as VP of Operations. His work in decentralized trials includes the operationalization of technology and novel measures in global trials. John started his career in rare disease patient advocacy at the Jett Foundation. He has a BA from Colby College.
Jennifer Campbell, Principal Scientist, Preclinical Development, Merck
Jenny is currently the Preclinical Sourcing Lead for Merck’s Preclinical Development organization. Prior to this role, Jenny completed a rotation in the Global Digital Analytics and Technologies organization, focusing on the patient-centric sampling and patient experience aspects of decentralized clinical trials, as well as operational excellence within the organization. Jenny is a Richard T. Clark Fellow and worked with the Infectious Disease Research Institute to develop an automated machine learning modeling system for IDRI’s Tuberculosis drug discovery efforts. Jenny has 17 years of experience in ADME and Bioanalytics and holds a bachelor’s in Bioengineering from Penn State University.
Tracy Cannady, Senior Manager, Training, United Therapeutics Corp.
Tracy Cannady manages the Clinical Training sector of Clinical Operations at United Therapeutics Corporation. Tracy is a highly effective training professional with over thirty-five years of experience in the Pharmaceutical Arena. Tracy is results-oriented with proven expertise in facilitating employee development through training, coaching, and mentoring. An excellent public speaker and leader with diverse and extensive professional experiences. Tracy looks forward to elevating all fellow clinical research training professionals; with strategies and tools on keeping inspection readiness at the forefront of clinical operations.
Stacy J Carbaugh, Dir Strategic Partnerships, Strategic Partnerships, Life Science Connect
Stacy has spent 20 years working to improve patient care and the patient experience by helping professionals who work in life sciences, healthcare, and IT. As a member of Clinical Leader, he helps clinical trial operations teams to stay on-time and on-budget, while delivering quality data, to support and accelerate regulatory approval, including finding the eClinical technology partners needed to do so. His goal is to remove time from clinical development to add it back to patients’ lives.
Tina Caruana, Subject Matter Expert, eClinical Solutions, Digital & Decentralized Trials, Medrio
Tina is a clinical trial innovator with over 20 years of experience in Clinical Operations. She has worked in big pharma, small biotech, and CRO organizations, managing Phase I-IV global trials across multiple therapeutic areas. Tina has expertise leading remote, home health trials - decentralized, home-based, hybrid trials conducted around the world. She also serves as an IRB Board member, routinely reviewing drug and medical device trials with a focus on regulatory oversight, research ethics, and human subjects protections. Tina has a Master of Science from the University of London, London School of Hygiene and Tropical Medicine, and a Master of Business Administration from the University of Toronto’s Rotman School of Management. Tina currently serves as Medrio’s Subject Matter Expert for eClinical Solutions (Digital & Decentralized Trials).
Nathan Cashdollar, PhD, Director of Digital Neuroscience, Operations, Cambridge Cognition
With over a decade of experience in both academic and clinical research, Nathan develops scientifically valid and clinically sensitive digital solutions for measuring cognitive performance in health care and clinical trial research environments. Over the past 15 years, Nathan has had a breadth of Cognitive Neuroscience research experience using a synergy of novel methodology and clinical populations, across multiple institutions in North America, Europe and the United Kingdom.
Melissa Ceruolo, Senior Directior, Biomarker Analytics, Medidata, a Dassault Systemes company
Melissa Ceruolo leads digital biomarker discovery with over 20 years of experience in medical device development. Her role in Medidata’s Sensor Cloud is to convert physiological data from connected devices into meaningful outputs that can serve as endpoints in clinical research. With expertise in devices and data, Melissa guides the industry in device selection for remote monitoring and protocol design. Melissa holds a MS in Engineering Management from MIT and BS in Engineering from Carnegie Mellon University.
Lynne M. Cesario, Executive Director, Global Lead Risk Based Monitoring Program, Pfizer Global R&D Groton Labs
Lynne Cesario has more than 25 years of experience in clinical research and drug development in the pharmaceutical industry. She is currently an Executive Director in the Data Monitoring and Management department, leading the Global Risk Based Monitoring Program at Pfizer. As the overall business lead point of contact for RBM, Lynne coordinates and aligns all cross functional project workstreams. Lynne also manages the global Central Monitoring teams, as well as a Data Science team that focuses on AI and automations that can be employed in the biometrics space. Lynne is an active member of Transcelerate and PhUSE where she co-led the RBM Workstream.
Joan Chambers, Senior Director, Marketing & Outreach, Center for Information & Study on Clinical Research (CISCRP)
Joan develops and executes strategic marketing, promotional and outreach campaigns to support CISCRPs mission of raising awareness and understanding about clinical research and the important role it plays in public health. Additionally, directs, plans, and launches new initiatives for new growth opportunities. A well-known speaker at industry conferences, Joan has presented on a wide variety of topics specific to the clinical trials enterprise. Joan is on the Board of Directors for Greater Gift, the US PharmaTimes Steering Committee for CROY, Steering Committee for Pharma Intelligence/ Informa Clinical & Research Excellence Awards (CARE), Steering Committee for PopUp Star and is an active member of the Association of Clinical Research Professionals (ACRP) and the Drug Information Association (DIA). Joan was on the Advisory Board for The Center for Information and Study on Clinical Research Participation (CISCRP) for over 10 years. In the course of her career, she has published in clinical trade journals and was an instructor for Barnett International's CRA/CRC programs on the site identification/qualification process. Joan was formerly COO at CenterWatch. Her career included roles at ClinX, SCORR Marketing, CHI, Tufts CSDD and PAREXEL. Joan holds a B.S. in Marketing.
Christopher Chan, Vice President, FP&A, IGM Biosciences, Inc.
Chris Chan is Vice President of FP&A at IGM Biosciences, Inc., and has over 30 years of industry experience, including 25 managing clinical trial & R&D finances for biopharmaceutical companies of various sizes. He holds an MBA from UC Berkeley’s Haas School of Business and is a Certified Management Accountant (CMA) & Certified Financial Manager (CFM). Chris is participating in his 9th SCOPE conference as a speaker.
Alexandra Charge, Head of Clinical Planning and Patient Engagement & Recruitment, Clinical, Citeline
Alexandra Charge is a senior clinical operations leader with over 20 years of experience in the pharmaceutical and healthcare industry at AstraZeneca, Roche/Genentech, IMS Health/IQVIA, Allergan and GlaxoSmithKline and, most recently, Real Chemistry. Her expertise spans across a breadth of roles and her focus has been on clinical trial design, planning, feasibility and recruitment & retention, fueled by her passion for innovation and patient centricity.
Tony Clapsis, General Manager and Senior Vice President, CVS Health Clinical Trial Services
Tony is the General Manager and Senior Vice President of the CVS Health Clinical Trial Services (CTS) business unit. CTS’ mission is to expand access to clinical trials with a relentless focus on health equity, while improving research effectiveness and patient outcomes through a unique patient-centric delivery model. Prior to CTS, Tony built and led the CVS Health Enterprise Strategy Team that develops the long-term strategy for the overall business, CVS Pharmacy, CVS Caremark, and Enterprise Transformation. He has played a leading role in new growth opportunities, including the creation of CVS Kidney Care, acquisition of Aetna, and creation of the nationwide COVID-19 testing platform. Before joining CVS Health in 2015, Tony served as Chief of Staff to the CEO of Caesars Entertainment. As part of this role, Tony chaired the Business Roundtable (BRT) Health Care Committee, where he worked with Fortune 500 CHROs on national employer policy priorities. Tony’s additional experience includes serving as as Professional Staff on the Senate Finance Committee where he helped draft the Affordable Care Act (ACA), as part of a portfolio managing value-based care models, provider payments, and insurance markets. Tony also spent five years as a senior healthcare equity analyst at Lehman Brothers and Barclays Capital, after starting his career in the Massachusetts State Senate. Tony graduated Phi Beta Kappa from Boston University. He is currently an Aspen Institute Health Innovation Fellow, sits on the Board of Directors of Parsley Health, and serves on the Rhode Island Health Care Cost Trends Steering Committee and the Health in Rhode Island Committee.
Ivor Clarke, CEO, SubjectWell
Ivor Clarke is CEO and co-founder of SubjectWell, the risk-free clinical trials marketplace for patient recruitment. Since 2012, SubjectWell has been raising awareness about the benefits of clinical research and engaging the 96% of Americans who have never participated in a clinical trial. Ivor has over 12 years of C-suite experience in online marketing and specializes in the creation/operation of enterprise SaaS solutions. Before SubjectWell, Ivor served as President of Brightfire, a digital marketing startup.
Kevin R. Collier, Vice President, RTSM Product Management, Medidata
Kevin is Vice President of Product Management and leads product development and delivery of Medidata's Rave RTSM solution. Kevin has spent his entire 30+ year career in the Life Sciences arena working in clinical research, medical devices, systems and software delivery and project management including 10 years at NASA. Kevin first started in IRT/RTSM at ICON Clinical Research ?in 2002 ?where he led the Project Management team responsible for large clients and was instrumental in unique and innovative design initiatives. Immediately prior to joining Medidata, Kevin provided consulting in the Pharmaceutical R&D space at Accenture where he primarily focused on e-clinical technology, R&D IT strategy, data analytics, and solution assessments.
Patti Connolly, COO, Verici Dx
Patti Connolly, BSc, MSc, CLS, CCRA, ACRP-CPPatti Connolly completed her undergraduate studies in microbiology and her graduate studies in pathology and laboratory medicine at Indiana University. She then went on to complete a graduate certificate in medical device leadership from Xavier University. Patti is a licensed clinical laboratory scientist and trained CAP auditor. She co-founded a diagnostics company, taking it to over 10M per annum in revenue. She has established successful and compliant clinical laboratories in multiple companies including early phase organizations. She has spearheaded the development of numerous novel in vitro diagnostic (IVD) assays used to perform rapid diagnosis of invasive infectious diseases and more recently has lead product development for KidneyIntelX, the first AI-enabled IVD to seek FDA clearance. Currently, she is leading product development for a platform of AI-enabled next-gen transcriptomic assays in kidney transplant. Patti is highly experienced leading clinical trials operations and has served as Director of Clinical Services for a CRO and life sciences consulting firm. She is certified by the Academy of Clinical Research Professionals. Patti is co-author on over 60 manuscripts published in peer-reviewed journals. She served as member of high performance team of industry experts to lead first-ever MAGI MasterClass on “Medical Devices: the Path from Concept to Approval;” and is a speaker at multiple industry events, including SCOPE, ACRP and MAGI. She is a member of the Medical Device Regulatory Working Group (MDRWG) and serves as member of scientific advisory board at Amplified Sciences.
Matthew Cooney, Vice President, Therapeutic Development, Oncology, Medical Science, Tempus Labs
Dr Matthew Cooney is a practicing hematology and oncologist who previously was the multidisciplinary genitourinary team leader at University Hospitals Seidman Cancer Center. He has led and participated in dozens of phase I to III clinical studies. At Tempus Dr. Cooney supports the Therapies Team, which rapidly activates trials to match individual patients across the TIME network.
Anca Copaescu, CEO, Strategikon Pharma
Frustrated by current solutions, Anca created the Clinical Maestro platform based on more than 15 years’ experience in clinical research with both sponsors and service providers. As Head of Clinical Outsourcing at BioMarin, and with experience at two global CROs, Anca gained unique insights into clinical business operation. Clinical Maestro addresses the entire clinical study financial process: from planning, to outsourcing, to the end of the clinical contract and study analytics.
Anthony Costello, CEO, Patient Cloud, Medidata, a Dassault Systemes company
Anthony Costello is CEO, Patient Cloud at Dassault Systemes. In this role, Costello leads the development of Medidata’s patient-facing activities and solutions including decentralized trials technology and strategy, Patient Cloud, Dassault Systemes product apps, myMedidata patient portal, Disease Registries and Recruitment, Telehealth and Virtual Visits, and Sensor Cloud and Biomarker Discovery.
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Amanda Cross, Vice President, Biometrics, Worldwide Clinical Trials
Amanda Cross has over 25 years of industry experience, all in biometrics, having begun her career as a statistician. Now focused on overall data strategy, from collection through reporting, she works with her teams to create fit for purpose project-based data solutions focused on data integrity and accuracy. Amanda is based in Raleigh, NC.
Michelle Crouthamel, PhD, Head, Digital Sciences, AbbVie, Inc.
Michelle Crouthamel is an “intrapreneur” and a pioneer of mobile technologies in pharmaceutical development. As the Head of Digital Science at AbbVie, Michelle leads a team of digital health strategists and signal processing scientists to modernize outcome assessments and advance drug development programs. Prior to joining AbbVie, Michelle led many successful innovation programs in R&D at Merck and GSK and received numerous awards. She is a scientific advisor to many tech companies, an inventor who holds multiple patents, and an author who published extensively in Neuroscience, Oncology, and Digital Health. Michelle also collaborates broadly with academics, tech, consortia, and health authorities to drive progress and realize the value of digital health.
Beth Culver, Senior Executive Director, Global Head of Project Management, MRN
Beth has over 20 years’ experience in the pharmaceutical industry spanning data management, quality, IRT and project management. At MRN, she has global responsibility for the Project Management group which oversees every stage of a decentralized trial, from contract award and kick off through project closure. Beth looks forward to continuing to develop innovative approaches to DCTs as delivering successful trials for customers.
Hugh Dai, Associate Director, Design Hub, Eli Lilly & Company
Hugh Dai is the Associate Director of Design Hub for Eli Lilly and Company. Hugh is passionate in optimize clinical trial designs by surfacing relevant data insights and is partnering cross-functional teams to implement this new capability. Prior to joining Eli Lilly 7 years ago, Hugh worked in Healthcare industry for more than 20 years in both clinical research as well as hospital operations to focus on improving patient care efficiency. In his spare time, Hugh is inspired daily by his family and always looking for new BBQ recipes. He also likes playing soccer, travel and photography.
Inga Darville, MS, Cinical Evaluation Specialist, Boston Scientific
Inga Darville is a Clinical Evaluation Specialist on the Interventional Cardiology Clinical Evaluation Risk Team at Boston Scientific where she authors clinical evaluation deliverables and supporting documents for EU MDR submissions for Class III devices. In addition to clinical evaluations, she serves as a clinical representative on her cross-functional teams to support all related EU MDR processes and related-deliverables of interventional cardiology devices. Inga holds a Bachelor of Science in Biomedical Science and Master of Science degree in Applied Clinical Research from St. Cloud State University. Her unique background of medical writing, clinical trials and research has been acquired through her previous role as a Regulatory Affairs Specialist, writing over 26 CEPs and CERs for Class I through Class IIa wound care and surgical devices, multiple internship opportunities as a Medical Writer through her graduate program for Class II to Class III devices in various therapeutic areas, graduate coursework and as a Research Assistant in pre-clinical studies.
Darious Davis, Business Development Representative, Datacubed Health
Darious Davis is a clinical research professional where he has dedicated much of his time in the industry to business development operations. He has exceptional experience in business development operations, where he fosters and encourages relationships with various contract research organizations, as well as, pharmaceutical, biotech, and medical device companies.
Bhooshi de Silva, Senior Vice President, Global Head, Corporate Development, Strategy and Ventures, PPD, part of Thermo Fisher Scientific
Bhooshi de Silva serves as global head of corporate development, strategy and ventures for the PPD clinical research business of Thermo Fisher Scientific. He joined the company in 2014 as senior vice president of corporate development and strategy, with responsibilities in mergers and acquisitions and partnerships. In his current role, in addition to corporate development and strategy, de Silva leads the company’s enterprise data functions and manages venture partnerships. He collaborates with the senior leadership team on key strategic initiatives, leads data and disruptive innovation priorities, and plays a key role in driving the company’s evolution and growth. He is also serves on the boards of several of the company’s strategic investments, including PPD-SNBL and Science 37. In joining the business, de Silva brought 15 years of biopharmaceutical industry experience, including serving in several leadership positions. He started his career at Pfizer, where his roles included R&D portfolio management, U.S. commercial development, and U.S. customer strategy and negotiations. In 2009, de Silva was named vice president of business development evaluation and strategy, leading a team in the evaluation of licensing, acquisitions and corporate strategic initiatives for Pfizer. Later, he served as head of corporate development, corporate strategy and head of international at Optimer Pharmaceuticals. De Silva played an integral role in the commercialization strategy and Optimer’s sale to Cubist Pharmaceuticals in 2013. He has an impressive track record of achievement in corporate strategic initiatives and M&A transactions on both the buy and sell sides. De Silva holds degrees in finance, economics and engineering from Stanford University, London School of Economics and Imperial College of Science, Technology and Medicine in London.
Jenny Dean, Senior Project Manager, Clinical Research, ZOLL Medical Corp.
Mrs. Dean-Di Pasquale is a Senior Clinical Research Project Manager for ZOLL Medical’s Cardiac Diagnostics division. Throughout her 12-year tenure at ZOLL she has held progressive roles and responsibilities in leading clinical research teams and managing clinical trials of the ZOLL’s LifeVest Wearable Cardioverter Defibrillator and Heart and Arrhythmia Management System. Her daily routine supports ZOLL’s clinical and commercial industry and involves direct interaction with research participants, ZOLL business units, research institutions, prescribers, and vendors worldwide. Before accepting her current role, Mrs. Dean held various clinical research positions with the Department of Defense, multiple Clinical Research Organizations, and James H. Quillen College of Medicine. Mrs. Dean specializes in patient engagement, enrollment, relationships between research participants, research outcomes, and translational medicine. Driving her commitment is the goal to bridge the gap between scientific research and the target populations it is ultimately meant to serve. Mrs. Dean holds a Bachelor of Arts degree in Foreign Studies and a Master’s degree in Biochemistry and Molecular Biology. Mrs. Dean resides in Pittsburgh with her husband, Johnny Di Pasquale, the feisty feline DuPont, and the lovable bulldog, Hazel Mae.
Gregg Dearhammer, Senior Vice President, Data Sciences, Safety & Medical Services, IQVIA
Gregg is a biopharmaceutical industry veteran with more than 20yrs experience and has held senior positions with several CROs. Gregg joined IQVIA in 2017 and is Senior VP of Data Sciences & Safety. He leads numerous teams under the IQVIA Research & Development Solutions organization. Prior to IQVIA, he served as COO at inVentiv Health where he was responsible for all aspect of clinical operations. Gregg is an operational leader, who has leveraged his customer service focus to drive business success throughout his career.
Vicky DiBiaso, MPH, BScN, Global Head, Patient Informed Development & Health Value Translation, Sanofi
Vicky has 20+ years of clinical research experience focused on acute, chronic and rare diseases. She holds a Master of Public Health and is a nurse by training. She has been awarded the distinction as one of the Top 20 Industry Innovators for her efforts to integrate insights from patient communities and clinical trial institution into R&D decision making. Her work has been highlighted in the Wall Street Journal and other industry publications and key note speeches. Prior to establishing the Patient Informed Development & Health Value Translation team, she was the Region Head for the Clinical Study Units in Asia-Pacific, Eurasia, Middle East and Africa as well as the Global Head of Clinical Operations Strategy & Collaboration. As such, she oversaw all Phase I- IV clinical trials conducted in the AP-EMEA region as well the global feasibility, competitive intelligence, site and patient networks functions. A decade ago, she was one of the first industry leaders to establish a series of patient networks to provide patient advisory expertise to development staged clinical trials. These upfront partnerships with patients, and also trial sites, have transformed the company’s development model whereby the therapies of tomorrow are not simply developed for patients but rather in partnership WITH patients and healthcare professionals. She also was a co-developer of the Sanofi PAIRED (Patient Informed R&D) initiative that won the 2019 eyeforpharma Most Valuable Clinical Access Initiative award. She developed and co-lead Sanofi’s novel SMILE program (Sanofi Making Investigators Lives Easier) which resulted in the company going from 11th place to 1st in sponsor reputation in less than 2 years based on the CenterWatch global survey. Sanofi also received other key industry recognitions from ACRP, AVOCA and SCRS as a result of this initiative.
Eileen Doherty, Vice President, Enabling Business Information Solutions (EBIS), The Janssen Pharmaceutical Companies of Johnson & Johnson
Eileen Doherty is currently the Vice President/Head of the Enabling Business Information Solutions (EBIS) team within Global Development (as part of Janssen R&D). The EBIS team drives operational excellence in clinical development by delivering accurate and accessible information through innovative solutions and analytics around Clinical Data, Clinical Trial Operations, Portfolio/Project Management, as well as Business Process Optimization. Eileen joined J&J from UCB Biosciences in 2018 when she was hired as the Head, EBIS Clinical Operations Solutions. During her time with UCB, Eileen’s experience included leading teams covering clinical data management, reporting and analytics, and clinical systems. Earlier in her career, she worked as a Clinical and Statistical Programmer with Quintiles. Eileen studied Latin American Studies & Mathematics at the University of North Carolina at Chapel Hill (go Tar Heels!).
Hansu Dong, Executive Director, Clinical Outsourcing & Business Operations, Clinical Operations, Novavax
Hansu Dong is the Executive Director Clinical Outsourcing and Business Operations at Novavax. He has 20+ years in clinical outsourcing with expertise in strategic alliances, strategic relationship management, governance, sourcing and procurement, sourcing models, vendor and site contract negotiations, and technology solutions and implementation. Hansu has worked across small biotech to mid-size and Big Pharma, supporting everything from pre-clinical to Medical Affairs. In 2020, Hansu joined Novavax as their Sr. Director of Clinical Outsourcing and Business Operations, leading Novavax’s R&D team in selecting, negotiating, contracting, and providing alliance management support to Novavax’s CROs and other strategic vendor partners.
Keith Dorricott, Director, Dorricott Metrics & Process Improvement Ltd.
Keith Dorricott is an independent consultant and Director of Dorricott Metrics & Process Improvement Ltd. He developed his process thinking whilst at Kodak Ltd and is a Lean Sigma Master Black Belt. He has worked in two large CROs leading corporate process improvement for 10 years. Amongst other clients, Keith assists the Metrics Champion Consortium (MCC) by leading metrics development and best practice sharing on centralized monitoring, protocol complexity, vendor oversight, TMF, site start-up, and risk assessment & control. Keith regularly presents at conferences such as SCOPE and Clinical Trials Europe. His passion is in improving methods and skills for root cause analysis and he co-developed a novel approach for clinical trials - DIGR-ACT®.
Sara Doshi, PhD, Senior Director, Decentralized Design & Delivery Integration, Eli Lilly & Co.
Sara Doshi is currently Senior Director, Decentralized Design and Delivery Integration, at Eli Lilly and Company. Sara’s role focuses on helping Lilly achieve its goal of accelerating the Decentralized Clinical Trial (DCT) paradigm and making clinical research increasingly accessible to a larger and more diverse patient population. She strategically partners to set DCT program goals and measures, monitors the external environment and regulations, drives OCM, and enables DCT capabilities to be designed into Lilly trials. Sara spent her previous 22yrs at Lilly in various leadership roles in Global Medical Affairs. She graduated from Butler University with a Doctor of Pharmacy degree and went on to complete a Drug Information Residency.
Joanne Dourado, Senior Director, Medicines Quality Organization
Joanne Dourado, BSN, MBA is a Senior Director within the Medicines Quality Organization at Eli Lilly & Company. Joanne has over 20 years of clinical trial experience and has led operational execution for clinical trials in oncology, immunology, and COVID therapies. In her quality role, she is focused on embedding quality into all aspects of clinical trial execution, including DCT capabilities.
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Jennifer Duff, General Manager, Clinical Development Solutions, Product Management, Merative
Jennifer Duff has over 22 years of experience in the Life Sciences industry with specialization in enabling and scaling industry-leading services and technology solutions for biopharma clients. She has collaborated with teams across the Life Sciences industry, from large to mid-sized companies, as well as many of the major technology providers over her career.
Jennifer has an MBA in Biotechnology and Healthcare Management. Her focus is on challenging industry norms and seeking powerful, novel solutions that drive business growth and deliver improved outcomes for Life Sciences clients and the patients they serve.
Cassidy Duffany, Manager, Operations Finance, Elligo Health Research®
Cassidy Duffany is a Manager, Operations Finance with Elligo Health Research. Her responsibilities include financial, AR, and team management as well as budget and contract negotiations. Over the past twelve months, Cassidy has successfully negotiated over 100 clinical trial agreements. Cassidy joined the Elligo team directly from Saint Anselm College, where she graduated with degrees in finance and marketing.
Brian Dunton, Head, Client Services, Atreo.io
Brian came to Atreo with over 16 years of both RTSM service provider and in-house sponsor experience. The majority of his career was spent at Signant Health, where he most recently led a global Project Management team supporting several of the largest global sponsor organizations. Prior to his most recent role at Signant, Brian acted as the Global RTSM Category Manager for Roche Genentech, where he provided direct oversight of all preferred service providers. This experience provided a valuable and unique perspective into what fosters a successful sponsor partnership model, with a focus on quality and scalability. Brian has a passion for RTSM and knows first-hand the challenges common of traditional RTSM engagements. Atreo’s novel approach to RTSM delivery aligned with his vision of what can be accomplished with modern technology and is thrilled to bring our approach to the industry.
Kathi G. Durdon, Executive Director, Central New York Biotech Accelerator, SUNY Upstate Medical University
Kathi Durdon is Executive Director of the Central New York Biotech Accelerator (CNYBAC), State University of New York (SUNY) Upstate Medical University's New York State Certified Business Incubator. Kathi manages facility operations and development of biotech innovator support programs such as the grant renewed CNYBAC Medical Device Innovation Challenge, which she founded. Kathi also directs a monthly-held Concept to Commercialization Virtual Series and continually works to expand network connections for clients within a collaborative innovation ecosystem. Kathi serves as a Board Member of MedTech, a state-based non-profit biomed trade organization, and the Business Incubator Association of New York State (BIANYS) and is an Adjunct Assistant Professor at Upstate Medical University. Kathi presents for many organizations and serves as a Society of Clinical Research Associates (SOCRA) Good Clinical Practice (GCP) Certification Instructor, Device Conference Chair, as well as NYS Chapter Chair. Previous to administration of the CNYBAC, Ms. Durdon served as Director of the Clinical Trials Office at SUNY Upstate Medical University and then moved on to industry where she managed the Clinical Affairs team at Welch Allyn (now Baxter).
Nanci Eannucci, Director, Clinical Trial Recruitment Strategy, Bristol Myers Squibb
I am a clinical dietitian with over 18 years experience in the pharmaceutical industry and clinical trial space. My passion is finding creative and innovative ways to approach patient recruitment and site engagement while always staying centered around what is most important, the patient. I believe in keeping the patient first in every decision made with regard to clinical studies. If we do this, we can ensure success and build a sound foundation for future research.
Melissa Easy, Vice President & General Manager, Clinical Technologies, IQVIA
As Vice-President & General Manager of Clinical Technologies at IQVIA, Melissa Easy is responsible for the strategy, delivery and development of technology and technology-enabled services that improve clinical trial delivery for IQVIA and customer clinical trials. She believes we must take advantage of orchestrated technology to bring patients, sites, and sponsors together in a concerted effort to save time, money, and lives.
Samantha Eells, Co-Founder, Lightship
Sam is a vision-driven entrepreneur and epidemiologist with experience conducting clinical trials at UCLA, the Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, and Science 37. Throughout her career, Sam has worked to improve health and well-being in communities. At Lightship, Sam leads these efforts by providing access to clinical trials and treatment, especially those that find access to health systems difficult.
Sherrine Eid, Principal Industry Consultant, Health Care & Life Sciences, SAS
Eid has more than 20 years of experience in real-world evidence, epidemiology and biostatistics. Her passion for better public health led her to work for USAID, CDC and other donors in global health development with a focus on reproductive health and family planning and infectious diseases. Her current focus is supporting regulatory, safety, late-phase and post-marketing activities across therapeutic areas using clinical and real-world data to glean real-world insight.
Andres Escallon, Vice President, eClinical Innovation, Suvoda
Andres Escallon is Vice President of eClinical Innovation at Suvoda, a global clinical trial technology company that specializes in complex studies in therapeutic areas such as oncology, central nervous system (CNS), and rare disease. Andres is a career eClinical services professional having spent over 15 years in the clinical trial industry.
Jessica J. Federer, Managing Partner, Supernode Ventures
Jessica Federer is a recognized leader in the global life sciences industry. She was the first Chief Digital Officer for the Bayer AG group, as well as the first woman to hold that role in the industry. She led Bayer’s digital transformation across the pharmaceutical, consumer care, crop science, material science and animal health businesses during record setting years for both sales and EBITDA. Reporting into the Bayer AG Group Management Board, Federer united the company’s digital strategy and investments across divisions to accelerate growth across the 118,00 employees. During her tenure, the company acquired and integrated Merck’s consumer care business and Monsanto, becoming, respectively, the second largest consumer health and the leading agriculture businesses on the planet, and floated their material science division into Covestro. With a focus on scalable digital enablers to business integrations and success, Federer streamlined investments, modernized capabilities, and upskilled the workforce. Prior to leading digital for the group business, Federer established a track record inside Bayer for delivery across regulatory affairs, market access, product launches, and business turnarounds. This includes the launch team for the record holding biologic EYLEA ®, an overhaul in the animal health business, and establishing the market access function globally. Federer regularly contributes to publications and events for the FT, Reuters Health, Bloomberg, and leading consultancies. Ms. Federer joined BMP as a Venture Affiliate in 2018, and is a Partner for the Opportunity Fund. She is a graduate of George Washington University and received an MPH from the Yale School of Public Health.
Gabriela Feldberg, Head of Product, Planning & Design, AstraZeneca
Gabriela has spent 20 years in various roles across both pharma and CROs with much of her recent focus spent on building and leading highly effective global feasibility, site selection and patient engagement organizations. Gabriela’s current role as Practice Leader within the Data Science and Artificial Intelligence organization has continued to refine this mission with an additional emphasis on extracting maximum value for our patients by leveraging data science to provide valuable insights to better select investigators for clinical studies. Previously she has led global Feasibility, Site Selection and Patient Engagement groups at Covance and UCB. Prior to UCB, Gabi spent over ten years at Quintiles where she held positions of increasing responsibility. Gabi also held
Rust Felix, Co-Founder & CEO, Slope
As the Co-founder and CEO of Slope, Rust has led the development of the industry’s first data-driven solution to clinical trial supply chain management and automation. Slope’s eClinical Supply Chain Management platform brings stakeholder collaboration, real-time visibility, traceable chain of custody, and improved compliance to complex, early phase studies. Rust holds a Master’s Degree in Mechanical Engineering with a concentration in computational fluid dynamics. Throughout his career Rust has used complex data sets to inform mathematical models that solve real problems. Rust is also one of the few engineers who won’t bore you deeply at a dinner party.
Rosalie Filling, Vice President, Senior Global Head, R&D Operations, Endo Pharmaceuticals
Rosie earned her B.S. in Biology, Minor in Chemistry from the University of Pittsburgh. She has 19 years of clinical trial experience. Rosie began her career at PPD as a Research Assistant and moved into her first management position at PPD. She was responsible for the rapid site start-up and ongoing management of enrollment and site regulatory requirements across all therapeutic areas. After 5 years, she left PPD and began her pharmaceutical Sponsor career at Guilford Pharmaceuticals in Baltimore, MD. At Guilford, Rosie was responsible for the overall strategy for execution of clinical trials including the outsourcing needs and overall budget management for all of Research & Development. Guilford was acquired by MGI Pharma. Post the acquisition, Rosie was chosen to lead the new Clinical Operations team to establish a new set of processes and strategy for the new organization. MGI’s focus was on acute care and oncology. The new organization was very successful and was later acquired by Eisai. During Rosie’s tenure at Eisai, she moved into post-marketing and was responsible for executing Oncology and CNS post-marketing trials. Rosie then joined Teva in 2009, where she was the US site head of Clinical Operations and was responsible for the successful delivery of Inhalation, Women’s Health, and Cardiovascular clinical trials. Rosie joined Lupin in August 2014 to stand up the Clinical Operations Division. She recently joined Endo Pharmaceuticals in February 2018 as Vice President, Clinical Operations accountable for Clinical Operations, Biometrics, and Medical Writing. She has surrounded herself with highly skilled and energized colleagues and has laid the foundation for a successful clinical operations department. Rosie has been an active contributor to 6 NDAs, 8 SNDAs, and 6 ANDAs. Rosie resides with her husband of 18.5 years, Josh. They have 2 daughters Marlee (17) and Chloe (13) and two adorable boxer puppies, Brutus and Bodi. In her spare time you can find her at the gym, hiking or on the sidelines watching her daughters play soccer!
Marina Filshtinsky, Conference Producer, Cambridge Healthtech Institute
In her current role as Co-Founder and Senior Vice President of Strategy and Product Development at ClinEco, Inc., Marina Filshtinsky is leading platform development and working closely with an offshore team of engineers. She is also leading and coordinating the work with advisors and investors on go-to-market strategy, business model, and positioning the platform within the clinical trials industry. At her "day job" Marina is working as executive conference director for several CHI’s events including SCOPE and SCOPE Europe.
Charles K. Fisher, Founder & CEO, Unlearn.AI, Inc.
Dr. Charles Fisher is CEO at Unlearn.AI, a role he’s held since co-founding the company in 2017 with the aim of advancing artificial intelligence to eliminate trial and error in medicine. During that time, Unlearn has raised $85M in venture capital, grown to almost 50 full time employees (and still growing), and pioneered applications of AI in clinical research through pharma partnerships, regulatory qualifications, and peer-reviewed publications. Prior to Unlearn, Dr. Fisher was a theoretical physicist and software engineer working at the intersection of machine learning and biology. His research has spanned areas of biology from predicting clinical outcomes, to modeling the motion of atoms in proteins and RNA, to understanding the organization of large ecosystems. Dr. Fisher’s machine learning research has primarily focused on deep learning, probabilistic generative models, and Bayesian inference. In industry, he worked as a machine learning engineer at virtual reality startup Leap Motion, and as a computational biologist at Pfizer where he developed machine learning-based approaches to the analysis of large scale ‘omics data. As an academic researcher, Dr. Fisher was a Phillippe Meyere Fellow in theoretical physics at ecole Normale Superieure in Paris, France, and a postdoctoral scientist in theoretical biophysics at Boston University. He holds a Ph.D. in biophysics from Harvard University and a B.S. in biophysics from the University of Michigan.
Balazs Flink, Senior Director, Clinical Development Operations, Daiichi Sankyo, Inc.
R&D business strategy and analytics leader with 15+ years of pharma experience both in commercial and R&D. Graduated as a physician, explored medicine from the academic perspective before joining the pharmaceutical industry. Held leadership roles, built multiple teams in various countries from scratch to execute regional/affiliate level timely and high-quality clinical operations deliverables. Established and continuously developed an industry leading HQ feasibility and comprehensive trial business analytics capability. Demonstrated strength in finding, recruiting and developing people, visionary thinking, decision making, solving game changing problems and built analytics capabilities to connect strategy, science and execution through data, advanced analytics and insight generation.
Patrick A. Floody, Executive Director, Global Clinicl Trial Services, Regeneron Pharmaceuticals, Inc.
Patrick has over 27 years’ experience in new drug development. He joined Regeneron in March 2020. His current role is the Head of the Global Clinical Trial Services group, responsible for global site management, central monitoring, study feasibility and site selection, study/site start up, eCOA and patient technology initiatives. Prior to this, Patrick spent 25 years at Pfizer, with most of his time spent in clinical program operations but also includes GCP Quality (level 1) and Analytics. Patrick has extensive international experience in drug development. He helped establish the Pfizer country office development teams in Latin America, India and other parts of Asia. Subsequently, Patrick spent 10 years in Pfizer’s Development Japan organization as Head of Japan Development Operations and Development Japan Portfolio & Project Management Groups. Patrick is a former officer in the U.S. Army and is a veteran of the Gulf War.
Greg Folz, CCRP, Founder, Kits4Life
Gregory A. Folz, CCRP, recently retired as the Administrative Director for the Research Institute of Deaconess Clinic. Folz has overseen more than 800 clinical trials in his research career, and successfully secured nearly $190 million in clinical trial grants for physician group practices and hospitals across the US. Recognized as a 2018 Top 20 Innovators in the research industry, Folz is also a recipient of the Site Innovation Award for the Society for Clinical Research Sites. In 2016, Folz founded Kits4Life, an international nonprofit organization to enable the life sciences industry to repurpose surplus clinical trials supplies for humanitarian aid. In collaboration with top pharmaceutical companies and the Task Force for Global Health, the organization has now supplied much needed medical supplies and equipment to humanitarian aid organizations in ten countries. In addition to serving as a national consultant and speaker on the advancement of clinical research operations, he currently provides strategic guidance to the Cardiovascular Research Consortium, and the Heart Failure Society of America, supporting national networks of research-savvy cardiology practices throughout the US. Folz also oversees the development of one of the nation’s largest repositories of cardiovascular data for academic research in heart disease. He has earned a designation of Certified Clinical Research Professional and is active in several industry organizations. Folz and his wife Ann live in Warrick County and enjoy spending time with their four children and 11 grandchildren.
Kimberly Fookes, Global Head, Diversity & Inclusion in Clinical Trials, Novartis
Kim has 30 years of experience working in clinical research. Prior to being named the Global Head of DICT, Kim was responsible for all US clinical trial deliverables across Novartis’ portfolio, including early and late phase oncology and non-oncology. She joined Novartis from AbbVie where she was the Head of Site Management & Monitoring, overseeing Global Site Management. While at AbbVie, Kim also managed operations for the Global Medical Affairs’ Therapeutic Areas and US Medical Affairs. Prior to AbbVie, she worked at Takeda, CROs, and Site Research Centers.
Darcy Forman, Chief Delivery Officer, Science 37
Darcy Forman is the Chief Delivery Officer for Science 37, where she has responsibility and oversight for clinical operations service delivery, including patient engagement, clinical operations, data management, and nursing solutions.
Darcy has more than 20 years of experience bridging clinical operational expertise and strategic corporate development initiatives with a passion for innovative and decentralized clinical trial execution. Most recently, Darcy served as the vice president of corporate development at Firma Clinical Research, where she had oversight and leadership responsibility for the identification, development, and execution of corporate development opportunities, including the evaluation of Firma corporate strategies and strategic planning. Darcy started her career at Pfizer Pharmaceuticals as a bench scientist before transitioning into a role in Pfizer’s clinical research division. She continued her career with ascending clinical operations and project management positions at various CROs spanning large, mid-size, and niche including i3 Research (now Syneos Health), Health Decisions, Clinipace, and Firma Clinical. During her career, Darcy has fostered her passion for innovation and intelligent operational strategy by bringing metric-driven decision making to each role and organization. Darcy holds a B.A. in chemistry from Lake Forest College.
Emily Freeman, PhD, Senior Director, Patient Engagement, Global Medical Strategy and Operations, Gilead
Dr. Emily Freeman is a Senior Director of Global R&D Patient Insights at Lundbeck where she specializes in the understanding of patient insights and behaviors within drug development. Dr. Freeman is interested in the development of evidence-based communication tools to facilitate shared decision making for patients. Dr. Freeman is exploring how medical evidence (i.e. risk, benefit, and health outcomes) is constructed and communicated within the healthcare environment. Dr. Freeman is also interested in the development of digital health interventions and demonstrating their effectiveness. Finally, she has been involved for more than a decade in bringing a more patient-centered approach to drug development through patient-reported, centered, and defined outcomes.
Amy Froment, Head, Global Trial Optimization, Regeneron
Amy is passionate about bringing together data and expertise to inform clinical trial strategy and design. Focusing on operational efficiency in trial planning, bringing the science alongside the perspectives of patients and trial sites. Amy is an established leader in data-led strategic feasibility, site identification, and patient engagement, most recently responsible for the creation of these capabilities at Regeneron. Combined with a background in clinical trial and program management she also has extensive experience in complex global clinical trial delivery across a broad range of therapeutic areas and phases. She has been in the pharmaceutical industry for over 20 years and is currently the Head of Global Trial Optimization at Regeneron.
Christie Fry, Director, Strategic Technology Innovation, Clinical Development Solutions, AbbVie
Christie Fry is Director, Strategic Technology Innovation at AbbVie. Christie has 30 years of experience in clinical research, including patient recruitment, data management and digital health innovation. In her current role, she is responsible for leading strategy, operations and implementation of decentralized clinical trials (DCT). In addition, Christie actively assesses opportunities requiring innovative tactics to improve existing activities and processes within Clinical Development Operations. She is also involved in industry activities, focusing on technology, improving site experience in clinical trials and set up of new capabilities to drive patient centricity in drug development.
Ruby Gadelrab Tudor, CEO & Founder, MDisrupt
Ruby Gadelrab is the CEO and Co-Founder of MDisrupt. She is a seasoned digital health executive with a track record in successfully commercializing healthcare and healthtech products. She served on the executive team at 23andMe as VP of commercial marketing and has worked for many leading companies in the biotech and genetic spaces. Before founding MDisrupt, Ruby consulted for, advised, and mentored more than 25 digital health companies.
Aditya Gadiko, Director, Product Management, Saama
Aditya is the Director of Clinical Informatics at Saama, he is hyper-focused on accelerating the workflows of medical monitors, clinical scientists, safety physicians, and data managers. He is currently building an AI/ML guided clinical data workflow product by leveraging his deep understanding of clinical sciences, data standards, regulatory requirements, and tech expertise.
Jake, Galdo, PharmD, MBA, BCPS, BCGP ESPhA Pharmacy Quality Advisory and Consultant
Jake Galdo is Pharmacy Quality Advisory and Consultant of the Enhanced Services Pharmacy Alliance. In this role, he helps community pharmacies specialize in delivering health equity services to local communities, advance clinical services, and develop value-based contracts. He also spends his professional time staffing in a neighborhood community pharmacy, developing innovative clinical services, and representing the profession of pharmacy on various boards and advisory committees for regional and national organizations. Dr. Galdo has previous experiences in association management, quality measure development, continuing education, academia, and community pharmacy practice. He received his Doctor of Pharmacy and completed PGY-1 Community Pharmacy Residency training from the University of Georgia, earned a Master of Business Administration from Samford University, and is board certified in both pharmacotherapy and geriatrics. He lives in Birmingham, AL with his wife, daughter, and dad.
Carla Galdos, Assoc. Dir, Master Planning and Scheduling, Merck
Carla Galdos, Associate Director at Merck, responsible for Master Planning and Scheduling of Global Clinical Supplies. Supply Chain professional with 25+ years of experience in the pharmaceutical industry and broad experience in Sales and Operations Planning Process, ERP implementation process, and planning for research and development trials.
Chelsea Gallagher, Director of Innovation in R&D Analytics, BMS
Chelsea Gallagher is a Director of Innovation in R&D Analytics with ten years of analytics experience across multiple functions in pharma. Over the past three years, Chelsea has focused on developing an approach to quantitatively evaluating protocol design and predicting likely performance and quality outcomes. Chelsea has her MBA and BS from Drexel University.
Laura Galuchie, Senior Director, TransCelerate Program Lead, Oversight Committee, Merck
Laura has a unique role which blends internal and external components. Laura is Merck’s assigned leadership to the Oversight Committee of TransCelerate BioPharma, Inc. The Oversight Committee is the primary governing body for decisions related to the operational direction of TransCelerate, including project direction and expected outcomes. Laura draws on her experience as Director of Clinical Operations for a busy therapeutic area and Head of Clinical Performance, Analytics, and Innovation to provide this perspective. Within MSD, she has responsibility for driving internal engagement with key stakeholders. She facilitates adoption and internalization of TransCelerate solutions in alignment with MSD's objectives. Finally, she watches for opportunities to match innovative approaches to potential process improvement initiatives or other areas of focus.
Frances Gambino, MSLIS, Senior Director, Medidata Global Education, Medidata Solutions
Frances Gambino, MSLIS is the Senior Director, Medidata Global Education, and a global Customer Success Services and Learning Solutions Design leader with over 20 years of demonstrated expertise enabling customer success and organizational growth through the strategic design, application, and sustainable positioning of industry-excellent Learning & Development practices.
Victoria A. Gamerman, PhD, Global Head of Data Governance, Boehringer Ingelheim Pharmaceuticals, Inc.
Driven by intellectual curiosity, Victoria is focused on improving healthcare by connecting patient-centricity, digital health, and real-world evidence through innovation and digital transformation to evolve clinical research. In her current role as Global Head of Data Governance & Insights, Victoria is accountable for shaping the data strategy and data governance for Clinical Development and Operations. Victoria enjoys connecting with others who support he use of data to generate insights, especially with innovative applications to advance healthcare.
Naila Ganatra, MEd, General Manager, Barnett International
Naila Ganatra, MEd is responsible for the oversight and management of Barnett International, including the training consulting, live seminars, web seminars, eLearning and publications business lines. She has planned and overseen numerous training events that have been attended by thousands of industry professionals and has played an instrumental role in the development of Barnett’s training consulting and virtual learning programs. Prior to joining Barnett in 1996, Naila held positions with major medical centers and training providers, including Cedars Sinai Medical Center, the Harvard School of Public Health/Beth Israel Hospital, Baystate Medical Center, and International Business Communications. Naila holds a Master’s in Education from the University of Toronto, including a specialization in Workplace Learning.
Noelle Gaskill, Head, Clinical Research Operations, Mirati Therapeutics
Noelle Gaskill is a research executive with over 25 years of experience spanning across the industry from sites to biotechnology. With a personal motivator of providing novel therapies to community oncology, Noelle has led large scale research organizations, developed novel recruitment models and clinical research technology. Noelle is the chair of the nominations committee for ACRP and leads a non-profit focused on school safety in her “spare” time.
David Geismer, Senior Vice President, Professional Services, Medidata
David is a Sr Vice President of Professional Services responsible for our MidMarket, Medical Device and Clinical Operations delivery. During his 16 year tenure at Medidata, David has founded and/or led various groups within Medidata, including Strategic Consulting, Product Adoption and Optimization, Medidata Academy, Operational Excellence, US MidMarket Services, Academic services, CTMS and RCM SME teams, and UK Implementation Team.
Ken Getz, Executive Director, Tufts Center for the Study of Drug Development
Mr. Getz is an internationally recognized expert on R&D and clinical trial management practices and trends, the global investigative site landscape, site management and patient recruitment and retention practices, and the worldwide market for outsourcing clinical research functions. Mr. Getz’s research studies on protocol design complexity and clinical research efficiency and effectiveness, conducted over the past two decades, are considered by many in the research-based life sciences industry to be pioneering work. His 20+ years of original research benchmarking R&D management practices, global outsourcing and the investigative site landscape have contributed to industry-wide understanding of these critical markets and to improvements in management strategy and execution.
Ellyn Getz, Director, Patient Parthership, CSL Behring
Ellyn Getz is the Director of R&D Patient Partnerships at CSL Behring where she gathers input into clinical development and operations from patients, care partners, health care professionals, and researchers, and she develops strategies to support patient engagement and appreciation. Prior to CSL, Ellyn directed CISCRP’s community outreach programs to increase clinical trial awareness, education, and access. Ellyn holds a Master of Public Health from Harvard University and a Bachelor’s degree from Brandeis University.
Yusuf Ghadiali, Executive Director & Head, Clinical Trial Business Operations, Daiichi Sankyo, Inc.
Over 20 years of clinical operations experience leading and building several global capabilities including business operations teams, technology and systems, innovation center of excellence, process improvement, and metrics & analytics.
Amaury Ginart, Assoc. Dir, New Technologies, Merck
Amaury Ginart, Associate Director, responsible for the implementation of new technologies at Merck, with over 30 years of diverse experience in the Pharmaceutical industry, such as Manufacturing, Analytical Testing, Engineering, and all things Validation.
Tara Gipp, Associate Director, Clinical Trial Optimization, Recruitment & Retention, Regeneron Pharmaceuticals
Tara leads the patient engagement team within Regeneron’s Global Trial Optimization team. She has a passion for ensuring patient and site burden is reviewed and assessed during clinical study development and is committed to reducing burden and barriers to participation. Patient focus in her career started when developing HIV treatments whilst employed at Pfizer and was further cemented when spending 10 years at Cancer Research UK. At Cancer Research UK, she led initiatives to incorporate patient views into trial design and garner direct on-study feedback to improve patient experience on clinical trials. Her current work includes having a detailed understanding of patient and caregiver needs early in study design, ensuring clinical trial participation is easily accessible to all trial participants, collecting near immediate feedback on-study from sites and participants as well as a priori feedback on study design. Tara has a Bachelor’s degree in Chemistry from Northwestern University.
Lucas Glass, Vice President, Analytics Center of Excellence, IQVIA
The ACOE is a team of over 200 data scientists, engineers, and product managers that research, develop, and operationalize machine learning and data science solutions within the research and development space. Lucas has launched over a dozen machine learning offerings within R&D, such as site recommender systems, trial matching solutions, enrollment rate algorithms, drug target interactions, drug repurposing, and molecular optimization. His research has been published at AAAI, WWW, NIPS, ICML, JAMIA, KDD, and many others.
Gregory Goldmacher, MD, PhD, MBA, Head of Clinical Imaging, Merck & Co.
Gregory Goldmacher is Associate VP in Clinical Research, and Head of Clinical Imaging at Merck Research Laboratories. His team of radiologists and imaging scientists oversees the generation of efficacy and safety endpoints in over 200 trials. He has led internal research efforts and external collaborations focused on artificial intelligence, novel oncology response methods, imaging biomarkers, data standardization, and educational programs. He also supports business functions, including due diligence for M&A, internal venture capital funds, and an internal startup accelerator. Prior to joining Merck, he was a senior medical director, and the head of oncology imaging at a global CRO. Greg obtained his BA from the University of Chicago, his MD and PhD (in neuroscience) from the UT Southwestern Medical Center in Dallas, and his MBA from Temple University.
Jennifer Goldsack, Executive Director, Digital Medicine Society (DiMe)
Jennifer C. Goldsack co-founded and serves as the CEO of the Digital Medicine Society (DiMe), a global non-profit organization dedicated to advancing digital medicine to optimize human health. Jen’s research focuses on applied approaches to the safe, effective, and equitable use of digital technologies to improve health, healthcare, and health research. She is a member of the Roundtable on Genomics and Precision Health at the National Academies of Science, Engineering and Medicine and Technology Leader at the World Economic Forum. Previously, Jen spent several years at the Clinical Trials Transformation Initiative (CTTI), a public-private partnership co-founded by Duke University and the FDA. There, she led development and implementation of several projects within CTTI’s Digital Program and was the operational co-lead on the first randomized clinical trial using FDA’s Sentinel System. Jen spent five years working in research at the Hospital of the University of Pennsylvania, first in Outcomes Research in the Department of Surgery and later in the Department of Medicine. More recently, she helped launch the Value Institute, a pragmatic research and innovation center embedded in a large academic medical center in Delaware. Jen earned her master’s degree in chemistry from the University of Oxford, England, her masters in the history and sociology of medicine from the University of Pennsylvania, and her MBA from the George Washington University. Additionally, she is a certified Lean Six Sigma Green Belt and a Certified Professional in Healthcare Quality. Ms Goldsack is a retired athlete, formerly a Pan American Games Champion, Olympian, and World Championship silver medalist.
Gretchen Goller, Senior Director & Head, Patient Recruitment Solutions & Clinical Development Operations, Seagen, Inc.
Gretchen Goller leads the Patient Recruitment and Retention Solutions group at Seagen with a focus on oncology-specific solutions resulting in a holistic, patient centered approach ensuring that patients and their families have the most positive experience. Ms. Goller has over 20 years’ experience gained in pharma and CRO industries. Prior to Seagen, she was the Global Head of the Patient Recruitment and Retention team at ICON. Previously, Ms. Goller was the Patient Recruitment and Retention leader at sanofi-aventis. Other roles included Clinical Trial Manager, Medical Affairs at Wyeth and Study Manager at Astra Zeneca. She has held positions at the University of Pennsylvania including Study Coordinator and Site Director working on a range of therapeutic areas including vaccines, cardiovascular, cardiology, ophthalmology, women's health, HIV, and endocrinology. Ms. Goller has a BA from the University of Massachusetts and an MSW from the University of Pennsylvania and is located outside of Philadelphia, PA.
Lorena Gomez, Global Head, Study Start Up, COA, and Digital Implementation, AbbVie, Inc.
Lorena Gomez has over 25 years of experience in clinical operations and is currently the Global Head of Study Start-Up, COA Management, and Digital Implementation within Clinical Development Operations at AbbVie. Her current team is comprised of over 400 members in more than 40 countries and is responsible for the global execution of all submission and site activation related activities for AbbVie’s clinical development portfolio. Lorena joined Abbott (which became AbbVie) in 2008 as a Senior Clinical Operations Manager and went on to hold leadership positions in Clinical Field Operations, Clinical Program Development and Global Study Start Up and PRO Management at AbbVie and Allergan before returning to AbbVie in 2020 in her current role. Lorena holds a BS in Microbiology, a BA in Molecular Biology, and was an NIH fellow in the University of Texas at Austin Pharmaceutics PhD program.
Melanie Goodwin, Director, Patient Recruitment Programs, Clinical Development & Operations, Global Product Development, Pfizer Inc.
Melanie Goodwin is the Director of Patient Recruitment Programs at Pfizer and has been focused on clinical trial enrollment and retention in the pharmaceutical industry for 20 years. Her recruitment and retention experience spans across sponsor, CRO, Patient Recruitment agency, and research site, providing a unique and rounded view of the challenges and solutions. She has developed enrollment and retention strategies for over 200 clinical trials across all study Phases and therapeutic areas. Melanie holds a B.Sc. and M.Sc from Saint Joseph’s University in Philadelphia, Pennsylvania.
Sandra L. Goss, Director, Digital Health Strategy, AbbVie, Inc.
Dr. Goss joined the Digital Health strategy team at AbbVie in 2020, focusing on the development of more objective and sensitive efficacy measures in support of Immunology pipeline development. After completing her PhD at the University of Connecticut and Post-doctoral fellowship at the University of North Carolina, Sandy joined the Abbott/Abbvie clinical pharmacology department in 2008. She supported clinical pharmacology activities for all phases of development across multiple therapeutic areas and has been an advocate for novel analysis and clinical innovation. She joined the AbbVie Development Design Center in 2017 that fostered a collaborative environment to help clinical teams optimize the design and execution of their trials. She also led the exploration of decentralized trials and home health care to decrease the patient burden and helped integrate the use of real-world data in clinical decision-making.
Michael A. Greeley, Co-Founder & General Partner, Healthcare Technology, Flare Capital Partners
Previously, Michael was the founding General Partner of Flybridge Capital Partners, and earlier in his career was with Polaris Partners, as well as held positions at Wasserstein Perella & Co. and Morgan Stanley & Co. Current and prior board seats include Aspen RxHealth, Axuall, BlueTarp Financial, Cayaba Care, Circulation, Cohere Health, Explorys, Functional Neuromodulation, HealthVerity, higi, Iora Health, MicroCHIPS, Nuvesse, Oshi Health, PolyRemedy, Predictive Biosciences, Predilytics, T2 Biosystems, TARIS Biomedical, VidSys and Welltok (observer). Additionally, Michael served on the board of International Data Group, the founding partner of IDG Capital, a leading venture capital fund in China and other important innovation centers in Asia, and is on the board of The Forsyth Institute, the leading Harvard-affiliated oral health research organization. Michael serves on various innovation and investment advisory boards for Advocate Aurora Health, Boston Children’s Hospital, Cleveland Clinic, and MedStar Health, as well as serving on the Governor’s Digital Health Council and the Massachusetts Technology Collaborative. Michael also serves on the Investment Committee for the Partners Innovation Fund and on is the Advisory Board of Harvard Business School’s Health Care Initiative. He was past chairman of the New England Venture Capital Association and on the board and executive committee of the National Venture Capital Association. Michael earned a B.A. with honors in chemistry from Williams College and an M.B.A. from Harvard Business School.
Christina Greene, PhD, Director, Global Site Agreements, Merck
Christy Greene is a former private practice attorney with 7 years of experience in clinical trial research. Today as Director of Global Site Agreements in Merck's Global Clinical Trial Operations organization, she oversees the team that manages the process for site contracting for Merck's clinical trials globally.
Ian Greenfield, Chief Strategy Officer, Patient Engagement, YPrime
Ian Greenfield is YPrime's Chief Strategy Officer. Prior to this role, he led YPrime’s Data Innovation group, transforming how big data is used to impact the eClinical space. He has held leadership positions in numerous companies and non-profit organizations, including the world’s leading death with dignity advocacy group, Compassion & Choices. While serving in Governor John A. Kitzhaber, MD’s administration, he helped Oregon completely redesign its health delivery system, saving hundreds of millions of dollars.
Dennise Greensmith, Associate Director Clinical Operations, Orum Therapeutics
Dennise Greensmith received her Bachelors Degree in Molecular Biology and Microbiology from the University of Central Florida. Starting her career in the industry almost a decade ago, Dennise has accumulated a wide expertise in all operational aspects of initiating and managing Phase I to Phase III global oncology trials at small biotech companies. In her current role as Associate Director of Clinical Operations at Orum Therapeutics, Dennise supports clinical activities for Orum's leading candidate supervising cross-functional coordination throughout study planning, start-up and execution.
Gaby Grekin, Senior Director, Global Strategy, BBK Worldwide
The imperative to fight for improved representation and diversity-related outcomes is a career-long passion for Gaby. Before serving as senior director of global strategy for BBK Worldwide, she spent over 20 years working for educational equity and systemic change in large urban school districts both nationwide and internationally. In her current role, she sets the strategic direction for recruitment campaigns, ensuring trials are inclusive and accessible.
Jason Gubb, Clinical Operations Consultant and Co-Founder, Emergent Teams
Jason has over 25 years’ experience in Global Clinical Operations strategy and leadership. He has an applied knowledge of leveraging internal and external data, analytics, digital technology, and collaborative partnership to create actionable insights for study teams. Jason works with startups, pharma, vendors, and CROs to develop innovative approaches to optimize protocol designs, modernize clinical trial conduct, and accelerate delivery strategies. Jason has a passion for listening with empathy to patients. He believes that behavioural science and digital technology can be applied to deliver the right set of tools to drive trial literacy and education, increase empowerment for participation, ensure greater access and optionality, and thus deliver health equity for patients. Jason is also the Co-Founder of Emergent Teams, helping teams and organisations to thrive.
Sofia Guerra, Investor, Bessemer Venture Partners
Sofia is an investor in the Cambridge office, where she focuses on healthcare and biotech. Sofia began her career as a consultant at Bain and Company, where she worked on strategy, operations, and due diligence projects across healthcare and technology. Prior to joining Bessemer, she was an investor at BoxGroup Ventures and the co-founder and President of Nucleate Bio, a national life sciences entrepreneurship program helping PhDs, Post-docs, and students commercialize scientific projects. Sofia earned her MBA from Harvard Business School and her BA with high honors in Chemistry from Harvard University. While in school, she conducted research alongside Bob Langer, a serial entrepreneur and one of 12 Institute professors at MIT widely recognized for his contributions to drug delivery and tissue engineering fields.
Glenda Guest, President, Assured of Quality Consulting & Training
Glenda Guest, BS, CCRA, RQAP-GCP, FACRP, ACRP-MDP has an extensive background in the clinical research industry having worked as a monitor, project manager, data manager, database programmer, senior trainer, quality assurance auditor and regulatory consultant since joining the clinical research profession with Norwich Clinical Research Associates (NCRA) in 1997. Continuing as Vice President of NCRA, she is also now Principal and independent consultant for her own company, Assured of Quality Consulting & Training. Ms. Guest specializes in clinical quality assurance auditing, mock FDA inspections, development of clinical quality management systems and advanced GCP and FDA Regulations training. With 20+ years of regulated research experience and her extensive background in a clinical CRO she has developed a unique perspective, not only of the regulatory requirements for pharmaceutical, medical device and biologics development and market approval, and insights from collaboration with multiple sponsor companies’ varying approaches in meeting those requirements.
Divya Gupta, Knowledge Management Consultant, ZS
Divya Gupta is a consultant within the ZS R&D analytics (Knowledge Management) group and has over eight years of management consulting and industry experience. Within R&D consulting, Divya partners with leading pharmaceutical companies to innovate various analytical tools to optimize clinical trials. Divya has her MBA from Manchester Business School, U.K.; Master’s in pharmacy from NIPER, India and bachelor’s in pharmacy from UIPS, India.
Amanda Gutierrez, LMHC-QS, PMP, Director of Learning & Development, Learning and Development, Quality, Biorasi
Amanda Gutierrez, LMHC-QS, PMP is the Director of Learning and Development at Biorasi, a global CRO with its home base in Miami, Florida. As a mental health professional and project manager, she has had a variety of experiences working within her community, participated in academic-based psychological research, and provided community based mental health services to a range of populations of all ages; from children to adults. She has also worked with incarcerated individuals, catholic school children, supported COVID-19 and Unaccompanied Alien Children Emergency Response temporary facilities as a Project Manager and compliance specialist. These experiences, and leading in a variety of settings, has placed Ms.Gutierrez in a unique position to know how important and impactful a person's experience, learning, and understanding has on their existence; more importantly their role in their perceived world. Her philosophy is that learning and development is essential to an individual's (and the collective's) self-reflection, mindfulness, growth, and success.
David Hadden, Founder & President, Innovation, Pro-ficiency
David Hadden is the pioneer of AI-driven Virtual Patient Simulation technology. His last company, TheraSim, trained over 1 million physicians worldwide and was sold to WebMD in 2013. At Pro-ficiency, Dave has transformed clinical research training into a powerful study resource and analytics tool, and Pro-ficiency has become the leader in the proactive, metric-driven approach to training that contradicts the traditional, check-it-off-the-list approach.
Evan Hahn, Vice President North America, North America, TSS AB
Evan is currently working at TSS, the leader of cloud temperature monitoring solutions for the pharmaceutical industry, as VP, North America. Evan has over 20 years of experience in the life sciences industry applying innovative approaches through a combination of technology and sophisticated applications of data, driving insights and efficiency in clinical development. Previously to working at TSS, Evan served as the Principal for Medidata’s innovative Randomization and Trial Supply software solution (RTSM), and at Cytel promoting the adoption of adaptive trial designs and statistically based drug supply forecasting.
Rachel Haines, Dir Clinical Operations, Clinical Operations, Rinri Therapeutics Ltd
Rachel Haines is the Director of Clinical Operations at Rinri Therapeutics, a therapeutic discovery and development company working in the field of cell therapies for hearing loss. A hearing scientist by training, she has worked in both the public and private sector leading cross-functional teams in the design, set-up and delivery of multi-national, multi-centre Phase I-IV trials. Rachel has also taught on internationally attended GCP and trials methodology courses, and published trial results in high-impact journals, leading to guideline changes.
Adam Halbridge, MBA, Head of Clinical Trial Tokenization, ICON plc
Adam leads the Clinical Trial Tokenization team at ICON. He also helps pharma and biotech clients make strategic decisions around using data and
technology to inform their product and organizational decisions. Adam previously founded a company to develop a Mobile Health Platform, a
mobile-first solution for stakeholders in clinical trials and healthcare.
Meghan Harrington, Vice President Clinical Trial Financial Management, Medidata
Meghan serves as the VP, Clinical Trial Financial Management at Medidata driving roadmap and strategy across the Grants Manager and Site Payments products. Meghan started her career as a Masters-level psychologist working within a medical care team treating patients with ALS and traumatic brain injury. It was through this privileged relationship with patients facing devastating diagnoses that Meghan witnessed first hand the life-saving and life-enhancing effects of medical and therapeutic intervention thus piquing her interest in the drug development process. Meghan joined a CNS-focused start up in RTP and has spent the last 15+ years working in the life science technology industry. The last decade of this time has been solely focused on the investigator grant administration domain driving strategy and leading teams implementing payment technology in both BPO and enablement models.
Kandria Harry, BSN, Manager, Patient Engagement and Clinical Strategy, Astellas Pharma US, Inc.
Kandria has over nine years working within clinical operations with a focus on clinical trial management, site and patient engagement, and study recruitment. She has a passion for supporting clinical research advancements, increasing clinical trial participant engagement, diversity, inclusion, health literacy, and improving the participant and care partner experience. She is a contributing member on the Transcelerate Patient Experience team. The Transcelerate Patient Experience initiative seeks to facilitate and accelerate the industry’s progression towards a future where the patient experience is enhanced in clinical trials and patient burden is reduced.
Weili He, PhD, Distinguished Research Fellow, Head of Department, Medical Affairs and Health Technology Assessment Statistics, AbbVie, Inc.
Dr. Weili He is a Distinguished Research Fellow and head of Medical Affairs and Health Technology Assessment Statistics at AbbVie Inc. She has a PhD in biostatistics. Prior to AbbVie, she worked at Merck & Co., Inc. for over 20 years. Weili has published extensively in the areas of adaptive designs (AD), benefit-risk assessment (BRA), and RWE methodology research. She is the lead or co-author of more than 50 peer-reviewed publications in statistical and medical journals and the lead Editor of two books on AD and BRA. Since joining AbbVie in February 2017, Weili has involved extensively in RWD and RWE research for evidence generations. She is the co-founder and co-chair of the ASA Biopharm Section (BIOP) RWE SWG since 2018. The SWG’s efforts in the past 4+ yeas resulted in three peer-review publications in a statistical journal and recent submission of three additional manuscripts. Weili is also the BIOP Chair 2021, an AE for the journal of the SBR since January 2014, and an elected Fellow of the ASA.
Jane Hiatt, Executive Director, Site Management and Monitoring, Early-Stage Development, Merck
Jane Hiatt joined Merck in 1999 and is currently the Executive Director, Clinical Operations. She is responsible for the Site Management and Monitoring Organization, Site Relationship Management Team, and the Early Stage Development Team. Jane's background includes over 30 years of drug experience in CRO and large pharma environments, starting in data management followed by progressive roles in clinical trial operations and management.
Jonathan Hill, Associate Director, Digital Strategy, Innovation & Analytics, IQVIA
Jon Hill is an experienced clinical operations leader at IQVIA where his current focus is on driving digital strategy, innovation, and analytics. Highly involved in rethinking the future of clinical operations, he pulls from experience across sales strategy and analytics, sales operations, and marketing within domestic and international geographies.
Sunny Hoffman, MS, MPH(ABSA), Client Services Partner, Clinical Biosafety Services and Castle IRB
After obtaining degrees in biology and pathology, Sunny Hoffman was a molecular biologist at the University of Missouri for 15 years. After completion of a degree in public health, she transitioned over to the world of biological safety and served as the Biological Safety Officer and Laboratory Safety Manager for the University of Missouri before moving over to Clinical Biosafety Services and Castle IRB. A cancer survivor, she is excited to be a part of furthering oncology research. When not fostering relationships with clients, she enjoys spending time with her husband and four kids, camping, building their dream home (and documenting on YouTube), piano, and pouring hope and positivity into those around her
Kyle Hogan, President, Datacubed Health
Kyle has been dedicated to advancing the voice of the patient through the promise of ePRO/eCOA since 2007, in that time helping deliver over 500 successful trials for CROs and Pharmaceutical companies globally. He is a recognized expert for implementing innovative and patient centric ePRO/eCOA solutions with an aim to achieve sponsor confidence and study success across all phases of clinical trials.
Alison Holland, Executive General Manager, Digital and Decentralized Solutions, Medable
Alison (Ali) Holland is Executive GM, Digital and Decentralized Solutions at Medable and is chartered to design and expand the end-to-end capabilities needed to partially or fully virtualize clinical studies, building on the commitment to reduce clinical trial times by 50%.
Ali has over 20 years of experience in a variety of leadership roles, including Feasibility Head and Six Sigma Black Belt at Covance, and Business Head and global General Manager at Roche/Genentech in one of their therapeutic area business groups. Having been engaged in over 300 studies across Biotechs, Pharma and all geographies, Ali brings unparalleled clinical insight and technical excellence on the matter of operational needs for sites and patients.
Deborah Howe is Director, Global Patient Recruitment and Engagement at Alexion, Astra Zeneca Rare Disease. In this role, she leads the strategic development and implementation of a framework to support planning and delivery of global patient finding and engagement strategies for Alexion Rare Disease studies that leverage patient voice, strategic partnerships, healthcare data, and technologies. She also partners with Patient Experience and Patient Advocacy teams to develop and implement Friction Coefficient activities (patient, caregiver, investigative site) to assess clinical trial burden with the goal to influence protocol design and ensure mitigation and support services are embedded at the study level and based on the insights gained. Prior to joining Alexion, Deborah has worked at Celgene and Bristol Myers Squibb and has over 20 years of experience in patient recruitment in roles of increasing responsibilities and across various stages of drug development and therapeutic areas. Deborah enjoys participating in industry activities and working groups and her greatest passion is learning patient insights and turning them into meaningful actions.
Stacy Hubiak, Senior Director, Training & Learning Management, R&D Operations, Teva Pharmaceuticals
Stacy has over 25 years in the Pharmaceutical Learning and Development area. She started out working as an L&D Consultant at Berlex Laboratories in Wayne, NJ and then proceeded to work at Wyeth Pharmaceuticals, which later merged with Pfizer. Spending 20 plus years at Pfizer in the Sales and Marketing training group as well as procurement, and then within Clinical Operations, she proceeded to move to Teva Pharmaceuticals where she has been the Head of R&D Training working with colleagues around the globe on compliance, inspection readiness, procedural, systems and professional development training for over 6000 colleagues worldwide. Stacy resides in Coatesville, PA with her husband and has 3 daughters as well. She enjoys traveling and sports.
Esther Huffman O’Keefe, Director Adaptive Monitoring Excellence, Takeda
Esther is the Director of Adaptive Monitoring Excellence at Takeda, where she is heading up a new team in the RBQM group. Esther has been working in clinical trials for 25 years and her focus has always been on site monitoring processes and technology, continuous improvement, and quality. A long-time TransCelerate RBM leader, Esther looks for ways to drive solutions for RBQM and embed the RBM principles as “business as usual” across the industry.
Lindsay Hughes, PhD, Director, eCOA Science & Consulting, eCOA Science, Clario
Dr. Lindsay Hughes is a scientist & leader with 15+ years of experience in behavioral and life sciences. She has held key national leadership roles including advisor within the Obama/Biden administration’s global HIV response team, advisor to United Nations leadership and instructor at the CDC and USAID. An international speaker, Dr. Hughes is responsible for a team of scientific experts who provide guidance and analysis services related to the creation of electronic data collection systems for clinical trials.
Maria Napoliello Humagain, Director, Clinical Supply Technologies, Arcus Biosciences
With over 14 years of IRT development and management, Maria is an advocate for multiple functional areas including Supply Chain and ensures the Clinical Trial Teams has an IRT leader for guiding them through the whole process and guarantee timely and high-quality services. She leads as an industry subject matter expert for IRT, vendor management, and building standards and procedures. Moreover, Maria uses this knowledge to keep the company updated with processes and industry standards implement SOPs quickly to fulfill regulatory expectations and requirements.
Dan Hydes, CEO & Co-Founder, IgniteData
Dan led the critical work shaping and refining the value proposition, commercial model and global scaleup strategy for Archer, IgniteData’s EHR2EDC product. He has responsibility for the strategy and commercial areas at IgniteData. Dan loves to build successful teams and businesses around niche opportunities with huge market and social impact. The business Dan ran before IgniteData was one he set up with a consultant surgeon to bring together groups of clinicians for diverse projects ranging from expert symposiums to recruitment feasibility for clinical trials. Prior to that Dan led large commercial teams for global media organisations.
Adama Ibrahim, Vice President, Digital Strategy & Change Management, Novo Nordisk
An innovation award winning pharma industry advisory consultant, operational strategy expert, blockchain advocate, technology enabled clinical trials (direct to patients/Virtual Trials) and patient engagement thought leader with over 20 years in the NHS on commission by the DOH and in Industry (Hoffman La-Roche, Amgen, ALMAC, ICON, Biogen and Novartis). An R&D transformation change champion. Part of the DIA Patient Engagement Voluntary Community Leadership team. Driver for change through identifying unmet needs and opportunities, developing digital strategies, implementation and expansion of disruptive digital platform technologies Drug Development pathways.
Caroline Jackson, Executive Vice President, Patient Services, mdgroup
Caroline graduated from the University of Southampton with a BSc in Pharmacology. Over the last 28 years she has worked in the industry in a variety of clinical, commercial and leadership roles in pharma, CROs and other service providers. Caroline is committed to ensuring all patients, regardless of location, ethnicity or background, have access to clinical trials, and to making their experience of participation as positive as possible. Caroline is the EVP of Patient Services at mdgroup, where she is focused on the delivery of high quality mobile nursing and patient travel services, supported by technology, to ensure patient needs as well as study objectives, are met. Outside of work, Caroline is a keen field hockey player and enjoys skiing with her family.
Christopher L. Jenkins, Founder, Principal Partner & Chief Gene Therapy Biosafety Officer, Clinical Biosafety Service
Dr. Chris Jenkins, PhD, MPH, is the CEO, Founder, and Principal Partner of Sabai Global + Subsidiaries of Clinical Biosafety Services IBC, Castle IRB, and Shield Consulting. He has worked for 15+ years in the fields of pharmaceuticals, biological safety, gene therapy/gene transfer, corporate development, human research protections, and biosafety compliance fields in academic, private research institutes, and clinical settings. He has experience overseeing a broad range of entity research compliance chairing IBCs and IRBs at over 1500 convened meetings. His past positions include Saint Louis University, The Scripps Research Institute, the University of Missouri, WCG, and University of Texas at Austin. Chris conducted masters and doctorate studies in Public Health, with a focus on Biosecurity through the Saint Louis University School for Public Health and Social Justice. He is frequently consulted for ABSA workshops, webinars, presentations, and has a number of articles in print and review. He has 7 children with his amazing wife, and enjoys running, RVing, and playing the French horn when not slaying gene therapy dragons.
Ju Ji, PhD, Senior Research Scientist, Eli Lilly & Co.
Ju Ji got her PhD in statistics from Iowa State University and joined Eli Lilly advanced analytics and data science team in 2019. In Lilly, she supports digital biomarker studies including developing algorithms and novel digital endpoints. She also has research interests in causal inference and supports projects related to individualized treatment recommendations and mediation analysis.
Dr Chris Johnson, BM BCh, MA, FRCP, Chief Medical Information Officer and Associate Medical Director, Cambridge Biomedical Campus, Royal Papworth Hospital
Dr Johnson trained in clinical medicine at Cambridge and Oxford qualifying in 2000, and was appointed Chief Medical Information Officer at Royal Papworth Hospital in 2014. He has led several successful EHR programs including an EHR implementation, interoperability solutions and data applications. He holds a role with NHS Digital relating to EHRs and is concentrating on developing systems that enables the use of EHR data for medical research.
Corey Jones, Senior Manager, Data Visualization and Design, Janssen R&D Data Science, Johnson & Johnson
Corey Jones is a Senior Manager of Data Visualization and Design at Janssen R&D Data Science. His team is focused on creating human-centered products that are intuitive and support key business decision making. His team is responsible for developing key products and insights to help support the feasibility process at Janssen R&D.
Ryan Jones, CEO, Florence Healthcare
Ryan is CEO of Florence Healthcare. Florence advances clinical research through software-its electronic Investigator Site File (eISF) helps over 10,000 research teams around the world take their day back from paper. Before joining Florence, Ryan was president of Pubget (acquired by the Copyright Clearance Center), a research platform serving clinicians at over 600 hospitals and research institutions worldwide. Ryan joined Pubget from Microsoft’s SharePoint team, where he helped the web’s largest sites make information understandable and accessible with document management technology. Ryan has an AB from Dartmouth College and an MBA from UC Berkeley, where he was a Price Fellow. In his free time he is a pretty good pilot and a terrible golfer.
Matt Jones, Feasibility Product Leader, IQVIA Technologies
Matt leads the design and delivery of IQVIA Feasibility, a module of the Investigator Site Portal.
In this role Matt partners with Sponsors and CROs to transform their feasibility operations across people, process, technology, and data. Matt also ensures the voice of the customer is driving our product roadmap.
Tom Julian, Innovation Integrator, Gilead
Tom Julian works in clinical trial innovation, introducing new technologies to help trials run better, faster, and less expensively. He is passionate about patient centricity, diversity and inclusion, and plain language. Tom has run patient engagement, innovation, and technology projects at BMS and Gilead, and has partnered with many top entrepreneurs in our industry. He’s also a published science fiction author, avid cyclist, and is active in children’s charities.
Hassan Kadhim, Director & Head, Clinical Trial Business Capabilities, Bristol Myers Squibb Co.
Hassan Kadhim is the Global Head of Clinical Trial Business Capabilities, Clinical Innovation & Industry Collaborations at BMS. In his current role, Hassan's team owns the technology stack and capabilities within Global Development Operations, and drives change and innovation towards better outcomes for clinical trial stakeholders. Hassan is very passionate about transforming the clinical research arena in the pharma industry through the use of technologies and patient-centric clinical trials, and is a firm believer of the need for clinical innovation grounded in strong business practices for sustainability, change management and adherence to compliance and regulatory commitments. Hassan regularly appears and speaks at industry events around improving the clinical trial experience with digital tools, and wrote “The Remote Clinical Trials Model” whitepaper in 2016, to formalize a new patient-centric clinical trial research model leading to what we know today as Decentralized Clinical Trials. Beyond BMS, Hassan actively collaborates across industry collaborations such as Transcelerate and others to advance relevant and high-value industry challenges. He has a degree in bioinformatics and a graduate degree in pharmaceutical sciences, both from the University of Montreal in Canada.
Rob Kalesnik-Orszulak, Regulatory Innovation Lead, RWE & Data Science, Global Regulatory Sciences, Bristol Myers Squibb Co.
Rob Kalesnik-Orszulak is the Regulatory Innovation Lead for Real-World Evidence (RWE) and Data Science at Bristol Myers Squibb (BMS). In this role, he is responsible for building out the regulatory department's expertise, capabilities, and strategy around RWE from a regulatory perspective. A key part of this is the engagement of health authorities (HAs) on RWE in a more holistic context, in order to advance regulatory use cases, methodologies, and pilot projects. Prior to this role, Rob has had experience leading multiple interactions with FDA on individual projects utilizing RWE, as well as interactions with HAs globally as a Global Regulatory Team Lead. Rob received his PharmD from the University of Rhode Island and completed his post-doctoral fellowship at Rutgers University and BMS.
Aaron W. Kamauu, MD, Managing Director, Ikaika Health LLC
Dr. Aaron Kamauu (MD, MS Biomedical Informatics, MPH, University of Utah School of Medicine) is an industry-leading advisor in the Real-World Data (RWD) space, specifically focusing on leveraging real-world healthcare data to support a variety of clinical research, informatics, clinical trials, and drug development activities, including pharmacoepidemiology, outcomes research, protocol design, site identification, data-driven patient recruitment, and the use of RWD to support evidence generation & submission to regulatory agencies (e.g., FDA). He has this experience across the spectrum of pharmaceutical/biotech, entrepreneurship, and large CRO businesses.
Conor Kane, Senior Director, Janssen Clinical Innovation
Conor has worked to improve processes in the pharmaceutical industry for over 20 years. Conor joined Janssen R&D, in 2016 as Head, Process Data Integration then, in 2018 becoming a Global Program Leader, accountable for the operational delivery of global Immunology clinical studies. In 2021, Conor joined the Janssen Clinical Innovation team, where he is the Focus Area Lead for Non-Conventional-Trial Models; shaping alternative models for clinical trial conduct, enabled by technological, service, and process innovations.
Shirisha Kanthala, Associate Director, Trial Transparency and Disclosures, Incyte
Shirisha Kanthala leads the Trial Transparency and Disclosure team at Incyte. She has over 18 years of experience working in Pharma, 8 years of which have been within trial transparency and disclosure. In her current role Shirisha is not only responsible for establishing and improving various processes related to transparency and disclosures, but also engaged in implementing innovative digital methods to enable better patient recruitment and engagement. Shirisha has a Master’s degree from Villanova University.
Tina Karunaratne, Vice President & Head, Global Clinical Operations, Orum Therapeutics
Tina has over 20 years of leadership experience in clinical operations and project/program management. Tina is the Vice President and Head of Global Clinical Operations at Orum Therapeutics. Previously she served as Head of Clinical Operations at EUSA Pharma, focusing on oncology trials. Tina has also worked at organizations such as Astellas Institute for Regenerative Medicine, Vertex, and Organogenesis. She was also an adjunct professor of Project Management at Regis College. Tina has a Doctoral degree in Law and Policy and a Master of Science degree in Regulatory Affairs.
Nechama Katan, Director of Data Science, Data Monitoring and Management, Pfizer
Nechama Katan, is a Wicked Problem Wizard working at Pfizer as a Director of Data Science. She helps organizations understand technical processes and problems and then works to build trust and innovative solutions. Nechama has been supporting Pfizer’s Risk Based Monitoring team for over 6 years. Nechama has worked in multiple industries and organizations of all sizes, including high and low tech, finance, and pharmaceuticals. Nechama’s education includes an MSc from NYU/Courant Institute in Mathematics and an MA from Columbia University in Statistics.
Konstantina Katcheves, Senior Vice President, Business Development, Bristol Myers Squibb Co.
Konstantina Katcheves is Senior Vice President of Business Development at Bristol Myers Squibb (BMS). She has over twenty years of business development, corporate strategy and intellectual property experience. In her role at BMS, Konstantina is responsible for all business development activities for new technologies including early discovery partnerships, platform collaborations, digital innovation, precision medicine and cell and gene therapy technologies. She also leads a global team responsible for business development in Japan and China and innovation search and evaluation outside the U.S. Prior to joining BMS, Konstantina served as Vice President of IP and Licensing at Agilent Technologies and prior to Agilent was Vice President of Global IP and Licensing at Lonza. Konstantina holds a M.S. from the Johns Hopkins University, J.D. from the University of Oklahoma and B.S from the University of California at San Diego.
Nareen Katta, Head of Data Science & Analytics, AbbVie, Inc.
Nareen Katta works as the Head of Data Science and Analytics at AbbVie. Nareen has over 15 years of experience in the pharmaceutical industry. In his current role, Nareen is responsible for building and executing the advanced analytics strategy that covers both scientific and business operations, across clinical development continuum, geostrategy and study start-up, centralized and risk-based monitoring, site engagement, business performance, precision medicine, patient safety, and R&D. In addition, Nareen is actively engaged in evaluating the opportunities created by the technology trends like big data, automation, machine learning and AI, digital health, etc., and strategically instantiating them at AbbVie to drive organizational transformation. Nareen has an MBA from The University of Chicago Booth School of Business and an MS in electrical engineering from University of Texas at Arlington.
David Kaye, Vice President & General Manager, BioFortis, BioFortis, a Q2 Solutions Company
David is Vice President and General Manager of BioFortis, a Q2 Solutions Company, where he is responsible for managing the delivery of the BioFortis strategy, as well as the management of day-to-day operations and support. He is focused on ensuring that the full suite of BioFortis services and products is integrated into Q2 Solutions’ offerings, inclusive of its go-to-market strategy.
Sean Kennedy, MPH, Executive Director, Therapeutic Strategy Lead, Real World Evidence, Worldwide Clinical Trials
Sean Kennedy has supported real world evidence research for over 25 years with a majority of time spent delivering real world evidence operations and strategy. Sean has therapeutic expertise in immunology, hematology, oncology, and rare disease indications with extensive experience in all aspects of clinical operations, data management, biostatistics, business informatics, and study delivery.
Adriann Kern, Director, Clinical Affairs, Thrive, an Exact Sciences Co.
Adriann Kern is the Director of Clinical Affairs at Exact Sciences (Madison, WI) with over 20 years of experience in clinical research and development. In her current role, she leads the operations team responsible for the Multi-Cancer Early Detection suite of IVD and LDT studies, with a focus on driving innovation in the site start-up and clinical trial recruitment space for cancer screening laboratory tests. Prior to joining Exact, Adriann worked in pharma/biotech, CROs, and academia with a primary focus in oncology. She holds a BA in Psychology from the University of North Carolina, Chapel Hill, and currently resides in Salt Lake City, UT.
Shameer Khader, PhD, Senior Director AI & Machine Learning & Data Science, Digital Health & Bioinformatics, AstraZeneca Pharmaceuticals, Inc.
Dr. Shameer Khader is a senior director of advanced analytics, data science, and bioinformatics at AstraZeneca, a global, science-led biopharmaceuticals company. At AstraZeneca, he leads a global team of data scientists, biomedical scientists, statisticians, and software engineers. He oversees a portfolio of projects in oncology and biopharma to accelerate drug discovery and development using biomedical and clinical big data using machine intelligence approaches. He has published more than 120+ peer-reviewed research papers, patents and conference publications in pharma informatics, healthcare data science, bioinformatics, drug discovery, and precision medicine. Various national and international media, business, biotechnology, and scientific publishers have featured his work. His work was featured in media outlets including Forbes, FastCompany, Bloomberg News, Times of India, The Indian Express, HealthITAnalytics, ScienceDaily, The Sun, MedScape, Medical Express, MedPage Today, The Economic Times, Cardiology Today, NewsWise, BioPortfolio, Science Xpress, Business Standard, eCancer News, PhysOrg, UroToday, etc. His work was also featured worldwide publications and includes blogs by MedGadget, UNESCO, International Society for Computational Biology, American Chemical Society, American Heart Association, and the NEJM-Journal Watch.
Manish Khatri, Director & Scientific Lead Data 42, Global Drug Development, Novartis Pharma AG
Manish Khatri is a Director and Scientific Lead at data42 Novartis Global Drug Development. He has over fourteen years of experience in clinical development, advanced data analytics, and engineering. He is responsible for end-to-end delivery of scientific and evidence generation use cases with a 'data first' approach across early research, clinical trials, and post-marketing stages of development. Before this role, he held pharmaceutical R&D Data Analytics roles at EY, Cognizant, and Syneos Health.
Aman Khera, MBA, FRAPS, FTOPRA, Vice President, Global Head of Regulatory Strategy, Scientific Solutions, Worldwide Clinical Trials
Aman Khera is a global regulatory affairs leader and strategist. She has 26 years of regulatory experience in the clinical research industry, providing global strategic direction in regulatory affairs and clinical research. She has built her career on maintaining fastidious patient care with the pragmatism needed to help companies achieve effective end-to-end regulatory strategies.
Lukasz Kidzinski, PhD, Director of Artificial Intelligence, Research & Development - Imaging, Clario
Lukasz joined Clario through the acquisition of his startup Saliency, building software for automating imaging work in clinical trials. Previously, he was a researcher at Stanford University, working on using wearable devices for quantifying health. He obtained a PhD at Universite Libre de Bruxelles in mathematical statistics. He co-authored over 100 scientific publications.
Joseph Kim, Chief Strategy Officer, ProofPilot
As Chief Strategy Officer, Joseph Kim brings over 23 years of pharmaceutical research expertise to ProofPilot. Most recently serving in a senior leadership role as Senior Advisor in Lilly’s Digital Health Office, he brings a wide array of pharmaceutical research industry knowledge, integrating his experience working for a wide variety of organizations, including multiple Sponsors such as Merck and Takeda (Shire), as well as CROs, and technology vendors. He has a robust combination of experience across all phases of clinical research, and well-known history of innovation in the industry, recognized as one of the “Top 100 individuals on the 2015 MedicineMakers Power List,” and “20 Innovators Changing the Face of the Clinical Trials Industry” by CenterWatch. He holds a BS in Molecular Biology from Lehigh University and an MBA from Villanova.
Jeff Kingsley, Founder & CEO, IACT Health
Dr. Kingsley is Chair and CEO of Centricity Research, an integrated research organization (IRO), with 40+ integrated clinical research offices across the U.S. and Canada. Centricity conducts phase I through IV research in nearly every medical specialty; inpatient and outpatient; pharmaceutical, biotechnology, and medical device. Dr. Kingsley is also founder, past Chair, and COO of hyperCORE International, an IRO with approximately 100 sites in five countries. Dr. Jeff Kingsley can be reached at 706-536-6619 and JKingsley@IACTHealth.com.
Olgica Klindworth, Senior Director, R&D, RBQM, Medidata, a Dassault Systemes
Olgica Klindworth is a Senior Director, Product Development at Medidata focusing on Data Management and Centralized statistical monitoring technologies. Prior to joining Medidata in 2021, she spent 17 years at PPD, Inc. leading data management teams and spearheading the development of RBQM processes and tools. Olgica received her BA in Microbiology from the University of Texas and her MS in Analytics from Texas A&M University.
Todd Kole, Vice President, Clinical Project Services, Clinical Technologies, Almac Group
Todd Kole has 30 years of experience in clinical research. As a pharmacist, he started his career on the sponsor side; working as a manager in Clinical Logistics for Bristol-Myers Squibb and Amgen. In 2010, Todd transitioned to the vendor side of the business, joining ClinPhone as US employee number 2. Today, he is currently the Vice President of Clinical Project Services for Almac Clinical Technologies.
Kenny Kong, Director, Life Sciences & Health IT, Exostar LLC
Serving as Exostar’s Director of Health IT & Life Sciences, Kenny has consulted and advised some of the world’s largest Healthcare and Biopharmaceutical companies in enabling on-demand access to eClinical technologies using digital identities to securely extend trust across traditional enterprise boundaries. Kenny's experience makes him a leader and trusted advisor in the clinical implementation of technology.
Seongjoon Koo, PhD, Head of Data and Analytics, Global Development Operations, Data & Analytics Global Dev Operations, Amgen Inc
Seongjoon ("Joon") Koo, Ph.D. is a data & analytics leader with over two decades of experience solving real-world problems across the biotech/pharmaceuticals, financial services, and automotive industries. Joon is currently leading Data and Analytics at Amgen, supporting Global Development Operations. Before joining Amgen, he led the development of AI-based companion diagnostics and remote monitoring for cardiovascular diseases at Bristol Meyers Squibb. Previously he was the inaugural Chief Data Officer at J.D. Power and led the development of intelligent Software-as-a-Service applications for Automotive, Financial Services, and other industry verticals. Prior to joining J.D. Power, he led data science teams with increasing responsibility and successfully delivered many ML/AI solutions for financial services applications. Before his financial services career, Joon worked on prostate cancer detection with ML at Hologic and developed accelerated drug discovery methods with ML at Ionis Pharmaceuticals. Before joining the biotech industry, Joon was a researcher at the National Cancer Institute. Joon has authored more than 20 peer-reviewed publications in Physics, Chemistry, Biology, Computer Science, and Behavior Economics. He is also an inventor on 4 issued U.S. patents. Joon holds a Ph.D. from the University of California, Los Angeles.
Alan Kott, Clinical Vice President, Practice Lead, Data Analytics, Signant Health
Dr. Kott is based in Signant’s Prague office and until recently was Senior Clinical Manager for Europe. Having led the development of the Data Analytics Program for Bracket, he has overseen the design and reporting of data analytics in multiple large schizophrenia studies. For the past seven years, he has also provided training to investigators as an Expert Trainer.
Bari Kowal, Senior Vice President & Head, Development Operations & Portfolio Management, Global Development, Regeneron Pharmaceuticals, Inc.
Bari Kowal joined Regeneron in 2015 and became Head of Global Clinical Operations in 2017. She currently serves as Senior Vice President, Development Operations and Portfolio Management and is responsible for clinical trial strategy and execution, along with overseeing our development shared services functions. She was previously at Pfizer where she held the positions of Vice President, Business Operations and Analytics, and, prior to that, Vice President, Strategic Alliance and Development Operations Lead. Ms. Kowal also served as Vice President, Clinical Operations, on the clinical research organization side of the industry and at a number of biotech organizations in a variety of clinical research roles early in her career. She holds a BS in Biology from the Binghamton University and an MS in Neuroscience from New York University.
Jeff Kozloff, Board Member: ProofPilot, VersaTrial, Lokavant, Signallamp Health
Jeff is a serial healthcare entrepreneur with over 20 years of commercial and clinical pharmaceutical experience. Jeff currently serves on the Board of Directors for four rapidly growing companies: Signallamp Health (Series B), ProofPilot (Series B), Lokavant (Series B) and VersaTrial (SEED). He was previously on the Board of Directors for Analytical Wizards (acquired by Definitive Healthcare), iContracts (acquired by RLDatix) and RippleScience. As a full-time operator, Jeff was CEO of TrialScope, a global SaaS leader in clinical trial compliance, data sharing and patient engagement. Jeff went from board member to CEO in 2018, re-positioned the company for rapid growth and led the company’s sale to Informa (LSE: INF) in October 2020. Prior to TrialScope, Jeff was the co-founder/CEO of Verilogue, the global software leader in conversation analysis of physician-patient exam room dialogues. Verilogue was acquired by Publicis (PUB:FP) in Dec 2013. Jeff is an EY Entrepreneur of the Year finalist and is the co-author of a method and system patent for analyzing the effectiveness of marketing strategies.
Jeff Kozloff, Executive Chairman, VersaTrial
Jeff is an entrepreneur with 20 years of commercial and clinical pharmaceutical experience. Jeff currently serves on the Board of Directors for four rapidly growing companies: VersaTrial, Signallamp Health, ProofPilot, and Lokavant. Jeff was formerly CEO of TrialScope, a global SaaS leader in clinical trial compliance, data sharing and patient engagement. Prior to TrialScope, Jeff was the co-founder/CEO of Verilogue, the global software leader in conversation analysis of physician-patient exam room dialogues.
Randy Krauss, Executive Director, Metrics, Analytics, & Performance, Merck
Randy Krauss is the Head and Executive Director of Metrics, Analytics, and Performance within the Global Clinical Trial Operations at Merck. In this role, his group supports the optimization activities of planned studies, as well oversight of our portfolio, studies, and processes. Prior to joining Merck in 2016, Randy worked in similar roles at other pharmaceutical/biotech companies including Genzyme (Sanofi), Shire & Alexion. Randy began his focus on this research discipline at Sanofi (formerly Genzyme), where he served as Director - Metrics, Analytics and Performance. There he led a cross-functional team to identify and maintain KPIs and other metrics to ensure operational success and compliance related to product development and support across multiple therapeutic areas. His first position at Genzyme was as Associate Director, R&D Portfolio Management, where he conceived, developed and maintained an enterprise-wide tool containing project status, timelines and global development plans to drive the portfolio decision-making process. Randy also spent four years in academia at the Boston University School of Medicine, first as a Lab Coordinator in a biotech training program and as an Instructor of Biochemistry. Randy received his B.S. from the State University of New York at Fredonia and his Ph.D. in Microbiology from the University of Alabama at Birmingham. He completed his post-doctoral Fellowship at the University of Massachusetts Medical Center in Worcester.
Josh Kravitz, Kits4Life Program Coordinator, MedSurplus Alliance
Josh Kravitz has managed and built the capacity of nonprofit organizations since 2000. Currently, he coordinates the Kits4Life program, a MedSurplus Alliance (MSA) initiative that connects excess clinical research supplies with charitable projects. Plus, Josh supports other nonprofit organizations through his consulting firm, Extra Good. Previously, he was the COO of Dispensary of Hope while it built a national platform for donating pharmaceuticals to charitable pharmacies and clinics in the United States. Josh also led international aid work at MedWish International and MedShare. Josh has a bachelor’s degree from American University, where he received the Charles Glover award for best-combined citizenship and business leadership. He also holds a master’s degree from Arizona State University, where he earned the President’s Award for Innovation associated with teamwork growing a service-learning program. Josh is originally from New York and lives in Atlanta, Georgia.
Avi Kulkarni, Ph.D., SVP, Head of Life Sciences Strategic Business Unit, Cognizant
Avi Kulkarni leads Cognizant’s global life sciences business. He is responsible for commercial development, planning, and P&L execution for Cognizant’s biopharma and medical device clients across research and development, commercial, and digital functions. Avi has been a leader in the industry for three decades, building new drug formulations and diagnostic tests, conducting clinical studies with a focus on cell and gene therapies, and publishing in personalized medicine.
Sunny Kumar, Partner, GSR Ventures
Sunny Kumar is a Partner at GSR Ventures, where he primarily invests in early-stage companies deploying emerging technologies to transform healthcare delivery, including lead investments in Medable, Deep 6 AI, and Osso VR. Sunny is a physician as well as a published medical researcher with a focus on applying informatics and artificial intelligence to translational medicine in the fields of neurosurgery and gene therapy. He is a serial entrepreneur and most recently founded a company to reduce readmissions for high-risk patients with chronic diseases using voice-enabled natural language processing technology. Sunny received a BS in Molecular Biology from Yale University, an MD from Stanford University School of Medicine, and an MBA from Stanford University Graduate School of Business.
Suman Kumar, Senior Manager, Life Sciences, Deloitte
Suman Kumar has 19+ years of experience working for Life Sciences companies and brings a specific focus on creating specialized products offerings in areas of medicine development. He has a deep understanding of the Clinical R&D landscape having worked with large pharmaceuticals, contract research organizations, niche data vendors and more. He has led multiple large scale Clinical Data Analytics programs that aim to reduce cycle time and bring therapies faster to patients.
Jason LaRoche, Director and Focus Area Leader, Janssen Clinical Innovation
Jason has over 19 years of experience working in Pharma, 14 years of which have been with Janssen. For the last 5 years, he has been a member of Janssen Clinical Innovation where he applies his strong technical and collaboration skills and global project leadership in delivering transformational innovation projects that have the goal to shape the future of clinical trial operations at Janssen. Jason is the Focus Area Leader for Environmental Sustainability in Clinical Research and is leading the transformation of Janssen’s global clinical operations towards sustainability.
David Lacagnina, Chief Business Officer, Company Management, Cyntegrity Germany GmbH
Before joining Cyntegrity, David held leadership management positions at endpoint, Comprehend Systems, Pharmasol, and ThoughtSphere, helping guide these companies through their early stages of business and corporate development to establish themselves as premier technology providers. David also serves on the Board of Advisors at Strategikon Pharma, Inc. David heads our newly established Americas operations and is responsible for expanding our RBQM services into the North and South American continents.
Amir Lahav, Head of Strategic R&D, Digital Healthcare Innovation, Mitsubishi Tanabe Pharma America
Amir Lahav is a Digital Health Advisor and a leading innovator at the forefront of clinical research. He is inspired by innovation, driven by science, and believes in the power of AI-driven technology to transform clinical trials and improve patient experience. Amir has nearly two decades of experience in the biotech and healthcare industries. He currently sits on the Advisory Board of leading HealthTech and DTx startups, and holds several consulting roles with pharma companies, including Head of Strategic R&D and Digital Health Innovation at Mitsubishi Tanabe Pharma, and Chief of Digital Health Strategy at Redenlab. Formerly, Amir served as the Head of Digital Innovation for Rare Diseases at Pfizer, and prior to pharma, was a PI on numerous clinical trials as a Neurology Faculty and Professor of Pediatrics and at Harvard Medical School.
Mary Jo Lamberti, PhD, Director and Research Assistant Professor, Tufts Center for the Study of Drug Development (CSDD)
Dr. Mary Jo Lamberti manages multi-sponsored and grant-funded research projects at Tufts CSDD. She has extensive experience conducting market research on pharmaceutical industry practices and trends affecting contract research organizations and investigative sites. She has been a speaker at conferences and has published articles in trade and peer-reviewed journals. Prior to joining Tufts CSDD, Dr. Lamberti was Director of Market Research at CenterWatch. She has also worked on federally funded research studies in science education reform. Dr. Lamberti holds a B.A. from Wellesley College and a Ph.D. in Psychology from Boston University.
Christopher P. Lamplugh, Associate Vice President & Head, Global Data Management & Standards, Merck & Co., Inc.
Christopher Lamplugh is Associate Vice President and Head of Global Data Management and Standards (GDMS) at Merck. GDMS provides Clinical Data Management services for ESD and LSD trials, including data standards, eClinical Interactive Response Technology (IRT), Clinical Outcomes Assessment (COA), Pharmacovigilance Case Processing, and other technical business enablement operations. Over his 18-year career at the company, Chris also led the creation, expansion, and operationalization of the company’s Data Management Centers (DMCs). Located strategically in centers around the globe, the company’s DMC network provides world class Data Management (DM) deliverables and Pharmacovigilance case process requirements for the company. Prior to his career at Merck, Chris worked for General Electric for 10 years in Sales Management, Sales Force Effectiveness, and Quality. He is a certified Six Sigma Black Belt and is active in many industry initiatives and forums within the pharmaceutical industry. He has a BA from Ursinus College and an MBA from Penn State University, with coursework in Health Policy from Jefferson University. Chris lives in Philadelphia with his wife and 4 children.
Jason Lanier, Global Program Leader, Director, Janssen Clinical Innovation
Jason has 20 years of experience in scientific research. This includes 7 years of clinical development within a large pharmaceutical company, 9 years of experience in contract research organizations (CROs), 1 year of pharmaceutical laboratory research and quality control, and 3 years of graduate ecological research. With his past experience leading global clinical trial delivery spanning Phases I-III, primarily in the oncology therapeutic area, Jason is now on a 1 year GROW assignment within Janssen’s Environmental Sustainability in Clinical Research team. Within this role, Jason will support Janssen’s goal of becoming an industry leader in measuring and innovating clinical trial operations to minimize their environmental impact.
Daniel E Larson, Vice President, Clinical Operations, ElevateBio
Over the past 20 years, Dan has served in multiple capacities within clinical research including data management, clinical monitoring, and trial management. He even flirted with SAS programming early in his career. He has worked at CROs, industry software companies, and sponsors. He has clinical research experience across a broad spectrum of therapeutic disciplines in pharmaceuticals, radiopharmaceuticals, biologics, medical devices, and cell therapies in all phases of studies. Currently, he heads up clinical operations at ElevateBio.
Andy Lawton, Director & Consultant, Risk Based Approach Ltd.
Andy Lawton has extensive experience in computing, statistics, data management, system design, Quality Management and Risk Based Approach in both Computer System Validation and clinical trials. He is currently consultant and director of Risk Based Approach Ltd. Previously, Andy held a variety of position at Boehringer Ingelheim. Andy was a Founding Committee Member of ACDM, Member of TransCelerate RBM work stream and a Member of EFPIA WG on Data Transparency. His publications include the TransCelerate papers on SDV and Central Monitoring in the TIRS Journal, for which he won “best author of the year 2015 and 2016” from the DIA.
Ward Lemaire, Head of Data Management, Integrated Data Analytics & Reporting, Janssen, J&J
Ward Lemaire is the Global Head of Data Management at Janssen, J&J. He has a Master's in Applied Biological Sciences: Cell and Gene Biotechnology. Ward is Belgian and enjoys living and working in the US. Accountable for all Data Management deliverables in support of the Janssen R&D portfolio as well as define & shape the Data Management Strategy and build the Data Management organization through innovation building high-end Data Management solutions for now and for the future.
Hugh Levaux, PhD, Vice President of Growth Strategy, Flatiron Health
Dr. Hugh Levaux is the Vice President of Growth Strategy at Flatiron Health. In this capacity, he helps drive product and overall strategy, as well as support commercial activities. Dr. Levaux joined Flatiron from Protocol First where he was Founder and CEO. Dr. Levaux brings over 20 years of dedicated experience in clinical trial design and operations, as well as web-based technologies-notably, SVP at United BioSource Corporation (UBC); VP of Product Strategy at Medidata Solutions; CEO of Ninaza, a web-based EDC provider; and SVP at Quintiles (now IQVIA). He has developed and commercialized multiple clinical research offerings including EDC, IVR/RTSM, ePRO/eCOA, remote monitoring, and EHR-to-EDC technologies. Prior to his career in the clinical trials industry, Dr. Levaux was an analyst at the RAND Corporation, where he worked for US government and private sector clients. Before RAND, he worked in Japan at Panasonic. Dr. Levaux holds a Ph.D. in Policy Analysis from the RAND Graduate School and has also received master’s degrees in international economics and international relations from SAIS at Johns Hopkins University and international politics from Universite Libre de Bruxelles in Belgium. He is fluent in English, French, Spanish and Japanese.
Carrie Lewis, Executive Director, Clinical Program Optimization, Endo Pharmaceuticals
Carrie Lewis is the Executive Director of Clinical Program Optimization at Endo Pharmaceuticals, since August 2022. Carrie manages multiple teams of people to implement industry standard processes and practices across the organization to prepare Endo for advancement and expansion in both domestic and global clinical programs. Prior to Endo, Carrie was the Director of Project Delivery at PRA Health Sciences overseeing global clinical studies and operational strategy of new bids. Carrie has 16 years of industry experience, holding various high level roles in clinical operations across both Branded and Generic programs and has experience working with academia, clinical sites, CROs and Pharmaceutical companies. Carrie has a BA in Psychology from West Virginia University and a MS in Clinical Research Administration from George Washington University. When Carrie is not working, she is chasing after her two children.
Nick Lewis, Head, PRO Development Strategic Sourcing, Bayer
As Head of Clinical Vendor and Contract Management, Nick is responsible for establishing and implementing an effective process to qualify and oversee external suppliers, including contract management, supplier performance, and issue resolution. With more than 15 years working in Procurement and Clinical Operations roles in several different countries, Nick is on a mission to speed up and standardise the qualification process.
Lada Leyens, PhD, PD Regulatory, Personalized Healthcare, Digital Health Regulatory Shaping Lead, Clinical Trial Innovation, F. Hoffmann-La Roche Ltd.
Lada Leyens has a background in human genetics, health economics and personalised medicine. She has worked at Health Authorities for over 8 years, mainly as a clinical trial assessor and GCP inspector at Swissmedic. At EMA she was in the specialised disciplines office working in the centralised procedure and with the PKWP and PGWP. At Roche, Lada is the Regulatory Shaping Lead on Clinical Trial Innovation and Regulatory Lead for digital health programs. In this role she is working to increase the use of innovations in our drug development programs and their acceptance by HAs.
Donna Libretti Cooke, JD, Director, Contracting & Budgeting & Sustainability Champion, Bayer
Donna’s career spans across the pharmaceutical industry, professional conference development and legal field as a former practicing attorney. These combined experiences pivoted Donna into her most experienced role in Clinical Operations, with a focus on clinical site contracting, budgeting and payments. Donna leads a global Contracting and Budgeting team for Bayer, building Fair Market Value site budgets and providing training to the country organizations around the world. She also provides guidance and support on contracting and budgeting best practices for the local country organizations. Additionally, Donna is project lead and/or provides support and consultation for several major initiatives at Bayer, including implementation of automated payments and decentralized clinical trials. Donna is also on the Advisory Council on behalf of Bayer for Kits4Life, a non-profit platform to repurpose lab kits and bulk medical supplies from clinical trials for humanitarian aid and research in developing countries. Donna is the Chair of the Site/Pharma on-boarding workstream for Kits4Life. Prior to converting to Bayer, Donna was an Associate Director for PRA Health Sciences and embedded at Bayer as the U.S. Contracts Manager. Donna grew and managed a U.S. team of over 20 clinical contract specialists and associates. She managed the contracts team and operational aspects of clinical contracts, budget negotiations, to those thorny site payment issues. Donna is also a Patient Educator with Pathways Women’s Cancer Teaching Project and a member of their Advisory Council. Her Patient Educator role entails speaking on panels or 1:1 interviews with medical students and residents about her experience as a triple-negative breast cancer survivor. They are unique opportunities for healthcare professionals to learn about patients’ personal experiences through educational dialogue in a less formal setting. Donna earned her JD degree at The Washington College of Law, The American University, and BS in Political Science at Douglass College, Rutgers University. Donna’s five-year residency in Rome, Italy spurred her love for travel and historical adventures. She is married with two daughters, residing in New Jersey. But her heart remains in bella Roma!
Craig Lipset, Founder & Advisor, Clinical Innovation Partners; Co-Chair, Decentralized Trials & Research Alliance (DTRA)
Craig Lipset is a recognized leader at the forefront of innovation in clinical research and medicine development. He is the founder of Clinical Innovation Partners, working as an advisor and board member with pharma, tech and venture capital to bring vision and driving action at the intersection of research, digital solutions, and patient engagement. Craig is also the Co-Chair for the Decentralized Trials & Research Alliance, the leading non-profit collaboration focused exclusively on improving access for research participation. Craig is Adjunct Assistant Professor in Health Informatics at Rutgers University, and Adjunct Instructor in the Center for Health + Technology at University of Rochester. He serves on the Board of Directors for the Foundation for Sarcoidosis Research and the MedStar Health Research Institute, as well as on the Editorial Board for Therapeutic Innovation & Regulatory Science. Previously Craig was the Head of Clinical Innovation and Venture Partner at Pfizer, on the founding Operations Committee for TransCelerate Biopharma, and on the founding management teams for two successful startup ventures. He has been listed among the PharmaVOICE most inspiring people in the life sciences (Red Jacket hall-of-fame), Pharmaceutical Executive’s Emerging Leaders, CenterWatch Top 20 Innovators in Clinical Trials, and the AlleyWatch Who's Who in eHealth.
Dario Lirio, Senior Director, Product Management, Clinical, ArisGlobal, Clinical Product Management, ArisGlobal
Dario Lirio is responsible for the ArisGlobal Clinical product strategy roadmap and the growth of the domain. Dario has nearly 18 years of experience with secure content sharing.
Prior to ArisGlobal, Dario worked at Intralinks and Veeva, working on Study Start-up, Safety Document Distribution, and eTMF.
Ankit Lodha, Director, Data Science Portfolio Management, Johnson & Johnson
Ankit Lodha is the Director of Data Science Portfolio Management at Janssen Research & Development. In his role, Ankit leads the data tokenization capability, a first-in-industry innovation project to link clinical trial data with real-world data (RWD) via tokenization. It enables real-world effectiveness studies and long-term follow-up (LTFU) to allow groundbreaking real-world evidence generation prior to licensure. In this role, Ankit executes various AI/ML models in supporting the execution of clinical trial portfolios. He worked on the COVID-19 vaccine program to build a data-driven COVID-19 Vaccine Development approach for Janssen. He operationalized it across multiple high-priority areas to ensure Janssen R&D continues to deliver on transformational medicines for patients. These include building new capabilities such as creating best-in-class R&D data science platforms and datasets by selecting the highest priority questions to pursue and systematically deploying Data Science capabilities while being a key catalyst in forming strategic external partnerships to accelerate ongoing efforts. Ankit has more than 10 years of global healthcare experience in pharmaceutical, biotechnology, and business. Prior to joining Janssen, he was a Team Lead at Takeda where he has led and executed multiple strategic initiatives across research, CRO management, clinical development, mergers and acquisitions, and operations. Preceding this role, he was working at Amgen in their clinical systems & analytics organization within R&D, areas of focus included portfolio governance and decision-making, R&D operating model optimization (including both clinical development and operations), external innovation, and Digital Health. Ankit received a Bachelor’s in Biotechnology Engineering from Dr. D.Y. Patil University, a Master’s in Business of Bioscience from Keck Graduate Institute, and an MBA from the University of Redlands - School of Business. He is the recipient of EB-1A status i.e., Alien of Extraordinary Ability (aka Einstein visa) in the field of Clinical Trial Analytics from the U.S. government (USCIS). This honor is awarded to less than 1% of professionals globally who have risen to the very top of their endeavor and brought major significance to their field at the national and international level.
Karen Lodigiani, Senior Director, Head, Site Contracts & Budget Management, Daiichi Sankyo
Karen Lodigiani is currently Senior Director, Global Clinical Operations at Daiichi-Sankyo, Inc. leading the Site Contract and Budget Management Team. Karen has a Pharmacy degree from the University of Connecticut and a JD and a Master of Bioethics degree from the University of Pennsylvania. She served as Director of the Partners Clinical Trial Office (Mass General Brigham), representing Harvard affiliated institutions on the ACTA project and as a Director, Global Clinical Operations at Biogen, leading a Site Contracts, Financial Operations and Informed Consent teams.
Robert Loll, SVP, Business Development & Strategic Planning, Praxis Communications, LLC
Robert Loll is SVP of Business Development & Strategic Planning at Praxis, a full service patient recruitment & retention agency that specializes in optimizing study enrollment for research studies. Designing and deploying effective patient recruitment campaign strategies since 2004, Robert’s clinical background includes 15 years providing patient care for top collegiate, Olympic and disabled athletes around the world and working for outpatient rehabilitation companies including Baxter, Caremark and NovaCare.
Neha Londono, Director, Clinical Trial Diversity & Inclusion, Seagen, Inc.
Neha Londono has over twenty years' industry experience within the Sponsor, CRO, and biotech environment. She has extensive knowledge of clinical trials process through career advancement and has driven industry-wide efforts to develop solutions for the diversification of participants in clinical trials across the ecosystem. Neha is currently leading the global clinical trial diversity and inclusion strategy at Seagen, focused on increasing the representation of diverse populations, and improving the lives of all people with cancer.
Rana Lonnen, Managing Director, dRx Capital, Novartis
Rana Lonnen is a healthcare technology investor, entrepreneur, and molecular biologist. At Novartis, she leads strategic investments in technology companies, on a mission to transform the healthcare ecosystem and make positive impact on people’s lives. Previously, Rana was Head of Preclinical Development at a UK biotech, Auspherix; investment consultant to IP Group in London; Founder and CSO of a UK based Biotech, Axendos therapeutics. Prior to this she was a Wellcome Trust backed principal investigator in drug discovery in the field of Infection, Immunity and Inflammation, author and inventor on high impact peer-reviewed publications and patents; before this, Rana worked at Bristol-Myers Squibb, in sales and marketing. Rana holds a PhD in molecular biology and an MBA from Imperial College London. She personally cares about equitable healthcare, social justice, sustainability and the future of antimicrobial resistance. In her down time Rana likes to make culinary experiments, be in nature and read. Rana is a board observer at Aktana, Cota Healthcare, H1 Insights, Koneksa, Mekonos, NuvoAir, and Dopavision. She is based out of Basel, Switzerland.
David MacMurchy, CEO, Lightship
David MacMurchy is Chief Executive Officer of Lightship where he established the patient-first approach and commitment to operational excellence. Focused on developing better access to healthcare and improving patients’ well-being, David is a leader in the health life sciences sector with over two and a half decades’ experience working for leading organizations. Prior to joining Lightship, David led a more than 9,000-strong team operating clinical trials across Europe, Asia and Africa at PRA Health Sciences (ICON). David helmed the Life Sciences practice as a Partner for EY (Ernst & Young) in Europe supporting pharmaceutical and biotechnology companies, focusing on growth, planning and technology capabilities. He also collaborated with companies in the United States, Europe, and China while at Pfizer and IMS Health (IQVIA).
Alejandra Maciel, Vice President, Clinical Affairs, Medical Device, Epigenomics, Inc.
Experienced Clinical Research Professional with 15 years of medical device and in vitro diagnostics trial design. Ms. Maciel has a broad background in point-of-care and IVD diagnostics, Software as Medical Device and mobile-based health solutions. Ms. Maciel brings her site, sponsor, and CRO experience into study design and operations, ensuring clinical trial programs are scientifically based and operationally feasible.
Mark Maietta, President, YPrime
As President, Mark Maietta provides executive leadership and directs the company’s commercial strategy. With oversight of sales, marketing and business development functions, he is responsible for ensuring the company’s commercial objectives and service delivery align and evolve with customer needs.
Marcin Makowski, PhD, Head, Centralized Monitoring & Data Analytics, GlaxoSmithKline
Marcin Makowski is the Head of Centralized Monitoring and Data Analytics at GSK. Previously Marcin held similar positions at AstraZeneca and UCB. Last 10 years of Marcin’s career was revolving around establishing and improving Risk Based Monitoring models including centralized monitoring and quality tolerance limits. Marcin holds MD and PhD degrees from the Warsaw Medical University.
Marina Malikova, PhD, Executive Director, Surgical Translational Research, Operations and Compliance, Boston University School of Medicine
Dr. Malikova has over 15 years of experience in the clinical research field, with 8 years’ experience on executive level. She has managed Phase I - IV studies involving investigational drugs, devices, biologics and combination products. She has worked on Industry-sponsored and Investigator-initiated trials in the fields of Surgery, Cancer Diagnostics and Interventional Radiology. Dr. Malikova graduated from the Institute of Biochemistry, Russian Academy of Science, in Moscow, Russia with a PhD in Biochemistry. She has a strong background in biomedical sciences and has completed her postdoctoral fellowship in the field of cell signaling and cell migration. She also holds a Master’s Degree in Clinical Investigation, Certification in Project Management from Boston University and dual board certified in Regulatory Affairs (RAC) for pharmaceutical products and medical devices by Regulatory Affairs Professionals Society (RAPS). She also holds professional certification in Clinical Safety and Pharmacovigilance by Drug Information Association (DIA). In her current role as the Executive Director, Dr. Malikova manages research efforts in 13 divisions of the Department of Surgery at Boston Medical Center. She is responsible for clinical research operations, financial management, quality assurance, risk management, strategic planning, billing and regulatory compliance assurance and macro-management of research programs. Dr. Malikova has 12 years of teaching experience as an Instructor for Clinical and Biomedical Sciences Program, Metropolitan College. She has developed and taught several courses such as: Design and Conduct of Clinical Trials, Drug Development, Introductory Pharmacology, Clinical Trials Management at Boston University, School of Medicine. She also served as an Instructor of the Good Clinical Practices (GCPs) course for the Master of Science Program in Clinical Investigation, Division of Graduate Medical Sciences, Boston University, School of Medicine. Dr. Malikova is a member of Association for Clinical Research Professionals (ACRP), Drug Information Association (DIA), Regulatory Affairs Professionals Society (RAPS) and European Society of Radiology (ESR).
Rakesh Maniar, Head of eClinical Technologies, Global Data Management & Standards, Merck & Co.; Co-Lead, TransCelerate eSource Initiative; Immediate Past Co-Chair/Co-Founder, SCDM eSource Implementation Consortium
Rakesh is a transformative clinical and health data sciences pioneer with 27 years of experience in the Industry. He is a SCDM eSource Implementation Consortium former Co-Chair/Co-founder and TransCelerate eSource Initiative Co-Lead. At Merck, he is the Head of eClinical Technologies, Global Data Management and Standards in the Global Clinical Trial Operations function. His broad range of responsibilities includes strategic evaluation, drive improvements of current technologies landscape, enablement and adoption at scale of innovative eClinical Technologies such as eSource, Digital Health and Decentralized Clinical Trials Technologies in conjunction with data strategy, standards & processes. Rakesh is an author of several scientific publications, and a frequent speaker at industry conferences and symposiums. Rakesh holds MS in Biomedical Engineering from USA and has completed MIT Sloan Executive Education Program in Artificial Intelligence: Implication for Business Strategy.
Kwame Marfo, Market Strategy and Innovation Lead, Clinical Development, Komodo Health, Inc.
Kwame is the Market Strategy and Innovation Lead for Clinical Development at Komodo Health. He has 15+ years of experience in healthcare, working in strategy and operations leadership roles across manufacturing technical operations, commercial and R&D. Prior, Kwame served as a Director of Insights and Analytics for Roche/Genentech’s Global Clinical Operations. Kwame graduated with a BS in Chemical Engineering from Stanford University and an MBA from the University of California, Berkeley.
Kevin Marsh, Vice President, Global Head, Patient-Centered Research, Evidera
Kevin Marsh is Vice President of Patient Centered Research (PCR) at PPD. Kevin's focus is in the use of patient preference data to inform health decisions, including pipeline optimization, trial design, authorization, reimbursement, and prescription decisions. Kevin has recently led the development of StudyGage, a preference-data based tool to allow sponsors to simulate participation rates in clinical studies
Jowita Marszewska, PhD, Scientific Advisor, eCOA Science & Consulting, Clario
Jowita Marszewska, PhD is a Scientific Advisor at Clario, a global data and technology company that helps minimize risk in clinical trials. Dr. Marszewska has experience with electronic data capture and data management in clinical research. She advises on eCOA best practices, diary and instrument design and training for participants, caregivers and raters. Dr. Marszewska earned her MSc and PhD degrees in the field of chemistry and has authored 10 publications. She has been an advocate for STEM education throughout her career.
Brian Martin, Head of AI, R&D Information Research, Research Fellow, AbbVie, Inc.
Brian joined AbbVie in October of 2018 as the head of the newly formed RAIDERS team within Research & Development’s Information Research division, focused on accelerating, scaling, and amplifying the work of AbbVie’s R&D community using Artificial Intelligence technologies like machine learning, deep learning, and cognitive computing. Brian came to AbbVie after spending five years in technology consulting across many industries, and over a decade of additional experience before that working in trading and financial markets technology. During his consulting time, Brian architected the United States’ Common Securitization Platform and was a founding member of Publicis.Sapient’s AI practice. While his primary focus is AI technologies, his interests are much broader, and he has presented at multiple conferences on topics including optical networking, quantum computing, blockchain, cognitive architecture, and other emerging technology concepts that are all part of digital transformation. Brian holds a BS degree in Computer and Cognitive Science from Alma College and an MS in Computer Science from the University of Chicago. He is actively involved with technology incubator and educational programs at multiple high schools and universities in North America.
Christina Masturzo, Head of Product for Patient Engagement and Recruitment, Citeline
Christina Masturzo is the Head of Product for Patient Engagement and Recruitment at Citeline. She is an experienced product leader with over 15 years leading product organizations focusing on the direction and strategic vision of the Citeline Connect portfolio of products. She is passionate about helping patients find treatment options and uses the power of tech products to unlock more doors to more patients around the world.
Robert J. Mather, Executive Director & Head, Advanced Science & Collaboration Group, Pfizer Inc.
Joe Mather is an Executive Director in Pfizer’s Early Clinical Development Organization. Joe has over twenty-five years of pharmaceutical research and clinical development experience. Before joining the Digital Medicine team after tenures with Pfizer and AstraZeneca’s research & development organizations. Joe leads the Advanced Science group. His team validates digital health technologies, qualifies novel digital endpoints, and continues to expand Pfizer’s decentralized trial capabilities furthering Pfizer’s goal of becoming a leader in digital medicine.
George Mathew, Chief Medical Officer, North America, Dedalus
George Mathew, MD MBA FACP, serves as a clinical expert and healthcare thought leader for Dedalus North America, with experience in transforming healthcare marketplaces in payer, provider, life sciences and federal, state, and local government healthcare businesses. His experience includes consulting, technology development, and business development work at GE, Goldman, Sachs and Co., WebMD, Pfizer, Medidata Solutions, Aetna/CVS, Hewlett-Packard Enterprise Services, and DXC Technology. Dr. Mathew brings a strong technology innovation focus to this role having founded a healthcare technology start-up earlier in his career, and advises several healthcare IT startups through the Health 2.0-NYC community. Dr. Mathew graduated from Boston University School of Medicine and completed his residency in Internal Medicine at Greenwich Hospital/Yale University in Connecticut. He also holds a Master of Business Administration from Duke University’s Fuqua School of Business. Dr. Mathew is Board Certified in Internal Medicine, Clinical Informatics, and Medical Quality, and certified by the American Board of Artificial Intelligence in Medicine. Dr. Mathew also served as a member of CMS’ Office of the National Coordinator - Health Information Technology Joint Consumer Task Force.
Lydia Matombo, Director, Risk Evaluation & Adaptive Integrated Monitoring, System & Data Integration Lead, MSD
Lydia Matombo is a Director, Risk Evaluation & Adaptive Integrated Monitoring (REAIM). In her role, she establishes technical and cross-functional business needs, aligns with stakeholders, and oversees data integration activities between Merck and Suppliers resulting in the build-out, testing, implementation, and maintenance of business-critical Key Risk Indicators (KRI)s in support of Adaptive Integrated Monitoring (AIM), Global Clinical Trial Operation’s (GCTO) risk-based initiative to further the organization’s risk-based quality management (RBQM) approach through advanced analytics. She ensures that supplier systems are ready and maintained throughout the study life cycle to enable the execution of central analytics and monitoring activities, including Quality Tolerance Limit analysis, Key Risk Indicator analysis, and Central Statistical Analytics. This enables each Clinical Trial Team to support the effective identification of important study issues that require monitoring, management, and adaptation of study plans. Lydia collaborates with other functions, Quality Assurance, Ethics’, and compliance, to ensure that systems and any outlined processes are compliant and Inspection ready. BACKGROUND Lydia has more than 20 years of clinical database management expertise, leading end-to-end clinical trial conduct and execution, strategic implementation of quality-by-design data collection systems, building and leading high-performing teams across many therapeutic areas, and is now in the role of Risk Systems Data Integration Lead. Lydia is committed to creating a diverse and inclusive work environment. She is a member of the GCTO’s Diversity, Equality, and Inclusion Ambassadors and Merck’s League of Employees of African Descent (LEAD). Lydia holds a BSN (Honors) from Fairleigh Dickinson University in New Jersey, is a Registered Nurse, and is Project Management Professional (PMP) certified.
Celia J. Maxwell, MD, Associate Dean for Research, Howard University College of Medicine, Medicine & Health Affairs, Howard University Hospital
Dr. Maxwell currently serves as the Associate Dean for Research at Howard University, College of Medicine in Washington D.C. She is also a Professor of Medicine in Infectious Diseases, as well as the Principal Investigator of several prestigious projects. They include: The Center for Infectious Disease Management and Research’s, Ryan White EIS program, The DC DOH Routine HIV Testing Program and as Co-PI for the PEPFAR funded HBCU Clinical Practice Transformation Project in Zambia. Dr. Maxwell was selected by Sharon Pratt-Kelly, former Mayor of Washington, D.C. to co-chair the Transitional Task Force on AIDS services, and was also appointed to the Healthcare Reform Task Force chaired by former First Lady, Hillary Rodman Clinton. As well was appointed by Dr. Donna Shalala, then Secretary of Health and Human Services, and served on the Office of AIDS Research Advisory Council of the National Institutes of Health. Additionally, from 1994-97, she served as a Special Assistant to the Commissioner of Food and Drugs, Dr. David Kessler. Dr. Maxwell served as a health legislative assistant for Senator Tom Harkin (D. Iowa). She was inducted into the Washington D.C. Hall of Fame and is currently serving as a member of the Scientific Advisory Board, of the US President’s Emergency Plan for Aids Relief (PEPFAR), as well as a member of the External Advisory Board for the CITI program. Dr. Maxwell obtained a Bachelor of Science in Nursing from Hunter College and her medical degree from Columbia University College of Physicians and Surgeons, both in New York City. She completed her residency training in Internal Medicine at Howard University Hospital and a Fellowship in Parasitology at the National Institutes of Health, Laboratory of Parasitic Diseases. Her research interests then involved the investigation of the immune response of humans to the hookworm parasite. Dr. Maxwell is a Professor of Medicine and in the Department of Medicine Division of Infectious Diseases. She is board certified in Internal Medicine and Infectious Diseases, and is a Fellow of the American College of Physicians and the Infectious Diseases Society of America, as well as a member of several boards and scientific associations. To date she has conducted international medical site visits or served as a lecturer in Cuba, Haiti, Panama, Dubai UAE, Uganda, Zambia, Senegal, Beijing, India and Brazil.
Cris McDavid, Director, Clinical Operations, RBQM, Parexel
Cris McDavid is the Risk Based Quality Management Operational Business Lead at Parexel and has over 20 years Clinical Research Experience. Cris's expertise spans across multiple therapeutic areas and indications, medical devices, electronic databases, and statistical analysis platforms.
Tara McEvoy, Associate Director, Learning Center of Excellence, Development Services and Operational Excellence, Regeneron Pharmaceuticals, Inc.
Tara McEvoy is an Associate Director, Business Partner in the Global Development Learning Center of Excellence (LCoE) at Regeneron. As an LCoE Business Partner, supporting Development Operations and Portfolio Management, she is responsible for the design, development, and deployment/delivery of learning solutions, compliance metrics, and measuring learning effectiveness. Tara has over 20 years of experience in various roles within Pharma including clinical programming, learning and development, and help desk management. She has a Master’s degree in Adult Education and Training from the University of Phoenix and is PROCSI change management certified.
Karl McEvoy, Product Director, Decentralized Trial Technology, eCOA Product Innovation, YPrime
Dr. Karl McEvoy has over a decade of industry experience in both the vendor and sponsor sides. His clinical trial experience spans from set-up to delivery across all phases in a wide variety of disease and therapeutic areas. Karl has collaborated with the world's top 20 pharmaceutical companies and has extensive experience in patient-centered outcomes research, eCOA strategy, and drug development.
Maggie Kuhl, Vice President, Research Engagement, Michael J Fox Foundation for Parkinsons Research
Maggie Kuhl is Vice President of Research Engagement at The Michael J. Fox Foundation. She leads recruitment and retention strategy for the landmark Parkinson’s Progression Markers Initiative study and directs a team that communicates the Foundation’s scientific progress and programs to various stakeholders. Prior to joining the Foundation in 2013, Maggie led media relations and internal communications for the National Institutes of Health Clinical Center, America’s research hospital.
Heidi McIntyre, Director, Clinical Data-Central Monitoring and Oversight, Moderna
Heidi is an experienced professional with over 25 years in the pharmaceutical industry encompassing all phases of global clinical trials across multiple therapeutic areas. Heidi leads the centralized data monitoring team at Moderna, working cross functionally to establish an end-to-end RBQM strategy which focuses on critical data and processes by enabling innovative technology.
Kelly McKee, Vice President, Decentralized Clinical Trials (DCT), Medidata
Kelly McKee serves as vice president of Decentralized Clinical Trials (DCTs) in Patient Cloud at Medidata. She is responsible for creating new solutions to engage clinical trial patients pre-trial, in-trial, and post-trial, as well as developing patient and product communications around all Patient Cloud Products for decentralized and hybrid clinical trials. Kelly is a proven clinical trial leader and trailblazer in operationalizing global patient-focused solutions across organizations including innovations in clinical trial awareness, access, and improvements in patient experiences. Prior to Medidata, she spent over 20 years within clinical operations and patient recruitment at top-tier pharmaceutical companies including Sanofi, Merck, Eli Lilly and Co., and Vertex Pharmaceuticals. Kelly is passionate about celebrating the role that clinical trial participants bring in making new medicines and vaccines possible and was named one of Life Sci Voice’s Top Industry Leaders in 2022, PharmaVoice’s 100 Most Inspiring Leaders in 2020, Centerwatch’s Top 20 Innovators of 2018, and PharmaTimes’ Clinical Researcher of the Year, Clinical Research Teams, in 2012.
Sarah McKeown-Cannon, VP Growth, Publicis Health
Sarah McKeown-Cannon is Vice President, Growth at Langland, a Publicis Health company that specializes in Clinical Trial Experience (CTE). She helps sponsors deliver innovative recruitment and retention solutions that provide measurable results, enriching study experiences by turning healthcare intelligence into creative engagement and putting the patient at the forefront of every clinical trial. Driven by making a difference in peoples’ lives, Sarah and her team develop recruitment and retention initiatives by combining innovation with a keen focus on the patient and site perspective. In doing so, she continuously delivers bespoke strategies and campaigns that bring big results, encouraging clients to always think further.
Patrick McLaughlin, CEO, Anaheim Clinical Trials
Patrick McLaughlin is the co-founder of Anaheim Clinical Trials (ACT) and has been with the company for over 23 years. After a sale of ACT to Cenexel in 2019, he has remained on as its CEO. ACT is one of the largest Phase I clinical research sites in the United States and specializes in all special population early phase studies with a strong track record with Asian Bridging and Type II Diabetes studies.
Brigid McTague, Vice President, Global Head, Planning, Resourcing and Partnerships Management, Janssen R&D
Brigid McTague is the Vice President, Global Head, Planning, Resourcing and Partnerships within Janssen R&D, LLC (a subsidiary of Johnson & Johnson). She has been responsibility for driving a vision and strategy to enable a cohesive capability, a strategically connecting functional and clinical planning, the resource demand needed to execute the portfolio, and the external partnerships with suppliers to achieve industry leading operational effectiveness. In partnership with our internal Global Development functions, Brigid oversees resourcing utilizing data analytics to enhance the various stages of the decision-making process. Brigid has over 20 years of clinical operations and research experience. She started her career as a Clinical Information Specialist with Schering Plough Research Institute after which she moved on to L’Oreal USA Products Inc to work as a Senior Clinical Research Associate in the consumer and OTC areas. In 2003, she joined J&J as a Local Trial Manager and took on roles of increasing responsibility including Global Trial Manager, Head of Global Enrollment Strategies, Head of Clinical Forecasting & Analytics, Global Program Leader in Oncology as well as Head of our clinical operations alliance management team, Strategic Partnerships. Brigid has an MBA in Pharmaceutical Management from Drexel University as well as Masters and Bachelor degrees in Biology.
Shivani Mehta, Associate Director Data Science, Janssen R&D
Shivani Mehta is an Associate Director of Data Platform Strategy at Janssen R&D Data Science. Her team provides thought leadership to evolve data science data and platform strategy for R&D Data Science. Her team does this by driving vision-driven strategies to drive innovation.
Anne Marie Mercurio, Clinical Trial Volunteer and Patient Advocate
Anne Marie Mercurio is a patient research advocate who is privileged to work beside investigators and design teams on the development of clinical trial protocols and accompanying digital tools. Sher serves on advisory boards for several NCI designated cancer centers and for medical technology companies. Anne Marie was treated for invasive lobular breast cancer in 2006 and she was her mom’s care helper throughout her treatment for metastatic breast cancer. Anne Marie is passionate about equity and inclusion across diverse populations and ensuring quality of life is fully captured and appropriately addressed for all patients
Dmitri Mikhailov, PhD, Director & Global Head, Biomarker Coordination, Novartis Institutes for BioMedical Research, Inc.
Dmitri Mikhailov is the Global Head of Biomarker Study Coordination, Translational Medicine at Novartis. Dmitri’s team is responsible for clinical biomarker study setup across multiple therapeutic areas, and for developing new processes and technologies to improve clinical study conduct. As part of his role, Dmitri represents Novartis on the Patient Centric Sampling IQ consortium, developing best practices for new generation clinical trials. Dmitri is also the global lead for Novartis Human Tissue Network, the company wide effort to develop risk-based strategy and efficient processes to enable translational research using human samples. Dmitri joined Novartis in 2003 and had several positions of increasing responsibility in early biology, lead discovery, safety pharmacology and drug repositioning. Dmitri Mikhailov holds a Ph.D. in Biology and M.S. in Physics & Applied Math.
Shawn Milheim, EdD, Director Learning & Development, Research & Development, Organon & Co.
Shawn Milheim, Ed.D. is a leader in learning, organizational change and quality management and is passionate about driving engagement and innovation. Shawn has deep healthcare and drug development expertise and has led and managed numerous, successful, global learning and change initiatives for companies such as Johnson & Johnson, Pfizer and BMS. Shawn holds a bachelor’s degree in finance and a master’s degree in instructional technology from Bloomsburg University of Pennsylvania as well as a doctorate in education from the University of Pennsylvania.
Alexander M. Milstein, MD, Executive Vice President, Clinical Development and Medical Affairs, Chief Clinical Officer, Paracrine, Inc.
Dr. Milstein is a seasoned leader in Clinical Development and Medical Affairs. He has more than 20 years of experience in successful design, execution, and reporting clinical trials resulting in timely product approvals and competitive positioning of medical products in modern value-based healthcare. Dr. Milstein is currently Executive Vice President of Clinical Development and Medical Affairs with Paracrine Inc, - an emerging biotechnology company developing the world’s first device-based custom biologic platform for the treatment of ischemia-driven chronic debilitating conditions. Prior to Paracrine, Dr. Milstein served as Chief Medical Officer at Olympus Corporation of the Americas (2015 - 2020). At Olympus, Dr. Milstein established clinical affairs function to ensure timely product approvals and to demonstrate value of Olympus portfolio of products. In this role, Dr. Milstein was responsible for successful execution of clinical studies for six medical businesses with cumulative annual revenue of US$2.9 billion. In 2019 - 2020, Dr. Milstein was responsible for more than 20 concurrently run clinical studies. In 2013 - 2015, Dr. Milstein served as Vice President of Clinical and Medical Affairs at TriReme Medical - a US and Singapore-based company engaged in development of new and differentiated therapeutic solutions to address specific unmet clinical needs in the treatment of complex vascular disease. At Trireme, Dr. Milstein was responsible for the design and successful execution of all clinical trials of drug-device combination products in the IS and in Asia-Pacific, as well as for all pharmacovigilance (PV) and medical device reporting (MDR) activities. Prior to TriReme, Dr. Milstein served as the head of clinical development and medical affairs at Cytori Therapeutics Inc (2005-12). and Cardio3 Biosciences (2012-13). In these roles, Dr. Milstein successfully developed and successfully executed clinical strategies for cellular therapy products for cardiovascular, reconstructive surgery, urology, graft versus host disease, and other indications, including first-in-human, registration, and continued access studies. At Guidant Corporation (2000 - 2003) and Medtronic Corporation (2003 - 2005), Dr. Milstein was responsible for global clinical development of drug-device combination products, including design, approval, and successful execution of clinical studies in the US, EU, MENA, and ANZ. At Medtronic, Dr. Milstein developed, negotiated, and successfully executed an innovative strategy resulting in accelerated approval of a $3.5 Billion product. Dr. Milstein holds a Medical Doctorate from Moscow State Medical School (currently - Pirogov Russian National Research Medical University). He has completed clinical fellowship in pediatric surgery at Moscow State Medical School (Prof. Isakov) and research fellowship at Harvard University (1991 - 1994). Dr. Milstein has co-authored or shadow-wrote fourteen publications and successfully ran more than fifty (50) clinical trials ranging from first-in-human (FIH) to pivotal and post-marketing studies.
Trinette Mitchell, Head, Emerging Priorities & Innovation, Takeda Pharmaceuticals, Inc.
Trinette Mitchell is part of Takeda’s Innovation and Data department within the R&D Global Development organization. She leads the Emerging Priorities and Innovation team, who are focused on creating the next-generation clinical trial, where technology and the patient journey converge. With over 30 years of industry experience, Trinette has led global teams through technology transformations. She achieved success by partnering with cross-functional leaders to ensure process change and technology adoption are accompanied by Return on Investment (ROI). In her current role, Trinette often taps into experience she has from prior leadership roles in functional management, partnership management and professional services. Trinette is a lifelong learner who is passionate about revolutionizing clinical trials. She holds a BA from the University of Dayton.
Shah Fahad Moin, Senior Manager, Clinical Systems, Edwards Lifesciences
Shah joined Edwards Lifesciences in 2016 and project managed various cross-functional systems and technology initiatives in the areas of Clinicals, Supply chain, Sales & Marketing, Infrastructure. Currently, he leads a team responsible for creating technical solutions that serve patients through clinical research fighting mitral and tricuspid disease.
Dara Moore, M.Ed., Associate Director, Learning and Development, Clinical Development and Safety Quality, Center of Excellence, AstraZeneca, Alexion Rare Disease Unit
Dara Moore, CPLP/CPTD, lives every aspect of her life embracing diversity. This deeply informs her aspiration to make every learning experience personal and relevant for each learner. Her learning strategy and learning solution design approaches are guided by her 25 years of robust experience in the Learning & development field and her educational background. They are founded in sound adult learning principles, fired by the desire for innovation, and balanced by pragmatic approaches necessary for business. Dara specializes in learning solution design & development for global audiences, systems training, VILT design and development, elearning design & development, and curriculum design, just to name a few; and was instrumental in creating a global learning operating model for a global biopharma company. She integrates vast critical-thinking and problem-solving skills to drive innovative and thoughtful approaches to learning strategy, process, policy, curriculum, and staff development. Dara stays current and active in the Learning & Development field through membership in the national Association for Talent Development (ATD), the local Suncoast ATD chapter, and was formerly the VP of Membership for the Chicagoland Chapter of ATD (ATDChi). She has been a presenter at multiple learning conferences, a keynote speaker for multiple conferences at hospitals and informatics organizations across the US, has written multiple articles for the learning field, and is currently co-authoring a new book about global training. Dara’s education includes a B.S. in Biology, an M.A. in Adult Education and Training, her national certification, CPLP (Certified Professional in Learning and Performance), and a certificate in Dan Pink’s Drive motivation model. She has been on multiple Boards of Directors, and has experience in the fields of learning consultation, biopharma, healthcare, professional services, financial services, oil & gas, insurance, global online retail, non-profit advocacy, purchasing, medical billing, medical supply, retail, and customer call centers.
Wendy Morahan, Senior Director, Clinical Data Analytics, IQVIA Technologies
Wendy is part of the product strategy leadership team for the Clinical Data Analytics Suite at IQVIA providing SaaS solutions for the market as well as IQVIA’s internal CRO needs. As part of the CDAS team, Wendy is responsible for strategy, product management leadership, and Go to Market activities and is passionate about delivering technology solutions that help bring treatments to patients faster.
Parag More, Executive Director, Quest Healthcare Analytics Solutions, Quest Diagnostics
Parag More has spent over 20 years in healthcare and life sciences with a focus on improving patient outcomes using data and technology innovations. In his current role as Executive Director, Healthcare Analytics Solutions at Quest Diagnostics, he is responsible for leading the Clinical Trials business through market initiatives, solutions and services development and industry partnerships. Before Quest, he was a VP in the Research & Insights group at Syneos Health.
Erika Moree, Head of Learning and Development, ProofPilot
Erika Moree is a 16-year learning executive with deep expertise in behavioral science, corporate training, people development, and learning technology innovation. Working at institutions like Health First and Synchrony as the VP of Learning Solutions, Erika has worked across industries to build best-in-class learning programs rooted in people motivation and positive psychology. She has her B.S. in Technical and Industry Education, an adult education degree from the University of Central Florida.
Grant A Morgan, PhD, Founder, CamAlex Castle Consulting
Grant Morgan has more than twenty years in the Biopharma industry focused on operations and development strategy. He has a broad experience in areas such as project and portfolio management, clinical operations and resource planning. To better support accurate clinical resourcing for future pipeline changes Grant developed a predictive resource tool based on role-specific productivity algorithms. This tool enables objective resource projections across all roles that support clinical development. Grant has a BSc in Biomedical Sciences and a Ph.D. in Microbiology and is PMP certified.
Amit Mudgal, Associate Principal, ZS
Amit is an Associate Principal with ZS and leads the Clinical space from India. Apart from this, he leads the Clinical Platform venture and RDE Asset Development Organization. He is a BI professional with 15 years of IT experience focusing on Tech Ops. He has been focused on field reporting and data warehousing operations, alignment management, cycle planning and master data management solutions. His expertise has been setting up and running large multi-country operations projects.
Timothy Mudric, VP Head, Operational Strategy Leads & Strategic Feasibility, PPD, part of Thermo Fisher Scientific
Tim is Vice President and Head of the Operational Strategy Leads and Strategic Feasibility at PPD, part of Thermo Fisher Scientific. With over 30 years of industry and academic experience, Tim has held varying leadership roles across several divisions. As Head of the Operational Strategy Leads and Strategic Feasibility, Tim’s departments bring unique operational strategies supported by data driven feasibility to help our customers deliver science.
Joseph Munda, Senior Vice President Research & Venture, First Analysis Corp.
Joe Munda has worked in finance and investment for 16 years and joined First Analysis in 2015. He works with entrepreneurs as an investor and as an advisor on growth transactions to help build leading businesses in healthcare technology. He has played a leading role in building First Analysis’ franchise in drug development technology and has published several thought-leading white papers on the space. His work led to the firm’s investment in 4G Clinical as well as First Analysis' current investments in Transformative Pharmaceutical Solutions, VIDA Diagnostics and Yunu. Prior to joining First Analysis, he was an equity research analyst covering medical device and healthcare services companies at Sidoti & Co. Earlier, he worked in institutional sales at Bear Stearns/J.P. Morgan. He earned a bachelor's degree in finance from Fairleigh Dickinson University.
Jim Murphy, CEO, Executive, Greenphire
As Greenphire’s CEO, Jim leads the strategy for the company, including client satisfaction, business operations, commercial execution, and financial performance. He is committed to fostering a culture of growth, innovation, excellence and employee satisfaction. Jim has focused his career on building innovative eClinical software companies to address challenges and unmet needs within the global clinical research ecosystem.
Elizabeth Myers, Senior Clinical Research Planner, Abbott Nutrition
Elizabeth joined Abbott Nutrition in 2007 as a Procurement professional. She later held positions in Demand Planning and Retails Sales Planning until 2018 when she brought her Finance and Forecasting background to the R&D team as a Sr. Clinical Planning Specialist, responsible for forecasting budgets and timelines for clinical studies.
Manu Nair, Chair, US Clinical Practice and High Value Opportunities, Corporate Development, Mayo Clinic
Manu S. Nair is Chair, Corporate Development in the Department of Business Development at Mayo Clinic. Mr. Nair leads the business development efforts focusing on US clinical practice and high-value opportunities that are of highest strategic importance to Mayo Clinic. Prior to assuming this role, Mr. Nair served as vice president of Technology Ventures for the Oklahoma Medical Research Foundation (OMRF) in Oklahoma City. He was in charge of developing and commercializing OMRF’s technologies, establishing strategic industry collaborations, and managing the innovation fund dedicated to such development efforts. Mr. Nair started his technology commercialization career at OMRF in 2004 and was involved in OMRF’s intellectual property (IP) commercialization and startup company efforts. He later joined Mayo Clinic Ventures (MCV), the technology commercialization and investment arm of Mayo Clinic, where he served as a technology licensing manager and subsequently as senior licensing manager. He managed a diverse portfolio of technologies and was in charge of related IP protection, development and commercialization, including company formation and technology-based investments. He also led MCV’s international collaboration and funding initiatives. Appointed by the governor of Oklahoma, Mr. Nair served as vice chair of the Oklahoma Science and Technology R&D Board. He has served on the Board of Directors of the Legal Assistance of Olmsted County, Rochester, Minnesota and the Midwest University Research Network. He currently serves on the boards of Jupiter Bioventures, Nucleus Radiopharma, vMocion and the USA Healthcare Alliance, serves on the business advisory board of Progentec Diagnostics, and is a member of the External Advisory Committee for the NIH-funded SE XLerator Network Hub. In addition, Mr. Nair serves as a business consultant for several U.S. and international entities, including prominent research institutes and technology companies. Mr. Nair received his MBA from Lamar University in Texas and an advanced degree in law from the University of New Hampshire School of Law focusing on intellectual property, commerce and technology laws.
Rohit Nambisan, CEO, Lokavant
Trained as a neuroscientist, Rohit Nambisan is a product executive with experience leading product development organizations in pharma, medical devices, personalized medicine, health IT, healthcare data and analytics, and AI. Prior to co-founding and leading Lokavant, Rohit was most recently the Head of Digital Product at Roivant and the Head of Product at Prognos Health. Rohit holds advanced degrees from MIT, Boston University, and UC Berkeley.
Barrie Nelson, Founder & Executive Vice President, Clinical Innovation, Nurocor
Barrie Nelson is passionate about bringing order to clinical data and clinical development processes. His BioPharma experience spans Biostatistics, Clinical Data Management, and Data Standards organizations. After spending many years as a volunteer and team lead, Barrie became the lead for CDISC standards development. Now, as a founder of Nurocor, his expertise is focused on development of the Nurocor Clinical Platform, which enables BioPharma companies to fully realize a digital clinical development process.
Melissa Nezos, Executive VP, Clinical Operations, Firma Clinical Research
Since graduating from San Diego State University with a MA in Neuropsychology, Melissa has worked for over 20 years in a number of global organizations within Clinical Operations and Project Management. Her experience spans both large and mid-sized CROs, overseeing large, multi-continent clinical operations teams. Recognized within the industry as a champion for progression, Melissa has been instrumental in delivering global organizational change initiatives.
Virginia Nido, Global Head, Product Development Industry Collaborations, Genentech, a member of the Roche Group
Virginia Nido is the global head of Industry Collaborations for Roche and Genentech. She is the co-founder and board chair of the Clinical Research Data Sharing Alliance. Virginia serves on the Clinical Trials Transformation Initiative Executive Committee; she is a Global Impact Partner for the Society for Clinical Research Sites; former Board Director of the Association for Clinical Research Professionals; a strategic advisor to the Tufts Center for the Study of Drug Development; and former member of the TransCelerate Biopharma Integrated Leadership Team. She holds an undergraduate degree from Barnard College, a Master degree in education from the University of Pennsylvania, and professional certificates in Bioethics from Columbia University and Precision Medicine from the Harvard Business School. Virginia is passionate about the power of industry collaborations to improve the efficiency and quality of clinical research.
Alminaz Noorani, Senior Manager Clinical Systems, Global Development Operations, Ultragenyx Pharmaceutical, Inc.
Alminaz brings over 10 years of clinical trial experience with a unique combination of working on very niche trials on the sponsor side along with extensive experience on the vendor side supporting diverse therapeutic areas for sponsors needing unique solutions. Alminaz currently oversees the IRT and eCOA systems at Ultragenyx and collaborates closely with all functions to ensure the systems are accurately developed and supported from study start-up to close out.
Helene Nordahl, PhD, Director, Real World Data Science & Innovation, Novo Nordisk, Inc.
Helene Nordahl, PhD, MSC is Director of Innovative trial at Novo Nordisk, Inc. leading cross functional teamwork in the strategic planning and implementation of pragmatic and innovative trials design solutions. Experienced epidemiologist with a track record of leading multinational RWE programs, research partnerships, and designated RWE capability building across therapeutic area and product life cycle.
Carrie A. Northcott, PhD, Senior Director & Project Lead, Digital Medicine & Translational Imaging, Pfizer Inc.
Carrie Northcott, PhD is a Director/ Project Lead within Digital Medicine and Translational Imaging (DMTI), Early Clinical Development (ECD) at Pfizer. She leads a driven and diverse team that is evaluating and validating the use of wearable digital devices to more fully understand and characterize physiological endpoints, such as quantitatively measuring night-time scratch and sleep. Carrie has a diverse scientific background in Pharmacology, Toxicology, and Physiology which provides unique insight into understanding how these novel digital endpoints provide meaningful information to patients, doctors, and researchers to better treat and understand diseases.
Evan Norton, Founder & Managing Partner, SPRIG Equity
Evan Norton is a Founder & Managing Partner for SPRIG Equity, a healthtech growth equity and venture investment firm. Evan is on several healthtech boards. Prior to starting SPRIG Equity, he was a General Partner at Accelmed Partners. Evan has led over 30 financings and has had 15 of his prior investments either be acquired or become public companies. He previously spent a decade with Abbott Labs leading the corporate venture arm, Abbott Ventures. Prior to Abbott, he was a Principal with ONSET Ventures. He has a diverse background having worked for Stryker Endoscopy, J&J LifeScan and Acclarent. In addition to his medical device experience, Evan worked for the Investment Banking Group at J.P. Morgan Chase & Co and in the consulting practice at PriceWaterhouseCoopers. Evan holds an MBA degree from the J.L. Kellogg Graduate School of Management. He currently is an adjunct professor at Kellogg (Medical Products Commercialization and Funding) and serves on the Innovation and New Ventures Advisory Board and N.XT Fund investment committee at Northwestern University.
Erin O'Boyle, Vice President, Clinical Operations, Rezolute, Inc.
I have been working in the pharmaceutical industry for 20+ years. Most of that time has been filled working for a Sponsor, in small to mid-size companies. Thus far in my career, I have been fortunate to be part of a development team that successfully ran a program from an IND filing up through NDA approval. I have executed studies in several therapeutic areas, including large global studies (N>2,000 patients) down to rare pediatric global studies which were vastly smaller in size with a much higher degree of complexity (N<20 patients). In addition to clinical operations, I have spent a great deal of time in clinical outsourcing, with regards to trial budgeting and forecasting, vendor selection and ensuring proper Sponsor oversight of the selected vendors. Clinical trials are most successful when there is clear and consistent communication across all key contributors from beginning to end. Often, there is important information lost in translation, turnover, or termination. Don’t let these events impact all that has been learned and shared, keep lines of communication open and remember to ask questions, never make assumptions that are not supported with documentation.
Richard O'Hara, Director, Clinical Business Operations, Endo Pharmaceuticals
Rick O’Hara has been an Associate Director of Project Management and Business Operations at Endo Pharmaceuticals since February of 2012. Prior to this role, Rick spent about 13 years at Johnson & Johnson in various clinical outsourcing roles. His experience at J&J spanned across many therapeutic areas and all phases of clinical research. He also worked on J&J’s FSP models. Before J&J, Rick spent 2 years at Covance as a Business Manager and 4 years at the University of Pennsylvania as a Business Administrator. The early part of Rick’s career was spent performing various financial management roles within the banking industry. Rick holds both a BS and an MBA from St. Joseph’s University in Philadelphia and he lives in Rydal PA.
Bryan O'Neill, Global Head, Clinical Supply Operations, Daiichi Sankyo, Inc.
Bryan O’Neill is a Clinical Supply professional with 20 years in the industry, serving on both the vendor and sponsor side. He graduated with a Bachelor of Science in Clinical Psychology from the Pennsylvania State University (PSU) in 2001 and received an Executive Master’s in Supply Chain Mgmt from PSU in 2017. He has worked as both an individual contributor and people manager for big pharma, mid-sized biotech and clinical stage startup companies alike over his career, specializing in Oncology and constrained supply chains. As Sr. Director & Head, Clinical Supply Operations Daiichi Sankyo, Inc, Mr. O’Neill provides strategic direction to his group in all planning and execution areas across the Clinical Supply Chain, with a concentration in global drug pooling, deferred customization and inventory conservation practices for investigational and comparator products alike
Joseph O'Rourke, Head of Commercial Development, Walgreens Clinical Trials
Joseph “Joe” O’Rourke serves as the the Head of Commercial Development. He brings 20 years of experience in the clinical trials space and has a passion for increasing patient access and diversity to clinical trials. Joe recently served as the Strategic Alliance Lead and Vice President of Business Development at WCG Clinical. Over the course of 7 years, he was responsible for the growth of strategic partnerships, clinical trial enabling technologies, growth of endpoint solutions in CNS diseases, as well as the commercial integration of several acquisitions by WCG. Prior to WCG, Joe spent 8 years recruiting patients at Acurian (now Accelerated Enrollment Solutions, a part of PPD/Thermo Fisher Scientific) where he spent 4 years in operational delivery in a variety of roles and 4 years in business development. Joe personally delivered and oversaw more than 100 patient recruitment campaigns and helped to accelerate to market blockbuster new medicines in Diabetes and COPD. He also specialized in early digital patient recruitment from 2009-2011. In Joe’s last 4 years there, he was a Business Development leader supporting Acurian’s growth and account management within the large biopharma market segment. Joe has a MBA from Villanova University and a Bachelors in Kinesiology from West Chester University.
Gwenn Oakes, Director, Global Trial Optimization, Merck
Gwenn Oakes, Director, Global Trial Optimization, supports Merck's feasibility planning and recruitment and retention on behalf of Global Clinical Trial Operations. Beginning her career in patient recruitment of pediatric clinical trials, she has a passion for ensuring patient access to clinical trial information. Since 2013, Gwenn has supported the oncology portfolio at Merck through the creation and expansion of the Keynote Clinical Trial program and content and branding across Merck oncology clinical trials and Merck's clinical trials website.
Kenneth Olovich, Director, Sourcing and Finance, Chorus Division, Eli Lilly and Company
Mr. Ken Olovich is the Chief Financial and Procurement Officer for Chorus. Ken has over 32 years of pharmaceutical research experience. As one of the original founding members of The Chorus Group in 2002, Ken can be credited with designing and implementing much of the Chorus approach to clinical vendor relations, contracting, finance and budgeting, quality, and general operations. Prior to Chorus, Mr. Olovich served as Team Leader for Clinical Trial Operations in the Neuroscience Therapeutic Area where he supervised clinical associates and support staff in the planning and implementation of phase I/II neurology and psychiatry clinical trials. Prior to that role, Mr. Olovich was the Clinical Sourcing Team Leader within the Lilly Procurement division. Ken earned his Masters of Business Administration from Indiana Wesleyan University and his Bachelor of Pharmacy from Purdue University.
Jamie Orlando, Vice President of Market Development at Clinical Leader
Experienced Marketing Director with a demonstrated history of leadership within multiple organizations. Skilled in Inbound Marketing, Strategic Planning, Project Management, Team Building, and Manufacturing. Strong entrepreneurial skills with a focus in Program Management, Social Media, Sales and Business.
Tara Palermo, Director of Strategic Partnerships at Life Science Connect, Life Science Connect
Tara has a background in microbiology and pharmaceuticals in healthcare, but her career and passion for patient care has taken a full-circle approach by transitioning into the life sciences industry. She began working with Life Science Connect in April 2022 as a Director of Strategic Partnerships. Her goal is to create partnerships between key players in the drug development process to accelerate the advancement of life-improving, life-extending, and life-saving medicines. The teams at Life Science Connect and Clinical Leader partner with CROs, clinical trial technology companies, and other vendor companies to develop content marketing programs, helping them connect with sponsors/CROs seeking support on their clinical trials.
Acacia Parks, Fractional Chief Science Officer, Found
For the past 20 years, Dr. Acacia Parks has made it her mission to bring evidence-based, destigmatized health care to the public. She is a behavioral health executive with deep knowledge of scientific strategy, clinical product design, including coaching strategy. She has generated evidence strategies to support wellness, enforcement discretion, and 510k/DeNovo claims, and to meet expectations of enterprise, health care, pharma, and FDA audiences. As fractional Chief Science Officer at Found, she manages the research strategy and study pipeline. As CSO at Twill for the 10 years prior, she laid the foundation for clinical product strategy and managed scientific strategy on a suite of wellness and digital therapeutic products, including Twill Care, Happify's patient community platform, and Ensemble, the first transdiagnostic prescription digital therapeutic for depression and anxiety.
Sriram Parthasarathy, Chief Product Officer, Adlib Software
Sriram is an accomplished Product leader with over 25 years of experience and expertise in launching AI driven products that transform customer experiences. He has assisted multiple early-to-mid stage companies with product vision, go-to-market strategy, and technology execution to drive customer adoption & accelerate growth. Sriram is an accomplished author and speaker, he has published over 50 articles in industry magazines, and delivered several industry webinars and key-note speeches. Sriram enjoys listening to music and coaches a high school robotics team who compete in international Robotics competitions.
Rajneesh Patil, Vice President, Clinical Operations Digital Strategy, Innovation, Analytics, IQVIA
Rajneesh has been with IQVIA 16 years and is currently Head of Digital Strategy, Technology & Analytics where he leads a team focused on transforming operating models, risk-based monitoring and AIML implementation. He has 4 provisional US patents in technology and analytics, digital transformation, and advanced analytics. Rajneesh is a University Gold Medalist in Dental Surgery, studied Public Health in Australia and recently certified in Digital Strategy from Harvard Business School.
Jessica Paulus, ScD, VP of Research, OM1
Jess Paulus, is Vice President of Research at OM1 and leads a team of scientists with deep expertise in the designs and methods specific to leveraging real-world data networks to meaningfully inform clinical and regulatory decision making. Dr. Paulus provides senior scientific oversight regarding study design, analytic approaches, and dissemination strategies for RWD-based studies.
Prior to joining OM1, Dr. Paulus was faculty at Tufts Medical School for over a decade, where she served as Research Director of the Tufts Predictive Analytics and Comparative Effectiveness Center and Associate Director of the Clinical and Translational Science MS/PhD Graduate Program. At Tufts, she led the conduct of federally-funded studies related to methods development in areas including comparative effectiveness research, clinical prediction models and heterogeneity of treatment effect. She also served on the faculty of the Harvard T.H. Chan School of Public Health and the Heller School at Brandeis University.
Dr. Paulus graduated magna cum laude from Haverford College and received a doctorate in Epidemiology from Harvard T.H. Chan School of Public Health, where she focused on epidemiologic methods for the study of chronic disease using observational data. She remains engaged in teaching epidemiologic and RWD-methods as adjunct faculty at Tufts and as a lecturer at Harvard Medical School.
Melinda Pautsch, Vice President, Med Device & Diagnostics, Medidata, a Dassault Systemes company
Melinda Pautsch is VP of Medical Device & Diagnostics in the Life Sciences Engagement business at Dassault Systemes. She has over 20 years of experience in the life sciences industry and has been dedicated to the MedTech industry for the past 10 years. While at Medidata and Dassault Systemes, Melinda has focused on helping medical technology customers solve challenges across R&D, clinical trials, medical imaging, and commercialization. Today, Melinda leads the Medical Device and Diagnostics business in US and EMEA.
Narayanarao Pavuluri, Senior Director & Global Head, Clinical Database Services, Merck
Narayanarao (Rao) has been working in Pharmaceutical R&D and Consulting for the past 30+ years in the areas of Clinical Development, Statistical programming, and Submission preparation. Worked in and developed processes and software systems for all the functional areas. He has a passion for streamlining processes and systems to improve the quality of the work and outcomes, increase speed, and reduce cost at the same time.
David J Peloquin, PhD, Partner, Health Care, Ropes & Gray
David Peloquin is a partner in Ropes & Gray's health care group based in Boston who advises clients on a wide range of legal and regulatory issues in the area of clinical research, data privacy, provision of health care services and related activities. David guides clients through complex regulatory questions arising under the Common Rule and FDA regulations, data privacy regulations (including HIPAA, U.S. state privacy laws, and GDPR), and state and federal fraud and abuse laws and health care licensing requirements. David is also a member of the firm’s digital health practice and frequently advises clients on the use of digital technologies in research and clinical settings.
Priscilla Pemu, Doctorate, MBBS MS FACP, Associate Dean Clinical Research at Morehouse School of Medicine
Dr. Pemu is an internist whose goal is to improve the health of all patients similar to those that she encounters in her primary care practice. The complex interplay of patient, physician, practice setting, environmental and psychosocial factors in perpetuating disparities in health outcomes led to her interest and work with the Community Physicians Network. In the past 15years, we have developed a successful partnership based on a shared vision for improved care and outcomes among minority and underserved patients with Community Physicians who are part of the Morehouse Community Physicians Network (CPN). Overall focus has been on identifying gaps in treatment and outcomes and opportunities for improvement. As medical Director of the Community Physicians’ Network (CPN), she is responsible for planning and executing research and quality improvement initiatives. CPN established several disease specific registries for hypertension, Diabetes, heart failure and metabolic syndrome of 6500 individual patients. These were used to support research and quality improvement initiatives. Dr. Pemu is the Morehouse site PI for the All of Us Health Provider Organization called SEEC. She leads the Morehouse participant and clinical interactions unit (PCI) of the Georgia Clinical And translational Science award (GA-CTSA). In the role, she is directly involved in ensuring quality and efficiency of clinical research studies through training of staff, review and prioritization of resources for clinical projects and review of Data and Safety Monitoring reports as the chair of the institutional Scientific advisory Committee. She is part of a team at Morehouse School of Medicine that developed a system and method for chronic illness care that empowers patients to change behaviors relevant to their health through improved knowledge, support for goal setting and accountability in sustaining behavior change. Dr. Pemu completed a residency with the TED organization in May 2019. As a participant in this highly selective incubator for breakthrough ideas, she introduced the concept of Culturally Congruent Coaching. Her TED Talk, featured as Editor’s choice on TED.com, shared the results of 12 years of research observations about what predicts successful health behavior change. The talk brings attention to the impact of behavior on health and wellbeing among people living with chronic illnesses and the Doctors who care for them. She also discussed Culturally Congruent Coaching; a high-tech, high-touch approach to support behavior change that has produced great results among diverse patient groups. Priscilla Pemu is a Professor of Clinical Medicine; Associate Dean for Clinical Research and Director Clinical Research Center at Morehouse School of Medicine. She is also proud mother of four; wife to Igho of 27 years, a sister, friend and daughter. Contributions to Science include: 1. Patient and Consumer empowerment for improved health outcomes in chronic disease: Her work has focused on improving health outcomes by empowering the patient to be an effective consumer of healthcare. Along with colleagues, she has developed and successfully tested an eHealth application for improving self-management skills among high-risk diabetic patients. 2. Quality Improvement in primary care: Her efforts focus on improving care and outcomes for patients with chronic disease. 3. Translational health disparities research on obesity in African American women 4. Education/Mentoring of next generation of Clinical and Translational Researchers 5. Enhancing diversity of participants in clinical trials through practice based research networks
Daniel Perez, CCRP, Director and Global Head of Patient Experience, Patient Experience, Diversity & Inclusion, Worldwide Clinical Trials
As Director & Global Head of Patient Experience, Diversity & Inclusion, Daniel serves as strategic counselor, and architect for patient engagement, diversity, and inclusion efforts across 60 countries and 5 therapeutic areas. His focus is on geographic and therapeutic expansion of Worldwide's capabilities to cultivate a thriving ecosystem of investigative sites, clinician investigators, and patients.
Marlene Peters-Lawrence, Clinical Research Project, NIH, NINDS
Marlene Peters-Lawrence is a Clinical Research Project Manager within the Division of Clinical Research at the National Institutes of Neurological Disorders and Stroke (NINDS), at the National Institutes of Health (NIH). In this position, she supports large network clinical trials. Her research portfolio interest areas are pain, sickle cell anemia, patient engagement, community base participatory research, and NeuroCOVID-19. Ms. Peters-Lawrence oversees clinical trial operations for the Helping to End Addition Long-Term (HEAL) Initiative, Early Phase Pain Investigation Clinical Network (EPPIC-Net), and Pain Care Coordination in Health Delivery Systems implementation programs. She also leads the strategic development for community engagement, recruitment, and retention planning for diverse populations. Prior to joining NINDS, Ms. Peters-Lawrence served as Clinical Trial Specialist and Engagement Outreach in the Division of Blood Diseases and Research at the National Heart, Lung, and Blood Institute (NHLBI). She also serves as the trans-agency NIH Task Force for COVID-19, RECOVER Communication and Engagement, and co-chair the HHS Office of the Assistant Secretary of Health, Office of Minority Health, Sickle Cell Disease Stakeholder Engagement committee. Her leadership and advocacy have been recognized through awards from the NIH Office of the Director, NINDS Director, NHLBI Director, and Chief Nurse Officer. A licensed Registered Nurse and Respiratory Therapist, Ms. Peters-Lawrence received her master’s degree in public health from Johns Hopkins Bloomberg School of Public Health, her Bachelor of Science degree in nursing from Jacksonville University, and her associate of science degree in cardiopulmonary care from Valencia College.
Monique Phillips, Global Diversity and Inclusion Lead, Bristol Myers Squibb Co.
Monique is an optimistic catalyst for change who can deliver through her storytelling and coaching abilities. She is passionate about improving the diversity in clinical trials. Monique has 13 years pharmaceutical experience in roles spanning early discovery through clinical operation to approval. Monique is proven innovator with patents, publications, and program impact. She uses her clear, accurate and direct communication style to engage, motivate and minimize misunderstandings. Efficiency-driven process improvement professional skilled in systematization and information sharing. Able to distill complex problems to develop, evaluate, implement and communicate effective solutions. She is currently a Clinical Trial Recruitment Strategy Lead at Bristol-Myers Squibb and serves as Director of Community Engagement for Women of Color in Pharma.
Ken Phillips, CPTD, CEO, Phillips Associates
Ken is the founder and CEO of Phillips Associates and the creator of the Predictive Learning Analytics(PLA) learning evaluation methodology. He has more than 30 years of experience designing learning instruments and assessments and has authored more than a dozen published learning instruments. Ken also regularly speaks to Association for Talent Development (ATD) groups, university classes, and corporate L&D groups. Since 2008 he has presented at the ATD International Conference and Expo on measurement and evaluation of learning topics. Ken has written articles for TD magazine, Training Industry Magazine, and Training Today magazine. He also is a contributing author of five books in the L&D field and the author of the recently published ATD TD at Work publication titled Evaluating Learning with Predictive Learning Analytics. He earned the Certified Professional in Learning and Performance (CPLP now CPTD) credential from ATD in 2006 as a pilot pioneer and has recertified five times most recently in 2021.
Alekhya Pochiraju, Senior Product Development Lead, Clinical Operations, Genentech
Alekhya is a Senior Product Development Lead (Clinical Operations) at Genentech where she provides clinical oncology operations expertise. She believes, with the future of healthcare geared towards personalized medicine, biomarkers are a critical element of cancer drug development and cancer therapeutics. Her recent talk at Biomarkers & Precision Medicine USA Congress and Salesforce Women's Summit, focus on health equity disparity among minorities and people of color, specifically on the disproportionate impact COVID-19 pandemic can have. Alekhya holds an undergraduate degree from BMS College of Engineering, India in Biotechnology Engineering and a master's degree from Northeastern University in Biotechnology. Prior to joining Genentech, Alekhya worked in quality technology at Fluidigm and Sanofi-Genzyme.
Richard L Polgar, Sr Advisor, Danforth Advisors
With over 22 years of experience, Rich Polgar has worked at CROs, Big Pharma and consulting with a dozen of biotechs on their sourcing needs. Rich brings a unique perspective with his balance of science and business skills having earned his Masters in Neuroscience and his MBA. His experience ranges from translational science needs, clinical, functional service provider sourcing, core technology and clinical IT through to Real-world evidence and clinical data. Rich has setup and run several sourcing and governance teams at multiple companies and looks forward to strategic governance to create stronger partnerships between Sponsors and Suppliers.
Cory Potts, Senior Manager, Site Engagement, Diversity Lead, Bayer
Cory has worked in clinical research for 18 years from conducting research as a coordinator to managing clinical trial programs for pharma. He is currently a U.S. feasibility manager specializing in managing oncology relationships for Bayer, as well as a lead for diversity in recruitment of a large chronic kidney disease program. Cory calls central Texas home and lives on a ranch near Austin with his spouse, 13 year old twins, and a pointer puppy.
Tiffany Powell-Wiley, MD, Physician-Scientist, National Institutes of Health
Tiffany M. Powell-Wiley MD, MPH is an Earl Stadtman Investigator and Chief of the Social Determinants of Obesity and Cardiovascular Risk Laboratory at the National Institutes of Health with a joint appointment in the Cardiovascular Branch of the Division of Intramural Research at the National Heart, Lung, and Blood Institute (NHLBI) and the Intramural Research Program of the National Institute on Minority Health and Health Disparities. Dr. Powell-Wiley’s interdisciplinary team uses community-engaged research, epidemiologic methods, and translational approaches to better understand social factors that promote obesity and limit cardiovascular health. In 2021, Dr. Powell-Wiley’s innovative work was recognized with the American Heart Association’s Population Research Prize. Dr. Powell-Wiley is an associate editor for Frontiers in Cardiovascular Medicine, and she serves as an editorial board member for Circulation. At NIH, Dr. Powell-Wiley has mentored more than 50 research fellows at various career stages, several of whom are now tenure-track, NIH-funded faculty. She has been recognized through NHLBI Director’s awards for her mentorship of research fellows and for promoting diversity in the biomedical workforce through her mentoring efforts. Dr. Powell-Wiley graduated summa cum laude with a B.S.E. in chemical engineering from the University of Michigan in Ann Arbor. She received an M.P.H. in Epidemiology from the University of North Carolina at Chapel Hill. She graduated with an M.D. from Duke University School of Medicine, where she was inducted into the Alpha Omega Alpha Medical Honor Society. Prior to joining NIH, Dr. Powell-Wiley completed internal medicine residency at Brigham and Women’s Hospital and cardiology fellowship at the University of Texas Southwestern Medical Center, where she served as the Cardiology Division’s first chief fellow.
Gian Prakash, Associate Director, Data Engineering, Information Research, AbbVie Inc.
Gian has over 13 years of experience in clinical data, technology, and clinical data management operations. In his current role at AbbVie, Gian is responsible for the innovation, design, and implementation of clinical technologies to enable the clinical data collection, aggregation & submission. Before joining AbbVie, he had worked at Accenture, helping pharmaceutical organizations bring innovative technologies to optimize the business process.
Deborah Profit, PhD, Vice President, Clinical Management & Applied Innovation, Otsuka America Pharmaceutical, Inc.
Debbie began her career at Otsuka over two decades ago in Clinical Operations and has since held progressive leadership roles in R&D, as the Vice President of Otsuka Information Technology (R&D, Enterprise and Commercial) and now as the VP of Clinical Management and Applied Innovation. Debbie has played a key leadership role in driving novel solutions and real time data visualization of clinical trial data into Otsuka’s day to day processes. Debbie leads collaborations to disrupt clinical research by partnering with the likes of Verily, Amazon and Spenser Health to truly democratize clinical trials. She also contributed significantly to the clinical operations and development of digital medicine (“Abilify MYCITE”) to successful FDA submission and subsequent approval in November 2017. She possesses undergraduate degrees in both nursing and psychology, a Master of Science in Regulatory Affairs - Drugs, Biologics and Medical Device and earned her Doctorate in Leadership Studies - with a concentration in Innovation and Creativity.
Francesca Properzi, PhD, Director Research, Thought Leadership, DT Consulting
Francesca has more than ten years of experience in life science and healthcare research projects, including frontline scientific research, digital transformation, and innovative technologies. In her current role as director of research, she is steering the DT thought leadership team to generate valuable insights into customer experiences, specifically in the clinical and medical affairs areas of the biopharmaceutical value chain. Prior to joining DT Consulting, Francesca was a research manager at Deloitte’s UK Centre for Health Solutions, where she led two research projects: one on the state of healthcare digital transformation in the UK and Europe and one on the impact of artificial intelligence in various sectors of the biopharma value chain, including drug discovery and clinical trials. She authored several reports and blog posts on these topics and on other key industry trends. Francesca was previously a principal investigator at the Italian National Institute of Health, researching neurodegenerative diseases and innovative diagnostic and therapeutic approaches. She has contributed to more than forty research publications overall. Francesca earned a Ph.D. in neuronal regeneration from Cambridge University and recently completed an executive M.B.A. focused on innovation and healthcare at the Imperial College Business School in London.
Marisa Rackley, Vice President, Clinical Site Start Up, Site Engagement, Trial Optimization, Takeda
Marisa is the leader of the newly formed Clinical Site Start-up & Engagement group. This group was created as part of our GDO org redesign to support Future Fit in the predictable delivery of accelerated clinical trials. The new group brings together and grows key functions to optimize study start-up and feasibility, clinical trial diversity, patient recruitment and retention, site engagement, site contracting, and oversight of CRAs. Before coming to Takeda, Marisa worked at Vertex for 5 years, where she served as Global Head, Study Start-Up and Site Strategy. Also at Vertex Marisa headed up Site Engagement with responsibility for leading the North American Regional Site Advocate team and creating/maintaining investigator site relationships across the rare disease portfolio. Prior to Vertex, Marisa spent over 16 years at Merck, building her expertise in clinical operations including leading clinical operations teams, and leading Global Trial Optimization responsible for clinical trial feasibility and recruitment strategies for all Merck’s late-stage development projects.
Girish Rajeev, Global Head, Clinical Data Standards, Takeda Pharmaceuticals
Girish Rajeev has 20+ years of global pharmaceutical experience in the areas of technology, automation in quality and clinical standards space. He has led process automation and standardization activities across therapeutic areas to implement end to end standards effectively. He has driven deployment and data curation in the Metadata Repository and integration with Protocol Automation Tool, SAP module, CSR and CTD.
Joshua Ransom, PhD, Head of Customer Experience and Product, BEKHealth & Associate Director GBEMTI at the NAMCP, Customer Experience and Product, BEKHealth
Josh Ransom, Head of CX and Product at BEKHealth leads the development of (SaaS) platforms for clinical research. Josh focuses on developing AI software as a service for clinical trial recruitment and operations. Josh has past experience at multiple health technology and management consulting firms such as AcornAI, SHYFT Analytics, and Quintiles Consulting. Josh holds a Ph.D. in Biomedical Sciences and Genetics, a BS in Biochemistry, and a BA in Chemistry.
Prasanna Rao, Head, AI & Data Science, Data Monitoring and Management, Clinical Sciences and Operations, Global Product Development, Pfizer Inc.
Prasanna Rao is an AI practitioner and industry thought leader whose current role is Head of Artificial Intelligence and Data Science for Data Management and Monitoring at Pfizer. He has over 30 years of experience in information technology and analytics, with 10+ years in healthcare and life sciences. In his previous role as a Watson Solution Architect at IBM, he was instrumental in implementing many different AI systems from idea to implementation with various clients. In his current role, he works with various stakeholders, vendors, business SMEs, machine Learning developers, and data scientists to deliver innovation and drive adoption of AI. He has presented at several industry conferences including SCDM, DIA and SCOPE.
Ratan Ratnesh, Senior Director, Outsourcing & Vendor Management, Taiho Oncology, Inc.
Ratan Ratnesh is a Senior Director and Head of Outsourcing & Vendor Management at Taiho Oncology. Prior to joining Taiho/Otsuka, Ratan worked at Wyeth and Novartis where he managed different categories related to clinical outsourcing. Ratan has broad experience in strategic sourcing, clinical outsourcing, operations and supply chain improvements in Fortune 500 and growth companies. He started his career in management consulting specializing in supply chain across different industries and moved to clinical outsourcing in early 2000. He received his Bachelors in Mechanical Engineering from National Institute of Technology, India and an MBA from University of Louisiana.
Rose Redfield, Head of Biospecimen Operations, Daiichi-Sankyo
Rose Redfield is a seasoned biorepository/biospecimen professional with 25 years' experience in collection, storage, and governance of specimens for clinical research. Starting her career in the laboratory, her curiosity gravitated towards the “freezer of left-over samples” back in the corner. This led her on a journey within different roles of specimen management supporting clinical trials. Her career path at central labs, CROs and multiple Pharmaceutical Companies helped her developed best practice’s regarding specimen utilization for the benefit of future therapies.
Victoria Reid, Vice President, Freenome
Victoria Reid is Vice President of Development at Freenome Holdings Inc., a company with a multiomics platform for the early detection of cancer using a standard blood draw. In her role, Victoria leads corporate partnerships across health systems, hospitals and community practices to drive broad access to Freenome research, clinical studies and early cancer detection tests. With 18 years of executive management experience in healthcare and life sciences, Victoria has devoted her career to building teams to launch medical platforms innovations to improve and make a difference in patient lives. She is also passionate about structuring deals to advance medical innovations and create access to patients. Prior to Freenome, Victoria worked for some of the most recognized names in healthcare including Pfizer, Johnson & Johnson, and GSK. Victoria lives in the San Francisco Bay Area and loves to hike and mountaineer.
Jim Reilly, Vice President, Development Cloud Strategy, Veeva
As Vice President of Development Cloud Strategy at Veeva, Jim is responsible for customer engagement, market adoption, and strategic alliances. For the last 20 years, Jim has held various senior positions in life sciences technology, where he has led software delivery and sales efforts in clinical operations, regulatory, clinical data standards, and content management. Jim holds an MBA in information systems from Villanova University and a B.S. in neuroscience from the University of Scranton.
Valerie Reynaert, Head of Global Clinical Operations, CSL
Valerie Reynaert serves as the Head of Global Clinical Operations at CSL. She joined CSL in September 2019. Valerie has more than 20 years in clinical development and operations in a variety of leadership roles in Vaccines and Pharmaceuticals development in both Europe and the US. Valerie has a Masters in Medical and Social Sciences from the Catholic University of Leuven, Belgium.
Lori Rich, Vice President, Financial Operations, Elligo Health Research®
Lori brings over 13 years of experience in accounting and finance. Prior to Elligo she worked as VP of Financial Operations for ClinEdge and BTC Network for 6 years where she developed and executed on department goals and scaled the capabilities of the service offerings. Now as VP of Financial Operations for the Financial Management Services division of Elligo she is responsible for the management, operations, and growth of the network of research institutions within the service line.
Kimberly Richardson, Research Advocate, Founder, Black Cancer Collaborative
Kimberly D. Richardson is a two-time cancer survivor of both ovarian and breast cancer and has been active as a patient advocate since her first diagnosis in 2013. She collaborated with the University of Illinois at Chicago, Cancer Center and its College of Medicine students to launch an educational program for scientists and cancer survivors called, “Survivors Advising Scientists Educational Program” (SASEP). The mission of SASEP is to create a bidirectional educational platform that connects young investigators with cancer patients, survivors, research advocates and allies to increase scientific literacy and engagement across the community. Ms. Richardson is a member of several advisory groups on disparities in ovarian and breast cancer, serves on patient expert councils for global organizations striving for better patient outcomes in clinical trials, and advocates at the state and federal level for funding for cancer research. Her most recent appointments are to the NCI Moonshot IMPACT program, the American Board of Emergency Medicine, and the Ovarian Cancer Research Alliance Industry Council on Disparities and 2021 National Coalition for Cancer Survivorship, Ellen Stovall Award Recipient
LaShell Robinson, MS, Director Diversity, Equity & Inclusion in Clinical Research, Takeda
LaShell Robinson is the Director of Diversity, Equity & Inclusion in Clinical Research at Takeda Pharmaceutical Company, Ltd. Here she leads the company’s strategic vision for increasing the diversity of Takeda’s clinical research programs by fostering partnerships & implementing strategies focused on education, awareness, access, and operational excellence. LaShell brings her experience from Janssen Research & Development, a Johnson & Johnson Pharmaceutical Company where she held the position of Clinical Operations Lead, Diversity & Inclusion in Clinical Trials (DICT). In this role, she supported the vision to ensure that all patients have access to innovative, high-quality care and the best possible health outcome regardless of race or ethnicity. LaShell was responsible for providing D&I strategic and tactical support to trials, including the COVID-19 vaccine and treatments trials. LaShell’s previous roles centered on Patient Recruitment & Retention and Site supporting global clinical trial programs with disease-focused strategy to expedite trial enrollment. Her specializations included training clinical teams, facilitation of site & patient engagement workshops, managing small to large scale investigative site support programs all of which focused on highlighting the patient experience to enable a better clinical trial experience. LaShell is a proud alumna of Tuskegee University where she obtained a Bachelor of Science in both Biology & Physics. Here she saw firsthand the impact history has on the patient’s perception of clinical research. This continues to fuel and influence her passion for educating others about clinical research and the diversity of the patient experience. LaShell has a Master of Science in Biomedical Engineering from the University of South Florida. LaShell and her family currently reside in Maryland.
Sheila Rocchio, Digital Growth & Education, eClinical Solutions
Sheila Rocchio is the Chief Marketing Officer of eClinical Solutions. Sheila has more than 20 years of industry experience including marketing, product management and strategy roles in life sciences technology companies. At eClinical Solutions, Sheila manages all aspects of marketing including branding, communications, lead generation, product marketing and education and training. She enjoys finding creative ways to tell customer stories and building products and services that help clinicians, data scientists and technologists do the challenging and important work of bringing life-saving new therapies to market.
Angela Rochelle, Head of Diversity Initiatives, Publicis Health
Angela is the leading advocate for diversifying patient representation in Clinical Trial Experience (CTE) at Langland, a Publicis Health company, where she brings her considerable expertise to the agency’s established legacy of excellence in clinical trial recruitment and experience. Prior to joining Langland, Angela accumulated 20+ years of experience at some of the country’s leading multicultural advertising agencies working with high-profile clients such as Unilever, General Motors, Walmart, and Proctor & Gamble.
Isaac R. Rodriguez-Chavez, PhD, Vice Chair, IEEE-SA-DCT Program
Dr. Isaac R. Rodriguez-Chavez is a biomedical leader with expertise in Infectious Diseases, Viral Immunology, Viral Oncology, and Vaccinology. His experience covers the entire life cycle of medical products from basic, preclinical, interventional clinical research (phase I - IV), non-interventional clinical research, and post-marketing studies. Currently, he is SVP, Scientific & Clinical Affairs, and Head, Global Center of Excellence Strategy for DCTs & Digital Medicine, ICON plc. Past positions include FDA, CDER Senior Officer for Clinical Research, Regulatory Compliance and Policy Development modernizing clinical research through DCTs enabled by DHTs. He published numerous articles and has been an invited speaker in 100+ global conferences. He holds leadership roles at DiME, IEEE, DTRA, HCMA, and DIA Global Forum. He is also involved with 14 professional associations. He has a PhD in Virology and Immunology; a MS in Microbiology; a MHS in Clinical Research; and a B.S. in Biology.
Josh Rose, Clinical Trial Innovation and Drug Development Executive, CVS Health
Josh Rose, Vice President, CVS Health Clinical Trial Services (CTS), is a clinical research industry veteran with more than 20 years of experience. He leads the CTS clinical trial delivery business providing patient-first research within designated HealthHUB locations, the home and virtually. Josh is also responsible for CTS strategy and partnerships. Prior to joining CVS Health, Josh was Vice President and Global Head of Strategy for the Research and Development Solutions Business at IQVIA, while also launching and leading its decentralized clinical trial (DCT) and home research nursing service businesses. Josh has an MBA from Duke University and a Bachelor of Science in chemical engineering from the University of Illinois. He lives in Chapel Hill, NC.
Mathew Rose, MD, Co-Chair, IEEE, Founder and CEO, SAAVHA, Inc.
Dr. Mathew Rose is an Investor, Physician, Entrepreneur, and Blockchain Specialist focused on innovations that improve health and quality of life. He founded SAAVHA, a social impact start-up that personalized patient experiences to reduce inequity and administrative friction around patient consent. He currently serves as a Co-Chair for the IEEE-SA IC19-004-01 committee on Data Harmonization for Enabling Decentralized Clinical Trials and sits on the advisory board of several start-ups. Previously, Dr. Rose served as the Patient Identity Sub-committee lead for a PhUSE Blockchain in Clinical Trials initiative and has more than 15 years combined work in Clinical and Translational Medicine workflow. He has authored numerous peer-reviewed publications and spoken Internationally on Cybersecurity and Blockchain in Healthcare with mentions in Forbes, CoinDesk, and The Parallax. Dr. Rose holds a Medical Degree from the Royal College of Surgeons in Ireland, a Masters in Biotechnology from UPenn, a Masters in Physiology from Georgetown, and a Bachelors in Neuroscience and Business from the University of Pittsburgh.
Len Rosenberg, PhD, RPh, Head, Clinical Operations, Beat AML/LLS
Dr. Rosenberg is a 35 plus year executive with proven experience in driving operational excellence at all levels within the pharmaceutical, biotechnology, eclinical and contract research organization sectors. With his diverse background which includes executive management, clinical and regulatory operations, business development, eclinical technology solutions and new product/licensing evaluations, he brings tremendous hands on insights to optimizing the drug development cycle, from the early start-up stage to global product registration. Dr. Rosenberg is Head, Clinical Operations at Beat AML, LLC, a division of The Leukemia & Lymphoma Society and also Managing Partner of eP2Consulting, Inc. since 2001.
Arnab Roy, Decision Analytics Manager, ZS
Arnab is a member of R&D Excellence practice area, where he leads the development & global commercialization of ZS’ decentralized clinical trial strategy and analytics offerings. Arnab advises pharma & medical devices companies across a diverse set of issue areas including clinical development excellence, digital health in clinical development, patient & site engagement transformation for digital clinical trials and driving operating model transformations.
Ralph Russo, Senior Director & Global Head, Clinical Database Management, Pfizer Inc.
Ralph J. Russo, CCDM, is the Global Head of Clinical Database Management and Standards at Pfizer. In this role, Ralph is responsible for Clinical Trial Database builds and Clinical Data Standards at Pfizer. Ralph has over 35 years of experience in the pharmaceutical industry. Prior to joining Pfizer, Ralph worked at Merck where he was responsible for various groups including External Data Acquisition and Clinical Database Management. Ralph also has 14 years’ experience at Wyeth where he was responsible for designing clinical trial databases using the Oracle Clinical suite of applications. Prior to this, Ralph worked on various drug development teams in support of Discovery Research as a Research Chemist at Wyeth. Ralph has an MBA with a concentration in Management Information Systems from Temple University’s Fox School of Business, a Master of Science degree in Chemistry from Seton Hall University, and a Bachelor of Arts degree in Chemistry from Rutgers University.
Pramod Sachdeva, Founder and Managing Director, Princeton Blue
Pramod, Founder & Managing Dir. at Princeton Blue, has been helping organizations for 16 yrs with Low-code process automation solutions to modernize Clinical, Regulatory, Lab & Drug Safety processes. With over 35 yrs of business & technology experience, he brings tremendous knowledge to help clients navigate their process automation journey using the Appian Low-code platform. The goal is to unify the enterprise data view with standardized business processes & provide an efficient and transparent way to get work done.
Robert Sala, Director of External Research and CRO Integration, Research, Dexcom
Robert is responsible at Dexcom for the strategic aspects of CGM in regulatory pharmaceutical and device research. His current responsibilities include managing over 15 data CROs, worldwide logistics vendors and data scientists who are focused on building remote CGM capabilities in RCT. Prior to joining Dexcom, Robert worked with MiniMed Technologies and Medtronic, expanding therapies and technologies in lives of people living with diabetes.
David Sall, President & CEO, Marketing, Patient Enrollment Advisors LLC
David Sall is a marketing and engagement specialist with a focus on the healthcare industry. He was graduated with honors from The George Washington University with a Bachelor of Arts in Communications and a concentration in Business Marketing. David started his career in national broadcasting sales by representing hundreds of the nation’s top radio properties. As the media industry hit the technology revolution, David continued his career by building and managing the New York office of Hiwire, one of the original pioneers in digital streaming technology. With the opportunity to bring this knowledge to the traditional media space, David joined CBS Broadcasting’s management team and handled the flagship terrestrial radio news properties as well as the many digital assets of the Tiffany network. David is now the CEO and President of Patient Enrollment Advisors, which focuses on the recruitment and retention of qualified participants in medical clinical trials. This venture was born out of a clear need for the industry to approach the business of clinical trials with a unique set of eyes. “Our company takes a patient-focused strategy to help the healthcare industry quickly and safely bring products to market for those in need. Patient Enrollment Advisors not only finds qualified patients, but we also listen to them.” This humanistic approach makes the clinical trial process a better experience than ever before - for everyone involved - which ultimately helps pharmaceutical companies meet their research goals. Patient Enrollment Advisors reaches qualified trial candidates, retains them, and ensures they fulfill all requirements to bring a clinical trial to a successful, complete end. David is very excited to be a partner with SCOPE for the Participant Engagement Awards, and especially excited to highlight the innovation of engagement with study participants. He lives and works in New York City with his wife and two children.
Dennis Salotti, Senior Director & Head, Strategic Outsourcing & Clinical Innovation, Jazz Pharmaceuticals
Dennis Salotti is Senior Director & Head of Strategic Outsourcing & Clinical Innovation at Jazz Pharmaceuticals with a focus on building and executing clinical outsourcing strategies that maximize the value of our outsourcing relationships through innovation and operational efficiency. Prior to joining Jazz, Dennis lead The Avoca Group as Chief Operating Officer with accountabilities spanning across operations and commercial development. Dennis has 20 years of experience in the pharmaceutical industry across a variety of disciplines including clinical operations, eClinical technology, market research, business operations and strategic management. He holds a BS in Biology from Sacred Heart University, an MBA from the executive program at the New Jersey Institute of Technology and an MS in Clinical Research Organization Management from Drexel University where he also holds an adjunct faculty position.
Mary Frances Sassaman, Vice President, Project Delivery, ICON
Ms. Sassaman is a drug development professional with over 20 years of industry experience, predominantly in the CRO space, spanning first in human studies through phase 3 and post-marketing commitment studies. She empowers her teams to think creatively and strategically to solve issues and encourages teams to take a streamlined and pragmatic approach to study operations and delivery. Ms. Sassaman is particularly passionate about supporting small and emerging biotech companies and helping them to achieve their drug development objectives. She is a staunch advocate of transparent and collaborative communication with sponsor companies as a way of forging strong and lasting client relationships.
Jared Saul, Global Head, Healthcare + Life Sciences, Amazon Web Services LLC
Dr. Saul is the world wide lead for healthcare and life sciences at AWS focused on supporting the work of top investors and their most promising healthcare and life sciences startups-- bringing Amazon technology, resources and relationships to bear on the unique challenges and opportunities facing those at the cutting edge of healthcare. Dr. Saul began his career practicing clinical neuroradiology while also pursuing a variety of startup ventures and ultimately left clinical practice to fully pursue entrepreneurial ambitions as a founder, CTO, advisor and investor. Dr. Saul received his medical doctorate from the University of Medicine and Dentistry of New Jersey where he subsequently completed a residency in radiology. He then completed fellowship training in neuroradiology at the University of Arizona. He lives in New Jersey with his wife and two sons.
Gaurav Sawhney, Vice President, Head, Clinical Partner Management, Takeda Pharmaceuticals, Inc.
Senior executive with 25 years of global alliance management experience in the life sciences industry. A strategic leader with deep domain expertise in clinical research, life science technologies, RWE & RWD, and digital health. Currently oversees a global function responsible for oversight of all Clinical Supplier categories within R&D. Our mission is to curate the full value of our partnerships in delivering for patients and achieving Takeda's goals.
Scott Sawicki, MA, Senior Director, Strategic Sourcing & Vendor Management, ADC Therapeutics
Scott Sawicki is the Senior Director of Strategic Sourcing & Vendor Management at ADC Therapeutics. He has over 25 year’s career experience having predominantly worked in senior positions for large multi-national corporations, mostly as a R&D Sourcing professional. His varied industry experience with both sponsors and CROs includes R&D Sourcing, Supplier Relationship Management and Business Development, with sponsor companies Adare Pharmaceuticals, Novartis Pharmaceuticals, Aventis, and CROs Syneos Health and Covance. In 2020, Scott joined ADC Therapeutics as their Sr. Director of Strategic Sourcing & Vendor Management, leading ADCT's R&D team in selecting, negotiating, contracting, and providing business oversight and strategic insights of CROs and other suppliers in support of ADCT's R&D efforts, including Medical Affairs, Commercial and Marketing.
Seema Sayani, PhD, Senior Director, Life Sciences at Cognizant, Cognizant
Seema Sayani is an author and researcher by education and training. She has over 17 years of experience across the life sciences domain and drives key initiatives that create value for Cognizant's clients and partners alike. Seema currently leads the R&D practice for Cognizant's Life Sciences division, and in that capacity, helps enable services and create solutions for leading life sciences partners.
Richard Scaife, Vice President, Strategic Outsourcing & Vendor Management, VectivBio AG, PCMG Committee Member
Richard worked as an Intensive Care Unit Nurse in the UK and Saudi Arabia, managed a British Aerospace Medical Centre in Saudi, returning to the UK in 1990 to join Ciba-Geigy in Pharma sales roles, Sales Management and ultimately CNS portfolio Brand Management. He moved to the CRO sector in 1997 with Covance, then Fisher Clinical Services in Health Economics/Reimbursement and Marketing roles, then leading a BD and Proposals unit at Quintiles before joining Daiichi-Sankyo in 2005. The following thirteen years in clinical development outsourcing (moving to Mitsubishi Tanabe Pharma in 2009 to become Global Outsourcing Lead) have included EU and global level achievements ranging from creating a new outsourcing and contracts function, negotiating global CRO agreements whilst building long-term, effective, CRO working relationships. Since January 2017 Richard has been working on a freelance basis with financial, pharma and biotech companies on a broad range of clinical outsourcing projects whilst continuing his role as Committee Chair for the PCMG since 2013, having joined this Pharma outsourcing association in 2006.
Tina Schlecht, PharmD, MBA, Chief Pharmacy Officer at RxE2
Tina Schlecht is Chief Pharmacy Officer at RxE2. Her experience spans over 20 years in pharmacy and the biotechnology and pharmaceutical industries. She began her career at Clinical Supplies Management, Inc. (CSM) where she led the growth of Clinical Trials Research Pharmacist (CTRP) services. She went on to serve as president of Center Point Clinical Services. During her career, she was also employed by the National Community Pharmacists Association and ProPharma Group. Tina received her Bachelor of Science and Doctor of Pharmacy degrees from North Dakota State University and her MBA from the University of Oregon. Her pharmacy practice experience includes community and outpatient pharmacy in addition to clinical research.
Joan Severson, Chief Innovation Officer, Clinical ink
Joan is a human-computer interaction expert with over 20 years’ experience collaborating with pharmaceutical, government, and research institutions. Interdisciplinary by nature, her team integrates principles from computer science, medicine, engineering, human factors, and design to monitor patients’ real-world activity-including their behavior, cognition, voice, and movement. By delivering end-to-end, advanced technology capabilities, her work is transforming how virtual clinical trials are conducted.
Furat Shawki, Head, Product and Operations, Clinical Trials, NuvoAir
Furat carries 15 years of clinical trials experience, having held senior positions within both CRF Health (Signant Health) and Regeneron. Furat comes with a wealth of knowledge and exposure in developing improvements to patient-focused clinical trial solutions. He has led initiatives within eCOA, BYOD, Gamification, rare patient-population retention, and more, currently focusing on evolving the respiratory market space to bring improved care to patients.
David Sheleheda, Global Head, Clinical Operations, Integra LifeSciences Corp.
David Sheleheda holds a wealth of clinical research experience encompassing both the medical technology and pharmaceutical industries. He is currently the Global Head of Clinical Operations at Integra Life Sciences leading the gathering of clinical evidence for the complete lifecycle of Integra’s medical technology. Prior to Integra, David drove successful global clinical programs across multiple therapeutic areas for Novo Nordisk, Abbott Laboratories, and Pfizer. He also spearheaded the development of clinical operations organizations with solid underlying processes and high-performing cultures. A lifelong student of baseball, David understands that success requires applying the strengths and talents of all team members in constantly changing situations. He does so by leading through knowledge, positivity, and sincerity. David holds bachelor’s degrees in chemistry and English and received his MBA from Rutgers Business School. He also serves as a coach for youth sports, which probably taught him more than everything else combined.
Fei Shen, PhD, Managing Director, Boehringer Ingelheim Venture Fund
Fei received her Ph.D. in Neuropharmacology from Loyola University Chicago Stritch School of Medicine and a B.Sc in Biochemistry from East China University Science & Technology. In 2007, she started her industrial career at Theravance Biopharma as an in vivo pharmacologist and led a lab in driving multiple research projects from exploratory, lead optimization to development candidate nomination. In 2015, she joined Boehringer Ingelheim Pharmaceuticals Inc. Global Immunology and Respiratory Disease Research in Ridgefield where she started as a Laboratory Head and became the Head of in vivo Pharmacology group in 2016. In 2020, she joined the Boehringer Ingelheim Venture Fund USA as an Investment Director, and was promoted to be the Managing Director in 2021 and leads the US activities. She served as board member of Abexxa Biologics in Arlington and exited the company in 2021. Currently, she is on the Boards of Rgenta Therapeutics in Boston, ArrePath in Princeton and STRM. BIO in Cambridge.
Jie Shen, PhD, Director, Digital Science, AbbVie
Jie Shen, PhD is an innovative leader with a track record of building innovative solutions to address various drug discovery and medicine development problems. He is a Director of Digital Science at AbbVie, leading the digital health technology development, validation, and digital data analytics. Prior to his current role, Jie has led data science and advanced analytics capability development and execution for precision medicine, clinical trial optimization, digital health, and drug discovery at AbbVie and Eli Lilly and Company. Jie has published 50+ papers with more than 6000 citations.
Wanda Shoer, Head, Strategic Business Operations, Global Development, Johnson & Johnson
Wanda Shoer currently holds the position of Head, Strategic Business Operations, Global Development at Johnson & Johnson. In this role she oversees initiatives such as the Global Development talent management strategy, change and transformation capabilities, and learning & development strategy for clinical trials for Global Development. Wanda brings 20 years of experience in business operations, talent management, and learning. She has a track record of delivering business solutions and building effective partnerships across sectors and functions. Prior to her role in Global Development, she served as Global Head, IPV Strategy Realization where she played a critical role in delivering a new operating model. Prior to that, Wanda held the position of Strategy and Operations Support Leader for Global Medical Safety. Wanda joined Johnson & Johnson in 2012 as a Director in Global Talent Management and held several roles leading enterprise-wide initiatives aimed at enhancing employee experience and delivering operational excellence globally. Prior to joining J&J, she worked across multiple industries in Human Resources, IT, and Talent Development. She spent 10 years both in-house and consulting on organizational change and process improvement in the pharmaceutical and investment banking industries. Wanda holds a BA in Italian Studies and Economics from Wheaton College and an MBA from Simmons University.
Michelle Shogren, CEO & Owner, Innovate in What You Do!
Michelle is the Sr. Director of Innovation in Pharma R&D Clinical Operations at Bayer. She has over 20 years of experience in Clinical Research across many different roles. She began her journey as a research nurse and site director. From there she became a Clinical Research Associate at a CRO, and finally joined Bayer in 2008 where she has held multiple roles in: Clinical Operations; Training and Quality; and now in Business Excellence and Innovation. Michelle’s greatest passion is customer-focused innovation and responding to the voice of the patients and sites.
Kelly Simcox, Global Head, Clinical Operations R&D, Sanofi
Kelly Simcox is the Global Head of Clinical Operations at Sanofi U.S., and is based in Bridgewater, NJ. In this role, Kelly is responsible for global resources delivering >100 ongoing clinical trials/year; Kelly believes strongly in the power of strategic partnerships to achieve delivery. With over 29 years in the industry, Kelly’s background includes toxicology preclinical research, including various publications in peer-reviewed journals. In 2012, Kelly received the Rising Star award from Healthcare Businesswomen’s Association. Kelly has worked abroad and holds leadership roles representing Sanofi in cross-industry consortia. Recent external speaking events include virtual clinical trials workshop with The National Academies of Science, Engineering & Medicine and opening remarks at Gender Parity congress.
Sumeet Singh, CEO, Pharma Solutions
Sumeet Singh is the Founder & CEO of Pharma Solutions (fka Five Rivers RX). Sumeet founded Pharma Solutions in late 2015 and has grown the company into a premier SaaS and professional services provider to the life science supply chain, with over 50 employees and over 600 clients engaged. Sumeet is a three-time founder with two previous exits to strategic buyers.
Rajbir Singh, MD, Executive Director of Precision Medicine and Health Equity Trials Designs, Meharry Medical College
Dr. Rajbir Singh, Director of the college’s Clinical and Translational Research Center, said Meharry’s primary mission - education - includes Operation Warp Speed to provide Americans with a safe and effective vaccine to protect them against COVID-19. Dr. Singh is co-investigator with Dr. Berthaud and serves as Meharry’s contact person for volunteers.
Nick Slack, CEO ThesisDrive, Former President WCG Clinical
Nick Slack has spent his entire career in leadership positions at organizations that bring meaningful innovation and transformation to the clinical trials industry. Through his advisory practice, ThesisDrive, Mr. Slack sits at the cross-section of the investment community, operating companies, and healthcare organizations to align interests around new approaches to solve persistent challenges in healthcare. Mr. Slack was most recently President of WCG Clinical, a leading provider of solutions that measurably improve the quality and efficiency of clinical research. During Mr. Slack’s 10-years at WCG, the Company supported 90% of the new therapies approved by the FDA, acquired 31 companies to streamline the process of clinical research, and transformed the process of IRB oversight of clinical trials. Prior to joining WCG, Mr. Slack was an expert advisor to biopharmaceutical companies, research institutions, and contract research organizations - serving in roles as a management consultant, an accreditor of research programs, and an operational leader at Schulman Associates IRB (Advarra).
Sandra Smith, RN, MSN, AOCN, Senior Vice President, Clinical Solutions & Strategic Partnering, WCG
Sandy is an oncology-focused healthcare leader who has spent her career partnering with physicians and other healthcare stakeholders to drive customer value and clinical excellence in patient-centric oncology services.
Prior to WCG, Sandy was VP of US Oncology Research, where she worked with more than 1,000 investigators and their site staff to integrate lean six sigma processes and technology solutions to redesign clinical trial workflows for operational efficiency, reduced study start-up times, and data integrity.
Eric M. Snyder, Partner, Novo Ventures (US), Inc.
Eric Snyder is a Partner at Novo Ventures, where invests in biotech, medtech and digital health companies. Novo Ventures invests on behalf of the Novo Nordisk Foundation, one of the world’s largest philanthropic organizations with a vision to improve health and society. Before joining Novo Ventures, Eric earned a PhD in Neuroscience from Brown University and worked in strategic healthcare consulting.
Rachel E. Sobel, PhD, Executive Director & Head, Pharmacoepidemiology, Regeneron Pharmaceuticals, Inc.
Rachel E. Sobel, DrPH, FISPE is currently Executive Director and Head of Pharmacoepidemiology within Global Patient Safety at Regeneron Pharmaceuticals in Tarrytown, NY. Dr. Sobel is an epidemiologist with more than 20 years of experience in epidemiology, safety, and risk management strategy for biopharmaceutical products in a wide variety of therapeutic areas, including autoimmune, rare, and pediatric diseases. She leads a group of pharmacoepidemiologists responsible for the design and conduct of RWD studies to support safety evaluation across the Regeneron portfolio. Prior to joining Regeneron, she worked at United Biosource Corporation (UBC), a CRO, as Vice President, Epidemiology and Strategic Consulting after spending almost 20 years in roles with increasing responsibility in the Epidemiology group in Worldwide Safety at Pfizer Pharmaceuticals in NY, NY. Dr. Sobel has expertise in the use of real-world evidence for safety assessment, surveillance, and regulatory decision-making, and in the design, implementation, and analysis of observational studies and registries, including long-term global safety studies and PASS. She is an inducted fellow and an active member of the International Society for Pharmacoepidemiology (ISPE). Dr. Sobel has published in peer-reviewed journals, presented at major scientific meetings, and in textbooks such as Strom’s Textbook of Pharmacoepidemiology. She received her Doctorate and Master’s degrees from the Mailman School of Public Health of Columbia University, and her undergraduate degree from Barnard College in New York.
Rachel Soon, Director, Janssen Clinical Innovation
Rachel was trained as a pharmacist in Australia and started her career in the industry at the Novartis Institutes for BioMedical Research where she held roles in clinical operations, clinical sciences, patient engagement and advocacy, and clinical innovation. In light of the pandemic, she was assigned to lead the development and transition of ‘Next-Gen’ trial capabilities - including patient-centric trial models, digital platform solutions, and novel recruiting strategies - from pilot phase to systematic implementation across the early phase portfolio. Rachel was thrilled to join the Janssen Clinical Innovation team in 2022 where she continues to explore non-conventional trial models and recruitment solutions which aim to increase access to clinical trials for both physicians and patients, while also supporting the charge to develop strategic initiatives that encourage Diversity, Equity, and Inclusion in clinical trials at Janssen.
Michael Sorensen, Partner, QHP Capital
Michael is responsible for transaction origination and execution, portfolio company value creation initiatives, investment policy, and investor relations at QHP Capital (who manages NovaQuest Private Equity). Prior to joining QHP Capital, Mr. Sorensen was a director in BlackRock’s private equity group. In that role he was responsible for making investment decisions in a wide variety of geographies and industries, including healthcare, technology, and consumer/retail, among others. Prior to BlackRock, Mr. Sorensen worked at Sorenson Capital (no familial relation), a mid-market private equity firm based in Salt Lake City. Similar to his current role, he analyzed private companies in a wide range of industry sub-sectors and geographies. Mr. Sorensen also worked as a consultant for L.E.K. Consulting in Los Angeles, where he worked closely with clients’ senior management on projects that included asset optimization, strategic planning, and customer segmentation, primarily in the healthcare and media industries. Mr. Sorensen has an undergraduate degree from Brigham Young University, an MPA from Harvard University, and an MBA from the Wharton School at the University of Pennsylvania.
Matt Sowards, CIO, Scout Clinical
Matt is the Chief Information Officer for Scout Clinical, managing compliance, finance, and strategic partnerships. He has 15 years of experience working with companies to improve their technology, operations, and finances across a wide variety of industries. He brings this experience to Scout Clinical and helps leverage technology so we can focus our human capital on the constantly evolving needs of our clients, attendees, and patients.
Nicole Stansbury, Principal Consultant, BioTex Consulting LLC
Nicole has 30 years of experience in the industry, beginning as a study coordinator in a multi-therapeutic site, followed by 25 years at large, global CROs where she spent several years as a Clinical Research Associate (CRA) and Project Manager (PM) before moving into leadership roles. Nicole’s leadership roles included Head of Clinical Trial Management, Head of Central Monitoring, and Head of Global Clinical Performance, a group responsible for clinical metrics, systems, processes and quality.
Rene Stephens, MSHS, Independent Consultant
Rene Stephens is a biopharmaceutical research and development industry consultant with over 25 years of business operations, outsourcing, and relationship management experience. He has worked within large and small pharma/biotech, CRO, SMO, medical imaging, and academic CRO companies, fulfilling roles ranging from individual contributor to global functional head. Rene understands the critical path of development and has a wealth of experience in outsourcing/procurement strategies and practices; vendor oversight, governance, and strategic relationship management; budget and contract negotiations (vendor and site level); clinical operations and finance management; process development and improvement; and technology solutions. Rene holds a BA in Corporate & Organizational Communications (WKU), and an MSHS in Clinical Research Administration (GWU). He has been providing outsourcing and relationship management consulting services to various R&D companies since 2018. While at Astellas Pharma Global Development as Executive Director and global head of Contracts & Outsourcing, Rene also served as the Global Procurement Lead for TransCelerate Biopharma, Inc., acting on behalf of and supporting the 20 biopharmaceutical company consortium for vendor selection, negotiation, and governance. He is the standing moderator for the quarterly Linking Leaders Outsourcing Roundtable meeting, where current issues are discussed among development outsourcing heads; and is a regular speaker at conferences and symposia on business operations topics related to drug development, outsourcing, and vendor negotiation, management, and oversight/governance.
Dave Stevenson, COO & Managing Director, Merck Global Health Innovation Fund
Dave Stevenson is COO & Managing Director and a founding partner of GHI Fund since inception in 2010. Dave is responsible for identifying opportunities broadly across digital health and also manages the GHI portfolio and operations. Dave brings more than 25 years of healthcare strategy and operations expertise to the GHI team. Prior to Merck GHI, Dave was Head of U.S. Strategy at Sanofi responsible for development of the company’s new commercial models. Dave started his career with Novartis where he built their first clinical trial management system. He holds a MBA from Vanderbilt University and a B.A. from Washington University.
Lucy Stone, Clinical Evaluation Specialist, Vascular Devices Team, BSI
I am a BSN RN, with 26 years of hospital acute care experience, including post open-heart step-down recovery, critical care unit, cardiac catheterization, and electrophysiology lab, and interventional radiology (including neuro-intervention). I have 10 years of medical device industry experience in post-market safety surveillance, for devices in vascular, neurologic, and orthopedic applications. I have been with BSI for just over two (2) years and received my NBOG code competency as a clinical evaluation specialist. I am currently part of the clinical evaluation sub-team in the Vascular Devices Team at BSI Regulatory Services.
Crystal Stone, Director, Customer Engagement, Remarque Systems
Crystal Stone is the Senior Director, Customer Engagement at Remarque Systems. Crystal brings expertise from over 20 years of experience in R&D, clinical trial operations and management to her leadership role with Remarque Systems. In her current role, she leads a team of data and software subject matter experts to provide Remarque’s customers with strategic, operational, and technical services. She has a Bachelor’s degree in Biomedical Engineering.
Matthew Studney, Vice President, MRL IT, Merck & Co.
Matt Studney is the head of IT for Merck’s Research Laboratories (MRL) division, where he is responsible for all aspects of information technology from strategy to implementation for the Merck R&D function. As a strategic partner to the Research Leadership Team and member of the IT Leadership Team, his mission is to bring the power of technology to reimagine and accelerate how we translate breakthrough biomedical research into meaningful new therapies and vaccines that improve and extend the lives of people worldwide. Matt has more than 20 years of experience at Merck, across multiple business areas including Merck Research Laboratories (MRL), Merck Manufacturing Division (MMD), Corporate Strategy and Information Technology.
Mats Sundgren, PhD, Senior Industry Scientific Director, i-HD (European Institute for Innovation through Health Data)
Mats Sundgren, PhD, MSc, is a renowned expert in Health Data Strategy for Industry and Academia. Following a 12-year tenure as global integration lead for Electronic Health Records (EHR) services at AstraZeneca, Mats’ new portfolio encompasses the roles of Senior Industry Scientific Director for the i~HD (European Institute for Innovation through Health Data); Executive Strategic Advisor for IgniteData, developer of a system-agnostic EHR-to-EDC solution for clinical trials; and board member of the new Centre of Health Governance, University of Gothenburg. With over 37 years in the pharma industry (Discovery, Development, Manufacturing, IT R&D, Patents, Clinical Science and Data Science & AI), Mats is at the forefront of industry technology innovation. Career highlights at AstraZeneca include co-ordination of the European Innovative Medicine Initiative (IMI) EHR4CR project, pioneering trustworthy scalable Federated EHR research platform services (paving the way for commercial platforms such as InSite, TriNetX, Flatiron, Clinarion, and DEEP6). He also spearheaded AstraZeneca’s health data eSource capability build program for clinical trials, and co-led the EIT Health sponsored EHR2EDC project with European hospitals along with Sanofi, Janssen and ICON. Mats has authored over 70 publications, books and patents in Science and Economics (Health Data Science, Clinical Science, Medical Informatics, Business Modelling, Innovation & Creativity Management, and Device development.
Melissa Suprin, Head, Quality Risk Management, Clinical Development, Pfizer Inc.
Dr. Suprin completed her undergraduate studies in Chemical Engineering at Villanova University, has an MBA from the University of Rhode Island, and is a Lean Six Sigma Black Belt. She also has a Doctorate in Law and Policy from Northeastern University. Her career spans manufacturing, research, quality, EH&S, strategy, and operations. She started with air products and chemicals as a Production Engineer, moved to R.R. Donnelley and Sons as a Manufacturing Supervisor, and then transitioned to Pfizer in 2001. Her roles at Pfizer have given her a breadth of experience across Pfizer’s divisions and functions. Her leadership in operations and expertise in risk management led to her current role at Pfizer as the Head of Quality Risk Management for Clinical Development. She is the lead author of the TransCelerate paper on risk management, a contributor to the Quality Tolerance Limits publication and the lead of TransCelerate’s ICH E6/E8 workstream.
Lauren Sutton, Senior Director, Product Management, Clinical Research, Flatiron Health
Lauren Sutton is a Senior Director of Product Management at Flatiron Health where she leads the clinical research product team. Prior to Flatiron, Lauren worked as an oncology clinical research associate with Quintiles.
Lindsey Swank, MEd, Coordinator, Interactive Web Events, Barnett International
Ms. Swank earned her Master's of Education in 2015 and began her career teaching special education. After working with both elementary and high school students with a range of disabilities, she began working as an Adjunct Professor in the Special Education Department at East Tennessee State University. Lindsey wholly enjoys adult learning principles, which has led her to a position with Barnett International as a Web Events Coordinator, where she works with adult learners in a variety of clinical research training programs. She is focused on ways to make web-based events more impactful, engaging, and navigable for learners.
Shawntel Swannack, Director, Central Monitoring & Data Analytics, GSK
Shawntel Swannack is the Director of Central Monitoring and Data Analytics at GSK. Her career has spanned over the last 22 years in clinical research as a coordinator at the site level, CRO Clinical Research Associate (CRA), Sponsor CRA, Data Management, Asset Lead, Central Monitoring Lead, Manager to Director. Her passion has always been driven to help people live their best lives. Whether for the patients’ health through the clinical trials or the careers of her colleagues, seeing people thrive, inspires her desire for success. For the last 12 years, her passion for effective ways of working and day to day efficiencies with pristine focus on data integrity and quality has driven her career to Risk Based Quality Management.
Lindsey Synder, Account Executive at Life Science Connect - Clinical Leader
Lindsey Snyder is passionate about improving the drug development process to help get treatments to patients. After getting a PhD in neuroscience, she worked in the start-up space for several years helping early-stage life science companies communicate their value propositions and execute their go-to-market plans. Now, at Life Science Connect and Clinical Leader, she works with clinical research organizations and clinical technology companies on their content marketing plans to help connect them with drug development companies looking for support with their clinical trials.
Ying Tabak, PhD, VP, Global RWE & HEOR, UBC
Dr. Tabak joined UBC in 2022 and brings more than 20 years of multidisciplinary knowledge and extensive leadership experience in real world evidence (RWE), health economics and outcomes research (HEOR), epidemiology, and data science. In this role, Ying leads UBC’s global RWE business and is responsible for the development and implementation of evidence generation strategies, powered by rigorous science, designed to create exceptional value for stakeholders.
Michael Tanen, Director, Head of Laboratory Operations and Logistics, Merck
Michael Tanen is the director of the Clinical Biomarker Specimen Management group at Merck Research Laboratories. Michael leads a group that is responsible for collection, tracking, and storage of clinical biomarker specimens collected in clinical trials. During his 20 years at Merck he has been involved in the utilization of clinical biomarker specimens from the prospective of discovery research through the usage for diagnostic development. His team has established an industry leading specimen management solution that support data integration between clinical data and specimens, improving how we make utilization decisions in the complex area of biomarker research.
Leslie Taylor, Director, Global Clinical Supply Chain Technologies, Incyte Corp.
Leslie has over 20 years of experience working in Pharma, 13 years of which have been within Clinical Supply Chain. Leslie is an advocate for the development of forecasting models with IRT integration to ensure accurate and continuous supply to programs while reducing risk in end to end planning. Her work with Robotic Process Automation at Incyte has streamlined IRT integration by allowing her organization to autonomously prioritize and execute integration with reduced cost and lead time. Leslie supplements the forecasting models with custom-built tools to visualize localized risk of missed patient doses across the portfolio.
Michele Teufel, Site Management & Monitoring Therapy Area Strategy & Portfolio Delivery, Development Operations, AstraZeneca Pharmaceuticals, Inc.
Senior Director, Therapy Area Strategy & Portfolio Delivery within Development Operations, over 20 years in various roles within Clinical Operations, where I delivered early and late phase clinical studies across different therapeutic areas. I was responsible to ensure project standards and scientific requirements from study design concept through study closeout. Currently, I am working within our Site Management and Monitoring Organization. In this role, I ensure consistent communication and collaboration across clinical operations, study management, and the country teams across the globe.
Jaydev Thakkar Thakkar, Chief Operations Manager, Director, Biofourmis
Jaydev currently leads Biofourmis global operations across various business functions, including Customer Success, Sales and Marketing Operations, Clinical Research Operations and Supply chain. Jaydev has over 25 years of experience in leadership roles at organizations that include fortune 100 companies and rapidly growing start-ups. Prior to Biofourmis, Jaydev was instrumental in founding a Digital Health and Innovation group at world’s leading biotech, Amgen, where he served for 14 years. During this time, he led its “beyond the therapy” digital innovation strategy to maximize product value and clinical outcomes across the patient journey-from clinical development through product launch and post-marketing. At Amgen, Jaydev also led information technology operations for the company’s large portfolio of global clinical trials-including some of the largest ever in the industry, with more than 27,000 participants across 50 countries and more than 1,000 sites. Before Amgen, Jaydev was a telecommunications, technology and finance consultant who co-founded a technology startup and also managed his family’s manufacturing business in India.
Piet Theisohn, Vice President, Resource Management, Clinical Development & Operations, R&D Clinical Operations, Bayer AG - Pharma
More than 25 years of experience in various areas of Pharma R&D, from IT strategy and operations over Research support, scientific information to Clinical Operations and Development. Over the last decade, significantly expanding responsibility to manage the external clinical study cost (grants and CROs) and the resources for Clinical Operations.
Kevin Thomas, PhD, Director of Artificial Intelligence, Research & Development, Clario
Before Clario, Kevin co-founded Saliency, a Silicon Valley-based startup developing AI-enabled medical imaging biomarkers. The startup was acquired by Clario in 2020. Kevin has a Ph.D. in biomedical informatics from Stanford University and completed the first two years of medical school at Stanford School of Medicine. Before attending graduate school, he conducted research in Canada as a Fullbright Scholar.
Katie Thrush, Section Manager, Clinical Operations & Clinical Planning, Abbott Laboratories
Katie has been a clinical operations professional for 25 years. She leads a team of clinical project managers and the clinical planning and resource management group at the Nutrition division of Abbott Laboratories. She is energetic and passionate about patient engagement and evolving clinical trial management through efficiency improvements and the implementation of new technologies and serves on several committees at Abbott on these topics.
Aman Thukral, Director & Head, Clinical Systems & Digital Operations, AbbVie, Inc.
Aman Thukral is the Head of Clinical Systems & Digital Operations at AbbVie. He has over twelve years of experience in clinical development, technology planning & business-technology alignment. In his current role, he is responsible for eCOA operations, wearables and sensors, piloting new technology initiatives. Before this position, he had worked in Deloitte, Cognizant & GlaxoSmithKline at various levels.
Robert Thwaits, Managing Director, Declaration Partners
Robert Thwaits is a Managing Director and a member of the growth equity investment team where he focuses on healthcare. Prior to joining Declaration in 2021, Robert spent seven years at Warburg Pincus investing in healthcare growth companies. He began his career at Barclays in the Healthcare M&A Investment Banking Group. Robert graduated from Harvard College, where he studied Economics. He earned his MBA from Stanford’s Graduate School of Business where he was an Arjay Miller Scholar. Robert currently serves on the board of Springtide, a Redesign Health portfolio company, and is a Board Observer at PetDx. In his spare time, Robert enjoys international travel, board games, and science fiction.
Lisa Tindell, Vice President, Clinical Research Operations, Sponsored Clinical Trials, Minneapolis Heart Institute Foundation
Lisa Tindell is the Vice President of Clinical Research Operations at MHIF. In this role, Lisa leads a team of 40 clinical staff that execute on all types of cardiovascular studies across all areas of the cardiovascular specialty. In the 15+ years dedicated to clinical research, Lisa previously as a Principal Clinical Research Scientist at Boston Scientific where she successfully managed the execution of clinical trials in both the domestic and international spaces. She also served as a Clinical Advisor for the Electrophysiology Division in which she’s authored worldwide pre-market and post-market clinical trial protocols and regulatory reports in support of post market requirements, product approval, indication expansion and label claim support. Lisa has over 35 years of professional nursing experience in critical care settings, electrophysiology lab and cardiac rhythm device patient management as well as experience as a cardiology nurse clinician.
Kara Titus, Head of Clinical Vendor Management, Sage Therapeutics
Kara has over 18 years of experience in the Pharmaceutical/Biotech industry, with 12 of those being in various roles overseeing clinical vendor relationships. Her passion is for developing internal and external relationships to help serve the organizational needs, leading and developing individuals in a motivational, empowering way, building trust to help the business thrive.
Francois Torche, Co-Founder & CEO, CluePoints
Over the past 18 years in the pharmaceutical industry, Francois has held positions as statistical programmer, SAS and JAVA developer, and IT project leader for companies such as GSK, UCB, and IDDI. During his ten-year tenure with IDDI as an IT Specialist, Mr. Torche assisted in the development of the SMARTo engine, a patent-pending software solution and the underpinning of CluePoints. Francois has served as CluePoints’ CEO since the company’s inception in 2012.
Norris G. Turner, PharmD, PhD, resident & CEO, Turner Healthcare Quality Consulting, Inc.
As President & CEO at Turner Healthcare Quality Consulting, Inc., I lead engagements with biopharmaceutical clients in the development and implementation of health care quality strategy with the aim to optimize market access strategy and impact for prioritized brands. We work hard to understand biopharmaceutical clients’ pain points and opportunities and where we can help solve problems and deliver value. We help biopharmaceutical companies, particularly those that are small-to-medium size, “stand in the shoes” of their prioritized payer and provider (including pharmacy) customers. The value-based payment paradigm shift with the aim to progressively advance on the Quadruple Aim - the tenets of which are to improve patient experience, improve provider experience, improve population health outcomes, and do so at lower cost - compel the need for a quality strategy by organizations committed to the development of biopharmaceuticals in the quest of improving human health. Based on my 20 years as an executive in the pharmaceutical industry, working across a diverse range of functions (i.e., clinical development, medical affairs, market access, quality strategy), I gained strong marketplace knowledge of the challenges and opportunities confronting the biopharmaceutical industry to achieve optimized market access. This experience is complemented by my health policy and quality expertise, from a two-year health policy educational certificate program, four years in a healthcare quality strategy role at Johnson & Johnson, and almost two years as a senior executive at a non-profit, quality measure development organization in the Washington D.C. area.
Kris Ulstad, Staff Clinical Software Engineer, Clinical Data Operations, Abbott
Kris architects and developments custom software to automate and improve efficiencies within various facets of clinical trial operations and management. This includes web-based applications, mobile applications, customized reporting and database objects. Kris joined Abbott in January 2017 when the company acquired St. Jude Medical
Caro Unger, Director, Clinical Operations, Kinnate Biopharma, Inc.
Oncology clinical operations professional with over 15 years of industry experience providing oversight on all phases of studies: global phase III confirmatory to phase 1 heathy volunteer. Have worked in melanoma, prostate, ovarian, solid tumor, AML, myelofibrosis, CLL/SLL, pancreatic, CRC, RCC, NCSCL, HCC, pediatrics, basket, and platform trials.
Jason Urban, PhD, Executive Director, R&D Quality Risk Management, Governance, & Analytics, Gilead Sciences
Jason leads Gilead's R&D Quality Data Science and Risk Programs assuring visibility and mitigation of issues and risks across GxP R&D activities. As head of these programs, he is shaping the strategic direction on Quality Analytics & Insights and Quality Risk Management, focusing on the risks that matter through the enabling of a culture of risk awareness, action, and ownership. Jason brings over 18 years of leadership across the public and private sectors in the fields of risk management, quality operations, analytics, and business strategy. Prior to his current role, Jason led Alexion AstraZeneca Rare Disease Quality Compliance & Risk group. While in this role he established Alexion’s end-to-end GxP Risk Management program and delivered a harmonized approach to Risk-Based Quality Management (RBQM) in R&D Clinical operations. Prior to Alexion, Jason held leadership positions at Bristol Myers Squibb and Celgene in risk management. Before taking on his roles in pharmaceuticals, Jason led policy and risk program development activities in the areas of quality analytics, regulatory compliance, supply chain, and operations at the US Food and Drug Administration. Jason holds a PhD in Cellular Biology and is an active member of the editorial board of Life Science Leader Magazine.
Taylor Uttley, Senior Director, Head of Strategy and Operations, Data Strategy & Solutions, Vertex Pharmaceuticals, Inc.
Taylor Uttley is the Head of Strategy and Operations for the corporate data science team at Vertex Pharmaceuticals, where she has worked for almost 14 years. She has held several roles of increasing responsibility in trial operations at Vertex. Taylor has applied innovative strategies as an operations program lead to multiple rare disease programs, where her teams have achieved industry-leading speed in execution. In her current role, she leverages her deep expertise in development execution to identify opportunities to deploy machine learning and AI for business efficiencies and decisions in clinical trials, commercial and other areas. She also leads the industry's only MBA AI program across Vertex which is focused on grooming next generation AI savvy leaders across business units.
Eddie Valaitis, Director, Pharma and Life Sciences, R&D Analytics & AI, PwC
Dr. Eddie Vallaitis has developed and leads a large team of data scientists and management consultants who design and implement transformational programs for embedding cloud-based analytics, AI and automation into business processes to accelerate drug development at leading pharma companies. Dr. Valaitis has a PhD in Mathematical Statistics from Yale University and has over 15 years experience in the Pharma & Life Sciences industry.
Andrea Valente, CEO, ClinOne
Andrea Valente is a transformational leader with more than 20 years of consistent over-achievement and demonstrated success in life sciences technology product development, delivery operations, customer loyalty, and M&A strategy.
Andrea joined ClinOne from Medable where she served as Chief Operating Officer. Prior to Medable, she was Vice President of Pandemic Response Systems at Oracle, where she led business development, product development, and service delivery of the cloud-based Oracle Health Management System (OHMS). She also led the partnership with the Tony Blair Institute for Global Change to deploy OHMS in Africa.
At ERT, Andrea was the Executive Vice President, Chief Development Officer, and member of the Senior Leadership Team. During her tenure at ERT, she had global leadership responsibilities for Research and Development, Innovation Lab, and Information Technology. She was a key participant in critical business growth and transformation activities which included executing four strategic acquisitions and ensuring the successful sale of ERT from Genstar Capital to Nordic Capital.
Haleh Valian, PhD, Director, Quality Analytics, Biogen
Haleh is Biogen's Head of R&D Data & Quality Analytics. She has more than 21 years of expertise utilizing sophisticated analytics to solve complex business problems involving process optimization, statistical modeling, predictive modeling, data mining, and data monitoring in a variety of industries, including pharmaceutical, healthcare, and financial. She holds a bachelor's and a doctorate in Industrial and Systems Engineering.
Saartje Vansteenkiste, Director, Global Clincial Operations, CSL Behring
A passionate, dynamic, and forward-thinking leader with more than 17 years of international experience in a variety of leadership roles in the pharmaceutical industry. Skilled in global clinical operations, change and performance management, and building/leading high-performing global teams. Ability to effectively engage, adapt, and lead in a rapidly evolving environment. Passionate about working with people, driving teams, and building network at all levels. Global experience in working across multiple geographical areas including Europe, U.S., Emerging Markets, and Asia Pacific.
Christina Villar, Head, Global Clinical Operations, Philips Healthcare
Christina Villar joined Philips as Head, Global Clinical Operations in April 2016. In her role Christina is responsible for the oversight of clinical studies globally across Philips. Prior to joining Philips, Christina consulted as the Lead Business Process Expert for clinical business process modelling and framework deployment. In this role Christina dynamically engages business leadership across Philips functional areas to drive business practice change. Christina Villar is a pharmaceutical and medical device executive and consultant with more than 25 years of experience overseeing public health, policy, preclinical and clinical research conducted by industry, contract research organizations, academia, and non-governmental organizations. Christina has partnered with international regulatory authorities, including US FDA, the UK DFID, and the Netherlands RIVM in the development and implementation of training initiatives for industry in the areas of GMP, GLP, vaccine manufacturing, product release and testing, and GCP. While working with the World Health Organization in Geneva, Switzerland Christina collaborated with USAID, World Bank, and other donor organizations to establish and fund a critical childhood vaccine training initiative. Christina received a Master in Public Health degree, International Health Policy from George Washington University, Washington DC and a Bachelor of Arts degree in International Relations from the American University, Washington DC. Christina has led the conduct and oversight of anti-infective, surgical, ophthalmology, cardiovascular, immunology, biologics, and oncology device, drug, and combination product studies both nationally and internationally. At Johnson and Johnson Christina led the Vision Care clinical affairs team to conduct more than 400 clinical trials in five years through lean, process led management. Christina was formerly with Stealth Peptides, Inc. where she conducted preclinical and clinical research in cardiovascular and ophthalmology indications for new chemical entities manufactured in China. Christina has expertise in Good Manufacturing Practices (GMPs), Good Laboratory Practices (GLPs), and Good Clinical Practices (GCPs) as they apply to research and manufacturing of drug and biological products in Asia, Europe, Latin America and the United States. Prior to her role with Stealth Peptides, Inc. Christina was Director, Clinical Research with IOMAI Corporation (currently Intercell Vaccines) where she was instrumental in the development, evaluation and submission of a novel vaccine delivery system combining a biologic with a device.
Michael A. Walega, Head, Centralized Monitoring, Bristol Myers Squibb Co.
Michael Walega is the Head of Centralized Monitoring at BMS. In this capacity, he is responsible for providing protocol teams with actionable insights to achieve higher quality, ensure that centralized monitoring processes are aligned to ICH E6 (R2), and championing risk-based quality management approaches to clinical trial monitoring activities. He was previously at Covance, where he led the team responsible for development and growth of Covance’s Risk-Based Monitoring (RBM) solutions, processes, and operational delivery. Additionally, while at Covance, he led the Late Stage Biostatistics and Programming groups, as well as the Process Excellence team. Mike is a qualified Biostatistician and a Six Sigma Master Black Belt.
Adrienne Walstrum, Program Director, Merck & Co.
Adrienne Walstrum has worked in clinical trial operations for twelve years. She is currently a Program Director with Global Trial Operations at Merck focusing on feasibility and patient recruitment strategies across the Oncology and Hem-Onc Portfolios. She holds a Master’s of Science in Management with a concentration in Organizational Leadership from Wilmington University.
Matt J. Walz, CEO, Trialbee
Matt is the CEO of Trialbee, a company dedicated to creating the future of global patient recruitment and enrollment for clinical trials. In 2021 Trialbee was named one of PM360’s Most Innovative Companies and in 2022 Matt was named to the PharmaVoice 100, recognizing the most inspiring individuals in Life Sciences. A software engineer at heart, Matt was introduced to clinical development early in his career while working at Microsoft when he was assigned to an initiative with a large pharmaceutical company. Matt later founded NextDocs, a venture backed software company which grew to be a global leader in clinical, quality and regulatory document management with offices in the US, Europe and Japan. NextDocs was acquired by Aurea Software in 2015. Matt and his family of six are natives of Wilmington, Delaware and he received his Bachelor of Science in Computer Science and Master of Business Administration both from University of Delaware.
Xia Wang, PhD, Head of RWE Early Solution, Global Real World Evidence and Digital Sciences, UCB
Xia currently is a senior leader at UCB to manage a talent team and drive the strategic development & implementation for R&D in delivering integrated real-world evidence (RWE) across full cycle of medicines development. Previously Xia held a Director position at Data Science & Artificial Intelligence (DSAI) group within the AstraZeneca R&D organization, where Xia led the health data science efforts in RWE to support clinical development, epidemiology, innovative payer strategy and market research. Prior to stepping into the clinical divide, Xia was with the AstraZeneca Neuroscience Discovery in the areas of informatics and computational modeling to support early drug discovery in lead identification and lead optimization. Xia holds a Ph.D. in computational chemistry.
Li Wang, PhD, Senior Director & Head, Statistical Innovation, AbbVie, Inc.
Li is a Ph.D statistician with more than 15 years of pharmaceutical development experience from phase 2 to phase 4. Currently, Li is Senior Director, Head of Statistical Innovation Group, in AbbVie Data and Statistical Science. The responsibilities of his group include statistical innovative methodology, publication, consulting, advanced predictive modeling and machine learning/deep learning projects. Li is leading Design Advisory initiative in AbbVie to provide quantitative and strategic consulting for all study teams in six Therapeutic Areas. Li is also co-leading Development Advanced Analytics capability in AbbVie to partner with Development organization and Key R&D partners to drive innovative deployment of advanced analytics and ML/DL in AbbVie drug development to benefit patients ultimately.
Stephanie Weber, Vice President, SampleGISTICS, SampleGISTICS, LabConnect
Stephanie is one of the industry’s leading experts in virtual global sample tracking and management, overseeing LabConnect’s Advanced Therapy and SampleGISTICS services. She joined LabConnect in 2009 bringing more than 10 years of combined central and specialty laboratory project management experience across domestic and global clinical trials. Stephanie has spent the last decade working with top pharma clients to help develop LabConnect’s comprehensive sample tracking platform, SampleGISTICS™.
Irena Webster, Vice President, Head of Development Operations, Forma Therapeutics
Irena Webster is the Vice President, Head of Development Operations at Forma Therapeutics. Irena oversees Clinical Operations and Biometrics, leading the planning and oversight of operational strategy and trial execution. Prior to Forma, Irena served as Director, Head of Early Clinical Development Operations at Sage Therapeutics, where she led an operational team that worked closely with the lead optimization, translational, and medical teams focused on experimental medicine, including signal-finding trials and biomarker development in neurological disorders and rare disease. Prior to Sage, she worked at Alkermes where she was the Clinical Operations lead on multiple clinical programs across depression, schizophrenia, addiction and reward disorders. Throughout her career, Irena has led global trial execution in cardiovascular disorders, oncology, rare diseases, and central nervous system disorders, contributing to multiple NDAs and sNDAs. Irena earned a Master of Public Health degree from New York Medical College.
Neil Weisman, President, Continuum Clinical
Neil Weisman is the president of Continuum Clinical, one of the largest, independent patient recruitment firms that is partnering with five of the top six pharmaceutical and biotech companies. Neil has been a leader in patient engagement, recruitment and retention for more than 23 years. During that time, he has seen the industry evolve from newspaper, radio and, occasionally, television outreach to full dependency on the Internet of Things.
Chris Wells, Study Statistician, Roche Pharmaceuticals
Chris Wells MSc graduated from Hertfordshire University with a BSc in Business Decision Sciences, followed by 5 years as a Data Manager for GSK and a smaller pharma. This was then followed by attending the London School of Hygiene and Tropical Medicine where she graduated with an MSc in Medical Statistics and moved into a career as a biostatistician. She worked initially as a statistician for a clinical research organization and then joined Roche Products, UK Ltd in December 2008. During her time at Roche Products Ltd, Chris has worked as the study statistician on a range of clinical studies ranging from early to late development leading a number of them into filing. Chris was instrumental in bringing Growth Analysis to Roche and has been involved in sharing this knowledge across the company. Since 2016, Chris has been instrumental in bringing Statistical Monitoring and Quality Tolerance Limits into Roche. She was the team lead of the Central Statistical Resource team from 2016 - 2019 when she moved into Technical Excellence and during 2020/21 was the Scrum Team Lead for Stats Monitoring/QTLs/KRIs/Data Quality and Site Management Analytics Oversight with the Central Monitoring initiative. Currently Chris is a member of the Tech X team and as such is the Capability owner for the ongoing development and strategy for Quality Tolerance Limits. Chris has been on the list of authors for many publications relating to the various studies and is currently co-lead on the Phuse Working Group on QTLs, Co Lead on QTLs for Transcelerate and Team Member on the EFSPI QTL Working Group.
Bob Weney, Director, Global Client Services, Clinical Project Services, Almac Group
Bob Weney graduated from St. Francis University with a Bachelor’s of Science in Mathematics and Computer Science. Bob started with Almac in 2006 and has 14 years in management positions across varying disciplines that include software testing, software development, relationship management, process/performance optimization and most recently overseeing front line support teams including first and second level support for ACT’s systems as the Director, Global Client Services.
Mike Wenger, Founder and CEO, VersaTrial
Mike Wenger is a software developer who has been building solutions for clinical research for over 15 years. Mike worked at the Michael J. Fox Foundation for Parkinson's research connecting Parkinson's patients to clinical studies, built Citeline Connect to connect patient recruitment companies and pharmaceutical companies, and is now the founder and CEO of VersaTrial, a platform that provides new site enablement and engagement tools paired with operational insights to support sites and sponsors for the ultimate win-win.
Darren Weston, Senior Vice President, Integrated Data Analytics and Reporting (IDAR) and Janssen Clinical Innovation (JCI), Janssen Pharmaceuticals, Inc.
Darren Weston is Senior Vice President, Head of Integrated Data Analytics & Reporting (IDAR) and Janssen Clinical Innovation (JCI), Janssen R&D. In this role he is responsible for leading the IDAR organization in delivering our portfolio on time, within budget, and with robust quality while continuously improving to optimize efficiency and drive innovation through JCI in how we execute our programs. IDAR and JCI have a globally distributed workforce of more than 1000 internal and external employees who are responsible for the operational execution of all Phase I - IV studies (including Medical Affairs programs) across all therapeutic areas and all geographic regions. They are accountable for identifying and implementing innovative clinical trial approaches and technologies that meet the current and future needs of our portfolio while also shaping our environment to build for the future. IDAR is comprised of six global functions: Data Management, Clinical & Statistical Programming, Risk Management-Central Monitoring, Regulatory Medical Writing, Clinical Data Standards & Transparency, IDAR Business Operations, in addition to IDAR Therapeutic Area leadership. Prior to joining Janssen in 2017, Darren was the Vice President of Data Sciences & Scientific Operations at Novartis where he had spent 16 years holding positions of increasing leadership scope within the Biometrics area. He has served as an external advisor to several technology companies, and supported several key industry groups such as PhUSE and PSI. He is a UK graduate in Applied Statistics of Brighton University (BSc 1st Class/summa cum laude), and Sheffield Hallam University (MSc Distinction/summa cum laude) and lives in Mendham, NJ. In his spare time, when not playing with his two children, Darren has a passion for learning and mastering new skills ranging from playing guitar, piano, singing, close-up magic, playing soccer/football, brewing beer to name just a few.
Gayna Whitaker, Director, Strategic Feasibility, AstraZeneca
Gayna Whitaker has 25 years of clinical research experience and a MBA in Pharmaceutical Marketing and Healthcare Management. “It has always been my mission to educate the community about the clinical research process, to reduce healthcare disparities in the African-American community and to be a voice for the underrepresented in clinical research. The industry and the community must come together for better health outcomes for all.” Gayna is a Director of Strategy & Feasibility in Global Feasibility and Site Intelligence at Astrazeneca and the President and Founder of Genesis Medical Research Group (GMRG).
Kelly White, Senior Director, Head, Global Trial Optimization, Oncology, Merck & Co.
Kelly White leads the Merck Oncology feasibility and trial optimization function. She has a track record of data driven problem solving and execution planning success. She has continued to evolve and expand the strategic approach of her team and draws on her prior experience in clinical nursing, academic and community based clinical research practice. She has a unique focus on both patient and site experience in oncology clinical trial participation and has significant experience in deploying novel and strategic initiatives to support these critical stakeholders.
Madeleine Whitehead, Process Excellence Leader, Product Development Quality Solutions, Roche Products Ltd.
Madeleine Whitehead has over 15 years of industry experience focusing on clinical process excellence, gained in both Sponsor and CRO settings. Madeleine is passionate about robust, user-centric processes which enable a compliant risk-based approach in the conduct of clinical studies. In her current role at Roche, Madeleine is dedicated to supporting Process Owners of global clinical development processes to created innovative, effective, and efficient mechanisms to operationalize clinical studies. Madeleine is a devotee of Good Clinical Practice who works to promote the understanding, appreciation, and application of GCP in clinical activities.
Kendal Whitlock, Head, Digital Optimization, RWE Clinical Trials, Walgreens Boots Alliance
Kendal K. Whitlock is the Head of Digital Optimization, RWE Clinical Trials, with Walgreens Boots Alliance. This role leverages data assets and partnerships to advance culturally responsive approaches to clinical research. In her role, Ms. Whitlock focuses on digital solutions to drive access and opportunities that are both flexible and convenient for participants. Ms. Whitlock brings nearly 25 years of pharmaceutical industry experience to this new role. During her tenure, she has worked globally in digital clinical trials, and in both medical and commercial roles. Ms. Whitlock holds a Master of Public Health degree in Sociomedical Sciences from Columbia University and is currently working toward a doctorate. She earned a BA with honors from Spelman College. Ms. Whitlock has published in peer-reviewed journals, speaks internationally, is a Co-Lead of the 3C Decentralized Clinical Trials (DCT) Research Curriculum Initiative for the Decentralized Trials Research Alliance (DTRA), Chair of the Product Development and Clinical Research Sub-committee for the Med Tech Color Collaborative Community, and a member of the Personalized Medicine Coalition (PMC) Health Equity Task Force.
Laura Whitmore, Head, Clinical Operations, Cerevel Therapeutics LLC
Laura Whitmore has been Senior Director, Clinical Operations, Oversight at Cerevel Therapeutics since 2019. Prior to this role, she was Director on an Innovation team at a mid-size pharma company. A career-changer, she moved from the Banking industry 10 years ago and has never regretted the shift.
Warren Whyte, Vice President, RWE Sciences, ERACE Lead, ConcertAI
Warren Whyte leads ConcertAI’s health equity work in assuring that its data are representative, that technologies explicitly remediate racial and ethnic biases, and activities and strategies proactively contribute to the elimination of research and health inequities. During his tenure, Warren has established ConcertAI under the ERACE (Engaging Research to Achieve Cancer Care Equity) program and its medical society and biopharma partners as a leader in health disparity research and solutions. Prior to joining ConcertAI, Warren led strategic delivery of RWD and analytics offerings at Accenture, and facilitated the establishment of Syros Pharmaceuticals, a Boston-based cancer genomics start-up.
Warren has a BA in Biology from Cornell University, and a PhD in Genomics from MIT.
Michael Wichtendahl, Director, Clinical Drug Supply Management, AbbVie
With over 27 years of experience in clinical supplies, experienced and highly motivated Clinical Supply professional with experiences that include Clinical Supplies Project Management, Primary Packaging Operations, Label Design, Labeling, and Secondary Packaging Operations, Distribution, Clinical Supplies Returns and Reconciliation, Destruction. Experienced in GMP and GCP Inspection Readiness and Representation during Sponsor and Site Inspections, Due Diligence, and Acquisition Assessment of Clinical Supply programs. Served as manager of personnel at all phases of Clinical Drug Supply lifecycle. Performed in roles related to Packaging Design, Selection, and Procurement as well as Third Party Vendor Management. Key driver in Process, Training, and Continuous Improvement.
Alethea Wieland, Managing Expert, Advarra
Alethea Wieland is a managing expert for Advarra, bringing 30-plus years of expertise in analyzing the intersection of healthcare innovation and policy. As part of the Advarra Consulting team, Alethea provides invaluable insight into various biopharmaceutical companies, resulting in highly successful market launches.
Carrie Williams, Vice President & Partner, McKesson Ventures
Carrie Williams joined McKesson Ventures in 2017, bringing with her more than 15 years of experience in health care from several vantage points within the industry. Prior to McKesson Ventures, Williams served as vice-president of strategy and business development for behavioral medicine developer Omada Health, having held roles within McKesson’s strategy and business development team previously, working to advance strategies aimed at innovation within hospital pharmacy and clinical trial patient recruitment. She began her career in drug development, where she managed oncology clinical trials in both large pharmaceutical and biotech settings. Williams holds an MBA from the Haas School of Business at the University of California at Berkeley and an undergraduate degree in biology from the University of Massachusetts Amherst.
Ashley Wills, Senior Director, Clinical and Medical Data, Analytics, and Insights, Mirati Therapeutics
Ashley Wills is responsible for the Clinical and Medical Data and Analytics strategy for Mirati Therapeutics, supporting site identification, clinical performance, forecasting, and medical engagement strategies. She spent a significant portion of her career within Medical Affairs, supporting general operations, Investigator Sponsored Research, and field strategy within the oncology therapeutic area. She holds a BS in Microbiology & Cell Science from the University of Florida, with minors in both Chemistry and Statistics.
