2024年の講演者

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.

• Feasibility & Study Start-Up

Amy P. Abernethy, MD, PhD is the President of Product Development and Chief Medical Officer at Verily, where she leads teams in the development and delivery of solutions that bridge the gap between clinical research and care.

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.  

• Digital Measurements

Monique Adams is Director, Janssen Clinical Innovation in Global Development at Janssen Pharmaceuticals a Johnson & Johnson company. She is a thought expert on identifying innovative ways to improve the clinical trial experience for patients, clinical sites and the clinical teams who design and run the studies. She also manages the innovation project leads. Monique has a broad understanding of clinical development, gained through years of experience across Medical Affairs and Global Clinical Operations in different market environments. Monique is also the Vice-President of Women of Color in Pharma (WOIP) a nonprofit professional society founded in March 2015. WOCIP is committed to providing an environment that nurtures and empowers Black and Latina women employed in the pharmaceutical industry to take charge of their professional and personal development.

• Patient-Centric Trial Design & DEI

Ngozi leads the hematology community engagement and advocacy strategies at Gilead, spearheading the implementation of innovative advocacy programs and initiatives. She works closely with the Executive Leadership team, overseeing the strategic direction for the Public Affairs - Hematology division, driving partnership development and ensuring synergy in pivotal cross-collaborative programs. With responsibilities that covers enterprise-wide priorities, Ngozi ensures that patient perspectives are seamlessly integrated into both internal and external programs at strategic junctures. Her extensive advocacy expertise encompasses a diverse range of disease areas, including inflammation and oncology, with a recent focus on hematology. Throughout her career, Ngozi has been instrumental in forging networks with key strategic stakeholders across various sectors, fostering partnerships that drive collaborative efforts and program innovation within community and academic settings. Ngozi has a Bachelor of Science in Public Health from Rutgers University, complemented by a Master of Healthcare Administration from Seton Hall University. Her educational background, coupled with her professional experiences, positions her as a pivotal figure in the advocacy and public affairs landscape within the healthcare industry.

• Recruitment & Engagement

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 PhD 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.

• Biomarkers & Precision Medicine Trials

Ryan Ahern, MD, MPH, Chief Medical Officer at Truveta, brings data/healthcare strategy and is a practicing physician at the University of Washington. Before Truveta, Ryan was Head of Corporate Development and Data Strategy for Clarify Health. Ryan was also an attending physician at Massachusetts General Hospital and Weill Cornell Medical Center, a Clinical Assistant Professor of Medicine at New York Presbyterian, and a clinical fellow and instructor at Harvard Medical School.  

• Real World Evidence

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.

• Clinical Trial Tech: Venture, Innovation & Partnering

Dr. Bassil Akra is CEO and Owner of AKRA TEAM GmbH, a globally acting consultancy company from Germany. Dr. Akra was the Vice President of Strategic Business Development at the Global Medical Health Services of TUV SUD Product Service GmbH. He has vast experience in leadership, business management, research, development, quality management, and regulatory approval of medical devices, combination devices, and ATMP Products. Dr. Akra played an essential role during the implementation of the medical device regulation in Europe. He was also involved in the drafting of several European guidance documents (e.g. MEDDEV, MDCG, etc.) and International Standards. He spent the last years of his career at TUV SUD training and educating various stakeholders on EU Legislations (e.g. MDD/AIMDD, MDR and IVDR), supporting their implementation towards achieving relevant designation ensuring continuity of the healthcare system in the interest of patient populations.

• Med Device Trials

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.

• Real World Evidence
• Digital Measurements

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.

• Real World Evidence

I am a research professional with an academic background in the healthcare sector. My educational achievements include a Doctorate in Health Information and Research Management, which has provided a solid foundation in healthcare principles, data management, and research methodologies. My career has evolved through various roles in clinical research and healthcare industry including recruiter, coordinator, physician marketing, and now director of business development. In this position, I work to expand our sites reach and foster collaborations between physicians and research institutions. I enjoy adding to the field of research by coming up with processes and structures that support physician-to-site research engagement.

• Budgeting & Resources
• Recruitment & Engagement

Adrelia Allen is a 24-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.

• Patient-Centric Trial Design & DEI

Dr. Jodie Allen leads Clinical Trial Diversity at AstraZeneca and is responsible for global strategy and capability building in clinical development and operations. A medical sociologist by training, Jodie has 15+ years experience working across academic public health, life science consulting, and in pharma (Commercial and R&D). The red thread in her work is delivering large scale organizational change to improve patient access, experience, and outcomes. Her background in human behaviour in clinical settings, experience in technology implementation, and impact measurement are currently being combined to ensure that clinical trial populations reflect disease state populations in AZ sponsored trials.

• Patient-Centric Trial Design & DEI

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.

• Med Device Trials

No bio available.

• Patient-Centric Trial Design & DEI

Marigrace is a Director in PwC's Pharmaceutical & Life Sciences R&D Advisory Services practice with 10+ years of experience working in clinical R&D, clinical data management, and clinical operations. Marigrace has focused on clinical trial innovation at the intersection of technology and operations for clinical trials to create and implement fit for purpose solution tailored to fit specific needs across clinical scientists, operations, data management, and IT. 

• Feasibility & Study Start-Up

Access to treatment is essential for so many people - almost everyone I know has a loved one that could benefit from a cancer or central nervous system treatment. Standards and governance processes are crucial to an organization's ability to fulfill its life-changing mission. For this reason, optimizing how clinical data is collected and converted is essential in getting treatments to patients faster.

• Clinical Operations for Small Biopharma

Vice President Medical Affairs, Integrated Diagnostic Solutions, BD Life Sciences. Emphasis on pandemic response, elimination of cervical cancer: BD Onclarity HPV assay, BD SurePath cytology, self-sampling; BD COR; BD MAX Vaginal Panel and vaginal microbiome; infectious disease testing. Innovative improver, quality and safety focused, patient-centered healthcare executive and physician with more than 30 years of diversified team leadership experience in private clinical, academic, and business organizations spanning hospitals, surgical centers, ambulatory care, health systems, healthcare industry. Resourceful, strategic, empathetic medical executive and team leader; synthesizes complex and disparate data, plain-talking explainer, learning agile, relational coordination savvy, evidence-based medicine guru, continuous learner; passionate about organizational and team development, with demonstrated ability to work at all organizational levels and across executive functional areas. Board-Certified Gynecologist with over 30 years of clinical experience, and over 20 years of academic leadership responsibilities and clinical/research/education/administration experience at Duke University and at Vanderbilt University, and healthcare business positions as Chief Medical Officer and as Medical Director, an EBM guru, and expert in quality improvement, patient safety, and performance improvement. Currently based in the Sparks, Maryland / Washington, DC area, and visiting the world.

• Med Device Trials

Artem is a highly accomplished, experienced professional in the field of clinical data quality and biostatistics. As CEO of Cyntegrity, he brings over 25 years of expertise, having worked on various projects in the pharmaceutical industry. He holds a Ph.D. in Mathematical Modelling and an Executive Master of Business Administration from Cass Business School. He is committed to pushing the boundaries of RBQM and driving it to new frontiers.

• Quality & Monitoring

Brian Arnold, MBA, MS, PMP is currently working at Insmed Pharmaceuticals as the VP of global Development Operations where he and his colleagues are on a mission to transform the lives of patients living with serious and rare diseases. His main areas of responsibility include Clinical Trial Operations, Business Operations, Program Optimization and Innovation, Medical Writing and Trial Transparency and Disclosure. Brian’s educational background, grounded in both science and business, enables him to contribute to both aspects of drug development. He has a BS degree in Animal Science, MS degree in Microbiology & Molecular Genetics, and MBA degree in Pharmaceutical Management. Brian has been in the pharmaceutical industry for 25 years and his experience extends across global clinical development and project management. He spent the first half of his career in large pharma, running clinical trials and programs and with increasing responsibility at Schering-Plough, Merck, and Novartis. The second half of his career has been in leadership roles at small- to mid-sized companies including Galderma, Mallinckrodt and Insmed. During his career, he has had the privilege to contribute to the regulatory approval and commercialization of several therapies for patients in need. Brian has led Teams around the globe and maintains a curiosity for people and cultures. He is passionate about patient centricity and studying diseases where there are few, if any, therapies. His additional interests include leveraging technology to accelerate clinical development, connecting with people and elevating the performance of Teams.

• Budgeting & Resources

Mary Arnould is Director, RBM Lead, Clinical Science Program Management at Astellas Pharma and has been with Astellas almost 3 years. She has over 25 years of clinical operations and site monitoring management experience, focusing on RBM implementation since 2014. Mary supported the implementation of RBM at Bristol-Myers Squibb before joining Astellas after a long career in site monitoring. She has been able to apply that experience to the evolution in the risk-based approach implemented at Astellas exploring ways to evaluate effectiveness, promote adaptability, leverage technology, and enhance processes to meet the challenges presented by the current pandemic. Mary is an active member in the TransCelerate RBM work stream and has had the opportunity to share her experience with RBM implementation over the past few years at multiple conferences. Mary earned a BSN from Ball State University and a MSN from Indiana University.

• Quality & Monitoring

I have been in the clinical research industry for over 10 years where I have worn several hats (accountant, financial manager, clinical outsourcing lead) and am currently an AD in Clinical Outsourcing & Innovation at Jazz Pharmaceuticals, Inc.

• Outsourcing

At Deep 6 AI, Jason Attanucci uses his nearly 20 years of experience in life sciences sales leadership to expand the life sciences eClinical market. Prior to Deep 6 AI, Jason was the Global Head of Customer Solutions and Sr. Director of Sales and Partnerships at BioFortis, a clinical research technology solutions provider. He holds a BS in both microbiology and molecular biology from the University of Pittsburgh, and attended the University of Pittsburgh School of Medicine, Immunology.

• Budgeting & Resources

Sol Babani is a seasoned biopharma executive with over 25 years industry experience. The last 10 years he has been on the CRO side of the business, while the 17 years before that he was on the “sponsor” side in a variety of roles including: bench scientist, finance, project management, outsourcing and alliance management. Sol has spent time in large pharma (Pfizer and Novartis), biotech (Regeneron), and virtual development organizations (Auven/Celtic Therapeutics) and has thus seen the industry from many viewpoints. Mr. Babani also has a passion for innovation and how to better apply technology to the clinical research space, and has spoken at industry conferences on the topic of, “The Role of the CRO in the Healthcare Model of the future.” With this experience, Sol has established himself as an expert in building and maintaining strategic partnerships, alliances, and collaborations. In his current role as Senior Vice President & General Partner at ICON, Sol is responsible for providing executive oversight for a large portfolio of biotech clients driving revenue of over $400 million per year.

• Outsourcing

Behtash Bahador is the Director of Health Literacy at the non-profit organization CISCRP, and holds a Master of Science in Health Communication from the Tufts University School of Medicine. Since 2014, he has collaborated with a range of stakeholder groups to establish and implement patient- and community-centric initiatives across the life-cycle of clinical research. This has included supporting the development of regulatory and cross-disciplinary best practice guidelines, operationalizing key elements of evidence-based public health programing into research engagement activities, and always keeping the needs of patients, participants and the public at the forefront of his work.

• Recruitment & Engagement

Innovative IT Professional with experience as a Program Manager, Business Analyst, Project Manager, Solution Architect, Account Manager, Principal Instructor, Systems Engineer, Team Leader, and Manager.

• Clinical Operations for Small Biopharma

No bio available.

• Budgeting & Resources

No bio available.

• Decentralized & Hybrid

No bio available.

• Patient-Centric Trial Design & DEI

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.

• Data
• Real World Evidence

Tuba is a Senior Director at Clinical Center of Excellence (CCoE) team as Clinical Capabilities Lead, serving as Global Process Owner for Clinical Protocol Development Process. Some of the highlights from her work are leading cross-functional teams to success for process improvement activities and contributing to organizational excellence. Prior to her role at CCoE, Tuba was a Senior Clinical Development Scientist at BMS Melanoma Program providing scientific leadership and expertise to execute clinical trial activities. Before joining BMS Tuba served as Lead Clinical Scientist at Merck for the Keytruda Lung Program leading her teams to successful global approvals. She was also the Data Monitoring Committee (DMC) coordinator for the Oncology Lung Program. Before her career at Merck, Tuba served as a Postdoctoral Research Scientist at EMD Serono in Translational and Biomarker Research, and Research Fellow at two different academic institutions, the Albert Einstein College of Medicine Cancer Center and Biomedical Engineering Department at Worcester Polytechnic Institute. Tuba has a Bachelor’s degree in Chemistry and Master’s degree in Environmental Sciences from Bogazici University, and earned a PhD in Biomedical Sciences from the University of Massachusetts Medical School based on her work in the laboratory of Nobel Laureate, Craig C. Mello, identifying new components of the Wnt signaling pathway in C. elegans; and her work in Kobertz Lab on glycobiology that provided a new biogenic mechanism for channelopathies. In the course of her academic and pharmaceutical career, Tuba has published extensively over a variety of diverse topics including organic chemistry, intracellular signaling pathways, animal models, hematopoietic stem cell physiology, NSCLC, and melanoma. In her spare time, Tuba enjoys traveling, plenty of outdoor activities (hiking, swimming, playing tennis), gaming (computer and board), learning (clarinet, piano, new concepts/languages), reading Sci-Fi books, and socializing with friends and family. Tuba is a happy puppy mom; and she loves spending time with her pup, “Lucky.”

• Patient-Centric Trial Design & DEI

Experienced clinical research, project management professional with more than 15 years of experience in the industry. In-depth knowledge of drug development process and industry practices. Broad background in overseeing the conduct of the clinical trial at designated sites following elements of the ICH/GCP or GPP in observational, non-interventional studies. Experience in conducting and overseeing study start-up, maintenance, and termination activities, including but not limited to, site identification, feasibilities, SRP review, ICF negotiations, IRB/EC and Regulatory Authority submissions, review and approval of essential documents, remote Site initiation visits (SIV), Monitoring Visit (MV), Source data verification (SDV)/ Source Data Review (SDR), drug accountability, site payments, and close out visits. Extensive study and site management experience. Experience in leading a cross-sectional study team responsible for clinical study delivery as the primary point for contact for leadership. Experience with several EDC systems as well as IVRS. Extensive knowledge of ICHGCP, GPP, and other relevant regulations at local/country level. Knowledge of project management processes and tools.

• Clinical Operations for Small Biopharma

Amanda Beasley is a Director in the Representation in Clinical Research (RISE) team at Amgen, Thousand Oaks. Her pronouns are she/her. She has been working in preclinical and clinical research for 17 years. She holds a Master's degree in Clinical Research Administration and a Doctorate in Human Services. Her dissertation and passion is in informed consent comprehension in clinical research. She has been actively involved in LGBTQ+ initiatives since 2014 in multiple roles and has been Global Vice Chair of the Amgen PRIDE Employee Resources Group since January 2020 and an active member since joining Amgen in 2018. Amanda has therapeutic area experience in cardiometabolic, neuroscience, inflammation, and general medicine. In her free time, she loves to travel with her husband, spend time with her five pets, hike, and sit on the beach.

• Patient-Centric Trial Design & DEI

Jimmy Bechtel is the Society for Clinical Research Sites' (SCRS) Vice President of Site Engagement. He brings experience from both the site and sponsor sides of the clinical research industry to his critical role with SCRS. Jimmy provided a variety of support within the site spectrum in previous positions as data specialist, patient recruiter and operations manager. On the pharma side where he worked in innovation project management, Jimmy utilized his previous professional experience to encourage a site-centric environment and create ease for sites working with a major sponsor company. This multifaceted background allows Jimmy to bring a unique perspective to the work he does on behalf of the sites. At SCRS, Jimmy is in charge of developing and executing the company's site-facing initiatives, and works closely with key industry partners to build out various SCRS partnership programs. Additionally, Jimmy drives the implementation the Membership department’s site focused operations as well as design and marketing.

• Decentralized & Hybrid
• Budgeting & Resources
• Outsourcing
• Feasibility & Study Start-Up

Dylan is an Associate Director in Janssen's Global Regulatory Policy and Intelligence group. In his current role, Dylan is responsible for US policy-shaping activities on the topics of decentralized clinical trials, clinical trial diversity, and advanced therapies. Dylan played a formative role in the Decentralized Trials Research Alliance (DTRA) Workstream 4B, which focused on regulatory gaps for the conduct and operationalization of decentralized trials. Subsequently, he has remained involved in DTRA's regulatory forum which addresses the evolving regulatory landscape surrounding DCTs and drives the creation of work-product to guide sponsors, sites, and CROs through this regulatory landscape. Prior to joining Janssen, Dylan worked for a variety of roles at Genentech including in regulatory policy, where he focused on similar topics as those he covers in his current role. Dylan has BAs in Molecular and Cell Biology & History from UC Berkeley, an MS in Biotechnology from Johns Hopkins University, and is currently in his third year of a part-time JD program at American University Washington College of Law (AUWCL). He lives in Washington DC with his wife.

• Decentralized & Hybrid

Graduated from Lehigh University with a B.S. in Chemical Engineering and George Washington University with an M.S. in Project Management. Obtained the Project Management Professional (PMP) certification in May 2008. Worked in various industries including chemicals, gases, defense contracting (industrial pumps for U.S. naval aircraft carriers and submarines) and industrial valve systems in engineering and project management roles prior to joining J&J. Started with J&J as a Project Manager in May 2011 working in New Product Development for Medical Devices; was promoted into different project and program management roles including establishing a PM Excellence infrastructure for Medical Devices. Transitioned into a Project Manager role in July 2019 working for J&J Pharma to establish a biomarker prescreening operating model and currently lead the Patient Matching Solutions team which delivers strategies to enhance clinical trial recruitment with a focus on underserved communities.

• Real World Evidence

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. He has led various educational workshops, webinars, and seminars on a variety of industry topics. Prior to ScienceMedia, Philip worked for Johnson & Johnson, GetWellNetwork, and AdMed.

• Feasibility & Study Start-Up

Cerdi Beltre is a clinical research executive with over 25 years of experience in driving operational excellence, compliance, and site engagement. As the Chief Operating Officer for Innovo Research, Inc., Cerdi oversees the company's provider-led integrated network of high-performing medical groups, which serves over 4 million patients and utilizes clinical research as a key part of their population health strategy. With a proven track record of success, Cerdi has held leadership positions at reputable organizations in the industry, including WCG, IBM Watson Health, and Northwell Health. Her expertise spans a wide range of areas, including site operations, ethics, product management, sales enablement, investigator performance, and research site network management. She is also the primary inventor on a U.S. patent called "Monitoring Clinical Research Performance," which aimed to provide a global investigator performance score (akin to an Experian score for investigators conducting research) to enable a more efficient and effective monitoring of study performance across the industry. Cerdi is deeply passionate about practical innovation and efficiency in clinical research.

• Feasibility & Study Start-Up

Kathy has over 25 years of experience performing health outcomes research and has consulted on a number of communications with the FDA and EMA regarding patient reported outcomes (PRO) endpoints in clinical trials and developed PRO measures and dossiers for regulatory review. Kathy has numerous preference/PRO publications and regularly leads workshops and presentations at industry conferences. She is a founding member of the International Academy of Health Preference Research (IAHPR).

• Data

Samit is the Vice President for the Clinical Trial Patient Solutions team at Myonex. He is responsible for the team’s growing global operations in North America, Europe, Australia, and New Zealand. Samit has over 13 years’ experience in the pharmacy and pharmaceutical industry; managing successful formulary status and relationship management with payers, significant understanding of healthcare contracts, and knowledge of medical and pharmacy benefits including specialized knowledge across different therapeutic areas. Samit holds both a Doctor of Pharmacy degree and an MBA from Drake University.

• Patient-Centric Trial Design & DEI

Karina Bienfait, PhD is the Executive Director of Specimen Infrastructure and Informed Consent within Global Biospecimen and Imaging Management at Bristol Myers Squibb (BMS). In this role, Karina oversees a team of leaders with subject matter expertise in informed consent, biobanking, specimen logistics, and specimen data and analytics. Since joining BMS, she has strategically transformed end-to-end consent operations for specimens for both protocol-related and future-use testing. She has also overseen implementation of a state-of-the-art specimen management system, as well as implemented policies and processes to ensure specimen oversight. Prior to BMS, Karina was at Merck & Co. for 10 years, where she held positions of increasing responsibility within Clinical Pharmacogenomics and Clinical Specimen Management. Her last role was head of Global Genomic Policy, Process, and Compliance (GPPC), where was responsible for evaluating the impact of global genomic and biospecimen policies and laws/regulations on Merck’s research programs; developing Merck policies, processes, and consent related to genomics and biobanking; and ensuring the compliant use of biospecimens. In this role, Karina also implemented routine genotyping of patients participating in Merck’s clinical trials to identify genetic predictors of drug response. Karina is currently an Advisor to SCOPE for Biomarkers and Biospecimens and co-chair of the Industry Pharmacogenomics Working Group. She has also served as a member of the Genomics Roundtable of the National Academy of Sciences, Engineering, and Medicine. Karina completed an internship in Clinical Psychology at Nassau University Medical Center and a postdoctoral fellowship in Clinical Psychopharmacology in the Department of Psychiatry at Rutgers University - Robert Wood Johnson Medical School. She holds a PhD in Clinical Psychology from St. John's University and a B.A. in Psychology and French from New York University.

• Biomarkers & Precision Medicine Trials

Malachi Bierstein leads global sales and marketing and drives the commercial growth of the ScienceMedia. 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). Malachi is a pioneer of technology licensing models and digital video delivery solutions. 

• Feasibility & Study Start-Up

No bio available.

• Patient-Centric Trial Design & DEI

Allison Billups is VP of Business Development at Advanced Clinical. Allison has served in the clinical research industry for over 20 years working for multiple contract research organizations (CROs) and directly for a large pharmaceutical company. She has held multiple Business Development positions within Advanced Clinical. Previous positions have included Sales Leader, Team Leader, Account Manager, & Pharmaceutical Sales Representative. Allison has a bachelor’s degree in marketing from Florida State University.

• Outsourcing

Scout Clinical CEO Paige Bingham has a wealth of global pharmaceutical meeting planning experience and a proven record of success. With a passion for enhancing patient experience, she has driven adoption in the some of the Top 10 pharmaceutical and contact research organizations. Paige oversaw development of online platform Atlas Clinical Academy and was pivotal in establishing and managing parent company Meeting Protocol Worldwide’s London base.

• Patient-Centric Trial Design & DEI

Eric heads engineering R&D for Medidata's RTSM solution. He has worked on the RTSM system for over a decade, starting as a software developer, and currently leads several teams of engineers. Before he was engaged with life sciences, he practiced law as a patent litigator, handling cases involving a wide range of technology, including computer software. As an engineer, he has extensive experience designing and implementing software-as-a-service applications, machine learning pipelines and service-oriented architectures to deliver broad, cross-functional solutions. Eric holds a J.D. from Fordham Law School and undergraduate degrees in Computer Science and Mathematics from Indiana University.

• Clinical Supply

No bio available.

• Decentralized & Hybrid

No bio available.

• Clinical Supply

Lukasz 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 programs 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 the 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.

• Quality & Monitoring

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.

• Clinical Trial Tech: Venture, Innovation & Partnering

Dr. Ariel Bourla serves as Senior Director on Johnson & Johnson R&D's Data Science and Digital Health team, where she leads efforts to apply real-world data and other innovative technology solutions to advance and accelerate Oncology clinical programs. Dr. Bourla holds a strong background in Medical Oncology, Immunology, and Data Science. She spent 6 years at Flatiron Health as a Medical Director and Clinical Trials Lead. In this role, she led research teams executing prospective real-world studies, methodologic and observational research projects, and development of new technologies for sites and sponsors participating in clinical trials. Dr. Bourla received her MD/PhD training from the Mount Sinai School of Medicine, with a subsequent internship and residency at New York Presbyterian-Columbia University Medical Center, and a Medical Oncology fellowship at Memorial Sloan Kettering Cancer Center. She earned a BA in English Language and Literature from Yale University.

• Real World Evidence

Melaina is the Americas Regional Head of In-Country Study Operations for EMD Serono responsible for the delivery of the development of clinical studies across therapeutic areas of oncology, neurology, and immunology. She has over 18 years of experience in clinical operations and is passionate about driving innovation using available data for insights and decisions to reduce patient and site burden. Melaina is leading the Diversity, Equity, and Inclusion Strategy for Clinical Trials within the organization, with a mission to integrate strategies that reinforce an inclusive mindset in the development framework. Melaina has a strong international and leadership experience having led teams and projects in North America, Europe, and Asia. Melaina has a Bachelor of Science, a post-graduate degree in Clinical Research, and a Master’s in Health Informatics.

• Patient-Centric Trial Design & DEI

Mariel is a Senior Product Manager at Flatiron Health on the Clinical Research team, where she leads the development of Flatiron Clinical Pipe. During her 7 years at Flatiron, Mariel has worked across both Flatiron’s prospective and retrospective research offerings, giving her a unique perspective into the development of Flatiron Clinical Pipe. Prior to joining Flatiron, Mariel spent multiple years conducting clinical research at various prestigious Academic Medical Centers, focused on Oncology. Mariel graduated from Fordham University with a BS in Biology.

• Clinical Operations for Small Biopharma

Walker Bradham is the Product Management Lead for Zelta, Merative’s clinical trials solutions business. He 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. A champion of 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.  

• Med Device Trials

Charles Bradley was 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.

• Clinical Operations for Small Biopharma

Alex Bragat currently serves as Head of Data Management at N-Power Medicine, Inc. and has over 20 years of clinical research and data science experience in the pharmaceutical industry and academia. Prior to N-Power Medicine, he held leadership positions at NYU Langone Health, Amicus Therapeutics and Bristol-Myers Squibb in the areas of data coordinating center management and administration, clinical data management, pharmacokinetic/pharmacodynamic data analysis, and biomarker assay development.

• Quality & Monitoring

Danilo Branco, Director of Central Monitoring at Fortrea, is a passionate, optimistic, tech savvy clinical trials Risk Based Quality Management, Central Monitoring, Project Management and Clinical Operations professional with 20 years' experience managing complex studies in both big Pharma and CRO settings. He co-leads a team of 50+ employees globally in the mission of improving data quality while bringing efficiencies to Clinical Trials conduct. Last 8 years dedicated to lead and encourage processes creation, continuous assessment and enhancements to maximize the positive impact of the RBQM adoption in full alignment with regulatory expectations.

• Quality & Monitoring

Christina Brennan, MD, has devoted her career to clinical research and currently serves as Northwell Health’s senior vice president of clinical research. Committed to the advancement of science and medicine, Christina has more than 23 years of extensive clinical research experience, including over 19 years in clinical research management roles. Throughout her career she has served many roles on clinical trials from PI to sub-investigator to operational oversight. During the pandemic alone she ran all the COVID-19 trials, where in a few short weeks, 1,200 patients were enrolled in trials at Northwell Health. She also performed Northwell's first fully remote (DCT) trial, in which they held their own IND. During that period, she was interviewed by Scott Pelley on 60 minutes prime time which captured more than 8 million viewers. Christina always keeps the patient as a focus point, currently she has partnered with Press Ganey (leading global company for over 30 years for patient surveys) for a pilot as the first site to focus on patient satisfaction surveys for clinical trial participants. She is on the board of trustees for the Association of Clinical Research Professionals and will be the incoming Vice Chair in 2024. She is on the steering committee of the Clinical Trial Transformation Initiative (CCTI), with Duke University and the FDA. She is on the advisory board for Florence Healthcare. She also sits on the oncology advisory board and technology site advocacy group with the Society for Clinical Research Sites (SCRS). She is also an active member of the Women in Bio and the American College of Healthcare Executives. Christina also has authored chapters in textbooks, coauthored many manuscripts and abstracts, and has presented at numerous scientific and research meetings. She developed a clinical trial budget course for CITI. She is an adjunct professor at Yeshiva University and CUNY York College, teaching graduate students on clinical trials.

• Decentralized & Hybrid

Jessica Brescher, MPH is the Chief Research Officer of SGM Alliance and brings 17 years of clinical trial experience in pharmaceuticals and medical devices. At her day job at Bristol Myers Squibb Co., in addition to being a Senior Clinical Scientist, she co-leads an initiative to allow patients to self-identify their sexual orientation, gender identity, and intersex status in their clinical trials. Jessica is also a Doctoral Student at Drexel University, where her research focus is the ethical inclusion of sexual and gender minorities in clinical research. Her commitment to diversity and representation as a moral imperative underlies the passion she brings to all her work.

• Patient-Centric Trial Design & DEI

As Vice President Clinical Research with the Centre for Neurology Studies (CNS), Sonia specializes in building high performing teams and resilient processes to make awesome things happen in a variety of different contexts. She is a well-published neuroscientist, Certified Clinical Research Professional, and a long-standing research nerd. Sonia is passionate about finding efficient ways to bridge the gap between research and reality in clinically meaningful ways. Her team conducts trials in pharmaceuticals, medical devices, digital health, and natural health products in the brain and mental health space, and offers contract research services to early stage companies that need help getting started with clinical research.

• Med Device Trials

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.

• Feasibility & Study Start-Up

Dr. Uli Broedl, MD, is the Corporate Senior Vice President and Head of Global Clinical Development & Operations at Boehringer Ingelheim. He is passionate about research, development, and digital innovation to improve patient access and care. Dr. Broedl held various leadership roles at Boehringer Ingelheim over the last 14 years, including Global Head of Late Clinical Development of Boehringer Ingelheim’s diabetes portfolio in the Therapeutic Area Metabolism, Country Medical Director Canada, and Head of Global Clinical Operations. Dr. Broedl is adjunct Professor of Medicine at the University of Munich, Germany, and holds a Doctorate of Medicine degree from the University of Munich. He completed a Postdoctoral Fellowship in Dr. Daniel J. Rader´s lab, Institute for Translational Medicine and Therapeutics, University of Pennsylvania School of Medicine, Philadelphia, USA, and completed his training in Internal Medicine, Endocrinology, and Metabolism at the Medical Center of the University of Munich.

• Decentralized & Hybrid
• Biomarkers & Precision Medicine Trials
• Quality & Monitoring
• Clinical Supply
• Budgeting & Resources
• Med Device Trials
• Data
• Clinical Operations for Small Biopharma
• Outsourcing
• Patient-Centric Trial Design & DEI
• Real World Evidence
• Recruitment & Engagement
• Feasibility & Study Start-Up
• Digital Measurements

Dr. Denise Bronner is a patient-focused strategist with 5+ years of experience developing global operational plans that have maintained a robust track with DEI recruitment goals. Prior to tenure at Janssen, she was a hypothesis-driven scientist with over 7 years of experience investigating cellular stress pathway impact on innate immune responses. She has published 12 high-impact publications, served as a keynote speaker in front of audiences ranging from 250-8000+ attendees. She holds a PhD in Microbiology & Immunology from the University of Michigan where she served on executive boards of organizations focused on increasing minorities and women presence in STEM fields. She recently started a LinkedIn newsletter called the Pulse which focuses on uncovering challenges in clinical research & the solutions for achieving health equity for all. Denise serves as a Director within the Diversity, Equity, and Inclusion in Clinical Trials team where she develops all of the DEI strategies for the Janssen Immunology portfolio.

• Feasibility & Study Start-Up

Mary Ann Brown joined Cambridge Healthtech Institute (CHI) in 1992 as a Data Entry Associate. At that time CHI was a start-up company with many roles to fill and explore. She quickly realized that conference production which combined creativity and love of learning was the path for her. Mary Ann’s conference portfolio is varied from biologics to batteries where she is organizes over 15 scientific meetings a year along with being a Team Lead for several Key Events. Mary Ann graduated from Doane College in 1978 with degrees in Biology, Environmental Studies, and Geology.

• Clinical Supply

Results-driven leader with extensive experience leading cross-functional matrixed teams. Focus on building relationships that are collaborative and trusting. Broad proficiency in Clinical Operations provides strong foundation of project management and tactical execution, coupled with a resourceful, no-nonsense approach to problem-solving. Unique ability to see the larger strategic picture and be able to move down into the details when required. High emotional intelligence that compliments work experiences across many cultures, allowing for excellent communication skills across cultural borders. Extensive experience in operations, with three years of experience in Cell Therapy External Manufacturing in Cell Therapy Supply Chain.

• Clinical Operations for Small Biopharma

Tricia Buchheit has over 25 years of Patient Recruitment, Retention, and Project Management industry experience through her work at agencies, CROs, core labs, and biotechnology companies. This vast experience provides a 360-degree perspective of the challenges key stakeholders encounter with recruitment and retaining patients into clinical trials. Currently, Tricia focuses on the development and implementation of thoughtful recruitment and retention strategies and solutions to bring much needed RNAi therapeutics to market.

• Decentralized & Hybrid
• Biomarkers & Precision Medicine Trials
• Quality & Monitoring
• Clinical Supply
• Budgeting & Resources
• Med Device Trials
• Data
• Clinical Operations for Small Biopharma
• Outsourcing
• Patient-Centric Trial Design & DEI
• Real World Evidence
• Recruitment & Engagement
• Feasibility & Study Start-Up
• Digital Measurements

Lee is an experienced senior executive and corporate director with deep commercial expertise in the biotechnology sector. His management experience includes as CEO and VP of public and private biotech companies, as well as providing management and strategic consulting services to public and private bio-pharma companies in Canada, the United States, Middle East, Japan, and Europe. Lee’s deepest expertise is in the cell therapy and regenerative medicine sector having lead several transformative transactions including multinational investment and licensing deals involving companies in North America, Europe, and Asia. Lee has particular experience in Canada, the United States, and Japan. Lee holds a Bachelors of Education and a JD from the University of British Columbia.

• Clinical Supply

Dr. Kevin Bugin is an experienced pharmaceutical professional who has made significant contributions to drug development and regulatory science. He currently serves as the Deputy Director of Operations in the Office of New Drugs (OND) in FDA's Center for Drug Evaluation and Research (CDER). In this role, Dr. Bugin plays a key leadership role in the evaluation of new drugs and ensures their safety and effectiveness. Prior to his current role, Dr. Bugin served as the Chief of Staff for the Therapeutics Response Efforts as part of the US Government's HHS and DOD operation known as Operation Warp Speed. His leadership during this time played an important role in the successful development and distribution of COVID-19 therapeutics. Dr. Bugin is also an adjunct faculty member at the George Washington University in the Clinical Leadership and Regulatory Affairs Programs, where he focuses on areas of clinical research and medicines development, and the science of team science.

• Decentralized & Hybrid
• Biomarkers & Precision Medicine Trials
• Quality & Monitoring
• Budgeting & Resources
• Data
• Clinical Operations for Small Biopharma
• Outsourcing
• Patient-Centric Trial Design & DEI
• Real World Evidence
• Recruitment & Engagement
• Feasibility & Study Start-Up
• Clinical Trial Tech: Venture, Innovation & Partnering
• Digital Measurements

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.

• Clinical Trial Tech: Venture, Innovation & Partnering

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.

• Real World Evidence

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.

• Decentralized & Hybrid

Andrea Carney is a subject matter expert in cellular therapy specializing in TCR based and CAR-T immunotherapy techniques. Andrea has brought her expertise from the clinical setting into industry to support the collection of T cells and supply chain logistics for immunotherapy manufacturing. Having worked in both the commercial setting at Novartis supporting Kymriah, and now in Phase I/II clinical trials with Immatics, Andrea has a broad range of experience in clinical supply chain management.

• Clinical Supply

At Janssen R&D, Oscar leads the development of platforms, capabilities, and quality management systems to enable deployment of productionized AI/ML models in clinical trial and real world settings. Oscar has extensive experience leading AI/ML algorithm development for advancing drug development programs across multiple therapeutic areas, including oncology, CVM, and immunology. He completed postdoctoral training at MIT and holds a PhD from Duke University, focusing on medical imaging technologies. Oscar's scientific contributions in industry and academia have resulted in 110+ publications and presentations.

• Real World Evidence
• Digital Measurements

No bio available.

• Feasibility & Study Start-Up

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.

• Quality & Monitoring

Joan is the Senior Director of Marketing, Communication, & Education at the Center for Information & Study on Clinical Research Participation (CISCRP) where she develops, plans, and executes strategic integrated marketing and business development campaigns, and community engagement and event programs with her team to support CISCRP’s mission of raising awareness and understanding about clinical research and the important role it plays in public health. Joan’s experience spans 25+ years in the health life sciences and currently serves on the Board of Directors for Greater Gift, the US PharmaTimes Executive Steering Committee for CROY, Steering Committee for Pharma Intelligence/Informa Clinical & Research Excellence Awards (CARE), and is an active member of the Drug Information Association (DIA). She was previously on the CISCRP Advisory Board for over 10 years. During her career, she has published in clinical trade journals and is a well-known speaker at industry conferences. Joan was formerly COO at CenterWatch. Her career included roles at ClinX, SCORR Marketing, CHI, Tufts CSDD and PAREXEL.

• Recruitment & Engagement

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.

• Budgeting & Resources

Janice Chang is the Chief Operating Officer at TransCelerate BioPharma Inc. Ms. Chang has been involved with the organization since its inception. In her current position, Ms. Chang works closely with the CEO and the Board of Directors to shape the long-term strategic vision and priorities for the organization and its 30+ initiatives. Ms. Chang defines and guides TransCelerate’s overall external engagement strategy with global health authorities, governmental agencies, industry groups, and TransCelerate’s country network spanning across 30 countries. She has accountability overseeing TransCelerate’s corporate operations and works closely with her team to drive strategic delivery of TransCelerate’s portfolio. Ms. Chang also actively participates in various cross-stakeholder global discussions to help evolve our R&D paradigm. Most recently she joined the Advisory Council for HL7 International’s Vulcan Accelerator. Vulcan, which is a global strategic effort to bring together stakeholders across the translational and clinical research community to align on data exchange standards to bridge existing gaps between clinical care and clinical research, enabling more effective acquisition, exchange, and use of healthcare data in translational and clinical research. With a background of 20+ years of experience leading initiatives in large pharma and biotech companies, Ms. Chang has experience spanning across regulatory, clinical, and manufacturing. Ms. Chang is passionate in driving meaningful change across our ecosystem and not settling for the status quo. She believes in reimagining the way we advance innovative medicine and advocates for the power of open collaboration across stakeholder groups.

• Decentralized & Hybrid
• Biomarkers & Precision Medicine Trials
• Quality & Monitoring
• Clinical Supply
• Budgeting & Resources
• Med Device Trials
• Data
• Clinical Operations for Small Biopharma
• Outsourcing
• Patient-Centric Trial Design & DEI
• Real World Evidence
• Recruitment & Engagement
• Feasibility & Study Start-Up
• Digital Measurements

Sarthak Chatterjee is a postdoctoral fellow in the Global Digital Analytics & Technologies group within Translational Medicine at Merck. His work focuses on building digital analytics capabilities for digital biomarker development in multiple therapeutic areas, especially Parkinson’s Disease. Sarthak obtained his PhD with focus on the mathematical theory of optimization and control in 2021 from Rensselaer Polytechnic Institute. Prior to that, he received his Master’s degree in 2018 from Rensselaer Polytechnic Institute and his Bachelor’s degree in Electronics and Telecommunication Engineering in 2015 from Jadavpur University.

• Real World Evidence
• Digital Measurements

No bio available.

• Real World Evidence

Dr. Scott Chetham, Faro Health CEO, leads innovative clinical development via data-driven decisions. Formerly, Head of Clinical Research at Verily (Google Life Sciences), he directed multi-faceted operations and strategy, including Google and Google[x]. Versant Ventures Partner, Co-founder (ImpediMed), VP Clinical Affairs (ImpediMed), his expertise steers impactful clinical research.

• Decentralized & Hybrid

Experience managing and monitoring IND, IDE, and non-IND clinical trials in the following therapeutic areas: analgesia, pain management, hematology, ophthalmology, dental, neurology, pulmonology, and transplantation. Proven ability to manage and monitor several multi-center clinical trials in different therapeutic areas simultaneously, including drug and device studies. Excellent verbal and written communication skills; strong work ethic combined with a strong customer-focused orientation. Detailed knowledge of GCP and ICH guidelines, including a comprehensive understanding of regulatory requirements. Proficient with business applications such as MS Word, PowerPoint, and Excel, as well as clinical trial management systems and electronic data capture systems, including Medidata Rave/Balance, iMedNet, OnCore, PhlexEview, and Veeva. Serves as liaison between the internal study team, participating clinical centers, third-party contractors, and sponsor; experience in start-up, maintenance, and close-out.

• Clinical Operations for Small Biopharma

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 a 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.

• Decentralized & Hybrid

Kelly Clark is Head of US Partnerships and Global Site Development at Merck. Kelly has been working in the biopharmaceutical industry since 1997 and has spent the last 22 years at Merck in clinical trial operations. She joined Merck Canada as a Clinical Research Associate and advanced through her career as Senior CRA, CRA Manager, Clinical Project Manager, Territory Research Manager, and a Regional Clinical Project Manager Lead for North and South America. She joined Merck US clinical trial operations in 2018 as a Clinical Research Director overseeing specific oncology programs until she moved to her current position in 2022. In her current position, Kelly is responsible for leading and developing high quality programs to develop research-naive and less experienced clinical trial sites with a focus on oncology. She is also responsible for building and sustaining partnerships with key sites across the US which involves supporting them to efficiently execute clinical trials with the highest quality. Kelly holds a BScN and a MSHS in Clinical Research Administration from The George Washington University.

• Patient-Centric Trial Design & DEI

Norbert Clemens, MD, PhD, CPI FACRP, is a board-certified physiologist. He served as medical director for several pharma companies; as general manager at CROs; as Vice President of Clinical Operations; as Senior Manager, Science & Clinical at MedTech companies; and in his current position as Director, CTM EMEA at HOYA Surgical Optics. He was President of the DGPharMed and ACRP ABoT Chair. Dr. Clemens is a well-known trainer for investigators and site staff.

• Med Device Trials

Lee F. Clough, RN, Hemapheresis Practitioner (ASCP) has been a nurse for the last 40 years working in the ICU, and then apheresis, where she learned from the best at The Children's Hospital of Philadelphia. Lee has a vast experience in therapeutic apheresis procedures and collections leading teams at American Red Cross' Holland Laboratory, Inova Blood Donor Services, Children's National Medical Center, and West Chester Medical Center. Lee has utilized this knowledge and began working with several Biotech companies, Dendreon, Blue Bird Bio, and now Novartis helping to create their Leukapheresis Manuals and provide guidance to clinical and commercial sites to provide the best starting material for the manufacture of their specified autologous drugs. Lee is currently the Global Cell Steward at Novartis and working on several platforms to help improve access for all eligible CAR-T patients.

• Clinical Supply

No bio available.

• Recruitment & Engagement
• Feasibility & Study Start-Up

No bio available.

• Outsourcing

Lisa, a Registered Nurse, joined BSI in 2020 as a Clinical Evaluation Specialist with the Vascular Medical Devices team. Prior to joining BSI, Lisa started her career caring for critically ill patients in Cardiovascular Intensive Care units at major university hospitals in the US. She later moved into clinical research roles supporting cardiovascular clinical outcomes, pharmaceutical, and medical device studies. After leaving the hospital setting, Lisa spent over 15 years in the Medical Device Industry where she held various roles in post-market surveillance, provided global clinical and technical support, and held management positions in Clinical Affairs and Medical Safety and Performance. Her number one focus in all positions has been patient safety. and she has brought her clinical expertise to BSI to ensure the safe and effective use of medical devices.

• Med Device Trials

Bill founded MedPoint Digital in 1990. He has recently shifted his attention to the Innovation Lab at MedPoint, with the goal of developing powerful new digital solutions for leading global biopharma companies. Bill’s career has spanned positions at Wyeth/Pfizer, AbbVie (pharmaceuticals), Abbott (diagnostics) and Discovery/Publicis Healthcare.

• Quality & Monitoring

Frustrated by current solutions, Anca created the Clinical Maestro platform based on over 15 years’ experience in clinical research. Head of Clinical Outsourcing, Anca advanced BioMarin's global outsourcing, vendor management and clinical analytics. She drove strategic corporate development activities at two top CROs, gaining unique insights into clinical business operations. Clinical Maestro addresses clinical business operations process: from planning, to outsourcing, to the end of the clinical contract and study analytics.

• Budgeting & Resources

With direct, hands-on management experience working with executive management, P&L management, strategic planning, mergers and acquisitions, and organizational optimization, Brandon Cormier brings diverse business experience to his role as Elligo’s Chief Commercial Officer. He has a long history of exceeding sales goals and nurturing relationships that support a company’s growth. Cormier’s nearly 20-year career has been focused in the life sciences. Before Elligo, he held various business development roles of increasing responsibility at Syneos Health, Ventana Clinical Research, INC Research, GlaxoSmithKline, and DuPont Pharma. Cormier was also a member of the board of directors for INC Research Canada, and received Bachelor of Science degrees in biology and economics from the University of Toronto.

• Decentralized & Hybrid

With almost 20 years of experience and industry roles spanning across small to large CRO and Sponsor organizations, Jodi attributes developing budgets and proposals in her early CRO days to deepening her understanding of the critical relationship between CROs and Sponsors. As she progressed in her career, she transitioned to supporting Sponsor organizations in Outsourcing Management, developing processes and negotiating CRO budgets and contracts for Phase I-IV clinical trials. Her passion for developing effective communication and governance structures expanded as she discovered a gap in “true strategic partnerships” between cross-functional trial teams. With the addition of ICH E6 R2, Jodi found her niche as she began to lead and develop strategic and innovative vendor management and performance management oversight solutions between Sponsor and CRO matrix organizations. She is highly passionate about establishing internal and external cross-functional communication processes, effective issue escalation pathways and finds joy in building positive strategic partnerships that drive quality performance in support of clinical trial development.

• Outsourcing

Amy Elizabeth Cramer draws on her experience as a cardiac critical care nurse, clinical research coordinator, certified healthcare quality professional, and clinical research informaticist. Amy has worked in a community hospital, an independent academic medical center, and a world-class, academic medical institution. She is currently a Director on the Global Product Development Strategic Partnerships team for Pfizer, Inc. Amy also is Co-Chair for the HL7 FHIR Accelerator dedicated to Translational and Clinical Research, Vulcan - and Vice Co-Chair for the Society for Clinical Data Management (SCDM) eSource Consortium. Throughout her career, Amy’s focus has been to determine improvements that provide better patient-centric care, whether that is in developing a visualization for a complex hypoglycemia protocol, developing a transplant quality program, or optimizing the use of the electronic health records for clinical research. Currently, Amy has been engaged in discussions about clinical trials solutions, which includes eSource; specifically, the secondary use of EHR data for clinical research. Prior to her current efforts, Amy served as co-Chair of HL7 Clinical Interoperability Council. She is a TransCelerate member and reviewer for many professional journals. Amy received a Master in Management of Clinical Informatics from Duke University School of Medicine.

• Data
• Feasibility & Study Start-Up

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.

• Digital Measurements

No bio available.

• Summit for Clinical Ops Executives (SCOPE)

Business-minded researcher and team leader with strong clinical background, graduate training in epidemiology and health economics, and over 15 years of experience designing, conducting, and communicating scientific research to health care providers, hospital administrators, health plan executives, policy makers, and others. Extensive hands-on experience with study design, execution, data analysis, and scientific writing, as demonstrated by track record of publications and presentations. Skilled in development and synthesis of evidence in acute and chronic pain, spinal disorders, musculoskeletal conditions, neurologic disorders, rare genetic diseases, and other therapeutic areas.

• Real World Evidence

Bart is an Associate Director in Janssen R&D’s Risk Management-Central Monitoring Group, which is dedicated to the implementation of Analytical Risk-Based Monitoring on clinical trials. He has over 25 years of experience in clinical research and drug development. Prior to his ARBM-focus, Bart worked in clinical trial and site management at Janssen R&D, Eli Lilly and Quintiles in a variety of therapeutic areas. He was also a chemist and study coordinator at St. Luke’s Hospital lipid metabolism lab in Kansas City. Bart holds a bachelor’s degree in Biology and a master’s degree in Business Administration.

• Quality & Monitoring

Inga Darville is a Clinical Data Specialist on the Interventional Cardiology Clinical Evaluation Evidence 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, conducting numerous 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.

• Med Device Trials

Ebony Dashiell-Aje, PhD is currently the Senior Director and Head of Patient Engagement and Outcomes Research in Regulatory Affairs at BioMarin. Dr. Dashiell-Aje is a leading expert in patient-centered outcome tool development including clinical outcome assessment (COA) design and implementation, digital health technology tool development and optimization, and related study endpoint issues in regulatory science. As a health outcomes researcher and methodologist, Dr. Dashiell-Aje is driven by her passion for public health and promoting patient-focused medical product development. Dr. Dashiell-Aje has notably contributed her research expertise in academic, consulting, and regulatory environments to arrive at evidence-based solutions, to shape health policy.

• Biomarkers & Precision Medicine Trials
• Recruitment & Engagement

Mike has over 30 years of pharmaceutical research experience at Abbott/AbbVie and has held positions in Diagnostics, Data Management, Clinical Program Development, the Development Design Center, Study Feasibility and Recruitment. He is currently a Director on AbbVie’s Study Feasibility Team and is primarily focused on supporting Country/Site Selection and Design Feasibility for studies within the Oncology portfolio. He enjoys mentoring and is passionate about driving innovation and increasing patient centricity in clinical trials. For the past 4 years Mike has been a member of the Clinical Feasibility Consortium that was formed to collectively tackle common challenges and shape the role of feasibility organizations in an evolving era of data science, informatics and advanced analytics.

• Feasibility & Study Start-Up

20+ years in the industry including positions in central lab supplier, EDC and sponsor roles. Currently, leading a new organization that has grown out of the goal for end to end management of biospecimens from collection to destruction.

• Biomarkers & Precision Medicine Trials
• Clinical Supply

Angela DeLuca is the Vice President, Head of Oncology and Cell Therapy, Clinical Operations at Takeda. Angela is responsible for leading the clinical operations group to drive the clinical development operational strategy and execution of clinical trials. During more than 18 years in the biopharmaceutical industry, Angela has extensive oncology experience and has lived and worked in the US and Japan. Angela has been recognized for her ability to lead the progress of global clinical development excellence through the creation of innovative operational strategies and the early adoption of digital health initiatives, to optimize the R&D landscape to accelerate products to the global market. Before joining Takeda, Angela was Head of Global Site Management, Clinical Development Operations at AbbVie where she spearheaded the transformation of the clinical development operations enterprise, developing a knowledge center of excellence to create an industry leading clinical development function. During her years at AbbVie and Abbott, Angela held other leadership roles such as Head of Strategy and Operations for Portfolio Program Management serving as consulting arm to R&D Leadership team, assessing & executing innovative improvement opportunities across the R&D enterprise. Angela also served as Head of Innovation where she managed the Japan Design Lab’s team and ensured digital technologies, health technologies, big data and predicative analytics were used to support enhanced clinical trial design and business decision making. Angela holds an MBA in Innovation from the University of North Carolina Chapel Hill, Kenan Flagler Business School, and a Bachelor’s in Chemistry from The Ohio State University. She is also a certified PMP.

• Decentralized & Hybrid
• Biomarkers & Precision Medicine Trials
• Quality & Monitoring
• Budgeting & Resources
• Data
• Clinical Operations for Small Biopharma
• Outsourcing
• Patient-Centric Trial Design & DEI
• Real World Evidence
• Recruitment & Engagement
• Feasibility & Study Start-Up
• Clinical Trial Tech: Venture, Innovation & Partnering
• Digital Measurements

No bio available.

• Recruitment & Engagement
• Feasibility & Study Start-Up

Jade is a global clinical development leader with over 20 years experience across Phase I-IV trials within Pharma/Biotech with a current focus on pioneering innovative approaches in protocol optimization using data and analytics to drive better & faster decisions to design clinical programs with a patient-centric and data-informed focus.

• Data
• Feasibility & Study Start-Up

No bio available.

• Med Device Trials

Alex leads Flatiron's Clinical Research business, building upon Flatiron’s established leadership in real-world evidence and point-of-care technology (EHR) with new solutions and services designed to better integrate research into everyday clinical care. Flatiron partners with sponsors and CROs to design and execute fit for purpose prospective studies, broaden access and representativeness in clinical trials, take a data-driven approach to patient matching, streamline clinical trial data acquisition, accelerate trial timelines, and reduce the operational burden typically associated with clinical research. Flatiron also works closely with a large network of research sites comprising leading community and academic centers, enabling them to gain efficiency, save time and offer more patients the opportunity to participate in research. Alex joined Flatiron in 2016 and held multiple positions where he was responsible for building partnerships with biopharma companies to support evidence generation strategies before stepping into his role as VP & General Manager of Clinical Research. He came to Flatiron with over a decade of experience in strategy consulting where he worked with oncology-focused pharmaceutical and biotech companies to enable a wide range of strategic and operational priorities in the R&D space. Alex received a bachelor of science in biological engineering and a master of engineering in biomedical engineering from Cornell University.

• Real World Evidence

Rob joined IBM in 2018 after a long career in Pharmaceutical R&D spanning nearly 30 years; 25 with GlaxoSmithKline where he served in a variety of leadership positions. While at GSK, Rob was the Vice President of Clinical Pharmacology Sciences and Study Operations with a global footprint that included the US, UK, Australia and China. Rob’s team designed clinical trials aimed at profiling new medicines, establishing proof of concept and delivering critical data for product labelling. He also led the development a number of late phase oncology projects leading to successful product approvals. In 2015, Rob launched a Clinical Innovation and Digital Platforms Team at GSK where he focused on identifying, evaluating and piloting emerging technical solutions to automate different areas of clinical trial design and implementation. Under his leadership, Rob’s team launched the first industry sponsored Apple Research Kit Study to assess disease burden in rheumatoid arthritis patients in a real-world setting. In addition to his GSK responsibilities, Rob also led the Common Protocol Template and Digital Data Flow work streams sponsored by TransCelerate, a non-profit organization of 19 pharma companies. He was also one of the team leads for the Clinical Trials Transformation Initiative (CTTI) sponsored Mobile Clinical Trials Novel Endpoints project. Rob received his Doctor of Pharmacy Degree from the University of the Sciences in Philadelphia. His areas of expertise and interest include clinical trial design, clinical operations, protocol quality and ethics in research.

• Decentralized & Hybrid

Martha Dockery is a highly accomplished professional in the field of clinical research, currently serving as a Senior Manager of Clinical Monitoring at Exact Sciences. With a wealth of experience in this role, Martha has successfully overseen and directed a diverse portfolio of clinical trials, demonstrating exceptional efficiency and strict adherence to regulatory standards. In addition to her clinical expertise, Martha is deeply committed to advancing Diversity, Equity, and Inclusion (DEI) within the realm of clinical trials. Serving as a staunch DEI advocate, she actively promotes and showcases the importance of diverse representation in research studies. Moreover, Martha excels as a strategic leader and dedicated people manager, fostering an inclusive and supportive work environment that enables her team to thrive and achieve remarkable results. Martha's unwavering dedication to advancing DEI initiatives in clinical research exemplifies her steadfast commitment to social equality and her innovative approach to transforming healthcare practices.

• Med Device Trials

No bio available.

• Med Device Trials

Experienced Director in clinical operations management with a demonstrated history of creating and building global teams. Enthusiastic about 20+ years in the pharmaceutical industry skillfully managing stakeholders, leading projects/management of projects, and line management. Passion: Patients and strengthening their awareness and involvement in clinical research; being part of the solution for companies and communities to increase participation and diversification in clinical trials leading to better medications for everyone.

• Patient-Centric Trial Design & DEI

Keith Dorricott is an independent consultant and Director of DMPI Ltd since 2016. 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. He provides expert training and consulting services in metrics (KPIs, KRIs, QTLs), process improvement and root cause analysis in clinical trials. He provides leadership to the Avoca Quality Consortium on metrics across the clinical trial spectrum including RBQM, QbD and DCT. He is a member of the Scientific Advisory Board at the Centre for Pharmaceutical Medicine Research at King's College London. Keith's passion is improving the effectiveness and efficiency of processes by working with those on the ground who are running those processes.

• Quality & Monitoring
• Outsourcing

Tom Dougherty is the Director of RWE Partnerships and Innovation at Pfizer within their RWE Center of Excellence. He is responsible for scouting, developing, and launching therapeutic area-specific external data partnerships and bringing novel technologies into Pfizer. Prior to joining Pfizer, Tom was the Director of Strategic Accounts for Premier Applied Sciences where he supported life science organizations on population health improvement solutions and real-world data partnerships. Tom has over 15 years of experience in healthcare with Merck, GE Healthcare, and Boston Scientific. He received a bachelor’s degree in Chemistry and an MBA from Villanova University.

• Real World Evidence

Shannon Duffany serves as the Global Clinical Trials Early Planning Lead for Solid Tumors Oncology at Sanofi. She has over 20 years of clinical research operations experience, from study coordinator positions at various hospitals, to clinical operations roles within multiple companies in the pharmaceutical and medical device industry. Currently, she leads a team that is responsible for building global clinical trial strategies in planning country and site feasibility for Sanofi’s solid tumor portfolio. Additionally, her team designs patient recruitment strategies for these trials.

• Recruitment & Engagement

Joe is an innovator sitting at the intersection of life sciences and technology with goals focused on making the whole drug development process faster for pharma and better for patients. Recent world events have brought the reality of how complex clinical trials are into the mainstream news and this pandemic has been a rallying cry for our industry resulting in the rapid acceptance of new ways to conduct clinical trials, designed with the patient experience at the center and technology that works smarter for all stakeholders. For almost 20 years, Joe has been a vocal and visible force in the Life Sciences industry specifically in the realm of eClinical Technology starting in the eCOA space, and most recently finishing up a 12-year run with Medidata. He has worked with top Pharmaceutical, Biotech, and CRO organizations on innovation, change management, implementation, product development, sales, and consulting. Joe is a graduate of Roger Williams University Gabelli School of Business with a degree in Computer Information Systems and Political Science. He is a member of the Drug Information Association’s Regional Advisory Council and the Leadership Council for the CNS Summit.

• Feasibility & Study Start-Up

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.

• Recruitment & Engagement

Gary Ellsworth leads the North American Alliance Management team at IQVIA. He has been in the industry for 18 years and has spent the last 7 years establishing and overseeing strategic partnerships with small to midsize biopharmaceutical companies. Prior to his role in Alliance Management, he held various roles in clinical operations and therapeutic strategy at IQVIA and other CROs.

• Outsourcing

Jeff Elton is CEO of ConcertAI, an AI SaaS solutions company providing research & patient-centric solutions for life sciences innovators & the world’s leading providers. ConcertAI focuses on accelerating & improving the precision of retro & prospective clinical studies using provider EMRs, LISs, & PACSs systems as the source for all study data;. It is a long-term partner of American Society of Clinical Oncology & its CancerLinQ program, US FDA, NCI Health Equity initiatives, & 100 healthcare providers across the US.

• Real World Evidence

Part of Bayer AG since 2014, always somewhere around the Procurement process, collaborating with all 3 divisions- Pharma, Consumer Health and Crop Science. Currently focusing on Pharma Clinical Trial Technologies and overlaps with other service categories in the DCT ecosystem.

• Outsourcing

Emily Epstein is Genetic Social Worker at the Genetics and Personalized Cancer Prevention Program at Weill Cornell Medicine/New York Presbyterian Hospital. Emily holds a bachelor’s degree from New York University and a Masters in Social Work from Fordham University’s Graduate School of Social Services. Through her work as a clinical behavioral health specialist and research coordinator, she provides valuable support to patients and their families as they navigate hereditary cancer syndromes She has been referred to as an "empathy advisor" due to her commitment to helping healthcare providers and researchers approach their patients with compassion and understanding. Through her personal and professional experience as a patient with Hereditary Breast and Ovarian Cancer Syndrome due to a BRCA2 mutation, Emily brings awareness and perspective to panels, advisory boards, and support groups. She is actively collaborating with esteemed professionals, such as Dr. Melissa Frey and Dr. Ravi Sharaf at New York Presbyterian-Weill Cornell Medicine, to enhance patient-centered testing, coordinated care, support, and research in hereditary cancers at the Genetics and Personalized Cancer Prevention Program. Emily's dedication to making a profound impact on the lives of those affected by hereditary cancer is evident in her involvement in this groundbreaking initiative. With her warm personality, expertise, and dedication, Emily Epstein is a valuable asset in promoting mental health and patient-centered care in the medical and research community.

• Biomarkers & Precision Medicine Trials
• Recruitment & Engagement

Susan Erondu-Afolayan is a highly skilled Clinical Research Professional with over 16 years of experience in operationalizing clinical trials. Her passion for improving the accessibility and diversity of clinical trials has led her to become a strong advocate for underrepresented communities. Her personal experience as the sister of a misdiagnosed autoimmune warrior has given her a unique perspective on the importance of patient advocacy and the need for better healthcare outcomes for all.

• Budgeting & Resources
• Clinical Operations for Small Biopharma
• Outsourcing

Candice Estes is as a Clinical Trial Manager at Incyte and works extensively in the decentralized trial space. She holds her Masters of Public Health in Epidemiology from the University of Alabama at Birmingham and has worked in Clinical Research since 2013 in a variety of roles including a Data Manager, Biostatistician, Oncology Research Coordinator, Clinical Trials Specialist and multiple levels of Clinical Research Associate. Ms. Estes’ specific focus lies in pushing dermatologic products forward, bridging the gap between clinical operations and global monitoring and operationalizing decentralized trials.

• Decentralized & Hybrid

Dave Evans is recognized industry-wide as a leading technology visionary for developing and implementing complex process and system solutions and as an expert in the areas of information standards, regulatory compliance and quality governance. He was the architect and developer of the first electronic drug submission to the FDA in 1985 and has been responsible for more than 100 electronic regulatory submissions and complex clinical data warehouse systems. He brings over 40 years’ experience to CDISC, serving in various executive-level positions in software development, clinical research, regulatory and healthcare industries. Most recently, he was the Global Head of Quality Governance and Regulatory Compliance for Accenture Life Sciences. Prior to that, he was CIO of Octagon Research Solutions and co-founder of Premier Research and Research Data Corporation. He has also served on the CDISC Board and has been an active member of many other industry organizations and initiatives. Dave received his MS in Biomedical Engineering from Drexel University and his BS in Biology from Ursinus College.

• Decentralized & Hybrid

Dr. Everhart is an innovator, educator, and leader in the pharmaceutical and biotechnology industries with over 25 years of experience in the practice of medicine and over 14 years of experience in clinical research.  Board-certified in Internal Medicine and a Fellow of the American College of Physicians, he is one of Signant Health’s experts in decentralized trials, rater training, blinded data analytics, and placebo response mitigation. 

• Decentralized & Hybrid

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.

• Clinical Trial Tech: Venture, Innovation & Partnering

Olivia began her career as a clinical research associate at a contract research organization prior to becoming a lead clinical research associate and then a project manager, overseeing the operations of clinical trials in multiple therapeutic areas. After several years in project management, Olivia transitioned to the risk-based monitoring space. She supported the start-up of RBM within the CRO, including process design, procedural document development, RBM platform support and performing central monitoring activities. In 2019, Olivia joined CSL Behring to lead the central monitoring group and the implementation of Risk Based Quality Management practices.

• Quality & Monitoring

Dr. Jonathan Feldstein has had a career spanning clinical medicine, entrepreneurship, and private equity. As an anesthesiologist and pain medicine physician, Jonathan started his own practice in New York City. When his mother was diagnosed with early onset Alzheimer's, he became frustrated with the current health system and transitioned away from clinical medicine to trying to solve bigger problems in healthcare. After years of working at McKinsey, specializing in clinical development acceleration and pipeline strategy for Pharma R&D clients, Jonathan started an analytics company during COVID to help biotechs maintain their clinical development timelines. Most recently, Jonathan founded Profound Research, a network of clinical research sites expanding access to clinical research to the community.

• Decentralized & Hybrid

No bio available.

• Outsourcing

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!

• Budgeting & Resources
• Outsourcing

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.

• Decentralized & Hybrid
• Biomarkers & Precision Medicine Trials
• Quality & Monitoring
• Budgeting & Resources
• Data
• Clinical Operations for Small Biopharma
• Outsourcing
• Patient-Centric Trial Design & DEI
• Real World Evidence
• Recruitment & Engagement
• Feasibility & Study Start-Up
• Clinical Trial Tech: Venture, Innovation & Partnering
• Digital Measurements

John Finn has over 30 years of experience in clinical development through the various positions he has held within private research, CRO, and large pharmaceutical organizations. Before rejoining Pfizer in 2016 (John previously was Head of Repository Management at Pfizer), he was the Global Head of Clinical Data Management Functional Excellence at Genentech and oversaw the process and training management, service provider management, and systems management groups, whose shared purpose was to ensure Data Management's effective and compliant delivery of decision databases through utilization of nimble processes, right-fit systems, and skilled flexible resources. Prior to that, he served as the Global Head of Data Management at Parexel International. He currently oversees a global CDS team of professionals whose mission is to deliver on-time quality data for decision making in innovative and patient-centric ways across phase 1-IV inflammation and immunology and rare disease clinical studies at Pfizer.

• Data

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. 

• Clinical Operations for Small Biopharma

Zoma Foster has 10+ years’ experience in clinical research with focus on feasibility and site identification. She is currently the Head of Strategic Feasibility at UCB, a global biopharmaceutical company. She leads a team that supports various aspects of clinical trial planning globally in different therapeutic areas. She is passionate about ensuring that clinical trials are positioned for success with the optimal country footprint and ideal sites using a data-driven approach. Zoma is also a core member of UCB’s team focused on driving diversity, equity, and inclusiveness in clinical trials. She worked at large CROs prior to joining UCB. Zoma holds a PhD in Biochemistry from the University of Houston. She also completed a postdoctoral fellowship with the Department of Pharmacological and Pharmaceutical Sciences at the University of Houston before joining the clinical research industry.

• Feasibility & Study Start-Up

Diana L. Foster, Ph.D., is the CEO and Chief Diversity Officer for TOTAL Diversity Clinical Trial Management, a full-service Diversity Organization whose mission is to enhance diversity and inclusion in clinical research trials. Foster also served as the Vice President of Diversity, Equity, and Inclusion for the Society of Clinical Research Sites (SCRS) originating programs such as the Global Impact Partner Programs and many other industry supported initiatives. Foster is a thought-leader and sought-after expert in diversity and clinical site best practices. She is the author of Diversity Site Assessment Tool and has published numerous research papers on the topic. Over the past two decades, she has addressed audiences across the world, published multiple papers and articles, and written five authoritative industry books including Global Issues in Patient Recruitment and Retention. Most recently, Foster and Dr. Jerome Adams, former US Surgeon General and the Chairman of the Board for TOTAL Diversity wrote and published a book titled, Diversity in Clinical Trials: Best Practices and Perspectives for Industry and Clinical Research Sites. Foster holds a Ph.D. in Research Theory and Statistics from Texas Woman’s University. She previously was a partner in Metroplex Clinical Research Center, a multispecialty research site, founder of D. Anderson and Company, a global centralized recruitment firm, and Rheumatology Research International (RRI), one of the first Site Management Organizations. Her personal honors include recognition by the Global EXEC Women’s International Council as a 2009 International Woman of Influence, being named a finalist for Ernst & Young’s Entrepreneur of the Year Awards in 2008, and an induction into the 2006 PharmaVOICE “100 Most Inspiring People in the Life-Sciences Industry.” She is among accomplished women around the globe who are changing the way international clinical trials are conducted.

• Budgeting & Resources
• Clinical Operations for Small Biopharma
• Outsourcing

Experienced clinical operations professional with 25 years of proven success in the industry, including 20 years of oncology clinical trial management in both large and small biopharma. Strong program and project management leader, with expertise in operational strategy, planning, execution and reporting in all phases of development, trial development and design, CRO/vendor management, and budget oversight.

• Clinical Operations for Small Biopharma

Magnus is a Partner with PEN Partnership, helping Life Sciences' companies to reimagine how they engage their patients and partners in healthcare to deliver better experiences & outcomes. He has worked with AstraZeneca since 2019 to embed patient centric operations and making science and clinical trials more accessible to all patients. Before PEN, Magnus was part of the Life Sciences' team at PA Consulting and Head of Research at eyeforpharma. He is a thought-leader in patient-centricity, digital health, and real world evidence.

• Patient-Centric Trial Design & DEI

Dr. Joy Frestedt is President and CEO of Frestedt Incorporated, a service provider group with over 70 experts providing services in broad CRQE areas of clinical trial development and execution, as well as US and international regulatory compliance, management of corporate quality systems and biomedical engineering, and Alimentix, focused on running clinical research projects for low-risk food-related products. Dr. Frestedt has managed clinical trials, negotiated regulatory submissions, and updated quality systems for more than 40 years in health care, pharmaceutical, medical device and food industries including University of Minnesota, Orphan Medical, Johnson and Johnson, Astra Zeneca, CNS Therapeutics, Mayo Clinical Trial Services, Medtronic, and many others. Dr. Frestedt holds a PhD in Pathobiology from the University of Minnesota Medical School and BA in genetics from Knox College. She is a member of AAPS, ASCO, RAPS, SOCRA and many other organizations. Dr. Frestedt is among the “100 Most Inspiring People in the Life Sciences Industry” (PharmaVOICE, 2011) and top 25 “Industry Leaders” (Minneapolis/St. Paul Business Journal, 2011). She has authored two books: “Warning Letters: 2016 Reference Guide” with Barnett International and “FDA Warning Letters About Food Products: How to Avoid or Respond to Citations” with Elsevier.

• Med Device Trials

Lilly Frohlich is an experienced clinical operations professional, with expertise in clinical trial strategy, execution, and oversight. Lilly currently oversees the execution of the schizophrenia clinical trials at Cerevel Therapeutics, a biopharmaceutical company focused on unraveling mysteries of the brain. Lilly has worked in clinical trial oversight and execution across a multitude of indications including neurology, psychology, and rare disease therapeutic areas. She has her Bachelor of Science degree in public health from Syracuse University. She received her Master’s in Public Health with a concentration in epidemiology and a certificate in pharmaceuticals from Boston University.

• Feasibility & Study Start-Up

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.

• Patient-Centric Trial Design & DEI

Michael’s focus on patient centricity has led to innovative initiatives, such as linking PROs and Patient Reported Data like Social Determinants of Health to Claims and EHR data, providing unique patient insights. He previously worked at Kantar Health for more than 16 years in multiple roles, including as the Global Head of Innovation (RWE). He holds an MBA in Healthcare Administration from the University of Miami Herbert Business School.

• Real World Evidence

Silvio Galea is the Chief Data & Analytics Officer of WCG, where he leads the overall data and analytics strategies to create competitive differentiation, improve business agility, and create operational efficiency across the enterprise.  Silvio has over two decades of experience leading and managing software, data, & AI organizations across a range of industries including Healthcare, Finance and Publishing.

• Data

Dr. Karim Galil, MD, is the CEO and Co-founder of Mendel.ai. Mendel’s mission is to make medicine objective by enabling the world’s largest index of patient journeys leveraging AI technologies that understand medicine like a physician. Dr. Galil’s experience as a physician demonstrated that medicine does not advance at the same rate as technology. With Mendel, he aims to bridge this gap, facilitate clinical research at scale, and make medicine truly objective. 

• Real World Evidence

Chelsea Gallagher is the Senior Director of Drug Development Innovation and Digital Health Analytics. She is a thought leader in clinical design innovation and has spent the past few years building analytics solutions to optimize trial design for patients, investigators and sponsors, resulting in sustained tens of millions of dollars in cost avoidance per year . Her recent work has shifted focus to automation and optimized process, achieving timeline acceleration and reduced resource burden. With over ten years of experience in analytics across multiple functions, Chelsea has leveraged her expertise in design thinking, change management, and analytics techniques to solve challenging problems at BMS. She works with stakeholders to identify root cause pain points, recognize synergies across functions, and design solutions that meet future and current business needs

• Clinical Supply

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.

• Decentralized & Hybrid
• Biomarkers & Precision Medicine Trials
• Recruitment & Engagement

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.

• Data

Neil Garrett is the Head of Regulatory Medical Writing at Johnson & Johnson and has over 25 years’ experience in medical writing in the pharmaceutical and CRO industry. Neil has held medical writing leadership positions in a number of organizations and been a lead writer on multiple filing submissions across a range of therapeutic areas. In his current role at J&J, Neil has accountability for the efficient production of clinical and regulatory documents supporting the J&J portfolio. Neil is interested in how AI can assist and enhance the authoring process. Neil has a PhD in Pharmacology and is based in the UK.

• Decentralized & Hybrid
• Biomarkers & Precision Medicine Trials
• Quality & Monitoring
• Budgeting & Resources
• Med Device Trials
• Data
• Clinical Operations for Small Biopharma
• Outsourcing
• Patient-Centric Trial Design & DEI
• Real World Evidence
• Recruitment & Engagement
• Feasibility & Study Start-Up
• Digital Measurements

Jennifer J. Gaskin, CCRP, CMQ-OE, is the Senior Director and Head of Clinical Operations at Celldex Therapeutics. Her experience includes leading several initiatives in inspection readiness and participating in FDA, MoH, and Health Canada Inspection teams. She has built and led teams across several small companies in the biotechnology and biopharmaceutical space. Her experience includes directing the selection and oversight of clinical operations vendors at multiple companies. Her clinical research experience also includes managing research units, along with clinical and research projects in both the private and academic sectors.

• Clinical Operations for Small Biopharma

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.

• Decentralized & Hybrid
• Biomarkers & Precision Medicine Trials
• Quality & Monitoring
• Budgeting & Resources
• Data
• Clinical Operations for Small Biopharma
• Outsourcing
• Patient-Centric Trial Design & DEI
• Real World Evidence
• Recruitment & Engagement
• Feasibility & Study Start-Up
• Clinical Trial Tech: Venture, Innovation & Partnering
• Digital Measurements

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.

• Outsourcing

Debbie Gilmore has over 20 years of clinical research experience, with a focus on transforming project management and monitoring organizations. Debbie is currently responsible for leading ICON's strategic alliance with Sanofi.

• Outsourcing

Tiffany Girardi, Associate Director, Global Trial Optimization has been working with Merck since October 2016 in the Oncology Therapeutic Area, focusing on initially Hematology and Melanoma, however, for the greater part of her time at Merck has primarily worked on Lung. Recently she has also focused on Neuro research. Tiffany is also the GreenPhire Subject Matter Expert for colleagues implementing GreenPhire’s services across all indications on behalf of GTO and Merck. Prior to joining Merck Tiffany worked in Patient Recruitment as a Site and Patient Analytics manager overseeing and managing the site relations department and optimizing connecting patients with clinical trials. Her work also included analyzing site performance as well as marketing strategies near study centers to enhance visibility of trial to patients and increase the success of patients being connected to study centers conducting trials. Prior to that Tiffany entered the research industry training raters in Neuro studies on cognitive assessments. She has 7 years of oncology experience and over 12 years of CNS experience.

• Recruitment & Engagement

I am a senior consultant with a deep knowledge and long-term experience in research (PhD in Molecular Biology and PostDoc in Cell Signaling and Immunology) followed by over 6 years experience as a consultant in the Pharmaceutical Industry. I am very passionate about learning about customers’ processes, challenges and needs and helping them to solve their problems and achieve efficiencies and excellence by implementing state-of-the art digital solution. My current activities are focused on clinical operations, including biosamples management, data standardization, harmonization, and streamlining information scattered across multiple systems to achieve effective clinical trial management.

• Biomarkers & Precision Medicine Trials

Mr. Goldberg is an Operating Partner of Arsenal where he focuses on networking and sourcing transactions for the healthcare team. Prior to joining Arsenal in 2014, Mr. Goldberg was a Managing Director, Corporate Development of Endo Pharmaceuticals. Previously, he was a founding Partner of ProQuest Investments and the founding CEO or founder of three biotechnology companies that were acquired or taken public. In addition, he also held executive positions at Becton Dickinson and at GSK. He serves on Dana Farber Cancer Institute Visiting Committee and board of NIH/Cambridge/Oxford Scholars program.

• Clinical Trial Tech: Venture, Innovation & Partnering

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.

• Decentralized & Hybrid
• Biomarkers & Precision Medicine Trials
• Quality & Monitoring
• Clinical Supply
• Budgeting & Resources
• Med Device Trials
• Data
• Clinical Operations for Small Biopharma
• Outsourcing
• Patient-Centric Trial Design & DEI
• Real World Evidence
• Recruitment & Engagement
• Feasibility & Study Start-Up
• Digital Measurements

I lead the Clinical Technologies and Innovation team at AbbVie which strategizes around new technologies that can enhance and optimize our clinical ecosystem. I have had the amazing opportunity to implement large-scale strategic initiatives from concept through delivery across leading Pharma and Biotech giants for close to 25 years. With the evolution of technology at a rapid pace there are still a lot more opportunities that exist and avenues like this conference enable discussion amongst peers to move the industry in the right direction.

• Data

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.

• Feasibility & Study Start-Up

Steve Gompertz (CMQ/OE, CMDA, RAC-US, CMII) is a leader in Quality Systems management with over 30 years of experience in the medical technology industry. His career includes roles in quality systems development and implementation, project management, engineering automation, configuration management, audit, and software development for companies including Pelican BioThermal, St. Jude Medical (now Abbott), Boston Scientific, Medtronic, Vital Images, and Control Data. He is now a consultant to the medical technology industry providing guidance on quality systems and regulatory compliance. Steve holds a B.S. in Mechanical Engineering from Lehigh University, and certifications in quality management, medical device auditing, regulatory affairs, project management, and configuration management. Steve started his professional career in software development and then moved into systems implementation project management. After joining the medical device industry, he transitioned from implementing quality-related IT solutions to managing quality organizations and processes. Steve also helped St. Cloud State University develop and is a Sr. Adjunct Instructor in the “M.S. in Medical Technology Quality” program. Steve can be reached at Steve.Gompertz@QrxPartners.com, and more information about his experience is available at https://www.linkedin.com/in/stevegompertz/

• Med Device Trials

No bio available.

• Outsourcing

Rob is the Senior Vice President and Head of Clinical Development & Operations within Pfizer Research and Development, a discipline focused on accelerating clinical development innovation and execution with an emphasis on quality, speed, and cost. Rob has over 30 years of industry experience in clinical operations, safety, and regulatory. He is an executive Six Sigma Black Belt and has been a past member of PhRMA (Pharmaceutical Research and Manufacturers of America), past board member for CDISC (Clinical Data Interchange Standards Consortium), current member of the SCDM (Society for Clinical Data Management) advisory board and former co-chair for the Vulcan HL7/TransCelerate research accelerator. In 2021, Rob was recognized in PharmaVoice magazine as one of the top 100 most influential leaders in healthcare. Rob holds a B.S. in Psychology from Eastern Connecticut State University, a M.S. in Research, Measurement, and Evaluation from Southern Connecticut State University, and an M.B.A. in Pharmaceutical and Chemical Studies.

• Decentralized & Hybrid
• Biomarkers & Precision Medicine Trials
• Quality & Monitoring
• Budgeting & Resources
• Med Device Trials
• Data
• Clinical Operations for Small Biopharma
• Outsourcing
• Patient-Centric Trial Design & DEI
• Real World Evidence
• Recruitment & Engagement
• Feasibility & Study Start-Up
• Digital Measurements

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.

• Digital Measurements

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 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.

• Decentralized & Hybrid
• Biomarkers & Precision Medicine Trials
• Quality & Monitoring
• Budgeting & Resources
• Data
• Clinical Operations for Small Biopharma
• Outsourcing
• Patient-Centric Trial Design & DEI
• Real World Evidence
• Recruitment & Engagement
• Feasibility & Study Start-Up
• Clinical Trial Tech: Venture, Innovation & Partnering
• Digital Measurements

Kelly Gregory is a Manager of Platform Operations with Janssen R&D Data Science & Digital Health. A PROSCI-certified Change Practitioner, Kelly develops change strategies and communications for Data Science platforms. She creates engaging communications and training materials to enable user adoption of innovative AI and digital health solutions.

• Data

Lily Grey is a Global Strategic Sourcing Leader at Roche in Basel, Switzerland. With over 20 years experience in the Pharmaceutical industry in a number of organizations, primarily in biometrics beginning in data management and moving into vendor alliance management over 12 years ago. Currently she works in a strategic sourcing team within Data Science (Biometrics) at Roche, focusing on, amongst other things, pan-functional strategic vendor governance and oversight and strategic sourcing.

• Budgeting & Resources

Irina Grishina has over 10 years of experience working in the clinical trial space, working at vendor and sponsor level. Irina has been with CSL Behring since 2018 as a Senior IRT Project Manager supporting studies across various therapeutic areas including cardiovascular, immunology/inflammation, respiratory and gene therapy. Irina holds MBA from Monmouth University.

• Clinical Supply

An experienced Vice President with over 25 years of experience in clinical operations strategy and leadership, Jason has an applied knowledge of leveraging data and analytics, digital technology, and collaborative partnerships. Jason provides consulting services for biotechs, pharma, vendors, and CROs to develop innovative approaches to optimise protocol designs, modernise clinical trial conduct, and accelerate delivery strategies. Jason is the Co-Founder of ClinOpsClarity, which provides a bespoke service for scoping, selecting, and onboarding outsourcing partners, and the Co-Founder of Emergent Teams, which equips teams and outsourcing partnerships to navigate constant change and accelerate performance in today’s fast-moving world. Jason is also a member of the ClinEco Advisory Board.

• Clinical Operations for Small Biopharma
• Outsourcing

Baris Guc is a Senior Data Scientist on the global clinical operations team at Roche. His main focus is speeding up the execution of late-stage clinical trials using advanced analytics. He has a Masters degree in Computer Science from ETH Zurich, with a focus on machine learning.

• Patient-Centric Trial Design & DEI

As the Chief Architect of QuartzBio's suite of fully connected SaaS solutions, Tobi builds data management and business intelligence tools to enable life science business to transform information to insights from their sample and biomarker data. Tobi has decades of experience working across the pharmaceutical and biotech space, leading regulatory submissions, translational informatics, and precision medicine R&D. He has developed novel data science methodologies, translating to value at the patient level.

• Biomarkers & Precision Medicine Trials

Glenda Guest, BS, CCRA, RQAP-GCP, TIACR, ACRP-MDP, FACRP 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 a small privately held CRO in 1997. A credentialed Auditing (RQAP-GCP), Monitoring (CCRA), Medical Device (ACRP-MDP) and Training (TIACR) professional, Ms. Guest currently provides routine and specialty GCP auditing services, mock FDA GCP Inspections, clinical quality system consulting, product development regulatory consulting and customized training on regulated research and Good Clinical Practice for her company Assured of Quality Consulting & Training, established in 2017.

• Med Device Trials

Maria Gujral is the Head, Global Biospecimen Management at Bristol Myers Squibb (BMS) with over 18 years of biospecimen and vendor management experience. In her current role, she is responsible for supporting biospecimen management for early development, including clinical pharmacology and cell therapy trials. Her team of Global Biospecimen Leads ensure timely and efficient delivery of all biospecimen operational aspects of dynamic clinical studies, across all stages (start-up, conduct and close-out). Maria has led and participated on several continuous improvement initiatives focused on enhancing end-to-end specimen tracking oversight. She has also overseen several strategic BMS vendor partnerships across Central and Speciatly labs. She received her BS from The College of New Jersey (NJ, USA) and MS in Quality Assurance and Regulatory Affairs from Temple University (PA, USA).

• Biomarkers & Precision Medicine Trials

Experienced in clinical research, clinical operations, & clinical development. Competent in the interpretation of the U.S. Food and Drug Administration (FDA) regulations, ICH, & GCP, literature review, and in utilizing and applying scientific and technical information to generate clinical study designs. Expertise includes CRO & FSP oversight management, EDC/CTMS, Sponsor representation during FDA (BIMO) and PMDA inspections. Builds a partnership with KOLs & collaborates with R&D and regulatory affairs and contributes to the authoring of the clinical sections of the IND and NDA and controlled correspondences to regulatory agencies. Therapeutic areas of experience and competence include oncology and schizophrenia (phase 1, 2 & 3).

• Clinical Operations for Small Biopharma

Dr. Arkady Gusev is the Executive Director of Laboratory Excellence and Operations in Biomarker Development/Translational Medicine at Novartis Institute for Biomedical Research. In his current role, he is responsible for the scientific and operational leadership of clinical biomarkers, assay outsourcing, sample operations, central laboratory setup, and vendor management. Previously, Arkady Gusev led the Business and Technology Operations units in the Department of Pharmacokinetics, Dynamics, and Metabolism in Pfizer Global Research Division. Arkady Gusev received his PhD (1992) in mass spectrometry from the Institute of Space Research, Russian Academy of Sciences. Following his PhD, he joined the Department of Chemistry, University of Pittsburgh as a postdoc and held a Research Assistant Professor position in the Department of Chemistry at Vanderbilt University before joining the industry in 1997. Arkady Gusev is the author and co-author of 60+ peer-reviewed publications in different areas of bioanalytical technologies, bioanalysis, biomarkers, and clinical operations. Arkady Gusev’s recent research interests include patient-centric technologies, bioanalytical and biomarker assay outsourcing, vendor management, clinical operations, and the art of operational excellence and portfolio management.

• Biomarkers & Precision Medicine Trials

Motivated and passionate Clin Ops leader with medical background and about 20 years of experience in clinical research, mostly oncology. Operational and safety oversight of clinical programs (early phase and late phase), cross-functional coordination, and leadership. Leading program management team and vendors. Coaching and mentoring. Training programs, process development, and improvement, SOP writing.

• Clinical Operations for Small Biopharma

With over 25 years in life sciences, Sheila specializes in R&D organizational transformations, encompassing system design, technology implementation, and inspection readiness. As a consulting leader, she drives transformation and performance improvement through industry-leading methodologies, excelling in organizational design, technology enablement, and inspection readiness planning. Sheila tailors operating models to a company's development stage, successfully implementing global inspection readiness and compliance remediation strategies. Passionate about fostering a culture of quality and innovation, she turns it into a competitive advantage.

• Quality & Monitoring

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.

• Outsourcing

Duncan has over 25 years’ experience in the life sciences technology sector. Duncan started TRI in 2013 with the specific aim of making Risk-Based Quality Management (RBQM) simple and accessible in all clinical trials. He has overseen the development of OPRA, the user friendly RBQM platform that integrates risk assessment and management with central monitoring. Duncan’s extensive RBQM knowledge and approachable style make him a much sought-after speaker at industry events.

• Quality & Monitoring

Seth Halvorson is the General Manager of WCG’s Site Solutions that includes WCG’s study start up teams, site network, CTMS, and enrollment & retention services. He joined WCG in 2018 as the General Manager of WCG ThreeWire. Prior to WCG, Seth was Vice President and Assistant General Counsel at Syneos Health for 9 years.

• Recruitment & Engagement

Alex Hammond is a Business Development Manager for the National Institute of Health and Care Research (NIHR) and his role is to advise life sciences companies, funders and researchers on the Network’s capability and capacity to deliver their research pipeline in the UK. Alex works closely with the Network’s portfolio of free services alongside an array of world renowned expertise from patient groups to clinical and academic research professionals. He has a close relationship to all clinical specialities with strong links specifically in Oncology, Oral and Dental and Surgery. Alex joined the CRN in September 2021 previously having had over 15 years working in the NHS clinically, operationally and in Business/Service Development. This included working in programme managing the Covid 19 Vaccine roll out in Leeds, UK and designing and implementing large scale system wide services in Yorkshire and Humber.

• Feasibility & Study Start-Up

No bio available.

• Med Device Trials

Don Harder has spent his 25-year career focusing on design and innovation in clinical trials. He started as a biostatistician designing and analyzing clinical trials and has leveraged those experiences to implement innovative solutions with multiple pharma sponsors, service, site, and tech organizations.

• Recruitment & Engagement

Camisha Harge has spent more than 25 years in the biopharmaceutical, CRO, and healthcare industries serving as a global drug development and clinical operations specialist within all study phases and across multiple therapeutic areas. During her tenure, Camisha has developed an expert knowledge of strategic global clinical program planning and execution, and quality management, in addition to having established successful strategic Sponsor-CRO partnerships that have effectively fostered innovation, led to recognition of efficiencies, and resulted in expedited milestone achievement. Across the teams she has led in both the biopharma and CRO spaces, Camisha has maintained a results-driven approach to succeeding where obstacles have seemed impossible to overcome. Thriving on challenges in development, she has been successful at implementing strategies to reduce recruitment timelines by up to 25%, to increase participation of African-American subjects in a given clinical trial from an expected 5% to 40%, and through the use of technology, has created and executed patient-centric clinical trial designs that have proven effective in both recruitment and retention across studies of various complexities and therapeutic areas. Having contributed to multiple successful global drug approvals, Camisha looks forward to sharing her thoughts and experiences with her colleagues in drug development.

• Clinical Operations for Small Biopharma

Meghan serves as the Vice President, Clinical Trial Financial Management at Medidata, driving roadmap and strategy across our Grants Manager and 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 20 years working in the life science technology industry. The last decade of this time has been solely focused on the clinical trial financial domain driving product strategy and leading teams responsible for complex system implementations.

• Budgeting & Resources

Dr. Patrick Harrington has over 25 years of scientific research and clinical experience in a broad variety of neuropsychiatric disorders. He has presented his research at professional meetings both nationally and internationally, and co-authored several publications in peer-reviewed journals. Patrick has worked on numerous psychiatry trials with sponsors all around the globe. He was the leader for a Clinical Surveillance and Training team where he helped develop pre-enrollment review and a statistical analysis program to assess ongoing patient ratings. He also created several scales used in clinical trials, collaborated with PIs on randomization decisions within the trial, and helped identify diagnostic and rating problems. In his role with Elligo, Patrick is helping to revolutionize the way clinical trials are designed and run. He holds a doctorate in clinical psychology, with a focus in clinical neuropsychology, from University of Texas at Austin. He won the American Neuropsychiatric Association Young Investigator Award in 1997. 

• Budgeting & Resources

I am the Chief of the Digital & Mobile Technologies Section and member of the scientific staff of the Division of Clinical Innovation within the National Institutes of Health's (NIH) National Center for Advancing Translational Sciences (NCATS). In this role, I manage and coordinate programmatic and research activities relevant to the section. My team focuses on bringing more interventions to more people, faster. Furthermore, to enable participants from more diverse backgrounds, those whom have been traditionally medically underserved, and from rural regions of the country to be able to participate in clinical trials. We tackle challenges in the remote delivery of care, building infrastructure for the decentralization of clinical trials, and working to implement solutions for providers and their community to engage and co-design remote patient monitoring. Our vision is to move the needle from bringing patients-to-care, to bringing care-to-patients. We implement this vision by way of the Clinical & Translational Science Award (CTSA) program - the single largest program of its kind within the U.S. DHHS that supports our Nation's clinical research ecosystem and its infrastructure. Prior to joining NCATS, I served as a program director in the Division of Cancer Treatment and Diagnosis at the NIH NCI. During my tenure at NIH, I have founded, guided and managed multiple programs. Prior to joining NIH, I was a member of the research staff at the NIST for projects focused on biomedical and national security applications, as well as subsequent collaborations with the U.S. Department of Defense, U.S. Department of Justice, NIH, Merck and Pfizer.

• Decentralized & Hybrid
• Biomarkers & Precision Medicine Trials
• Quality & Monitoring
• Med Device Trials
• Digital Measurements

David Hayes currently serves at ICON as Director of DCT Strategic Operations with a specialization in Hybrid & Full DCT trials and mobile health technologies. With over 21 years of clinical research at ICON, the majority of his experience in Clinical Operations and Project Management (Oncology and Neurology). David has spent the last 5 years specializing and focusing on mobile and digital strategies for internal based technologies and 3rd party vendors.

• Decentralized & Hybrid

Andrew Hedin is a partner in Bessemer’s Cambridge office where he focuses on investments broadly across the healthcare ecosystem, including new biotech therapeutics as well as software and services sold to healthcare verticals. Prior to joining Bessemer in 2015, Andrew worked at F-Prime Capital, Fidelity’s healthcare-focused venture capital fund where he invested in early-stage biotech and digital health technologies, as well as Leerink Partners as an advisor to the biopharma industry. He earned an MBA with honors from The Wharton School, where he majored in health care management and finance, as well as a degree in biological basis of behavior from the University of Pennsylvania.

• Clinical Trial Tech: Venture, Innovation & Partnering

Jonathan Helfgott is an FDA regulatory, clinical, and market access expert, specializing in the commercialization of medical products at all phases of development. As Co-Founder of Healthcare Innovation Catalysts, Inc Jonathan is responsible for overseeing global clinical research and regulatory activities, including overall product development, approvals, submissions, clinical trial design/conduct, inspections, and communications with health authorities and payors. In addition to his role at Healthcare Innovation Catalysts, Inc. Jonathan serves as Faculty, Senior Lecturer, and Coordinator for the MS in Regulatory Science & Food Safety Regulation Programs at Johns Hopkins University (JHU). Jonathan also serves as the Vice President of the Association of Graduate Regulatory Educators (AGRE) and has lectured extensively at various other academic institutions and professional organizations.

• Med Device Trials

Brian has a B.S. in Mathematics from Villanova University and an M.S. from Temple University in Quality Assurance and Regulatory Affairs. He brings a deep and broad understanding of the development, analysis, and compliance of clinical trial data to support regulatory submissions. Through his time in previous organizations, Brian has experience leading operational teams in planning, managing, and executing clinical data operations services across all phases and numerous therapeutic areas. Brian’s most recent experience includes successful implementations to support strategic transformational initiatives specific to data management, statistical programming, and data science needs. In his current role, Brian leads a global team supporting in life report development enabling study data cleaning & conduct, mapping of clinical data based on standards to support studies & downstream analysis, & decommissioning and study archival supporting key regulatory & compliance requirements.

• Data

Dr. Claudia Hesselmann, a chemist by training with a Ph.D. in molecular biology, boasts two decades of experience in early drug development. Leading ARENSIA Exploratory Medicine in DUsseldorf, Germany, Claudia aims to expedite drug development, fostering agile patient access to cutting-edge therapeutics through her unique blend of expertise, social acumen, and a keen understanding of the pharmaceutical landscape.

• Summit for Clinical Ops Executives (SCOPE)

Matthew Hewitt, PhD, currently serves as Vice President, Technical Officer for CGT and Biologics at Charles River Laboratories (CRL) playing a critical role in driving CGT strategic vision as well as leading multiple operational initiatives across CRL’s CGT sites. Before joining CRL, he was Head of R&D and Clinical Development for Lonza’s Personalized Medicine Business Unit leading Cocoon platform development, a closed, automated, scalable cell therapy manufacturing solution. In addition, he executed numerous collaborations across academia and industry leveraging the Cocoon. Prior to Lonza, Matt led the Tumor Immunology and Microenvironment program at Bellicum Pharmaceuticals, focusing on improving cell therapy efficacy in solid tumors. He also led the Immunology group at the University of Pennsylvania’s Gene Therapy Program, leading and contributing to numerous AAV gene therapy programs. Matt received his PhD in Biophysics and Physiology from the University of Alabama at Birmingham and completed his postdoctoral fellowship at Johns Hopkins University.

• Clinical Supply

Alyson Higgins is Director of Study Feasibility and has been with Abbott/AbbVie more than 25 years holding various roles in Pharma R&D and Diagnostics. Experience includes clinical trial design and execution, country and site optimization, project management, change management, operations management, quality assurance and manufacturing operations. Alyson is passionate about leveraging technology to work smarter and drive efficiency for development operations through interdisciplinary collaboration. The Study Feasibility team supports clinical teams with insights to inform strategic decisions from early concept through enrollment.

• Feasibility & Study Start-Up

Brad has worked at the site-level in clinical research for almost 15 years and is the former Executive Director of the Oklahoma Heart Hospital Research Foundation. Brad has since started his own integrated site network, Hightower Clinical, and hosts the Note to File podcast - a podcast for clinical research sites.

• Feasibility & Study Start-Up

Jenn Hill is a site contracts and payments expert, with more than 15 years' experience working in pharmaceutical companies and contract research organizations of all sizes. At Vertex Pharmaceuticals, Jenn leads a global team responsible for global clinical site contracting.

• Budgeting & Resources

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.

• Digital Measurements

No bio available.

• Patient-Centric Trial Design & DEI

Faith Holmes, M.D., brings more than 30 years of experience in direct patient care, and 11 years of medical practice management to her role as Elligo’s Chief Medical Officer. Her unique perspective plays an important part in building the company’s network of Research Ready physician practices and preparing them to conduct research. Holmes’ rich perspective - including experience in family medicine, hospice, and palliative medicine that spans solo practice and single specialty and multispecialty group practices - allows her to build rapport with study managers, site staff, and investigators, and provide medical and scientific knowledge to support future growth. Holmes has served as the Principal Investigator for interventional, diagnostic device, and observational trials in several therapeutic indications in Elligo’s eSolutions model and at the Elligo Clinical Research Center. She earned her B.S. in chemistry and biology from Trevecca University, her M.D. from ORU School of Medicine, and is board certified in family medicine and hospice and palliative medicine

• Med Device Trials

Randy Holzberger has experienced a wide ranging Clinical Research career spanning over 17 years across CROs and Pharma. He spent over 10 years within Clinical Operations as a CRA and Study Lead before transitioning to a role in the Risk Based Monitoring space. This exciting area has allowed Randy to further explore his interests in data and push the envelope of how to better, more efficiently monitor a study while maintaining a high level of data quality and oversight of patient safety.

• Quality & Monitoring

Amanda Hovda has more than 20 years of R&D contracting, financial, resource, and relationship management experience on both the CRO and Pharma/Biotech sides of the industry. She has an MBA in Organizational Leadership and a BS in Business Administration and is a seasoned leader in outsourcing, people management, and data and analytics measurement/trending.

• Outsourcing

Kevin Hudziak works on the CoDesign team at Lilly where he gathers participant and HCP feedback to influence the design and execution of clinical trials. He has a passion for innovation in research while ensuring that participant preferences and needs are incorporated into Decentralized Clinical Trial capabilities. Kevin previously supported novel recruitment and retention at Lilly while also developing the Lilly Trials website with a focus on educating potential participants and helping them match to trials. He also participated in the Transcelerate eConsent project and CTTI for Informed Consent.

• Patient-Centric Trial Design & DEI

Esther is the Director of Adaptive Monitoring Excellence at Takeda, where she is heading up a new team for Risk-Based Monitoring Strategy and Assessment activities 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.

• Quality & Monitoring

As a seasoned clinical trials expert with 24 years of industry experience, Tammy brings a wealth of knowledge to her role as VP of Study Start-up at ICON. With 17 years dedicated to optimising study initiation processes, she combines her roots as a site research coordinator with strategic oversight of site activation. Based in Philadelphia, she leads teams in streamlining study start-up for successful clinical trial execution.

• Feasibility & Study Start-Up

Ann-Marie started her pharma/biotech career over 20 years ago in data management, but quickly transitioned to the clinical operations space. Ann-Marie serves as the Senior Director of Clinical Operations at TriSalus Life Sciences. She has spent the majority of her career, and has a passion for IO drug development.

• Clinical Operations for Small Biopharma

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.

• Clinical Supply

Dr. Brigham Hyde is CEO and co-founder of Atropos Health since August 2022. He provided funding and support for Atropos Health’s official launch in late 2020. Hyde has a significant track record of building businesses in the health tech and real-world data (RWD) space and most recently served as President of Data & Analytics at Eversana. Prior to that role, Mr. Hyde served as a healthcare partner at the AI venture fund Symphony AI, where he led the investment in, co-founded, and operated Concert AI, an oncology RWD company - most recently valued at $1.9B. Hyde held previous roles as Chief Data Officer at Decision Resources Group, which was acquired by Clarivate for $900M in 2020. He has also served on the Global Data Science Advisory Board for Janssen, as a research faculty at MIT Media Lab, and served as adjunct faculty at Tufts Medical School.

• Clinical Trial Tech: Venture, Innovation & Partnering

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.

• Clinical Trial Tech: Venture, Innovation & Partnering

Bill is the Head of Collaboration and Technology Strategy, in the Clinical Development and Analytics function at Novartis and is currently responsible for developing the Analytics strategy, and initiating improvement projects. He has developed and led large-scale technology and business process transformation projects in data and digital across the pharma R&D landscape. He was appointed as lead for the Transcelerate Digital Data Flow initiative in June 2018. Bill has over 25 years of industry experience in R&D spanning subject areas of Cancer Epidemiology, Health Care Cost/Utilization Research; Preclinical Safety, and Clinical Development and Regulatory Affairs, and functional experience in Data Mgmt, Programming, Statistics, Data Standards, Data Governance, Information Technology and Operations. He holds a Master’s Degree in Public Health (Biostatistics) from the University of Michigan and a Bachelor’s degree in Psychology from Providence College.

• Data

Joe Im is currently the head of digital health technology operations at Regeneron. He has 15 years of experience within the clinical trial space, where he’s been able to exercise his interest in cutting edge technologies and his passion to improve the lives of patients. He has held positions on the supplier and sponsor sides within the COA project management function, as well as in innovations and imaging category management. In his current role, he leads a team responsible for deploying and operating digital health technologies such as eCOA, sensor devices, digital apps, medical devices, and eClinical solutions into clinical trials. Joe has successfully led initiatives at Regeneron including the COA operations team development, adoption of eCOA BYOD as a standard modality, and development of a decentralize trial operating strategy. Joe is happy to share his experiences and learn from the industry, ways we can contribute to improving the lives and outcomes of our patients.

• Digital Measurements

I am Clinical Trials Operations expert with over 26 years of experience across all phases of clinical research (clinical pharmacology, Vaccines, and later phase trials across multiple therapeutic areas). I have managed large teams of study managers and clinical research associates, and as Head of US Clinical Operations for GSK, I led the establishment of a new team responsible for local delivery of clinical trials in the US. I am committed to developing people and have been trained and practice as a coach. Until February 2020, I represented GSK on TransCelerate Biopharma workstreams, leading both the Site Qualification and Training team as well as the Patient Experience team. I am passionately dedicated to improving the patient experience in clinical research and in particular, increasing the diversity of participants in clinical trials. I was a member of GSK's Clinical Trial Diversity team, as well as SCRS's Clinical Trial Diversity Team, and currently serve as a member of the Harvard MRCT Clinical Trial Diversity Working Group. I have spoken on these topics at Industry conferences. In addition, I am trained in lean sigma and change management methodologies and am fascinated with the opportunity offered by digital data flow and AI to revolutionize clinical operations. In my role at Mallinckrodt Pharmaceuticals, I will work to facilitate the establishment of new methodologies to incorporate patient perspectives, digital innovation, and define risk-based strategies for maintaining compliance within the organization and at clinical trial sites.

• Clinical Operations for Small Biopharma

No bio available.

• Feasibility & Study Start-Up

With over 17 years of expertise in technology, clinical trial leadership and execution, Sheela is a seasoned thought leader specializing in program management for clinical trial feasibility. In her current role as Associate Director of Data Science Program Management at Johnson & Johnson Innovative Medicine, she leads programs that develop and deliver solutions to enable data-driven decisions. She also serves as a co-owner on the Trials360.ai team to align portfolio priorities across therapeutic areas, ensuring timely delivery of meaningful insights. Before joining Johnson & Johnson Innovative , Sheela worked at Intel Corporation where she led cutting edge embedded computing and internet of things programs.

• Feasibility & Study Start-Up

Tommy Jackson initially joined Prelude as COO and quickly advanced to CEO. Under his guidance, Prelude has transformed data collection in clinical research. Starting as an equity analyst at Baird, he specialized in medical devices before moving to AI-driven marketing at BloomReach. His entrepreneurial spirit led him to Stonewall Equity Partners and eventually Prelude. Tommy holds a BS in Finance from BYU and an MBA from Northwestern's Kellogg School.

• Clinical Operations for Small Biopharma

Paul Jacobs is Associate Director of Global Development Innovation at Regeneron. He is part of a function responsible for enabling clinical trials innovation by bringing innovative thinking, tools and techniques to the table through an innovation pipeline process. Before joining Regeneron in 2021, Paul worked in innovation roles at LEO Pharma as Head of Innovation, helping to establish and grow the R&D Data and Analytics function and, before that, as a founding member of the LEO Pharma Innovation Lab. Paul has also held roles in consultancy with Frog (Capgemini Invent) as Head of the UK Life Science Practice and various Medical Editing, Digital Strategy and Client Service roles at Publicis Healthcare, Sonic Boom and Nucleus Group companies. Paul received his Masters Degree in Biomedical Sciences from King’s College, London and his Bachelor’s degree in Biological Sciences from The University of Salford.

• Real World Evidence

Ross Jaffe, MD is an experienced healthcare venture capitalist who is also a co-founder and the Chairman of Faro Health, a software company focused on improving the design and implementation of clinical trials. Ross is one of the co-founders and is now a Managing Director emeritus of Versant Ventures, a leading healthcare venture capital firm. From 2019 through 2023, he also served as a Venture Advisor and board representative for New Enterprise Associates (NEA). During his 30+ year career in venture capital, Ross has served on the boards of multiple successful medical technology companies, including Acclarent (acquired by JNJ), Therasense (acquired by ABT), Insulet (NASDAQ: PODD), Novacept (acquired by HOLX), St. Francis Medical Technologies (acquired by MDT), Ablation Frontiers (acquired by MDT), Webster Labs (acquired by JNJ), Vertiflex (acquired by BSX), and Relievant (acquired by BSX). He started his venture career at Brentwood Venture Capital, where he was a General Partner. Ross has played an active role in the venture capital and medical innovation communities, including serving on the board of the National Venture Capital Association (NVCA) and the Medical Device Innovation Consortium (MDIC). He has been honored with the NVCA Outstanding Service Award and recognized on the Forbes “Midas List” of leading venture capitalists. Ross has served as Chair of the Board of Advisors of the Geisel School of Medicine at Dartmouth, and as Chair of the Board of The Children’s Health Council, a venerated not-for-profit organization in Palo Alto, CA providing mental health and educational services for children and adolescents. Ross earned a BA in Policy Studies from Dartmouth; an MD from the Johns Hopkins School of Medicine; and an MBA from the Stanford Graduate School of Business. He completed his residency and board certification in internal medicine and served part-time as an attending physician at the University of California, San Francisco.

• Clinical Trial Tech: Venture, Innovation & Partnering

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.

• Clinical Operations for Small Biopharma

Ding Jiang is a data scientist currently working at Bristol Myers Squibb (BMS), where he excels in leveraging innovative machine learning algorithms and advanced statistical methodologies. His primary focus involves harnessing key insights from complex data to facilitate significant improvements in drug development and address pertinent research questions within the realm of clinical trials. His research interests notably include machine learning, survival analysis, missing data analysis, and clinical trials. Ding obtained his Ph.D. degree in Statistics from Florida State University.

• Real World Evidence

No bio available.

• Biomarkers & Precision Medicine Trials

I’m a life sciences professional with 11 years clinical trial experience in biosample operations management with an academic background in Microbiology and Bioprocessing. My experience covers CRO central laboratory testing, biomarker vendor management and clinical trial management on regional and global levels. In my current role as a Biosample Operations Portfolio Lead, I’m accountable for the strategic and operational oversight of biosample collection and management across the early-phase clinical development portfolio. I’m passionate about challenging the status quo of biosample management practices and striving to introduce innovation in this space, hence I have been leading or contributing to a number of digital solutions.

• Biomarkers & Precision Medicine Trials

Dr. Otis Johnson is the Founder of Trial Equity, whose purpose is to ensure that medicines are safe and effective for all people by providing solutions for diverse patient recruitment in clinical trials. Recognized for his leadership by Pharmavoice, Informa Connect and Mogul, he has served on the diversity advisory boards of the Association of Clinical Research Organizations (ACRO) and the Association of Clinical Research Professionals (ACRP). He is also on the advisory board of Wake Forest University’s Master’s Degree Program in Clinical Research Management and a Global Advisory Board Member of the Healthcare Businesswomen's Association (HBA).

• Decentralized & Hybrid
• Biomarkers & Precision Medicine Trials
• Quality & Monitoring
• Clinical Supply
• Budgeting & Resources
• Med Device Trials
• Data
• Clinical Operations for Small Biopharma
• Outsourcing
• Patient-Centric Trial Design & DEI
• Real World Evidence
• Recruitment & Engagement
• Feasibility & Study Start-Up
• Digital Measurements

No bio available.

• Patient-Centric Trial Design & DEI

Denise Johnson Sura is a recognized leader in drug development. Her background has driven a strong patient focus and desire to find innovative ways to deliver new therapies to those burdened by disease across the globe. Denise has extensive clinical trial experience with specific expertise in global operations and data & analytics. Denise holds a bachelor’s degree in Toxicology from the University of Wisconsin, Madison, and is the current Associate Vice President for Clinical Trial Design, Patient Engagement, and Diversity in Clinical Trial Capabilities at Eli Lilly and Company, enabling access of clinical trials across Lilly’s portfolio.

• Patient-Centric Trial Design & DEI

I am a strategic-minded, global operations professional with many years of developing key initiatives and business solutions in biotech, academic, technology, and hospitality sectors. I am a results-driven change-maker with strong analytical and communication skills who effectively collaborates in a matrixed environment (e.g. internal, external, all levels including senior leaders). I’m motivated by solving complex challenges and leveraging team capabilities to drive strategy through possibility and imagination. I contribute vigorously and enthusiastically and believe fun, laughter, and open communication is a key component of an effective and dynamic work environment. Over the course of my career, I have developed a servant leadership approach to managing and motivating my high-performing teams (currently 27 people in 8 countries). I build safe environments and identify growth opportunities where team members are encouraged to develop their own successful careers while at the same time achieving optimal outcomes.

• Budgeting & Resources

As Senior Director of Sponsor Transformation at OneStudyTeam, Emily Jordan is passionate about improving patients' lives and solving for sites' and sponsors' pain points by streamlining start-up and recruitment for clinical trials. Formerly Director of Trial Design at OneStudyTeam, Emily also has deep experience building clinical trial protocols and schedules into technology platforms to streamline site workflows.

• Patient-Centric Trial Design & DEI

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.

• Decentralized & Hybrid

No bio available.

• Feasibility & Study Start-Up

Rasika Kalamegham, PhD, is Executive Director and Head of U.S. Regulatory Policy at Genentech, a member of the Roche Group. She joined Genentech in 2015, bringing considerable scientific, regulatory, and policy experience to her role. Her portfolio includes personalized medicine including targeted therapies, cell and gene therapy, and companion diagnostics. Rasika has recently been focused on influencing the FDA’s regulation of digital health-from SaMDs to development of novel digital endpoints to decentralized clinical trials. A geneticist by training, she studied cell-fate specification during her post-doctoral work at the NIH. She then worked in increasingly senior positions at Friends of Cancer Research (FoCR), The Pew Charitable Trusts, and The American Association for Cancer Research (AACR) before joining Genentech. She plays an active role in many trade groups including BIO, PhRMA, Transcelerate, and DTRA, and serves in leadership positions on several workgroups. Her work has led to important regulatory policy outcomes including FDA guidance (Codevelopment of Two or More New Investigational Drugs for Use in Combination; Use of Public Human Genetic Variant Databases to Support Clinical Validity for Genetic and Genomic-Based in vitro Diagnostics, etc.); passage of the Generating Antibiotics Incentives Now or GAIN Act (signed into law by President Barack Obama); Research to Accelerate Cures and Equity(RACE) for Children Act; Vice President Biden’s Cancer Moonshot Initiative, and others. She is widely published in peer-reviewed journals and has authored several text book chapters.

• Digital Measurements

Kimberley Kallsen is a cell biologist with public health expertise and +9 years of international pharma industry experience. She has a proven track record in patient-centricity and clinical development, with strong engagement of healthcare professionals and patients, as well as cross-functional collaboration and international networking. Currently, she is Head of Global Clinical Development & Operations Patient & Site Engagement at Boehringer Ingelheim. In this role, she is leading the global patient- and site-centric clinical development strategy to create the best trial experience for patients and trial sites.

• Patient-Centric Trial Design & DEI

Currently supporting ARBM for late development trials within the rare neurodegenerative disease space. Ex-research coordinator at The University of Rochester's Strong Memorial Hospital.

• Quality & Monitoring

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.

• Real World Evidence

Dr. Daniel Rollings Karlin, MD, MA is the Chief Medical Officer at MindMed (Mind Medicine Inc). He is board-certified in Psychiatry, Addiction Medicine, and Clinical Informatics. Previously, he was the Co-founder and the CEO of HealthMode, a company that developed digital measurement technology for medicine and clinical trials, which was acquired by MindMed. During this time, he also served as the Chief Medical Officer for NightWare, where he led development through FDA clearance. He was previously the Head of Clinical, Informatics, and Regulatory Strategy for Digital Medicine at Pfizer, having passed through several roles on the way to this position including Senior Director, Quantitative Medicine, Group Lead for Human Biology and Medical Informatics with Pfizer's Neuroscience Research Unit in Cambridge, MA. He is an Assistant Professor at Tufts University School of Medicine in Boston and had been the Director of Psychiatry Informatics, and the Associate Training Director for Psychiatry. He was the Co-Founder and former Chief Medical Officer of Column Health, an addiction treatment startup. Dr. Karlin trained in Psychiatry at Tufts Medical Center, attended medical school at the University of Colorado School of Medicine, and graduate school for Clinical Informatics and Cognitive Science as well as undergraduate studies in Neuroscience and Behavior at Columbia University.

• Digital Measurements

Tina is the Founder and CEO of Karuna Integrated Clinical Services (KICS), a niche Clinical Research Organization. Prior to the launch of KICS, Tina worked in both Healthcare and mid to small Biotech and Pharma Companies. More recently, she was the Vice President and Head of Global Clinical Operations at Orum Therapeutics, a clinical-stage Biotech company pioneering a novel class of protein degraders in Oncology. Tina is on the Board of Advisors at Arstat Pharmaceuticals. She also serves on the Board of Directors for DOVE (Domestic Violence Ended) and Children Across America (CAA), an organization focusing on enriching the lives of minority children in STREAM (Science, Technology, Reading, Engineering, Arts, and Mathematics). She is involved with many other foundations where she mentors young women in Women’s Empowerment, Project Management, and Financial Independence. When she is not working, she is busy raising funds for the many charities she supports in her home country, Sri Lanka.

• Clinical Operations for Small Biopharma

Asma Kasuba is Senior Director, Global Development Data and Science and Digital Health at Johnson and Johnson Innovative Medicine. Her career in the pharmaceutical industry spans across all phases of clinical development and multiple therapeutic areas, enabling a diverse and broad lens to drug development. Asma has held roles in increasing responsibility across Regulatory Affairs, Program Management, Strategy, and Operations and Data Science in R&D, Medical Affairs and Commercial. In her current role, Asma is leading a team of Data Science PMs to build and utilize RWD, RCT, and AI/ML modeling capabilities to optimize clinical trial design, site selection and accelerate trial execution, and scaling these capabilities for greater impact across the portfolio. Asma has a Bachelor's Degree in Biochemistry from Rutgers University and an MBA in International Business. She is a PMP Certificated and a Stanford University Certified PM. Prior to joining Johnson and Johnson, Asma has prior experience at Pfizer and Biomatrix.

• Feasibility & Study Start-Up

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.

• Quality & Monitoring

Lindsay Kehoe manages the development and implementation of projects at the Clinical Trials Transformation Initiative (CTTI). Lindsay has close to 10 years of experience coordinating clinical research. Prior to joining CTTI, she served as a clinical trial lead at Children’s National Medical Center in Washington, D.C., coordinating both physician-driven and industry-sponsored trials. She also served on the hospital's Institutional Review Board. Lindsay is a certified genetic counselor with extensive experience in both pediatric and adult genetic counseling. Early in her career, Lindsay worked in the pharmaceutical sector, first in early phase drug development at Millennium Pharmaceuticals (now Takeda Oncology) and then in post-marketing laboratory surveillance at Sanofi Genzyme. Lindsay has a B.A. from the University of Virginia and an M.S. in Genetic Counseling from Boston University School of Medicine.

• Decentralized & Hybrid

Allison Kemner is VP Clinical Sciences and Operations executive at Tyra Biosciences. A summa cum laude University of Pennsylvania grad with dual Masters, she transitioned from clinical nursing to pharma R&D. Over her 19 + year career, Allison has held senior and executive positions at GlaxoSmithKline, OxOnc Development, Incyte and Tyra Biosciences where she now oversees oncology clinical sciences and operations. Her passion for patient access to clinical trials is grounded in her experiences as a heme-onc transplant Nurse at the Hospital of University of Pennsylvania. Putting this passion into action, she uses layered measures to break down barriers to entry that can holistically support inclusivity to augment diversity in clinical trials.

• Budgeting & Resources
• Clinical Operations for Small Biopharma
• Outsourcing

Kelsey Kern is a Clinical Trial Supply (CTS) Manager at CSL Behring where she puts quality, reliability, and the patient at the forefront of her approach to end-to-end supply chain for complex clinical studies in the rare disease space. Having spent over half of her life in the pharmaceutical industry, Kelsey brings her creativity and diverse knowledge into each clinical study she manages. Dedicated to the patient (and site) experience in these studies, she’s passionate about how to better design a streamlined, efficient supply process that best suits the disease state and the diverse patient populations that are represented throughout her global studies. In the last 5 years, she has been able to bring this vast experience in the Direct-to-Patient (DTP) operating model that CSL has established as the CTS Subject Matter Expert (SME). The launch of this project came just in time to support patients during the COVID Pandemic, where DTP was utilized to ensure consistent and reliable supply for patients who were immediately at risk of not having access to life saving medications. Since then, Kelsey remains an internal SME for clinical programs looking to utilize DTP or Patient Home Treatment models. She is an active member of CSL’s internal Patient CARE Network, which is a cross functional team of employees who seek to revolutionize the clinical and commercial patient experience. She and her IRT colleague are excited to share why it’s so important to build a flexible IRT system to support the patient experience while also reducing waste and overage in studies. She also looks forward to gaining insights from the audience and other presenters while at SCOPE.

• Clinical Supply

Dr. Irfan Khan is the founder and CEO of Circuit Clinical. Dr. Khan is a cardiologist who served as a principal investigator on both therapeutic and device clinical trials for more than a decade and is passionate about improving access and equity in clinical trials, community engagement, and patient education and empowerment. Over the last six years, he has overseen Circuit Clinical’s growth to more than 2.5 million patients, involving 30+ partner locations including multi-specialty physician practices, Accountable Care Organizations, and Federally Qualified Health Centers. His work at Circuit Clinical has also included the creation of TrialJourney™, the first-ever ratings and reviews platform for clinical trial participants and people seeking clinical research as a care option. Under Dr. Khan's leadership, Circuit Clinical was awarded a "World Changing Ideas" recognition from Fast Company™, as well as being named an Inc. Magazine™ Best Workplace 2021, and a Fast Company™ Best Workplaces for Innovators 2021.

• Decentralized & Hybrid

Anisa Khan is a Senior Scientist in Global Trial Optimization at Merck. As the indication lead for the Oncology Early Development portfolio, she developed a methodology for the forecasting and management of enrollment in complex, early phase, and adaptive design studies. Additionally, she facilitates the optimization and alignment between key stakeholders in resource management and clinical teams within this space. Passionate about Bayesian statistics, she is always seeking out improvements for enrollment forecasting and management through the blending of data and real-world expertise. Anisa has 10+ years of experience in project management and various functional roles within clinical operations. Her current role allows her the opportunity to apply her thirst for process improvements and data analytics to support oncology research. In her free time, she loves spending time with her friends and family and researching practical scenarios where big data can be applied to improve the quality of life.

• Recruitment & Engagement

Shafaat Ali Khan, MB, BS, Eli Lilly and Company Associate Director - Investigator Engagement Clinical Research Lead (CRL) Ali is a seasoned clinical research professional with a passion for revolutionizing the way clinical trials are conducted. As the leader of Lilly's Site and Investigator Engagement organization, Ali spearheads efforts to operationalize and execute highly decentralized clinical trials, driving efficiency and innovation in the field. With a strong focus on patient empowerment, Ali is on a mission to enhance patient education and improve access to novel investigational therapies and diagnostics. By leveraging advanced technologies and patient-centric approaches, Ali strives to break down barriers and ensure that more individuals can benefit from cutting-edge treatments. Recognizing the absolute need for achieving greater diversity in clinical trials, Ali is dedicated to promoting inclusivity and equity within the research landscape. By actively seeking to engage diverse patient populations, Ali aims to eliminate disparities in healthcare outcomes and contribute to more comprehensive and representative data. Ali's unwavering commitment to accelerating drug development is fueled by the desire to bring life-changing therapies to patients faster. He leads multidisciplinary teams at Lilly, to closely collaborate with sites and investigators to drive innovation across the drug development lifecycle. Combining his extensive expertise in clinical research with a genuine passion for improving patient outcomes, Ali is a catalyst for change in how clinical trials are conducted.

• Feasibility & Study Start-Up

Dr. Angana Kharge is a seasoned R&D and Clinical development professional, with expertise in the realms of biomaterials, biotechnology, and lung disease. Dr. Kharge serves as a Clinical Development Scientist II at Exact Sciences, where she is dedicated to advancing the cause of early cancer detection. She is an advocate for clinical trial diversity and is committed to diminishing cancer disparities while enhancing diversity metrics in cancer trials. Before her tenure at Exact, Dr. Kharge served as a Senior Scientist at Integra LifeSciences, specializing in the research and development and commercialization of regenerative technologies (510k/PMA) primarily for wound care and plastic and reconstructive surgeries. Furthermore, she serves as a dedicated mentor, coaching students and scientists to empower and motivate them towards successful careers.

• Med Device Trials

Garo Kiledjian is the Founder, President, and CEO of SGM Alliance, a 501c3 nonprofit that focuses on educating and advocating for inclusive Sexual and Gender Minority (SGM) participation in clinical trials, life sciences, and the evolution of healthcare. Garo also serves as the Chief Operating Officer for Trialogic, a Site Network for one of the largest global LGBTQIA+ healthcare providers. Having served in multilevel roles within administration, research, pharmacy, operations, and finance, Garo brings a versatile skill set to his leadership role. He also serves on the Membership Planning Committee for Society for Clinical Research Sites (SCRS) and is on the Executive Committee for the National LGBTQ Task Force-one of the oldest social advocacy groups that focuses on legislative and policy changes at the grassroots level in Washington, DC. He is passionate about DEI and offers a unique perspective on how the intersectionality of race and ethnicity overlap with gender and sexuality. Garo earned his Bachelor’s from UCLA and studied Leadership and Global Strategy at Woodbury’s Graduate School of Business.

• Patient-Centric Trial Design & DEI

Joseph Kim brings 23+ years of expertise to ProofPilot. Recently serving in Sr. Advisor roles at Lilly in Digital Health, Design, and Innovation departments, he also brings experience from Merck, Takeda (Shire), CROs, and tech vendors. He was recognized as a “Top 100 individual on the 2015 MedicineMakers Power List,” and “20 Innovators Changing the Face of the Clinical Trials Industry” by CenterWatch. 

• Budgeting & Resources

Mark J. King, MA, ACRP-CP, vice president, research and innovation at Novant Health, is responsible for the strategy and execution of all clinical research operations across a 16-hospital system based in NC. With teams across the Charlotte, Winston-Salem, and Wilmington, NC markets, the group works to improve patient access to clinical trials, expand the health system’s clinical research portfolio, and partner with providers, health system leaders, pharmaceutical companies, and device manufacturers, as well as research consortia and academic research centers. Ethics, safety, quality, and compliance are the hallmarks of Novant Health’s research program. Mark holds academic degrees and certifications from the University of Connecticut, Holy Apostles College and Seminary (BA, MA), Fairfield University (Cert.), the Association of Clinical Research Professionals (ACRP-CP), CITI (HSR, GCP), and the American Board of Artificial Intelligence in Medicine (ABAIM). Mark has held senior research leadership positions in multiple health systems, as well as pharmaceutical and agricultural research.

• Feasibility & Study Start-Up

As  Head of Clinical Development North America, Antoinette leads and manages delivery of high-quality clinical trials for biotech, pharma, and medical device clients. With over 30 years of experience, Antoinette is passionate about improving the lives of patients through science and innovation. She has therapeutic expertise in rare disease, oncology, respiratory, cardiovascular, diabetes, and women's health. Antoinette is a graduate of the UCLA Anderson School of Management Executive Program. 

• Clinical Operations for Small Biopharma

Brett has spent the past two decades as a life sciences industry executive, taking several companies from infancy to market leader. In recognition of his career achievements in ‘Tackling the Impediments to Clinical Trials’, Kleger was named to the PharmaVoice 100 in 2018.

• Data

No bio available.

• Decentralized & Hybrid
• Biomarkers & Precision Medicine Trials
• Quality & Monitoring
• Clinical Supply
• Budgeting & Resources
• Med Device Trials
• Data
• Clinical Operations for Small Biopharma
• Outsourcing
• Patient-Centric Trial Design & DEI
• Real World Evidence
• Recruitment & Engagement
• Feasibility & Study Start-Up
• Digital Measurements

No bio available.

• Clinical Operations for Small Biopharma
• Recruitment & Engagement

Anna Kosenko is leading a Biomarker Sample Management and Data Operations Team within Oncology and Cell Therapy Precision and Translational Sciences department at Takeda Pharmaceuticals. Anna joined Takeda in early 2022 and played a critical role in building a biomarker operations team with clinical sample and data operations capability to support Takeda’s oncology and cell therapy portfolio of Phase I through III global studies. Before joining Takeda, Anna worked in Oncology Biomarker Sample and Data Management role at Seagen (formerly Seattle Genetics). Anna spent 7 years at Parexel International, where she gathered a wealth of experience in clinical operations across therapeutic areas by supporting clinical trials for 20+ pharmaceutical and biotechnology companies. Anna holds an MS in Bioinformatics from Freie University of Berlin (Germany).

• Biomarkers & Precision Medicine Trials

Director, Oncology Data Management Operations at Bayer. Mary’s professional background includes over 20 years experience in the pharmaceautical industry involving end to end data management of Pediatric and Adult Phase I-IV clinical trials. Her primary focus is within the Oncology therapeutic area. A results oriented leader focused on quality, efficiency, adaptability, and team engagement. Mary received her B.A. degree from New York University and was employed by American Home Products, Roche, and Novartis prior to joining Bayer in 2015. Mary lives in New Jersey with her husband and 2 boys and enjoys traveling and baking in her spare time.

• Data

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.

• Clinical Trial Tech: Venture, Innovation & Partnering

Born in Bulgaria, lived in Germany for few years before moving to USA in 1994. Diverse educational background and professional interests including Basic Science and Research (MSc. in Molecular Biology & Biochemistry); worked as a Registered Nurse & a Pathology lab manager at Mt. Sinai Hospital, NYC, followed by a move to Pharma Clinical R&D. Have spent the last 25 years in Clinical Data Management, leading large global projects and teams in several pharma companies, including Merck, Schering Plough, Eisai, Novartis & Bayer AG. Passionate about individual and team development, creating effective team dynamics, drives strategic process improvement initiatives, and actively works on devising streamlined Data Management vision and mission. Having some difficulties in committing to and dedicating sufficient time to maintaining an active lifestyle outside of work, but loves traveling, beaches and taking flower and sunset photos. Currently working at Bayer Pharmaceuticals, Oncology Specialty Business Unit, Oncology Dev Ops, as the Global Head of Data Management Operations.

• Data

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.

• Outsourcing

Marcy has been in the pharma industry for more than 20 years. She has honed her operational expertise through roles in Pharmaceutical Sales, Clinical Research Site operations, Sponsor Global Clinical Operations, Medical Affairs Scientific Publications, and Early Clinical Development operations. Throughout her career, Marcy has had multiple opportunities to craft new roles and build new organizations aimed at streamlining and simplifying operations in order to better serve patients. Marcy joined EMD Serono (Merck KGaA) in October 2018 and is building out the Operational Design Center within Global Clinical Operations. This capability will provide operational design scenarios for the organization to make decisions based on data and ultimately make our clinical trials accessible to more patients. Marcy has an MBA from DePaul University and a BS in Marketing from the University of Connecticut.

• Feasibility & Study Start-Up

Sarah KrUg is the CEO of CANCER101, a patient advocacy organization, whose mission is to empower patients and their families to navigate their cancer care and partner with their healthcare team to make informed decisions. Sarah is also the founder of the Health Collaboratory, a global innovation hub, that’s built on the foundation of advancing health equity, understanding the impact of behavior science, and cultivating trust by amplifying the voice of the patient, care partner and clinician in the co-design of the future of healthcare. The Health Collaboratory has launched various innovations such as Prescription to Learn®, a Health GPS, and the Patient Shark Tank®, among others that have been co-designed with patients. Through the Patient Shark Tank ®, over 25,000 patients and care partners across disease states have evaluated/partnered on innovations across the globe, including technology, education, research, and policy. The Health Collaboratory is comprised of a network of >300 subject matter experts. Sarah is on the board and past president of the Society for Participatory Medicine, a patient: clinician member driven organization, whose mission is to enable collaborative partnerships between patients and healthcare professionals. She was also on the board of the National Organization for Rare Disorders. Sarah is the author of “A Roadmap to Wellness” with another book “Health Confessions” to launch in 2024. She is a global speaker and recently gave a TEDx talk called “The Patient: Doctor Tango”. She previously held the position of Global Education Director, as well as Patient Advocacy Lead at Pfizer. She also established the Global Investigator Initiated Research Program at Pfizer. Prior to joining Pfizer, Sarah spearheaded the development of the Disease Management Clinical Pathways and conducted clinical research at Memorial Sloan- Kettering Cancer Center.

• Decentralized & Hybrid
• Biomarkers & Precision Medicine Trials
• Quality & Monitoring
• Clinical Supply
• Budgeting & Resources
• Med Device Trials
• Data
• Clinical Operations for Small Biopharma
• Outsourcing
• Patient-Centric Trial Design & DEI
• Real World Evidence
• Recruitment & Engagement
• Feasibility & Study Start-Up
• Digital Measurements

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.

• Clinical Trial Tech: Venture, Innovation & Partnering

As the Director of Clinical Data Systems (EDC & IRT) at AbbVie, Lance Kupka is a highly accomplished professional with expertise in Lean Six Sigma Process Improvement, Metrics & Analytics, and Project Management. Renowned for his proficiency in OC/OC-RDC Database Design Training and Documentation, Lance has showcased mastery in platforms such as DataLabs, RAVE, and InForm. His extensive experience also encompasses strategic oversight of CRO Outsourcing/Management and Line Management, underscoring his commitment to developing people within the realm of clinical data management. Lance stands as a key figure at the intersection of technology and clinical research, driving advancements in data systems for AbbVie.

• Data

Jake LaPorte founded and is Global Head of The Biome-the digital innovation lab of Novartis. Prior to that, he was Global Head of Digital Development at Novartis and responsible for leading the company’s digital efforts to advance future, patient-centric paradigms of clinical trials. Jake began his career at McKinsey & Company, where he was a leader in their Pharmaceutical R&D practice, during his six-year tenure, developing an expertise in large, complex transformations and innovation. It was on a fateful, extended journey, however, where Jake read Ray Kurzweil’s The Singularity is Near and became captivated by the possibility of digitalizing the Pharmaceutical R&D engine; he has focused his career to the realization of this concept ever since. He co-founded Snapdragon Chemistry with the Head of the Chemistry Department at MIT, which seeks to enable companies to implement continuous flow chemistry in discovery, development, and manufacturing, with the ultimate goal of fully digitizing chemical synthesis. Jake has also held various leadership positions at PPD, Inc., where he collaborated with executives to develop and implement C-level, strategic initiatives, including a long-term transformation to create industry-leading approaches to clinical development in key therapeutic areas. Jake completed his PhD in Organic Chemistry from Harvard University, where he was an HHMI doctoral fellow, and received his BSc in Biochemistry and Mathematics, summa cum laude, from the University of Delaware.

• Decentralized & Hybrid
• Biomarkers & Precision Medicine Trials
• Quality & Monitoring
• Budgeting & Resources
• Data
• Clinical Operations for Small Biopharma
• Outsourcing
• Patient-Centric Trial Design & DEI
• Real World Evidence
• Recruitment & Engagement
• Feasibility & Study Start-Up
• Clinical Trial Tech: Venture, Innovation & Partnering
• Digital Measurements

No bio available.

• Clinical Trial Tech: Venture, Innovation & Partnering

Amir is a Digital Health Advisor and a Board Member who helps Pharma and Medtech companies strategize, develop, and implement innovative solutions in clinical research and medicine. Amir is the Founder and CEO of SkyMed Digital. He sits on the Advisory Board of multiple startups and holds strategic consulting roles with pharmaceutical companies. Amir brings over 20 years of clinical experience in the biotech and healthcare industries. He leverages his expertise in medical devices, wearable technology, AI, and data intelligence to digitize disease-monitoring and enable the detection of various diseases much earlier than is currently possible within the conventional healthcare system. Amir's mission and goals are to go beyond the pill, make home the new clinic, automate medicine with AI, accelerate personalized therapies, improve patient care, and create a path for better patient experience using digital technology. During his time at Pfizer, Amir led the development of digital solutions for gene therapy trials, primarily in rare diseases. Prior to pharma, Amir was a PI on numerous clinical trials as a Neurology Faculty and Professor of Pediatrics at Harvard Medical School.

• Digital Measurements

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.

• Recruitment & Engagement
• Feasibility & Study Start-Up

BS in Pharmaceutical Marketing from Saint Joseph’s University. 17 years experience in clinical research, the last 10 of which were with Merck in Global Trial Optimization where my responsibilities include protocol feasibility and study timeline assessment, country and site feasibility, patient recruitment and retention planning and execution and the management of clinical trial services vendors.

• Recruitment & Engagement

Mark Laney has over 20 years experience in the life sciences software industry, focused on delivering the right solutions for customers. At Merative, he is responsible for solving customer challenges using the breadth of functionality and flexibility of Zelta’s unified CDMS, while facilitating partnerships with leading vendors to offer customers a robust technology solution. Mark holds a BS in Chemical Engineering from NC State University and lives in North Carolina with his wife and three boys.

• Feasibility & Study Start-Up

Jason Lanier holds a BS and MS in Marine Biology from UNCW, as well as a Project Management Professional certification. After somewhat accidentally finding a career in clinical research operations, 17 years later, Jason now returns to his passion for the environment in his latest assignment as a Director within Johnson & Johnson Innovative Medicine’s Environmental Sustainability Focus Area. In this rotational growth assignment, Jason is leveraging his years of clinical operations expertise to help measure the environmental impact of Johnson & Johnson’s global clinical trial development program and to identify science-based targets for improvement throughout Johnson & Johnson and across industry collaborations.

• Budgeting & Resources

Dr. Ade Lawrence is a Physician Investigator and the Founder/Chief Executive of Bioluminux Clinical Research, where he leads initiatives to support clinical trial studies for Pharmaceutical companies and CROs. He also provides clinical development consulting and contracting services to small pharmaceutical companies and start-up biotech. He earned a Doctor of Medicine degree at the Universitatea de Medicina si Farmacie "Grigore T. Popa” din Iasi, Romania, and a Master's degree in Regulatory Affairs for Drugs, Biologics, and Medical Devices at the Northeastern University, Boston. Dr. Lawrence has a special interest in promoting diversity in clinical research with a strong cultural and patient-centred approach.

• Feasibility & Study Start-Up

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.

• Outsourcing

Sheri Lee is the CEO and Principal Consultant at Premier Regulatory Consulting (PRC), a leading boutique firm specializing in providing strategic guidance and expertise to companies worldwide. PRC assists corporations in navigating complex regulatory and quality landscapes to ensure compliance with local and international regulations. Her work at PRC is a culmination of the skills acquired throughout her career. Sheri’s strong background in the pharmaceutical industry was fostered during her time spent at the US Food and Drug Administration (FDA). Sheri spent 10 years at FDA in positions of increasing responsibility with a global scope. At FDA Sheri was the National BIMO Program Expert in the Office of Medical Products and Tobacco Operations. Prior to that she held a position as a National Recall Officer for the Office of Enforcement and Import Operations. During the start of her professional career she worked at non-profits, national and local organizations, hospitals managing clinical trials and developing public health initiatives. After Sheri left the FDA she held various leadership positions in the pharmaceutical industry, at Pfizer, Bayer and Organon to name a few. These roles provided her with invaluable experience managing diverse teams, driving organizational growth, building strategic partnerships, and achieving operational excellence. She brings a deep understanding of the industry's challenges, trends, and regulatory landscape. Her expertise spans a wide range of areas, including recalls, clinical trials, regulatory affairs, pharmacovigilance, and quality. She also has skills in manufacturing quality, ensuring compliance with strict regulations for drugs and devices. Sheri is a native New Yorker, who resides in Atlanta Georgia with her husband Darius and their two children Quinton and Lauren. She also enjoys spending time with family and friends, her two dogs Levi and Milo, practicing yoga and traveling.

• Quality & Monitoring

Disa has 15+ years of experience working in technology and innovation, especially in the pharmaceutical industry. She is the Head of Integrated Clinical and Operational Analytics at Janssen Pharmaceutical Companies part of Johnson & Johnson. She was previously at UCB as the Head of Innovation and held other leadership roles. Prior to joining the pharma, she was a co-founder of an IT company. She has an EMBA and B.S. in Pharmaceutical Chemistry. In 2017, Disa started a consortium, a cross-industry collaboration on blockchain via PhUSE. Recently, she was awarded Top 100 Women in Technology, Financial Times' top 100 most influential BAME Leader, and featured on the cover of CIO Look celebrating Women in Tech 2019. Her passion is closing the gap for patients with unmet needs and exploring the right digital technologies to accelerate the implementation of end-to-end patient solutions.

• Data

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.

• Data
• Clinical Trial Tech: Venture, Innovation & Partnering

Joe Lengfellner is a dedicated digital health innovator with a passion for applying technology strategies in clinical research. He strives to enhance the experiences of patients, clinicians, and research teams by implementing cutting-edge solutions that streamline processes, bolster communication, and optimize data management. As the Senior Director of Clinical Research Informatics and Technology at Memorial Sloan Kettering Cancer Center (MSK), Joe has spearheaded numerous large-scale research technology initiatives, such as the implementation of MSK's Clinical Trial Management System (CTMS), the development and deployment of eConsent for research, and the management of the Electronic Data Capture (EDC) ecosystem at MSK. Joe is deeply interested in streamlining clinical data pipelines from EHR systems to research platforms, aiming to reduce the data management workload on sites and simultaneously enhance data quality, while also lowering costs for both sites and sponsors. A strong advocate for collaboration, he believes in forging partnerships among clinical research sites, technology vendors, and industry sponsors to develop clinical trial technology solutions that benefit all stakeholders and ultimately accelerate the pace of clinical trial execution.

• Feasibility & Study Start-Up

No bio available.

• Clinical Trial Tech: Venture, Innovation & Partnering

Steven Levine, PhD, is a renowned biomedical engineer and Senior Director of Virtual Human Modeling at Dassault Systemes. He is a visionary leader in medical simulation and modeling, known for founding the Living Heart Project-an international consortium that developed the first digital twin of the human heart. With over 150 global partners, the project has received numerous awards for its groundbreaking approach to medical research and education. Dr. Levine's influential work is transforming the field of medical engineering, and he is a sought-after speaker and principal investigator on collaborative projects, including one with the FDA. Elected into the College of Fellows in AIMBE in 2017, Dr. Levine holds a PhD in Materials Science from Rutgers University.

• Med Device Trials

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.

• Budgeting & Resources

Barry L. is a Senior Product Manager who has a decade of experience developing healthcare technology products, from wearables to machine learning algorithms to clinical research solutions. With a background in biomedical engineering, Barry works closely with cross-functional teams of engineers, epidemiologists, data scientists, and clinicians to develop innovative solutions in the clinical research space. Barry holds a BS in Biomedical Engineering from Johns Hopkins University, and is a current MPH student in Health Economics at the London School of Hygiene and Tropical Medicine.

• Real World Evidence

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.

• Digital Measurements

Alex Li is a director of Janssen R&D Data Science, embracing this role since July 2020. His journey began with a profound 18-year chapter at GSK, where he contributed extensively across diverse domains, including bioinformatics, discovery, and clinical research. Since joining Janssen, Alex has been dedicated to pioneering data science solutions that drive advancements in precision medicine and innovative clinical trial design.

• Digital Measurements

Micah has 20 years of experience in the biopharma industry. He is an Executive Director at Cambridge Healthtech Institute (CHI) where he is a producer, content developer, and facilitator of the Summit for Clinical Ops Executives (SCOPE), the leading event in the US and Europe for biopharmaceutical industry executives focused on driving innovation in clinical trials and digital health. On a daily basis, he builds a broad community of clinical research stakeholders and industry thought leaders, performs market research, and ascertains ever-changing industry trends in clinical trial optimization, clinical innovation, patient recruitment, digital health, drug development, clinical trial technology, and population health. He is also the Co-founder and Vice President of Community and Business Development of ClinEco. ClinEco unites sponsors, CROs, service providers, and sites on the world's first B2B global clinical trial marketplace so each can expand clinical partnerships. He is continuously onboarding companies and leaders in clinical research to: Explore the Ecosystem. Engage Partners. Exchange Capabilities. SCOPE and ClinEco are owned by Cambridge Healthtech Institute (CHI). Please join our SCOPE and ClinEco communities! https://clineco.io/ www.SCOPEsummit.com www.SCOPEsummiteurope.com

• Decentralized & Hybrid
• Biomarkers & Precision Medicine Trials
• Quality & Monitoring
• Clinical Supply
• Budgeting & Resources
• Med Device Trials
• Data
• Clinical Operations for Small Biopharma
• Outsourcing
• Patient-Centric Trial Design & DEI
• Real World Evidence
• Recruitment & Engagement
• Feasibility & Study Start-Up
• Clinical Trial Tech: Venture, Innovation & Partnering
• Digital Measurements

No bio available.

• Budgeting & Resources

Diane Lijfrock RN, BSN, CCM is the Patient Insights and Inclusion Lead at Sanofi creating Diversity & Inclusion Goals and Patient Experience Narratives for all R&D studies. Beth Brooks, MPH is the Head of Patient Insights and Behavioral Sciences at Sanofi, a team responsible for providing insights into patient populations, behavioral science tools, and support for diverse recruitment.

• Patient-Centric Trial Design & DEI

Stacey Limauro, Executive Director of Clinical Operations at Deciphera Pharmaceuticals, has over 25 years of industry experience across all Phases of clinical development in both small and large Pharma organizations. In her current role, she provides leadership and oversight for the entire clinical development operations team and portfolio at Deciphera, including contributing to the operational strategy and implementation of process development and improvement within the department. One of Stacey’s most influential accomplishments was leading the successful approval of Deciphera’s first drug, QUINLOCK in 2020 for the treatment of GIST. She enjoys working with high-performing cross-functional teams to bring therapeutic treatments to patients in need. She received her BS in Chemistry from Trinity College in CT, and an MS in Biochemistry from Boston College in MA.

• Outsourcing

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.

• Decentralized & Hybrid

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.

• Recruitment & Engagement

No bio available.

• Decentralized & Hybrid
• Biomarkers & Precision Medicine Trials
• Quality & Monitoring
• Budgeting & Resources
• Data
• Clinical Operations for Small Biopharma
• Outsourcing
• Patient-Centric Trial Design & DEI
• Real World Evidence
• Recruitment & Engagement
• Feasibility & Study Start-Up
• Clinical Trial Tech: Venture, Innovation & Partnering
• Digital Measurements

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.

• Clinical Trial Tech: Venture, Innovation & Partnering

Matt has been with Praxis right from the beginning, constructing campaigns that connect with patients in emotional and rational ways - always rooted in a single, powerful idea. Today, he provides strategic and creative direction for sponsors that include Moderna, Alexion, Eli Lilly and Company, Vertex, Takeda, and Neurocrine Biosciences.

• Recruitment & Engagement

David currently leads the sustainability, environmental, occupational safety and business continuity functions for PPD, a part of Thermo Fisher Scientific. David has over 30 years experience in the field, primarily with pharmaceutical industry. He holds a bachelor's degree in chemistry from The Johns Hopkins University and a masters in public health from Tulane University School of Public Health and Tropical Medicine.

• Feasibility & Study Start-Up

Dr. Subha Madhavan is a dynamic and results-driven leader with a strong track record of excellence in organizations that operate in the nexus of science, technology and business. She is a world-class leader in AI/ML, Drug R&D, Precision Medicine, Digital Health, Data Science & Analytics, Bioinformatics, Product development, Clinical informatics and Health IT. She and her team were responsible for initiation, design and execution of several large national and international clinical research programs including Cancer Moonshot, TCGA, CPTAC and Human Cell Atlas. In her role as the Founding Director of the Innovation Center for Biomedical Informatics at Georgetown, she developed a workforce of over 25 employees, to include staff scientists, health IT, and operations personnel with full P&L responsibility for the business center and its R&D team. She has initiated and successfully directed several productive research and development programs at the Lombardi Comprehensive Cancer Center, MedStar hospital network, FDA, NCI and industry. She was co-leader of the FDA Center for Excellence in Regulatory Science at Georgetown and worked with the Oncology Center for Excellence, Vaccines and related biological products, and Office of the Chief Scientist. As an industry advisor, she advices biopharma, federal, academic clients develop organization-wide R&D, data science and digital health strategy.

• Data

Asha is a director in the Data Sciences, Platforms and Privacy group. Her expertise lies in strategizing and managing data science platforms to manage high-dimensional & large-scale datasets and development and deployment of AI & digital health applications in clinical workflow. Asha has been with Johnson & Johnson for over 15 years. She successfully led major initiatives for commercial and R&D functions with strong focus on data, analytics, and customer engagement.

• Feasibility & Study Start-Up

Dr. Malikova is an Assistant Professor of Surgery at Boston University, School of Medicine, and an Executive Director of Research at the Department of Surgery at Boston Medical Center. Dr. Malikova has PhD in Biochemistry with strong background in biomedical sciences. She also holds a Master’s Degree in Clinical Investigation and Master’s of Business Administration in Health Sector Management from Boston University. She has over 18 years of experience in the biomedical product R&D, clinical development, operations and regulatory compliance fields; with the past 11 years on executive level. In her current role as Executive Director, Dr. Malikova macro-manages research programs in 13 divisions of the Department of Surgery at Boston Medical Center. She is responsible for clinical trials and basic biomedical research operations and compliance, strategic planning and execution oversight of clinical trials; safety and risk management. She is a member of International Society of Pharmacovigilance (ISoP), and currently serves as the Vice-President of NASoP.

• Outsourcing

Paul Mancinelli, PhD, is the Chief Technology Officer of WCG where he leads technology overall, including infrastructure, software engineering, and application development across the organization to support WCG’s strategy and enhance productivity, efficiency, and synergy throughout the enterprise.

• Data

No bio available.

• Outsourcing

Sylvia Marecki is Senior Director and Head of the Operational Design Center within Global Development Operations at EMD Serono. Her team brings data-driven decision making to study design and operational planning, driving efficiency and innovation in study planning and execution. Prior to joining EMD Serono, Sylvia led development and commercialization of data-driven analytic products and services at Citeline/Informa, DRG (Clarivate), and TriNetX, empowering informed decision-making across clinical and commercial functions at all stages of the product life cycle. She received her Doctorate in Pathology and Immunology from Boston University School of Medicine.

• Feasibility & Study Start-Up

Cindy Markham has more than 25 years of leadership experience in public and private full-service CROs where she has led the global expansion of Phase II-IV business, along with business support functions, resulting in substantial organizational growth. She brings a deep understanding of customer challenges in drug development and is known for driving transformation. Cindy’s customer-centric approach is derived from experience in operations and commercial. She is passionate about serving customers and creating high-performing teams that do the same. Most recently, Cindy served as SVP, Commercial for PPD, a large, global CRO. She earned a Master’s in Public Health from the University of North Carolina at Chapel Hill.

• Biomarkers & Precision Medicine Trials

Brian joined AbbVie in 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, graph computation, and cognitive computing. Brian is a part of the leadership team building and directing the AbbVie R&D Convergence Hub (ARCH) as part of the R&D Convergence initiative and a member of the ACOS Scientific Innovation Council. 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 was the architect of the United States’ Common Securitization Platform and the technology founder of Publicis.Sapient’s AI practice. While his primary focus is AI technologies, he was also a co-founder of the QuPharm quantum computing community and the Pistoia/QED-C Quantum Community of Interest. He is a frequent presenter at conferences on topics as diverse as optical networking, quantum computing, blockchain, cognitive architecture, and other emerging technologies that are all part of digital transformation. Brian holds a B.S. degree in Computer and Cognitive Science from Alma College and a M.S in Computer Science from the University of Chicago. He is a board member for the Chicago Innovative Executives League and for the Mundelein High School Business Incubator program. He has been involved with the Creative Destruction Lab at the University of Toronto’s Rotman School and as a panelist/reviewer for the National Science Foundation Secure and Trusted Cyberspace grant division. Brian lives in Lake Bluff, Illinois with his wife and four children.

• Decentralized & Hybrid
• Biomarkers & Precision Medicine Trials
• Quality & Monitoring
• Budgeting & Resources
• Med Device Trials
• Data
• Clinical Operations for Small Biopharma
• Outsourcing
• Patient-Centric Trial Design & DEI
• Real World Evidence
• Recruitment & Engagement
• Feasibility & Study Start-Up
• Digital Measurements

No bio available.

• Clinical Operations for Small Biopharma

Fred Martin is CEO of SubjectWell, the patient access marketplace that connects patients with relevant clinical trials and market-ready treatments.  Fred has over 25 years of experience in the healthcare industry. Before SubjectWell, Fred served as COO for Medrio, where multiple product launches led to five years of double-digit growth. Prior to that, he was VP of Product Management at Sigmacare, where he led the company to a successful exit. Fred has a Communications BA, a Master of Industrial and Labor Relations, and an MBA.

• Recruitment & Engagement

Mike has nearly 20 years of healthcare consulting experience. He currently leads ZS’s clinical development practice area. Mike has expertise across clinical development with a focus in study design, planning and patient/site experience. Outside of clinical development, he has also worked extensively within medical affairs and bridging R&D to commercial through portfolio strategy. Mike has spent all of his time with ZS focused on pharmaceuticals and biotech.

• Summit for Clinical Ops Executives (SCOPE)

Brian is an experienced life sciences investor who focuses on early to mid-stage companies. Prior to joining Norwest, Brian worked at Blackstone Life Sciences, where he helped lead over $1.5B of investments across biotech, medical devices, and diagnostics. He was a Board Observer or Alliance Committee Member at 5 companies, working closely with management teams on clinical trials, FDA approval process, and commercial strategy. Brian was previously an Engagement Manager at McKinsey & Company, where he advised companies across the healthcare industry. Brian has a medical degree from Stanford and MBA from Harvard. His research on prostate cancer, diabetic macular edema, and patient safety has been published in multiple peer-review journals.

• Clinical Trial Tech: Venture, Innovation & Partnering

No bio available.

• Patient-Centric Trial Design & DEI
• Feasibility & Study Start-Up

Patricia Matthews, RN, BSN, is a seasoned clinical research professional with over 20 years of experience, with a focus in the areas of oncology, and infection and inflammation diseases. Holding a Bachelor of Science in Nursing, she possesses a comprehensive background encompassing direct patient care, management, and clinical research. Patricia currently serves as a Senior Director of Clinical Science and Operations Project Leader at Sanofi. In her pivotal role, she leads high-performing, cross-functional global teams engaged in Phase I-IV clinical trials. Notably, Patricia co-leads the Activated Recruitment and Retention Initiative, wherein she plays an instrumental role in identifying gaps, to support facilitating early planning, and development of robust patient and recruitment strategies. Her dedication and expertise have made her a driving force in advancing clinical research and patient-centric healthcare.

• Recruitment & Engagement

Sarah McClure is a Global Data Engagement Lead, Clinical Studies Unit, at Sanofi. Her pharmaceutical career spanning over 20 years has included site monitoring, local and global project management, technology and process solutions and implementation efforts. Sarah current role is leading the relationship with data source vendors and ensuring appropriate aggregation of data sources so that Sanofi can leverage data driven decisions.

• Feasibility & Study Start-Up

Tom has over 20 years of industry experience in various roles within clinical trial supply and execution. Nearly half of this time has focused on the clinical supply chain-including raw materials, investigational supplies, lab kits, and biospecimens. When not concentrating on optimizing global logistics, Tom enjoys spending time with his family, boating and music.

• Clinical Supply

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.

• Decentralized & Hybrid
• Biomarkers & Precision Medicine Trials
• Quality & Monitoring
• Clinical Supply
• Budgeting & Resources
• Med Device Trials
• Data
• Clinical Operations for Small Biopharma
• Outsourcing
• Patient-Centric Trial Design & DEI
• Real World Evidence
• Recruitment & Engagement
• Feasibility & Study Start-Up
• Digital Measurements