Jill Abell, MPH, Ph.D., Team Leader, Real World Evidence, Janssen
Jill E. Abell, MPH, PhD is a Team Leader, Real World Evidence at Janssen. Dr Abell received a master degree in Epidemiology from Emory University and a doctoral degree in Epidemiology from the Medical University of South Carolina, where she was supported by an American Heart Association Pre-Doctoral Fellowship. Her current work focuses on advancing new capabilities, methodological strategies and pragmatic approaches to research implementation that advance real world evaluations in populations and individuals. She maintains a strong passion for innovation, rigor and relevance, with a special focus on the promotion, collection, and incorporation of patient-centered information into clinical trials and observational studies.
Mitzi Allred, Director, Clinical Research, Clinical Content Standards, Merck & Co
Mitzi Allred has over 20 years of experience in the biopharmaceutical industry in Regulatory and Clinical Operations. Mitzi focus has been on process improvement through information design and structured reuse. Over the last fifteen years, she has lead submission improvements for electronic documents, structured content management reuse implementations for labeling, CMC and Clinical Operations. As a member company participant, Mitzi has participated in the TransCelerate Common Protocol development work stream. In 2013 and 2014, Mitzi was a presenter for a session on topic-based authoring at the Labeling, Drug Information Association Annual Conference, DIA Labeling and DIA Europe. Additionally, Mitzi has PhD in electrical engineering and has 15 years of experience in Aerospace.
Debora Araujo, Associate Director, Clinical Contracting Services, Boehringer Ingelheim Pharmaceuticals, Inc.
Debora S. Araujo has over 11 years of experience within clinical trial operations with a special focus in the areas of global clinical contracting, clinical outsourcing and clinical financial management. Her previous roles include both large and small pharmaceutical sponsors, as well as the investigative site side of clinical trials. Working within organizations such as Novartis Pharmaceuticals, Eisai, Inc., and Merck & Co., among others, has given Debora unique insight into the systemic blind spots sponsors have regarding clinical contracting, clinical outsourcing and clinical financial management. In her current role as Associate Director, Site Budgets and Payments within Boehringer Ingelheim, Debora manages, from both a strategic and tactical level, driving global harmonized processes for clinical site contracting, budgets and payments with a strong customer focus.
Julie Argento, Sr. Manager, Development Data & Analytics, Development Design Center (DDC), Amgen
Scott Askin, Director, Digital Development, Lead for eSource and eICF, Portfolio, Strategy & Innovation (PS&I), Novartis Pharma
Having been working in the Pharma industry for over 15 years, Scott Askin is digital strategist, intrapeneur and a self-proclaimed master of Data Management. Based in Basel Switzerland, he is a member of the Novartis Digital elite and leads the company's work in the area of electronic Source (eSource) and electronic Informed Consent (eICF/eConsent). Spending the first years of his career working within a CRO and later moving into Pharma, Scott spent the majority of his working life in Data Management, later moving into Data Standards and more recently into the ever evolving and exciting world that is Digital. Scott has a proven track record of demonstrated success, in taking on and overcoming the "impossible" and bringing new technologies to fruition through identifying, testing and bringing solutions to scale, in close collaboration with internal and external stakeholders.Scott enjoys hiking, cycling, cooking and since moving to Switzerland has become an avid skier. Scott has a BSc (Hons) in Computing and Management Sciences from Sheffield Hallam University in the United Kingdom.
Munther Baara, Senior Director, Development Business Technology, Pfizer
Munther has over 20 years of experience in the pharmaceutical industry. He is currently Sr. Director of Development Business technology at Pfizer, a worldwide pharmaceutical company. Munther is currently the head of Clinical Paradigm within the WRD-BT Development at Pfizer, Munther is spearheading initiatives driving innovation in development operations to align with the paradigm shift in the clinical trials execution model and emerging technologies. Munther Led the Clinical Aggregation Layer (CAL) implementation of a high-profile, large-scale clinical private cloud of clinical and operational data. In addition, he has extensive experience in application and system strategies, best practices, and standards that work for clinical and enterprise architecture, information management, workflow/process automation and integration of both home-grown and commercial applications across mixed platforms.
Geraldine E. Baggs, Ph.D., Principal Research Statistician, Statistical Sciences, ANRD Scientific and Medical Affairs, Abbott Nutrition
Geraldine has completed her Ph.D. in Statistics from The Ohio State University. She is currently section manager of the Statistical Sciences department at Abbott Nutrition R&D. In this role, she provides statistical leadership in the design, monitoring, analysis, and interpretation of clinical trial data, contributes to regulatory submissions and registration efforts globally, assists legal, QA and Food Safety groups, and manages the strategic direction of the Statistical Sciences group.
Heather D. Baldwin, MPH, Principal Consultant, Frogbottom Consulting, LLC
Heather has managed clinical research projects at sites, hospitals, CROs and sponsors since 2005. She recently started Frogbottom Consulting, LLC focusing on diagnostics of the use of human capital in clinical research operations and resulting change management. She has a double Bachelor's degree in Psychology and Sociology; a Master's in Public Health with a focus on Social Behavioral Sciences and is certified in Change Management. She has received recognition and awards from sponsors for optimizing work and increasing efficiency in their clinical trials and in operations. She currently resides in Minneapolis, MN.
Lan Bandara, Director, Clinical Outsourcing, Medicines Development Centre, Coordination Department, Eisai Limited
Raj Bandaru, Senior Director, Data Sciences Strategy, Translational Medicine, Sanofi
Kevin Bateman, Distinguished Scientist, Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Merck & Co.
Kevin holds the position of Distinguished Scientist in the Pharmacokinetics, Pharmacodynamics and Drug Metabolism (PPDM) Department at Merck & Co. As PPDM's senior bioanalytical scientist, he provides strategic scientific leadership for the BA organization through oversight of bioanalytical activities for all programs at all stages of the pipeline.
Susan Bennett, Senior Clinical Data Manager, Center for Human Experimental Therapeutics, University of Rochester
Susan Bennett, AAS, is a Senior Clinical Data Manager at the University of Rochester, Center for Human Experimental Therapeutics (CHET)/Clinical Trials Coordination Center, a center that seeks to advance knowledge of clinical trial development through traditional and innovative means. Susan has been involved in clinical research for over 25 years. She has extensive experience in research areas involving Huntington and Parkinson disease, Tourette's, dental caries, pediatric epilepsy and cancer research. Susan utilizes her clinical trial experience to serve as a mentor to other data managers and research sites, teaching them the importance of proper study documentation and quality data to aid in preparation for study audits.
Durgesh Bhandary, Senior Director, HEOR, AstraZeneca
Karina L. Bienfait, Ph.D., Head, Global Genomics Policy, Process and Compliance, Principal Scientist, Clinical Pharmacogenomics and Operations, Genetics and Pharmacogenomics (GpGx), Translational Medicine, Merck Research Laboratories
Karina Bienfait, PhD is a Principal Scientist in Genetics and Pharmacogenomics within Translational Medicine at Merck Research Laboratories, and the head of Global Genomic Policy, Process and Compliance (GPPC). As head of GPPC, Dr. Bienfait helped to implement routine genotyping of patients participating in Merck's clinical trials to identify genetic predictors of drug response. She is responsible for evaluating the impact of global genomic policies and 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 capacity, Dr. Bienfait works closely with Merck's global subsidiaries to develop strategies to address countries recalcitrant to genomic research and with global health authorities and ethical boards to negotiate approvals for genomic research in the context of Merck's clinical trials. Dr. Bienfait 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.
Kimberly Bojczuk, Investigator, Discovery Supply - Global Biological Assets, RD Platform Technology & Science, GSK
Kimberly Bojczuk joined SmithKline Beecham in 2000 after receiving her B.S. Biochemistry from Temple University and has worked in various roles to continuously improve and develop the capabilities of the Biological Asset Management efforts at GlaxoSmithKline. She is currently in the Biological Assets group, which is developing a central platform for the provision, processing, quality control, storage and distribution of biological materials for drug discovery and development. Kimberly obtained her Project Management Certificate from Lehigh University and worked closely with an IT Development team to implement a biological registration and inventory application that supports GSK's global biobanking efforts. She has also focused efforts on implementation of a sample storage strategy, coordinating off site long term storage of clinical and nonclinical samples globally. She is currently an Investigator in the Discovery Supply group of which maintains and develops innovative platforms and services to enhance and deliver small molecule and biological samples and leverage expertise in automation, IT, compliance and QA for the benefit of the GSK enterprise.
Sagarika Bollini, Director, Head of Clinical Partner Management, Central Clinical Planning and Solutions, Global Clinical Operations, Bristol-Myers Squibb
Sagarika Bollini has more than 10 years of clinical trial operations and is a Director of Clinical Partner Management within the Global Clinical Operations group at BMS. In this role she manages a team which oversees clinical partnerships across Phase I-IV including outcomes trials (CRO strategic partnerships, Functional Service Providers and Regional Outsourcing) and quality and infrastructure with clinical trial vendors. She has experience with driving initiatives that impact global processes, people and technology which creating value for external partners and the company.
Ron Bourque, Associate Director, RDI, Clinical Biologics, MedImmune/AstraZeneca
Ron is RDI Associate Director for Clinical Business Management and Analytics with MedImmune (Biologics business unit of AZ). Ron successfully migrated the eClinical Trial Management System over to a shared platform with AstraZeneca in support of the entire biologics trial delivery across clinical functions. He has provided leadership roles in various eClinical projects and has promoted the practical use of integration of eClinical ecosystems, environment and analytics that has enabled more real time based decisions in clinical research and trial delivery. Ron has over 30 years of experience from across clinical and clinical research, project management, system management to information analytics in healthcare and biopharmaceutical industries. Ron started as a monitor and data analyst, and then moved quickly into clinical research focusing on the use of data collection tools and their practical use in the day-to-day business in the fields of healthcare, clinical research and clinical trials.
Danielle M. Boram, Esq, MPA, Clinical Contracts Attorney, Associate Director of Contract Management, Clinical Development, ImmunoGen, Inc.
Ms. Boram is a Clinical Contracts Attorney and the Associate Director of Contract Management for Clinical Development at Immunogen, Inc. where she combines her legal background with her clinical operations experience to support the Clinical Development team with contract execution and document review, and provide general legal support across a broad array of issues. Prior to joining ImmunoGen, Ms. Boram has served similar roles in both small and large biotech companies and a CRO. Serving on both sides of the pharma-CRO collaboration allows Ms. Boram a unique perspective into maximizing the outsourcing relationship. Ms. Boram obtained her law degree from the University of North Carolina at Chapel Hill and her Master of Public Administration from North Carolina State University
Marisa Bower, Director, Global Supplier Management & Supply Bus Dev, Merck
Loni Branon, Director, Sitetrove/Chinatrove, Pharma Intelligence-Informa
Director Loni Branon develops strategies to identify the best investigators and trial sites for our clients' clinical trials. She manages Sitetrove, our clinical investigator and trial site solution, and Chinatrove, our CFDA certified China hospital solution. Loni has worked with the Sitetrove solution as a Research Associate, Assistant Manager, Manager and Director. Her areas of expertise include site feasibility and staff management. Loni is one of our thought leaders in clinical trial planning. For SCOPE 2016 she developed a white paper that showcased utilizing multiple data sources to maximize the potential for recruitment success. Before joining us, Loni worked as a Trial Search Coordinator for the University of Vermont. She also worked at Brown University, studying the effects of iron chelators and vitamin D analogs on PC3 and neuroblastoma cell lines.
Bonnie Brescia, Founding Principal, BBK Worldwide
Bonnie A. Brescia is co-founder of BBK Worldwide, the world leader in patient recruitment and engagement for clinical research and development. An early and consistent voice for patient centricity, Bonnie helped to shape the patient recruitment discipline. Her insights into the workings of the clinical research community inform BBK's product development and global expansion. She shares her expertise as an author, speaker, and member of numerous industry initiatives.
Christina Brennan, M.D., Vice President, Clinical Research, Executive Research Administration, Northwell Health
Christina Brennan is a physician who has devoted her career to clinical research. She is dedicated and committed to the advancement of science and medicine. She has over 17 years of research experience in various roles from coordinator to manager to director. She is currently the Vice President of Clinical Research of Northwell Health.
Christine Buesnel, Director, Product Development, Biometrics, Roche
Christine Buesnel is a Global Director, with in the Medical Data and Information Systems Group, in Product Development, at Roche. Prior to this role Christine has been the Global Head of the Project Management Office for Biometrics, and held various Project and Process Management roles in Product Development and Manufacturing at Roche and Genentech. She has been with the company for 13 years, and also has been a Management Consultant for the 10 years prior to working at Roche. Her background is Operations Engineering.
Jeri Burtchell, Director, Patient Initiatives, HealthiVibe LLC
Jeri Burtchell has extensive experience as a patient advocate after being diagnosed with multiple sclerosis in 1999 and joining a Phase 3 study for the first-ever pill form of treatment for MS. She blogged her trial from start to finish in what would later become recognized as the first ever patient blog to chronicle study participation. In her role at HealthiVibe, Ms. Burtchell works closely with patients and advocacy groups to recruit participants for qualitative research projects, is editor-in-chief of the blog at HealthiVibe, is extensively involved in developing patient-facing materials for projects, and produces all of the patient testimonials and compilation videos. Ms. Burtchell has participated in five research studies including two wearable device studies. She is considered a Subject Matter Expert on the topic of clinical trial participation and patient-centricity. She has a strong passion for helping sponsors develop protocols that are patient-friendly, with a particular interest in simplifying the Informed Consent Form. In November 2015, Ms. Burtchell was invited by Vanderbilt University to give a slideshow presentation on the patient perspective regarding the Informed Consent at a NIH town hall meeting about the Notice of Proposed Rule-Making. Ms. Burtchell is also a Stanford Medicine X (MedX) ePatient Scholar, bringing her passion for advocacy to the main stage in 2016 and 2017.
Eva Bush, Senior Director, QA Lead, Americas Audit Excellence Quality Assurance Team (AEQAT), Global Clinical Quality Assurance, QuintilesIMS
Amy B. Calvin, BS, MT (ASCP), MBA, Digital Strategy and Implementation, Advisor, Eli Lilly and Company
Amy has 20 years' experience in the Pharmaceutical Industry. Her career at Lilly has allowed for many rich experiences from Bioassay Development to Decision Sciences; Clinical Innovation and presently Digital Strategy and Implementation. In 2014, Amy began researching and developing a business case for a capability that focuses on potential values and opportunities associated with the generation and utilization of digital data within a clinical trial. As this idea evolved throughout the industry, the term Digital Biomarkers emerged. Amy's passion for her work relating to nascent technologies, digital biomarkers and possibilities associated with novel digital endpoints keeps her motivated. She believes, there are many untapped opportunities associated with faster development, richer data and more robust decision making - all to be explored in the years to come.
Hui Cao, M.D., Ph.D., Executive Director, Real-World Evidence, COE for RWE, Global Medical Affairs, Novartis Pharmaceuticals Corporation
Hui Cao's career spans over 15 years in medicine, consulting and life sciences with a track record of accomplishment in these areas. She brings her comprehensive knowledge of medicine, healthcare systems, pharma R&D and data science to develop innovative solutions to solve R&D and business challenges. As a medical doctor and an expert in RWE and research methodologies, she has applied her creative thinking and used a holistic approach in medical and payer evidence generation, to support product medical and payer strategy. She led the development of RWE platform at a top pharmaceutical company and brought creative RWE solutions to optimize trial feasibility, accelerate patient recruitment, and build disease-area strategy. She is results-driven and known for her energetic management style and skilled collaboration, leading and motivating cross-functional teams to execute challenging, global, large-scale projects. Dr. Cao received her M.D. and a M.S. in medical genetics in China, and a Ph.D. in medical informatics from Columbia University. Specialties include Real-world Evidence (RWE), Payer & Medical Evidence Generation, Observational Research, Evidence-based medicine, Real-world data analytics, Health IT, R&D, clinical decision support, and data & text mining,
Katherine Capperella, Global Patient Engagement Leader, Janssen
As global head of patient engagement for Janssen, Katherine leads a cross-functional team responsible for developing and driving patient engagement strategy and measuring progress over time. She and her team are focused on leading Janssen to incorporate direct patient voice early and throughout the entire product lifecycle, beginning with disease area strategies and including product development, formulation decisions and clinical trial strategies. Katherine has over 20 years of experience at Johnson & Johnson, in commercial, strategy and new business development leadership roles. She has a keen focus on the customer, the ability to envision and develop new approaches, and to bring people together to realize success.
Cathy Carfagno, Associate Director, MRL IT, Merck & Co, Inc.
Cathy Carfagno is currently the Business IT Lead for the Global Clinical Trial Operations area of Merck. Responsible for the IT Portfolio programs that drive operational efficiencies within Merck Research Labs (MRL). In this capacity, she is responsible for several multiyear programs and supports the overall execution of them and drives adoption and future strategy and alignment with Merck in general. Cathy has over 25 years at Merck and served in various roles within the business and IT. She started her career in MRL in Biostatistics and Research Data Systems (BARDS) area supporting clinical trials and led the Remote Data Entry Program. She spent seven years as a Medical Program Coordinator in the Merck J&J Joint Venture, over the counter (OTC) group and ten years in the Global Human Health division (GHH) as a manager of the Business Process Improvement and Operational Excellence group supporting the Clinical development /Medical Affairs & Marketing areas. She spent seven years in MRL IT supporting Program Management for the Clinical Trial Operations area and the Account Manager of the CPAC Portal. Three years in Enterprise Integration and Customer Collaboration (EICC). In this capacity, she was Account Lead responsible for the overall change execution and communication planning for the EngageZone (EZM) External Partner Program an enterprise wide multiyear cross divisional program and its development efforts. Cathy's interests lay primarily in driving change and transformation Initiatives across Merck and the Industry. She chaired the Clinical Portal Forum 2010-2012 and Industry workshops to outline the biggest problems the industry faces in conducting Clinical trials. She is very interested in innovation and new technologies supporting Merck's IT Strategy. Most recently she is a Merck consultant for the TransCelerate Bio Pharm initiative. Cathy holds a BA in Business Administration, MS in Education and a certified PMP, Scrum Master (CSM), Sigma Green Belt and Change Agent Capabilities (CAC).
Frank Carnevale, Senior Outsourcing Lead, Takeda
Taras Carpiac, Director, Global Development Operations, Amgen
Taras Carpiac is Director, Innovation, Planning & Platform Services at Amgen, currently focused on development of tools and processes enabling Amgen's risk-based monitoring model. Taras has over 17 years of experience in the biotechnology and pharmaceutical industries, holding various leadership and technical positions in Clinical Data Management, Regulatory Compliance, and Information Technology, and was the co-founder of a software company developing content management software. He has extensive experience with the design and support of RBM technologies and methodologies. Taras holds a Master of Business Administration from Golden Gate University and a Bachelor of Sciences in History from the University of California, Berkeley.
Elisa Cascade, President, Data Solutions, DrugDev
As President of the Data Solutions division of DrugDev. On a day to day basis, she oversees back office operations and works closely with our Databank partners to ensure DrugDev provides a reliable and disruptive service for our clients. Elisa's personal mission is to significantly reduce the time required to integrate disparate data sources to help pharmaceutical companies make better decisions in clinical study planning, feasibility, and site selection and decrease the administrative burden for investigators. Elisa brings to DrugDev almost 20 years in strategic healthcare consulting, and is a nationally recognized expert in the analysis of health data. Elisa has an MBA from the Wharton School of Business and industry leading experience in the capture and integration of complex healthcare data. Prior to joining DrugDev, Elisa worked for 15 years as a Vice President at Quintiles where she had responsibilities in consulting and patient-centric research. Elisa has an MBA from The Wharton School and a B.S. with High Honors and High Distinction from the University of Michigan.
Divya Chadha Manek, Head of Business Development (Commercial), Clinical Research Network, National Institute of Health Research
Divya Chadha Manek is the Head of Business Development (Commercial) for the NIHR Clinical Research Network (CRN). Divya's role is to maintain strategic relationships with Global and UK life sciences companies. Divya facilitates key discussions between life sciences industry and the Clinical Research Network. Divya provides advice and works collaboratively with companies on how they are able to tap into the Clinical Research Network services to ensure clinical studies are set up quickly and efficiently so that they recruit to time and target. Divya also leads on ensuring that the Clinical Research Network is abreast of new study delivery innovations to ensure that the organisation is evolving to service life sciences industry requirements. With a degree in Clinical Psychology and a Masters in Clinical Research, Divya has worked with the Clinical Research Network for the past nine years. Divya's first role with the CRN was delivering commercial contract clinical research within a National Health Service hospital. Prior to her current role, Divya worked as the Industry Manager within the Mental Health team, performance managing and maintaining oversight of the national mental health portfolio of studies. Thus, Divya has experience of clinical research from a site level and from a national perspective in the UK. Divya is also currently studying for a PhD in Dementia Care from the University of Birmingham.
Chris Chan, Executive Director, R&D Finance, Finance, FibroGen, Inc.
Chris Chan is Senior Director of R&D Finance at FibroGen, Inc, and has over 25 years industry experience, including 20 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 6th SCOPE conference as a speaker.
Uli Chettipally, M.D., MPH, CTO, CREST Network, Division of Research, Kaiser Permanente
Jerome Chiaro, Vice President, Clinical Site Operations, StudyKIK
Jerome is Vice President of Clinical Site Operations at StudyKIK and regularly presents at industry and non-profit workshops. Previous to the clinical trial industry, Jerome was a social media consultant for businesses across the US and he has published multiple e-books and video training series' on the topic of social media marketing. His professional passion is the use of Social Media as a new highly innovative and disruptive technology to clinical trials; the latest techniques for patient recruitment, retention and advocacy across the new and old platforms including: Snapchat, Instagram and Facebook.
Christopher Chinn, BA, MSc, ACA Head of RWE Strategy for Market Access Health Economics and Value Assessment, Sanofi
In his current role within Sanofi's Global Health Economics and Value Assessment group, Chris leads on the use of real world data to support market access; during development and over the lifecycle of medicines. Chris was also the initial coordinator of the IMI GetReal consortium "Incorporating real-life clinical data into drug development"; and is the co-chair of the EFPIA Real World Evidence Community.Chris graduated from Oxford University with a degree in Biochemistry; is a qualified chartered accountant and has a Masters in Health Economics from City University, London. Over the last 20 years he has also lead health outcomes groups and real world evidence projects at SmithKline Beecham, Lilly, and GlaxoSmithKline.
Yan Chow, M.D., MBA, Medical Director, Digital Health, Amgen
Yan Chow, MD, MBA is Medical Director for Digital Health in the Medical Sciences Early Development Group at Amgen, a leading human therapeutics biotechnology company. His prior engagements included Chief Innovation Officer at LongView International Technology Solutions, a federal health IT services provider ranked #5 in Washington Technology Magazine's 2014 Fast50 list; and former national Medical Director of the Innovation & Advanced Technology Group (IAT) at Kaiser Permanente, the largest private integrated care delivery system in the nation.Dr. Chow has founded and advised startups in the Internet, health care technology, storage, and database spaces, and has 3 U.S. patents. Dr. Chow earned his A.B. with honors from Harvard University and his M.D. from UC San Diego. In 2005 he received his MBA from UC Berkeley, where he graduated as valedictorian.
Jae Chung, President & Founder, goBalto
Jae Chung is the founding visionary of goBalto. A startup evangelist, he works with Rock Health to mentor healthcare technology startups. He previously co-founded Celltrion (068270:KOSDAQ), a leading biopharmaceutical manufacturing company and was a strategy consultant with McKinsey & Company. A self-described "geek" and Apple fanboy, he established goBalto to introduce elegant, easy-to-use web-based applications for life science organizations. He believes that by leveraging a workflow-based solution in the cloud, companies can dramatically accelerate clinical trial timelines, thereby getting medicines to those in need faster. In 2013 Jae was recognized as a FierceBiotechIT Top-10 Techie list and in 2010 was awarded the Bio-IT World Judges Prize for Technology Innovation. Jae has an MBA from New York University and holds a CPA.
Ivor Clarke, CEO, SubjectWell
Ivor Clarke is the CEO of SubjectWell, the first risk-free clinical trials marketplace for patient recruitment. SubjectWell engages the 96% of Americans who have never participated in a clinical trial and only charges for patients who randomize. Ivor has over 12 years of C-suite experience in online marketing and specializes in the creation and operation of enterprise-class SaaS solutions. Before SubjectWell, Ivor served as President of Brightfire, an internet marketing and call center operation that helps more than one million people a month find better jobs by providing job matching and career support. Ivor has also held positions at Datran Media, where he delivered a 150% increase in revenue while improving customer satisfaction, and Microsoft, where he oversaw the user interface for Mac Office. Ivor graduated from Carnegie Mellon University, earning degrees in Human Computer Interaction and Information and Decision Systems.
Ieuan Clay, Ph.D., Group Lead Digital Endpoints, Translational Medicine, Novartis Institutes for Biomedical Research
Throughout his career Ieuan Clay has focused on technology and analytics development; Following his graduate work at Cambridge University in the field of Next Generation Sequencing, he joined Novartis in 2010 as part of early target discovery concentrating on novel assays, screening and profiling methods. This role evolved into piloting technology deployment in clinical settings, and after a short sabbatical in a startup company, he now leads the Digital Endpoints group within NIBR-Translational Medicine, developing novel analytics for sensor technologies to capture objective, functional readouts tailored to specific demographics and clinical questions.
Craig Coffman, Executive Director, Clinical Business Operations & Outsourcing, Nektar Therapeutics
Craig Coffman is currently Executive Director, Clinical Business Operations & Outsourcing at Nektar Therapeutics. He is focused on providing strategic direction, oversight and expertise to the organization in order to bring operational excellence to the business planning and financial management of clinical trials; and to the identification, selection and management of external service providers. Prior to his career in outsourcing, Craig has held senior management and leadership positions with CROs in a variety of functions including Business Development, Corporate Marketing, and Clinical Operations across pre-clinical, clinical, and contract manufacturing service providers.
Evi Cohen, Vice President, Global Pharma & Life Sciences, Appian
Evi Cohen has over 19 years of pharmaceutical industry experience. In his role at Appian he is responsible for ensuring client success and continued steady growth in license revenues across all pharmaceutical clients. His previous positions include VP of Global Innovation & Portfolio Management at Catalent Pharma Solutions and Director of Legal Affairs at Teva Pharmaceuticals. Evi holds an MBA in Pharmaceutical Management, and an MS in Biotechnology, Biochemistry and Food Science from Drexel University in Philadelphia.
Gavin Coney, Head, Clinical, Clarivate Analytics
Gavin Coney is the Head of Clinical Products for Clarivate Analytics. In this role he manages a portfolio of products dedicated to supporting decision making by professionals within Life Science organizations who are interested in gaining intelligence relating to Clinical Development, Clinical Operations and Competitive Intelligence. Gavin has worked within informatics for 17 years and within the Life Sciences for the last 8 years.
Christopher Conklin, Director, Feasibility Center of Excellence, Pfizer
Chris is a Director in the Feasibility Center of Excellence at Pfizer where he is responsible for all aspects of protocol feasibility including program country strategy, protocol optimization, enrollment modeling, investigator strategy and assessment of competitive landscape. Chris has nearly 15 years of experience in the clinical research industry coming to Pfizer from Merck's Global Trial Optimization organization where he spent 7 years in positions of increasing responsibility. Chris has also led projects designed to increase the use of Social Media in clinical trials and served as Project manager for the launch of a clinical trials website designed to education and inform the public about clinical trials opportunities. Chris's prior experience includes roles in project management and study coordination at Johnson & Johnson PRD, Acurian and the Fox Chase Cancer Center.
Laura Cooke, Executive Director, Amgen Development Design Center, Global Development Operations, Amgen
Anca Copaescu, CEO, Strategikon Pharma
Anca is the CEO and Founder of Strategikon Pharma. Most recently she served as Head of Clinical Outsourcing and Analytics at BioMarin Pharmaceuticals where she was in charge of outsourcing, vendor management and R&D Finance. She had leadership positions with top CROs, such as Icon and PharmaNet development group and co-founded eMetagen, an early stage drug discovery company.
Nurcan Coskun, Ph.D., Global Risk Based Monitoring Program and Technology Solutions Manager, Medtronic
I have 20 years of clinical research experience, contributing in roles such as Clinical Research Manager and Clinical Research Associates Supervisor, Global Clinical Operations Oncology Group Leader, Project Leader, Clinical Monitoring Manager and recently as Global Risk Based Monitoring and Technology Solutions Manager. After obtaining my M.Sc. and Ph.D. degrees on Cancer Epidemiology, completed my Master degree on Medical Informatics at Erasmus University, Rotterdam in the Netherlands. During my studies, I worked as Researcher in the field of Cancer Epidemiology especially in Registries and conducted clinical trials as data manager and statistician. I contributed in the activities of SOP writing, trainings, publications, leading task forces on different topics and presenting at congresses and meetings. My current focus is on Risk Based Approach to Clinical Trials. With collaboration with other authors one whitepaper published on RBM in Medical Device companies and attend the conferences as speaker on the subject.
Brieana Cox-Buckley, PharmD, MS, Executive Director, US Field Medical & Value Based Outcomes, Bioverativ
Brieana Buckley, PharmD, MS is an Executive Director, US Field Medical & Value Based Outcomes with Bioverativ. Bioverativ is an independent biotechnology company spun out of Biogen's hemophilia business. Bioverativ is dedicated to transforming the lives of people with hemophilia and other rare blood disorders, united by a singular purpose: to create progress where patients need it most. In her role, Brieana leads a medical team committed to the design, execution and communication of medical value as it relates to key healthcare decision makers. Dr. Buckley graduated from the University of Utah College of Pharmacy with a Doctor of Pharmacy degree and from the University of Florida with a Master of Science degree in Pharmaceutical Outcomes and Policy. She has been a longtime member of several pharmacy associations and has served in various leadership positions, including the inaugural President of the Academy of Managed Care Pharmacy (AMCP) Utah Affiliate.
Cathy Critchlow, Ph.D., Vice President, Center for Observational Research, Amgen
As Head of the Center for Observational Research (CfOR), Dr. Critchlow provides operational and strategic leadership for the design and conduct of observational research within Amgen. The CfOR Real World Data (RWD) Platform provides widespread access to patient health data and visualization and analytic tools based on innovative technologies to aid teams in the generation of real world evidence in support of drug development and commercialization of Amgen products. Dr. Critchlow joined Amgen in 2004 where she led a number of Therapeutic Areas within Global Epidemiology prior to being named Head of CfOR in 2012. Prior to joining Amgen, Dr. Critchlow was a faculty member in Epidemiology at the University of Washington. Dr. Critchlow was a member of the Endocrinologic and Metabolic Advisory Committee of the Food and Drug Administration and has served on a number of research review committees for the National Institutes of Health. Dr. Critchlow earned her bachelor's degree from Stanford University, and both her master's degree in biomathematics and her doctorate degree in epidemiology from the University of Washington. Dr. Critchlow is an Affiliate Professor of Epidemiology at the University of Washington and a Fellow of the American College of Epidemiology.
Michelle Crouthamel, Digital Platform Leader, GSK
Michelle Crouthamel is the Digital Platform Leader in the Clinical Innovation Unit at GlaxoSmithKline. Her team at GSK focuses on harnessing digital technologies and platforms to transform the way clinical trials are conducted in Pharma R&D. She also leads the mHealth effort and demonstration projects in the TransCelerate eSource work stream. Her previous roles in pharma R&D have included leadership of many discovery and clinical development projects from target to market at both Merck and GSK. She published extensively in the areas of Neuroscience, Oncology and mHealth and holds multiple patents.
Karim Damji, Senior Vice President, Products, Solutions & Marketing, Saama Technologies
Karim joined Saama from Plantronics, where he led software strategy and product management, focusing on driving developer platforms, strategic partner integrations and contextually enabled UC solutions. Prior to joining Plantronics, Karim served in leadership positions spanning business development, product management, sales and network engineering at Cisco, Vocera Communications, MobileIron and DiVitas. At Vocera Communications, Karim was the founding product manager responsible for driving product concept to market-leading solutions.
Eric Delente, President, Patient Solutions, DrugDev
Eric has more than 20 years of experience leading technical and creative teams in the design and implementation of numerous award-winning online science, healthcare and clinical research web applications - most recently by leading SecureConsent (acquired by DrugDev), the industry's definitive e-consent solution. His professional focus has consistently centered on the academic, medical and scientific communities, and he has delivered applications, web portals and back-office tools for clients as diverse as The New York Academy of Sciences, Wolters Kluwer, Elsevier, Swets, The American College of Physicians, The National Cancer Institute, The European Society of Cardiology, The Food and Drug Administration, The Aircraft Owners and Pilots Association, The American Red Cross and many of the top 20 Pharmaceutical companies. Eric's profound understanding of the Science and Healthcare sectors, academic sectors, online publishing, coupled with his track record of developing complex but intuitive electronic data-driven applications makes him uniquely qualified to lead these technical teams
Robert DiCicco, Pharm.D., Vice President, Clinical Innovation and Digital Platforms, GlaxoSmithKline
Rob DiCicco is currently the Vice President of the Clinical Innovation and Digital Platforms Group at GlaxoSmithKline. He is also the Work Stream Leader for the Common Protocol Template Project sponsored by TransCelerate BioPharma and one of the Team Leaders for CTTI's Novel Endpoints Work Stream as part of the mHealth in Clinical Trials Initiative. Rob has more than 25 years of experience in clinical development in a variety of leadership positions in CRO, mid-sized and large pharmaceutical companies. He received his Doctorate of Pharmacy degree at the University of the Sciences of Philadelphia. Over the course of his career he has had a key role in the development of a number of successful new medicines. Rob's area of expertise includes clinical pharmacology and experimental medicine, innovative clinical trial design, project management and ethics in human research.
Julie Dietrich, MS, Director, Development Design Center, Amgen
Julie Dietrich is a Director in Amgen's Development Design Center (DDC). The DDC is a group of drug development experts that partners with product teams to design and plan optimized clinical programs and studies and implement innovative solutions. Julie also is leading company-wide initiatives related to patient centricity and evidence generation planning. She is committed to refining and advancing ideas for how to partner with patients throughout clinical development.Over the past 20 years Julie has held positions at Amgen, Purdue Pharma and Bristol-Myers Squibb. She has designed and managed phase 1-4 global studies. She holds a Master's in Neuroscience from the University of Virginia.
Tara Dubois, Head, Clinical Trial Cost Management, Pfizer
Biography coming ....
Brian Dudt, Senior Director, Study and Business Operations, CSL Behring
Biography coming ....
Bhaskar Dutta, Principal Scientist, Advanced Analytics Center, AstraZeneca
Biography coming ....
Anthony Everhart, MD, FACP, Vice President, Medical Informatics, Chiltern International, Inc.
Biography coming ....
Jane Fang, M.D., MS, Head of Research & Development Information for Clinical Biologics, Medimmune Biologics Science Unit of AstraZeneca
Jane is the head of AZ/MedImmune R&D Information for Clinical Biologics. She is a physician scientist with training in healthcare management and informatics. She has 25 years of broad experiences across from medical practice, clinical research to eClinical strategy and information analytics in healthcare and biopharmaceutical industries.
Ryan E. Ferguson, ScD, MPH, Director, VA Cooperative Studies Program Coordinating Center
Dr. Ryan Ferguson is the Director of the VA Cooperative Studies Program Coordinating Center in Boston, MA, where he is involved in the design and conduct of large multi-center randomized clinical trials. Dr. Ferguson joined the Cooperative Studies Program in 2001 and has since focused on clinical trial methodologies for conducting pragmatic comparative effectiveness trials. He currently serves as a Co-Principal Investigator for the VA's Point of Care Research Program which is focused primarily on pragmatic clinical trials and innovation in translational science. In addition to his interests in clinical trials methodology and pragmatic trials, Dr. Ferguson's research interests are focused on the epidemiology of acute kidney injury and chronic kidney disease, as well as the molecular epidemiology of cancer. Dr. Ferguson's published work includes first authored publications, abstracts, presentations and book chapters on pragmatic trials. Dr. Ferguson is on faculty at Boston University School of Public Health where he is a Clinical Assistant Professor of Epidemiology. He is also a member of the Society for Clinical Trials, the Society for Epidemiologic Research, and the American Statistical Association.
Gerald Finken, CSO/Founder and Innovator, Clinical Supplies Management
Biography coming ...
Balazs Flink, M.D., Clinical Trial Analytics Lead, R&D Business Insights and Analytics, Bristol-Myers Squibb
Biography coming ...
John Fontenault, COO, Omnicomm
Emily C Freeman, MSC, Ph.D., Director, Risk Management Sciences, Abbvie
Dr. Emily Freeman is a social/behavioral scientist interested in the development of evidence-based behavioral interventions to facilitate patient engagement and activation. In addition, she is exploring how medical evidence (risk, benefit, and health outcomes) is constructed and communicated within a patient-HCP clinical encounter to promote shared-treatment decision making. Finally, she is interested in bringing a more patient-centered approach to drug development through patient reported and defined outcomes and patient focused benefit-risk assessments.
Charlotte French, Executive Director, Outsourcing & Contracts, Medical and Development, Astellas
Charlotte currently serves as the Executive Director, Outsourcing and Contracts at Astellas Pharma Global Development, leading the global sourcing activities for Medical & Development. In this role she leads the Service Provider Relationship Management team together with the Outsourcing/Contracts. Charlotte is also leading the implementation of a tripartite Sourcing Strategy for the Development organization. Prior to joining Astellas in May 2017, Charlotte was Senior Director, Contracting and Outsourcing within Global Clinical Operations at EMD Serono. In this role she led the team of Contract/Outsourcing Managers responsible for supporting the commercial aspects across both the Regional and Global Clinical Operations portfolio. Prior to her transition to Pharma, Charlotte had more than 15 years in the healthcare industry during which time she has led a number of different business functions within CRO sector at 'top three' CRO's, including Finance & Administration, Global Bids and Contracts and Global Management Services. One of her key strengths is the ability to assess opportunities for improvement and then work across multiple functions to develop and measure process improvement initiatives. This was demonstrated during her tenure in the non-governmental environment for a period of three years during which she provided support and leadership on contract/grant management to ensure audit readiness for a number of country assignments in African and Asian countries, including a move to Ghana to lead a regional program for Neglected Tropical Diseases.
David Freschi, Senior Director, R&D Procurement and Clinical Outsourcing, Regeneron
Gilles Frydman, Patient Advocate; Co-Founder Smart Patients and ACOR (Asssociation of Cancer Online Resources)
Gilles Frydman is a pioneer of medical online communities. He is the founder in 1995 of the Association of Cancer Online Resources (ACOR), the largest online social network for cancer patients, composed of nearly 200 support groups for individuals with cancer. ACOR has served over 600,000 cancer patients and their caregivers to optimize patient care, for which Frydman was named by CNN in 2008 as one of six Empowered Patient's Health Heroes. He blogs regularly at e-patients.net, is a frequent speaker to health care audiences in the US and France, and has appeared in many publications ranging from the British Medical Journal to the Wall Street Journal.
Dawn Furey, Head, Global Clinical Trial Operations, Merck & Co.
Dawn Furey is the Head of Global Operations at Merck & Co., Inc. She has ~20 years of clinical research operations experience, ranging from trial management to regional field operations leadership and functional leadership where she drove reorganization of the process for drug ordering and simplified the budget and contracting processes. Mrs. Furey leads a team to support the Merck Research Laboratories portfolio through the development of clinical trial timeline scenarios and country and site allocation through the use of data analytics, development of patient recruitment and retention strategies and authoring patient informed consents, maintaining standards for research contracts and building study site budgets in compliance with appropriate regulations. Mrs. Furey has a passion for using Sigma methodology to improve process to get medicines to patients faster, she participates in the corporate Global Diversity & Inclusion initiative and is a long-standing advocate for patient-centricity. Mrs. Furey graduated from Rutgers University with a B.A. from Rutgers University College where she was a part of the Dean's Summer Scholar Program.
Henry Galio, Senior Director, Vault CTMS, Veeva Systems
Henry is involved in developing the strategy for Veeva Vault CTMS. He has nearly 25 years of experience in the enterprise software industry and 20 years of experience in clinical, implementing more than 50 CTMS projects and advising approximately 200 life sciences clients on CTMS. Most recently, Henry was senior director of clinical for Oracle, where he led a group of solutions architects creating cloud service offerings for CTMS and CDA.
Nicolle Gatto, Group Lead, Senior Director, Epidemiology, Worldwide Safety and Regulatory, Pfizer
Nicolle Gatto, PhD, MPH, is a Senior Director/Group Lead with the Worldwide Safety Strategy Epidemiology Group at Pfizer. In this role, she provides strategic leadership, oversight of comprehensive epidemiology strategies to examine the safety of medicines, and expertise on specific methods-related epidemiologic issues. She has designed and implemented several studies, and guides other epidemiologists in research strategy, and study design, execution and analysis. In addition to her work in pharmacoepidemiology, Nicolle is an Adjunct Assistant Professor of Epidemiology at Columbia University School of Public Health and Tulane School of Public Health and Tropical Medicine. Nicolle holds a PhD in epidemiology from Columbia University and an MPH from New York University.
Dalvir Gill, Ph.D., Chief Executive Officer, TransCelerate BioPharma Inc.
Dalvir Gill, PhD, is the Chief Executive Officer of TransCelerate and serves on its Board of Directors. Dr. Gill has more than 25 years of drug development experience. Prior to his appointment as CEO of TransCelerate in December 2012, Dr. Gill was the President of Phase II-IV Drug Development at PharmaNet-i3, an international contract research organization. In this role, he was responsible for a global business spanning nearly 40 countries and had P&L responsibility for all operational departments and business development. Dr. Gill earned his BSc in Applied Biology from the University of Hertfordshire and his PhD in Pathobiology from the Royal Free Hospital School of Medicine, University of London. He also holds a diploma in the health economics of pharmaceuticals from the executive program of the Stockholm School of Economics. Dr. Gill has presented his research and spoken at numerous conferences, and has authored more than 30 scientific publications. He also is an elected fellow of the Royal Society of Medicine.
Ken Getz, MBA, Director, Sponsored Research Programs, Research Associate Professor, Tufts Center for the Study of Drug Development
Mr. Getz is an internationally recognized expert on R&D and clinical trial management practices and trends, the global investigative site landscape, site management and patient recruitment and retention practices, and the worldwide market for outsourcing clinical research functions. Mr. Getz's research studies on protocol design complexity and clinical research efficiency and effectiveness, conducted over the past two decades, are considered by many in the research-based life sciences industry to be pioneering work. His 20+ years of original research benchmarking R&D management practices, global outsourcing and the investigative site landscape have contributed to industry-wide understanding of these critical markets and to improvements in management strategy and execution.
Jody Goldstein, Senior Clinical Project Manager, Center for Human Experimental Therapeutics, University of Rochester
Jody Goldstein, BS, is a Senior Clinical Project Manager at the University of Rochester, Center for Human Experimental Therapeutics (CHET)/Clinical Trials Coordination Center, a center that seeks to advance knowledge of clinical trial development through traditional and innovative means. She also is a member of the CHET Innovative Team and is the Co-Chair of the Huntington Study Group Executive Coordinator Council. Jody has been involved in clinical care and research for 17 years. In addition to her current position, she served as the Clinical and Research Coordinator of the HDSA Huntington's Disease Center of Excellence, at the University of California, San Diego. Jody is dedicated to seeking treatments that make a difference for patients with Huntington disease and to the initiation and implementation of clinical trials efficiently and effectively. Susan Bennett, AAS, is a Senior Clinical Data Manager at the University of Rochester, Center for Human Experimental Therapeutics (CHET)/Clinical Trials Coordination Center, a center that seeks to advance knowledge of clinical trial development through traditional and innovative means. Susan has been involved in clinical research for over 25 years. She has extensive experience in research areas involving Huntington and Parkinson disease, Tourette's, dental caries, pediatric epilepsy and cancer research. Susan utilizes her clinical trial experience to serve as a mentor to other data managers and research sites, teaching them the importance of proper study documentation and quality data to aid in preparation for study audits.
Christian Gossens, Ph.D., MBA, Global Head Early Development Workflows, Research & Early Development Informatics, F. Hoffmann-La Roche Ltd
Christian is leading an informatics team supporting the global early development function in Roche's Research and Early Development (pRED) organization. A computational biochemist PhD and MBA by training, he started his career in a leading management consultancy before joining Roche as a director in the Emerging Technology team in the Group Research department - identifying strategic, game changing trends in the pharma information/informatics space and developing strategies to act on those.
Sindhya Govind, Specialist Business Systems Analyst, Amgen
Susan Griffing, Vice President, Global Head Country Clinical Operations, Roche
Susan has been a leader in the drug development industry for over 25 years. After spending seven years building her career with Abbott Laboratories and Baker Norton Pharmaceuticals, Susan joined Genentech in 1998 to lead global Clinical Operations for the Avastin program, and other Oncology products. When Roche and Genentech merged in 2009 Susan became Global Head for Oncology Operations, focusing on the late stage portfolio, as well as being involved in critical Pharma Development initiatives such as Optimizing Data Value. In 2012 Susan was promoted to her current role of Vice President, Global Head, CCO, an organization that focuses on implementing global and local programs for the successful development and registration of novel drugs which support market access and make a difference in the lives of patients. CCO achieves this through broad understanding of science and medicines and by leveraging its diversity, local knowledge and relationships.With this promotion Susan moved to Shanghai and also took on additional leadership responsibilities locally in China. In 2015 Susan relocated and is now based in Basel, Switzerland. She holds a Bachelor of Science degree from Saint Mary's College in Notre Dame, Indiana.
Ajay Gupta, Associate Director, Clinical Supplies, Merck
Vikram Gupta, Technology Innovation Senior Manager, Amgen
Vikram Gupta joins Technology Innovation group at Amgen as an accomplished IT Professional with 15+ years of experience in managing global systems and processes focused on strategizing and leading global business / IT initiatives, establishing technology strategy vision and roadmap. In this current role, the primary responsibilities involves assessment of innovative technology capabilities seeking potential disruptive changes to the traditional processes. Vikram works very closely to Product Innovation Leads, Global Hub Leads and Venture Capitalist group and IT organizations. Prior to joining Amgen, Vikram has worked in various financial institutions such as Credit Suisse First Boston, Lehman Brothers, Morgan Stanley and other mid-to-small startups in New York and Mumbai. Vikram has played various role such as Lead Developer, System Integration Engineer, Technical Lead, Solution Architect and Project Manager.Vikram has Masters in Business Administration (MBA) from California Lutheran University, USA and Post Graduate Diploma in Computer Application, India.
Shwen Gwee, Head of Digital Strategy, Global Clinical Operations, Biogen
Shwen is a well regarded thought leader and a recently (2015) recognized "Top 40 Healthcare Transformer" who currently heads up Digital Customer Insights in the Digital Health Technology & Data Sciences team at Biogen. He brings over a decade of experience in digital strategy, social media and pharmaceutical marketing/communications; both on the client-side and at leading agencies. Shwen sits on a variety of advisory boards, including: Google, SXSW Health Track, AARP Live Pitch, Digital Health Coalition, and more. He is a mentor at Rockstart Accelerator and has acted as an advisor/mentor to multiple startups and at events like DataDesignDiabetes and the MIT Grand Hack 2015. He is also heavily involved with MIT Hacking Medicine, where he helps run their digital and social channels. Shwen is passionate about healthcare and social media.
Lynn Hagger, Ph.D., Patient Engagement Director, Respiratory, INA & CVMD, Global Medical Affairs, Astra Zeneca
Having obtained her PhD in Microbiology and Medical Genetics from the University of Toronto, Canada, Lynn began her career with AstraZeneca in 1998, and has served as a successful member and leader of cross-functional teams in Local and Global Medical Affairs, US Marketing, and Global Clinical organizations, across a variety of therapeutic areas. Since June 2015, Lynn has been the Patient Engagement Director for Respiratory, Neuroscience, Inflammation/Autoimmune and CV/Diabetes within Patient Centricity at AstraZeneca.
Beth Harper, MBA, Workforce Innovation Officer, Association of Clinical Research Professionals (ACRP)
Beth is the President of Clinical Performance Partners, Inc. a clinical research consulting firm specializing in enrollment and site performance management. Beth is also serving as the Workforce Innovation Officer for the Association of Clinical Research Professionals (ACRP). She has passionately pursued solutions for optimizing clinical trials and educating clinical research professionals for over three decades. Beth is an Adjunct Assistant Professor at the George Washington University who has published and presented extensively in the areas of protocol optimization, study feasibility, site selection, patient recruitment and sponsor-site relationship management. Beth is currently serving on the CISCRP Advisory Board as well as the Clinical Leader Editorial Advisory Board among other industry volunteer activities. Beth received her B. S. in Occupational Therapy from the University of Wisconsin and an M.B.A. from the University of Texas.
Maria Harrison, Vice President, Real World Solutions, PRA Health Sciences
Ms. Harrison is responsible for overseeing PRA's global real world research in the areas of: product registries, disease registries, risk management programs (including REMS and EU-RMP), PASS, minimal risk diagnostic biomarker, retrospective chart review, and Phase IV studies. Studies cover multiple indications and all services from protocol development through manuscript publication, and range in size from small investigator initiated studies to large, global registries inclusive of over 10,000 patients, 500 sites and in 30+ countries.
Lisa Hegg, Ph. D., VP, Head Project Planning and Management, Project Management and Business Performance, GSK
Lisa Hegg is currently VP, Head of Project Planning and Management at GSK. In her current role, Lisa is responsible for the planning and execution of drug development project plans by project teams driving and delivery of GSK's portfolio of medicines. Lisa received her Ph. D. in Chemistry from Clarke University in Worcester, MA. Following a post doctoral appointment at the University of Massachusetts Medical School, Lisa joined the SmithKlineBeecham (SB) in the discovery organization. Lisa has been active in the area of project leadership and management for over 20 years and has held positions in the discovery and development organization which have included projects spanning multiple therapeutic areas in all lifecycles of development.
Masha Hoffey, MS, Director, Clinical Analytics, Informatics, PerkinElmer
Angelique Hopkins, MPH, Associate Director Clinical Trial Analytics, Business Insights and Analytics, Bristol-Myers Squibb Company
Angelique Hopkins is an Associate Director of Clinical Trial Analytics in Business Insights & Analytics at Bristol-Myers Squibb supporting clinical trial planning. She has a B.S. in Biology from The College of New Jersey, a M.P.H from Drexel University and is completing her doctoral work in epidemiology.With 10 years of experience in clinical trial planning, forecasting, and analytics, Angelique is passionate about the use of data to driven faster and more informed decision-making.
Keith Howells, CTO, Omnicomm
Keith Howells has 25 years of experience in the development of software solutions for clinical research. As Chief Technology Officer for OmniComm Systems, he is responsible for the company's flagship EDC product, TrialMaster, and its product for Phase One clinic automation, TrialOne. Prior to joining OmniComm in 2011, Keith was responsible for the Rave product line at Medidata Solutions and for the Oracle Clinical product line at Oracle. Keith has a degree in physics from Oxford University, England.
Chris Hoyle, MBA, Executive Director, Elite Research Network
Mr. Hoyle entered clinical research in 2001 after obtaining his MBA. While working at a dedicated research site, he was involved in all aspects of investigator site management, including patient recruitment, budgets and contracts, and business development. He founded the Elite Research Network in 2004. Since then, Mr. Hoyle has been responsible for leading the company from a network of four sites to its current size of twenty-seven sites. He earned his BS in Zoology from NC State University and his MBA from UNC - Wilmington.
Sandra Hudgens, MT(ASCP), BS, MBA, Associate Principal Scientist, Clinical Specimen Management Operations, Merck
I have 25 years experience in the biopharmaceutical industry supporting Ph I - III, global clinical trials. My career began at Covance Central Labs where I led a cross-functional Protocol Services Team supporting global clinical trials, as well as, leading the Investigator Services department. My next career opportunity took me to Eli Lilly where I provided support as a Manager of Oncology Data Management for Phase II and Phase III clinical trials for 9 years. For the past 10 years, I have been at Merck where I am a Business Lead for both Inventory Management and implementation of software solutions to support the Clinical Biomarker Specimen Management organization.
Kevin Hudziak, Innovation Lead, Clinical Innovation, Eli Lilly & Company
Kevin Hudziak works in the Clinical Innovation team at Eli Lilly and Company. Kevin focuses on delivering digital solutions to meet the needs of patients and help them find clinical trials that are right for them. He has worked on industry collaborations like CTTI and TransCelerate to help deliver meaningful solutions for patients.
Jeff James, MBA, CEO, Wilmington Health
Jeff James is currently the CEO of Wilmington Health in Wilmington, NC. Wilmington Health is a multispecialty group practice with 200 providers covering 37 specialties in 22 locations. He is responsible for the strategic vision and its deployment as well as all financial and operational aspects of the practice. Under his leadership, Wilmington Health was named an honoree for the prestigious Acclaim Award, by the American Medical Group Foundation in 2013 and the Optum Healthcare Transformation Award in 2016. Jeff is a frequent national speaker on a diverse range of subjects including: Healthcare finance, strategy, ACO development, lean/process improvement, cultural transformation, incentive alignment, physician leadership, public policy, clinical research and healthcare system redesign. He is a physician advocate and healthcare executive with over 20 years of strategic and operational experiences. He has lead or facilitated several physician organizations in their individual pursuits of continuous improvement, quality, and financial strength. He is responsible for the development of multiple Accountable Care Organizations (ACO) and is currently providing leadership for Wilmington Health's ACO, "Physicians Healthcare Collaborative (PHC)". Between 2013 and 2015, PHC has consistently ranked at the top of all ACOs in the country for value, including the number 1 ranking in 2013 and the number 3 ranking in 2015. He has participated as an active board member for several community and healthcare related organizations including: American Medical Group Association, Coastal Connect Health Information Exchange, North Carolina State Medical Society's ACO Steering Committee, North Carolina Governor Pat McCrory's Healthcare Transition Team and the Public Policy Committee of the AMGA. Jeff holds a Master of Business Administration Degree and is a Certified Public Accountant.
Abhay Jha, Principal, Business Technology Lead, R&D Excellence Practice, ZS Associates
Abhay has 20+ years of consulting experience advising life sciences companies on the application of information technology to drug development. His areas of expertise include clinical development, real world data strategy, digital strategy and defining and building industry leading solutions in clinical & drug safety. Abhay is proud to lead the RDE business technology team and drive ZS's mission of helping clients increase the effectiveness of their R&D investment
Liping Jin, Data-Driven Recruitment Lead, Pharmaceutical Research & Early Development, Roche Innovation Center New York
Liping Jin is a data-driven recruitment lead at Roche Innovation Center in New York. He has been driving the innovation adoption of real world data and predictive analytics to support clinical teams better decision making in protocol design, trial strategy and execution. Recently, Liping is applying social media dimension into his data-driven approach to help clinical teams to better understand patients and recruitment.
Therese Johnsen, Clinical Trial Intelligence Manager, Global Drug Development, Novartis
Therese Johnsen is a Clinical Trial Intelligence Manager in Global Drug Development at Novartis. Deeply committed to strong collaboration to create patient centered clinical trials in drug development, Therese was an early innovator in the patient engagement adoption in her organization and designing how to embed the process into operational long term thinking, trial design, enrolment, recruitment. Helping clinical trial teams better understand how to create evidence driven patient plans for indications and trials.
Ram Josyula, Master Black Belt, R&D, BMS
Ram Josyula has been enabling speed and quality of clinical trials at BMS since 2007. He is an operational excellence leader and AI consultant for various industries. He holds an Masters degree from MIT Technology Policy Program and Bachelors from Indian Institute of Technology.
Francis Kalush, Ph.D., Health Programs Coordinator, Professional Affairs and Stakeholder Engagement (PASE), CDER, FDA
Dr. Francis Kalush is the Health Programs Coordinator in the Professional Affairs and Stakeholder Engagement (PASE) at the Office of the Center Director, Center for Drug Evaluation and Research (CDER )at the Food and Drug Administration(FDA). She. provides a focal point for advocacy, to enhance two-way communication and collaboration with healthcare professionals, patients, patient groups, and others on CDER issues concerning drug development, drug review, and drug safety. Dr. Kalush provides leadership and strategic planning direction for educating, developing, communicating, implementing, and assessing an advocacy and stakeholder relations strategy for CDER. She is CDER's Network of Experts Coordinator. Before joining CDER, Dr. Kalush was a Senior Science Health Advisor at the Office Center Director at the Center for Devices and Radiological Health (CDRH) at FDA. She directed and managed center wide initiatives, led the development of a FDA National Medical Device Curriculum Program, enhanced communication and transparency by leading outreaching activities to patient advocates consumers and professional associations. As the Diagnostics and Personalized Medicine Network Leader at CDRH, she planned, managed and coordinated the activities for the Network, encompassing premarket, post market, compliance, science, personalized medicine collaborations and communications to enhance safety of medical devices within the total product life cycle. Since 2008 she is the Healthy People 2020 Medical Product Safety Interagency Workgroup Coordinator. Dr. Kalush was the representative to the Global Harmonization Task Force (GHTF) In Vitro Diagnostics working group. Playing an important role in the international regulatory arena, she assessed COFEPRIS, Ministry of Health, Mexico on setting up their new regulatory reform for medical devices and over the counter medicines. Francis was essential on setting up Pharmacogenomics guidances and roundtable meetings with industry organizations and FDA to address the regulatory, scientific and co-development concerns of drug-diagnostics targeted therapies in Personalized Medicine. Before Joining FDA, Dr. Kalush was the Director, Pharmacogenomics at Celera Genomics. She was responsible for the development of Celera SNP Databases, online support for Applera Projects. Oversaw input from academic and commercial markets and public health programs for the development of Pharmacogenomics, Toxicogenomics and Genetics products. She is the author of multiple publications including "The Sequence of the Human Genome "and she is a well-known international speaker. Dr. Kalush holds a Ph.D in Chemical Immunology from the Weizmann Institute of Science, MSc. in Human Microbiology from Sackler Schoold of Medicine, Tel Aviv University and BSc. in Chemistry and Biology from the Hebrew University, Jerusalem.
Avanti Karandikar, Sr Manager Clinical Business & System Analysis RDIS, MedImmune (AstraZeneca Biologics)
Avanti Karandikar - I have been in Biopharmaceutical industry for over 10+ years and my main domain expertise are primarily in: Patient Safety, Clinical, (including Clinical Data management and SAS programming and related processes), Clinical Compliance (Trial Master File, Clinical Trial Transparency), Regulatory submissions &tracking and Medical Affairs I have extensive experience in biopharmaceutical industry in business and system Analysis, business process reengineering, process Improvement, AS-IS & TO-BE process modeling, user requirements & functional specifications, validation, operational qualifications(OQ), performance qualifications (PQ), installation qualifications (IQ), document management, technical delivery management, project management, solution delivery and application support, COTS (Commercial Off The Shelf) system implementation for regulated (GxP) and validated systems, change management, vendor management, business cases, licensing and contract management, release management. support planning, standard operating procedures (SOPs) and work instructions(WIs).I am well versed in the system landscape and have extensive experience in implementing the systems primarily in patient safety, clinical and regulatory domains such as Arisg, Electronic Trial Master File, Documentum, DsNavigator (Medical Coding), CTMS (Clinical Trial Management System), IVRS, EDC, RAVE Safety Gateway, Smart Supplies, PharmaCM (which is now Trial Scope), JMP Clinical, Clinical Contracting systems etc.
Martin Karpefors, Ph.D., Informatics Science Director, CardioRenal, Autoimmune & Neuroscience TA Lead, AstraZeneca
Martin Karpefors is an Informatics Science Director at AstraZeneca. He holds a MSc in Engineering Physics and a PhD in Biochemistry and \Biophysics from Chalmers University of Technology, Gothenburg, Sweden. His expertise is primarily in data analytics and visualization.
Jeffrey Kasher, Ph.D., Founder, Patients Can't Wait
Jeff Kasher is a known pharmaceutical development change expert with 28 years of experience at Eli Lilly. He is passionate for improving outcomes, bringing patients and research sites into the development process, and dramatically decreasing time to market. His expertise includes novel product development from bench through market launch, research and clinical trial leadership, innovation center start up as well as new industry paradigm creation. Jeff is President of Patients Can't Wait, Chairman of Advisory Board for DrugDev as well as member of Advisory Board of TrialReach, Cytolon, and GoBalto. He sits on the DPharm steering committee and faculty, and is a member of Linking Leaders. In 2013 CenterWatch Jeff was named one of the "20 Innovators Changing the Face of the Clinical Trials Industry." He received a B.S. in Chemistry from Franklin & Marshall College, a Ph.D. in Pharmacology from the State University of New York, and a Post-Doctoral Fellowship in Physiology at Yale University School of Medicine.
Helen Kellar-Wood, Ph.D., Lead, Immunoscience Diversity & Patient Engagement, Global Clinical Operations, Bristol-Myers Squibb
Helen has more than 15 years' experience in in the Pharmaceutical industry, working for several companies and academic institutions in both the UK and the US. Helen joined Bristol-Myers Squibb almost five years ago, and transitioned her career from a director in public affairs and corporate communications to advocacy relations and patient engagement. Currently, Helen leads advocacy, diversity and patient engagement strategy for Bristol-Myers immunoscience portfolio in R&D. This robust and diverse portfolio covers both inflammatory and autoimmune disease conditions. Helen interacts with a broad variety of patient facing organizations and groups to identify ways Bristol-Myers Squibb can work in collaboration with these groups to better understand and incorporate patient, caregiver and advocacy perspectives to improve our clinical studies. Helen completed his undergraduate studies at the University of Southampton, U.K., and received her Ph.D. from the University of Cambridge, U.K., studying the molecular genetics of Multiple Sclerosis in the Department of Medicine.
Francis Kendall, Technology Evaluation and Implementation Leader, Product Development, Roche
Francis has over 25 years experience in the industry working at several major Big Pharma companies (Hoecsht, Sandoz, Nycomed, Roche, Novartis & now Roche) mainly leading and working within Biometrics groups, His first degree is in Applied Statistics, then he went on to be a Chartered Statistician and Chartered manager and also completed his MBA. He has a keen interest in new technology and the democratisation of data. His current role is within the Strategic Innovation group which helps the organisation look at future digital strategies and opportunities such as Machine Learning and Big Data.
Jackie Kent, Senior Director, Product Deliver, Supply Planning & Systems, Eli Lilly
Jackie joined Eli Lilly and Company in 1990, within the IT organization. Jackie has held a variety of positions within IT both technical and leadership before moving into Lilly Research Labs, supporting global clinical development in 2001. Presently, Jackie is responsible for the organization that supplies clinical trial material globally supporting the Lilly portfolio. She also has responsibility for the Product Delivery global operations & IT systems. Jackie represents Lilly on the TransCelerate Operating Committee and is the sponsor of the Shared Investigator Platform Program.
Joe Kim, MBA, Senior Advisor, Clinical Innovation, Eli Lilly and Co
Joseph Kim serves as a Senior Advisor in Clinical Innovation at Lilly, focusing on developing and implementing innovative patient engagement solutions. He has spent over 18 years in the Pharma industry utilizing a unique approach that integrates his experiences working for Sponsors such as Shire and Merck, CROs, and technology vendors. He has a robust combination of experience that includes early and late phase clinical research, and a well known history of innovation in the clinical research industry, recognized as one of "Top 100 individuals on the 2015 MedicineMakers Power List, and "20 Innovators Changing the Face of the Clinical Trials Industry" by CenterWatch in 2013. He holds a BS in Molecular Biology from Lehigh University and an MBA from Villanova. He can be reached at firstname.lastname@example.org and on Twitter: @JoPeKim
Jeff Kingsley, Chief Executive Officer, IACT Health
Dr. Jeff Kingsley received his Bachelor of Science degree from the University of Scranton in 1995 with concentrations in biology, chemistry, history, and cultural anthropology, and his Master of Science degree in 1997 in biochemistry. His medical degree was received from the Philadelphia College of Osteopathic Medicine in 2001 and his MBA was received from Emory University's Goizueta Business School in 2011. Dr. Kingsley has been faculty with the Columbus Regional Health Family Medicine Residency as well as Director of Family Medicine and Urgent Care. He currently holds faculty appointments with the Mercer School of Medicine and Georgia Regents University. Dr. Kingsley is founder and CEO of IACT Health, a research management organization, and eight wholly owned and integrated clinical research offices throughout Georgia. The family of companies conduct phase I through IV research in nearly every medical specialty; inpatient and outpatient; pharmaceutical, biotechnology, and medical device. He has dedicated his career to clinical research since 2006. Dr. Kingsley currently serves as Chair of the Board of Trustees for the Association for Clinical Research Professionals which represents more than 13,000 clinical research professionals internationally. He is the former Treasurer for ACRP and APCR, Past President of ABSAME, sits on three additional Boards, and participates on numerous other local, national, and international committees. He enjoys each day with his wife Christine and four beautiful children.
Brett Kleger, Chief Commercial Officer, DrugDev
As CCO of DrugDev, Brett Kleger is responsible for leading the company's commercial strategy and development. He spearheads the DrugDev initiative to bring new capabilities to market, and is responsible for the success of new DrugDev solutions, including a seamless customer experience. Prior to DrugDev, he created global solutions for IMS Health where he founded a division focused on clinical trials. Brett holds a business degree from the University of Maryland, and a juris doctorate from Villanova School of Law.
Peter Koerner, Associate Director, Site and Patient Access, INC Research/inVentiv Health
Sophia Kourliouros, Senior Manager, Global Regulatory Operations, Eisai Inc.
Sophia has over 15 years of experience in electronic submissions publishing (eCTD) and Global Submissions Management. In addition to daily maintenance submissions, she has directly managed and submitted over 15 initial INDs, 4 original Global NDA/MAA/JP NDAs, 5 sNDAs, 2 sNDSs, 2CTAs and submissions to Brazil and Mexico. Sophia has greatly contributed towards continuous business process improvements and is currently focusing on Global standardization and harmonization activities.
Geoff Kremer, Director, CMR Informatics, Strategy & Operational Effectiveness, Novo Nordisk
Geoff has over 20 years of experience in reporting and analytics (15+ years in Healthcare/Pharma industry). He has experience with a variety of data visualization tools, such as Tableau, Qlik, and SAP Dashboards. He currently is the Associate Director of CMR Informatics (Strategy & Operational Effectiveness) at Novo Nordisk. He has an MBA from LaSalle University.
Jim Kremidas, Executive Director, Association of Clinical Research Professionals
Jim Kremidas is currently the Executive Director for ACRP, a not-for profit association the represents the clinical research enterprise. Prior to that he conducted consulting services for a variety of clients including support for investigator sites, academic institutions, sponsors and suppliers. He was the SVP of Patient Recruitment at two different large CROs for over 6 years where he and his team were responsible for developing and implementing patient enrollment strategies for global clinical trials. Prior to that, he spent 24 years with Eli Lilly and Company. From 1999 to 2008 he led their clinical trial patient recruitment and retention efforts. In this role, he focused on predicting and accelerating the enrollment rates for all corporate studies. While in Strategic Sourcing he was responsible for the outsourcing of clinical development projects to strategic suppliers including CRO's, scientific staffing firms and Patient Recruitment Suppliers. Before his assignment in clinical development strategic sourcing, Mr. Kremidas led Lilly's efforts to select and establish relationships with direct to consumer and professional advertising agencies, as well as, implement standardized processes for the development and implementation of marketing materials. He is on the advisory board of CISCRP (a non-profit organization focused on enhancing patient participation in clinical trials) and is also a volunteer for the Clinical Trial Transformation Initiative (CTTI) with Duke and the NIH. He is a frequent presenter at Industry Conferences and his articles/papers have been published in a wide variety of trade journals.
Amir Lahav, ScD, Rare Disease Research Unit, Pfizer
Ian Lauf, Head, Clinical Business Operations, Shionogi, Inc.
Andy Lawton, Director & Consultant, Risk Based Approach Ltd.
Andy Lawton was most recently at Boehringer-Ingelheim for 28 years ago. At BI Andy was responsible for managing the statistics, data management and programming groups with BIs UK operation. The group has specialised in the management of large scale trials and the implementation of risk based approaches within them. His experience covers over 33 years in clinical trials, but he also has extensive experience in the areas of computing, statistics, Data Management, RDE and system design. Andy was a founding Committee Member of ACDM and aided in the initiation of CDISC with the provision of the business model. Before joining BI, Andy worked as a statistician in the NHS and in computing in a geophysical exploration company.
Carol Lee, Associate Director, Clinical Drug Supply, Logistics, & IRT, Regeneron
Martin Lee, M.D., Vice President, Scientific Services, Scientific Affairs, PRA Health Sciences
Board certified in internal medicine and medical oncology, Dr. Lee has 19 years of clinical experience in the front-line care of cancer patients, has participated in numerous supportive care trials as an investigator, and served as an institutional review board chairman. In addition to working directly with PRA's hematology/oncology clients, he provides executive oversight for PRA's Feasibility, Site Engagement, and Central Review Services teams.
Jennifer Lentz, Consultant, Global Informed Consent Business Lead, Global Clinical Operations, Eli Lilly and Company
Jennifer Lentz has been the Global Informed Consent Business Lead at Eli Lilly and Company for the last 5 years. As part of her role, she has been leading the adoption of eConsent. Externally, she has been involved in the eConsent project with Transcelerate and consent projects with Clinical Trials Transformation Initiative and Innovative Medicines Initiatives. Her prior experience includes roles as a study monitor, study coordinator, disease field investigator, and lab researcher. She became interested in informed consent during her own involvement as a research participant.
Tine Lewi, Ph.D., MBA, Scientific Director, Quantitative Sciences/Real World Evidence Partnerships, Janssen Global Research & Development
Carrie Lewis, MS, Associate Director, Clinical Operations, Lupin Research, Inc.
Carrie Lewis has 14 years of varied Clinical Research experience. Carrie is currently an Associate Director with Lupin Research Inc. where she oversees the day-to-day global clinical operations activities of Phase 1 through 3 clinical trials. Prior to Lupin, Carrie garnered extensive knowledge in many roles while in academia, at large sponsors including Teva as well as a global CRO. She has a Master's Degree in Clinical Research Administration and has experience in Inhalation, Women's Health, CNS, Oncology, and Vaccine Therapy.
Sandy Lewis, BSN, Director, Patient Centered Outcomes Assessment, RTI Health Solutions
Sandy Lewis is a Director of Patient-Centered Outcomes Assessment at RTI HS. She has more than 20 years of experience in the pharmaceutical industry, the majority of which has been focused on the development and validation of patient-reported outcome (PRO) measures and implementation of PROs within clinical trial programs. Ms. Lewis has supported developmental efforts for PRO evidence dossiers for submission to the Food and Drug Administration to support label claims. Throughout the span of her career, Ms. Lewis has worked in numerous therapeutic areas, including gastroenterology, neuropsychology, infectious diseases, respiratory, endocrinology, rheumatology, ophthalmology, orthopedics, urology, cardiovascular, and vaccines. Ms. Lewis has a strong interest in pediatric patient populations and has conducted numerous interviews with children and adolescents between the ages of 6 and 17. Additionally, Ms. Lewis has extensive experience in the standardization and development of training materials and instruction for the administration of multiple instruments and has supported the development and implementation of rater certification programs. During her tenure at Merck, Ms. Lewis was part of the Business Process Implementation team for incorporation of ePRO technology, which developed the guidance documents, working instructions, joint validation plan, and business processes surrounding adoption of the technology at the company. Ms. Lewis has strong project management skills and has wide-ranging experience in all aspects of data collection, from protocol development to report writing. Prior to entering the pharmaceutical arena, Ms. Lewis, a licensed registered nurse, worked for 3 years in a step-down critical care unit as a primary care nurse.
Janis Little, Vice President, Global R&D Quality, Allergan
Janis Little is Vice President, Global R&D Quality at Allergan. In this role she is responsible for the oversight of the R&D quality function, setting strategic direction for the organization and ensuring development and implementation of a risk-based audit program for pharmaceuticals, biologics, medical devices, cosmetics and generics for preclinical, clinical, and pharmacovigilance activities, and related computerized systems, inspection management, quality metrics and product development quality assurance. Prior to joining Allergan, Janis was Global Head, Product Development Quality Auditing at Roche/Genentech where she was responsible for a comprehensive quality program, including audit oversight for clinical, preclinical, and pharmacovigilance activities, and computerized systems, inspection management, quality harmonization, pandemic planning, investigations, ethics and training, CAPA management, and quality metrics. Prior to joining Roche/Genentech, Janis held leadership positions in clinical and pre-clinical compliance, clinical operations, and medical affairs at Johnson & Johnson (Ethicon, Johnson & Johnson Pharmaceutical Research & Development, Centicor), Altana Pharma and Hoechst-Roussel Pharmaceuticals.
Terrie Livingston, PharmD, Senior Director, Real world outcomes, Innovative Partnerships & Insights (RI2), Biogen
Terrie Livingston obtained her Doctorate of Pharmacy from the University of California, San Francisco (UCSF) and completed a general residency and specialty residency in Home Infusion and Business Administration from UCSF. She has over 25 years of Managed Care expertise and 16 years of Pharmaceutical/Life Sciences experience. She was a Managing Partner and Vice President of Pharmacy Operations and Business Development for a Specialty Pharmacy in California. She has held various positions with increasing research, management and leadership responsibility within the pharmaceutical industry at various companies including Pharmacia, Novartis and Biogen. Currently, Terrie is Head of the Real world outcomes, Innovative Partnerships & Insights (RI2) team in US Medical at Biogen. In her role Terrie is responsible for leading a team dedicated to real world evidence generation that is actionable for multiple external stakeholders in this evolving healthcare landscape. She is also responsible for the strategic medical engagement and building medical excellence with Providers, Payers, Advocacy Organizations, Professional Societies, and Health Care Policy Makers. The team seeks opportunities for collaborations and innovative partnerships that provide bold and impactful solutions to healthcare and improved patient outcomes. As a business leader and researcher, Dr. Livingston has studied racial disparities in various settings to champion diversity inclusion and advocate for underserved populations. She is also responsible for research focused on comparative effectiveness research, outcomes research, quality improvement, PROs, patient engagement and quality measure science. Terrie's growing experience and leadership outside of Biogen includes participant as a PCORI reviewer, member of the PQA Patient and Caregiver Advisory Panel, member of the Board of Directors for the Specialty Pharmacy Board Certification, speaker in Panel presentation at SxSW 2017 in Austin, and presenter at World Orphan Drug Congress 2017.
Jill Loftiss, MHS, Head of Oncology Clinical Operations, Medimmune Biologics Science Unit of AstraZeneca
Jill is the head of Medimmune clinical oncology operations. She has extensive clinical research experience in Oncology and Immuno-oncology areas where she has overseen a large number of global studies, cultivated strong relationships with key oncology sites around the world, and was involved in the approval of multiple cancer drugs.
Suzanne Lukac, Director, Risk-Based Monitoring Implementation, Merck
Elizabeth MacLean, Pharm.D., Director, Global Health and Value/Outcomes & Evidence, Pfizer
As Director, Regional Outcomes Research, Elizabeth MacLean, PharmD, PhD is a member of Pfizer Global Health & Value / Outcomes & Evidence group. In this role, Dr. MacLean works with U.S. based payers, specialty pharmacies and other large organizations to provide clinical and health outcomes information regarding Pfizer's oncology portfolio. In this role, MacLean also leads development of non-interventional studies to address questions related to "real world" experience in Pfizer oncology disease areas and/or use of Pfizer oncology compounds. Additional responsibilities include generation of deliverables to support formulary review of Pfizer oncology compounds such as AMCP dossiers and budget impact models as well as healthcare economic information that meets the FDAMA 114 standard of competent and reliable evidence. Prior to joining Outcomes & Evidence and supporting Pfizer Oncology in the U.S. in 2011, MacLean was a Medical Outcomes Specialist with Pfizer in Boston, MA. In this role, she collaborated with the healthcare community (payers, medical groups, health systems, employers) regarding the design, implementation and evaluation of quality improvement initiatives and outcomes assessment. Related responsibilities included education of the healthcare community regarding the role of observational research and use of this real world data to inform decision making. This role with Pfizer also involved educating clinicians and healthcare decision makers regarding clinical and pharmacoeconomic data related to Pfizer primary care products and related disease states. MacLean joined Pfizer in June 2001 from the Memorial Hospital of Rhode Island where she served as Clinical Coordinator of Pharmacy Services and managed the clinical practice of pharmacists and related patient care delivery in acute medical-surgical care, obstetrics, and oncology. MacLean has several publications in peer reviewed journals and has presented numerous posters at scientific congresses. Dr. MacLean earned her undergraduate degree in pharmacy from Northeastern University and Doctor of Pharmacy degree and PhD in Pharmaceutical Sciences with specialization in Pharmacoepidemiology from the University of Rhode Island.
Ibraheem (Ibs) Mahmood, CEO, DrugDev
Ibraheem Mahmood defined the DrugDev vision: to provide technologies and services to clinical trial doctors that allow the pharma industry to conduct trials faster, smarter and cheaper. His strategy to deliver this vision has been to build a world-class team backed by an outstanding investor base. Since joining in 2011, Ibraheem has overseen the growth of the company from just a handful of people to the 300 plus company it is today. In addition, his was responsible for raising an initial $50m investment from Invesco Perpetual. Ibraheem is an obsessive traveler, at one point spending three years on a career break photographing in 113 countries, including every country in Asia (apart from North Korea and Iraq). This global outlook is just as well as it pervades DrugDev from its multilingual core operations team in London, UK (who can connect with clinical trial doctors in most countries on Earth in their own language) to the global nature of virtually all DrugDev clients and their clinical trials.
Charles Makin, Vice President & Global Head, Late Phase Research, Commercialisation & Outcomes, ICON
Charles Makin is a leader in RWE and HEOR, with two decades of experience developing and implementing roadmaps for demonstrating drug value, safety and effectiveness. He has served as Principal Investigator on 100 + research projects in prospective and retrospective RWD collection, with 70 peer-reviewed publications. He leads late phase research at ICON, one of the industry's largest research teams dedicated to patient and disease registries, phase IIIb/IV (pragmatic) clinical trials and expanded access programs.
Marina Malikova, Ph.D., MA, Executive Director, Surgical Translational Research Operations and Compliance, Boston University
Dr. Malikova has eleven years of experience in the clinical research field. She has managed Phase I - IV studies involving investigational drugs, devices and biologics. She has worked on Industry-sponsored and Investigator-initiated trials in the fields of Vascular Surgery, Neurosurgery, Cancer Diagnostics and Interventional Radiology. Dr. Malikova has a PhD in Biochemistry and a Master's degree in Clinical Investigation and Project Management Certification from Boston University. In her current role as Executive Director, Dr. Malikova manages research efforts in 11 divisions of the Department of Surgery at Boston Medical Center. She is responsible for clinical trials and basic biomedical research operations, compliance and risk management, financial management, quality assurance, strategic planning, and macro-management of research programs. She provides assistance to investigators with protocol and informed consent writing, regulatory submissions, clinical trial agreements and budget development.
Kathleen Mandziuk, MPH, RN, Executive Director, Scientific Affairs, Real World Solutions, PRA Health Sciences
Kathleen Mandziuk has worked exclusively in real world research for 15+ years, with leadership roles in both data management and project management. In addition to being responsible for protocol development and strategic support for clients and study teams, Kathleen oversees clinical operations, data management, pharmacovigilance, biometrics, and external vendors.
Angie Maurer, RN, BSN, MBA, Clinical Operations Consultant, PALM/Clinical Operations, Gilead Sciences
Angie has spent over 19 years in healthcare and 15 years in the drug development and medical device industries spanning biopharmaceutical, medical device and CRO organizations. Her experiences include drug safety, study monitoring, study and program management, process development, therapeutic area and clinical operations training, and risk management. Over the past several years Angie has concentrated her efforts on clinical operations process development and implementation of risk management tools and trainings to support risk management programs.
Mari Maurer, BSN, Pharma Clinical Solutions Consulting LLC
Mari has 25 years of experience in sponsor side clinical operations, covering a diversity of therapeutic areas including oncology, cardiovascular, and rare genetic diseases including those with novel therapeutic modalities such as gene therapy. Currently she is a biopharmaceutical consultant assisting clients with the development of clinical operations business infrastructure, including building the tools, systems, and processes to scale their work to the right level of quality and efficiency to fit their organizational needs. Ms. Maurer's has held several leadership positions with sponsors such as REGENXBIO, Ultragenyx, BioMarin and others.
Kelly McKee, Advisor, Clinical Innovation, Eli Lilly and Co
Kelly Johnston McKee is a clinical trial innovator and problem solver with a focus on patient recruitment and engagement. As a leader in the Clinical Innovation and Optimization group at Eli Lilly and Company, she is responsible for the design and successful deployment of game-changing strategies and tactics worldwide. Kelly has been in the industry for over 18 years with previous positions at Merck and Sanofi-Aventis. She has an in-depth understanding and application of novel tactics and technology in protocol feasibility, site selection, and patient recruitment. Kelly was named Pharma Times US Clinical Researcher of the Year in 2012 in the clinical research team category.
Jyotsna Mehta, MS, B.Pharm., Principal and Owner, KevaHealth
Jyotsna Mehta is the Principal and Owner of KevaHealth. She was most recently the Director, Economics Value Evidence and Outcomes at Alkermes. Her responsibilities include providing strategic HEOR capabilities and insights to maximize access and uptake at launch and throughout the lifecyle of Alkermes products. Jyotsna has worked in the pharmaceutical industry since 2008, including positions of increasing responsibility at Astra Zeneca, Sanofi Aventis, EMD Serono in multiple therapeutic areas. Prior to this, she has worked at FDA and Harvard Medical School as a researcher for 8 years. Jyotsna has an M.S. in Pharmacoeconomics and Pharmacoepidemiology and is a pharmacist by training . She has published widely in peer reviewed journals and made presentations to professional organizations and participated in panels and invited talks.
Doug Meyer, MBA, RPh Associate Director, Clinical Drug Supply, Biogen, Inc.
Doug Meyer is Associate Director, Operations and Capabilities Management for Biogen's Clinical Drug Supply department. In this role he oversees the operational support and all critical business systems, including IRT. Doug has over 20 years in the industry with a focus on investigational product planning and logistics, development and implementation of clinical supply chain systems and leading continuous process improvement projects. He holds a BS in pharmacy and an MBA both from the University of Connecticut. He is a certified Project Management Professional (PMP), an APICS Certified in Production and Inventory Management (CPIM) and a Certified Supply Chain Professional (CSCP).
Dmitri Mikhailov, Ph.D., Director, Head, Biomarker Study Coordination, Novartis
Dmitri Mikhailov is the global Head of Biomarker Study Coordination, Translational Medicine at Novartis. His team is responsible for clinical biomarker study setup across multiple therapeutic areas, and for developing new processes and technologies to improve clinical study conduct. Dmitri is also the global lead for Novartis Human Tissue Network, the company wide effort to develop risk-based strategy and efficient processes to enable translational research using human samples. Since joining the industry Dmitri had several positions of increasing responsibility in early biology, lead discovery, safety pharmacology and drug repositioning. Dmitri Mikhailov holds Ph.D. in Biology and M.S. in Physics & Applied Math.
Diane Miller, Director, Vendor Management, AbbVie
Diane Miller is the Director, Vendor Management at AbbVie, responsible for operational oversight and governance of clinical, data and statistical sciences vendor engagements. Diane is accountable for leading the strategic vendor management plan, driving efficiencies and maximizing the value of external engagements. Diane spent most of her career at Pfizer where she helped build a remote site monitoring organization. She implemented the first Functional Service Provider relationship and grew several vendor relationships from transactional to strategic. She joined AbbVie in 2013 to build strategic partnerships with CROs and has established a Vendor Management function to support multiple critical vendor categories.
Sean Mooney Ph.D., Chief Research Information Officer, UW Medicine
Professor Mooney has spent his career as a researcher and group leader in biomedical informatics. He now leads Research IT for UW Medicine and is leading efforts to support and build clinical informatics platforms as its first Chief Research Information Officer (CRIO). He is a professor in the Department of Biomedical Informatics and Medical Education at the University of Washington. Previous to his CRIO role, he was an Associate Professor and Director of Bioinformatics at the Buck Institute for Research on Aging. As an Assistant Professor, he was appointed in Medical and Molecular Genetics at Indiana University School of Medicine and was founder and director of the Indiana University School of Medicine Bioinformatics Core. In 1997, he received his B.S. with Distinction in Biochemistry and Molecular Biology from the University of Wisconsin at Madison. He received a Ph.D. in 2001 at the University of California in San Francisco, and then an American Cancer Society John Peter Hoffman Fellowship at Stanford University.
Paulo Moreira, Vice President, Global Clinical Operations - External Innovation, EMD Serono, Inc.
Paulo Moreira is a Clinical Development executive with 25+ years of experience in Clinical R&D. He has been with EMD Serono for the last 17 years in diverse positions within Clinical Development. Presently serves as the Head of Global Clinical Operations External Innovation. In this capacity, Paulo is responsible for Clinical Innovation as well for Patient Centricity in Clinical Development and Operations where he has had a preponderant role in establishing EMD Serono as an industry leader in patient centricity around clinical trials. Paulo is also a Visiting Scholar at Boston College where he teaches at the Essentials of Clinical Research and Project Management Program. Paulo is very active in several industry-wide organizations. He dedicates some of his time to the Steering Committee of the Clinical Trial Transformation Initiative (CTTI). He leads TransCelerate's Clinical Research Awareness & Access workstream and represents EMD Serono on TransCelerate's Operations Committee and fulfills the role as the Global Impact Partner of the Society for Clinical Research Sites (SCRS). Paulo also serves on the Advisory Board of a couple of companies that provide services to the Pharma/Biotech industries. Lastly, Paulo was named twice to PharmaVoice's 100 Most Inspirational Leaders of 2015 and 2017 recognizing his industry leadership around patient centricity.
Grant Morgan Ph.D. PMP, Sr. VP & Head of Portfolio Planning, R&D Finance, Systems & Analytics, Portfolio & Project Management, BTG PLC
Grant has more than 20 years in the life sciences and has held roles of increasing responsibility across Biotech, mid- and large pharma and more recently Med. Tech companies. Grant is currently the head of portfolio planning, R&D finance, systems and analytics for BTG International. In this broad role he has accountability for R&D operations including ownership of the R&D annual budget incorporating financial management best practices and oversight. In addition, he focusses on developing the processes, systems and analytics to facilitate best in class portfolio, project & clinical management in harmony with strong financial oversight leading to maximize return on investment for the company.He also leads portfolio planning that builds on strong Development practices and Commercial acumen to realize a robust pipeline of high value products for future growth across all areas of the Company. Grant emphasizes strengthening accountabilities and deliverables towards enhanced productivity, reduced costs, improved on-time delivery of products to market, all within a constrained but flexible budget.
David Morin, Director, Research, Holston Medical Group
Dr. David Morin has participated as a Principal Investigator in hundreds of studies (Phase I-IV) since 1989. A Certified Principal Investigator (CPI) since 2007 and an ACRP Credentialed Clinical Research Trainer (CCRT) in 2010. He received the "Outstanding Physician Leadership in the Profession" award by ACRP 2012. He currently serves on the ACRP Board of Trustees and the Academy Board. He is a member of the ACRP Governance and Awards &Recognition Committee. He also served on the CPI committee. He is a chief instructor for ACRP and also assists with the development of educational programs. He achieved his pharmacy and medicine degree with honors, and completed residency training at the University of Virginia in Charlottesville. More recently, he studied computer science at Northwestern University. He is Board Certified in Internal Medicine and is a Fellow of the American College of Physicians. He continues to practice medicine and is the Director of Research for Holston Medical Group, a large physician owned multispecialty practice headquartered in Kingsport, TN. He co-founded several companies including Trike, LLC which developed SiteOptex™ software, a proprietary methodology aimed at improving the efficiency of clinical research.Past activities included serving as a teaching attending for the ETSU College of Medicine, employee health director for a large hospital system, medical director of a CRO and an Accountable Care Organization. Also as a pharmaceutical consultant, speaker, author, and protocol writer.
Rick Morrison, Co-Founder and CEO, Comprehend Systems
Rick is responsible for the overall direction and management of Comprehend Systems. In 2012, Rick was named to the PharmaVOICE 100, which recognizes the 100 most influential people in life sciences. Prior to Comprehend, Rick spent a decade developing clinical analytics tools, including tools used by the FDA and top pharmaceuticals, such as Integrated Clinical Systems, where he led the design and implementation of several major new features. Rick holds a B.S. in Computer Science from Carnegie Mellon University, PA.
Younus Muhammad, Director, Epidemiology, Worldwide Safety and Regulatory, Pfizer
Younus Muhammad serves as Director, Epidemiology in the Worldwide Safety Strategy at Pfizer Inc. He has over 8 years of experience in developing and executing pharmacoepidemiology safety strategies to inform benefit-risk decisions for several products and has led multiple studies utilizing real world data. Younus received his medical degree in Pakistan and PhD in Epidemiology from Michigan State University.
Mary Murray, Associate Director, Diversity & Patient Engagement, Global Clinical Operations, Bristol-Myers Squibb
As an Associate Director for Diversity and Patient Engagement at Bristol-Myers Squibb, Mary Murray develops initiatives through collaboration with Advocacy groups, community organizations and internal functions to help engage patients in our clinical research. With a background in training development, Mary joined Bristol-Myers Squibb's R&D training organization in 2009. Before joining BMS, Mary was the principal in a consulting firm, servicing Fortune 500 companies and small businesses on a range of intercultural approaches to reach diverse audiences. Mary has published in trade journals and presented at pharmaceutical industry conferences on the topic of establishing cultural competence in multinational clinical trials and global drug development. Mary completed her undergraduate studies in Russian at Bryn Mawr College, and received a graduate degree in international management from Thunderbird School of Global Management.
Vaibhav Narayan, VP Research and Therapeutic Area IT, Janssen
John P. Neal, Founder and Chairman, PCRS Network
John P. Neal is Founder and Chairman of PCRS Network, LLC, a unique independent network of clinical research sites focused on high quality and high enrollments. John's experience with the pharmaceutical industries spans over 35 years, having provided management services to many early stage pharmaceutical, biotech firms, and having managed several clinical research sites. Having founded several companies and organizations over his career, Mr. Neal has established a reputation as being a visionary entrepreneur. Individually, and through his companies, John has helped hundreds of businesses in a wide variety of industries to achieve their goals. Under his leadership, PCRS Network has forged close relationships with many Sponsors and CROs to help reduce study delays and minimize the overall time required for new drug and device approvals. By streamlining the site selection, budget and contract negotiation, and site initiation processes, PCRS Network Members, Sponsors, and CROs all benefit. John is a thought leader in the clinical research industry, frequently speaking at industry conferences on clinical research topics. Conferences at which he has presented include ACRPi, MAGIii, ExL Pharmaiii, Clinical Research Operations Forumiv, and Site Solutions Summitv. He has written numerous articles, including The 50th Percentile Budget: Good Intentions, Bad Outcomes of Database-Driven Study Budget Development published in the September 2010 The Monitor magazine, a series of articles on the topic of clinical research study budgeting, and is the author of the PCRS Network blog on clinical research topics.
Rob Nichols, Chief Commercial Officer, Algorics
Rob has had extensive experience in the eClinical sector, with leadership roles at DATATRAK, Phase Forward, Oracle and Quintiles. As part of high performing management teams in the technology and life sciences space, Rob has delivered successful outcomes across regions including USA, Japan, India, China and Europe. Currently, Rob leads the eClinical Interest Group for the Association for Clinical Data Management and has previously chaired, and served in a number of roles for, this association.
David Nickerson, Head of Clinical Quality Management, EMD Serono
Dave has 30 years of industry experience spanning the disciplines of Drug Metabolism & Pharmacokinetics, Project/Program Management, and Clinical Quality Management. He joined EMD Serono (a business of Merck KGaA, Darmstadt, Germany) in November 2016 as Head of Clinical Quality Management. His previous 23 years had been with Pfizer. Dave was a member of the Expert Working Group that was responsible to develop the addendum to ICH E6 (ICH E6 R2).
Marija Nikolic, Associate Director, Vendor Management, Contracts & Outsourcing, Vendor Management, Astellas Pharma Global Development
Marija Nikolic has held numerous Procurement, Project Management, and Process roles throughout her professional career. Her 12+ years of Strategic Sourcing experience spans several industries including industrial supplies, telecom, corporate retail, and pharmaceuticals. In 2008, she obtained her certification in project management (PMP) and assisted in the launch of 10+products. Marija joined Astellas in 2013 as a Senior Optimization Manager in Medical Affairs, Global. She led several global cross-functional teams to standardize processes for Investigator Sponsored Research and Medical Communications. Marija is an Associate Director in Vendor Management where she has responsibilities for managing several of the Development external provider governance and oversight. She also leads process and communication efforts for the VM team. Marija earned a Master's in Business Administration from the University of Illinois in Champaign - Urbana. She also holds a Bachelor of Music degree from Northwestern University and double majored in Violin Performance and Communication Studies. She is a member of the Healthcare Businesswomen's Association (HBA) and the Project Management Institute (PMI).
Winnie Nelson, PharmD, MS, MBA, Senior Director HEOR, Mallinckrodt Pharmaceuticals
Dr. Winnie Nelson, Pharm.D., MS, MBA is Senior Director, Health Economics & Outcomes Research at Mallinckrodt Pharmaceuticals, responsible for leading the development and execution of value evidence generation and dissemination strategies for multiple therapeutic areas. Winnie had over 20 years of experience in health economics, outcomes research, and managed health care. Prior to joining the pharmaceutical industry, Winnie had conducted health economics and outcomes research in the consultancy business, academic research, and in payer organizations. Her research has contributed to an extensive catalog of publications to the scientific literature, with over 100 journal articles, book chapters, and congress presentations. Winnie received her Pharm.D. and her Masters degree in Health Services Research, Policy, and Administration from the University of Minnesota. She received her MBA from the Jack Welch Management Institute. Her post-doctoral training includes a Managed Care Residency at Express Scripts, followed by a Research Fellowship at the University of Wisconsin, Hospital and Clinics.
Brian Nugent, Executive Director of Clinical Solutions and Compliance, Ultragenyx
Brian has spent over 30 years in health care and 15 years in the drug development industry spanning both biopharmaceutical and CRO organizations with director-level responsibility for quality, clinical operations, process development, TMF and safety. Over the past several years, Brian has concentrated his efforts on clinical operations process development and the establishment of quality systems to include QRM/QbD, as well as the standardization of risk management plans.
Christopher O'Brien, VP Strategic Partnerships, myHealthTeams
Experienced Vice President of Strategic Partnerships with a history of working in all sides of the healthcare industry. Strong sales professional with a Executive MBA focused in Systems Thinking from Villanova University. Demonstrated success in a variety of healthcare related industries including Pharmaceuticals supporting R&D, ambulatory healthcare networks supporting electronic health record initiatives and acute care health information management. Involved with a variety of non-profit organizations including the MHE Research Foundation in support of a cure for a rare disease called Multiple Hereditary Exostoses.
Charles O'Donnell, Director, Early Clinical Development Portfolio, AstraZeneca
Trained as a molecular biologist, Charles started his career in the pharmaceutical industry, in AstraZeneca in 2003. Since then he has worked in various therapy areas including cardiovascular, respiratory and oncology in many different roles ranging from bench scientist to functional project lead. More recently he has diversified his experience into business focussed activities, specifically in the areas of alliance and supplier relationship management, and demand/capacity management in the clinical operations space.
Richard O'Hara, Associate Director, Clinical Outsourcing, Endo Pharmaceuticals
Rick O'Hara has been an Associate Director of Project Management and Business Operations at Endo Pharmaceuticals since February of 2012. Prior to this role, Rick spent about 13 years at Johnson & Johnson in various clinical outsourcing roles. His experience at J&J spanned across many therapeutic areas and all phases of clinical research. He also worked on J&J's FSP models. Before J&J, Rick spent 2 years at Covance as a Business Manager and 4 years at the University of Pennsylvania as a Business Administrator. The early part of Rick's career was spent performing various financial management roles within the banking industry. Rick holds both a BS and an MBA from St. Joseph's University in Philadelphia and he lives in Rydal PA.
Kenneth Olovich, Chief Financial and Procurement Officer, Chorus
Mr. Ken Olovich is the Chief Financial and Procurement Officer for Chorus. Ken has over 23 years of pharmaceutical research experience. As one of the original founding members of The Chorus Group in 2002, Ken can be credited with designing and implementing much of the Chorus approach to clinical vendor relations, contracting, finance and budgeting, quality, and general operations.Prior to Chorus, Mr. Olovich served as Team Leader for Clinical Trial Operations in the Neuroscience Therapeutic Area where he supervised clinical associates and support staff in the planning and implementation of phase I/II neurology and psychiatry clinical trials. Prior to that role, Mr. Olovich was the Clinical Sourcing Team Leader within the Lilly Procurement division. Ken earned his Masters of Business Administration from Indiana Wesleyan University and his Bachelor of Pharmacy from Purdue University.
John Oidtman, Ph.D., Senior Vice President, Head of Global Clinical Operations, EMD Serono, Inc.
John Oidtman is a seasoned leader with over 30 years experience in the global pharmaceutical industry. He has a passion for patients and value in enabling high-performance clinical trials. John is currently leading Clinical Operations at EMD Serono. Prior to this position, John held various leadership positions in clinical operations and regulatory affairs in his 20 year tenure at Pfizer. Some of his noteworthy accomplishments include developing a multi-therapeutic, global network of preferred sites, implementing a data driven study/program feasibility organization and driving enterprise-wide transformation of Pfizer's in-country Clinical Operations to a fully outsourced model , to overseeing protocol conduct and monitoring site quality across the globe. John started his career at Rhone-Poulenc Rorer where he held positions in toxicology, quality assurance and regulatory affairs.
Ozgur Ozkan, Decision Science Director, Biometrics and Information Sciences, Astrazeneca Pharmaceuticals
Ozgur Ozkan, Ph.D. is a Decision Science Director with Biometrics and Information Sciences group at AstraZeneca Pharmaceuticals. His work is focused on modeling of clinical development processes and implementation of decision analysis methods and tools. He helped drug development teams in a various therapy areas including cardiovascular and metabolic disease, respiratory, oncology and neuroscience. Prior to AZ, Ozgur spent five years at Health Market Science developing data and analytics solutions to help with commercial strategy. Earlier in his career, he led the development of simulation-based training and decision-support solutions at a consulting firm.
Gahan J. Pandina, Ph.D., Senior Director, Compound Development Team Leader, Neuroscience, Janssen Research & Development
Gahan J. Pandina, PhD, is a Senior Director, Compound Development Team Leader in the Janssen Research and Development, Pharmaceutical Companies of Johnson & Johnson, in Titusville, New Jersey. Dr. Pandina leads two teams at Janssen. The first team is focused on developing tools and technologies to optimize novel medication development for Autism Spectrum Disorder (ASD). The second team is focused on developing disease interception approaches for prevention and early intervention in mood disorders. Over the past 15 years at Janssen, Dr. Pandina has served as the clinical leader for several global Phase 2a/2b drug development programs in the psychiatry including schizophrenia & cognition, ADHD, mood, anxiety, and sleep disorders. He has worked on three successful Phase 3 registration programs in schizophrenia and ASD, and conducted a number of Phase 3B/4 studies in schizophrenia, mood, ADHD, and anxiety disorders. He is an Adjunct Clinical Associate Professor of Psychiatry at Rutgers-Robert Wood Johnson Medical School in Piscataway, New Jersey, where he teaches in the psychiatry residency and psychology internship programs. Dr. Pandina is a licensed clinical psychologist (PhD, Binghamton University), and a member of several international societies including the American Psychological Association, Association of Clinical Research Professionals, and the International Society for CNS Clinical Trials Methodology. He is the author of numerous publications in both pediatric and adult psychiatry, psychology, and neuroimaging research in psychiatric disorders. He has a particular interest in clinical research on the efficacy and outcomes of psychiatric and psychological treatments. He serves on the board of a non-profit organization focused on mental health needs.
Eric Peacock, Co-Founder & CEO, myHealthTeams
Eric Peacock is the co-founder and CEO of MyHealthTeams. Eric is passionate about empowering people facing chronic health conditions and believes it should be easy for them to connect and learn from others sharing the same condition. Eric incubated MyHealthTeams with his co-founder, Mary Ray, while running the online review site Insider Pages, a local review site owned by IAC. Prior to that, at genetics startup Perlegen Sciences, Eric worked closely with patient communities in breast cancer, lupus, autism, Parkinson's disease, and other chronic conditions to enable research on the genetic underpinnings of those diseases. It was there that Eric developed his passion for helping people facing chronic conditions. Today, Eric regularly speaks at health industry conferences on the importance of engaging patient communities in the research and development of new therapies, and making sure the voice of real patients is heard at all stages of the process. Earlier in his career Eric was a VP of Strategy at E*TRADE and a partner at Oliver Wyman / Mercer Management Consulting. Eric is a graduate of Stanford Business School and Harvard College. He lives in San Carlos, CA with his wife and two children, and is a hopeless Red Sox fan.
Morten Pedersen, Senior Manager, Novo Nordisk
Al Peters, President, Clinical Operations and Finance, BTC Network
Bio coming soon...
Gerry Petratos, CEO, Hiteks Solutions Inc.
Gerry Petratos is CEO of Hiteks Solutions Inc. since 2011 when he co-founded it after leaving Genentech. Hiteks focuses on real-time, point-of-care quality and financial improvement with its clinically aligned revenue cycle suite of products in healthcare integrated with Electronic Health Records. Gerry leads Hiteks' approach to smart, innovative solutions integrated with physician workflow within EHRs to improve reimbursement through quality documentation and early surveillance. Gerry worked for 9 years in Pharma as Head of Data Analytics at Roche and Genentech and came to understand the economic impact of good data. His training at the NIH, Intermountain and University of Utah in Biomedical Informatics and Health Services Administration, with later exposure as a professor at Northwestern's Medical Informatics Program, confirmed that supporting physicians with good data, in real-time at the point-of-care can result in huge efficiencies in the healthcare system. Gerry has been on the forefront of early quality surveillance systems such as detection of adverse drug events, throughout his career, and now works with his team to promote quality improvement such as sepsis surveillance linked to clinical documentation improvement and speedy intervention to improve patient outcomes and reimbursement.
JoAnn Pfeiffer, DrSC., Director, Clinical Research Management, Arizona State University
JoAnn Pfeiffer is currently the Associate Director, Clinical Research Management Graduate Program at Arizona State University. She completed her Doctorate of Regulatory Science at the University of Southern California where she conducted a research survey of U.S. Principal Investigators and their role in the management of clinical trial agreements. The results of her study have been published in professional journals and presented at scientific meetings. She holds Masters' Degrees in Regulatory Science and Public Health. Her clinical research experience includes managing clinical trial operations, contract negotiations and management, budget development and management, site audits, IND research, regulatory compliance, IRB submissions, GCPs, regulatory reporting, protocol and consent development, staff development and management. She is certified by the Regulatory Affairs Professional Society and the Association of Clinical Research Professionals.
Daniel Piekarz, Senior Vice President, Healthcare & Life Sciences Practice Leader, DataArt
Daniel Piekarz leads business development efforts at DataArt's Healthcare and Life Sciences Practice, focusing on servicing Pharmaceutical and Healthcare organizations. He joined DataArt in 2013 and, with nearly two decades in Life Sciences IT, brings invaluable experience and deep industry expertise to the company. Dan's global experience includes providing technology services to over 130 countries in areas such as clinical trial management, prescription benefits management, and pharmaceutical sales automation.
Armelde Pitre, Senior Director, Quality Performance Management and Analytics, Pfizer, Inc.
Armelde Pitre, MBA has more than 25 years of experience spanning many aspects of drug development. She led clinical projects from feasibility to regulatory submission in all phases and in multiple disease areas. Her experience includes functional line management in biometrics, information technology, benchmarking and metrics, quality assurance, vendor management, and SOPs and training. Currently, Armelde is a Senior Director at Pfizer and the GCP Performance Analytics Group Lead. She is accountable for the advancement and oversight of Pfizer's GCP Quality Management System and Quality Taxonomy. She provides leadership and expertise in analytics, interpretation and presentation of performance intelligence to drive decision-making, process improvement and delivery in clinical trials.
Mark Price, MA, MEd Senior Director, Surveys and Observational Studies, RTI Health Solutions
Mark Price, MA, MEd, is a Senior Director of Surveys and Observational Studies where he works on both qualitative and quantitative tasks associated with prospective observational and survey studies. Mr. Price has designed, led, or supported numerous burden-of-illness studies centered on collecting patient-reported outcomes, functional assessment, and medical record data to support the development of economic models, outcomes research, and market access initiatives for industry clients. These studies have entailed leadership and coordination with multidisciplinary teams of key opinion leaders, health economists, epidemiologists, patient-reported outcomes experts, clinical research associates, survey development experts, and biostatisticians. Mr. Price has more than 15 years of experience in the design, collection, analysis, interpretation, and reporting of health data. Mr. Price has designed, coordinated, and analyzed data for studies in the specific disease areas of cardiovascular disorders, diabetes, gastrointestinal disorders, HIV, male sexual dysfunction, neurological and neuromuscular disorders (including multiple sclerosis and sporadic inclusion body myositis), obesity and dyslipidemia, oncology (including prostate cancer, melanoma, and non-small cell lung cancer), psychiatric disorders (including depression and schizophrenia), and respiratory disorders. Mr. Price's areas of expertise include both qualitative and quantitative research design and methodology (focus groups, patient interviews, survey development, online data collection), coordination and management of large scale, multinational cross-sectional and longitudinal studies, risk minimization evaluations, statistical analysis, psychometrics, and technical writing and editing. He has experience with statistical analysis, qualitative data analysis, and database programs. His language skills include fluency in French and an intermediate knowledge of Spanish, and he has designed parallel bilingual data collection protocols.
Deborah Profit, Ph.D., Vice President, Otsuka Information Technology
Deborah Profit has worked in pharmaceutical research and development for over two decades and is currently the VP, Otsuka Information Technology (OIT) at Otsuka Pharmaceuticals. In this role, Dr. Profit is responsible for both the commercial and the research and development IT arms of the Otsuka organization. Dr. Profit has been employed by Otsuka for fifteen years and is responsible for facilitating creative solutions across clinical development and commercial teams, coordinating engagements with external innovation companies/consultancies, promoting and further strengthen relationships with health care providers and clinical investigators, and actively lead cross-functional pilots and prototypes. She also plays a key role in transitioning pilots and prototypes to full-scale projects to leverage solutions that complement the business portfolio to include digital medicine, digital health and big data platforms. Preceding 2001, Dr. Profit was the Director, Project Management at a top tier global Clinical Research Organization. In advance of joining industry, she worked in the community mental health setting as the Director of Research supporting the administration of clinical drug studies, and federal and state grants, in accordance with various regulatory agency requirements.
Marisa Rackley, Director, Clinical Research Operations, Vertex Pharmaceuticals, Inc.
Marisa is the Director Clinical Development Support and Site Advocacy at Vertex Pharmaceuticals based in Boston Massachusetts. Prior to joining Vertex, Marisa was a Director at Merck & Co. where she worked for over 16 years with increasing areas responsibilities within Global Clinical Trial Operations. Most recently she led the Global Trial Optimization tasked with providing feasibility, recruitment and retention strategies across the late stage development portfolio. She has led cross functional development teams in bone, endocrine, metabolism, cardiovascular and atherosclerosis in end to end drug development. Marisa has a BS from the University of Scranton and an MHA from Seton Hall University.
Angela Radcliffe, Managing Director, Executive VP, FCBVIO
Angela Radcliffe is an innovator in healthcare communications who helps the research community problem solve and co-create solutions to express the impact of clinical trials to the general public. After losing a brother suddenly to an undiagnosed health condition, a clinical trial made a tremendous impact on Angela's family. This experience exposed the impact that research can have, not just on our health, but every social cause we care about. Angela is committed to the pursuit of more authentic patient engagement, the promotion of health literacy for all, and normalizing clinical research a care option.
Kaushik Raha, Ph.D., Associate Director, Head, Emerging Analytics and Advanced Visualizations, Data Sciences Pharma IT, Janssen Pharmaceuticals
Venkatraman Raman, Sr. Project Manager, R&D Information, Clinical Biologics, Astrazeneca
Venkat is a Sr. Project Manager in R&D Information department at AstraZeneca supporting Clinical Biologics. He has successfully led the eClinical program at MedImmune interconnecting the various Clinical systems and establishing a Clinical dashboard to enable real time decision making in Clinical research and trial delivery. He has also successfully managed several initiatives delivering technology solutions for Clinical Trial Management, Trial Transparency and Supply management. Venkat has more than 20 years of cross-industry (Financial & Pharmaceutical) technology leadership and delivery experience in roles of progressive scope and complexity. Throughout his career he has developed solutions & services and established key business relationships to enable business simplification through technology innovation.
Bruce Rankin, MD, Avail Clinical (An Accel Research Site)
Dr. Bruce Rankin serves as Medical Director for Avail Clinical Research. In this role, a position which he has held since 1998, Dr. Rankin oversees clinical studies across a diverse range of therapeutic areas, and is responsible for ensuring all clinical trials meet the highest standards of research integrity and ethical conduct. Dr. Rankin has served as Chief of Staff at Florida Hospital Deland, and was a physician advisor at West Volusia Hospital Authority. Dr. Rankin has served as Medical Director of the West Volusia Chapter of the American Cancer Society and is past president of the Florida Society of Family Medicine. In addition, he has managed a private practice in family medicine for thirty years. Dr. Rankin is a board-certified physician investigator, and is board-certified from the American College of Family Practitioners in Osteopathic Medicine and Surgery. He is a Diplomat of the National Board of Osteopathic Medicine. Dr. Rankin received his doctor of osteopathic medicine degree from Nova Southeastern College of Osteopathic Medicine. He earned a bachelor of science degree in chemistry from the University of Florida.
Bina Rathod, Associate Director & Business Lead, MRL IT Global Clinical Development, Merck
Bina Rathod is an Associate Director at Merck MRL IT Global Clinical Development supporting the Medical Writing Area in Clinical Operations. Bina has supported Data Management, Standards, IVRS and Early Medical Monitoring in the 15 years she has been with Merck. Bina has been instrumental in being the early adopter of DMW within the company. Bina holds a BSc in Biochemistry from University of North London.
Ratan Ratnesh, Director & Head, Clinical Outsourcing, Otsuka
Ratan Ratnesh is a director and head of clinical outsourcing at Otsuka. Prior to joining Otsuka, Ratan worked at Wyeth and Novartis where he managed different categories related to clinical outsourcing. Ratan has broad experience in strategic sourcing, clinical outsourcing, operations and supply chain improvements in Fortune 500 and growth companies. He started his career in management consulting specializing in supply chain across different industries and moved to clinical outsourcing in early 2000. He received his Bachelors in Mechanical Engineering from National Institute of Technology, India and an MBA from University of Louisiana.
Rochelle Redding, Associate Program Manager, MRL, Merck & Co. Inc.
Rochelle Redding is currently the Primary Care Associate Director of Trial Initiation for the Global Operations group of Merck. In this capacity she is responsible for managing a team of Trial Initiation Specialists that are accountable for delivering the global study budget. She provides expertise in relation to the development of study budgets, ensuring that the therapy area portfolio timelines are met, and tools are developed to improve the budget development and negotiation processes. Rochelle has over 30 years of experience in healthcare and pharmaceutical industries with a broad base of experience on both the site and sponsor side drafting, developing and negotiating clinical budgets for all Phases of global studies. She served as a Clinical Study Coordinator for 5 years in the Neurology and Addiction Medicine areas which really ignited her love of science and research. She has been at Merck a little over 6 years and has served in various roles within Global Operations preparing trial initiation documents including global per patient budgets with Fair Market Value, and supporting forecasting activities on a quarterly, yearly and ad hoc basis. Rochelle holds a BA in Healthcare Management, MS in Clinical Research and a Certified Project Manager CPM.
Jonathan Reuter, Associate Director Global Procurement R&D, Clinical Labs, Bristol Meyers-Squibb
Jonathan is the Associate Director of R&D Global Procurement responsible for Clinical Laboratory services at Bristol-Myers Squibb including Central and Specialty Laboratories, Biorepository and Tissue Procurement. He previously supported Vendor Strategy & Management at Schering Plough and Merck, before joining BMS in 2010, to support the Central Lab space.In 2011, he took on the additional responsibility of Specialty Labs and partnered with BMS scientific teams to put in place robust biomarker category strategies throughout each technology area. In 2011 and 2014, respectively, he added the additional responsibilities in Biorepository and Tissue Procurement, and has recently put in place a category strategy that will integrate these two book-ends of R&D to put forth an integrated category strategy to enable and enhance Translational R&D in all phases at BMS. Jonathan earned his BS in Business and Finance from Monmouth University.
Valerie Reynaert, Head, In-Country Clinical Operations for the Americas, R&D Projects Clinical Platform & Sciences, GlaxoSmithKline
Valerie Reynaert serves as the Head of Clinical Operations for the Americas region at GlaxoSmithKline. She joined GSK in 2000 and spend more than 15 years in clinical development and operations in a variety of leadership roles in GSK's Vaccines business in both Europe and the US. Within her last role in Vaccines she was the Head of Global study delivery (ph1-4, VEO and HO). Valerie moved to GSK's Pharma business in 2015 where she is currently responsible for the regional delivery of GSK Pharma's clinical trials portfolio. Valerie has a Masters in Medical and Social Sciences from the Catholic University of Leuven, Belgium.
David Richardson, Project Manager, Surveys and Observational Studies, RTI Health Solutions
David Richardson is a Project Manager in the Surveys and Observational Studies group of RTI-HS. He has more than 5 years of project management experience, supporting a wide range of studies through all phases of development. Mr. Richardson's experience includes study design and implementation, management of data collection activities, investigator and study coordinator training, and patient and site recruitment and retention.
Mark Ridge, Vice President, Clinical Development Operations, CSL Behring
Mark Ridge is the vice president of clinical development operations at CSL Behring, a $7B revenue biotechnology company focused and serious and rare disease. He has led the successful globalization of the development operations group at CSL and has delivered 5 new drug applications and 4 new drug approvals in his 6 years at CSL. Mark is passionate about bringing new therapies to patients and focuses on hiring great people and empowering them to deliver uncommon results.
Carla Romano, MS, Executive Director, Patient Centered Outcomes Assessment, RTI Health Solutions
Carla Romano, MS, is Head of Patient-Centered Outcomes Assessment in RTI HS. Ms. Roman has extensive experience in the rigorous development and validation of patient-reported outcome measures for use in clinical trials, as well as large-scale epidemiologic and population-based studies. She joined RTI HS after 15 years of working in the pharmaceutical industry and brings her experience with and understanding of the FDA Guidance for Patient-Reported Measures. Ms. Romano has worked to developed measures across a wide span of therapeutic areas, including but not limited to respiratory illness (asthma, chronic obstructive pulmonary disease, allergic rhinitis, influenza), oncology (non-small cell and small cell lung cancer), Alzheimer's disease, infectious disease (including sexually transmitted disease), sleep disorders, hair loss (male and female), menopausal symptoms, cognition, acne, benign prostatic hyperplasia, osteoarthritis, rheumatoid arthritis, diabetes, and migraine. Measures have included multiple types of patient-reported outcomes, including quality of life, treatment satisfaction, symptom severity, daily event logs, patient diaries, utility measures, and other patient-reported outcomes. She has specialized in both the qualitative and quantitative aspects of instrument design and has worked toward creating a clear path from measure development to interpretation.
Jonathan Rowe, Ph.D., Executive Director & Head, Quality Performance and Risk Management, Pfizer
Since 1996, Jonathan Rowe has been working within and supporting large and small pharmaceutical companies to develop medical therapies from the clinical, operational and business perspectives. Currently, Jonathan holds the position of Executive Director, Head of Clinical Development Quality Performance and Risk Management at Pfizer where his responsibilities include monitoring, modeling and predicting the Pfizer GCP Quality Management System, leading the analysis of Pfizer's Clinical Trial Quality Performance and ensuring clinical trial quality risk management is built into all trials. At Pfizer he has held a number of roles of increasing responsibility including Clinical Director, Cardiovascular Risk Factors Group with responsibility for the phase IIIb and IV Lipitor program; Director, Intellectual Property Strategy Management; and Senior Director Pharmaceutical Sciences Process and Performance. Jonathan spent a number of years in supporting the growth of small pharmaceutical companies. From 2009-2014 he was the Head of Intellectual Property and Portfolio Strategy for Amarin and Dignity Sciences, and was a member of the team that managed the Phase III clinical program and eventual approval of Vascepa. Jonathan earned his PhD and MS from the Department of Biochemistry at the Albert Einstein College of Medicine and his MA in reproductive endocrinology from the State University of New York at Binghamton. He has authored articles in peer-reviewed journals across the basic and clinical sciences, is an inventor on a number of patents and has served as a consultant on the topics of Innovation and Strategy Implementation.
Christopher Rull, Principle Consultant, CR Consulting, LLC; Former Vice President, Head of Business Development & Account Management, UBC
Chris Rull's most recent role was as Vice President of Business Development and Account Management. In this role, Chris leads the Business Development and Account Management team, which is focused on UBC's clinical and commercial offerings, including clinical trial recruitment, late stage research, risk management, pharmacovigilance, reimbursement, patient assistance, nursing and adherence services, as well as healthcare analytics and technology solutions. His team is exceptionally qualified to leverage UBC's unique strength: providing integrated business solutions that support the lifecycle of a drug. Prior to joining UBC, Chris spent more than 15 years in various roles within the healthcare industry, the last 13 of which were in different roles of increasing responsibility on both the buy and sell sides of drug development. In these roles, Chris has had the opportunity to collaborate on a global basis with CROs, large biotech companies and some of the largest pharmaceutical companies in the world to support initiatives focused around change management, oversight, business and commercial management, portfolio delivery, and innovation. Most recently, as the Global Head of Service Provider Management within Global Clinical Operations at EMD Serono, Chris focused on developing and launching a new singular global team that brought together several disparate functions across the company that focused on building, implementing and optimizing a new virtual delivery model for all Clinical Development projects.
Patrick Ryan, PhD. Sr. Director and Head, Epidemiology Analytics, Janssen Research and Development
Janelle A. Sabo, PharmD, RPh, MBA, Sr. Group Director, Product Delivery, Eli Lilly
Dr. Janelle A. Sabo is a recognized leader in product delivery and drug development. Her unique background has driven a strong patient focus and desire to find innovative ways to deliver faster new therapies to patients and the global medical community. Janelle is the current global head for product delivery at Eli Lilly and Company enabling product development while delivering the right drug to the right patient at the right time, every time. Over the last 5 years, this organization has doubled the portfolio supported, improved cycle times by 15% YOY, created operational efficiency exceeding $45M while dramatically improving customer satisfaction. Janelle has extensive drug development experience including development and implementation of next generation development, portfolio management and project management organizations. She is the recipient of multiple awards at Eli Lilly and in the industry for innovation, mentorship and achievements in drug development. Janelle holds a Doctorate of Pharmacy from the University of Missouri, Global Executive MBA from Georgetown University and a Global Executive MBA from ESADE- Barcelona, Spain. Dr. Sabo is a guest lecturer at several universities and colleges of pharmacy on drug development and has spoken at conferences within the pharmaceutical industry and recently was the keynote graduation speaker for the UMKC School of Pharmacy. To connect with her, visit @ https://www.linkedin.com/in/janelle-sabo-16248114.
Archana Sah, Therapeutic Area Leader, Oncology, Genentech, Inc.
Archana Sah is a Clinical Operations executive with extensive (20 years) end-to-end experience in pharma and biotechnology drug development. In her current role as Therapeutic Area Leader, Oncology at Genenetech/Roche she is accountable for the strategy and oncology portfolio clinical trials delivery for US drug approvals with the FDA. She is also a Core member of Clinical Operations Leadership Team, which provides overall strategic direction and management of the clinical operations management team. She is a strategic advisor to executive Leadership on emerging topics ranging from therapeutic landscape/healthcare trends expertise to business strategy and operations. She has contributed to setting vision for North America clinical operations in alignment with organizational goals and setting road map for its implementation. She has contributed to the research and development strategies for multiple approved products. She holds global patents and peer reviewed publications, has received several performance awards.
David Sall, President & CEO, Patient Enrollment Advisors (PEA)
David Sall is a marketing and engagement specialist with a focus on the healthcare industry. He was graduated with honors from The George Washington University with a Bachelor of Arts in Communications and a concentration in Business Marketing. David started his career in national broadcasting sales by representing hundreds of the nation's top radio properties. As the media industry hit the technology revolution, David continued his career by building and managing the New York office of Hiwire, one of the original pioneers in digital streaming technology. With the opportunity to bring this knowledge to the traditional media space, David joined CBS Broadcasting's management team and handled the flagship terrestrial radio news properties as well as the many digital assets of the Tiffany network. David is now the CEO and President of Patient Enrollment Advisors, which focuses on the recruitment and retention of qualified participants in medical clinical trials. This venture was born out of a clear need for the industry to approach the business of clinical trials with a unique set of eyes. David is very excited to be a partner with SCOPE for the Participant Engagement Awards, and especially excited to highlight the innovation of engagement with study participants. He lives and works in New York City with his wife and two children.
Theodora Sarver, Manager, Product Management, Almac Clinical Technologies
Theodora Sarver serves as Almac's Manager, Product Management. She oversees a group of product managers and is responsible for executing the full product roadmap and strategy from inseption to commercialization and maintenance. She has successfully delivered a number of SaaS, custom and B2B products used in clinical trial supply management and operations. Theodora holds a BS in Electrical Engineering, from the University of Thessaloniki, Greece and a Masters in Biomedical Engineering, from Drexel University.
Roslyn Schneider, MD, Global Patient Affairs Lead, Pfizer
Roz joined Pfizer in 2006 and is the Global Patient Affairs Lead on Pfizer's Medical Leadership Team of the Chief Medical Office (CMO). In this newly created role, Roz drives patient centricity and integration of the voice of the patient throughout the lifecycle of medicines and their development. Just prior to this she worked with the CMO on Medical Strategy and has held other leadership roles in Medical Affairs and Medicine Development at Pfizer. Roz received her Bachelor of Science from the Sophie Davis School of Biomedical Education of the City College of New York, MD from Mount Sinai School of Medicine, and later her MSc in Pharmaceutical Medicine from Hibernia College. Roz is a retired Clinical Professor of Medicine of Albert Einstein College of Medicine, an Internist, Pulmonologist, Intensivist, and cared for patients at Beth Israel Medical Center, NY, for twenty years. She presented and published primarily in the areas of pulmonary complications of HIV infection, venous thromboembolic disease, medical ethics and medical education. Roz was a Program Director for the Fellowship in Pulmonary and Critical Care, the Residency in Internal Medicine, and Assistant Chair of the Department of Medicine. She is a fellow of both the American College of Physicians and the American College of Chest Physicians where she Chairs the Clinical Research Network. She also serves as Secretary on the Board of Trustees of the Physician Assistant Foundation, and is on the Advisory Council of the Keck Graduate Institute.
Scott Schliebner, MPH, Vice President, Rare Diseases, Scientific Affairs, PRA Health Sciences
Mr. Schliebner is a clinical strategist with over 20 years' in clinical development specializing in rare diseases and orphan drug development. He provides strategic and scientific consultation aimed at accelerating the development of these therapies to treat rare disease patients. His close working relationships with rare disease research consortia, patient advocacy organizations, study research groups, and key opinion leaders, helps informs PRA's patient-centric approach.
Earl Seltzer, Director, Global Feasibility, INC Research/inVentiv Health
Earl has over 12 years' experience in clinical research, starting as a study coordinator at a community based clinical research site, then in the CRO space. Earl has worked in global feasibility helping develop data driven global trial scenarios, and in therapeutic strategy and planning. He focuses on the use of health informatics data to plan clinical trials as well as assessing feasibility of trials in pediatrics and rare diseases. He has presented at several industry conferences from both the CRO and site perspectives.
Joan Shaw, Vice President, Global Clinical Development & Operations, UBC
Joan Shaw has more than 20 years of experience in global clinical operations, including experience managing programs for small molecules, vaccines, and targeted biologics. Joan holds a Master of Science degree in Clinical Chemistry from West Chester University and a Bachelor of Science degree in Medical Technology from the University of Delaware. In addition, she earned Lean Six Sigma Black Belt Accreditation from Villanova University and is a Licensed Medical Technologist.
Greg Skalicky, Chief Enterprise Business Officer, inVentiv Health
Tom Skiendzielewski, Associate Director, Clinical Supply, Shire
Tom is currently serving as the Associate Director of Business Process and Integration in Shire's Clinical Supply Lexington, MA based operation. Within this role, he is responsible for the optimization and utilization of the in-house Clinical Supply Management Database currently deployed for all of Shire's clinical trials.In addition, Tom is also responsible for the Clinical Supply chain integration activities related to any mergers and / or acquisitions made by Shire. Prior to joining Shire, Tom lead the Logistics and Supply Chain Operations teams at two large Contract Manufacturing Organizations. Tom has been responsible for the implementation of multiple ERP systems / IRT solutions at a number of organizations throughout his career. These software solutions include SAP, Oracle, as well as a number of software applications developed "in-house". Tom has over 15 combined years of Clinical Supply experience from both the CMO and Pharma sides of the industry.
Dione Smart, Research Data Coordinator, Clinical Data Management, Abbott Nutrition
Dione Smart has worked as a Data Manager at Abbott Nutrition for more than 25 years. Her career in Clinical Data Management (CDM) includes CRF development, Database Development and Validation, lead Data Manager for multiple complex clinical trials both domestic and international, Safety Liaison, Systems Support member, Closeout/Archival leader, trainer on EDC systems for internal and external users and Dione ensures appropriate permissions are assigned to these users. Dione has served on several committees, including the cross-departmental Risk-Based Monitoring Task Force, to ensure GCP standards are enforced and to streamline efficiencies. Dione holds a Bachelors of Arts degree in Psychology from Otterbein University.
Cassandra Smith, Associate Director, Investigator and Patient Engagement Projects, Global Clinical Development Operations, Janssen R&D
Cassandra brings 15+ years of pharmaceutical industry experience - 10 of which have been within the Johnson & Johnson family of companies. During her career, Cassandra has held various roles supporting clinical trial operations of Phase I-Phase IV studies and she is currently Associate Director, Investigator and Patient Engagement Projects at Janssen Research & Development.
Jodi Smith-Gick, RPh, Sr. Advisor, Product Delivery and Supply, Eli Lilly and Company
Jodi is a registered pharmacist and received her pharmacy degree from Purdue University where she focused on Industrial pharmacy. She has worked for Eli Lilly and company for 22 years and for Bristol-Myers Squibb for 4 years previously. She is currently a Senior Advisor for the global Clinical Supply organization at Lilly. Previously she was the Global Director for Packaging, Labeling, North America Distribution and comparator sourcing for all of Lilly's Clinical Trials. Prior to joining the clinical supply organization she was the chief operating officer for drug development teams where she lead the Core Teams responsible for 11 new molecular entities while in development. These assets included both small and large molecule compounds across numerous therapeutic areas. Jodi also has lead CM&C teams, and was the Site Quality Leader, which includes QA, and QC for the US API biotechnology manufacturing locations. Jodi started out in the industry in various technical service roles where she led dry product scale-up projects, process validation, and coordinated the transfer of manufacturing from one site to another.
Sascha Sonnenberg, MBA, Vice President, Commercial Operations Americas & EMEA, Marken
Sascha Sonnenberg has studied economics at the University of Kassel in the field of Marketing. He started his career in the IT and Consulting industry. May 2003 until December 2004 he completed his MBA at the Kassel International Management School in the emphasis "International Business and Management". June 2004 he joined Faubel were he was responsible for Sales & Marketing and developing the strategy that has made them a leader in the Clinical Trial Supply industry. March 2009 he started Faubel Pharma Services Corp. a New Jersey, US based spin off from Faubel to build up there US presence in Clinical Trial Supplies. Since March 2011 Sascha is with Marken. He has held positions in global CTD Operations and Commercial Operations. He currently holds the position of Vice President Commercial Operations AMERICAS & EMEA at Marken and is subject matter expert for a broad range of service along the clinical supply chain such as eLabeling, Cell&Gene Therapies as well as global distribution strategies. Beside his profession Sascha Sonnenberg is engaged as an active member of the Steering Committee at the ISPE Community of Practice on Investigational Products. He worked on the ISPE Good Practice Guide for Booklet Labels and is currently involved in the ISPE eLabeling Task Team and setting up a Task Team to develop a Good Practice Guide for Patient Centric Logistics (Direct to/from Patient Service).
Joanne Spallone, Global Development Quality Audit Head, Franchise Operations and Strategy, Novartis
Joanne Spallone is Global Audit Head for GCP/PV, Global Development Quality, at Novartis. Joanne has 35+ years of experience in the pharmaceutical industry, and has spent more than half her career in the clinical and pharmacovigilance quality assurance field. The majority of her career has been with Novartis (and formerly Ciba-Geigy Corporation), where she has worked a total of 36 years. In her current position, Joanne leads the GCP/PV Audit program for Novartis, including audits of clinical sites, affiliates, service providers and systems/processes. Prior to re-joining Novartis in December 2006, Joanne worked at Schering-Plough Corporation where she was responsible for establishing a corporate pharmacovigilance audit group. She also worked at ALTANA Pharma from May 2003 until February 2005, where she set up a US clinical and PV quality assurance program. Joanne has led and managed specialized directed investigations, audits and inspections, and systems and due diligence/licensing audits. She has developed and led GCP/PV training programs for global QA and clinical research personnel. Joanne was formerly an active faculty member with the Pharmaceutical Education and Research Institute, Inc. (PERI) for approximately 13 years, involved as Co-Course Director for Basic GCP and as a faculty member for the Advanced GCP class. She spent several years on PhRMA's Bioresearch Monitoring Steering Committee (BRMC) in positions including Chairperson, Vice-Chair, Past Chair and member-at-large. Joanne has presented at several conferences.
Ginger Spitzer, MA, Executive Director, Foundation for Sarcoidosis Research
As Executive Director of Foundation for Sarcoidosis Research since 2012, Ginger Spitzer leads the implementation of a new strategic plan to support the Foundation's mission and to raise vital funds in a cost-effective and time-efficient manner. Building on the Foundation's previous successes, Ginger leads a comprehensive plan that both highlights and unifies the FSR's multiple research and education initiatives with the goal of bringing accelerated changes for sarcoidosis patients. With nearly 25 years of experience in managing non-profit organizational operations, Ginger provides expertise in organizational growth, best practices operations, and funder relations. Her professional endeavors encompass executive management positions for nonprofits with both a service and advocacy mission throughout nationally and globally. She also has held numerous adjunct university teaching positions. She currently is a member of the American Thoracic Society PAR committee, as well as the PAR Awards Committee and the PAR Health Disparities Committee. In addition, she is a member of DIA, a 2015 Fellow of DIA-PEC, and associate editor of the DIA-PEC Newsletter, as well as a member of the Pfizer Rare Disease Advocacy Board, and numerous other professional organizations. Currently she is a PhD candidate at the University of Chicago
Mark Springer, Project Lead, Clinical Innovation, Eli Lilly & Company
Mark Springer has been in the pharmaceutical industry for nearly 20 years. In this time he has held roles ranging from sales, trial management, research site evaluation and selection, country and therapeutic oversight as well as lead for Lilly's trial recruitment and retention group. Currently Mark is with Lilly's Clinical Innovation team working with internal and external leaders in our field to identify, develop, pilot, and implement novel approaches to enhance engagement with patients, more accurately predict and strengthen recruitment into clinical trials and optimize retention.
Manfred Stapff, M.D., Ph.D., CMO, TriNetX, Inc.
Manfred Stapff, MD, PhD, is a physician and board certified clinical pharmacologist with an extensive career in clinical and pharmaceutical medicine. He is currently the Chief Medical Officer of TriNetX, Inc. (www.trinetx.com), the global health research network for healthcare organizations, biopharma and CROs. He was formerly an Executive Director at Actavis, Forest Laboratories and Merck and also served as a Medical Officer in the German Air Force. Manfred earned his MD and PhD from Ludwig Maximilian University of Munich.
Abbe Steel, MSc, Founder & CEO, HealthiVibe, LLC
Ms. Steel is the Founder and CEO of HealthiVibe, a company that enables patients to contribute to the design of clinical trials, resulting in faster, more effective and less expensive research & development. She founded HealthiVibe out of her passion for patient engagement and firmly believes there are opportunities to improve clinical development programs by leveraging the patient voice. Ms. Steel has 25 years experience in the life sciences industry, leading clinical development and post-marketing programs. She is an advisor to pharma sponsors in the design and implementation of patient-directed global programs that leverage data, insights and mobile/digital technology to satisfy patient/caregiver, provider, payer and regulator needs. She has extensive experience designing and managing large-scale clinical development programs as well as successful patient adherence, clinical trial patient recruitment & retention and drug safety initiatives. Ms. Steel previously worked as Vice President of Patient & Physician Services at UBC-Express Scripts; worked at Sanofi on global marketing programs; was Senior Director, Patient Programs at PAREXEL; and was Vice President at a health IT start up. Ms. Steel received her Masters of Science in Health Communications from Boston University and her BA from George Washington University.
Annette Stemhagen, Dr.P.H., FISPE, Senior Vice President, Safety, Epidemiology, Registries and Risk Management, UBC: An Express Scripts Company
Annette Stemhagen has more than 25 years of public health epidemiological research experience, including 15 years in safety surveillance of pharmaceutical, biotech, and vaccine products. She holds adjunct faculty appointments at both the University of Pennsylvania School of Medicine Center for Epidemiology and Biostatistics and the Temple University School of Pharmacy. In 2004, she was appointed as the industry representative to the FDA Drug Safety and Risk Management Advisory Committee.
Stella Stergiopoulos, MS-MPH, Project Manager, Tufts Center for the Study of Drug Development, Tufts University
Ms. Stella Stergiopoulos manages multi-sponsored and grant funded research projects at Tufts CSDD. She has experience conducting research on pharmaceutical industry practices and trends affecting pharmacovigilance, non-clinical drug development, pharmaceutical outsourcing practices, cycle time metrics, resource management, and protocol design. She has also been a speaker at conferences and has published articles in peer-reviewed and trade journals. Prior to joining Tufts CSDD, Ms. Stergiopoulos was a research associate at The Brattle Group and a researcher at Massachusetts General Hospital. She holds a BA from Brandeis University, and an MS and MPH from Tufts University.
Adrienne Strickler, Associate Director, Risk Management-Central Monitoring, Janssen
Adrienne Strickler has over 12 years of clinical research experience, including risk-based monitoring, clinical trial management, and data management. She is currently an Associate Director in the Risk Management-Central Monitoring Group at Janssen R&D, where she is responsible for a team of Central Monitoring Managers overseeing the set-up and execution of RBM for the Immunology and Neuroscience Therapeutic Areas. She has been a part of the RM-CM team since its formation in 2013 and has been involved in many aspects of the development, implementation, and improvement of Risk Based Monitoring at Janssen R&D over the past 4 years. Adrienne holds a BA in Neuroscience from Columbia University.
Linda Sullivan, Co-Founder & President, Metrics Champion Consortium LLC
Linda B. Sullivan is Co-Founder & President of the Metrics Champion Consortium (MCC), an industry association dedicated to leading the drug-development enterprise in the adoption and utilization of standardized metrics and benchmarks to drive performance improvement. She has been a featured speaker at Performance Metrics, Risk-Based Monitoring, Quality Management & Clinical Trial Oversight industry meetings. Ms Sullivan received a B.S. in Biology from Trinity College and a M.B.A. from Dartmouth College where she was named a Tuck Scholar.
Yiwen Sun, Senior Clinical Research Associate, Samumed, LLC
Yiwen started her professional journey in clinical research just as the industry was adapting to a risk-based approach to trial management. She has the unique experience of growing alongside RBM and is an advocate for its adoption at Samumed. Over the past 2 years, Yiwen actively participated in this transition and gained first-hand experience evolving from a traditional CRA into a central monitor. She is an integral part of the RBM team that continues to lead the company towards its risk-based trial management goals. Yiwen graduated from UCSD as a Bioengineer in 2011 and has been with Samumed since 2013.
Steven Sweeney, Vice President, Clinical Development Operations, Quartet
Steve has been involved in clinical research for over 20 years and has experience in several therapeutic areas including neuroscience, pain, inflammation, oncology and cardiovascular/metabolic disease. His experience spans Phase 1 first in human through Phase 3b global registration studies. In addition to his experience designing, running and analyzing clinical trials, Steve has led or participated in a numerous clinical technology and process improvement initiatives. Steve started his career in clinical research in the 90's and has since held leadership positions in Development Operations at Pfizer and Infinity pharmaceuticals before making the move to start-ups. Over the last few years Steve helped build Arteaus Therapeutics, which was acquired by Lilly in December 2013, and Annovation Biopharma, which was acquired by The Medicines Company in January 2015. He most recently served as Vice President of Global Product Development leading the Clinical Development of ABP-700, a novel new anesthetic at The Medicines Company prior to joining Quartet.
Michael Tanen, Director, Clinical Biomarker Specimen Management, Merck
Michael Tanen is the director of the Clinical Biomarker Specimen Management group at Merck Research Laboratories. Michael leads a group that is responsible for collection, tracking, and storage of clinical biomarker specimens collected in clinical trials. During his 20 years at Merck he has been involved in the utilization of clinical biomarker specimens from the prospective of discovery research through the usage for diagnostic development. His team has established an industry leading specimen management solutions that support data integration between clinical data and specimens, improving how we make utilization decisions in the complex area of biomarker research.
Rehbar Tayyabkhan, Vice President, Global Data Strategies & Solutions, Global Clinical Operations, Bristol-Myers Squibb
Reb and his group are responsible for establishing and implementing clinical data strategies to enable the collection and provision of high-quality patient data supporting regulatory filings, publications and other activities. Reb joined Bristol-Myers Squibb in 2003 in Pharmaceutical Development Informatics and moved to clinical operations in 2005. In his most recent role, Reb was the Head of Central Clinical Services, which included the oversight of outsourcing, vendor management, and clinical contracting/payments, and transparency efforts for all clinical operations groups. Reb has also held various leadership positions in Global Development Operations, which included resource and financial management, vendor management, process improvement and management of Regional Clinical Operations for Mexico, Argentina and Brazil. Reb co-led Project Galaxy, a development-wide initiative to identify clinical service providers leading to the selection of two primary clinical research organization providers.Prior to joining Bristol-Myers Squibb, Reb worked as a management consultant at Price Waterhouse Coopers and as an engineer at Merck. Reb holds an MBA from New York University, a Master's in Chemical Engineering from Cornell University and a Bachelor's in Chemistry from New York University.
Shawn Tedman, MBA, Head of Product Offerings, Clinical Trial Optimization Solutions (CTOS), QuintilesIMS
Shawn Tedman is Head of Product Offerings within the Clinical Trial Optimization Solutions (CTOS) group at QuintilesIMS. Previously, Shawn built and led the global Strategic Feasibility team within the Site & Patient Solutions group at UCB BioSciences. Shawn's background is largely in clinical operations - as a clinical monitor, project manager, and auditor. More recently he has led teams focused on optimizing site/country selection strategies and enrollment modeling to inform operational planning. In his current role at UCB, Shawn's team has focused on balancing quantitative data from multiple sources with qualitative feedback from diverse stakeholder groups in order to optimize site and country selection strategies at each step along a product's development lifecycle.
Jaydev Thakkar, Clinical Trial Design and Management - Global IS Service Owner, Director Information Systems, Amgen
Jaydev leads IS group at Amgen supporting Clinical Trial Design and Global Development Operations. Currently, he is IS lead for a strategic cross functional program (driven by CEO staff), working in close partnership with business executives for streamlining Clinical Trials, delivering a suite of IS solutions that enable significant cost efficiency, cut down cycle time and enable Amgen to be a sponsor of choice for Clinical Sites and Patients. His responsibilities include defining Amgen's Clinical IT vision, managing execution of IS portfolio with a multi-year roadmap, and identifying innovations in health care industry that Amgen can leverage in Clinical Development such as Digital Health, Mobile Apps, wearables & sensors, Virtual/Remote trials, Real World Data etc. Over 25 years experience developing and applying technology for finance, telecom, manufacturing and Life sciences industry.
Stuart Thiede, President, Payments, DrugDev
For the last eight years, Stu Thiede has led the DrugDev payments team of highly skilled and experienced professionals to reach a milestone of $2 Billion in total Investigator payments in 2017. Prior to DrugDev, Stu worked in various leadership roles in both Fortune 500 and startup enterprises both in the US and abroad in technology, software, and professional service solutions serving the pharmaceutical industry.
David Thompson, Ph.D., Senior Vice President, Real-World & Late Phase, INC Research/inVentiv Health
Dr. Thompson is a health economist with over 25 years of experience in the health economics arena, including work in economic modeling, retrospective database analysis, trial-based economic evaluations, and patient-reported outcomes. His work has been global in nature, with extensive experience in North American & European markets as well as the emerging markets of the Asia-Pacific and Latin American regions. Prior to joining inVentiv Health, he held leadership positions at Quintiles, i3 Innovus/OptumInsight and PAI.
Aman Thukral, Assistant Director, Data and Statistical Sciences, AbbVie
Aman Thukral is an Assistant Director, Strategy & Innovation in Development Operations at AbbVie. He has over ten years of experience in clinical development, technology planning & business-technology alignment. In his current role, he is responsible for eClinical strategy, piloting new technology initiatives & digital partner for patient engagement group. Before this position, he had worked in Deloitte, Cognizant & GlaxoSmithKline at various levels
David Turner, MS, CISA, CEO/Founder, Parallel6, a PRA Health Sciences Company
David is the CEO and Founder of Parallel6, and the inventor of Clinical6 an mClinical platform serving both Pharma and Healthcare verticals. With over 20 years of executive, operations, and engineering experience managing small to mid-size teams and businesses in the technology and services space, David has served in multiple capacities and executive leadership positions including the Board of Directors for technology and services companies both in the US and abroad.
Thomas Verish Sr Director, Data Operations & Clinical Infrastructure CSL Behring
Tom is the Senior Director of Data Operations & Clinical Infrastructure in Global Clinical Operations at CSL Behring. He is responsible for the functional groups that support data management activities, eClincal technologies, procedural documents and continuous improvement. Prior to CSL, Tom held leadership positions at BMS and Pfizer with a focus on data management, technology and statistical programming.He is a clinical research leader possessing 20+ years of successfully coordinating adaptive, industry-leading data management, statistical programming, and informatics programs for complex pharmaceutical research and development initiatives.
Jeff Van Noy, Vice President, Global Proposal Development and Business Information, ICON
Jeff Van Noy is the Vice President, Global Proposal Development and Business Information at ICON. Jeff leads ICON proposal and RFI development for all service lines across the organization. Prior to his current role, he was Vice President, Business Operations and the Global Business Lead for ICON in the largest partnership in the industry for the past 6 years. He has worked in the CRO industry for over 25 years with varying degree of leadership and responsibilities. Jeff's experience at several CROs includes accounting, finance, business/project analysis and reporting, operational resource management, commercial/pricing, proposal development, and contracts management.
Sonya Verrill, Manager, Clinical Projects, Clinical Operations, Abbott
Sonya Verrill has worked in clinical research for more than 20 years. She is currently a Manager of Clinical Projects at Abbott Nutrition (AN). In this role, she provides global clinical study leadership to assure studies are conducted per regulatory standards to support claims and/or submissions for the Adult/Therapeutic and Pediatric Businesses. In her career, she has led many process improvement committees to improve operational efficiencies in clinical study management and execution. She is currently leading the AN Risk Based Monitoring (RBM) Task Force to create solutions that enhance the current AN RBM approach to study oversight. The RBM Task Force facilitates the implementation of efficient and effective use of monitoring strategies that ensure both patient safety and the quality of clinical data. Sonya holds a Master's Degree in Pharmaceutical Science from the University of Cincinnati's College of Pharmacy.
David Vulcano, AVP & Responsible Executive for Clinical Research, Hospital Corporation of America (HCA)
David is a well-known expert and leader in the clinical research industry. He was born and raised in New Orleans, Louisiana. He has a Masters degree in both Social Work and Business Administration and holds the additional status of Certified IRB Professional (CIP) and Regulatory Affairs Certification (RAC). He is the Responsible Executive for Clinical Research for Hospital Corporation of America (HCA). He is and has been in many other industry leader roles both in the United States and globally, including Chair of the Board of Trustees for the Association of Clinical Research Professionals (ACRP). He is also the President of the Nashville Angel Capital Group. He is married with 2 children and lives south of Nashville, Tennessee where he involves himself in work, family life as well as other charitable and entrepreneurial opportunities. David was recently honored with the "Outstanding Speaker" award, presented at the 2015 MAGI West conference.
Amelia Wall Warner, Ph.D., RPh, CEO & Founder, Global Specimen Solutions
Dr. Amelia Warner founded Global Specimen Solutions, Inc. in 2013 with the vision of improving translational science through powerful new pipeline data management analytics. Prior to GSS, Amelia served as CEO, President and Director of the Board for Gentris and led the successful sale of the company. At Merck Research Laboratories, Amelia served as the Head of Clinical Pharmacogenomics and Clinical Specimen Management, and was the MRL Pharmacogenomics Expert for the Translational Science Research Network.
Sean Walsh, MBA, Chief Development Officer, Raleigh Neurology Associates
Sean joined RNA in 2013 and has spent the last few years building a leading clinical research program at RNA. He has worked extensively on both the sponsor and research site sides of the business and has used his expertise in study start-up and execution, audit oversight, contracting and budgeting to create a program that delivers value to patients and helps advance clinical research. Sean is a retired USAF Officer (Captain) and holds a master's degree in business administration from Webster University and an undergraduate degree from Boston University in Music.
Jian Wang, Ph.D., CEO, BioFortis, Inc.
Dr. Jian Wang received his Ph.D. in Bioengineering from the University of Washington. For the past 20+ years, Dr. Wang developed several software products with customers in academia, government and the pharmaceutical industry. Jian has deep knowledge in the rapidly evolving field of precision medicine and its associated biomarker-driven clinical trials. As CEO of BioFortis, a precision medicine technology solution company, Jian delights in applying his experience to help researchers solve real-world problems.
Xia Wang, Director, Health Informatics, Global Medicines Development Unit, R&D,AstraZeneca
Xia holds a Director position at Health Informatics group within the AstraZeneca clinical development unit. Xia has records of accomplishment in applying novel informatics solutions and real world data analytics to all phases of medicines development life cycles, spanning diabetes, respiratory and autoimmune therapeutic areas. Currently Xia is leading informatics efforts in AstraZeneca Real World Evidence (RWE) studies to support patient safety, epidemiology, comparative effectiveness, payer & pricing strategy and marketing research. Prior to stepping into the clinical domain, Xia was with the AstraZeneca drug discovery unit in the areas of informatics and computational modeling to support candidate drug identification and optimization. Xia holds a Ph.D. in computational chemistry and has extensive training in broad areas of Informatics.
Jolie Weintraub, Executive Director, TA Head Oncology, MRL Quality Assurance, Merck
Dawie Wessels, M.D., CMO, Synexus Clinical Research
Dr. Dawie Wessels joined Synexus as Chief Medical Officer in 2016, following a 17 year career at Parexel, where he developed a new medical strategy with a scientific focus, established a transparent operational governance process and accelerated the use of scientific expertise to serve clients better.
Lynn Wetherwax, Senior Manager, Biobank, Translational Sciences Operations, Amgen
Lynn is a Senior Manager at Amgen with over 25 years of experience in multiple aspects of clinical trials including bioanalytical testing, clinical drug supplies and specimen management. She is currently responsible for managing Amgen's biobank as well as informed consent tracking related to specimens and use of banked specimens for research
Jacqui Whiteway, Ph.D., Senior Director, Feasibility, Scientific Affairs, PRA Health Sciences
Dr Whiteway manages and oversees the global feasibility team. She has over 9 years' experience conducting feasibility assessments, and oversees all aspects of feasibility projects, from study design through summary report activities. She has more than 6 years of experience in basic and clinical research in academic and industry settings and is a primary and contributing author to a number of peer reviewed scientific publications and presentations.
Kenneth Wilson, Director, Business Operations; Clinical Outsourcing Lead, Pfizer
Ken has 27 years of experience in clinical research with varying levels of responsibilities at several CROs as well as 4 years in Outsourcing at Pfizer. Ken began his career at Quintiles in 1987 as a Statistical Programmer and then moved into Statistical Programming line management. He was appointed and served as the Director of Biometrics for Quintiles CNS division until 2000. Following Quintiles, Ken served as Site Director for I3 Statprobe's San Diego office for a few years with overall business and operational management responsibility. Ken has also worked in Business Development at Clinimetrics/Omnicare selling full-service CRO services in various therapeutic areas as well as helping initiate FSP models with different clients in the industry. Ken has managed many projects from full-service to single service-contracts in many different indications. Ken is currently a Director in Business Operations at Pfizer, Inc. where he is responsible for Clinical Outsourcing of five of Pfizer's key development programs.
Paul Whitehead, Ph.D., Head, Early Development Workflows, Roche
Paul received his PhD in liquid thermodynamics, specifically measurement and modelling of excess properties, at the University of Natal in South Africa and in part at the University of Delaware in the U.S. He started his career at Aventis in London developing scientific software using Microsoft.Net and Oracle, and then moved to Paris and finally New Jersey, where he managed software projects to support drug discovery. In 2007 he moved to Roche, where he led a department providing workflows, cheminformatics and statistics support to research scientists, and in 2012 he moved to Shanghai as head of informatics for Roche pRED. Since mid-2016 Paul has been working in the area of digital pharma in New York City, to on-board and operationalize emerging digital technology in support of clinical trial execution.
Taylor Wong, LRL Procurement, Medical and Regulatory, Eli Lilly & Company
Taylor Wong provides procurement support for novel and innovative projects in the medical and clinical development groups at Eli Lilly and Company. In this role, he has responsibility to make Lilly's diverse supply base as a source of competitive advantage to better serve patients and customers worldwide. Prior to this role, Taylor supported the internal operations of the Global Procurement Organization through global process and sourcing tool implementations that supported all areas of the business. Taylor joined the procurement organization in 2013 after earning degrees in Finance and Operations Management from Indiana University's Kelley School of Business.
William Wong, Technology Strategy, Innovation Senior Manager, Amgen
William joins Technology Innovation at Amgen with 15+ years in discovering, evaluating, designing, developing, integrating, deploying, operating and transforming enterprise scale business and scientific applications in biotech, financial, logistics, telco, publishing and retail industries. Works closely with Product Innovation Leads, Technology Hub prospectors, Venture Capital firms and internal Technology Groups across the portfolio to discover, evaluate, select and pilot innovative technologies.In his career, William has had a variety of roles including hiring & managing high performing Agile teams, architecting & developing technology solutions, and integrating various systems and platforms. William has a Bachelor of Science in Computing from the University of Portsmouth in UK.
Brenda Yanak, Global Head, Specimen Strategy & Innovation, End-to-End Specimen Management, Q² Solutions
Brenda recently joined Q2 solutions as Global Head. Brenda was Director, Clinical Innovation at Pfizer. In this role she advised senior executives regarding opportunities to innovate the clinical development space, whether it's identification of new policy gaps, process needs, or technology infrastructure or tools. Brenda has held leadership roles in science, operations, and IT at Merck and Pfizer, and also acted as a management consultant at IBM. She recently led an effort to operationalize Precision Medicine through building the infrastructure to support Pfizer's Human Tissue and Biospecimens Policy.
Richard Young, Vice President, Veeva Vault EDC, Veeva Systems
As vice president for Veeva Vault EDC, Richard Young is responsible for establishing Veeva Vault EDC as the best in class solution for all data acquisition, management and reporting purposes. With almost 25 years of experience in life sciences, Richard is known for his executive vision and proven operational experience in data management, eClinical solutions, and advanced clinical strategies. Most recently, Richard served as vice president of global consulting partners at Medidata Solutions, where he established new partner relationships with the leading life science consulting organizations. Richard also spent a number of years leading the mid-market Europe, Middle East, and Africa sales team at Medidata, where he was responsible for all customer interactions and driving new business. In his roles, Richard spent considerable time consulting on adaptive trials, risk based monitoring, big data, mobile health, and other major data strategies with sponsors and partner organizations across the globe. Richard also held operational roles in both pharmaceutical and contract research organizations, such as GlaxoWellcome, Novo Nordisk, Chiltern and PAREXEL, before moving into business development with Cmed. Richard holds a bachelor of science degree in biochemical sciences from Coventry University.
Walter Young, Head, Strategy, Outsourcing and Governance, CSL Behring
Xiaosong (Sue) Zhang, MS, MAS, Staff Statistical Analyst, Clinical Program & System Support, Abbott Nutrition
Sue Zhang is a Staff Statistical Analyst. She has been with Abbott Nutrition for the past 18 years. She develops programs to generate data tables, listings, and figures for clinical studies including the key risk indicator reports as defined in the Monitoring Plan. She serves as a SAS Technical leader for the Programming team at Abbott Nutrition. Sue holds a Master of Applied Statistics degree and a Master of Science degree in Environmental Toxicology from the Ohio State University and a Bachelor of Science degree in Biology from Lanzhou University in China.
Sean Zhao, M.D., Head, US Patient Safety Surveillance, AstraZeneca
Dr. Sean Zhao is a senior pharmaceutical executive with over 15 years of diverse working experience and proven ability in pharmacovigilance, pharmacoepidemiology, risk evaluation, management and mitigation, post marketing safety studies, safety process development and refinement, and outcomes research. He successfully led global safety department, safety surveillance teams, and pharmacoepidemiology teams in various mid- and large-size biotech and pharmaceutical companies. He has deep knowledge in safety regulations and guidance enforced by regulatory agencies worldwide. Dr. Zhao currently serves as head of US Patient Safety Surveillance at AstraZeneca Pharmaceuticals LP.
Jay Zinni, Associate Director, Procurement, Incyte Pharmaceuticals
Healthcare Executive with a broad range of experiences and a proven record of driving innovation resulting in increased productivity, improved quality and reduced costs. Specialties include International management, strategic planning, business portfolio management, productivity improvement, business integration, information system implementations, client and vendor contract negotiations and six sigma.
In Memory of Gerald "Jerry" Matczak
Gerald "Jerry" Matczak, lead consultant in clinical innovation at Eli Lilly & Co., was a rare breed in the pharmaceutical world,
someone who not only embraced social media, but also listened to activist patients. He has been a part of the SCOPE conference since its inception and
won the Patient Engagement Award on Wednesday, the day before his passing. Matczak died suddenly on Feb. 2 at age 54. We will all miss him.
- Cambridge Healthtech Institute (CHI)