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Virtual Event

2022 年 06 月 14 日 2:00 下午 - 2022 年 06 月 14 日 5:00 下午

(Eastern Standard Time)

Real-World Evidence: The Evolving Landscape of Regulators, Data, and Integrated Use

Instructors

Jaclyn  Bosco, PhD, MPH, FISPE

Jaclyn Bosco, PhD, MPH, FISPE

Vice President and Global Head of Epidemiology, IQVIA, United States

Dr. Jaclyn Bosco Global Head of Epidemiology in Real World Solutions at IQVIA, is responsible for driving real-world evidence (RWE) generation for regulators, clinicians, patients and payers using passive and primary data collection through clinicians and person-generated health to support the safety and effectiveness of drugs, biologics, and medical devices from early clinical development through the post-approval phase. She identifies the best approach for capturing data on a global scale as well applies local approaches to address market-specific needs. As a thought leader in real world research, she is invited to speak at international congresses and sits on scientific advisory boards and committees.

Matthew  Reynolds, PhD, FISPE

Matthew Reynolds, PhD, FISPE

Vice President, Real World Evidence, IQVIA, United States

Dr. Reynolds is a member of the Center for Advanced Evidence Generation, Real World Solutions at IQVIA. He designs innovative solutions for real world evidence on effectiveness and safety. Dr. Reynolds brings more than 20 years of diverse experience in non-interventional research and has a deep expertise in the usage of real world data to address questions of effectiveness, safety, and value of pharmaceutical products. He founded and led the successful Database Special Interest Group for the International Society of Pharmacoepidemiology where he served as an elected executive leader. Dr. Reynolds earned his graduate and doctoral degrees in epidemiology and preventive medicine from the University of Maryland at Baltimore in January 2000.

Rachel  Sobel, DrPH, MPH, FISPE

Rachel Sobel, DrPH, MPH, FISPE

Vice President, Head of Pharmacoepidemiology, Regeneron , United States

Dr. Sobel has over 24 years of experience in epidemiology, risk management, and registries. She is currently Head of Pharmacoepidemiology at Regeneron in Global Patient Safety and has held roles of increasing responsibility at Pfizer Inc and UBC, a CRO. She has extensive experience in the use of RWE for regulatory decision making and using epidemiology to support multiple aspects of drug safety, such as post-authorization safety studies and Risk Evaluation and Mitigation Strategy (REMS) for FDA, EMA, and others. Her work has been published in multiple peer review journals, and she is also an active member of the International Society of Pharmacoepidemiology (ISPE), where she has held a number of leadership positions.

Robert  Reynolds, DrSc, MSc, FISPE

Robert Reynolds, DrSc, MSc, FISPE

Vice President, Epidemiology & Patient-Centered Outcomes, VEO, GSK, United States

Dr. Reynolds is Vice President, Epidemiology & Patient-Centered Outcomes in Value Evidence and Outcomes, part of Research and Development at GSK. He heads a group responsible for leading the epidemiologic and patient components of integrated evidence plans. He is also an Adjunct Associate Professor of Epidemiology at the Tulane School of Public Health and Tropical Medicine. Prior to joining GSK, he worked at Pfizer for twenty years, most recently leading Epidemiology in R&D. He is a Fellow and former Board member of the International Society for Pharmacoepidemiology. He holds a MSc in Epidemiology and ScD in Population and International Health from the Harvard T.H. Chan School of Public Health.

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