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Jun 11, 2024 9:30 AM - Jun 11, 2024 12:30 PM

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

This is a virtual pre-meeting Short Course in conjunction with the DIA Global Annual Meeting.


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.

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.

Linda  Kalilani, PhD, MSc

Linda Kalilani, PhD, MSc

Senior Director and Head of Oncology Epidemiology, GlaxoSmithKline, United States

Linda Kalilani is Senior Director & Head of Oncology Epidemiology at GlaxoSmithKline. She has worked as an epidemiologist in the pharmaceutical industry for over 10 years. She has led the development of cross-functional real-world evidence strategies, has extensive experience leading the design and execution of real-world evidence studies, and leading initiatives to improve governance processes for implementing real world evidence studies. Linda holds a PhD in Epidemiology from the University of North Carolina at Chapel Hill, a Masters’ Degree in Epidemiology from University of Cambridge, UK and a Medical Degree from the University of Malawi.

Tara  MacCannell, PhD, MS

Tara MacCannell, PhD, MS

Global Head, RWE, Vertex, United States

Tara MacCannell, PhD MSc, is the Global Head and Executive Director of Real World Evidence at Vertex Pharmaceuticals. In her role, Tara leads a team of epidemiologists responsible for the strategy and execution of observational studies in support of early development and Phase I/II programs up through to the end of Phase III. Before joining Vertex, Tara led teams of data scientists and epidemiologists in Real World Evidence and HEOR at Gilead Sciences.

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