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Virtual

Oct 12, 2023 10:00 AM - Oct 12, 2023 2:00 PM

Short Course: How Good is Good Enough? Fit-for-Purpose Considerations for RWD/RWE for Regulatory Purposes

This Pre-Conference Short Course is held in conjunction with the Real-World Evidence Conference

Instructors

Sunday  Clark, DrSc, MPH

Sunday Clark, DrSc, MPH

Director Oncology Global Evidence & Outcomes, Takeda Pharmaceuticals, United States

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.

Emily  Castellanos, MD, MPH

Emily Castellanos, MD, MPH

Senior Medical Director, Research Oncology, Flatiron Health, United States

Emily Castellanos is a medical oncologist and hematologist who serves as medical director at Flatiron Health, where she leverages her clinical and research expertise to develop innovative approaches to real-world evidence generation and inform product strategy. She has a special interest in integrated approaches to real-world data, such as clinico-genomics, clinico-claims, or imaging data, as well as novel approaches to real-world study design.

Jonathan  Assayag, DrSc, PhD, MSc

Jonathan Assayag, DrSc, PhD, MSc

Director, RWE Scientist Oncology, RWE Platform, Pfizer, Canada

Jonathan is a Director and RWE Scientist in the RWE Center of Excellence at Pfizer, where he designs and executes on RWE strategy and works with teams across the drug development lifecycle. Jonathan has more than 10 years’ experience utilizing real-world and clinical data to conduct and communicate healthcare research. His prior work includes working in medical affairs where he also led RWE education initiatives for Pfizer colleagues. Jonathan holds a PhD from McGill University in Pharmacoepidemiology where he is also currently an instructor in the department of Medicine.

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