As the Covid-19 pandemic shifts our work and life realities, biopharma executives are asking how they can efficiently direct resources in advancing their R&D programs.

Real-world evidence (RWE) offers potential as a complement to randomized controlled trials (RCTs) to answer regulatory questions on not only safety, but on effectiveness as well.

This webinar brings together global biopharma leaders to discuss how to use RWE to support development and post-marketing studies. Speakers will discuss best practices, potential pitfalls, and how to ensure success in today’s rapidly changing environment — including use of a platform for decision-ready evidence generation.

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You’ll learn:

• How RWE can help fill evidence gaps in the current global environment to ensure patients receive safe and effective treatments with minimal delay.
• Which data sources, methods, and processes support the generation of regulatory-grade real-world evidence.
• How external control arms derived from real-world data can be used in regulatory approvals where RCTs are not ethical or feasible, e.g. in oncology and rare diseases.
• Considerations for using real-world data sources to address questions about Covid-19 treatment approaches.

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Speaker

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Prior to founding Aetion, Dr. Rassen was Assistant Professor of Medicine at Harvard Medical School, where he focused on methods to improve the quality and validity of real-world data studies. Dr. Rassen frequently speaks and publishes in peer-reviewed publications on how real-world data can be used to measure the safety, effectiveness and value of medications, and other treatments.

Before coming to Harvard, Dr. Rassen worked in Silicon Valley at a variety of technology companies, including Hewlett-Packard and Epiphany, Inc. His focus was on high-performance software for the creation and analysis of large databases.

Dr. Rassen received his bachelor’s degree in Computer Science from Harvard College and his masters and doctorate degrees in Epidemiology from the Harvard T.H. Chan School of Public Health.

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Speaker

Sebastian Schneeweiss, M.D., Sc.D.,

Professor of Medicine and Epidemiology at Harvard Medical School

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Sebastian Schneeweiss, M.D., Sc.D., is a Professor of Medicine and Epidemiology at Harvard Medical School and Chief of the Division of Pharmacoepidemiology, Department of Medicine at Brigham and Women’s Hospital.

His research focuses on the comparative effectiveness and safety of biopharmaceuticals. He has developed analytic methods to improve the scientific validity of epidemiologic analyses using complex longitudinal healthcare databases for newly marketed medical products. The overarching theme of his research is applying advanced real-world data analytics for regulatory decision making transparently and in rapid cycles. His work is published in 400 articles, and is funded by NIH, PCORI, Arnold Foundation, IMI, and FDA where he is also a voting consultant.

Dr. Schneeweiss is Director of the Harvard-Brigham Drug Safety Research Center funded by FDA/CDER, and Methods Lead of the FDA Sentinel program. He is Past President of the International Society for Pharmacoepidemiology and is a Fellow of the American College of Epidemiology, the American College of Clinical Pharmacology, and the International Society for Pharmacoepidemiology.

He received his medical training at the University of Munich Medical School and his doctoral degree in Pharmacoepidemiology from Harvard.

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Hosted by

Maire Gerrard

Custom Content Writer

Informa Pharma Intelligence