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Biologics and Biosimilars: Payers, Industry, and Academia Collaborating on Post-Marketing Surveillance
Session Chair(s)
Charles Barr, MD, MPH
Chief Medical Officer, Adaptic Health, United States
Once seen as unreliable when compared to randomized control trials, use of real world evidence (RWE) beyond traditional observational studies is gaining traction. The focus of this forum is to describe how a collaborative effort—involving payers, industry, academia, medical societies, and regulators—strategically influences real world data (RWD) and RWE improvements that are achievable in the near term. The panel’s focus will be on real-life examples from our multi-stakeholder collaboration.
Learning Objective : Analyze the payer/industry/academia collaboration on surveillance of biologics and biosimilars and the fit-for-purpose outcomes from this collaboration; Discuss the role of BBCIC's multi-stakeholder approach to driving solutions for FDA regulatory use cases; Describe real world evidence (RWE) and real-world data (RWD) and how they intersect to reduce time and cost of creating evidence.
Speaker(s)
Kevin Haynes, PHARMD
Director of Clinical Epidemiology, HealthCore Inc., United States
Payer Contributions to Biosimilar Safety Surveillance
Hillel P Cohen, PHD
Biosimilars Expert, Retired, United States
Pharmaceutical Industry Experience With Biosimilar Post-Marketing Safety
Nancy Lin, DRSC, MS
Senior Scientist, Epidemiology, Optum, United States
Research Challenges in Biosimilar Safety and Surveillance
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