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DIA 2018 Global Annual Meeting


Payers, Industry, and Academia Collaborating on Post-Marketing Surveillance

    Session Chair(s)
      Charles E Barr, MD, MPH

      Charles E Barr, MD, MPH

      • Chief Science Officer, BBCIC
      • AMCP BBCIC, LLC, 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 : Describe the payer/industry/academia collaboration on biologic and biosimilar surveillance 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 their relationships and how they intersect to reduce time and cost of creating evidence.
    Speaker(s)
      Mark J Cziraky, PharmD

      Payer Contributions to Biosimilar Safety Surveillance

      Mark J Cziraky, PharmD

      • Vice President of Research
      • Anthem HealthCore, United States
      Hillel  Cohen, PhD

      Pharmaceutical Industry Experience With Biosimilar Post-Marketing Safety

      Hillel Cohen, PhD

      • Executive Director, Scientific Affairs
      • Sandoz Inc., United States
      Nancy  Lin, DrSc, MS

      Research Challenges in Biosimilar Safety and Surveillance

      Nancy Lin, DrSc, MS

      • Senior Scientist, Epidemiology
      • Optum, United States