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Hyatt Regency Bethesda

24 oct 2017 7:00 a.m. - 25 oct 2017 3:30 p.m.

One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814-5326

Biosimilars Conference

Session 2: Role of Clinical Trials in Biosimilar Development

Session Chair(s)

Cecil J. Nick, MS

Cecil J. Nick, MS

FTOPRA, Vice President (Technical)

Parexel Consulting, United Kingdom

Clinical trials currently represent a fundamental component of the biosimilar development program but are the trials that are currently advocated by the regulators designed to address the right questions, and how feasible will such trials be in the future? Often the potential for therapeutic equivalence may be obvious from in vitro, PK, and PD studies without the need for extensive therapeutic equivalence trials. Still, residual uncertainties might persist that only clinical studies in patients can address. Speakers will explore what these issues are and whether clinical trials are always needed; where trials are needed, what questions they should address, and if better approaches exist than are currently applied.

Learning Objective :
  • Contribute to the design of a clinical program that will meet the needs of the regulators and maximize on the value of the study
  • Describe the areas of residual uncertainty that need to be addressed through conduct of clinical trials
  • Challenge the need for conduct of unnecessary clinical trials to support biosimilarity
  • Speaker(s)

    Cecil J. Nick, MS

    Speaker

    Cecil J. Nick, MS

    Parexel Consulting, United Kingdom

    FTOPRA, Vice President (Technical)

    Julie Ann Rosenberg, MD

    Speaker

    Julie Ann Rosenberg, MD

    Pfizer, Inc., United States

    Development Asset Lead, Oncology Biosimilars, Pfizer Essential Health

    Richard  Markus, MD, PhD

    Speaker

    Richard Markus, MD, PhD

    Amgen Inc., United States

    Vice President, Global Development

    Sue  Lim

    Speaker

    Sue Lim

    FDA, United States

    Director of the Scientific Staff, TBBS, OND, CDER

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