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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 1: Emerging Approaches to Demonstrating Structural and Functional Similarity

Session Chair(s)

Emily  Shacter, PhD

Emily Shacter, PhD

Independent Consultant

ThinkFDA, LLC, United States

This session will address the tools used for the demonstration of similarity based on biochemical, physicochemical, and functional comparison of a proposed biosimilar to a reference product. Presentations and a panel discussion will provide data and insights on the use of state of the art analytical techniques and biological assays that can identify and quantify molecular similarity and differences. The use of quantitative approaches for evaluation of the similarity data, as well as application of scientific considerations to the acceptability of observed differences, will be discussed.

Learning Objective :
  • Achieve a deeper understanding of powerful analytical techniques used for the demonstration of analytical similarity
  • Gain insights into the role and utility of various biological/functional assays
  • Describe how regulators and sponsors justify and/or reject certain molecular and functional differences
  • Speaker(s)

    Patrick J. Lynch

    Speaker

    Patrick J. Lynch

    U.S. Food and Drug Administration, United States

    Biologist, Product Quality Reviewer

    Martin  Schiestl, PhD

    Speaker

    Martin Schiestl, PhD

    Sandoz GmbH, Austria

    Global Head Regulatory Affairs Policy

    Elizabeth  Pollitt, PhD

    Speaker

    Elizabeth Pollitt, PhD

    BioPharma CMC Regulatory Consultancy Services, Ltd., United Kingdom

    Director

    Kyung-Ah   Kim, PhD

    Speaker

    Kyung-Ah Kim, PhD

    Samsung Bioepis, Korea, Republic of

    Vice President, Head of Bioanalysis

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