• Stephanie Frasier Ph.D.
  • Heather Myler Ph.D.
  • Dominique Gouty Ph.D.

Proposal Description:

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Bioanalysis is a critical function in the drug development process whether the drug be a new molecular entity or biosimilar. Numerous important bioanalytical and biosimilar guidance's have been released in the last few years including:

  • FDA Draft Guidance on Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product, released December 2016.
  • FDA Draft Guidance on Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Products, released April 2016.
  • EMA Draft Guideline on Immunogenicity assessment of biotechnology-derived therapeutic proteins, released August 2015.
  • FDA Draft Guidance on Bioanalytical Method Validation, released September 2013 with several countries following suit including China, Columbia and more.

Learning Objectives

  • To understand the various platforms and technologies used to support pharmacokinetic (PK) and immunogenicity assays, detailing key selection criteria.
  • To discuss the evolution of bioanalytical assays from discovery through the regulated phases of development for new molecular entities and biosimilars and how this correlates to the guidance documents.
  • To introduce and discuss AAPS white papers on PK and immunogenicity of biosimilars.
  • To understand the impact of PK and immunogenicity data in supporting clinical trials and filings.
  • To engage members of the bioanalytical and biosimilar communities in a dialogue.

Target Audience
Scientists involved in bioanalysis of new molecular entities and biosimilar drugs, understanding and interpretation of PK and immunogenicity data supporting clinical trials and filings, and utilization of standard and new technologies for biologics support will be interested in this workshop, as well as regulators and academicians.

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