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April 29-30, 2017
Marriott Marquis San Diego Marina, San Diego 
 

Background

Bioanalysis is a critical function in the drug development process whether the drug is a new molecular entity or biosimilar. Both the Food and Drug Administration and the European Medicines Agency have released important bioanalytical and biosimilar guidance’s in the last few years, and several countries have followed suit including China, Columbia, and others. This workshop will provide essential insight from key opinion leaders.

Goals and Objectives

  • To understand the various platforms and technologies used to support pharmacokinetic (PK) and immunogenicity assessment, 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 drug development and regulatory filings.
  • To engage members of the bioanalytical and biosimilar communities in a dialogue. 

Who Should Attend

Scientists, Regulators and Academicians involved in:

  • bioanalysis of new molecular entities and biosimilar drugs
  • understanding and interpretation of PK and immunogenicity data supporting clinical trials and filings
  • utilization of standard and new technologies for biologics support