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Regulated Large Molecule Bioanalysis: Fundamentals, the New FDA Guidance and Beyond

Organizers: Rebecca Elliott, Weili Yan and Surinder Kaur (Genentech)
Date: 2020-09-17
Time: 8:45-17:00 Pacific Time
Registration fee: (USD): Regular: $195; For unemployed or students: $30; Academic: $125; For major-sponsor rep (incl lunch): $0; For vendor-show rep: $35
Location: SF Bay Area: Foster City Crowne Plaza
Major Sponsor: (2)KCAS Bioanalytical & Biomarker Services; WuXi AppTec
Vendor show vendors registered to date: (7)BioAgilytix Labs; Covance; ICON Clinical Research; Mercodia; MicroConstants; Syneos Health; Three Pillars Biotechnology Consulting
Registration deadline:2020-09-16  (it will close sooner if the seating cap is reached)

About the Topic

Validated bioanalytical methods for the quantitative evaluation of large molecule drugs and biomarkers in a given biological matrix are critical for the successful conduct of nonclinical and clinical studies. These validated methods under regulated GxP environment provide critical data to support the safety and effectiveness of drugs and biologic products. Ligand binding assays (LBA) and emerging new technologies are widely used for regulated large molecule bioanalysis.

The workshop includes an introduction to regulated bioanalytical method development/validation and sample testing, focusing on new FDA guidance and future global harmonized guidance for large molecule bioanalysis. Applying general bioanalytical principles to emerging new technologies and/or new drug entities such as cell and gene therapy to meet health authorities’ compliance requirements will also be presented by industry recognized experts.

The following topics will be covered:

  • Introduction: Fundamentals of large molecule bioanalysis- method development, regulated validation and sample testing
  • 2018 FDA bioanalytical method validation guidance, changes from previous guidance, future global harmonized guidance
  • Hybrid LBA/LC-MS bioanalytical method
  • New technologies in large molecule bioanalysis
  • Cross validation
  • Life cycle management of bioanalytical method (critical reagents)
  • Bioanalysis in gene and/or cell therapy
  • Method transfer, validation, production from CRO perspective

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