Webinar Download

Originally Hosted:
Wednesday, February 6, 2019
12:30pm-1:00pm EST (30-minutes)

In Vitro Relative Potency Assays for Commercialization of Gene Therapy Products

Presenter: Karen Doucette, MBA
Director of Operations, ACF Bioservices

What you will learn:

  • Considerations for in vitro potency assay development for AAV products with complex MOA(s)
  • Logistics of transferring an existing potency assay from R&D to GMP
  • Statistical and regulatory insights into potency assay release testing for clinical and commercial gene therapy products
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Karen Doucette has worked for preclinical contract research organizations (CROs) for over 17 years. She joined Absorption Systems in 2003 as an Associate Scientist performing in vitro permeability and metabolism assays for ADME profiling of drug candidates. As Project Manager for Absorption Systems, she was instrumental in streamlining preclinical in vivo PK and toxicology studies, collaboratively driving research and expansion of Absorption Systems’ in vivo ocular services in San Diego, CA, and increasing company-wide study throughput. In her current role as Director of Operations, Karen oversees a team of project managers as well as a wide variety of US-based and international accounts. Her account support spans consultative study design, internal and external project management, and study execution and reporting. She plays a key role in coordinating research innovation with customer need, particularly in the areas of in vitro DDI and BE testing, and potency assays for cell and gene therapy products. Prior to joining Absorption Systems, Karen was a Senior Research Pharmacologist at NovaScreen Biosciences where she developed and performed high throughput receptor-binding assays for pharmacological profiling of new molecular entities. Karen has a Bachelor’s degree in Animal Science from the University of Delaware and an MBA from Goldey-Beacom College.