Gene Therapy Products: Phase-Appropriate Analytical Development Strategies

SUNDAY APRIL 7, 2:30 - 5:30 PM

Instructors:

Francis Poulin, PhD, Director, Analytical Development, Sanofi 

Claire Davies, PhD, Associate Vice President, Bioanalytics, Sanofi

Introduction:

This short course introduces concepts that can be used to facilitate analytical development for gene therapy products. The instructors will review regulatory guidance and present phase-appropriate analytical development and control strategies. Several challenges unique to this modality will also be discussed. The course combines instruction and an interactive workshop on platform method development.

Topics covered include:

• Overview of Manufacturing for Gene Therapy Products
• Analytical Development Strategies
• Phase appropriate Control strategy
• Comparability and Stability
• Regulatory guidance and unique challenges for gene therapy
• Interactive workshop on platform method development

Who Should Attend:

• Research Associates
• Scientists
• CMC and Analytical Project Leads
• Department Heads
• Regulatory Affairs Specialists and Managers
• Process Analytics
• Analytical Development
• Regulatory CMC

About the Instructors:

Francis Poulin, PhD, Director, Analytical Development, Sanofi

Francis Poulin is a Director of Analytical Development at Sanofi in Framingham, Massachusetts, where he is responsible for the development, qualification and validation of bioassays and molecular assays to support the release of biologics in preclinical and clinical development, including gene therapy products. Prior to joining Sanofi, Francis was a postdoctoral fellow at HHMI/University of California, Berkeley and the Lawrence Berkeley National Laboratory. Francis received his PhD in Biochemistry from McGill University.

Claire Davies, PhD, Associate Vice President, Bioanalytics, Sanofi

After obtaining her PhD from the University of London in 2001, Claire Davies performed her postdoctoral work at the William Harvey Research Institute (WHRI) at Bart’s and The London, Queen Mary's School of Medicine and Dentistry and Joslin Diabetes Center, Harvard Medical School, Boston. Over the last 16 years, Dr Davies has led analytical and CMC teams in product development and analytical method development and validation. Currently, Dr Davies leads Bioanalytics, a group responsible for developing methods and strategies to support process development, product characterization and release and stability testing for therapeutic proteins and gene therapy products in preclinical and clinical development.