SC15: Introduction to Gene Therapy Products Manufacturing and Analytics
Monday, August 31 |
ABOUT THIS COURSE: This short course introduces concepts that can be used to facilitate CMC development for gene therapy products. The instructors will review regulatory guidance and present phase-appropriate control strategies. Several CMC challenges unique to this modality will also be discussed, along with different manufacturing platforms. The workshop will include an interactive session on developing an integrated control strategy.
- Overview of Manufacturing for Gene Therapy Products and Parallels with Protein Therapeutics
- Analytical Development Strategies
- Phase-Appropriate Control strategy
- Regulatory Guidance and Expectations for Gene Therapy Products
- Specific Challenges in Comparison to Protein Therapeutics
- Potential for Leveraging Platforms and Benefits
- Interactive workshop on developing a control strategy
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.
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.