Chair, Biologics Monographs 5–Advanced Therapies Expert Committee
Career Highlights:
- Kite, a Gilead Company: Vice President, Regulatory Affairs, CMC, and Early Development
- Baxter/Baxalta/Shire: Head of Regulatory CMC
- Simon Fraser University: Assistant Professor
- Cal State University Channel Island: Adjunct professor
Education:
- Johns Hopkins School of Medicine, Ph.D., Biochemistry, Cell, and Molecular Biology
Awards, Recognition, Admissions:
- Invited speaker, European Directorate for the Quality Medicines& Healthcare (EDQM) at the occasion of 10th edition of European Pharmacopeia A
A Few Favorite Professional Achievements:
- 30 years of experience in biologics development, biological product life cycle, quality, and regulatory affairs
- Developing and managing the life cycle of genetically modified cell therapy products
- Managing a group of scientists in protein characterization research and development
- Interaction with different health authorities on various topics
- Biological product development, quality requirements and regulatory approval and management of post-approval changes
- Quality control, quality assurance of new products, stability, and device and combo product development
