FDA Director to Address Developments in Regenerative Medicine
ISPE announced Wilson Bryan, MD, Director, Office of Tissues and Advanced Therapies, FDA, as a newly confirmed keynote for the 2020 ISPE Biopharmaceutical Manufacturing Conference, taking place 1–3 June 2020 in Boston, Massachusetts.
Wilson Bryan is a neurologist who graduated from the University of Chicago Pritzker School of Medicine. He served on the neurology faculty of the University of Texas Southwestern Medical School for 13 years. He has been an investigator on clinical trials in cerebrovascular disease and neuromuscular disorders, particularly amyotrophic lateral sclerosis. Dr. Bryan joined the United States Food and Drug Administration (FDA) in 2000, and now serves as Director of the Office of Tissues and Advanced Therapies (OTAT) in the FDA’s Center for Biologics Evaluation and Research (CBER).
Dr. Bryan's keynote presentation will provide insights into current developments in regenerative medicine, future trends, and challenges with a special focus on the clinical development of gene therapies for rare diseases and implications for manufacturing.
The 2020 ISPE Biopharmaceutical Manufacturing Conference will focus on innovation in facilities, production methods and technologies that enable a competitive and sustainable biopharmaceutical product supply for the future. This conference will bring together experts that are developing, implementing, and operating advanced supply chains providing high-quality medicines to global markets.
Topics that will be addressed at this conference include:
- Innovations in facility design and operation
- Cell and gene therapy & biologics GMP
- Implications of ICH Q12 for biopharma
- Technology advancements
- Regulatory updates, insights, and best practices
- Automation and digitalization
- Single-use technology
- Preparing the biopharma workforce of the future
Immediately after the conference, ISPE will provide additional educational opportunities with the 2020 ISPE Continuous Manufacturing Workshop on 3–4 June and in-depth training on 4–5 June.