Three speakers from FDA will round out an agenda to help industry navigate through CMC challenges for cell & gene and other advanced therapeutic medicinal products.
BETHESDA, Md., May 10, 2023 /PRNewswire-PRWeb/ -- PDA today announced the confirmation of three U.S. FDA representatives as speakers at the 2023 PDA Advanced Therapy Medicinal Products Conference in Baltimore, Md., June 7-8. The three confirmed FDA speakers are all from Center for Biologics Evaluation and Research (CBER) and include:
· Tiffany Lucas, PhD, Gene Therapy CMC Reviewer
· Brenton K. McCright, PhD, Biologist
· Mikhail V. Ovanesov, PhD, Branch Chief
The conference's theme, "Navigating through CMC Challenges," was developed to ensure attendees expand their knowledge and understanding of industry best practices in applying novel approaches to the development, manufacturing, and distribution of cell and gene therapies.
Day 1 will kick off with a discussion on the intersection of clinical and regulatory strategy with CMC in order to advance innovative cell therapies toward approval. The plenary sessions that follow will give you an in-depth look at managing complex manufacturing networks, cell banking and ATMP development, and supply chain. Day 1 will close with the can't miss networking reception where you can connect with peers and suppliers to build your network!
The agenda for Day 2 is also packed! Start this day with a breakfast session on exceptional release, followed by a plenary session on industry and agency perspectives for analytical method lifecycle steps, where you will explore valuable lessons learned from working in an accelerated development environment. Also on the agenda for Day 2 are plenary sessions covering raw material management and control, and a risk-based and science-driven approach to manufacturing process design and implementation.
Finally, you won't want to miss the closing panel discussion with regulatory and industry panelists answering all your final questions that may not have been answered during the plenaries.
For more information or to register, go to: 2023 PDA Advanced Therapy Medicinal Products Conference.