The United States Food and Drug Administration (FDA) announced a public workshop titled, “Facilitating End-to-End Development of Individualized Therapeutics,” focusing on development of individualized therapeutic products for one or a small number of patients. This workshop will be on March 3, 2020 from 8:30 am to 5:00 pm ET, and can be attended in person or via webcast. Registration is required.
Per the FDA announcement, the objectives of the workshop are:
- “To discuss scientific challenges to development of individualized therapeutics, and ongoing efforts to adapt products manufactured based on a technology platform to treat diseases affecting one individual or a very small number of patients; explore lessons learned, logistical challenges, failures, and successes.
- To examine challenges under the current U.S. regulatory framework that need to be addressed to have a clear pathway for access to individualized therapeutics, including licensed manufacture and consistent delivery of safe and effective products.
- To explore challenges from the patient perspective that limit development and access to individualized therapeutics; consider research and development, ethical, and product availability and access issues.
- To identify new models of collaboration or synergies that may facilitate aspects of development, including manufacturing, preclinical testing, clinical development, and continuing evaluation for consistent production, availability, and delivery of individualized therapeutic products.”
For more details and to register, see the FDA announcement.