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Dr. Tsai-Yu Lin recommends sessions highlighting regulatory challenges during the upcoming Annual Meeting.
Gene and cell therapies (GCT) are relatively new disease treatment approaches. Regulatory guidelines and policies have been adapting and evolving to keep up with the rapid advances and growth of the field. In addition to the exciting scientific reports on novel and innovative development of the field, I am also interested in and looking forward to several symposia during the ASGCT Annual Meeting that will discuss aspects of regulatory challenges.
Tuesday, May 16
Wednesday, May 17:
A symposium Accelerated Approval for Cell and Gene Therapies will discuss the past and future of the Accelerated Approval pathway in the Cell and Gene Therapies (CGT) field, followed by an in-depth panel discussion on the future of using Accelerated Approval pathway.
Another symposium, Refinement of NHP usage in gene therapy drug development, will address the current advances in animal models for GCT drug development after the passage of the FDA Modernization Act that has terminated the FDA mandatory animal testing of experimental drugs before human clinical trials. EU’s perspectives on limited large animal drug testing will be shared.
Thursday, May 18
Friday, May 19
The symposium N=1 and Beyond: Small Patient Studies to Enable New Therapies for Genetic Disorders will address several attributes of developing remedies for ultra-rare diseases. Panel discussions will be held about the bespoke program and gegulatory perspective on ultra-rare disorder treatment.
A panel discussion on Evolution of Genetic Medicines: Navigating the Challenges and Synergies Among Therapeutic Modalities will address selected aspects, including regulatory changes and challenges of old and new therapeutic modalities.
Use these words to search in th program and abstract modules:
Tsai-Yu Lin, Ph.D, is associate director of Gene Therapy Testing Laboratory and assistant professor of clinical medical and molecular genetics at Indiana University School of Medicine. He is a member of the ASGCT Communications Committee.
May 7-11, 2024 | Baltimore, MD
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