Annual Meeting 2023

Meeting Preview: Spotlight on Regulatory Challenges

Tsai-Yu Lin, PhD - May 05, 2023

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.

Recommended sessions

Tuesday, May 16

  • A scientific symposium on Comparability Challenges for CMC will discuss a CMC comparability roadmap that could support incorporating CMC changes throughout the different stages of product development. The panel discussion consists of two comparability case studies and perspectives on GCT compatibility from a formal FDA reviewer.

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

  • A scientific symposium Emerging Regulatory Trends will be held in a fireside chat format to discuss tegulatory topics including new policies, guidance, and collaborative efforts of regulatory bodies from global health authorities.

Friday, May 19

Keywords

Use these words to search in th program and abstract modules:

  1. Regulatory
  2. Policy
  3. Guideline
  4. Compliances
  5. Accelerated Approval
  6. Modernization Act

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.

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