Regulatory

Browse and view ASGCT's regulatory-focused content on-demand. This resource is made available exclusively for ASGCT members.

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Find Regulatory Content

Critical CMC Issues for CGT Products

December 3, 2021
This café begins with an introduction to CMC issues for gene and cell therapy products and will also help attendees understand the critical CMC development issues from a regulatory perspective. 🔒

House Cancer Caucus Briefing: Immunotherapies

January 26, 2023
ASGCT members presented in collaboration with the bipartisan House Cancer Caucus. Speakers touched on the pipeline of CAR T therapies and its exponential growth in recent years, the potential for immunotherapies to treat rare cancers and solid tumors, and the patient experience. 🔒

Introduction to GMP Regulations

July 15, 2022
This month’s café focuses on Good Manufacturing Practices (GMPs). While these regulations are governed by the FDA, their applications to the field of gene and cell therapy are still being developed. During this event, speakers present pre-recorded pieces on their views of GMPs. 🔒

Lunch and Learn: Recently Approved Therapies

February 23, 2023
Speakers focused on gene therapy approvals in 2022 including Skysona (for CALD), Zynteglo (for beta thalassemia), and Hemgenix (for hemophilia B). 🔒

Lunch and Learn: Roadblocks to Developing a Treatment

March 30, 2023
This session explored some of the areas where treatments can get stopped while en route to an approval. 🔒

Lunch and Learn: The Pathway to Approval

September 30, 2022
Speakers explore the clinical pathway for getting a therapy through a clinical trial and into the approval phase, and thoughts on cost and access once a therapy is approved. 🔒

Novel Approaches for Treating Genetic Diseases

February 8, 2023
Although regulatory approvals seem to indicate a lag in innovation, they represent an important proof of principle that the technical, regulatory, and commercial hurdles can be cleared for new modalities. This event provides an overview of some of the exciting developments in this area. 🔒

Recent CMC Guidance for Cellular and Gene Therapies

April 11, 2024
This presentation focuses on recent CMC guidance for cell and gene therapies, specifically the Manufacturing Changes and Comparability and Potency Assurance guidance documents. 🔒

State of the Field: Highlights and Approvals for CGT in 2023 Community Quick Takes

February 28, 2024
2023 was an exciting year for the field, but what do all these approvals mean for access, safety, and long-term outcomes in the communities they affect? 🔒

Utilizing AI in Gene + Cell Manufacturing

February 16, 2024
Explore the roles of AI and automation in propelling the latest advances in genetics and regenerative medicine and the rapid pace of progress. 🔒

2025

Class Considerations on Immunogenicity for AAV GT Products

January 22-23, 2025 | Virtual

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