Regulatory Policy

An ASGCT strategic objective is to promote a regulatory environment that supports clinical translation of gene and cell therapies. The unique attributes of these therapies and the rapid expansion of the pipeline in recent years pose challenges to both regulators and developers.

The Society advocates for predictable, efficient regulatory requirements to facilitate development of safe and effective therapies to alleviate human disease. Some examples of the policies ASGCT supports are as follows:

• Robust federal appropriations to the US Food and Drug Administration (FDA).

• Additional allocation of user fee dollars to FDA’s Center for Biologics Evaluation and Research (CBER).

• Updated post-market surveillance expectations.

• Use of surrogate endpoints when a strong mechanistic rationale exists.

• Convergence of regulatory requirements across regulatory bodies globally.

Committee Involvement

The Regulatory Affairs Committee provides oversight of ASGCT’s efforts on regulatory policy through various activities, including an annual liaison meeting with the FDA to promote dialogue on the most pressing regulatory matters in the field. The committee also provides Society representation to entities developing gene and cell therapy standards. The Regulatory Affairs and Commercialization Committees develop programming for the Annual Meeting and annual Policy Summit on these topics.

Collaborative Efforts

ASGCT is a member of the following organizations:

• Alliance for a Stronger FDA
• United States Pharmacopeia (USP) Convention

The Society also has representation in the following groups:

• National Academies of Sciences, Engineering, and Medicine Forum on Regenerative Medicine
• Standards Coordinating Body for Regenerative Medicine