OTAT Announces Growth Program at ASGCT/FDA Liaison Meeting

ASGCT Staff - November 12, 2021

Learn about the new OTAT program and view presentation slides from ASGCT's fourth annual liaison meeting with the FDA this week.

At ASGCT’s annual liaison meeting with the FDA this week, Wilson Bryan, MD, director of FDA’s Office of Tissues and Advanced Therapies (OTAT), outlined next steps in a new initiative—the OTAT Growth Program. This effort aims to address the challenges brought on by rapid growth in the development of gene and cell therapies.

“If gene and cell therapies continue to take off at the pace they have,” said Bryan, “we’re going to have to think about doing business differently.”

Toward this goal, OTAT has already gathered ideas during the first phase of the program from staff from OTAT and the Center for Biologics Evaluation and Research (CBER) more broadly, as well as 25 sponsors and four organizations in the space, including ASGCT. The information from interviews, focus groups, and listening sessions spurred solutions to pilot to improve communications with stakeholders and increase capacity and efficiency in OTAT operations.

Related to an ASGCT suggestion in its listening session, the agency plans to increase the frequency of scientific exchange by collaborating with scientific and trade organizations, including ASGCT, to create more workshops, webinars, and/or white papers. Because the process of developing a guidance document takes time, both to develop regulator experience and to enable the science to evolve, increasing the provision of these other formats may be an interim step to facilitate mutual learning.

Among the other pilot solutions, OTAT will be revising its website within the next six to 12 months, with an initial focus on content on sponsor/OTAT meetings, and consolidating resources related to cell and gene therapies. With about 2/3 of meeting requests receiving “Written Responses Only” (WROs), another important plan is for the office to standardize practices to provide clarifications after meetings, particularly after WROs.

A longer-term project will involve investigating opportunities for increased communication regarding status of submissions, including both original INDs and IND amendments. OTAT staff are thinking about the circumstances under which reviewers will comment on amendments, since they are not able to comment on all of them.

Bryan noted that publicly available information on the proposed commitment letter for the Prescription Drug User Fee Act reauthorization (PDUFA VII) indicates that cell and gene therapy will likely get attention in FDA goals, which will contribute to creating more staff and management capacity and sustainability.

View the slides from Bryan’s presentation, as well as slides from ASGCT’s presentations on rAAV Gene Therapy and Peripheral Nervous System Ganglia ToxicityIntegration/Insertion Considerations for AAV-Based Gene Therapy Vectors, and CMC Expectations for Gene and Cell Therapies. Watch for a full meeting summary coming soon.

View the Full Slide Deck

Share This Page