FDA proposes cell and gene therapy site tours to help regulators learn from industry

 It's no secret that cell and gene therapies have faced manufacturing hurdles as the advanced medicines have become increasingly popular in recent years. Now, the FDA is proposing to work directly with industry through a series of facility tours that could enable both sides to learn something from each other.

In a federal register post Monday, the Office of Therapeutic Products (OTP) of the FDA’s Center for Biologics Evaluation and Research (CBER) unveiled its Cellular and Gene Therapies Interactive Site Tours Program. The initiative is designed to let CBER project managers and reviewers swap regulatory know-how with their industry counterparts on-site.

CBER hopes the program will bolster its review skills by providing agency staffers with a better understanding of the biotechnology manufacturing industry and its operations, according to the post.

The goal of the program, which cell and gene therapy manufacturers are being invited to volunteer for by August 14, is twofold: grant CBER and OTP staffers “firsthand exposure” to the industry’s product development processes; and create a venue for sharing information about project management best practices with industry representatives.

Ultimately, the final program will likely only last for a few days, according to the FDA. While it’s running, a small group of OTP regulatory project managers and reviewers will be able to observe operations and biologics manufacturing or packaging facilities, plus pathology and toxicology labs and regulatory affairs operations.

The FDA staffers and their industry counterparts will also be able to take part in workshops focusing on “selective regulatory issues” important to both parties, the agency said. 

Given the sensitive nature of the FDA’s work and its relationships with those in the industry, the regulator stressed that the site tour and program is in no way meant to inspect, assess, judge or perform a regulatory function.

The sites the FDA picks will ultimately come down, in part, to the agency’s available resources. Additionally, for a cell and gene therapy manufacturer to qualify for the program, their facility must be in good standing with the U.S. drug regulator.

https://www.fiercepharma.com/pharma/fda-proposes-cell-and-gene-therapy-site-tours-help-regulators-learn-industry