Building Confidence in CGT Innovation

In a video interview with Pharma Commerce, Jenna Dale, direct of client relations at Cencora, shares how pharmaceutical manufacturers are able to handle supply chain disruptions. She explains that while these issues may arise due to political or environmental factors, they aren't new challenges for the industry. Manufacturers have faced similar hurdles before and are accustomed to managing risks that affect production. The key to overcoming these challenges, according to Dale, is having a robust continuity plan in place. Such plans help ensure that manufacturing remains uninterrupted, even when external factors like tariffs create obstacles. By identifying potential risks and preparing for them, manufacturers can continue the development and commercialization of therapies despite external pressures.

Dale also comments on key challenges preventing the United States from meeting the FDA’s forecast of 10 to 20 cell and gene therapy (CGT) approvals per year by 2025, the need for continued investment by the FDA in reviewers and staff to support clinical reviews, and much more.

A transcript of her conversation with PC can be found below.

PC: In your opinion, how important is the development of FDA guidance documents for manufacturers, and what areas of CGT development would benefit most from standardization?

Dale: Guidance from the FDA is really critical for these manufacturers. If we think about the cell and gene sector being in its relative infancy, compared to other sectors within the healthcare space, having that guidance from the regulatory agency can help provide clarity and predictability for the manufacturers navigating that early part of their product lifecycle, and can really help them facilitate compliance across the board in their programs.

I think that providing that level of comfort—as well as some guardrails—can help manufacturers feel more confident in the way that they're going about developing and establishing their company around a given asset or portfolio, and it really helps encourage innovation. When we provide some level of structure and framework for these companies, it oftentimes allows them to move more quickly, knowing that they're on the right path, especially for these cell and gene therapies that are complex and could potentially have variability, such as autologous therapies. Having that ability to mitigate risks as much as possible and standardize the processes can really go a long way, not only to ensure safe and effective products as much as possible, but to provide that pathway to success for these manufacturers.