Tackling Gaps in Manufacturing, Funding, and Expertise

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 approvals (CGT) 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: What are the key challenges currently preventing the United States from meeting the FDA’s forecast of 10 to 20 CGT approvals per year by 2025, and how can these be addressed?

Dale: So really, I think partially the complexity of development and manufacturing of these therapies— there's incredible complexity to understanding how to not only manufacture and scale according to different patient populations that need to be targeted, so navigating some of those challenges from the development and manufacturers perspective, but then also understanding what the regulatory hurdles may be. How do we effectively understand the outcomes that we're trying to study in the clinical trial setting that ultimately will help us achieve a regulatory filing approval and eventual launch?

Navigating some of those regulatory hurdles through communication with the agency is really key as well. I mentioned the clinical trial challenges—I think having that dialog between the manufacturers and the agencies, from pre-clinical development through clinical development, and ultimately gearing toward that regulatory filing, makes a big difference in trying to expedite that pathway to market, and really understanding what the criteria are going to be, so that we can proactively try to mitigate those challenges and risks.

There's also COVID. COVID did a number on the entire sector. We really saw a decrease in financing and funding available. We know that these therapies are incredibly complex and require a high cost of investment to develop and ultimately achieve a commercial launch. Navigating funding hurdles as well has been a challenge, and I think really slowed some of the progress to an extent. And then finally, I think the workforce and expertise shortages come into play here. As a sector, the cell and gene sector is still relatively in its infancy stages, and so finding folks that have had an opportunity to work through the development and commercialization, both on the manufacturing side and from the regulatory agencies perspective as well, just to understand these therapies, and ultimately, how to develop and commercialize them. I think all of those things have really factored into why we haven't yet achieved the goal, but the exciting part is, I see a lot of progress being made in each of these areas that hopefully will start to see us catch up to that goal a little bit more quickly here in the near future.