The Value of Workforce Development and Advanced Data Tools

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: You mentioned the need for continued investment by the FDA in staff to support clinical reviews. What are some specific areas where this investment could have the greatest impact in accelerating approval timelines?

Dale: Investment by the FDA mirrors what we try to see in terms of investment needed on the manufacturing side of things, specifically in terms of the training and development of the workforce. Coming back to that again, these therapies are very novel and complex, and we need a partner, as a manufacturing organization and as a regulatory agency. This consists of really partnering to understand, and training, developing, and investing in the workforce so that ultimately, we can become more proficient, not only in the development but through the reviewers’ lens as well, and expanding the review team.

The FDA has made publicly available statements in terms of their commitment to increasing the workforce. The more that they can expand their teams, the more throughput there's going to be, the more opportunity for collaboration between the manufacturers and the agency. Having that increased volume, coordination, and communication between both parties, I think can only help to expedite the pathway to market. I also think that the development of advanced data analysis tools can be really helpful here.

Looking at very complex clinical data, advancing the technology that can help these reviewers get through data analysis, and really understand the clinical trial data more efficiently and effectively, can help expedite some of the review as well. Continued investment in the regulatory pathways and just development of potentially expedited pathways, or just alternative ways more to engage with the manufacturers more [are also important]. We know that the RMAT (regenerative medicine advanced therapy) designation has been a huge factor for a lot of companies to pursue that and open up additional engagement with the FDA, so I think a continued investment in those areas can really go a long way.