Forge Biologics Emphasizes Role of CDMOs in Shaping Gene Therapy Regulation

A LinkedIn post from Forge Biologics highlights an internal “Hearthside chat” with Scientific and Medical Advisory Board member Maritza McIntyre, Ph.D., focused on experience across the FDA, emerging biotech, and industry. The discussion, as described in the post, emphasizes the potential for industry participants and CDMOs to contribute practical development-stage insights that inform how regulators approach advancing science.

The post suggests that by sharing what is technically and operationally feasible, companies like Forge and their partners may help bridge the gap between innovation and regulation in gene therapy development. Forge is portrayed as investing in the broader field through work on novel technologies and close collaboration with regulators and partners, with an eye toward safely expanding patient access to gene therapies.

For investors, this emphasis on regulatory engagement and development know-how may indicate a strategic focus on de-risking later-stage programs and shortening time to approval for clients. Positioning as a CDMO that actively interfaces with regulators and shapes best practices could strengthen Forge’s competitive standing, potentially supporting revenue growth from sponsors seeking experienced partners in a complex regulatory environment.

If effectively executed, this approach may enhance Forge’s value proposition in the gene therapy supply chain, particularly as regulatory scrutiny of advanced therapies intensifies. It could also create opportunities for deeper, longer-term client relationships and higher switching costs, factors that are often supportive of more resilient margins and a defensible market position in the CDMO segment.