Forge Biologics, a CDMO which manufactures genetic medicines, joined the Bespoke Gene Therapy Consortium (BGTC), a public-private collaboration designed to accelerate the delivery of new gene therapies to patients with rare diseases. Forge has appointed Christopher Shilling, senior vice president of regulatory affairs and quality, to represent the company on BGTC’s steering committee.
The BGTC is managed by the Foundation for the National Institutes of Health (FNIH) as part of the Accelerating Medicines Partnership® program, a public-private partnership between the NIH, FDA, biopharmaceutical and life science companies, and nonprofit and other organizations on the consortium, to collectively work towards speeding the process of gene therapy development and manufacturing for rare diseases.
The consortium was formed to help bridge the gap that exists in the current drug development model that makes it difficult for companies to recover the costs required to develop gene therapies to treat patients with rare diseases. By creating a standardized, reusable approach that reduces up-front costs, the BGTC will help to lower development barriers, enabling meaningful advancement against a number of rare diseases.
“Forge has a shared goal with the BGTC of accelerating access of effective genetic therapies to patients with rare diseases. The tools and resources for clinical development, particularly large-scale platform cGMP manufacturing and regulatory evaluation of AAV therapies will provide a much-needed standardized approach, enabling meaningful progress for rare disease gene therapy development,” said Shilling. “Forge is committed to supporting this collaboration with the NIH, the FDA, and like-minded partners on the BGTC, to provide a critical development platform that will enable the future of AAV therapies for patients.”
“As one of the largest AAV manufacturers in the world, Forge Biologics has the necessary industry expertise and manufacturing capacity to be a meaningful partner to the BGTC,” said Courtney Silverthorn, PhD, associate vice president of science partnerships at the FNIH, and program lead for BGTC. “We are certain their knowledge and capabilities will help the BGTC realize its goal of streamlining the drug development process to reduce costs and enable companies to bring more gene therapies to patients.”