COLUMBUS, Ohio–(BUSINESS WIRE)– Forge Biologics, a leading manufacturer of genetic medicines, announced today that it has joined the Bespoke Gene Therapy Consortium (BGTC), a public-private collaboration to accelerate the delivery of promising 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 the 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 National Institutes of Health (NIH), the U.S. Food and Drug Administration (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 Christopher Shilling, Senior Vice President of Regulatory Affairs and Quality. “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, Ph.D., 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.”
About the Bespoke Gene Therapy Consortium
The Bespoke Gene Therapy Consortium (BGTC) is part of the Accelerating Medicines Partnership® (AMP®) program, a public–private partnership among the NIH, the U.S. Food and Drug Administration (FDA), multiple pharmaceutical and life sciences companies, and nonprofit and other organizations. The AMP program, which is managed by the FNIH, aims to improve current models for developing diagnostics and therapies. The BGTC is establishing platforms and standards to speed the development and delivery of customized or “bespoke” gene therapies that could treat millions of people affected by rare diseases, including diseases too rare to be of commercial interest. The BGTC is the first AMP initiative focused on rare diseases and the sixth AMP initiative overall. It also is the first to focus on a therapeutic platform. To learn more, visit https://fnih.org/our-programs/AMP/BGTC.
About the Foundation for the National Institutes for Health
The Foundation for the National Institutes of Health (FNIH) connects the world’s leading public and private organizations to accelerate biomedical breakthroughs for patients, regardless of who they are, where they live, or what disease they have. Together with leading scientists and problem-solvers, and a successful track record of navigating complex problems, the FNIH accelerates new therapies, diagnostics, and potential cures; advances global health and equity in care; and celebrates and trains the next generation of scientists. Established by Congress in 1990 to support the mission of the NIH, the FNIH is a not-for-profit 501(c)(3) charitable organization. For more information about the FNIH, please visit fnih.org.
About Forge Biologics
Forge Biologics is a hybrid gene therapy contract manufacturing and clinical-stage therapeutics development company. Forge’s mission is to enable access to life-changing gene therapies and help bring them from idea to reality. Forge’s 200,000 square foot facility, the Hearth, utilizes 20 cGMP suites in Columbus, Ohio, to serve as its headquarters. The Hearth is a custom-designed cGMP facility dedicated to AAV manufacturing and hosts scalable, end-to-end manufacturing services. Offerings include process and analytical development, plasmid DNA manufacturing, viral vector manufacturing, final fill, as well as regulatory consulting support to accelerate gene therapy programs from preclinical through clinical and commercial stage manufacturing. By taking a patients-first approach, Forge aims to accelerate the timelines of these transformative medicines for those who need them the most. To learn more, visit www.forgebiologics.com.
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