Forge Biologics Creates an Independent Scientific and Manufacturing Advisory Board, Comprised of a Panel of Gene Therapy Industry Leaders

  • Gene therapy industry leaders bring expertise in gene therapy development and manufacturing to promote Forge’s proprietary technologies, customer offerings and pipeline development from preclinical to commercialization

COLUMBUS, Ohio, May 18, 2022–(BUSINESS WIRE)–Forge Biologics, a contract development and manufacturing organization specializing in gene therapies, today announced the creation of an independent committee of leading experts, the Scientific and Manufacturing Advisory Committee. Advisory Board, SMAB), in order to advise the Company on its gene therapy manufacturing offers as well as on the development of its pipeline of therapeutic products. The committee will fulfill the traditional functions of a scientific advisory board, with a distinct and strategic focus on advancements in manufacturing.

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Credit: Forge Biologics

“We are delighted and honored to have brought together such a renowned group of experts in the field of gene therapy development and manufacturing, to work with us to deliver quality products to our customers, especially at the time where we will accelerate the production of AAVs, thanks to our new 5,000 liter bioreactor,” said Timothy J. Miller, Ph.D., CEO and co-founder of Forge Biologics. “The committee’s recommendations will allow us to focus on our mission to manufacture potentially life-saving therapies for patients suffering from genetic diseases. »

Members of Forge’s Scientific and Manufacturing Advisory Committee include:

  • Steven J. Gray, Ph.D., Associate Professor, Department of Pediatrics, University of Texas Southwestern Medical Center (UTSW). Dr. Gray is director of the Viral Vector Center at UTSW. He has specialized skills in the design of vectors for adeno-associated virus (AAV) gene therapies, as well as in the optimization of approaches intended to deliver a gene to the nervous system. Additionally, his research focuses heavily on the development of AAV-based treatments for neurological diseases, several of which have been tested in clinical trials.

  • Robert Kotin, Ph.D., executive and scientific co-founder of Stealth Newco; scientific co-founder of Generation Bio and Frontera Therapeutics; vice president of production at Voyager Therapeutics. Dr. Kotin is a leading expert in the field of AAV gene therapy manufacturing, and the co-inventor of the baculovirus-based AAV production system. He joined Voyager from the National Heart, Lung and Blood Institute of the National Institutes of Health, where he held positions of increasing responsibility for more than 20 years, most recently as Principal Investigator and Laboratory Director. Previously, Dr. Kotin served as the Gene Therapy Program Manager at VAA at Genetic Therapy, and as a Principal Investigator in the Medical Research Division at Lederle Laboratories.

  • Karen Kozarsky, Ph.D., co-founder and chief scientific officer of SwanBio Therapeutics. Dr. Kozarsky has over 25 years of experience in the field of gene therapies, with a specialization in the development of gene therapies for inherited rare diseases, using AAV vectors. She participates in the development of multiple gene therapy products, which are currently undergoing clinical trials. Previously, Dr. Kozarsky was President of Vector BioPartners, Vice President of R&D at REGENXBIO Inc., and Head of Gene Therapies at the Center of Excellence for Drug Discovery at GlaxoSmithKline Biopharmaceutical.

  • Haiyan Ma, Ph.D., Scientific Director of Northern Biomolecular Services. Dr. Ma is a scientific leader with over 30 years of experience in academic laboratories, in the pharmaceutical industry and in contract research. She has extensive experience in the fields of molecular and cellular biology, gene and cell therapy applications, DNA, RNA and protein bioanalysis, and virology. She spearheaded the establishment of a GLP-compliant molecular biology laboratory, and has acted as study director or collaborating scientist in over 150 studies.

  • Simon N. Waddington, Ph.D., professor of gene therapy at University College London. Dr. Waddington’s research spans viral and non-viral vector gene therapies. He has published articles on the biology of adenoviruses, AAVs and lentiviruses in journals Cell, Nature Medicineet Science Translational Medicine. Some of the fruits of this labor are in late-stage clinical trials.

The committee will advise Forge’s management on strategic direction and objectives, particularly in the areas of manufacturing, as well as the development of scientific or therapeutic programs.

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“The clinical gene therapy landscape is constantly changing, and we look forward to working alongside our committee members to ensure that we are observant, thoughtful, and agile in our responses to changes in the field,” said Erandi De Silva, Ph.D., co-founder and senior vice president of product development at Forge. “We are working to effectively build strategies to overcome barriers to the efficient manufacture and development of gene therapies, and the recommendations of this group will be extremely valuable.” »

About Forge Biologics

Forge Biologics is a hybrid company focused on the contract manufacturing of gene therapies, and the development of clinical-stage therapies. Forge’s mission is to enable access to breakthrough gene therapies, and to help bring them to fruition. Forge is headquartered in The Hearth, a 200,000+ square foot site in Columbus, Ohio. A custom-designed cGMP facility specializing in AAV vector manufacturing, The Hearth will house end-to-end manufacturing services to accelerate gene therapy programs from preclinical to clinical and commercial. By adopting a patient-centric approach, Forge aims to speed up the process, so that those who need it most can benefit from these medical advances as soon as possible. To find out more, see www.forgebiologics.com.

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Contacts

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