COLUMBUS, Ohio--(BUSINESS WIRE)-- Forge Biologics, a gene therapy-focused contract development and manufacturing organization, announced today the formation of an independent board of preeminent experts, a Scientific and Manufacturing Advisory Board (SMAB), to advise the Company on its gene therapy manufacturing offerings and therapeutics pipeline development. The board will serve the traditional functions of a scientific advisory board, with a distinct and strategic emphasis on manufacturing advancements.

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Credit: Forge Biologics

“We are thrilled and privileged to have gathered such a renowned group of experts in gene therapy development and manufacturing to work with us to us deliver quality products to our clients, especially as we accelerate AAV production with our new 5,000L bioreactor,” said Timothy J. Miller, Ph.D., CEO, President, and Co-Founder of Forge Biologics. “The board’s guidance will help focus our mission of manufacturing potentially life-saving therapies to patients suffering from genetic diseases.”

Members of Forge’s inaugural Scientific and Manufacturing Advisory Board include:

• Steven J. Gray, Ph.D., Associate Professor, Department of Pediatrics, University of Texas Southwestern Medical Center. Dr. Gray serves as the director of the UTSW Viral Vector Facility. His core expertise is in adeno-associated viral (AAV) gene therapy vector engineering, followed by optimizing approaches to deliver a gene to the nervous system. His research focus has also been heavily focused in developing AAV-based treatments for neurological diseases, several of which have translated into clinical trials.

• Robert Kotin, Ph.D., Executive and scientific co-founder at Stealth Newco; Scientific co-founder of Generation Bio and Frontera Therapeutics; Vice President of Production, Voyager Therapeutics. Dr. Kotin is a preeminent expert in 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 served for more than 20 years in roles of increasing responsibility, most recently as Senior Investigator and Laboratory Chief. Previously, Dr. Kotin served as head of the AAV gene therapy program at Genetic Therapy and as Senior Research Scientist of the Medical Research Division at Lederle Laboratories.

• Karen Kozarsky, Ph.D., Co-Founder and Chief Scientific Officer, SwanBio Therapeutics. Dr. Kozarsky has over 25 years of experience in gene therapy, with a primary focus on the development of gene therapy for inherited rare diseases utilizing AAV vectors. She has been involved in the development of multiple gene therapy products that are in clinical trials. Previously, Dr. Kozarsky was President of Vector BioPartners, Vice President of R&D at REGENXBIO Inc., and Head of Gene Therapy in the GlaxoSmithKline Biopharmaceutical Center of Excellence for Drug Discovery.

• Haiyan Ma, Ph.D., Director of Science, Northern Biomolecular Services. Dr. Ma is a scientific leader with over 30 years of experience in academic laboratories, pharmaceutical industry, and contracted research. She has a broad background in molecular and cell biology, applications of cell and gene therapy, bioanalysis of DNA/RNA/proteins, and virology. She led the establishment of a GLP compliant molecular biology lab, and served as Study Director or Contributing Scientist in 150+ studies.

• Simon N. Waddington, Ph.D., Professor of Gene Therapy at University College London. Dr. Waddington’s research has spanned viral and non-viral gene therapy. He has published in Cell, Nature Medicine, and Science Translational Medicine on Adenovirus, AAV and lentivirus biology. Some of the fruits of this work are in late-stage clinical trials.

The board will advise Forge leadership on strategic direction and goals, specifically in the areas of manufacturing and scientific or therapeutic program development.

“The landscape for clinical gene therapy is constantly evolving, and we are eager to work with our board members to ensure that we are observant, thoughtful and agile in our responses to the developments in the field,” said Erandi De Silva, Ph.D., Co-Founder and Senior Vice President of Product Development at Forge. “We are striving to effectively build strategies to overcome the barriers to efficient manufacturing and development in gene therapy, and this group’s guidance will be invaluable.”

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 has a 200,000 square foot facility in Columbus, Ohio, the Hearth, to serve as its headquarters. The Hearth is a custom-designed cGMP facility dedicated to AAV vector manufacturing and will host end-to-end manufacturing services 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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