A strong partnership between gene therapy developers and their CDMOs is paramount for any program’s success. Equip yourself with the right questions and collaborate with your CDMO to reduce friction during the development and manufacturing process. Hear from leading gene therapy developers and Forge Biologics as they delve into the key questions they’re asking their partners around yield, commercial readiness, validated scale-down models, automation of analytical assays, and more.
David Dismuke serves as Chief Technical Officer and came to Forge Biologics with more than 15 years of experience in large-scale manufacturing. He is an authority in the bioprocessing and design of gene therapy vectors and has led CMC operations in the manufacturing of pre-clinical and clinical-grade AAV vectors for more than 10 years. Prior to joining Forge, Dr. Dismuke was the Vice President of Manufacturing at StrideBio where he directed the development of manufacturing and analytical processes for AAV vectors that utilize novel capsids. In addition, he led the design of therapeutic and reporter transgenes and innovative molecular enhancements to improve AAV production and therapeutic function. He also served as Head of Vector Production at Voyager Therapeutics, where he led teams in the manufacturing and analytical testing of AAV using the baculovirus/Sf9 production system. Prior to Voyager, Dr. Dismuke was Director of the UNC Vector Core, where he oversaw GMP operations as well as the production of research-grade vectors. He earned his Ph.D. from Vanderbilt University, focusing on the molecular biology and lifecycle of HIV-1, and conducted postdoctoral research at UNC Chapel Hill.
Mr. Maslowski is Chief Commercial Officer at Forge Biologics. He served as the President and Chief Executive Officer of Castle Creek Biosciences, Inc. from January 2020 to March 2021 and served in the same role at Fibrocell Science, Inc. (a NASDAQ rare disease cell and gene therapy company) from 2016 until Fibrocell was acquired in 2019. Prior to the acquisition, Mr. Maslowski served as Senior Vice President of Scientific Affairs and Vice President of Operations of Fibrocell between 2012 to 2016. Mr. Maslowski has extensive experience in the field of cell and gene therapy, including advancing D-Fi, a genetically modified autologous fibroblast therapy, to pivotal clinical trials, and LAVIV ®, a non-modified autologous fibroblast therapy, through U.S. FDA approval and commercialization. Mr. Maslowski also serves on the board of Alliance for Regenerative Medicine, the scientific advisory board of Castle Creek Biosciences, and the advisory board of Life Science Cares Philadelphia. Mr. Maslowski previously served as the Chairman of the board of directors of Falcon Therapeutics, a privately held Durham, N.C. company focused on the development of cell therapy products for oncology, from 2019 to 2021, and on the board of directors of Castle Creek Biosciences and Fibrocell from 2016 to 2021. Mr. Maslowski has 20+ years of experience in pharmaceutical and biologics development at major pharmaceutical companies including Wyeth Pharmaceuticals, Merck & Co., Inc., and Teva Pharmaceuticals Industries Ltd. Mr. Maslowski received his B.S. in biology from Ursinus College and his M.S. in microbiology from Villanova University.
Jenny Holt, PMP, is an experienced biotech and pharmaceutical executive with more than 25 years of experience primarily in gene therapies, ophthalmology, and oncolytic viral research. She is a graduate of UC Santa Barbara. Her first roles included scientist positions at UCSF Gladstone Institutes, Onyx Pharmaceuticals, and Novartis Institute of Biomedical Research. Most recently Jenny was head of project management at 4D Molecular Therapeutics, a leading AAV-based gene therapy company, where she managed five gene therapy products from discovery to early-stage clinical development. Jenny also was a co-founder/advisor at Ignite Immunotherapy which was purchased by Pfizer in 2019.
Karen Kozarsky has 25+ years of experience in gene therapy, with a primary focus on the development of therapies for inherited rare diseases, utilizing adeno-associated virus (AAV) vectors. Karen has deep experience evaluating potential therapeutic opportunities, identifying new areas, and developing products from the earliest preclinical stages through IND.
She has been involved in the development of multiple gene therapy products that are in clinical trials. Previously, Karen was President of Vector BioPartners, Vice President of R&D at REGENXBIO Inc., and Head, Gene Therapy in the GlaxoSmithKline Biopharmaceutical Center of Excellence for Drug Discovery. Prior to that, she was a Research Assistant Professor at the University of Pennsylvania in the Institute for Human Gene Therapy and completed postdoctoral fellowships at the University of Michigan in gene therapy and in immunology.
Karen was named by the Alliance for Regenerative Medicine as the first co-Chair of the Gene Therapy Section to support policies to advance novel gene therapies and has been a committee member for the American Society of Gene & Cell Therapy. She received a PhD in biology from the Massachusetts Institute of Technology and a BA in biology from Amherst College.
Arsalan Arif is a news media entrepreneur who set out in 2015 to build his vision of an independent biotech news company at Endpoints News.