Akron Biotech, a leading developer and manufacturer of cGMP-compliant ancillary materials for cell and gene therapy development and commercialization, today announces the appointment of a new Scientific Advisory Board.
The board is comprised of world-leading scientists and experts in the cell and gene therapy field. It will provide additional guidance and support on commercial growth strategies and scientific technologies for Akron Biotech to continue to lead the supply of ancillary materials for the rapidly evolving cell and gene therapy sector.
The Akron Scientific Advisory Board appointments are:
Dr. Mark Bonyhadi, PhD is a Senior Advisor at Qiming Venture Partners USA, in Seattle, WA. Prior to joining Qiming USA in December of 2018, Dr. Bonyhadi held positions of Vice President of Research, Head of Academic Affairs, and Vice President of Process Research Sciences from 2013-2018 at Juno Therapeutics (acquired by Celgene Corporation). Dr. Bonyhadi’s focus for over 20 years has been to drive the development of bench-based ideas and early phase clinical studies into the commercialization of novel cell therapies. His special interests include gene-modified T cells, hematopoietic stem cells, new technologies for cell processing/manufacturing, as well as technologies that can correlate cell characteristic from collection through formulation and clinical outcome.
Sylvia Daunert, PharmD, MS, PhD is the Lucille P. Markey Chair of Biochemistry and Molecular Biology at the Miller School of Medicine and the Director of the JT Macdonald Foundation Biomedical Nanotechnology Institute of the University of Miami. Dr. Daunert was the Gill Eminent Professor of Chemistry and Professor of Pharmaceutical Sciences at the University of Kentucky. Dr. Daunert was also a Distinguished Professor of the College of Arts & Sciences and a University of Kentucky Research Professor. Dr. Daunert’s research focuses on the development of bio-inspired nanotechnologies to solve biomedical and environmental problems. Her group genetically engineers living cells and proteins for environmental detection, molecular sensing, molecular diagnostics, point-of-care tests, biomarker identification, and drug delivery. Additionally, the research of the group focuses on the development of targeted and responsive drug delivery systems. Dr. Daunert’s work has been featured in over 300 publications, patents, and highlighted by the scientific media and popular press. Dr. Daunert was elected to the Real Academia Nacional de Farmacia of Spain and is an Academic D’Honor of the Reial Acadèmia de Farmàcia de Catalunya. In 2015, Dr. Daunert received the title of Ilustrísima Doctora and in 2016 the title of Excelentísima Doctora from the Kingdom of Spain. Finally, in 2018 Dr. Daunert was awarded a Professorship at the Institute of Hematology and Blood Diseases of the Chinese Academy of Medical Sciences and the Peking Union Medical College.
Dr. Bruce Levine, PhD, Barbara and Edward Netter Professor in Cancer Gene Therapy, is the Founding Director of the Clinical Cell and Vaccine Production Facility (CVPF) in the Department of Pathology and Laboratory Medicine and the Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania. Dr. Levine has overseen the production, testing and release of 3,000 cellular products administered to more than 1,300 patients in clinical trials since 1996. He is co-inventor of the first FDA-approved gene therapy (Kymriah), chimeric antigen receptor T cells for leukemia and lymphoma, licensed to Novartis. Dr. Levine is co-inventor on 28 issued US patents and co-author of over 180 manuscripts and book chapters with a Google Scholar citation h-index of 90. He is a Co-Founder of Tmunity Therapeutics, a spinout of the University of Pennsylvania. Dr. Levine is a recipient of the William Osler Patient Oriented Research Award, the Wallace H. Coulter Award for Healthcare Innovation, the National Marrow Donor Program/Be The Match ONE Forum 2020 Dennis Confer Innovate Award, serves as President of the International Society for Cell and Gene Therapy, and serves on the Board of Directors of the Alliance for Regenerative Medicine.
Dr. Jerome Ritz, MD is an Executive Director of Connell and O’Reilly Families Cell Manipulation Core Facility and a Professor of Medicine at Dana-Farber Cancer Institute, Brigham and Women’s Hospital and Harvard Medical School. Dr. Ritz’s laboratory focuses on the assessment of donor immune function after allogeneic hematopoietic stem cell transplantation (HSCT) and characterization of immune mechanisms responsible for graft versus leukemia (GVL) and graft versus host disease (GVHD). These laboratory studies have led to new clinical approaches to enhance GVL and prevent or treat GVHD and further laboratory studies to assess the immunologic effects of these new treatments. His laboratory study also incorporates other novel immune therapies for hematologic malignancies. These include cytokines, checkpoint inhibitors, cancer vaccines and adoptive cellular therapies such as CAR-T cells and activated NK cells. Dr. Ritz is also the Executive Director of the Connell and O’Reilly Families Cell Manipulation Core Facility at DFCI. This GMP cell manufacturing facility supports both adult and pediatric hematopoietic stem cell transplant programs at DFCI, Brigham and Women’s Hospital and Boston Children’s Hospital and provides a variety of novel cellular products for patients enrolled on clinical trials at DFCI and affiliated hospitals. This facility is a critical resource for both academic investigators and industry sponsors interested in developing innovative cellular therapies.
Dr. Isabelle Rivière, PhD is the Director of the Michael G. Harris Cell Therapy and Cell Engineering Facility at Memorial Sloan Kettering Cancer Center (MSK), New York, NY. During her graduate studies at the Whitehead Institute in Cambridge, MA, she developed MFG/SFG based retroviral vectors for in vivo long-term expression of transgenes in hematopoietic cells which are widely used in clinical studies worldwide. After completing her postdoctoral work at NYU, she joined the faculty of MSK in 1999 where she focuses on developing novel strategies for cell therapies and immunotherapies. Her laboratory investigates genetic approaches to enhance various cell types including T lymphocytes and stem cells for the treatment of cancer and genetic blood disorders. Over the past 20 years, she has conceived and implemented multiple gamma-retroviral vector, hematopoietic and T cell manufacturing processes for several Phase I/II clinical trials. Her lab currently supports multiple CAR T cell-based clinical trials for the treatment of hematological malignancies and solid tumors. She also investigates immunological functions of CAR T cells in clinical trials and animal models. She has served as member of the Board of Directors of the American Society of Gene and Cell Therapy (ASGCT) and the Alliance for Regenerative Medicine (ARM). She currently serves on the Advisory Board of the Center for Commercialization of Cancer Immunotherapy C3i (Canada) and the National Science Foundation (NSF) Engineering Research Center (ERC) for Cell Manufacturing Technologies (CMaT). She is Scientific Co-founder of Juno Therapeutics Inc.
The new board will be chaired by Dr. Anthony Davies, Chemical Engineer, Molecular Biologist and expert in the cell and gene therapy field for over 20 years. Dr. Davies is the Executive Chairman of Dark Horse Consulting, a boutique consulting practice which focuses on strategic CMC and product development issues in cell and gene therapy. Dr. Davies has led the process development of multiple live-virus gene therapy products, at scales ranging from bench through multi-thousand litres in pre-commercial mode. During his time at Onyx Pharmaceuticals, Dr. Davies was involved in the development of the kinase inhibitor BAY 43-9006, now better known as Nexavar, a cancer drug approved worldwide which reached >$1B sales in 2012. At Geron Corporation, Dr. Davies served as Vice President, Product Development and was responsible for all cell therapies’ process and analytical science and manufacturing, including both autologous and allogeneic products. During his tenure, the world’s first IND for a human embryonic stem cell-derived product was successfully filed with the FDA and tested in a human clinical trial. More recently, while Dr. Davies was Chief Technology Officer at Capricor Therapeutics, a large, randomized, placebo-controlled clinical trial for an allogeneic cardiac stem cell product was initiated. The company later became publicly traded by reverse merger, and a CMC-focused collaboration agreement was executed with Janssen Biotech, Inc. worth up to $325M.
Akron Biotech is a leading materials manufacturer and services provider to the regenerative medicine industry. An ISO 13485-certified company operating in line with cGMP guidelines and international standards, Akron leverages more than 100,000 square feet of development and manufacturing capacity to provide advanced therapy developers the scale, compliance, and regulatory support necessary to drive novel treatments from discovery to commercialization. For more information, please visit www.akronbiotech.com.
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