May 8, 2019, Long Beach, CA
Michael Blackton is responsible for the global quality organization at Adaptimmune inclusive of Quality Control, Analytical Development, Quality Assurance, and Quality Lifecycle Management spanning sites in the Philadelphia Navy Yard and Oxford, UK. Michael's career spans over 25 years in biotechnology, medical device and pharmaceuticals where he has held leadership positions in manufacturing, quality, operations, and engineering. Prior to joining Adaptimmune, he spent 11 years with Eli Lilly and Company and ImClone in roles of increasing responsibility directing facilities maintenance operations, qualification, cleaning validation, multi-product strategies, regulatory documentation, and technology transfer initiatives supporting a portfolio of products and approvals, including CYRAMZA® (ramucirumab). Prior to joining Lilly, Mr. Blackton served in various quality management roles at Millennium Pharmaceuticals and Inhale Therapeutics. He earned his Master of Business Administration degree from New York University.
Dr. Hawkins is Chief Technology Officer at Pluristyx, Inc, which provides Ready-to-Differentiate, Ready-to-Use Pluripotent Stem Cells, cell line contract development and manufacturing services, and knowledge support to companies in the field of drug development, regenerative medicine, and cellular therapies. Dr. Hawkins received his Ph.D. in Molecular Cell Biology and Biotechnology from Virginia Tech and completed his postdoctoral training at the University of Pennsylvania. He began his career as an assistant professor and founding member of the Mitochondria and Metabolism Center in the University of Washington School of Medicine, where he investigated how alterations in cell metabolism influence both health and disease. Dr. Hawkins transitioned to industry in 2014 and served as Scientific Applications Director at BioLife Solutions, where he applied cell metabolism expertise to the study of cryopreservation, and helped guide numerous academic and industrial groups on steps to optimize cryopreservation processes for multiple cell types. Dr. Hawkins is currently President-elect of the PDA Pacific Northwest Chapter and team lead on the PDA Cryopreservation Standards Task Force, and is active in the PDA Biopharmaceutical Advisory Board and PDA Letter Editorial Committees. He retains an affiliate faculty position in the Department of Anesthesiology and Pain Medicine at the University of Washington.
Peter Makowenskyj has over 13 years of experience in pharmaceutical and biopharmaceutical industries. Peter held various technical roles in process solutions for the biotech industry prior to moving into management positions in technical and sales roles. He has extensive knowledge of bioprocess manufacturing and helped design new facilities and retrofit existing facilities with single use technologies. Peter joined G-CON Manufacturing in 2016 where he now consults with clients in the design of their facilities utilizing G-CON’s pre-fabricated autonomous clean rooms.
Peter received his Bachelor of Science in Chemical Engineering and a Minor in Biomedical Engineering from Cornell University. He received is M. Eng in Chemical Engineering from Cornell University.
Dr Veronica Fowler is the Senior Virologist within the Centre of Expertise for Adventitious Viral Agents (CoE-AVA) at Merck/MSD. CoE-AVA operates under three viral control pillars: “Prevention, Detection and Response and Recovery”. Veronica leads the “prevention pillar” responsible for designing and implementing evidence based viral mitigation strategies. Fundamental to viral mitigation, Veronica is responsible for designing and executing end-2-end viral risk assessments for existing and pipeline products including assessing the raw materials, cell banks/viral seed stock qualification and manufacturing process including the capacity to detect and remove viruses. In addition to this, Veronica is a virology technical expert providing global support to regulatory teams and works alongside the group director to develop the future viral prevention vision within Merck/MSD. Veronica has a PhD in Virology obtained in 2006 from the Royal Veterinary College, and prior to joining Merck/MSD in 2017 Veronica spent 15 years as a research scientist leading global translational projects in the field of vaccines and diagnostics for the most infectious viral diseases on Earth.
Dominick A.Vacante, Ph.D. has been with Janssen R&D, LLC since 2009 and is a subject matter expert in virology, TSEs and mycoplasamas, providing support for pharmaceutical development and marketed products. He has responsibility for CMC strategy, viral clearance, cell banking and testing, and development of monoclonal antibody and microbial products. Prior to that, he was at Ceregene, Inc. developing gene therapy products for neurological diseases leading process development, the contract manufacture of viral vectors, DNA plasmids and delivery devices; in-house quality control, assay and vector development. Prior to that, he was at BioReliance developing new assay technologies, starting up a viral contract manufacturing facility and process development. Earlier in his career at BioReliance, he was study director for virus detection assays, virus clearance studies and virus production. Prior to that, he was at the National Institute of Neurological Diseases and Stroke in the Infectious Diseases Branch researching the molecular neurovirology of human polyomaviruses (JCV, BKV) and HIV. He earned his Ph.D. degree in biochemistry from the University of Illinois in Chicago and his B.A. degree in biochemistry and molecular biology from Northwestern University.