May 6-7, 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.
Kim Carnes has 19 years of work experience in the biotechnology field with 16 of those years spent in Quality Assurance operational and compliance roles. She has worked at Celera Genomics, Human Genome Sciences (HGS), and GlaxoSmithKline (GSK) supporting both clinical and commercial biotechnology products. In her current role at REGENXBIO, a gene therapy company, she has responsibility for implementing Quality Systems and overseeing compliance for GXP activities.
Lori Daane is the Director of Scientific Affairs at bioMérieux and has experience in clinical, environmental and industrial microbiology. She is a technical expert on rapid and alternative methods and provides scientific support to the Healthcare Business in North America. Lori received her Ph.D. from the University of Minnesota in Microbial Ecology. She also holds a Master’s degree in Limnology from the U of MN and a Bachelor’s degree in Medical Technology from Ferris State University.
Eden Fucci is Vice President of Biologics Manufacturing at Torque. Eden was previously the Senior Director of CMC at Aeglea Biotherapeutics, where he led process development, manufacturing, and supply chain for clinical studies and drove the early and late stage strategy for product development. Prior to that, Eden was Senior Director of Drug Product Manufacturing and Supply Chain at Aldeyra Therapeutics, which included responsibility for program management and business development; Director of Supply Chain at Alexion Pharmaceuticals (via acquisition of Synageva Biopharma), where he was responsible for strategic oversight of global commercial outsourced manufacturing; and CMC leadership positions at Pall Corporation, Eli Lilly, and Johnson & Johnson. He holds an M.S. in Biotechnology Enterprise and Entrepreneurship from Johns Hopkins University and a B.S. in Biology from Pennsylvania State University.
Michael Kuczewski is the Associate Director of oncology CMC at bluebird bio and leads the bb2121 CMC team. Previous roles at bluebird include Vector Purification Process Development and Manufacturing Sciences and Technology. Prior to joining bluebird bio, Michael led purification process development for biosimilars at PERCIVIA, LLC, and was an applications development engineer for viral filtration at Millipore Corp. He holds a BS in chemical engineering from WPI.
David Smith leads the Innovation & Engineering Center at Hitachi Chemical Advanced Therapeutics Solutions’ with the drive to develop, evaluate and provide novel technology solutions in order to realize commercial success of cell therapies. Before joining the company in 2015, David completed his PhD at Loughborough University establishing Quality by Design principles within cell therapy manufacturing with an interest in Process Analytical Control. Prior to this, David completed a Masters in Biochemical Engineering based at University of Bath, along with extensive periods at UNSW, Australia and DSM, Netherlands. This interdisciplinary background allows David to enhance the robustness and reproducibility of processes whilst analyzing costs and sustainability to supplement Hitachi Chemical Advanced Therapeutics Solutions’ Development by Design paradigm.