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.
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.
Irving Ford is currently the Head of CAR T QC Laboratories at BMS. Irving has over 28 years of QA/QC leadership experience, included consent decree remediation, in the pharmaceutical/biotechnology and cell and gene therapies industries.
Irving is an active participant in various industry groups and has served on the numerous planning committee’s for industry related conferences. Irving is also an author/contributor for PDA Technical Reports, White Paper publications and various Standards setting committees.
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.