May 9-10, 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.
Chris has over thirty years experience in the development, manufacturing, and quality control of clinical and commercial biopharmaceutical products, as well as in vitro diagnostics. He led teams in process improvement, technology transfer, manufacturing, quality improvement, facility design, CMC reviews, and validation of processes, equipment, and facilities. As a site head, he had responsibility for operational success, quality policy, and maintaining regulatory licenses. He has worked on 30 large-molecules (antibodies, vaccines, and peptides) and 10 small-molecules, from Preclinical to Phase IV. Since joining PDA in 2001 he has contributed to the Biotech Advisory Board, the Biotech Interest Group, and many Task Forces with fondest memories of getting TR42 published. Chris holds a PhD in Chemical Engineering from William Marsh Rice University and a BA in Chemistry with emphasis in Biochemistry from the University of California at San Diego.
Jody has worked in various Regulatory Affairs roles for more than 25 years, supporting pharmaceutical product development, approval, and life-cycle management. Her experience includes small molecules, biologics, and vaccines; she was involved in the initial licensures of Remicade and Shingrix. Jody is currently leads US Regulatory Policy and Intelligence for GSK Vaccines.
Dr. Bev Ingram is a Senior Director within the Global Regulatory Affairs team supporting the biosimilar products portfolio at Pfizer Inc. She is located at the Manufacturing and Pharmaceutical Science R&D facility in Massachusetts USA where she has a global portfolio development role and global regulatory lead. Bev has been working in the area of biosimilars since 2010 and has engaged with regulatory agencies including FDA, EMA and PMDA regarding a range of biosimilar development topics. She is a highly experienced Regulatory professional with over 20 years industry experience, managing full product life-cycle for small and large molecules and preparing global regulatory submissions including biosimilars, monoclonal antibodies and antibody drug conjugates. She has previously worked for GlaxoSmithKline and Wyeth. She started her scientific career in the pharmaceutical industry supporting development of cell culture processes for the production of therapeutic macromolecules by mammalian and microbial cells, having gained her PhD at the University of Manchester Institute of Science & Technology (UK).
Stephan O. Krause is AstraZenca's Director of QA Technology. Stephan has published many articles in respected industry journals in the US, Europe, and Asia. His bestseller book on risk-based method validation strategies (PDA/DHI Publications, April 2007) won the 2007 PDA Distinguished Author Award. This award recognizes significant contributions to improve industry standards. Stephan won PDA's Fred Simon Award in 2017 for the best article published in 2016, and, won PDA’s Distinguished Service Award in 2018
Stephan is the primary author and task force leader of PDA TR 57 (2012). He is co-author of PDA TR 65 for Tech Transfer (2014), PCMO's task force leader for IMP Specification Setting (2015), and co-chair of PDA’s Biosimilar Conference/Workshops (2016-18). He is a member of PDA's BioAB, RQAB, EAB, and TRI. In 2012 and 2015, Stephan was invited by the OBP/FDA to present industry perspectives to the OBP CMC reviewer teams at FDA's headquarters.
Ms. Duffy has been with Merck since 1988, her entire career in the vaccine manufacturing field. Kim's first position was as a technician in viral vaccine manufacturing and she has held positions in Quality Control, Laboratory Operations, Vaccine Manufacturing, and Regulatory Affairs. Kim joined the Regulatory CMC group in 2007 and has managed global registrations and post-approval changes for a variety of vaccines; specializing in US, Europe, Japan, and China.