Steve Kozlowski, MD
Director, Office of Biotechnology Products, US Food and Drug Administration
Dr. Kozlowski is Director of the Office of Biotechnology Products, Office of Pharmaceutical Science, at the Center for Drugs Evaluation and Research, FDA. He received his medical degree from Northwestern University and trained in pediatrics at the University of Illinois. Prior to joining the FDA, Dr. Kozlowski worked as a staff fellow in the Molecular Biology Section of the Laboratory of Immunology, NIAID, NIH. He studied the immune responses to proteins and peptides during his fellowship.
Dr. Kozlowski joined the Division of Monoclonal Antibodies in 1993 and was tenured as Senior Investigator in 2000. He has been involved in all phases of the regulatory process as a reviewer, from pre-IND product development through inspections, licensing, and post-approval supplements. Dr. Kozlowski served as acting Director of the Division of Monoclonal Antibodies from 2004 to 2005. He has also served as an instructor and as an adjunct clinical reviewer at the FDA. Dr. Kozlowski’s research interests include the effects of drugs on the immune system. He has been very involved in promoting Quality-by-Design approaches for the manufacture of biopharmaceutical products.
Wassim Nashabeh, PhD
Vice President, Regulatory Policy and International Operations, Roche Pharmaceutical Group
Katy Stein, PhD
Principal, Kathryn Stein Consulting
Former Director, Division of Monocolonal Antibodies, US Food and Drug Administration and Senior Vice President, Product Development and Regulatory Affairs, Macrogenics
Pamela M. Klein, MD
Principal, PMK BioResearch
Former Chief Medical Officer, Intellikine (acquired by Millennium/Takeda) and Vice President, Development, Genentech
Patrick Swann, PhD
Vice President, Quality Science and Technology, Amgen
Former Vice President, CMC Regulatory Affairs, Biogen and Deputy Director, Division of Monoclonal Antibodies, US Food and Drug Administration
Patrick Swann is Vice President of Quality Sciences and Technology (QS&T) at Amgen. QS&T encompasses multiple Quality functions including oversight of commercial specifications, stability programs, comparability strategy, annual product review, data sciences, nonconformance investigations, inspection preparation and Quality Control/Assurance for clinical and commercial products produced at Amgen’s Thousand Oaks facility. Previously, he held positions at Biogen including leadership of the Global Regulatory CMC group and the Analytical Development group. Prior to joining industry, Patrick served for 15 years at the U.S. FDA including roles as the Deputy Director of the Division of Monoclonal Antibodies and deputy topic lead for FDA on the ICH Q11 Expert Working Group. He obtained his Ph.D. in pharmacology from the University of Illinois at Chicago. He has presented at numerous international conferences on topics including Quality by Design, process validation, and bioanalytical method development/validation.
October 9, 2018
and Engineering Complex (ISEC)
805 Columbus Ave.
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September 7, 2018