Steve Kozlowski

Keynote Speaker
Director, Office of Biotechnology Products, FDA

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

Keynote Speaker
Vice President, Regulatory Policy and International Operations, Roche Pharmaceutical Group

Wassim Nashabeh, PhD, the global head of technical regulatory policy and strategy at Genentech, has joined the Editorial Advisory Board of BioPharm International. Wassim Nashabeh received his PhD in analytical chemistry from Oklahoma State University in 1993, and his post-doctoral fellowship from the Barnett Institute of Chemical and Biological Analysis at Northeastern University, where he developed new approaches for the separation of closely related recombinant protein variants. He joined PerSeptive Biosystems as a senior scientist from 1994–1996, where he codeveloped new schemes for antibody modification with fluorescent and enzymatic labels for use in microfabricated chip-based immunoassays.
In 1996, Nashabeh joined Genentech (A member of the Roche Group) as a scientist, and has since held several positions of increasing responsibilities, most recently global head of technical regulatory policy and strategy for the Roche Pharma Group. His current responsibilities include the development of global innovative regulatory strategies.
Nashabeh is a member of the expert working group for the International Committee on Harmonization representing the BIO organization on quality topics. He also is a member of the Board of Directors of CASSS, co-founder and chair of the International Symposium of CE in the Pharmaceutical and Biotechnology Industries, a permanent committee member of the CMC Strategy Forum conference series, co-founder of the CMC Forum Europe Conference Series, and a member of the program committee for the WCBP conference series.

Katy Stein

Principal, Kathryn Stein Consulting; formerly Director of the Division of Monocolonal Antibodies FDA and SVP Product Development and Regulatory Affairs, Macrogenics

Stein is an immunologist with over 30 years of experience in biotechnology as a senior manager at the FDA and as an executive in industry. She is an expert in the field of polysaccharide-protein conjugate vaccines and monoclonal antibodies. During her 22 years at the FDA, the last 10 as the first Director of the Division of Monoclonal Antibodies, Dr. Stein was a leader in developing policies to regulate polysaccharide-protein conjugate vaccines, monoclonal antibodies and other recombinant DNA-derived products. She was lead or co-author on all of the guidance documents published by the FDA with respect to monoclonal antibodies and a co-author of the FDA guidance on comparability. Dr. Stein was one of the approving officials for the Haemophilus influenza type b (Hib) vaccines for routine use in infants. She was a member of the review committee of the first approved monoclonal antibody, OKT3™, and one of the approving officials for the subsequent 15 monoclonal antibodies approved through the first half of 2002, including abciximab, rituximab, palivizumab, trastuzumab, infliximab, and alemtuzumab. Dr. Stein received numerous awards for her review and policy work at the FDA. She was the 2014 recipient of the John and Samuel Bard Award in Medicine and Science from Bard College, Annandale-on-Hudson, NY. In 2002, Dr. Stein left the FDA to join MacroGenics where she was responsible for establishing the Product Development and Regulatory Affairs, Project Management, Quality and Manufacturing departments. She served as Senior Vice President, Product Development and Regulatory Affairs until 2016. Under Dr. Stein’s leadership during her 14 year tenure, MacroGenics brought eight products into the clinic, seven of them newly developed by MacroGenics and one in-licensed as a phase 2/3 asset. Dr. Stein received a BA in chemistry from Bard College and a PhD in microbiology and immunology from the Sue Golding Graduate Division of the Albert Einstein College of Medicine. Prior to joining the FDA, she was a post-doctoral Fellow at Harvard with Dr. Harvey Cantor and at NIH with Dr. William Paul. At FDA she was a Staff Fellow, Senior Investigator, and the first Director of the Division of Monoclonal Antibodies, Office of Therapeutics Research and Review, CBER, FDA. She maintained a research laboratory for her entire 22 year career at FDA and was a leading investigator in polysaccharide-protein conjugate vaccines. She has over 60 peer-reviewed publications.

Patrick Swann

Vice President, Quality Science and Technology, Amgen

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


Northeastern University
Interdisciplinary Science
and Engineering Complex (ISEC)
805 Columbus Ave.
Boston, MA 02118

September 7, 2018