BSc (Hons) in Biochemistry from University of Cape Town. Working in regulatory affairs and clinical development for over 30 years with focus on biological medicines and particular expertise in biosimilars. Joined PAREXEL in 2001 prior to which was with Novo Nordisk Ltd.

Dr. Hillel P. Cohen PhD is Executive Director of Scientific Affairs at Sandoz, helping explain the principles of biosimilars and biosimilar policies to the healthcare community, patient advocacy groups, and health authorities. He has published and given presentations in the areas of biosimilar education, switching, interchangeability, naming and safety. Dr. Cohen led Sandoz efforts for the first biosimilar presentation (Zarxio®) to an FDA advisory committee and participated in both BsUFA 2 and BsUFA3 negotiations on behalf of industry. Hillel is active on the Education Committees including the Biosimilars Council and the Biosimilars Forum. Dr. Cohen received a BA from New York University and a PhD in Biology from Dartmouth.

Steven Kozlowski is the Director of the Office of Biotechnology Products, Office of Pharmaceutical Quality, at the Center for Drugs Evaluation and Research (CDER), FDA. He received his medical degree from Northwestern University and trained in Pediatrics at the University of Illinois. OBP is responsible for the quality review of monoclonal antibodies and most therapeutic proteins at CDER. Dr. Kozlowski is involved in ongoing policy development for biosimilars and advanced approaches for the manufacture of biopharmaceutical products.

Dr. Abernethy has published more than 200 original papers in the general areas of geriatric clinical pharmacology and prediction of adverse drug effects. Following academic positions at Tufts, Baylor College of Medicine, Brown University, and Georgetown, he was in the National Institute on Aging Intramural Research Program, until he joined the FDA in his current position 5 years ago.

Dr. Leah Christl is Executive Director, Global Biosimilars Regulatory Affairs and Regulatory and R&D Policy at Amgen. She serves as head of the global regulatory affairs team within GRAAS with responsibility for development and execution of global regulatory strategy for Amgen’s biosimilars portfolio. Dr. Christl also leads the global biosimilars regulatory and R&D policy with responsibility to develop and advance Amgen’s policy positions. Prior to joining Amgen, Dr. Christl served as the Director of the Therapeutic Biologics and Biosimilars Staff at the US FDA. Dr. Christl received her PhD in Molecular and Cellular Biology and Pathobiology – Marine Biomedicine and Environmental Science from the Medical University of South Carolina.

Dr. Lemery is a Lead Medical Officer (Team Leader) at the Food and Drug Administration within CDER’s Office of Hematology and Oncology Products. Dr. Lemery has been with the FDA for 10+ years and joined the FDA after completing his training in hematology and oncology at the National Institutes of Health.

Dr. McCamish is a physician scientist with a long history of drug, biologic, and biosimilar development in large and small organizations. He is currently Global Head of Biopharmaceutical Development for Novartis biosimilar development housed in Sandoz International.

Laura McKinley is a Director of Regulatory Policy at Pfizer. Laura has been with Pfizer for over 10 years and has extensive experience working on biosimilars. Laura represents Pfizer on industry trade association biosimilar committees and was an industry representative during the initial BsUFA negotiations. Prior to joining the Global Regulatory Policy team at Pfizer, she was a Global Regulatory Lead on biosimilar development teams working to advance the development of Pfizer's portfolio of monoclonal antibody biosimilars. She received her Ph.D. in Pathology from University of Michigan in Ann Arbor, Michigan.

Dr. Brad Jordan is a Head of Regulatory Affairs Policy at Flatiron Health, where his team works to advance the use of Real-World Evidence for regulatory decision-making. Brad was at Amgen for 15 years prior to joining Flatiron, where he led Global Regulatory and R&D Policy for Oncology and for Biosimilars and Biologics.

Dr. Rifkin received his MD from the University of Colorado. He completed his Residency in Internal Medicine and Hematology/Oncology Fellowship at the University of Arizona. Dr. Rifkin is currently in private practice at Rocky Mountain Cancer Centers. He is also a Clinical Associate Professor of Internal Medicine at the University of Colorado, Division of Medical Oncology and serves as an Associate Medical Director for the US Oncology Hematology Research Committee as the lead for Multiple Myeloma. Additionally, he serves as the Medical Director of Biosimilars for McKesson Specialty Health and US Oncology. He oversees clinical research in Biosimilars and participates in strategic development/introduction into the US marketplace.

Dr Daisaku Sato is Director, Compliance and Narcotics Division, the Ministry of Health, Labour and Welfare (MHLW). From August 2018 to September 2021, he was assigned to be Chief Management Officer, Pharmaceuticals and Medical Devices Agency (PMDA). From June 2016 to July 2018, he was Director, Pharmaceutical Safety Division, MHLW. Dr Sato worked for more than 25 years as a technical administrator at MHLW as well as PMDA. He experienced various regulatory responsibilities in pharmaceuticals and regenerative medical product review, pharmacovigilance, clinical researches, international harmonisation .etc. He is a registered pharmacist and was received Ph.D. degree (pharmaceutical sciences) from the University of Tokyo.