Fundamentals of Biologicals Regulation

Dr. Susan Neadle is a recognized international Combination Products, Medical Device, and Digital Health expert with over 35 years industry experience. She is well networked, published, and highly active in numerous industry groups with links to teaching institutions. Neadle’s leadership, innovation, and best practices have been recognized with multiple awards, including the Johnson Medal, Johnson & Johnson’s highest honor for excellence in Research & Development, and most recently, as a Finalist in TOPRA’s 2021 Awards for Regulatory Affairs Excellence. Neadle retired from a distinguished and impactful 26-year career at Johnson & Johnson. She is now Principal Consultant at Combination Products Consulting Services LLC, providing international Q&C, regulatory and design excellence services, to the pharm, biotech and device industries. Neadle serves as Chair of the ISPE Combination Products CoP, and Lead Author in Combination Products Working Groups through ASTM International, AAMI and PQRI. She teaches curricula in Combination Products through UMBC and AAMI, as well as customized training upon request.

Dr. Ivana Knezevic, MD, PhD Scientist, Technologies, Standards and Norms Team, Group Lead, Norms and Standards for Biologicals, Department of Essential Medicines and Health Products (EMP), Health Systems and Innovation (HIS) Cluster, World Health Organization (WHO), Switzerland. She is a specialist in medical microbiology and parasitology. She received her MD from the University of Novi Sad, MSc in medicine (microbiology) and PhD in medicine (virology) from the University of Belgrade, Republic of Serbia. Ivana Knezevic has 24 years of professional experience in standardization, scientific and regulatory overview of biologicals. Dr. Knezevic is the author of many publications that made broad audience aware of WHO initiative in the development, establishment, and implementation of standards for vaccines and biotherapeutic products. She is also contributing to the peer-review scientific journals with the international reputation.

Dr. Mehmet Tosun is a physician-scientist with over 15 years of experience in clinical trials and research endeavors. He is an adjunct faculty member in the Biotechnology Program at the University of Maryland, Baltimore County. He served as the Director of Research to develop mRNA-based cell therapy for autoimmune diseases, rare disease and cancers in a clinical-stage biotechnology company in Gaithersburg, Maryland.

He worked as a Project Scientist in tissue engineering group to develop biomaterials for the repair of visceral hollow organs at University of California, Irvine, School of Medicine. He joined the team to identify the systems-level machinery governing vertebral segmentation during embryonic development at Albert Einstein College of Medicine, Department of Genetics. He completed his postdoctoral fellowship at Baylor College of Medicine, Department of Pediatrics at Texas Children Hospital. He specifically focused on neuronal stem cells resides in hippocampus to explain the adult neurogenesis mechanism. He developed a unique method to characterize the complex lipid features of the different parts of the brain. He has expertise in clinical drug development, translational clinical research, immunotherapy, and clinical data monitoring.

Dr. Kathryn C. Zoon is a U.S.-based immunologist, elected to the U.S. Institute of Medicine in 2002 for her research on human interferons and administrative public health contributions. She is the former scientific director of the Division of Intramural Research at the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) in Bethesda, Maryland (2006-2015). From 1992 to 2002, Dr. Zoon was director of the FDA Center for Biologics Evaluation and Research (CBER). She is currently Scientist Emerita, NIH and on the Board of Directors of Emergent Biosolutions, Inc. and the International Biomedical Research Alliance. Dr. Zoon obtained her B.S. cum laude from Rensselaer Polytechnic Institute in 1970 and her Ph.D. in biochemistry from Johns Hopkins University in 1976. Soon after receiving her Ph.D., she undertook a training fellowship in the NIH laboratory of Christian B. Anfinsen, who had won the 1972 Nobel Prize in Chemistry.