Dr. Parag Kolhe is a leader in the field of biotherapeutics and vaccine development, boasting over 20 years of experience in the pharmaceutical industry. He currently holds the position of Senior Director of Drug Product Design and Development at Pfizer. In this role, he co-leads a global organization dedicated to developing innovative biotech products across various therapeutic areas, including oncology, rare diseases, immunology, and infectious diseases. Dr. Kolhe oversees the formulation, process development, and control strategy aspects of these products and is also accountable for medical device and combination product design control for prefilled syringe-based kits. His organization is responsible for early-stage development through commercialization. His contributions span several modalities, such as monoclonal antibodies, antibody drug conjugates, vaccines, gene therapy, and CAR-T therapy.
Dr. Kolhe earned his PhD in material science from Wayne State University. He has published over 30 peer-reviewed manuscripts, numerous book chapters, and review articles on topics related to biotherapeutics, vaccines, and sterile product development. He is an editor of two books focused on sterile product development and vaccine drug product development. Additionally, he is an inventor of several patents in his area of expertise. Dr. Kolhe is an active member of various professional societies and committees, particularly within the American Association of Pharmaceutical Scientists (AAPS).