John Pakulski

John Pakulski is the Senior Vice President of Regulatory Affairs at Prolong Pharmaceuticals. He also holds the same role at Kashiv Biosciences. Mr. Pakulski has over 35 years experience in regulatory affairs in the development and maintenance of novel drugs, biologics, 505(b)(2) products, and biosimilars. He has been a leader in global regulatory affairs for biosimilars and helped shape the biosimilar pathway in the US. He has served as Vice Chairman of the Biosimilar Council, Chair of the Association of Accessible Medicines (AAM) Biosimilars Working Group prior to the establishment of the Council, Chair of the Biosimilar Forum Regulatory Committee, and represented AAM during both Biosimilar User Fee Negotiations with FDA. Under his leadership at Mylan, the first biosimilar (trastuzumab) was approved in the U.S., two Biologics License Applications (BLAs) and 505(b)(2) biologics New Drug Applications (NDAs) were submitted to the U.S. F.D.A., and three Market Authorization Applications (MAAs) were submitted to the European Medicines Agency (EMA). He headed U.S. Biopharmaceutical Regulatory Affairs at Sandoz Inc., where he was involved with the approval of the first biosimilar in the US and with the submission of two additional biosimilars BLAs. Prior to his involvement with biosimilars, he worked for over 20 years on novel drugs and biologics, and 505(b)(2) products in roles of increasing responsibility within global and U.S. regulatory affairs at Pfizer, Aventis, and Sanofi. He has broad experience in the regulatory aspects of the technical and clinical development for drugs and biologics in a variety of therapeutic areas. Mr. Pakulski is a pharmacist and graduate of Rutgers College of Pharmacy.