Speakers

John Pakulski, SVP of Regulatory Affairs at Kashiv BioSciences LLC, has over 35 years of experience in regulatory affairs in the development, approval and post-approval maintenance of biosimilars, novel drugs and biologics, and 505(b)(2) products. John built and lead regulatory teams for 20 of these years. 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 AAM Biosimilars Working Group prior to the establishment of the Council, chair of Biosimilar Forum Regulatory Committee and represented AAM during the first two Biosimilar User Fee Negotiations with FDA. While at Kashiv, two biosimilars were approved and multiple biosimilars are under global development. Under his leadership at Mylan, the first biosimilar trastuzumab was approved in the US and 3 EU MAAs, 2 BLAs and a 505(b)(2) biologic NDA were submitted. He headed US Biopharmaceutical Regulatory Affairs at Sandoz where he was involved with the approval of the first biosimilar in the US and with the submission of 2 additional biosimilar BLAs. Prior to his involvement with biosimilars, he worked for over 25 years on novel drugs and biologics, and 505(b)(2) products in roles of increasing responsibility within global and US regulatory affairs at Pfizer, Aventis and Sanofi. He has broad experience on the regulatory aspects of the technical and clinical development for drugs and biologics in a variety of therapeutic areas. John is a pharmacist and graduate of Rutgers College of Pharmacy.