Dr. Antelman joined Biologics Consulting in April 2020 with over 25 years of Biopharma R&D expertise. Dr. Antelman has extensive experience in all aspects of CMC development from early stage to registrational activities. He has broad knowledge of product development in R&D as well as cGMP manufacturing and testing, including QA and compliance. Dr. Antelman has a strong background in analytical method development, qualification, validation and transfer and phase appropriate product release and stability testing.
Dr. Antelman has significant CMC-regulatory experience and served as the dossier lead for Quality Modules for several biologics including Belatacept, Dupixent and Sutimlimab. His regulatory experience includes INDs and amendments, BLA, sBLA, MAA, JNDA and associated prior approval supplements and variations. His regulatory CMC experience includes both early and late stage (registrational) submissions and responses to Health authority questions.
Dr. Antelman’s expertise includes biologics drug products, including liquid (vial, PFS) and lyophilized dosage forms as well as combination products. He has worked across functional areas (manufacturing, analytical, regulatory, clinical supply, stability, quality) to address the needs of CMC development programs.
Dr. Antelman previously worked at Sanofi as Director of CMC Dossier Development, and successfully submitted several BLAs, MAAs and JNDAs for multiple products and dosage forms. In this role Dr. Antelman provided regulatory strategy, authored and reviewed quality modules and managed the dossier through approval of the publishing of the quality modules.
Prior to Sanofi, he worked at Bristol Myers Squibb, managing a bioassay and ELISA development group, and later served as analytical lead for belatacept. In this role he coordinated all analytical development, characterization and validation work for the BLA. He issued COAs for clinical batches, collectively managed release and stability testing and coordinated reference material filling and qualification.
Dr. Antelman spent 3 years at Centocor developing process-specific HCP assays for epoietin-alfa, as part of a large investigation into PRCA in the European market. During this time he managed an external collaboration to develop polyclonal Abs to CHO HCP. Prior to Centocor, Dr. Antelman worked on Viral and non-viral gene therapy vectors at Canji. This work resulted in several US patents and publications for p53 and RB gene therapy.
Dr. Antelman received his B.S. in Biology from Rensselaer Polytechnic Institute in 1983 and his Ph.D. in biochemistry from the University of Illinois (Urbana-Champaign) in 1988. His education was followed by post-doctoral fellowships at F. Hoffman La-Roche and Hybritech, Inc.