Conference Speakers

Dr. Shaunak Pandya is the Director of CMC, R&D at Kashiv Biosciences LLC, where he leads phase-appropriate product development of biologics programs. He brings over 10 years of experience in clinical manufacturing and characterization of conjugate biologics and biosimilars. At Prolong Pharmaceuticals and Kashiv Biosciences, Dr. Pandya has spearheaded the Phase 2/3 manufacturing and development of PEG-Hb, PEG-GCSF, and immunology biosimilars. His current work focuses on improving manufacturing control strategies and enhancing product safety profiles to accelerate product development pathways. Dr. Pandya’s research experience spans hemorrhage control biomaterials and hemoglobin-based oxygen carriers (HbOCs) for trauma and hypoxia. He was part of the collaborative team at the University of Texas at San Antonio (UTSA) and the U.S. Army Institute of Surgical Research (USAISR) that contributed to FDA guidance on Cold-stored platelets. Dr. Pandya has multidisciplinary training in Pharmacy, Biomaterials Sciences, and Biomedical Engineering. He received his PhD in Biomaterials and Biomedical Engineering from the University of Texas at San Antonio and his MTech in Bioengineering from the Indian Institute of Technology Kanpur.