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Raja B. Velagapudi, PhD (he/him/his)

Sr. Director, Clinical Development
Tolmar Inc
Rockville, Maryland

Raja B. Velagapudi, PhD, is a seasoned clinical pharmacology and drug development leader with over three decades of experience spanning the FDA, global innovative and generic pharmaceutical companies. Currently Senior Director of Clinical Development at Tolmar Inc. focusing on Uro-Oncology product development, he has held senior leadership roles at Sandoz, Teva, and Abbott, where he led clinical programs for complex generics, biosimilars, and innovative therapeutics including HUMIRA. A former FDA pharmacokinetic reviewer, Dr. Velagapudi has deep expertise in regulatory strategy, PK/PD modeling, and bioequivalence studies. He has evaluated over 200 in-licensing opportunities and played a pivotal role in first-to-file ANDA and 505(b)(2) submissions. A recognized thought leader, he has spoken at FDA workshops and served in several leadership roles within AAPS. Dr. Velagapudi holds a PhD in Biopharmaceutics from the University of Texas at Austin and advanced degrees in Pharmacology and Pharmaceutics. His career reflects a commitment to advancing patient access to high-quality, affordable medicines through scientific rigor and regulatory excellence.

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