Former FDA; Over 24 years of exp in surgical oncology, immuno-therapy, and CGT, Dr. Jaigirdar also brings eight years of reg leadership from the US FDA.
Clinical Regulatory
Regulatory Affairs
Dr. Jaigirdar is a Surgical Oncologist, with subject matter expertise in clinical research and clinical trial design, including eight years of regulatory experience at the US FDA. Prior to DHC, he held various leadership roles in the FDA, both in CBER and CDER. Most recently he was the Deputy Division Director of Clinical Evaluation and Pharmacology/ Toxicology, in the Office of Tissues and Advanced Therapies (OTAT), CBER, and was also the Associate Director of Cell and Gene Therapy at the Oncology Center of Excellence (OCE).
During his time at the FDA, Dr. Jaigirdar led the clinical evaluations of numerous Phase 1 through 3 clinical trials and BLA applications of numerous first-in-class therapeutics, both within and outside of the field of CGT. Among the CGT products he evaluated were chimeric antigen receptor (CAR) T cells, T cell receptor (TCR) modified T cells, adoptive T cell therapies, genome-edited products, neoantigen-based therapies, oncolytic viral therapies, dendritic cell therapies, and combinations of these immune-oncologic therapeutics with checkpoint inhibitors and other targeted therapies. As Deputy Division Director, he provided key supervisory clinical direction on numerous drug development programs under the purview of OTAT that included: CGT, therapeutic vaccines, xenotransplantation products, purified and recombinant protein therapies for treatment in hematology, oncology, neurology, autoimmune, rare diseases, and other medical conditions.
Dr. Jaigirdar possesses valuable clinical knowledge regarding FDA regulatory policies related to complex, advanced therapy development and guided pharmaceutical and academic sponsors through numerous Biologics License Applications (BLA), Investigational New Drugs applications (IND), expedited program applications and regulatory meetings.
He has presented and moderated at several nationally and internationally acclaimed workshops, conferences and disease-focus groups, as well as playing a major role in organizing FDA Advisory Committee meetings. Prior to the FDA, Dr. Jaigirdar was a practicing surgeon and conducted clinical trials at NCI.
Dr. Jaigirdar has numerous peer-reviewed publications and several national and international presentations, including the following regulatory-focused publications and presentations in CGT and oncology:
FDA
US Navy
National Cancer Institute (NCI)
Dr. Jaigirdar is a surgical oncologist and a board certified surgeon by the American Board of Surgery. He is a member and a Fellow of the American College of Surgeon (FACS).
He received his B.S. degree (Summa Cum Laude) in Chemistry, and then his M.D. (Alpha Omega Alpha) from the University of Cincinnati. During this time, he also trained in cancer immunology focusing on tumor vaccines, at the National Cancer Institute (NCI) as a Howard Hughes Medical Institute-National Institutes of Health (HHMI-NIH) Research Scholar. He then completed his general surgery residency at the University of California, San Francisco (UCSF), where he studied mechanisms of immune tolerance in solid organ transplantation at the UCSF Division of Transplant Surgery as a post-doctorate fellow.
Dr. Jaigirdar completed his surgical oncology clinical fellowship at the NCI, where he also conducted clinical trials and basic science research in CGT and immunotherapy in the Surgery Branch under Dr. Steven Rosenberg.
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