September 23, 2024
Walnut Creek, CA—Dark Horse Consulting Group (“DHC”), the leading global consultancy to the cell and gene therapy (“CGT”) industry, today welcomes Adnan Jaigirdar, M.D., FACS to the consulting team as a Senior Principal and Head of Clinical. Dr. Jaigirdar brings with him 24 years of experience in surgical oncology, immuno-therapy, and clinical development. Prior to joining DHC, Dr. Jaigirdar spent eight years in positions of regulatory review and leadership with the US FDA, most recently as the Deputy Division Director of Clinical Evaluation and Pharmacology/ Toxicology in the Office of Tissues and Advanced Therapies (OTAT), CBER, FDA.
“Dr. Jaigirdar’s extensive experience in clinical research, clinical trial design, and regulatory policy make him uniquely positioned to build out additional clinical offerings,” said DHC COO and MP Katy Spink.
During his time at the FDA, Dr. Jaigirdar led the clinical evaluations of Phase 1 through 3 clinical trials and BLA submissions for numerous drug development programs including CGT products, therapeutic vaccines, xenotransplantation products, and protein therapies in fields including hematology, oncology, neurology, auto-immune, rare diseases, and other medical conditions. As Deputy Division Director in OTAT, he oversaw clinical review of a wide range of first-in-class therapeutics including 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.
Dr. Jaigirdar said, “I am excited to leverage my dual background as both a clinical researcher and a regulator to support DHC’s wide range of clients in advancing innovative cell and gene therapies.”
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. He is board-certified by the American Board of Surgery and is a member and Fellow of the American College of Surgeon (FACS).
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About Dark Horse Consulting Group
Dark Horse Consulting Group, a global company with offices in the U.S., U.K., and Singapore, was founded in 2014 with the purpose of accelerating cell and gene therapies through unmatched consulting expertise. DHC’s collective knowledge spans product and process development, analytical development, device development, facilities, manufacturing, & compliance, quality assurance, project & program management, regulatory affairs, nonclinical development, clinical regulatory, quantitative modeling, market expertise, and diligence & business strategy. DHC offers an unmatched understanding of the challenges faced by cell and gene therapy developers and applies best practices from this and other industries to address a diverse range of client needs.
Image used: Dr. Jaigirdar giving a talk at Stanford University: Stanford Medicine Big Data | Precision Health 2018. See the entire talk here: https://www.youtube.com/watch?v=ONZKFQYZ7oE
