Instructor

Niharika Kamat LinkedIn

"Bringing a drug to market is like running a marathon through a maze—full of unexpected turns, setbacks, and dead ends."

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NIHARIKA (NIHA) KAMAT, M.S., head of clinical operations, has close to 20 years of experience as a drug developer. She has worked across multiple industries—medical devices, pharmaceuticals, and biologics—focused on operationalization of complex, global phase I-IV clinical trials and bringing compounds to NDA/BLA approvals. Previously, she built the clinical departments at Tenaya Therapeutics and Catalyst Biosciences, while driving complex early phase trials in rare disease and gene therapy. Her experience in big pharma ad device at Gilead and Abbott vascular includes preclinical research, strategic planning, program management, leading inspections globally and experience in various therapeutics areas including cardiac stents, infectious diseases, hemophilia, cardiac genetic disorders, and pulmonary fibrosis. She received her Master's and Bachelor's degrees in Bioengineering from the University of Texas at Arlington and University of Mumbai respectively.

Associated Program(s)

Clinical Trials Design and Management

Drug Development Process