Harpreet Singh, MD, is chief medical officer at Precision for Medicine, where she leads medical and scientific strategy for biomarker-driven clinical development in oncology and rare diseases. Previously, she served at the US Food and Drug Administration, most recently as director of the Division of Oncology, overseeing regulatory review of oncology drugs and biologics. A medical oncologist, Dr. Singh is recognized for advancing precision medicine, innovative clinical trial design, and oncology regulatory science.
Experts Harpreet Singh and Steven Quay discuss FDA expedited regulatory pathways for biologics, including Fast Track, Breakthrough Therapy, RMAT, Real-Time Oncology Review, and the National Priority Voucher Pilot Program, and explain how these mechanisms can accelerate development without lowering evidentiary standards.
August 28th 2026
