Harpreet Singh, MD, is Chief Medical Officer at Precision for Medicine, leading biomarker driven clinical development in oncology and rare diseases. Previously Director of the FDA’s Division of Oncology, she is known for advancing precision medicine and innovative trial design. A trained medical oncologist, she completed medical training at USC and a fellowship at the NCI.
Harpreet Singh, former FDA Oncology Division Director and current chief medical officer at Precision for Medicine notes how evolving FDA review standards, expedited approval programs, and emerging AI tools are reshaping the regulatory landscape for biopharma companies.
Harpreet Singh, MD, notes that FDA’s internal AI system could improve efficiency in drug review by helping reviewers aggregate and synthesize complex data.
Harpreet Singh, MD, touches on how the Commissioner’s National Priority Voucher program is accelerating regulatory review timelines without fundamentally changing how pivotal trials are designed.
Harpreet Singh, MD, notes that the FDA’s broader shift toward accepting single pivotal trials reflects an evolution in regulatory thinking, while noting the agency still weighs disease severity, unmet need, trial design, and long-term safety
Harpreet Singh, MD, says understanding regulatory precedent, division-level dynamics, and the agency’s data-driven culture is critical for biopharma sponsors navigating today’s oncology approval landscape.
