Sima Patel, DABT RAC

Sima Patel, DABT RAC, is a board-certified toxicologist and experienced nonclinical drug developer with 15 years of biotech industry experience supporting clinical development programs from IND through NDA.

Her expertise spans the development and execution of nonclinical strategies, toxicology and efficacy studies, toxicokinetics, regulatory submissions, CRO and consultant oversight, and nonclinical due diligence for a range of therapeutic programs, including rare disease, oncology, immunomodulating, Parkinson’s disease, and 505(b)(2) candidates.

Throughout her career at organizations including Travere Therapeutics, Revelation Biosciences, Turning Point Therapeutics, and La Jolla Pharmaceutical Company, she has led cross-functional nonclinical programs, managed budgets and external partners, evaluated development risks, and communicated preclinical findings to inform strategic decisions.

Sima holds a Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society (RAPS), reflecting her commitment to integrating scientific and regulatory expertise in innovative drug development.