300 Pasteur Drive, Stanford, CA 94304
Presenter: Shivaani Kummar, MD, FACP
Professor of Medicine (Oncology) and Radiology
Her first job was as an assistant professor at the Yale Cancer Center, where she got interested in novel therapeutics for cancer. She was recruited back to the NCI to build the Developmental Therapeutics Clinical Program. For the past few years she was the head of early clinical trials development at the NCI before coming to Stanford.
While at the NCI, Kummar became the principal investigator of M-PACT, a randomized trial of patients with solid tumors resistant to standard therapy; the trial is designed to determine the usefulness of genetic sequencing to improve patients’ outcomes, using mutations found on sequencing to guide the choice of therapy.
Kummar specializes in conducting pharmacokinetic- and pharmacodynamic-driven first-in-human trials tailored to make early, informed decisions regarding the suitability of novel molecular agents for further clinical investigation. Her studies integrate genomics and laboratory correlates into early phase trials. She is interested in alternate trial designs to facilitate rational drug selection based on human data and to help expedite drug development timelines.
At Stanford, Kummar is building an integrated translational research program in Phase I drug development. This will be, as she describes it, “a full-fledged Phase I program to span different tumor types with different pathways. Recently, Phase I trials have become more scientifically driven, where they are not only focused on safety but also on informing proof of mechanism and proof of concept. The idea is to address as many initial questions as possible up front so they can guide what happens to the agent in subsequent Phase II and Phase III trials. Rationally guiding the development of novel anticancer agents will eventually increase the success rate of promising agents, while de-prioritizing agents that don’t achieve the required efficacy.”