Howard I. Scher

Head, Biomarker Development Program @Memorial Sloan Kettering Cancer Center

I advise and collaborate with a number of biotech and pharmaceutical companies, especially those developing new diagnostic tests and new agents primarily as an unpaid consultant and on Corporate Boards providing my expertise on developmental strategies to accelerate drug and biomarker approvals. A recent development is a blood based “liquid biopsy” test, now commercially available, that measures the nuclear localization of the AR-V7 protein in circulating tumor cells (CTCs) to predict whether a patient is more likely to respond to oral drugs such as enzalutamide or abiraterone or intravenously administered taxane-based chemotherapy. Similar results were shown with a biomarker that measures the diversity of CTCs: more diverse being less sensitive to AR-targeted therapies. I am a member of the National Cancer Institute (NCI) Prostate Cancer Task Force and Genitourinary Steering Committees, and work closely with the FDA on issues related to clinical trial design and biomarker development. As part of this effort, I led the Prostate Cancer Working Group 2 (PCWG2) and PCWG3 initiatives on clinical trial design for CRPC; published in 2008 and 2016 that are now standards for the field, and am collaborating with FDA to establish a CTC response measure for use in clinical trials. I also serve as the Principal Investigator of the MSK Prostate Cancer SPORE grant from the NCI, and lead the Department of Defense-supported Prostate Cancer Clinical Trials Consortium (PCCTC), a 30-institution academic collaborative started in 2006 to accelerate early-phase drug development to bring needed treatments to patients faster. We have now completed over 150 studies that have collectively enrolled over patients.