David C. Mitchell

Background

About David C. Mitchell

I am SVP and Head of Regulatory Affairs at Verastem Oncology, a biopharmaceutical company committed to developing and commercializing new medicines for patients battling cancer. Our lead clinical program is a treatment for Low-grade Serous Ovarian Cancer (LGSOC), a rare disease, which received FDA’s Breakthrough Therapy Designation for the combination of our avutometinib and defactinib oral compounds after one or more prior lines of therapy including platinum-based chemotherapy. An accelerated approval filing is planned, the timing of which will be based on data maturity and finalization of confirmatory study planning. There are currently no approved therapies indicated for recurrent LGSOC. Promising signals of clinical activity in various RAS pathway-driven cancers have been noted with avutometinib, which exhibits a unique RAF/MEK mechanism of action, including in patients whose tumors previously progressed on other MEK inhibitors. Various avutometinib combination treatments are under development for Colorectal Cancer (CRC), Non-small Cell Lung Cancer (NSCLC), metastatic pancreatic cancer, breast cancer, and melanoma. I previously served as SVP and Head of Regulatory for Sumitovant Biopharma and Head of Regulatory for Roivant Sciences, both based in NYC, and as VP of Regulatory Affairs and Quality at public biopharmaceutical firms in the US and Canada. I am deeply experienced in development of treatments for rare diseases and various cancers. Product development has included small molecules and biologics, antibodies, antibody drug conjugates, cellular and gene therapies, and tissue transplants. Career Highlights: • Developed and directed Regulatory Affairs and Quality teams at 12+ firms • Provided leadership on the development and submission of 150+ IND/CTA(s) and 12+ NDA/BLA/MAA(s) Specialties: Regulatory Affairs and Quality Assurance, RMAT/BTT/OD/Rare Pediatric designations, Ad/Promo/Labeling, GXP Compliance, Conduct of Internal and 3rd Party Audits, GXP Inspection Strategies and Negotiations, Drug Development Requirements (FDA, EMA, PMDA, ICH), FDA and Board-level Presentations, Development and Supervision of RA/QA Departments, Drug Development Strategies (CMC, Clinical & Non-clinical), Clinical Protocol Development, International Drug Registration (IND, BLA, NDA, CTA/IMPD, MAA)