I have a proven track record of successfully directing development teams, coordinating asset management from discovery, through IND-enabling toxicology/regulatory submissions, and early-stage clinical development. Founder, President and Chief Scientific Officer of Aminex Therapeutics, Inc., developing a novel first-in-class oncology immunomodulator product (AMXT 1501 plus DFMO). Raised $31M from angel investors; collaborated with academic partners to win multiple million-dollar NIH grants; motivated and successfully managed CRO laboratories during GLP toxicology and GMP drug manufacturing outsourcing. Lead inventor and author on 19 issued US Patents and 28 scientific articles in leading journals.I founded Aminex Therapeutics by out-licensing the patents for AMXT 1501 from my former employer MediQuest Therapeutics. For this small molecule oncology immunomodulator asset, I led the financing (total $31M), IND-enabling toxicology, CMC drug substance and product manufacturing to allow successful FDA regulatory approval for first-in-human Phase 1, and follow-up Phase 1B/2A clinical testing in adult solid tumor patients. Led the design of clinical trials and writing of Protocols and Investigational Brochures. Facilitated parallel collaboration with academic consortium performing pediatric testing of AMXT 1501 plus DFMO.
Listed skills include Biotechnology, Biopharmaceuticals, Oncology, Cell, and 16 others.