Dr. Keith R. Fandrick is the Chief Operating Officer of OrphAI Therapeutics, where he leads operations, chemistry, manufacturing, and regulatory strategy for a pipeline of novel therapeutics targeting oncology and rare diseases. With over 18 years of experience in the pharmaceutical and biotech industries, he brings deep scientific, operational, and developmental expertise to clinical-stage development and commercialization. At OrphAI Therapeutics, Dr. Fandrick oversees all operations and CMC functions, external manufacturing partnerships, and technical intellectual property management. He is instrumental in aligning R&D strategy with business execution and advancing therapies from inception through clinical supply and NDA readiness. Prior to joining OrphAI, he was group leader in the Chemical Development group Boehringer Ingelheim (BI), where he led the development of scalable commercial processes for multiple development candidates and played a role in the marketing approval of Jardiance. He also established the Development DFT computational chemistry capabilities at BI employing HPC infrastructure and led the BI portion of the computer-aided synthetic route design initiative as part of an industry consortium. Dr. Fandrick holds a Ph.D. in Chemistry from Harvard University and an MBA from the University of North Carolina's Kenan-Flagler Business School. He is Regulatory Affairs Certified (RAC), a credential that underscores his command of global regulatory frameworks and compliance. An accomplished author with over 75 peer-reviewed publications and patents, he continues to contribute as a scientific advisor and advocate for cutting-edge pharmaceutical innovation. His leadership at OrphAI Therapeutics underscores his commitment to translating scientific innovation into therapeutic solutions for rare diseases.
