Keith Fandrick, Ph.D., M.B.A., RAC

Keith R. Fandrick, Ph.D., M.B.A., RAC, serves as Chief Operating Officer of IRulya Therapeutics. In this role, he provides strategic and operational leadership across the company, guiding the advancement of novel therapies from research and development through clinical-stage execution. Drawing on nearly two decades of biotechnology and pharmaceutical industry experience, Dr. Fandrick oversees corporate operations, chemistry, manufacturing and controls (CMC), regulatory strategy, program management, intellectual property, and external development and manufacturing partnerships, aligning scientific innovation with business execution to accelerate the delivery of transformative therapies to patients.

Prior to becoming COO, Dr. Fandrick served in several senior leadership positions at OrphAI, including Chief Development Officer and Head of CMC, helping build the company’s development infrastructure and advance its therapeutic pipeline. Since joining the company in 2017, he has played a central role in shaping the organization’s growth, operational strategy, and product development capabilities. He also served on the Scientific Advisory Board of Drug Farm, providing guidance on pharmaceutical development, CMC strategy, and corporate growth.

Before joining OrphAI, Dr. Fandrick spent a decade at Boehringer Ingelheim, where he held positions of increasing responsibility in Chemical Development. During his tenure, he led process development initiatives for multiple therapeutic programs, and helped advance innovative approaches in computational chemistry and route design.

An accomplished scientist and biotechnology executive, Dr. Fandrick has authored or co-authored more than 78 scientific publications and patents. He holds a Ph.D. and A.M. in Chemistry from Harvard University, where he conducted research under Professor David A. Evans, an M.B.A. from the University of North Carolina’s Kenan-Flagler Business School, a B.S. in Chemistry from the University of California, San Diego, and a Regulatory Affairs Certification (RAC). Known for bridging scientific rigor with strategic business leadership, he has led multidisciplinary teams across global development programs and supported the advancement of therapies in rare diseases, pulmonary, oncology, and other areas of high unmet medical need.