Gerald Yakatan, Ph.D., Founder, Chairman & CEO of IRISYS, has decades of pharmaceutical development, clinical trial strategy and design, and regulatory affairs experience. He interacts with high-level FDA personnel and has planned and engaged in numerous FDA meetings with U.S. and foreign clients. Dr. Yakatan leads a management team that has a deep understanding of current regulatory philosophy and standards. We have experience working directly with the FDA at all levels. IRISYS’ history of successful drug development spans a wide range of therapeutic categories including anti-viral, neurology, oncology, gastroenterology, and OTC products.