Management

Sarah Tuller has 25 years of experience in regulatory strategy and operations, spanning numerous clinical and commercial-stage products across a wide range of therapeutic indications, including multiple cell and gene therapies and orphan disease programs. She has led or been a part of numerous successful IND, NDA, MAA and BLA applications, including those of Portrazza® in metastatic, squamous NSCLC, Phoslyra® in ESRD, Removab® malignant ascites, and Avonex Pen® in relapsing MS. Prior to joining Opus, she was Chief Regulatory Officer and Head of Medical Writing at Tenpoint Therapeutics, as well as Vice President and Global Head, Regulatory, Medical Writing and Quality at Disc Medicine, and held regulatory leadership positions at Astellas Pharma, where she was Senior Director and Medical Specialties Therapeutic Team Leader and supported the ophthalmology gene therapy, mitochondrial diseases, and regenerative (cell) medicinal product franchises, as well as prior appointments of increasing regulatory responsibility at companies including Biogen, ImClone, Fresenius, and Baxter. She earned her Juris Doctorate (JD) in IP law from the University of Dayton School of Law, holds a B.S. in Chemistry, and is RAC certified in Regulatory as well as a member of RAPS in US and TOPRA in EU.