Company: Opus Genetics
Job title: Chief Regulatory Officer
Ms. Tuller has over 20 years of experience in regulatory strategy and operations, spanning numerous clinical and commercial-stage products across a wide range of indications, including multiple orphan disease programs. She has as J.D. in IP law and is RAC certified, and has led IND to BLA/NDA applications, and has led the RA function as Chief Regulatory Officer at Opus Genetics and VP at Disc Medicine, as well as prior RA roles of increasing responsibility at Astellas Pharma, Biogen, ImClone, Fresenius, and Baxter.
Exploring the (Mis)Alignment Between FDA & EMA Approaches to Clinical Submissions 1:50 pm
In what areas of clinical trial submissions do the FDA and EMA differ in their approaches, and where is their scope for potential harmonization? How can drug sponsors develop pathways to fulfil both EMA and FDA requirements in these domains? Outlining key strategies to set up for success when filing clinical trial submissions to both…Read more
day: Clinical Stream 2