Navigating the FDA’s New Draft Guidance for Obesity Clinical Trials LinkedIn Live
In January (2025), the FDA issued draft guidance for clinical trials evaluating weight-reduction medications, such as GLP-1 agonists. Our experts, Todd Rudo, M.D., and Paul Strumph, M.D., will host a LinkedIn Live to discuss key recommendations found in the guidance. They’ll also share strategic insights into how to best approach clinical outcome assessments (COAs), endpoints to understand the type of weight loss, and other pivotal considerations for your clinical trials.
Topics will include:
- Key messages from the FDA’s draft guidance for obesity drug development
- The evolving role of clinical outcome assessments (COAs) and how they can impact labeling claims
- How to navigate regulatory strategy and differentiating your product in a fast-growing market
Session information:
Time:
- 10:00 a.m. – 10:30 a.m.ET (NA-East)
- 14:00 – 14:30GMT (UK)
- 15:00 – 15:30CET (EU-Central)
Speakers
Todd Rudo, M.D.
Executive Vice President, Chief Medical Officer at Clario
Dr. Todd Rudo is EVP and Chief Medical Officer at Clario, providing medical and scientific leadership across the organization. He has nearly 20 years of clinical cardiology and pharmaceutical research experience, with a career predominantly focused on drug safety. Dr. Rudo has board certifications in cardiology, cardiac electrophysiology, nuclear cardiology, adult echocardiography and internal medicine. His team provides expert consulting to clients on scientific and regulatory strategy, and ensures Clario’s product portfolio is scientifically robust, generating high quality clinical trial endpoint data. Dr. Rudo has a particular interest in applying innovative technologies to improve the scientific rigor of clinical trials, while maintaining focus on the customer experience, including minimizing patient and site burden.
Paul Strumph, M.D.
Diabetes & Metabolism Key Opinion Leader, Clinical Science & Consulting at Clario
Dr. Paul Strumph has been advising Clario on diabetes, metabolism and obesity clinical development strategy since 2021. He brings more than 20 years of experience in pharmaceutical development. Recent positions include CMO of Seraxis Inc, Metavant Sciences and JDRF. He has also served as Vice President, Clinical Development, at Lexicon Pharmaceuticals where he led global clinical development from early phase 2 work through NDA and MAA filings achieving the EU approval of sotagliflozin, an oral adjunct to insulin in type 1 diabetes. At Quintiles (now IQVIA) he was the Founder and Chair of the Diabetes Center of Excellence and served as the Diabetes Strategy Lead and North America CMO.