Navigating the FDA roadmap for new approach methodologies
8:00 AM PDT / 11:00 AM EDT / 4:00 PM BST / 5:00 PM CEST
The panel will focus on the regulatory application of New Approach Methodologies (NAMs), exploring how companies can build a compelling evidence package using multiple NAMs to support the safety assessment of new therapies. As the FDA continues to advance its roadmap to reducing animal testing in preclinical safety studies, the discussion will examine what regulators are likely to expect from future submissions and the practical considerations for companies preparing NAM-based regulatory packages.
Speakers
Dr. Nadine Stokar is a veterinary toxicologic pathologist specializing in bridging the gap between traditional anatomic pathology and cutting-edge New Approach Methodologies (NAMs). She leads the Investigative Pathology at Roche and is a co-lead for the Roche NAMs strategy for regulatory acceptance, where she drives innovation in complex in vitro model tissue technology and non-standard approaches in preclinical drug development. Dr. Nadine Stokar is an author of many peer reviewed publications and co-leads the joint ESTP & STP Working Group on "Complex in vitro models & Pathology" where she connects experts and raises awareness across NAMs experts to foster collaborations and the interdisciplinary exchange.
Prof. von Herrath is head of the Diabetes Research Center at the La Jolla Institute for Allergy and Immunology and is generally regarded as one of the world's leading researchers in the type 1 diabetes field. He has made several key advances and has been recognized on numerous occasions for his achievements. He is the recipient of the Juvenile Diabetes Research Foundation's prestigious Scholar Award and in 2008 received the Outstanding Scientific Achievement Award from the American Diabetes Association.
Due to his renowned research on type 1 diabetes, Prof. von Herrath was selected to head a translational diabetes center opened in 2012 in Seattle by Novo Nordisk, and is now Vice president in the Global Chief medical Office of Novo Nordisk. Focused on the development of type 1 diabetes immunotherapies, Prof. von Herrath's position will allow him to realize his dream of playing a key role in clinical trials on potential type 1 diabetes treatments, while continuing to lead his distinguished research program at the La Jolla Institute on a part-time basis.
The speaker's biography will be added soon.
The speaker's biography will be added soon.