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 a Senior Medical Executive with 30+ years of healthcare leadership spanning academic immunology research, Institute leadership, and pharmaceutical R&D. Proven track record of building high-performing units (up to 150 people), managing $50M+ portfolios, and successfully prioritizing novel therapeutic approaches in biotech and academia. Expert in translational medicine, clinical drug development, and regulatory strategy with a focus on cross-functional collaboration.
Dr. Madhu Nag, MBS, PhD, is Chief Scientific Officer at InSphero and a recognised leader in advanced cell models and New Approach Methodologies (NAMs), with over 20 years of experience across government, biotechnology and industry. She leads InSphero’s scientific and platform strategy, focusing on 3D microtissue and microphysiological systems for drug discovery and safety assessment. Previously, she held senior positions at the FDA, NIH and Day One Biopharmaceuticals, leading programmes in regulatory science, translational research and precision medicine. She works closely with regulatory agencies and industry partners to advance the development, validation and adoption of human-relevant models in drug development.
Imein Bousnina, Pharm.D, is a Director of U.S. Regulatory Policy at Genentech, a member of the Roche Group. Over her decade at Roche-Genentech, she has served as a subject matter expert and led the implementation of regulatory policy strategies on topics such as FDA and EMA's regulation of alternatives to animal testing, digital health, rare disease drug development, companion diagnostics, and PDUFA, among others. She actively engages in several external groups, including BIO, PhRMA, IQ, among others, and has served in leadership roles on some of their taskforces. Imein trained as a pharmacist and holds an MSc in International Regulatory Affairs.