Unlock the Full Potential of New Approach Methodologies (NAMs) for the Future of Food Safety and Nutrition
- Understand the transformative power of NAMs and how they are reshaping regulatory decision-making processes.
- Examine the benefits and risks associated with adopting these innovative methodologies so your company can stay at the forefront of regulatory and safety advancements when developing new products.
- Learn how NAMs can streamline assessments and strengthen safety protocols for consumers.
- Explore how NAMs can help drive the development of safer, more effective nutritional products.
Don't miss this session on how industry and food safety professionals can leverage NAMs to enhance consumer health and shape the future of food safety, toxicology, and nutrition.
Session 2 – New Approach Methodologies (NAMs): What is being left out?
Tuesday, April 8, 2025 | 11:40 a.m. – 1:10 p.m.
The Lineup You Won't Want to Miss:
Session Chair:
- Omari Bandele, PhD, FDA, USA
- Craig Llewellyn, PhD, Exponent, USA
Speakers and presentations:
Benefits:
- Advancing Regulatory Decision-Making through New Approach Methods (NAMs) – Omari Bandele, PhD, FDA, USA
- FDA Efforts on NAMs – Suzanne Fitzpatrick, PhD, FDA, USA
Hazards: (Missing Whole-body Metabolism, Organ Crosstalk, Matrix Effects, etc.)
- What's Missing/Needed? NAMs in Toxicology – A. Wallace Hayes, PhD, University of South Florida College, Michigan State University, and special employee, FDA, USA
- Humans and Foods are Complex Biological Systems that may not be Fully Captured by New Approach Methodologies – Sharon M. Donovan, PhD, RD, Department of Food Science and Human Nutrition, University of Illinois at Urbana-Champaign, USA
Advancing Regulatory Decision-Making through New Approach Methods (NAMs) – Omari Bandele, PhD, FDA, USA
Abstract: As the landscape of food safety evolves, advancing regulatory decision-making through New Approach Methodologies (NAMs) is becoming increasingly important to enhance safety assessments, improve regulatory efficiency, and protect public health regarding chemicals in food. NAMs (e.g., in silico, in chemico, and in vitro methods) offer innovative opportunities to strengthen predictive toxicology, improve human-relevant safety evaluations, and reduce reliance on traditional animal testing. Despite their promise, broad regulatory acceptance of NAMs remains a challenge. Establishing confidence in these methodologies requires demonstrating their applicability, reliability, reproducibility, and alignment with regulatory safety expectations. This presentation will explore how NAMs are being considered within regulatory science, their benefits and challenges, and considerations for their successful implementation in regulatory safety assessments.
Dr. Omari Bandele is a Senior Advisor for Toxicology in FDA’s Human Foods Program (HFP) (formerly Center for Food Safety and Applied Nutrition, CFSAN) where he provides leadership on scientific initiatives and research related to developmental toxicology and provides advice on integrating new approach methods (NAMs) to support regulatory assessments of food chemicals. Dr. Bandele earned a Ph.D. in Biochemistry from Vanderbilt University and a B.S. in Chemistry from Tennessee State University. He completed his postdoctoral training at the NIH National Institute of Environmental Health Sciences, where he received the NIH Fellows Award for Research Excellence. Previously, Dr. Bandele served as Branch Chief of the Toxicology Review Branch for food contact substances (FCSs) within CFSAN’s Office of Food Additive Safety, overseeing safety assessments of FCSs. He also has worked as a regulatory toxicology reviewer, conducting pre- and post-market safety assessments of FCSs. As a research fellow in CFSAN, he applied in vitro and in vivo toxicological approaches to assess the developmental toxicity, nephrotoxicity, and hepatotoxicity of food constituents and contaminants. Dr. Bandele has authored numerous peer-reviewed publications, including work related to the development and application of non-animal approaches for chemical safety assessment.
