Register: Streamlining Nonclinical Development with FDA NAMs

Date: Wednesday, July 1, 2026 10–11am EDT
Event Location: Virtual

FDA’s draft guidance on the validation of New Approach Methodologies (NAMs) is reshaping how nonclinical programs are designed and justified. This webinar explores how sponsors can apply NAMs to streamline development, improve human relevance, and support IND decision-making within a weight-of-evidence framework.

We will break down FDA expectations for validation, including context of use and fit-for-purpose application, and show how to position NAMs effectively in regulatory interactions.

Through real-world case examples spanning in vitro, in silico, and data-driven approaches, attendees will gain practical insight into how NAMs can address data gaps, reduce reliance on traditional models, and strengthen nonclinical programs.

Helen-Marie Dunmore, MSc

Senior Director, Toxicology | Certara

Helen-Marie has 20+ years Regulatory nonclinical experience (IB/IND/CTA/MAA documentation and FDA/EMA/NCA meetings), Early and late-stage nonclinical program design and execution, carcinogenicity, impurity/excipient qualification, 3Rs, thought leader in advanced therapy modalities.

Kevin Snyder, PhD

Director of Nonclinical Innovation and Emerging Technologies | Certara

Director of Nonclinical Innovation and Emerging Technologies | Certara
Kevin has deep expertise in nonclinical informatics, data standards, and regulatory science, with prior leadership experience at FDA/CDER as Associate Director of Nonclinical Informatics. His work has focused on advancing the regulatory use of CDISC SEND data and enabling data-driven decision-making in pharmacology/toxicology. At Certara, he guides pharmaceutical sponsors in integrating nonclinical data across development to enhance drug safety and innovation. Kevin is an active contributor to industry consortia, including CDISC, PHUSE, Pistoia Alliance, VICT3R, and BioCelerate, and a strong advocate for modernizing toxicology through data science, predictive modeling, and new approach methodologies (NAMs).

Marc Bailie, DVM, PhD

Vice President Toxicology | Certara

Marc has 25+ years of experience in Safety Pharmacology, Pharmacology, Pulmonary, Cardiovascular (hypertension, thrombosis, heart failure), inflammation, early and late nonclinical program design and execution. He is also a thought leader in cardiovascular risk assessment.

Georgi Kapitanov, PhD

Senior Director, QSP | Certara

Georgi Kapitanov, PhD is a Senior Director in Certara’s Applied Simulations group, where he leads QSP strategy across multiple programs and therapeutic areas. He joined Certara through the acquisition of Applied BioMath and previously worked in Pfizer’s Translational Modeling and Simulation group within Pharmacometrics, Dynamics, and Metabolism.

Fran Brown, PhD

Senior Vice President, Global Head, Drug Development Science | Certara

Dr. Fran Brown is a highly respected professional with proven leadership skills and 28 years of broad experience within pharmaceutical development and due diligence. She has extensive experience with strategic and operational global drug development from early discovery to filing and post-marketing. This experience spans multiple therapeutic areas, small molecules and biologics, global regulatory requirements and registration pathways. She possesses a broad knowledge of product development and portfolio management, with a special focus on development strategy, regulatory interactions and product filings.