Overview

The traditional nonclinical development model is entering a significant period of change. For decades, sponsors have built IND-enabling programs around established animal studies, toxicology packages and familiar FDA expectations. That landscape is now evolving as FDA moves toward greater consideration of New Approach Methodologies (NAMs) and other scientifically appropriate approaches, including human-cell-based systems, organ-on-a-chip technologies, computational models and AI-supported methods. This is no longer a future possibility. FDA’s actions in 2026 have made the changing nonclinical landscape a current regulatory issue for drug developers. The important question is not simply whether animal testing can be reduced. It is whether the nonclinical strategy your company is developing today will remain the most appropriate strategy as FDA’s expectations continue to evolve.

Why This Regulatory Shift Matters Now

FDA’s growing interest in NAMs creates both opportunity and uncertainty. A new methodology may offer the potential to generate more human-relevant information or reduce reliance on certain traditional studies. But scientific promise does not automatically translate into regulatory acceptance. A company could invest in an emerging technology expecting to streamline development, only to discover later that additional evidence or conventional studies are still necessary. The consequences can include additional studies, regulatory delays, increased development costs and a more complicated path toward an IND. Conversely, companies that continue using conventional approaches without considering the changing regulatory environment may miss opportunities to rethink their development strategy.

The gap between “technically possible” and “regulatorily usable” is becoming increasingly important.

What is Changing?

FDA’s approach to nonclinical development is evolving as NAMs, human-relevant models, organ-on-a-chip technologies, computational methods and AI become increasingly relevant to drug development. The challenge for sponsors is understanding where these approaches may fit within an FDA-regulated development program, where the uncertainties remain, and what the changing landscape could mean for future nonclinical strategies.

Why Should You Attend?

This webinar will help you look beyond the technology and understand the regulatory implications of FDA’s changing nonclinical expectations. You will gain an expert perspective on the opportunities, limitations and potential regulatory risks that sponsors should consider before making important decisions about their nonclinical development strategy.

What This Webinar will Examine

This webinar will provide an FDA-focused examination of the emerging nonclinical paradigm and its implications for sponsors developing drugs and biologics. The discussion will focus on the regulatory significance of NAMs—not simply how the technologies work—and will examine the opportunities, limitations and potential risks companies should consider before changing an established nonclinical strategy. The program will also address the growing regulatory relevance of AI, computational models, organ-on-a-chip technologies and other human-relevant approaches.

Who will Benefit?

Designed for professionals in Regulatory Affairs, Nonclinical Development, Toxicology, Pharmacology, Drug Development, Clinical Development, R&D, Quality and FDA regulatory strategy, particularly those involved in innovative drugs and biologics.

Don’t Wait Until the IND Is Being Prepared

Important nonclinical decisions are often made long before the IND submission is assembled. With FDA’s approach changing now, understanding the direction of this regulatory shift can help organizations make better decisions before their next development program is locked into a conventional strategy.