On March 18th, the FDA published draft guidance on validating new approach methodologies (NAMs), including complex in vitro models (CIVMs). For a field long operating without a clear regulatory benchmark, this is significant and it demands a collective response. Crucially, this is still a draft, and the feedback window is a genuine opportunity to adjust the guidance, so it reflects real-world scientific practice.
The guidance centers on four principles. The 11th 3D Tissue Models Summit (Boston, MA | April 28–30, 2026) is dedicating sessions to each one, so attendees can assess where their validation process stands and leave with substantive comments to submit to the FDA:
Context of use:
AbbVie, Biogen, Incyte and Vertex will share how they align model development with research timelines, ensuring deployment decisions are deliberate so your team can close the gaps in IND submissions before they become blockers.
Human biological relevance:
Novo Nordisk and Takeda will demonstrate how deliberate choices around cell types and anatomical characteristics build translatability into models from the start, giving your preclinical data the predictive credibility it needs to advance.
Technical characterization:
Merck and others will show how automation can be applied to improve model robustness and reproducibility so that when your CIVM data reaches the FDA, it carries the rigor needed to withstand regulatory scrutiny.
Fit-for-purpose:
The 3Rs Collaborative's DILI Project will reveal how direct collaboration with the FDA is establishing confidence in fit-for-purpose models, accelerating the kind of industry-wide CIVM adoption your organization can get ahead of now.
Beyond the sessions themselves, the summit gives you a dedicated space away from a busy day in the lab to review the guidance with peers, consolidate your thinking, and submit comments that help the FDA build something the industry can work with.
Learn more about what’s on the agenda here: https://ter.li/yhnxk6s6