On March 18, FDA released draft guidance for the validation of new approach methodologies (NAMs) involving complex methods. in vitro Model (CIVM). For a sector that has been operating for a long time without clear regulatory standards, this is critical and requires a collective response. Importantly, this is still a draft and the feedback window is a real opportunity to adjust the guidance so it reflects real-world scientific practice.
This guidance is centered around four principles. The 11th Annual 3D Tissue Model Summit (Boston, MA | April 28-30, 2026) will be dedicated to each session, allowing attendees to assess the current state of the validation process and leave with substantive comments to submit to FDA.
Usage:
AbbVie, Biogen, Incyte, and Vertex share how they align model development with research schedules and ensure deployment decisions are intentional, allowing teams to close gaps in IND submissions before they become roadblocks.
Human biological relevance:
Novo Nordisk and Takeda will demonstrate how intentional choices regarding cell types and anatomical features build translatability into models from the beginning, giving them the predictive confidence needed to advance preclinical data.
Technical characterization:
Merck and others will show how automation can be applied to improve model robustness and reproducibility, ensuring that CIVM data has the rigor necessary to withstand regulatory scrutiny when it reaches the FDA.
Fit for purpose:
The 3Rs Collaborative’s DILI project reveals how direct collaboration with the FDA builds confidence in a fit-for-purpose model and accelerates industry-wide CIVM adoption for organizations moving forward.
Beyond the session itself, the summit will provide a dedicated space to take a break from your busy day in the lab to review guidance with your colleagues, synthesize your thoughts, and submit comments that will help FDA build upon what the industry can do together.
For more information on the agenda, please visit: https://ter.li/yhnxk6s6
sauce:
Hanson Wade Group – 11th 3D Tissue Model Summit 2026
