What Can you Expect in 2026?
The FDA and NIH are moving away from animal models - FDA plans to phase out animal testing for monoclonal antibodies, and NIH will no longer fund animal-only studies. Organoids, spheroids, and MPS models are stepping in, but challenges remain: unclear validation, inconsistent reproducibility, and scaling issues for small teams.
The 11th 3D Tissue Models Summit will help you:
- Understand what the FDA considers a validated model and the data needed for leadership buy-in
- Improve reproducibility with quality cell sourcing, robust QC, and standardized microenvironments
- Scale through automation and optimized workflows for lean teams
- Upskill your teams with case studies and expert discussions
- Learn how leading companies like AstraZeneca, Novartis, Vertex, UCB, Biogen, Takeda, and others are deploying these models reliably at scale
Unmissable Event Highlights
Scalability Through Automation and Optimized Workflows
Machine learning and robotics are transforming complex in vitro model development. Introduce automation and improved workflows to reduce human error and variability when developing organoids and other systems. With variability causing significant readout differences across the same model types, automation could be the key to improving reliability.
Balance Between Speed, Validation and Translatability
You might have a validated, reproducible model, but knowing which models to develop and deploy for speed while ensuring translatability is critical. Biopharma expects candidates in the clinic fast. Since complex in vitro models take time to develop, you may need strategic planning to match the right model to immediate research questions.
Regulatory and Biostatistical Elements of Model Validation
The FDA's roadmap moves away from animal toxicity testing, but there's no guidance on what constitutes a validated model for them. Clarity on the biostatistical and experimental design of model validation is lacking too. Join us as we unpack these challenges to reduce wasted preclinical time and improve leadership buy-in for CIVMs.
Explore The Full Event Guide
- 18+ Expert Speakers
- 7+ Hours of Case Studies
- 5+ Hours of Networking
- 2 Hands-On Workshops
- 8 Hours of Peer Discussion
Attending Companies Include
Explore the Agenda
Discover how US and European biopharma are validating organoids, organ-on-chip, and MPS for regulatory acceptance.
Partner With Us
Connect your complex in vitro models with the biopharma leaders adopting them at scale.
Join Cross-Disease Leaders
Network with 3D tissue modeling experts tackling validation and translatability across oncology, autoimmunity, neurology, and beyond.