Supporting the FDA’s New Approach Methods (NAMs) with TrailBio iPSC-Derived Cells | Advancing Drug Development and Research
A New Era in Preclinical Testing
The U.S. Food and Drug Administration (FDA) has launched a strategic roadmap to reduce reliance on animal testing in drug development (FDA News Release). This initiative prioritizes New Approach Methodologies (NAMs), which apply to human cell-based assays, computational modeling, and organ-on-a-chip systems, in an effort to improve safety predictions, reduce costs, improve standards of animal ethics, and accelerate therapeutic innovation.
Backed by the FDA Modernization Act 2.0, recent Science Board recommendations, and strong bipartisan public support, this shift marks a new era in regulatory science that prioritizes human relevance, ethical responsibility, and scientific precision (FDA Roadmap to Reducing Animal Testing in Preclinical Safety Studies).
TrailBio® iPSC-Derived Cells: Enabling the Future of Preclinical Testing
Trailhead Biosystems® human iPSC-derived cells are developed to meet the demands of modern toxicology and drug development. We offer:
- Human-Relevant Biology
TrailBio iPSC-derived cells replicate native tissue architecture and function, enabling accurate modeling of human-specific responses. View our current cell line offering.
- Mechanistic Insights
Unlike animal models, our systems allow researchers to uncover underlying physiological mechanisms of toxicity, immunogenicity and pharmacodynamics through consistent and reliable iPSC-derived models.
- Integration with Advanced Platforms
TrailBio cells are compatible with many organoids, organ-on-chip devices, and microphysiological systems (MPS), including platforms like the Human Liver-Chip, which recently predicted 87% of hepatotoxic drugs in a validation study and was accepted into the FDA’s ISTAND pilot program.
- Real-Time Functional Monitoring
Trailhead’s cells support dynamic readouts such as electrophysiology, enzyme release, and biomarker expression, paralleling clinical safety markers and enabling earlier detection of adverse effects.
- Advancing Science with Ethical, Scalable Models
By reducing animal use, Trailhead’s iPSC-derived cells can help lower R&D costs, shorten development timelines and align with evolving regulatory and societal expectations.
Supporting In Silico NAMs with Human-Relevant Data
Our iPSC-derived cells provide the biological foundation for training and validating in silico models, including:
- PBPK Modeling
Simulate drug ADME using human-specific data to inform dosing and reduce animal use.
- AI/ML Predictive Models
Train algorithms to predict immunogenicity, toxicity and off-target effects using real-world human cell data.
- QSP and Pathway Modeling
Simulate drug interactions with complex biological networks to predict efficacy and safety.
- Bioinformatics Screening
Identify cross-reactivity and off-target binding using human proteomic data.
Applications Across the Drug Development Pipeline
- Monoclonal Antibody Safety Testing
Evaluate immune-mediated toxicity, cytokine release and off-target effects using liver, cardiac and immune cell models.
- Toxicology and Pharmacology
Replace long-term animal studies with high-throughput, mechanistically rich human cell assays.
- Therapeutic Development
Model disease states and patient-specific biology for precision medicine and early-stage screening.
- Multi-Organ Systems
Simulate systemic pharmacodynamics using interconnected organ chips (e.g., liver-tumor-immune setups for cancer immunotherapy).
Let’s Build the Future of Drug Testing Together
TrailBio kits and services are already supporting NAMs adoption at leading pharma and biotech companies. Request a sample kit or schedule a call with our team.
Trailblazers of NAMs Grant Program
Trailhead Biosystems is proud to announce the Trailblazers of NAMs Grant Program, in which we are helping the industry advance rapidly to the point we need by removing barriers of access to working with iPSCs. Your lab could get free iPSC-derived differentiated cells and customer support to help optimize your NAM solution. For more information, visit the Trailblazers of NAMs Grant Program page or reach out to info@trailbio.com