Foundational analysis
Why better tools did not automatically mean better R&D
Scannell and colleagues described a historical decline in new drug approvals per inflation-adjusted R&D dollar, despite improvements in many discovery tools.
THE EVIDENCE LIBRARY
Better questions
start here.
Research, regulatory references and practical methods, with an explanation of what each source can and cannot establish.
Human observational study
What a proteomic aging clock can tell us
A 204-protein clock, developed using 45,441 UK Biobank participants, was associated with future disease and mortality risk and evaluated in Chinese and Finnish cohorts.
Draft guidance
A validation framework for human-relevant methods
FDA’s March 2026 draft guidance sets out general scientific considerations for validating New Approach Methodologies in drug development and regulatory submissions.
Final guidance
How model-informed evidence should support a decision
ICH M15 addresses planning, evaluation and documentation of model-informed drug-development evidence. FDA’s final guidance is dated June 2026.
Regulatory explainer
A biomarker needs a clearly defined job
FDA distinguishes biomarker categories and explains qualification within a stated context of use. A biomarker can be a molecular, tissue, imaging or physiological measurement.
Regulatory explainer
A promising signal is not the same as a proven benefit
FDA explains why surrogate endpoints require careful evaluation: a biomarker may not capture a treatment’s full benefits and risks.
Model performance study
Putting a human Liver-Chip to a predictive test
Ewart and colleagues evaluated a human Liver-Chip for predictive toxicology using a defined set of compounds and an accompanying economic analysis.
Test guideline
Skin science offers a practical example of fit-for-purpose NAMs
OECD Test Guideline 439 describes reconstructed human epidermis methods for identifying skin irritation hazards in a defined testing context.
Draft guidance
AI credibility depends on the question being asked
FDA’s January 2025 draft describes a risk-based approach to evaluating AI models used to support regulatory decisions about drugs and biological products.
Research program
A public research program for tissue-chip translation
NCATS describes tissue chips built with human cells to model aspects of organ structure and function and investigate potential drug effects.
Tools & templates
A practical toolkit for model-informed development
FDA’s M15 resource center links the guidance, an overview, evidence-assessment templates and worked examples.