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.
Foundational analysis
Why better tools did not automatically mean better R&D
Nature Reviews Drug Discovery · Mar 1, 2012
What the source reports
Scannell and colleagues described a historical decline in new drug approvals per inflation-adjusted R&D dollar, despite improvements in many discovery tools.
Why it belongs here
A useful starting point for distinguishing experimental throughput from the productivity of the whole development system.
WHAT THIS DOES NOT ESTABLISH
This is a historical analysis, not a measurement of 2026 productivity or proof that any single technology will reverse the trend.
Before you use it
Read the original source, check its population or model and intended use, and review uncertainty, disclosures and any subsequent updates. This note is a guide to reading, not a substitute for the paper or guidance.
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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.