Health AI Central
Peer-Reviewed Publication
Regul Toxicol Pharmacol2026;106237.September 4, 2026Journal Article

Beyond NAMs versus animal models: Context of use as the governing framework for integrated nonclinical strategies in drug development.

Stefano Gaburro1, Brian Berridge2, Nicholas W Kelley3, Eckhard von Keutz4, Marc Ferrer5, Clive Roper6, Michael J Fossler7, Jeffrey J Bajramovic8, Jean-Pierre Valentin9, Timothy McGovern10, Todd Bourcier10, Ronald L Wange11, Kevin Snyder12, Michael A Phelan13, Jessica H Oliphant14, Derek J Leishman15, William R Proctor16, Sean Maguire16, Paola Dama17, Madhu Nag18, Dominic P Williams19, Adrian Roth20, Yasunari Kanda21, Szczepan Baran22
1Berlin, Germany; Digital Preclinical Society, Cambridge, MA, USA. Electronic address: stefanogaburro@gmail.com.
2B2 Pathology Solutions LLC, Cary, NC, USA. Electronic address: brberridge@b2pathologysolutions.com.
3Resonate GmbH, Riehen, Switzerland.
4formerly Head of Translational Sciences, Bayer Pharmaceuticals, Germany.
53D Tissue Bioprinting Laboratory, Translational Models Branch, National Center for Advancing Translational Sciences, Rockville, MD, USA.
6Roper Toxicology Consulting Limited, Edinburgh, UK.
7Cytel, Cambridge, MA, USA.
83Rs Centre Utrecht, Utrecht University, Utrecht, The Netherlands.
9UCB, Early Clinical Development and Translational Science, Braine-l'Alleud, Belgium.
10White Oak Regulatory Tox, LLC, Crownsville, MD, USA.
11Aclairo Pharmaceutical Development Group, Sterling, VA, USA.
12Certara USA Inc., Radnor, PA, USA.
13InnovApproach Consulting, Melbourne, Australia.
14U.S. Food and Drug Administration, National Center for Toxicological Research, Division of Systems Biology, Jefferson, AR, USA.
15Eli Lilly and Company, Lilly Research Laboratories, Indianapolis, IN, USA.
16GSK, Preclinical Sciences, Waltham, MA, USA.
17NAMina Bio Corp., New York, USA; University of Sussex, School of Life Sciences, Falmer (Brighton), UK.
18InSphero AG, Schlieren, Zurich, Switzerland.
19AstraZeneca, Clinical Pharmacology & Safety Sciences, Biopharmaceuticals R&D, Cambridge, UK.
20F. Hoffmann-La Roche Ltd, Basel, Switzerland.
21Division of Pharmacology, National Institute of Health Sciences, Kawasaki, Japan.
22Digital Preclinical Society, Cambridge, MA, USA; Instem Ltd, Boston, MA, USA. Electronic address: Szczepan@baran.cafe.
PubMed DOI

Abstract

New approach methodologies (NAMs) originated in chemical hazard assessment, where two forces operate together: the scale of characterizing many substances, and a long-standing ethical and legal commitment to replacing animal testing. Drug development is weighted differently. It is a translational and decision problem applied to small sets of compounds at pharmacologically active exposures. As NAMs…

Create a free account to keep reading

Free members get 10 full research views every month across publications, clinical trials, FDA clearances, adverse events, and NIH grants. No credit card required.

Create Free AccountSign In

Want unlimited research access? See Pro plans

Data Accuracy Notice: Research intelligence on Health AI Central is aggregated from public sources (PubMed, ClinicalTrials.gov, FDA, NIH, CMS, and others) and refreshed nightly. Classifications and derived metrics are produced by automated methods described in our Methodology. We recommend verifying critical data points against the primary sources before making decisions.