Peer-Reviewed Publication
Toxicol Pathol2026;1926233261455350.August 28, 2026Journal Article
Toxicologic Pathology Forum: ESTP/STP Working Group Opinion on the Evolving Landscape of New Approach Methodologies in Drug and Chemical Safety Development.
Nadine Stokar-Regenscheit1, Brian Berridge2, Julia Kühnlenz3, Frederic Schorsch3, Danilo Tagle4, Passley Hargrove-Grimes4, Dirk Schaudien5, Kerstin Hahn1, Martina Stirn1, Deidre A Dalmas6, Randolph S Ashton7,8, James Baily9, Eliah R Shamir10, Charles Havnar10, Camila Dores11, Tanja S Zabka10, Radhakrishna Sura12, Lindsay Tomlinson13, Steven T Laing10
1F. Hoffmann-La Roche Ltd, Basel, Switzerland.
2B2 Pathology Solutions LLC, Cary, North Carolina, USA.
3Bayer SAS, Sophia Antipolis, France.
4National Center for Advancing Translational Sciences/National Institutes of Health, Rockville, Maryland, USA.
5Fraunhofer Institute for Toxicology and Experimental Medicine, Hannover, Germany.
6Boehringer Ingelheim, Collegeville, Pennsylvania, USA.
7University of Wisconsin-Madison, Madison, Wisconsin, USA.
8Neurosetta LLC, Madison, Wisconsin, USA.
9Charles River Laboratories Edinburgh Ltd, Tranent, UK.
10Genentech, South San Francisco, California, USA.
11Altasciences, Everett, Washington, USA.
12Gilead Sciences Inc., Foster City, California, USA.
13Alnylam Pharmaceuticals, Cambridge, Massachusetts, USA.
Abstract
In April 2025, the US Food and Drug Administration (FDA) introduced a bold roadmap to phase out animal testing in drug development by promoting the integration of New Approach Methodologies (NAMs), beginning with monoclonal antibodies (mAbs). Similar roadmaps have also been created by European health authorities and chemical safety agencies around the globe. This opinion paper from the European So…
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