Modernizing Preclinical Drug Development: The Role of New Approach Methodologies

Phase I

MIDD

QSP

Preclinical

Regulatory interactions

ACS Pharmacol. Transl. Sci. 2025, 8, 6, 1513–1525

Mehta K, Maass C, Cucurull-Sanchez L, Pichardo-Almarza C, Subramanian K, Androulakis IP, Gobburu J, Schaller S, Sherwin CM

The FDA recently announced its plans to reduce animal testing in preclinical studies in favour of more effective, human-relevant methods, using a range of New Approach Methodologies (NAMs).

To help drug developers to navigate this new paradigm, our QSP Scientific Lead Lourdes Cucurull-Sanchez has co-authored a paper outlining how and when #QSP (Quantitative Systems Pharmacology) among other in silico tools, can be used to phase out animal testing in a cost-efficient, timely and reliable way.

QSP simulations rely on in vitro data generated in human molecular or cell-based systems, as well as contemporary knowledge and clinical data about human biology, physiology and natural history of disease. In the current context, this direct relationship to human systems is what confers on QSP simulations the reliability that is lacking from analyses of animal data, whether related to safety or to efficacy endpoints.