Navigating Between Right, Wrong, and Relevant: The Use of Mathematical Modeling in Preclinical Decision Making.

The goal of this mini-review is to summarize the collective experience of the authors for how modeling and simulation approaches have been used to inform various decision points from discovery to First-In-Human clinical trials. The article is divided into a high-level overview of the types of problems that are being aided by modeling and simulation approaches, followed by detailed case studies around drug design (Nektar Therapeutics, Genentech), feasibility analysis (Novartis Pharmaceuticals), improvement of preclinical drug design (Pfizer), and preclinical to clinical extrapolation (Merck, Takeda, and Amgen).

Informations de copyright

Copyright © 2022 Kondic, Bottino, Harrold, Kearns, Musante, Odinecs, Ramanujan, Selimkhanov and Schoeberl.

Déclaration de conflit d'intérêts

At present, AK and AO are employees of Nektar Therapeutics; CJM works at Pfizer, JS and DB at Takeda, BS and JK are employees of Novartis, JH works at Seattle Genetics and SR at Genentech. The Merck, Pfizer and Amgen case studies are based on previously published work when AK, JS and JH were at those companies. For each case study, all non-contributing authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.