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

Autor:	Kondic A; Nektar Therapeutics, San Francisco, CA, United States., Bottino D; Takeda Development Center Americas, Inc. (TDCA), Lexington, MA, United States., Harrold J; Seagen Inc., South San Francisco, CA, United States., Kearns JD; Novartis Institutes for BioMedical Research Inc., Cambridge, MA, United States., Musante CJ; Pfizer Worldwide Research Development and Medical, Cambridge, MA, United States., Odinecs A; Nektar Therapeutics, San Francisco, CA, United States., Ramanujan S; Genentech Inc., South San Francisco, CA, United States., Selimkhanov J; Pfizer Worldwide Research Development and Medical, Cambridge, MA, United States., Schoeberl B; Novartis Institutes for BioMedical Research Inc., Cambridge, MA, United States.
Jazyk:	angličtina
Zdroj:	Frontiers in pharmacology [Front Pharmacol] 2022 Apr 12; Vol. 13, pp. 860881. Date of Electronic Publication: 2022 Apr 12 (Print Publication: 2022).
DOI:	10.3389/fphar.2022.860881
Abstrakt:	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). Competing Interests: 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. (Copyright © 2022 Kondic, Bottino, Harrold, Kearns, Musante, Odinecs, Ramanujan, Selimkhanov and Schoeberl.)
Databáze:	MEDLINE
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