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Investigative safety science as a competitive advantage for Pharma

Moggs, Jonathan and Moulin, Pierre and Pognan, Francois and Brees, Dominique and Bouisset-Leonard, Michele and Busch, Steven and Cordier, Andre and Heard, David and Kammueller, Michael and Merz, Michael and Bouchard, Page and Chibout, Salah-Dine (2012) Investigative safety science as a competitive advantage for Pharma. Expert Opinion on Drug Metabolism and Toxicology, 8 (9). pp. 1071-1082. ISSN 1742-5255

Abstract

Introduction: Following a US National Academy of Sciences report in 2007 entitled “Toxicity Testing of the 21st Century: a Vision and a Strategy”, significant advances within translational drug safety sciences promise to revolutionize drug discovery and development. Here we outline why investigative safety science is a competitive advantage for Pharma.
Areas covered: Essential goals for modern investigative toxicologists are discussed including the cross-species target biology, molecular pathways of toxicity, and development of predictive tools, models and biomarkers that allow discovery researchers and clinicians to anticipate safety problems and plan ways to address them, earlier than ever before. Furthermore, we emphasize the importance of investigating unanticipated clinical safety signals through a combination of mechanistic pre-clinical studies and/or molecular characterization of clinical samples from affected organs.
Expert Opinion: The traditional boundaries between Pharma industry teams focusing on safety/efficacy and preclinical/clinical development are rapidly disappearing in favor of translational safety science-centric organizations with a vision of bringing more effective medicines forward safely and quickly. Comparative biology and mechanistic toxicology approaches facilitate: 1) identifying translational safety biomarkers; 2) identifying new drug targets/indications; 3) mitigating off-target toxicities. These value-adding safety science contributions will change traditional toxicologists from side-effect identifiers to drug development enablers.

Item Type: Article
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Additional Information: No Novartis projects or targets are discussed. This review article highlights some current trends and future directions for drug safety sciences within the Pharma industry.
Keywords: investigative, safety, toxicology
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Date Deposited: 13 Oct 2015 13:14
Last Modified: 13 Oct 2015 13:14
URI: https://oak.novartis.com/id/eprint/7378

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