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Safety differentiation: Emerging competitive edge in drug development

Uteng, Marianne, Urban, Laszlo, Brees, Dominique, Mueller, Patrick, Kullak-Ublick, Gerd-Achim, Tougas, Gervais, Bouchard, Page and Chibout, Salah-Dine (2018) Safety differentiation: Emerging competitive edge in drug development. Drug discovery today.


With increasing expectations to provide evidence of drugs’ efficacy, safety and cost-effectiveness, best-in-class is a major value driver for the pharmaceutical industry. Superior safety is a key innovation and differentiation criterion leading to better risk/benefit profiles, safety margins and broader co-medication opportunities. Achieving best-in-class safety profile is a competitive process with significant uncertainty at early stage to be mitigated by novel non-clinical and clinical approaches. Strategic adjustments to a clinical outcome-focused development approach are required upon the continuously evolving risk/benefit profile of a drug candidate. Key success criteria include scientific expertise and effective decisions during the entire drug development process.

Item Type: Article
Date Deposited: 13 Oct 2018 00:45
Last Modified: 13 Oct 2018 00:45