Safety differentiation: emerging competitive edge in drug development
Marianne Uteng1, Laszlo Urban2, Dominique Brees1
1Novartis Institutes for Biomedical Research, Translational Medicine, Pre-Clinical Safety, Basel, Switzerland.
Abstract:
With increasing expectations to provide evidence of drug efficacy, safety, and cost-effectiveness, best-in-class drugs are a major value driver for the pharmaceutical industry. Superior safety is a key differentiation criterion that could be achieved through better risk:benefit profiles, safety margins, fewer contraindications, and improved patient compliance. To accomplish this, comparative safety assessments using innovative and adaptive nonclinical and clinical outcome-based approaches should be undertaken, and continuous strategic adjustments must be made as the risk:benefit profiles evolve. Key success criteria include scientific expertise and integration between all disciplines during the full extent of the drug development process.
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