Safety differentiation: emerging competitive edge in drug development.

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 riskbenefit 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 riskbenefit profiles evolve. Key success criteria include scientific expertise and integration between all disciplines during the full extent of the drug development process.