Abstract
The pharmaceutical market arena is changing faster than in the past which forces pharmaceutical companies to adapt their drug development accordingly. In order to move more products to market faster, innovative operations and processes should be explored and implemented. Both a team-driven environment and a simplified operational framework significantly add value to the overall drug development process, cutting down development cycle times. The strategic drug development (SDD) concept emanates from the idea of consequently following the experience curve with a clear focus on competing against time. SDD has been used since 1990 in 14 new chemical entity (NCE) early phase clinical development projects. This paper presents a decrease in development cycle time achieved by an accumulation of experience, summarizes significant time advantages by learning, and thus, indicates options to manifest durable competitive advantages in the area of drug development.
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