Abstract
Reversing a 12-year trend, development cycle times have declined by 18% in the most recent three-year period. This paper explores the factors and company practices that are contributing to development speed. The authors analyzed 725 approved New Chemical Entities (NCEs) and conducted 19 interviews among representatives from the fastest drug development companies. Results show a high variability in cycle time—from Investigational New Drug (IND) filing to New Drug Application (NDA) submission—overall and within individual therapeutic areas. In addition, the fastest drug development companies consistently outperform their peers in multiple therapeutic areas, suggesting that successful practices can be generalized. Five primary speed drivers are identified as historical successful practices several practices are identified as potential future speed drivers.
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