Breaking the Development Speed Barrier: Assessing Successful Practices of the Fastest Drug Development Companies

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 a...

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Bibliographic Details
Published inDrug information journal Vol. 34; no. 3; pp. 725 - 736
Main Authors Getz, Kenneth A., de Bruin, Annick
Format Journal Article
LanguageEnglish
Published Los Angeles, CA SAGE Publications 2000
Springer Nature B.V
Subjects
Cycle time
Drug development
Successful practices
Drug development
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Summary: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.
ISSN:2168-4790
0092-8615
2168-4804
2164-9200
DOI:10.1177/009286150003400308