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

  • Kenneth A. GetzEmail author
  • Annick de Bruin


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.

Key Words

Drug development Successful practices 


Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.


  1. 1.
    Hallahan M. Hey Big Spender. Pharmaceutical Executive. December 1999:70–77.Google Scholar
  2. 2.
    Data from PharmaProjects CD-ROM. Richmond, Surrey, UK: PJB Ltd., December 1999.Google Scholar
  3. 3.
    DiMasi J. Impact Report. Tufts Center for the Study of Drug Development. April 1999, p 1–3.Google Scholar
  4. 4.
    Kaitin K. Faster Phase II. Clinical Trials. Institute for International Research Conference, Philadelphia, PA. November 1999.Google Scholar
  5. 5.
    Losing Ground in the Battle Against Development Delays. CenterWatch Newsletter. Boston, MA: CenterWatch, Inc., December 1998;1:3-6.Google Scholar
  6. 6.
    Arlington S. “Emerging Clinical Industry Standards in Pharmaceutical Development.” In: 1998 Pharmaceutical R&D Statistical Sourcebook. Waltham, MA. Parexel, 1998; p 3.Google Scholar
  7. 7.
    Correcting the Public CR. Market. CenterWatch Newsletter. Boston, MA: CenterWatch. Inc.; October 1999;1:5-8.Google Scholar
  8. 8.
    An Industry in Evolution. CenterWatch Newsletter. Boston, MA: CenterWatch, Inc.; 1999;71.Google Scholar
  9. 9.
    Sponsors Working to Make the Grade. CenterWatch Newsletter. Boston, MA: CenterWatch, Inc.; March 1999;1:3-7.Google Scholar
  10. 10.
    Getz K, Brookman S, Fisher S. Managing research centers as a portfolio of strategic assets. Drug Inf J 1995;29(2):551–562.CrossRefGoogle Scholar
  11. 11.
    Will EDC Finally Catch On? Center Watch Newsletter. Boston, MA: CenterWatch, Inc.; September 1999;1:5-8.Google Scholar

Copyright information

© Drug Information Association, Inc 2000

Authors and Affiliations

  1. 1.CenterWatchBostonUSA

Personalised recommendations