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

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.

This is a preview of subscription content, access via your institution.

References

  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.

  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.

  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.

  8. 8.

    An Industry in Evolution. CenterWatch Newsletter. Boston, MA: CenterWatch, Inc.; 1999;71.

  9. 9.

    Sponsors Working to Make the Grade. CenterWatch Newsletter. Boston, MA: CenterWatch, Inc.; March 1999;1:3-7.

  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.

    Article  Google Scholar 

  11. 11.

    Will EDC Finally Catch On? Center Watch Newsletter. Boston, MA: CenterWatch, Inc.; September 1999;1:5-8.

Download references

Author information

Affiliations

Authors

Corresponding author

Correspondence to Kenneth A. Getz.

Rights and permissions

Reprints and Permissions

About this article

Cite this article

Getz, K.A., de Bruin, A. Breaking the Development Speed Barrier: Assessing Successful Practices of the Fastest Drug Development Companies. Ther Innov Regul Sci 34, 725–736 (2000). https://doi.org/10.1177/009286150003400308

Download citation

Key Words

  • Drug development
  • Successful practices