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The drug diagnostic co-development concept paper

Commentary from the 3rd FDA-DIA-PWG-PhRMA-BIO Pharmacogenomics Workshop

The Pharmacogenomics Journal volume 6, pages 375–380 (2006)Cite this article

Abstract

At the Washington DC Pharmacogenomics in Drug Development and Regulatory Decision-Making: Workshop III – Three Years of Promise, Proposals and Progress on Optimizing the Benefit/Risk of Medicines (11–13 April 2005), one break-out session (Track 2) focused on co-development of therapeutic drug and diagnostic products. The Food and Drug Administration (FDA) released a draft concept paper shortly before the workshop was to convene. Track 2 was a forum for initial discussion of the content of the concept paper, and industry's initial reactions. After the workshop, formal commentaries on the co-development concept paper were submitted by several trade associations (e.g., Pharmaceutical Research and Manufacturers of America (PhRMA), Advanced Medical Technology Association (AdvaMed), American Association for Clinical Chemistry) and individual companies to FDA's Docket No. 2004N-0279. This paper includes a summary of the key features of the draft concept paper, the discussion in Track 2 of the April, 2005 meeting and highlights of the industry comments submitted to the FDA docket following the meeting.

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References

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Acknowledgements

We thank Dr Larry Lesko for his thoughtful review and helpful comments on this manuscript.

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Authors and Affiliations

  1. Hoffmann-La Roche Inc., Nutley, NJ, USA

    L M Hinman

  2. Office of Clinical Pharmacology and Biopharmaceutics, Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), Silver Spring, MD, USA

    S-M Huang

  3. Office of In Vitro Device Evaluation and Safety, Center for Devices and Radiological Health (CDRH), FDA, Rockville, MD, USA

    J Hackett

  4. Roche Molecular Systems, Pleasanton, CA, USA

    W H Koch

  5. Office of Combination Products, Office of the Commissioner, FDA, Rockville, MD, USA

    P Y Love & A Torres-Cabassa

  6. Division of Biostatisics, Diagnostics Branch, CDRH, FDA, Rockville, MD, USA

    G Pennello

  7. Millenium Pharmaceuticals Inc., Cambridge, MA, USA

    C Webster

Authors
  1. L M Hinman
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  2. S-M Huang
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  3. J Hackett
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  4. W H Koch
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  5. P Y Love
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  6. G Pennello
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  7. A Torres-Cabassa
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  8. C Webster
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Corresponding author

Correspondence to L M Hinman.

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Disclaimer: The views expressed here are those of the authors and do not necessarily reflect those of FDA, Hoffmann-La Roche or Millenium.

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Hinman, L., Huang, SM., Hackett, J. et al. The drug diagnostic co-development concept paper. Pharmacogenomics J 6, 375–380 (2006). https://doi.org/10.1038/sj.tpj.6500392

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