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Personalized medicines in late-stage development

Nature Reviews Drug Discovery volume 13, pages 324–325 (2014)Cite this article

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As advances in genomics, proteomics and imaging technologies help reveal more about the molecular basis of disease and drug response, biomarkers are increasingly being used to develop diagnostics that could help to differentiate, or stratify, the likely outcomes of therapeutic intervention — an approach often described as personalized medicine. However, the pace of the uptake of personalized medicine is widely perceived to have been slower than hoped. With the aim of helping to understand the current status of the field, in the latter part of 2013 the Tufts Center for the Study of Drug Development (CSDD) conducted a study examining the numbers and characteristics of personalized medicines in the late-stage pipeline (defined as beyond Phase II trials), which we report here.

The study used commercial databases, CSDD proprietary databases, as well as publicly available data sources, including the ClinicalTrials.gov website. A total of 850 products were identified as being in late-stage development (as defined above), and we found that 169 of these candidate drugs were initially identified as personalized medicines using basic search terms, but upon closer scrutiny only ~40% (n = 66) were reasonably likely to be marketed as such if approved; see Supplementary information S1 (box) for details and Supplementary information S2 (table) for a list of the products. Of these personalized medicines, approximately two-thirds have associated diagnostics that are considered by the authors to be companion diagnostics (that is, they are co-developed with a specific drug and linked to it by labelling), whereas the other one-third have associated complementary diagnostics (that is, they enhance patient stratification or utilization of the drug, but may be linked to a drug class rather than specific drugs, and typically do not require simultaneous approval).

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Figure 1: Personalized medicines in the late-stage pipeline.

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Authors and Affiliations

  1. Tufts University at the time of this study, working under the aegis of the Tufts Center for the Study of Drug Development, Tufts University Medical School, 75 Kneeland St, Suite 1100, Boston, 02111, Massachusetts, USA

    Christopher-Paul Milne, Steve Garafalo, Crystal Bryan & Marie McKiernan

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  1. Christopher-Paul Milne
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  2. Steve Garafalo
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  3. Crystal Bryan
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  4. Marie McKiernan
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Corresponding author

Correspondence to Christopher-Paul Milne.

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The authors declare no competing financial interests.

Supplementary information

Supplementary information S1 (box)

Details of data and analysis (PDF 176 kb)

Supplementary information S2 (Table)

Details of the 66 identified personalized medicines in late-stage development (PDF 191 kb)

Supplementary information S3 (figure)

Annual revenues (in 2012) of 68 companies identified with personalized medicines in late-stage development. (PDF 144 kb)

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Milne, CP., Garafalo, S., Bryan, C. et al. Personalized medicines in late-stage development. Nat Rev Drug Discov 13, 324–325 (2014). https://doi.org/10.1038/nrd4325

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