Personalized Medicines Are Shaping the Way Drug Development Is Done

Personalized medicine development, occupying an increasing role in the clinical pipelines of drug developers, is leading companies to alter their research and development (R&D) paradigms, including how they make go/no-go decisions, according to a completed study.

"Early indications show that development of personalized medicines is commanding more resources and fomenting more organizational change than is generally appreciated outside the industry,” said Dr. Christopher-Paul Milne, associate director at Tufts [University] Center for the Study of Drug Development (CSDD; Boston, MA, USA) and author of the study.

Dr. Miller noted that the scientific, regulatory, commercial, and practical challenges confronting developers in creating personalized medicines are significant, and as a result, approaches taken by individual companies in the search for these new medicines vary greatly. In particular, developers are working with academic medical centers to better understand disease mechanisms and identify strata of target populations, and with diagnostics developers to augment in-house capabilities.

The analysis, the first of its kind to measure the pharma/biotech industry's progress in developing personalized medicines, was based on interviews and a survey of nearly two dozen companies that are leading the way in this new field.

The study, reported in the November/December 2010 Tufts CSDD Impact Report, also found that (1) the extent of resources required to create personalized medicines means developers must team with multiple external partners, presenting challenges for project stewardship and intellectual property rights. (2) Biomarkers increasingly are used to understand patient response better, but companies still cannot use biomarker data to support approval until the regulators' capacity to asses it catches up to the science. (3) Lastly, oncology leads other therapeutic areas in the number of personalized medicines on the market as well as in the pipeline with the expectation that within the decade all oncology drugs will have a related diagnostic.

Other major therapeutic areas in which personalized medicine is making advances include cardiovascular, central nervous system, and immunologic therapies, whereas personalized medicine development is just getting started for metabolic and respiratory therapies, as well as virology.

Dr. Milne presented his results of his study on November 18, 2010, at a conference, Personalized Medicine: Impacting Healthcare, held at Harvard Medical School (Boston, MA, USA).

The Tufts Center for the Study of Drug Development at Tufts University provides strategic information to help drug developers, regulators, and policy makers improve the quality and efficiency of pharmaceutical development, review, and utilization. Tufts CSDD conducts a wide range of in-depth analyses on pharmaceutical issues and hosts symposia, workshops, and public forums, and publishes Tufts CSDD Impact Reports, a bi-monthly newsletter providing analysis and insight into drug development issues.

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