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You have full access to this article via your institution. Download PDF Although the potential of personalized medicine based on genomic knowledge has been widely discussed for more than a
decade, the pace of implementation has been less rapid than initially hoped. To better understand the current role of personalized medicine and pharmacogenomics in drug development, the
Tufts Center for the Study of Drug Development conducted interviews and a follow-up survey of a group of companies about the current role of personalized medicine and pharmacogenomics in
their company. Overall, information was collected from 21 companies (9 major biotechnology companies and 12 large pharmaceutical companies) between 2009 and 2010; see Supplementary
information S1 (box) for details). When asked what percentage of their company's current clinical development pipeline comprised personalized medicines, responses ranged from 12% to
50%. Up to half of a company's pipeline projects could have associated biomarkers, but substantially fewer projects (10% or less) had identified specific target populations or companion
diagnostics. All companies noted that biomarker research is done for compounds before they enter clinical development. However, having a biomarker was not a requirement to move into
clinical development for 70% of the companies; in addition, the follow-up survey indicated that across the companies about half of the compounds in early stages of development and a third in
late stages use biomarker data in the development process (Fig. 1a). All of the companies explained that the primary intent of biomarker development was to provide more information about
products internally, not for prescribing or monitoring a marketed product. For this reason, the few companies that require associated biomarkers for compounds in development also require
personalized medicine end points for all trials, and use these end points for decision making. These measures of usage across company pipelines varied considerably between therapeutic areas.
As indicated in Fig. 1b, oncology was the most cited area in which the companies that were investigated were focusing their personalized medicine research and development (R&D) efforts.
The responses indicated that R&D activity was also robust in immunology and neurology, as well as rapidly advancing in other therapeutic areas such as anti-infectives and
metabolic/endocrine disorders. Beyond the scientific problems, respondents considered that utilizing pharmacogenomic data was challenging because of a lack of regulatory guidance. Although
progress has been made — such as the release of draft guidance from the US Food and Drug Administration on pharmacogenomics in early-phase clinical studies — many companies felt that they
were unable to use pharmacogenomic data in an approval package until pathways are better defined. Overall, the respondents were generally optimistic about personalized medicine as a more
promising path forward for the industry than the blockbuster model. This approach may enable the industry to overcome its productivity shortfall, so they believe, because targeted medicines
are more likely to tip the scales of regulators' benefit–risk decisions in favour of approval, as well as influence payers' product value assessment more favourably towards
reimbursement. Thus, respondents believed that the impact of personalized medicines on R&D generally, on company portfolios and in the marketplace will be strongly felt for the
foreseeable future. AUTHOR INFORMATION AUTHORS AND AFFILIATIONS * Rachael Zuckerman and Christopher-Paul Milne are at the Tufts Center for the Study of Drug Development, Tufts University,
192 South Street, Suite 550, Boston, Massachusetts 02111, USA., Rachael Zuckerman & Christopher-Paul Milne Authors * Rachael Zuckerman View author publications You can also search for
this author inPubMed Google Scholar * Christopher-Paul Milne View author publications You can also search for this author inPubMed Google Scholar CORRESPONDING AUTHORS Correspondence to
Rachael Zuckerman or Christopher-Paul Milne. ETHICS DECLARATIONS COMPETING INTERESTS The authors declare no competing financial interests. SUPPLEMENTARY INFORMATION SUPPLEMENTARY INFORMATION
S1 Survey methodology (PDF 133 kb) RIGHTS AND PERMISSIONS Reprints and permissions ABOUT THIS ARTICLE CITE THIS ARTICLE Zuckerman, R., Milne, CP. Industry perspectives on personalized
medicine. _Nat Rev Drug Discov_ 11, 178 (2012). https://doi.org/10.1038/nrd3677 Download citation * Published: 01 March 2012 * Issue Date: March 2012 * DOI: https://doi.org/10.1038/nrd3677
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