Biomarkers in Drug Discovery - Earlier Usage of Biomarkers in Optimization Stage to Reduce Drug Attrition Rate Significantly
- Published: October 2011
Biomarkers have the potential to play a valuable role in simplifying the pharmaceutical development process. They can be used to identify patient populations, improve dosing regimens, and alter delivery routes to adjust responses.
This report describes how biomarkers (both tumor markers and imaging biomarkers) are developed and evaluated. In particular, the report focuses on the ways biomarkers have been used in clinical trials to date. We discuss the challenges in the development and use of assay-based biomarkers and examine ways in which biomarkers may impact oncology clinical development strategies, particularly as the number of targeted therapeutics in development continues to rise. We profile select drugs and review how the use of biomarkers—or the failure to incorporate biomarkers--influenced their development and later market success. Finally, we detail the regulatory response to the use of biomarkers and provide insight into the future of oncology clinical development.
- The identification and development of biomarkers for use in evaluating oncology biotherapeutics and drugs has the potential to simplify the arduous drug development pathway. Biomarkers can be used for both existing and emerging therapeutics to identify patient populations, improve dose regimens, and alter delivery routes to adjust responses.
- Increasingly, drug developers are looking for discrete, measurable end points for clinical trials to augment or replace the more traditional clinical end points of mortality and morbidity. The incorporation of these surrogate end points can be challenging, and care must be taken in the selection and validation of biomarker end points to ensure that they are accurate, relevant, and correlate well to clinical efficacy.
- Diagnostic tests used in combination with cancer therapies, particularly biotherapeutics, will become increasingly important. The ability to identify patients more likely to respond positively to a treatment is critical to developing the market for that biotherapy. As a result, we expect the identification of biomarkers and the development of assays to identify potentially responsive patients to become a routine part of product development.
- The FDA is committed to the development and application of biomarkers for use in oncology clinical trials. The agency has initiated specific projects such as guidance on pharmacogenomics and on genomic data submissions, including drug/test combinations, to improve the efficiency of drug development. In addition, the agency has created a regulatory path for the voluntary submission of pharmacogenomic data and is developing an advisory committee that will recommend ways to incorporate genomic biomarkers into clinical trials.
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Improving Cancer Therapies
Going Beyond Survival
Developing and Evaluating New Biomarkers
Application to Oncology Clinical Trials
The Future of Oncology Clinical Development
Table 1. Development Status of Gefitinib (AstraZeneca’s Iressa)
Table 2. Benefits and Risks of Biomarker Use in Drug Development
Figure 1. Growth of Novel Oncology Therapeutics, 2003-2004
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