Biomarkers in Drug Discovery - Earlier Usage of Biomarkers in Optimization Stage to Reduce Drug Attrition Rate Significantly
- Published: October 2011
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Novel Strategies in Oncology Clinical Trials: The Use of Biological and Imaging Biomarkers
Novel Strategies in Oncology Clinical Trials: The Use of Biological and Imaging Biomarkers
- Published: June 2005
- 13 pages
- Decision Resources, Inc
FEATURED COMPANIES
- Abbott
- AstraZeneca
- DakoCytomation
- Genentech
- ImClone
- Novartis
- MORE
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.
Business Implications
- The identification and development of biomarkers for use in evaluating oncology biotherapeutics and drugs has the potential to simplify the arduous drug development
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Improving Cancer Therapies
Going Beyond Survival
Biomarkers Defined
Developing and Evaluating New Biomarkers
Application to Oncology Clinical Trials
Regulatory Response
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
- Abbott
- AstraZeneca
- DakoCytomation
- Genentech
- ImClone
- Novartis
| Format | Properties | |
|---|---|---|
| Electronic (PDF) | The report will be emailed to you. The report is sent in PDF format. | This is a single user license, allowing one specific user access to the product. |
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