The FDA Is Encouraging The Use of Biomarkers In Clinical Trials And, In A Few Cases, Requiring The Development Of Companion Diagnostics

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Biotechnology and pharmaceutical companies are increasingly looking to biomarkers to help them increase R&D productivity and clinical trial success rates. They are using biomarkers to eliminate toxic compounds early in the development process and to improve patient selection in clinical trials. These companies are also interested in using biomarkers as tools for improving the effectiveness of target validation by connecting it more closely with clinical outcomes. In addition, researchers are using biomarkers in cellular assays for drug discovery. Despite the growing enthusiasm for biomarkers, their use for drug discovery and development is still in its early stages.

Decision Resources describe the various types and applications of current and emerging biomarkers and discuss industry's interest in the uses of these tools in drug discovery and development. We also explore regulatory and business issues that impact the development of the biomarker market sector and highlight the activities of select companies in the field.

Business Implications

• Biomarkers are an increasing focus of drug discovery and development organizations. Companies are seeking to use biomarkers to improve R&D productivity and clinical trial success. Biomarkers also promise to become important tools for eliminating toxic compounds early in development, improving target validation, and creating cellular assays for drug discovery.

• Researchers may develop biomarkers used in clinical trials to select patients, to assess a drug's efficacy, and/or as companion diagnostics for use in prescribing the drug or for monitoring its effects. Several companion diagnostics for molecularly targeted oncology drugs, including trastuzumab (Genentech's Herceptin), imatinib mesylate (Novartis's Gleevec), and cetuximab (ImClone's Erbitux), are already on the market.

• Despite the growing enthusiasm for biomarkers, their identification, validation, and use for drug discovery and development are still in their early stages. The difficulty and cost of characterizing and validating and/or qualifying new biomarkers have hampered rapid development in this field. To date, biomarker development has not yet improved pharmaceutical productivity.

• The identification and use of biomarkers are increasingly required steps in pharmaceutical company drug discovery and development efforts, and the advent of molecularly targeted cancer drugs is driving the development of companion diagnostics. The FDA is encouraging the use of biomarkers in clinical trials and, in a few cases, requiring the development of companion diagnostics. Nevertheless, industry skepticism abounds about the prospect of large-scale commercialization of biomarkers. Commercialized biomarkers are likely to emerge one at a time from drug discovery and development efforts and to be codeveloped with established diagnostics companies.

Topics Covered

• Introduction
  
• Biomarker Types and Applications
  
• Industry Interest in Biomarkers and Their Uses
  
• Identification and Application of Biomarkers
  
• Biomarkers: Still an Early-Stage Technology
  
• The FDA and Biomarkers
  
• Business Models for Biomarker Development
  
• Oncology: The First Major Use of Biomarkers
  
• Case Study: Gene Expression Profiles as Biomarkers in Drug Discovery
  
• Corporate Profiles
  
• Outlook for Biomarkers in Drug Discovery and Development

Companies mentioned in this report include:

SOURCE: Research and Markets