Disease-Related Biomarkers: Their Potential in Patient Screening, Prognosis, and Stratification

By Ken Rubenstein, PhD

FIGURES

Figure 2.1. Readout from an Affymetrix DNA Microarray Experiment

Figure 2.2. Affymetrix Photolithographic Process for DNA Microarray Manufacturing

Figure 4.1. National Cancer Institute Early Detection Research Network Organization

Figure 5.1. FDA’s Schematic View of a Typical Drug-Diagnostic Development Program

Figure 6.1. Respondents by Type of Organization

Figure 6.2. Pharmaceutical and Biopharmaceutical Company Respondents by Sector

Figure 6.3. Pharmaceutical and Biopharmaceutical Company Respondents by Position

Figure 6.4. Respondents by Stage of Work

Figure 6.5. Respondents by Research Focus

Figure 6.6. Involvement with Biomarkers by Pharmaceutical and Biopharmaceutical Companies

Figure 6.7. Types of Biomarkers Used

Figure 6.8. View toward Collaboration in Biomarker Development

Figure 6.9. Experience with Novel Disease-Related Biomarkers

Figure 6.10. In-licensing or Acquisition of Novel Disease-Related Biomarkers by Pharmaceutical and Biopharmaceutical Companies

Figure 6.11. Discovery or Development of Disease-Related Biomarkers by Pharmaceutical and Biopharmaceutical Companies

Figure 6.12. Means of Biomarker Discovery or Development

Figure 6.13. Technologies Used for Biomarker Discovery

Figure 6.14. Focus of Disease-Related Biomarker Work

Figure 6.15. Expected Fiscal 2007 Budget for Disease-Related Biomarkers

Figure 6.16. Diagnostics and Biomarker Discovery Company Respondents by Sector

Figure 6.17. Involvement with Biomarkers by Diagnostics and Biomarker Discovery Companies

Figure 6.18. Diagnostics and Biomarker Discovery Company Respondents by Position

Figure 6.19. Discovery or Development of Disease-Related Biomarkers by Diagnostics and Biomarker Discovery Companies

Figure 6.20. In-licensing or Acquisition of Disease-Related Biomarkers by Diagnostics and Biomarker Discovery Companies

Figure 6.21. Therapeutic Areas of Biomarker Work

Figure 6.22. Mode of Regulatory Approval

TABLES

Table 3.1. Selected Noncommercial Biomarker Programs in Cancer

Table 3.2. Selected Commercial Biomarker Products and Programs in Cancer

Table 3.3. Selected Noncommercial Biomarker Programs in Neurology

Table 3.4. Selected Commercial Biomarker Products and Programs in Neurology

Table 3.5. Selected Noncommercial Biomarker Programs in Cardiovascular and Metabolic Diseases

Table 3.6. Selected Commercial Biomarker Products and Programs in Cardiovascular and Metabolic Diseases

Table 3.7. Selected Noncommercial Biomarker Programs in Autoimmune and Inflammatory Diseases

Table 3.8. Selected Commercial Biomarker Products and Programs in Autoimmune and Inflammatory Diseases

Table 3.9. Selected Noncommercial Programs in Other Therapeutic Areas

Table 5.1. Stages of Commercial Disease-Related Biomarker Programs

Table 5.2. Stages of Noncommercial Disease-Related Biomarker Programs

Table 5.3. Deals Involving Disease-Related Biomarkers

Table 5.4. Analysis of Deal Types