Companion Biomarkers in Drug Development

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Publication Date: 2009-04-01

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The term "companion biomarker" means that a particular diagnostic test is specifically linked to a therapeutic drug either in drug development or in the clinic. Biomarkers of disease have long played an important role in diagnostic medicine as evidenced by the intense use of specific clinical laboratory tests in the diagnosis of disease. Biomarkers can be used in five very distinct ways in drug development:

1) companion biomarkers can be correlated with biological events during drug development in order to validate drug targets or to predict drug response;

2) biomarkers can be used as companion diagnostics in drug development to characterize patient populations in order to better understand the extent to which new drugs reach intended therapeutic targets can alter proposed therapeutic pathways and achieve successful clinical outcomes;

3) biomarkers can be used to stratify patient populations for drug response in primary prevention or disease-modification studies, particularly in specific clinical areas such as neuron degeneration and cancer;

4) clinically useful biomarkers are becoming increasingly useful to make proper therapeutic decisions regarding candidate drugs; and

5) clinically useful biomarkers are becoming increasingly required by the FDA and other outside authorities to make proper regulatory decisions regarding candidate drugs.

This report describes new biomarker technology platforms developed for the analyses of drug targets that are connected to the effectiveness of therapeutic agents in a clinical setting. The emphasis is on those companies that are actively developing and marketing new companion diagnostic tests for performing biomarker tests during drug development, as opposed to the more routine and clinically accepted companion markers that are manufactured and marketed by large diagnostic companies for routine clinical use.

Table of Contents

  • Appendix 1: FDA Guidance for Industry: Pharmacogenomic Data Submission309
  • A 1.1Introduction309
  • A 1.2 Background309
  • A 1.3Submission Policy310
  • A 1.3.1General Principles310
  • A 1.3.2Specific Uses of Pharmacogenomic Data in Drug Development and Labeling311
  • A 1.3.3Benefits of Voluntary Submissions to Sponsors and FDA312
  • A 1.4Submission of Pharmacogenomic Data313
  • A 1.4.1Submission of Pharmacogenomic Data during the IND Phase313
  • A 1.4.2Submission of Pharmacogenomic Data to a New NDA, BLA, or Supplement314
  • A 1.4.3Submission to a Previously Approved NDA or BLA315
  • A 1.4.4Compliance with 21 CFR Part 58315
  • A 1.4.5Submission of Voluntary Genomic Data from Application-Independent Research316
  • A 1.5Format and Content of a VGDS316
  • A 1.6Process for Submitting Pharmacogenomic Data317
  • A 1.7Agency Review of VGDSs317

  • Glossary319


  • INDEX OF FIGURES

  • Figure 2.1: Drug Discovery and Development Paradigm24
  • Figure 2.2: Paradigm of Drug Discovery and Development Illustrating the Central and Essential Role of Biomarkers in Screening25
  • Figure 2.3: Functional Genomic Process for Drug Development26
  • Figure 2.4: Reimbursement for Diagnostics in Healthcare Decision Making30
  • Figure 2.5: Market Growth and Evolution of Companion Biomarkers31
  • Figure 2.6: Medical Product Development Models32
  • Figure 2.7: Segmentation of the Biomarker Development Market33
  • Figure 2.8: Medical Research in the U.S. Outpaces the Rest of the World45
  • Figure 2.9: Worldwide Pharmaceutical Products Markets48
  • Figure 2.10: Biomarkers Market Drivers58
  • Figure 2.11: Challenges in the Biomarkers Space59
  • Figure 2.12: FDA Co-Developed Products64
  • Figure 3.1: Informatics Applications Along the Drug Discovery Value Chain91
  • Figure 3.2: Bioinformatics Software Flow Chart91
  • Figure 3.3: Growth of GenBank, 1982 - 200892
  • Figure 3.4: Role of Bioinformatics in the Drug Discovery Value Chain102
  • Figure 3.5: Challenges in the Study or Utilization of Proteomic Biomarkers107
  • Figure 3.6: Challenges in the Study or Utilization of Companion Diagnostic Biomarkers107
  • Figure 3.7: Top Unmet Needs in Products in the Biomarkers Space108
  • Figure 4.1: Growth and Evolution of the Biomarker Space120
  • Figure 4.2: Revenue Forecast Projections for Global Biomarker Markets by Segments, 2005 - 2012121
  • Figure 4.3: Biomarker Discovery by Therapeutic Area122
  • Figure 4.4: Kidney Biomarker Paradigm125
  • Figure 4.5: Hepatic Biomarker Paradigm127
  • Figure 9.1: IPRG Biomarker Qualification Process167
  • Figure 9.2: Critical Path for Drug Development180
  • Figure 9.3: Path for R&D Product Development181
  • Figure 9.4: Dimensions of the Critical Path181
  • Figure 9.5: FDA Interactions During Drug Development182
  • Figure 9.6: Problem Resolution During the FDA Review Process182
  • Figure 9.7: VGDS Process Flow193
  • Figure 10.1: Discovery, Validation and Use of Biomarkers201


  • INDEX OF TABLES

  • Table 2.1: Utility of Biomarkers as Companion Diagnostics to Drug Development20
  • Table 2.2: Biomarker End Points in Drug Development22
  • Table 2.3: Value of Biomarkers in Phase II Clinical Trials24
  • Table 2.4: Comparative Genome Sizes of Humans and Other Organisms27
  • Table 2.5: Global Pharmaceutical Drug Sales, 2004 - 201238
  • Table 2.6: Worldwide Generic Pharmaceutical Drug Market, 2003 - 201239
  • Table 2.7: Worldwide OTC Pharmaceutical Drug Market, 2003 - 2012 39
  • Table 2.8: Worldwide Biopharmaceutical Drug Market, 2003 - 2012 40
  • Table 2.9: Top Ten Pharmaceutical Companies by Worldwide Sales, 200840
  • Table 2.10: Pharmaceutical Companies' Drug Sales as Percent of the Worldwide Market, 200841
  • Table 2.11: Threats to Pharmaceutical Industry Productivity42
  • Table 2.12: Competitive Forces Governing the Pharmaceutical Industry 42
  • Table 2.13: Time Line for Development of Companion Diagnostics43
  • Table 2.14: Leading Therapy Classes for R&D, 2008 44
  • Table 2.15: Global Pharmaceutical Industry R&D Spending, 1995 - 200846
  • Table 2.16: Pharmaceutical R&D Expenditures by World Region, 1990 - 2006 46
  • Table 2.17: U.S. Government NIH Research Budget, 1995 - 200847
  • Table 2.18: Pharmaceutical Companies Ranked by Total R&D Expenditures, 200647
  • Table 2.19: Global Pharmaceutical Sales by Region, 200748
  • Table 2.20: World's Top-Selling Drugs, 200749
  • Table 2.21: Top Pharmaceutical Companies by Healthcare Revenue, 200850
  • Table 2.22: Leading Therapy Classes by Global Pharmaceutical Sales, 200750
  • Table 2.23: Leading Ten Therapeutic Classes by U.S. Sales, 2003, 2006 and 200750
  • Table 2.24: Top Ten Therapeutic Classes by U.S. Dispensed Prescriptions, 2006 and 200751
  • Table 2.25: Top Ten Brand Drugs by Retail Dollars, 200751
  • Table 2.26: Pharmaceuticals Industry Challenges54
  • Table 2.27: Reasons for Developing Phase I Biomarkers55
  • Table 2.28: Percentage of Non-Responders in Various Drug Classes56
  • Table 2.31: High Profile Drug Withdrawals from the Marketplace56
  • Table 2.30: Market Opportunities in Biomarkers59
  • Table 2.31: Challenges for Market Adoption of the Various Biomarkers Tests60
  • Table 2.32: Biomarkers Industry SWOT62
  • Table 3.1: Worldwide Microarray Market Size, 2004 - 201271
  • Table 3.2: List of DNA Array Manufacturers78
  • Table 3.3: U.S. qRT-PCR Market, 2007 - 201384
  • Table 3.4: Theranostics Technology Platforms-Timeline of Impact85
  • Table 3.5: Impact of Personalized Medicine on Various Therapeutic Areas86
  • Table 3.6: Hurdles in Biomarkers Development in Therapeutic Areas87
  • Table 3.7: Data Source and Bioinformatic Investigations95
  • Table 3.8: Drivers and Challenges of the Bioinformatics Industry98
  • Table 3.9: Bioinformatics Activities, Sub-Activities and Key Players104
  • Table 3.10: Concentration of Some Abundant Proteins, New Cancer Biomarkers Identified by SELDI-TOF, and Classical Cancer Biomarkers in Serum113
  • Table 3.11: Device Submission Elements for the FDA113
  • Table 3.12: Toxicogenomic Standards and Their Organizations117
  • Table 3.13: Genomic and Proteomic Technologies118
  • Table 4.1: Companion Biomarker Market Size, 2008 - 2013.119
  • Table 4.2: Kidney Biomarkers126
  • Table 4.3: Herceptin Worldwide Sales, 1999 - 2007129
  • Table 4.4: Characteristics of Different Cancer Biomarker Types and Associated Market Opportunities130
  • Table 4.5: Segmentation of the Cancer Biomarker Market by Type of Cancer Biomarkers and Market Size131
  • Table 4.6: Cancer Biomarker Market Estimates by Tissue of Origin132
  • Table 4.7: Companies Developing New Proteomic Cancer Biomarker Technology Platforms133
  • Table 4.8: Cancer Biomarkers Used to Maximize Likelihood of Response134
  • Table 4.9: Biomarkers for Monitoring Therapeutic Effectiveness and Resistance135
  • Table 6.1: Contract Research Companies146
  • Table 8.1: Stakeholders in Biomarker Development154
  • Table 9.1: Structure of the Critical Path172
  • Table 9.2: Device Submission Elements for the FDA184

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