Commercializing Biomarkers in Therapeutic and Diagnostic Applications
Biomarkers feature in thousands of published articles each year, evidencing the high level of interest and research in this field. This report focuses on issues that must be addressed to utilize this growing knowledge about biomarkers and successfully commercialize them in therapeutic and diagnostic applications. Included in this publication:
- Biomarker definitions and guidelines for their development and validation
- Applications of biomarkers in oncology, cardiology, neurology, drug safety, and other areas
- Selected companies in the biomarker research products/tools and services market
- Strategies for successful commercialization of biomarkers in the therapeutics and diagnostics markets
- Forty key companies to watch, plus the activities of 175 companies that are commercializing biomarkers and/or systems for their detection and measurement
- Expert interviews
Biomarkers can be valuable tools in clinical diagnostics as well as in therapeutic discovery and development. They can be used to predict response to therapy or risk of side effects for personalized medicine applications. Additional types include predisposition, screening, diagnostic, prognostic, toxicity, pharmacodynamic, and other biomarkers.
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Commercializing Biomarkers in Therapeutic and Diagnostic Applications: From Development to Validated Product focuses on questions that must be addressed to successfully take advantage of the potential of biomarkers. The analysis begins with a discussion of biomarker definitions and related terms, followed by an overview of the different types and applications of biomarkers. This is followed by brief summaries of the range of technologies that may be used to discover, identify, and measure biomarkers. Discussion then turns to a very critical issue: biomarker validation. This includes a discussion of recommendations and guidelines that have been made by many different groups and organizations for biomarker development and validation.
Next, examples are provided of the wide range of current and potential emerging applications of biomarkers in different fields such as oncology, cardiology, neurology, safety, and others. An examination of the market for research products (tools) and services in the field of biomarkers includes a discussion of selected companies and their activities, plus agreements and acquisitions in this area.
As part of a dual focus, Commercializing Biomarkers in Therapeutic and Diagnostic Applications: From Development to Validated Product then analyzes biomarker strategies for diagnostic companies, considering what is required to successfully commercialize biomarkers in the diagnostics market. Discussion includes: identification of novel biomarkers, analytical validation of diagnostic tests for new biomarkers, clinical validation and clinical utility of biomarkers, research and other information needs regarding biomarkers, models and options for diagnostic companies in the field of personalized medicine, strategic options for the delivery of novel biomarker assays, health economics and reimbursement, and other issues.
Similarly, this report also focuses on biomarker strategies for therapeutic development. This includes a discussion of the potential roles of biomarkers in various aspects of drug development, validation of biomarkers, regulatory issues, options for companies developing drug/diagnostic combinations, health economics and reimbursement in personalized medicine, and other issues. Also included is a compilation of agreements between pharmaceutical and diagnostic companies.
Similarly, this report also focuses on biomarker strategies for therapeutic development. This includes a discussion of the potential roles of biomarkers in various aspects of drug development, validation of biomarkers, regulatory issues, options for companies developing drug/diagnostic combinations, health economics and reimbursement in personalized medicine, and other issues. Also included is a compilation of agreements between pharmaceutical and diagnostic companies.
Forty key companies to watch are identified, plus 175 companies that are commercializing biomarkers and/or systems for their detection and measurement. The report concludes with Insight Pharma Reports’ interviews with experts in this field.
Table Of Contents
Executive Summary
Chapter 1
INTRODUCTION
Scope of the Report
INTRODUCTION
Scope of the Report
Chapter 2
BIOMARKER OVERVIEW2.1. What are Biomarkers? Definitions and Terminology
2.2. Types of Biomarkers and Biomarker Applications
2.3. Technology Overview: What Constitutes a Biomarker and How Is It Measured?
2.4. Development and Validation of Biomarkers: Recommendations and Guidelines
FDA, Biomarker Validation, and Fit-for-Purpose Method Validation
NCI/FDA Oncology Task Force
AACR-FDA-NCI Cancer Biomarkers Collaborative
Cancer Biomarkers Research Group, NCI
Cancer Diagnosis Program, NCI
REMARK (REporting recommendations for tumor MARKer prognostic studies)
Biomarkers Task Force of the NCI Investigational Drug Steering Committee
The Biomarkers Consortium
Critical Path Institute
Institute of Medicine
Other Recommendations
BIOMARKER OVERVIEW2.1. What are Biomarkers? Definitions and Terminology
2.2. Types of Biomarkers and Biomarker Applications
2.3. Technology Overview: What Constitutes a Biomarker and How Is It Measured?
2.4. Development and Validation of Biomarkers: Recommendations and Guidelines
FDA, Biomarker Validation, and Fit-for-Purpose Method Validation
NCI/FDA Oncology Task Force
AACR-FDA-NCI Cancer Biomarkers Collaborative
Cancer Biomarkers Research Group, NCI
Cancer Diagnosis Program, NCI
REMARK (REporting recommendations for tumor MARKer prognostic studies)
Biomarkers Task Force of the NCI Investigational Drug Steering Committee
The Biomarkers Consortium
Critical Path Institute
Institute of Medicine
Other Recommendations
Chapter 3
SELECTED BIOMARKER EXAMPLES
3.1. FDA: Valid Genomic Biomarkers in the Context of Approved Drug Labels
3.2. Biomarkers in OncologyBreast Cancer
Estrogen Receptor and Progesterone Receptor
Human Epidermal Growth Factor Receptor 2 (HER2)
Multigene Tests to Determine Breast Cancer Prognosis and Treatment
Other Tumor Markers/Biomarkers of Breast Cancer
Colorectal Cancer
Screening for Colorectal Cancer
Tumor Markers of Colorectal Cancer
Epidermal Growth Factor Receptor (EGFR)
KRAS Mutations
BRAF Mutations
UDP-Glucuronosyltransferase 1A1 (UGT1A1)
Multigene Tests to Determine Colorectal Cancer Prognosis and Treatment
Prostate Cancer
Gastric Cancer
Liver Cancer
Bladder Cancer
Cervical Cancer
Germ Cell Tumors in Males
Leukemia and Lymphoma
Other Cancers and Biomarkers
3.3. Cardiovascular Biomarkers
Prevention of Cardiovascular Disease: Risk Factors
Elevated Blood Cholesterol Levels and Lipidemia
Other Emerging Biomarkers for Cardiovascular Risk
Acute Coronary Syndrome and Acute Myocardial Infarction
Heart Failure
Stroke
Risk of Venous Thromboembolism
3.4. Biomarkers in Neurology
Alzheimer’s Disease
Treatment of Epilepsy: Carbamazepine
3.5. Safety Biomarkers: Prevention of Adverse Drug Effects
Drug Metabolism and Cytochrome P450
CYP2C9 and VKORC1 Variants and Warfarin Dosing
HLA-B*5701 and Hypersensitivity to Abacavir
Nephrotoxicity
3.6. Other Emerging Biomarkers
SELECTED BIOMARKER EXAMPLES
3.1. FDA: Valid Genomic Biomarkers in the Context of Approved Drug Labels
3.2. Biomarkers in OncologyBreast Cancer
Estrogen Receptor and Progesterone Receptor
Human Epidermal Growth Factor Receptor 2 (HER2)
Multigene Tests to Determine Breast Cancer Prognosis and Treatment
Other Tumor Markers/Biomarkers of Breast Cancer
Colorectal Cancer
Screening for Colorectal Cancer
Tumor Markers of Colorectal Cancer
Epidermal Growth Factor Receptor (EGFR)
KRAS Mutations
BRAF Mutations
UDP-Glucuronosyltransferase 1A1 (UGT1A1)
Multigene Tests to Determine Colorectal Cancer Prognosis and Treatment
Prostate Cancer
Gastric Cancer
Liver Cancer
Bladder Cancer
Cervical Cancer
Germ Cell Tumors in Males
Leukemia and Lymphoma
Other Cancers and Biomarkers
3.3. Cardiovascular Biomarkers
Prevention of Cardiovascular Disease: Risk Factors
Elevated Blood Cholesterol Levels and Lipidemia
Other Emerging Biomarkers for Cardiovascular Risk
Acute Coronary Syndrome and Acute Myocardial Infarction
Heart Failure
Stroke
Risk of Venous Thromboembolism
3.4. Biomarkers in Neurology
Alzheimer’s Disease
Treatment of Epilepsy: Carbamazepine
3.5. Safety Biomarkers: Prevention of Adverse Drug Effects
Drug Metabolism and Cytochrome P450
CYP2C9 and VKORC1 Variants and Warfarin Dosing
HLA-B*5701 and Hypersensitivity to Abacavir
Nephrotoxicity
3.6. Other Emerging Biomarkers
Chapter 4
BIOMARKER MARKET: RESEARCH PRODUCTS/TOOLS AND SERVICES4.1. Companies Marketing Biomarker Products/Tools for the Life Sciences Market
4.2. Companies Offering Biomarker-Based Services
4.3. Selected Biomarker Agreements and Acquisitions in the Life Sciences and Services Market
BIOMARKER MARKET: RESEARCH PRODUCTS/TOOLS AND SERVICES4.1. Companies Marketing Biomarker Products/Tools for the Life Sciences Market
4.2. Companies Offering Biomarker-Based Services
4.3. Selected Biomarker Agreements and Acquisitions in the Life Sciences and Services Market
Chapter 5
STRATEGIES FOR DIAGNOSTIC COMPANIES: WHAT IS REQUIRED TO SUCCESSFULLY COMMERCIALIZE BIOMARKERS IN DIAGNOSTICS?
5.1. Development of Diagnostic Tests Based on Novel BiomarkersIdentification of Novel Biomarkers
Analytical Validation of Diagnostic Tests for New Biomarkers
5.2. Need for More Research and Understanding of Biomarkers
Biomarkers and Other Factors Influencing Response to Therapy
Validation Studies and Outcome Studies; Clinical Validation and Clinical Utility
Other Research and Information Needs
5.3. Models/Options for Diagnostic Companies Identifying Novel Biomarkers for Personalized Medicine
5.4. Strategic Options for Delivery of New Diagnostic Tests: IVD versus CLIA Laboratory
Development and Regulatory Issues Facing Diagnostic Companies Developing IVD Tests
Development and Regulatory Issues Facing Companies and Clinical Laboratories Developing Laboratory-Developed Tests
5.5. Health Economics, Reimbursement, and the Payers’ Perspective
Health Economic Studies
Payer Perspectives and Policies
Medco Health Solutions
Generation Health
5.6. Penetrating the Market
Does the Test Affect Physicians’ Decisions?
Acceptance by Experts; Incorporation into Guidelines
Physician Education
5.7. Potential Benefits, Risks, and Challenges for Diagnostic Companies Developing Tests Based on Novel Biomarkers
STRATEGIES FOR DIAGNOSTIC COMPANIES: WHAT IS REQUIRED TO SUCCESSFULLY COMMERCIALIZE BIOMARKERS IN DIAGNOSTICS?
5.1. Development of Diagnostic Tests Based on Novel BiomarkersIdentification of Novel Biomarkers
Analytical Validation of Diagnostic Tests for New Biomarkers
5.2. Need for More Research and Understanding of Biomarkers
Biomarkers and Other Factors Influencing Response to Therapy
Validation Studies and Outcome Studies; Clinical Validation and Clinical Utility
Other Research and Information Needs
5.3. Models/Options for Diagnostic Companies Identifying Novel Biomarkers for Personalized Medicine
5.4. Strategic Options for Delivery of New Diagnostic Tests: IVD versus CLIA Laboratory
Development and Regulatory Issues Facing Diagnostic Companies Developing IVD Tests
Development and Regulatory Issues Facing Companies and Clinical Laboratories Developing Laboratory-Developed Tests
5.5. Health Economics, Reimbursement, and the Payers’ Perspective
Health Economic Studies
Payer Perspectives and Policies
Medco Health Solutions
Generation Health
5.6. Penetrating the Market
Does the Test Affect Physicians’ Decisions?
Acceptance by Experts; Incorporation into Guidelines
Physician Education
5.7. Potential Benefits, Risks, and Challenges for Diagnostic Companies Developing Tests Based on Novel Biomarkers
Chapter 6
STRATEGIES FOR PHARMACEUTICAL COMPANIES: BIOMARKERS AND DRUG DEVELOPMENT
6.1. Potential Roles of Biomarkers in Drug DevelopmentBiomarkers in Research and Preclinical Studies
Biomarkers in Clinical Trials
Predictive Biomarkers (Including Personalized Medicine Biomarkers)
6.2. Validation of Biomarker Assays and Biomarkers
6.3. Regulatory Issues Relating to Pharmacogenomics and Drug Development
6.4. Models/Options for Pharmaceutical Companies Developing Drug/Diagnostic Combinations
6.5. Health Economics and Reimbursement in Personalized Medicine
6.6. Potential Benefits, Risks, and Challenges for Companies Using Biomarkers in Drug Development and/or Personalized Medicine
6.7. Pharmaceutical Company Agreements with Diagnostic/Biomarker Companies, Including Acquisitions
STRATEGIES FOR PHARMACEUTICAL COMPANIES: BIOMARKERS AND DRUG DEVELOPMENT
6.1. Potential Roles of Biomarkers in Drug DevelopmentBiomarkers in Research and Preclinical Studies
Biomarkers in Clinical Trials
Predictive Biomarkers (Including Personalized Medicine Biomarkers)
6.2. Validation of Biomarker Assays and Biomarkers
6.3. Regulatory Issues Relating to Pharmacogenomics and Drug Development
6.4. Models/Options for Pharmaceutical Companies Developing Drug/Diagnostic Combinations
6.5. Health Economics and Reimbursement in Personalized Medicine
6.6. Potential Benefits, Risks, and Challenges for Companies Using Biomarkers in Drug Development and/or Personalized Medicine
6.7. Pharmaceutical Company Agreements with Diagnostic/Biomarker Companies, Including Acquisitions
Chapter 7
COMPANIES COMMERCIALIZING BIOMARKERS: SELECTED COMPANIES TO WATCH7.1. 20/20 GeneSystems
7.2. Activiomics
7.3. Advanced Cell Diagnostics
7.4. Agendia
7.5. Almac Diagnostics
7.6. Arrayit
7.7. Astute Medical
7.8. Asuragen
7.9. BG Medicine
7.10. Biocartis
7.11. Biodesix
7.12. BioMarker Strategies
7.13. bioTheranostics
7.14. Caprion Proteomics
7.15. CardioDx
7.16. Celera
7.17. Clarient
7.18. deCODE genetics
7.19. DiaGenic
7.20. DNA Direct
7.21. Genomic Health
7.22. Genoptix
7.23. HistoRx
7.24. Illumina
7.25. Integrated Diagnostics
7.26. Intrinsic Bioprobes
7.27. Invivoscribe Technologies
7.28. Myriad Genetics
7.29. NanoString Technologies
7.30. On-Q-ity
7.31. OPKO Health
7.32. Oxford Gene Technology
7.33. Pathwork Diagnostics
7.34. Philips
7.35. Psynova Neurotech
7.36. Qiagen
7.37. Rules-Based Medicine
7.38. SomaLogic
7.39. TcLand Expression
7.40. Tethys Bioscience
COMPANIES COMMERCIALIZING BIOMARKERS: SELECTED COMPANIES TO WATCH7.1. 20/20 GeneSystems
7.2. Activiomics
7.3. Advanced Cell Diagnostics
7.4. Agendia
7.5. Almac Diagnostics
7.6. Arrayit
7.7. Astute Medical
7.8. Asuragen
7.9. BG Medicine
7.10. Biocartis
7.11. Biodesix
7.12. BioMarker Strategies
7.13. bioTheranostics
7.14. Caprion Proteomics
7.15. CardioDx
7.16. Celera
7.17. Clarient
7.18. deCODE genetics
7.19. DiaGenic
7.20. DNA Direct
7.21. Genomic Health
7.22. Genoptix
7.23. HistoRx
7.24. Illumina
7.25. Integrated Diagnostics
7.26. Intrinsic Bioprobes
7.27. Invivoscribe Technologies
7.28. Myriad Genetics
7.29. NanoString Technologies
7.30. On-Q-ity
7.31. OPKO Health
7.32. Oxford Gene Technology
7.33. Pathwork Diagnostics
7.34. Philips
7.35. Psynova Neurotech
7.36. Qiagen
7.37. Rules-Based Medicine
7.38. SomaLogic
7.39. TcLand Expression
7.40. Tethys Bioscience
Chapter 8
EXPERT INTERVIEWS
8.1. Sriram Balasubramanian, PhDSenior Director, Translational Medicine
Pharmacyclics
Sunnyvale, CA
EXPERT INTERVIEWS
8.1. Sriram Balasubramanian, PhDSenior Director, Translational Medicine
Pharmacyclics
Sunnyvale, CA
8.2. Barbara Conley, MDAssociate Director, Cancer Diagnosis Program
National Cancer Institute
Bethesda, MD
National Cancer Institute
Bethesda, MD
8.3. Felix W. Frueh, PhDVice President, Research & Development, Personalized Medicine
Medco Health Solutions
Franklin Lakes, NJ
Medco Health Solutions
Franklin Lakes, NJ
8.4. William N. Hait, MDSenior Vice President and Worldwide Head of Oncology and Hematology R&D
Johnson & Johnson
Raritan, NJ
Johnson & Johnson
Raritan, NJ
8.5. Francis Kalush, PhDDiagnostics & Personalized Medicine Network Leader
Office of the Center Director, Center for Devices and Radiological Health (CDRH), US Food & Drug Administration (FDA)
Silver Spring, MD
Office of the Center Director, Center for Devices and Radiological Health (CDRH), US Food & Drug Administration (FDA)
Silver Spring, MD
8.6. Paul Kearney, PhDFounder, President, & CSO
Integrated Diagnostics
Seattle, WA
Integrated Diagnostics
Seattle, WA
8.7. Martin LeBlancPresident and CEO
Caprion Proteomics
Montreal, Quebec, Canada
Caprion Proteomics
Montreal, Quebec, Canada
8.8. Michael Liebman, PhDManaging Director
Strategic Medicine
Kennett Square, PA
Strategic Medicine
Kennett Square, PA
References
LIST OF FIGURES
Figure 1.1. Number of Abstracts Per Year From PubMed Search for “Biomarker” or “Biomarkers”
Figure 2.1. Conceptual Diagram of Fit-For-Purpose Method Validation
Figure 2.1. Conceptual Diagram of Fit-For-Purpose Method Validation
LIST OF TABLES
Table 2.1. REMARK (REporting recommendations for tumor MARKer prognostic studies)
Table 2.2. Summary of Recommendations for Effective Biomarker Evaluation
Table 3.1. Valid Genomic Biomarkers in the Context of Approved Drug Labels
Table 3.2. Potential Serum Markers for Gastric Cancer
Table 3.3. Serum and Tissue Markers for Liver Cancer
Table 3.4. Useful and Potentially Useful Urine Markers for Bladder Cancer
Table 3.5. Currently Available and Potentially Useful Serum Markers for Cervical Cancer
Table 3.6. Selected Examples of Common Translocations and Other Genetic Abnormalities Used to Characterize Leukemias
Table 3.7. Emerging Risk Factors for Cardiovascular Disease
Table 3.8. Cardiac Biomarkers Used in Acute Coronary Syndromes
Table 3.9. Selected Biochemical Markers Currently Available or Under Study for Clinical Diagnosis, Management, and Risk Stratification of Heart Failure
Table 3.10. Laboratory Tests That May Be Used to Evaluate Patients Suspected of Stroke
Table 4.1. Selected CRO or Testing Service Provider Agreements With Diagnostic/Biomarker Companies, Including Acquisitions
Table 6.1. Pharmaceutical Company Agreements With Diagnostic/Biomarker Companies, Including Acquisitions
Table 7.1. Selected Companies Commercializing Biomarkers and/or Systems For Their Detection/Measurement
Table 2.2. Summary of Recommendations for Effective Biomarker Evaluation
Table 3.1. Valid Genomic Biomarkers in the Context of Approved Drug Labels
Table 3.2. Potential Serum Markers for Gastric Cancer
Table 3.3. Serum and Tissue Markers for Liver Cancer
Table 3.4. Useful and Potentially Useful Urine Markers for Bladder Cancer
Table 3.5. Currently Available and Potentially Useful Serum Markers for Cervical Cancer
Table 3.6. Selected Examples of Common Translocations and Other Genetic Abnormalities Used to Characterize Leukemias
Table 3.7. Emerging Risk Factors for Cardiovascular Disease
Table 3.8. Cardiac Biomarkers Used in Acute Coronary Syndromes
Table 3.9. Selected Biochemical Markers Currently Available or Under Study for Clinical Diagnosis, Management, and Risk Stratification of Heart Failure
Table 3.10. Laboratory Tests That May Be Used to Evaluate Patients Suspected of Stroke
Table 4.1. Selected CRO or Testing Service Provider Agreements With Diagnostic/Biomarker Companies, Including Acquisitions
Table 6.1. Pharmaceutical Company Agreements With Diagnostic/Biomarker Companies, Including Acquisitions
Table 7.1. Selected Companies Commercializing Biomarkers and/or Systems For Their Detection/Measurement
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