Report Options  

Length:200 pages

Date Published:May 2011

For Corporate Subscriptions, Multi-Reports Orders, Discounts or Order Questions.  

Contact:
Kerri Kelley
Customer Service
781-972-1347 


IPR Bundle

Commercializing Biomarkers in Therapeutic and Diagnostic Applications - Table of Contents

Author: Lucy J. Sannes, MBA, PhD

Executive Summary v 

CHAPTER 1
Introduction 1
Scope of the Report 2
 

CHAPTER 2
Biomarker Overview 4
2.1. What are Biomarkers? Definitions and Terminology 4
2.2. Types of Biomarkers and Biomarker Applications 5
2.3. Technology Overview: What Constitutes a Biomarker and How Is It Measured? 6
2.4. Development and Validation of Biomarkers:Recommendations and Guidelines 7
 FDA, Biomarker Validation, and Fit-for-Purpose Method Validation 7
 NCI/FDA Oncology Task Force 8
 AACR-FDA-NCI Cancer Biomarkers Collaborative 8
 Cancer Biomarkers Research Group, NCI 9
 Cancer Diagnosis Program, NCI 9
 REMARK (REporting recommendations for tumor MARKerprognostic studies) 11
 Biomarkers Task Force of the NCI Investigational Drug Steering Committee 11
 The Biomarkers Consortium 11
 Critical Path Institute 12
 Institute of Medicine 12
 Other Recommendations 13

CHAPTER 3
Selected Biomarker Examples 14
3.1. FDA: Valid Genomic Biomarkers in the Context of Approved Drug Labels 14
3.2. Biomarkers in Oncology 19
 Breast Cancer 20
Estrogen Receptor and Progesterone Receptor 20
Human Epidermal Growth Factor Receptor 2 (HER2) 20
Multigene Tests to Determine Breast Cancer Prognosis and Treatment 21
Other Tumor Markers/Biomarkers of Breast Cancer 22
 Colorectal Cancer 22
Screening for Colorectal Cancer 23
Tumor Markers of Colorectal Cancer 23
Epidermal Growth Factor Receptor (EGFR) 24
KRAS Mutations 25
BRAF Mutations 25
UDP-Glucuronosyltransferase 1A1 (UGT1A1) 25
Multigene Tests to Determine Colorectal Cancer Prognosis and Treatment 26
 Prostate Cancer 26
 Gastric Cancer 27
 Liver Cancer 28
 Bladder Cancer 35
 Cervical Cancer 37
 Germ Cell Tumors in Males 39
 Leukemia and Lymphoma 39
 Other Cancers and Biomarkers 42
3.3. Cardiovascular Biomarkers 43 Prevention of Cardiovascular Disease: Risk Factors 43
Elevated Blood Cholesterol Levels and Lipidemia 43
Other Emerging Biomarkers for Cardiovascular Risk 45
 Acute Coronary Syndrome and Acute Myocardial Infarction 45
 Heart Failure 46
 Stroke 47
 Risk of Venous Thromboembolism 48
3.4. Biomarkers in Neurology 49 Alzheimer’s Disease 49
 Treatment of Epilepsy: Carbamazepine 50
3.5. Safety Biomarkers: Prevention of Adverse Drug Effects 50 Drug Metabolism and Cytochrome P450 51
 CYP2C9 and VKORC1 Variants and Warfarin Dosing 52
 HLA-B*5701 and Hypersensitivity to Abacavir 53
 Nephrotoxicity 54
3.6. Other Emerging Biomarkers 55 

CHAPTER 4
Biomarker Market: Research Products/Tools and Services 56
4.1. Companies Marketing Biomarker Products/Tools for the Life Sciences Market 56
4.2. Companies Offering Biomarker-Based Services 57
4.3. Selected Biomarker Agreements and Acquisitions in the Life Sciences and Services Market 57
 

CHAPTER 5
Strategies for Diagnostic Companies: What is Required to Successfully Commercialize Biomarkers in Diagnostics? 60
5.1. Development of Diagnostic Tests Based on Novel Biomarkers 60
 Identification of Novel Biomarkers 60
 Analytical Validation of Diagnostic Tests for New Biomarkers 61
5.2. Need for More Research and Understanding of Biomarkers 61 Biomarkers and Other Factors Influencing Response to Therapy 61
 Validation Studies and Outcome Studies; Clinical Validation and Clinical Utility 62
 Other Research and Information Needs 63
5.3. Models/Options for Diagnostic Companies Identifying Novel Biomarkers for Personalized Medicine 63
5.4. Strategic Options for Delivery of New Diagnostic Tests: IVD Versus CLIA Laboratory 65
 Development and Regulatory Issues Facing Diagnostic Companies Developing IVD Tests 66
 Development and Regulatory Issues Facing Companies and Clinical Laboratories Developing Laboratory-Developed Tests 68
5.5. Health Economics, Reimbursement, and the Payers’ Perspective 70 Health Economic Studies 70
 Payer Perspectives and Policies 71
 Medco Health Solutions 72
 Generation Health 74
5.6. Penetrating the Market 74 Does the Test Affect Physicians’ Decisions? 74
 Acceptance by Experts; Incorporation into Guidelines 74
 Physician Education 75
5.7. Potential Benefits, Risks, and Challenges for Diagnostic Companies Developing Tests Based on Novel Biomarkers 76 

CHAPTER 6
Strategies for Pharmaceutical Companies:Biomarkers and Drug Development 78
6.1. Potential Roles of Biomarkers in Drug Development 78
 Biomarkers in Research and Preclinical Studies 78
 Biomarkers in Clinical Trials 79
 Predictive Biomarkers (Including Personalized Medicine Biomarkers) 79
6.2. Validation of Biomarker Assays and Biomarkers 80
6.3. Regulatory Issues Relating to Pharmacogenomics and Drug Development 80
6.4. Models/Options for Companies Developing Drug/Diagnostic Combinations 81
6.5. Health Economics and Reimbursement inPersonalized Medicine 82
6.6. Potential Benefits, Risks, and Challenges for Companies Using Biomarkers in Drug Development and/or Personalized Medicine 83
6.7. Pharmaceutical Company Agreements with Diagnostic/Biomarker Companies, Including Acquisitions 85
 

CHAPTER 7
Companies Commercializing Biomarkers:Selected Companies To Watch 94
7.1. 20/20 GeneSystems 94
7.2. Activiomics 95
7.3. Advanced Cell Diagnostics 95
7.4. Agendia 95
7.5. Almac Diagnostics 96
7.6. Arrayit 96
7.7. Astute Medical 97
7.8. Asuragen 97
7.9. BG Medicine 98
7.10. Biocartis 99
7.11. Biodesix 99
7.12. BioMarker Strategies 99
7.13. bioTheranostics 100
7.14. Caprion Proteomics 100
7.15. CardioDx 100
7.16. Celera  101
7.17. Clarient  101
7.18. deCODE genetics 101
7.19. DiaGenic 102
7.20. DNA Direct  102
7.21. Genomic Health 103
7.22. Genoptix (A Novartis Company) 103
7.23. HistoRx 103
7.24. Illumina 104
7.25. Integrated Diagnostics 105
7.26. Intrinsic Bioprobes 105
7.27. Invivoscribe Technologies 106
7.28. Myriad Genetics 106
7.29. NanoString Technologies 107
7.30. On-Q-ity 107
7.31. OPKO Health 108
7.32. Oxford Gene Technology 108
7.33. Pathwork Diagnostics 108
7.34. Philips 109
7.35. Psynova Neurotech 109
7.36. Qiagen 110
7.37. Rules-Based Medicine 110
7.38. SomaLogic  111
7.39. TcLand Expression 111
7.40. Tethys Bioscience 112
 

CHAPTER 8
Expert Interviews 147
8.1. Barbara Conley, MD 147
8.2. Felix W. Frueh, PhD 151
8.3. William N. Hait, MD 153
8.4. Paul Kearney, PhD 156
8.5. Martin LeBlanc 159
8.6. Michael Liebman, PhD 163
 

References 168 

About Cambridge Healthtech Institute 194