Combination Drug Diagnostics: Fueling Growth of Personalized Medicine Report
CHI Insight Pharma Reports
April 1, 2010 242 Pages - SKU: CHI2709512
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Combination Drug/Diagnostics: Fueling Growth of Personalized Medicine details the commercial successes of an future pharmacological therapies and diagnostic test combination products.
Key topics covered include:
- Successful Rx/Dx products on the market
- Opportunities for future/drug diagnostic combinations
- Emerging new applications
- Strategic options for pharmaceutical and diagnostic companies
- Regulatory and reimbursement issues
- Physician education and acceptable hurdles
- Interviews with experts
Combination Drug/Diagnostics: Fueling Growth of Personalized Medicine examines the role of Rx/Dx products in cancer treatment and a variety of other disease indications. More than fifteen tables in this report summarize the broad activity in this product field. As examples of drug/diagnostic combinations succeed in the market, interest in this field continues to grow and offers promising opportunities for novel products. This report provides a comprehensive look at all available combination therapeutic and diagnostic products from regulatory required co-marketed products to label recommended combinations and identifies factors leading to market success.
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- Executive Summary
- Chapter 1
- INTRODUCTION
- Chapter 2
- Overview of Personalized Medicine
- 2.1 W hat is Personalized Medicine? What are Drug/Diagnostic Combinations?
- Drug/Diagnostic Combinations
- 2.2 S elected Terms Used in Personalized Medicine
- Pharmacogenomics
- Pharmacogenetics
- Other Terms Used in Personalized Medicine
- 2.3 Disease Applications in Personalized Medicine
- 2.4 Diagnostic Technologies Used in Personalized Medicine
- Chapter 3
- Selected Examples of Personalized Medicine Available Today
- 3.1 Cytochrome P450 and Drug Metabolism
- CYP2D6 Phenotype and Response to Tamoxifen
- Cytochrome P450 Enzymes and Other Drugs
- 3.2 E strogen Receptor and Progesterone Receptor Status and Hormone Therapy for Breast Cancer
- 3.3 HER2 Overexpression and both Herceptin and Tykerb - Tests for HER2 Overexpression Alone and in
- Combination with Other Biomarkers
- 3.4 Multi-Gene/Biomarker Tests for Determining Breast Cancer Prognosis and Treatment
- Agendia‘s MammaPrint
- Applied Genomics’ MammoStrat
- bioTheranostics’ Theros Breast Cancer Index
- Genomic Health’s Oncotype DX
- Ipsogen’s MapQuant Dx Genomic Grade
- 3.5 Multi-Gene/Biomarker Tests for Determining Diagnosis, Prognosis and Treatment of Other Cancers.56
- Applied Genomics‘ PulmoType
- Aureon Laboratories’ Prostate Px
- bioTheranostics’ Theros CancerTYPE ID
- Pathwork Diagnostics’ Pathwork Tissue of Origin Test
- 3.6 E pidermal Growth Factor Receptor (EGFR)
- Currently Available Therapies That Target EGFR
- Testing for Expression of EGFR
- Testing for EGFR Mutations
- DxS (now part of Qiagen)
- Genzyme Genetics
- AutoGenomics
- 3.7 KRAS Mutations and Anti-EGFR Therapy for Colorectal Cancer
- 3.8 B RAF Mutations and Anti-EGFR Therapy for Colorectal Cancer
- 3.9 UGT1A1 Genetic Variants and Treatment with Camptosar (irinotecan)
- Hologic
- AutoGenomics
- 3.10 DPYD and TYMS Variants and 5-Flurouracil Therapy
- Myriad Genetics
- AutoGenomics
- Others
- 3.11 B iomarkers in Leukemia and Lymphoma
- Gleevec and Other Tyrosine Kinase Inhibitors for Treatment of Philadelphia Chromosome Positive CML..91
- Philadelphia Chromosome and Busulfan
- PML/RARá and Vesanoid (tretinoin)
- Rituxan and Other Antibodies That Target CD20 Antigen for Treatment of Lymphoma or Leukemia
- Many Additional Biomarkers for Leukemia and Lymphoma
- 3.12 Personalized Medicine and HIV Therapy - Moving Beyond HIV Viral
- Load and Drug Resistance
- Testing
- HLA-B*5701 Testing and Hypersensitivity to Abacavir
- CCR5-Tropic HIV and Selzentry (maraviroc)
- 3.13 CYP2C9 and VKORC1 Variants and Warfarin Dosing
- 3.14 Thiopurine Methyltransferase and Metabolism of Thiopurine Drugs
- 3.15 S elected CNS Applications of Personalized Medicine
- HLA-B*1502 and Carbamazepine
- PGxPredict:CLOZAPINE
- 3.16 S elected Other Personalized Medicine Tests
- Chapter 4
- Development of Drug/Diagnostic Combinations - Personalized Medicine
- Products
- 4.1 Identification of Personalized Medicine Biomarkers
- 4.2 Validation of Diagnostic Tests for Personalized Medicine
- Combination Drug/Diagnostics: Fueling Growth of Personalized Medicine
- 4.3 Development and Regulatory Issues Facing Diagnostic Companies in Personalized Medicine
- Regulatory Issues and Consideration for Clinical Laboratories with Laboratory Developed Tests for Personalized Medicine
- Regulatory Issues and Consideration for Diagnostics Companies in Personalized Medicine
- The two basic review processes
- 4.4 Development and Regulatory Issues Facing Therapeutic Companies in Personalized Medicine
- 4.5 Selected Personalized Medicine Examples - What Tests are Used by Physicians?
- Why Isn’t Warfarin Sensitivity Testing Performed Routinely Now?
- Screening for HLA-B*5701 Hypersensitivity to Abacavir
- Genomic Health and Validation of OncoType DX
- Agendia and Validation of MammaPrint
- Chapter 5
- Strategic Issues Facing Pharmaceutical and Diagnostic Companies
- Developing Personalized Medicine Products
- 5.1 Need for More Research and Understanding
- Biomarkers and Other Factors Influencing Response to Therapy
- Validation Studies and Outcome Studies
- Other Research and Information Needs
- 5.2 Models/Options for Pharmaceutical Companies Developing Drug/Diagnostic Combinations
- 5.3 Models/Options for Diagnostic Companies Developing Personalized Medicine Tests - Test
- Development
- 5.4 Delivery of New Diagnostic Tests - IVD versus CLIA Laboratory
- 5.5 Health Economics, Reimbursement, and the Payers’ Perspective
- Health Economic Studies for Personalized Medicine Tests
- Perspectives Expressed in Expert Interviews
- Payer Perspectives and Policies
- Medco Health Solutions
- Generation Health
- 5.6 Intellectual Property Issues
- 5.7 Penetrating the Market
- Does the Test Affect Physicians’ Decisions?
- Acceptance by Experts; Incorporation into Guidelines
- Physician Education
- Chapter 6
- Company Perspectives on Personalized Medicine
- 6.1 Potential Benefits, Risks, and Challenges for Biopharmaceutical and
- Pharmaceutical Companies
6.2 Potential Benefits, Risks, and Challenges for Diagnostic Companies
Chapter 7
Potential Opportuniti es for the Future
7.1 Tests in Development for Prediction of Breast Cancer Prognosis and Determining Treatment
- Agendia
- Applied Genomics (Subsidiary of Clarient)
- Celera
- Genomic Health
- Nuvera Biosciences
- Prediction Sciences and Clarient
- Additional Tests in Development for Prediction of Breast Cancer Prognosis and Determining Treatment
- 153
7.2 Tests in Development for Determining Prognosis and Treatment of Other Cancers
- Agendia
- Applied Genomics (Subsidiary of Clarient)
- Genomic Health
- Additional Tests in Development for Prediction of Prognosis and Determining Treatment for Other (Non-
- Breast) Cancers
7.3 Other (Non-Cancer) Personalized Medicine Tests in Development and/or Used in Pharmaceutical
- Research
7.4 Pharmaceutical/Diagnostic Company Agreements
Chapter 8
Expert Interviews
Howard C. Coleman, Chief Executive Officer, Genelex Corporation
Cornelius Diamond, CEO, Prediction Sciences
Richard Ding, Chief Executive Officer and bioTheranostics (A bioMerieux Company) & Vice President of
Strategy and Business Development at bioMerieux (the parent company)
Stephen Eck, M.D., Ph.D., Vice President, Translational Medicine & Pharmacogenomics, Eli Lilly
Paul Harkin, President & Managing Director, Almac Diagnostics
Fareed Kureshym, Founder, Chairman, President and CEO, AutoGenomics
Stephen Little, Vice President of Personalized Medicine, Qiagen, Former CEO and Founder of DxS (which
was acquired by Qiagen)
References
Company Index with Web Addreses
TABLES
Table 3.1: Valid Genomic Biomarkers in the Context of Approved Drug Labels
Table 3.2: Selected Companies Marketing Tests or Reagents for Detection of Genetic Variants of Cytochrome
P450 [Not Including Warfarin Tests]
Table 3.3: Cytochrome P450 Drug Interaction Table - Clinically Relevant Drugs
Combination Drug/Diagnostics: Fueling Growth of Personalized Medicine
Table 3.4: Selected Companies Marketing Tests or Reagents for Estrogen Receptor (ER) and Progesterone
Receptor (PR) of Breast Tumor Tissue
Table 3.5: Selected Companies Marketing Tests or Reagents for Detection of HER2Overexpression
Table 3.6: Selected Companies Marketing Multi-Gene Tests for Determination of Breast Cancer Prognosis and
Treatment
Table 3.7: Selected Companies Marketing Multi-Gene Tests for Other Cancers (Besides Breast Cancer)
Table 3.8: Selected Companies Marketing Tests for Determination of Over-Expression of Epidermal Growth Factor
Receptor (EGFR)
Table 3.9: Selected Companies Marketing Tests for Determination of KRAS Variants
Table 3.10: Selected Companies Marketing Tests for Determination of BRAF
Table 3.11: Selected Companies Marketing Tests for Determination of UGT1A1 Variants
Table 3.12: Selected Companies Marketing Tests for Determination of DPYD and TYMS variants
Table 3.13: Selected Companies Marketing Tests for Biomarkers of Leukemia and Lymphoma
Table 3.14: Selected Companies Marketing Tests for Determination of Variants of the CYP2C9 and VKORC1
genes for Warfarin Sensitivity Testing
Table 3.15: Selected Companies Marketing Tests for Determination of Thiopurine Methyltransferase (TPMT)
Mutations or Activity
Table 3.16: Selected Companies Marketing Personalized Medicine Tests for CNS Applications
Table 3.17: Selected Companies Marketing Other Personalized Medicine Drug/Diagnostic Combination Tests..108
Table 7-1: Research Programs and Diagnostic Tests in Development for Cancer Personalized Medicine
Table 7-2: Research Programs and Diagnostic Tests in Development for Other (Non-Cancer) Personalized
Medicine, Plus Programs for Unspecified Disease Indications
Table 7.3: Selected Agreements Between Pharmaceutical/Biopharmaceutical Companies and Diagnostic
Companies in Personalized Medicine
Commonly Available Pharmacogenetic Tests
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