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薬剤と診断の併用:個別化医療の成長加速

Combination Drug Diagnostics: Fueling Growth of Personalized Medicine

発行 Insight Pharma Reports 商品コード 116972
出版日 ページ情報 英文 242 Pages
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薬剤と診断の併用:個別化医療の成長加速 Combination Drug Diagnostics: Fueling Growth of Personalized Medicine
出版日: 2010年04月15日 ページ情報: 英文 242 Pages

当商品の販売は、2016年07月01日を持ちまして終了しました。

概要

当レポートでは、癌など様々な疾患治療における処方薬/診断薬の役割、薬剤と診断の併用による成功事例とともに、将来の機会や製薬会社の戦略をまとめ、専門家のインタビューを交えながら、概略下記の構成でお届けいたします。

エグゼクティブサマリー

第1章 イントロダクション

第2章 個別化医療の概要

  • 個別化医療とは、薬剤と診断の併用とは
  • 個別化医療に用いられる用語
  • 個別化医療における応用
  • 個別化医療に用いられる診断技術

第3章 個別化医療において現在利用可能な技術事例

第4章 薬剤/診断併用の発展:個別化医療製品

  • 個別化医療バイオマーカーの特定
  • 個別化医療のための診断試験の評価
  • 個別化医療に関与する診断薬メーカーが直面する開発と規制の問題
  • 個別化医療に関与する治療薬メーカーが直面する開発と規制の問題
  • 個別化医療の事例:医師が用いる試験とは

第5章 個別化医療製品を開発する製薬・診断薬メーカーが直面する戦略的課題

  • さらなる研究と理解の必要性
  • 薬剤/診断併用を開発する製薬会社のモデル/オプション
  • 個別化医療試験を開発する診断薬メーカーのモデル/オプション
  • 新しい診断試験
  • 医療経済、償還、支払者の見通し
  • 知的財産問題
  • 市場への浸透

第6章 個別化医療に関する企業見通し

  • 生物医薬品・医薬品メーカーにとってのメリット、リスク、課題
  • 診断薬メーカーにとってのメリット、リスク、課題

第7章 将来の機会

  • 乳癌予後診断、治療決定のための開発中の試験
  • その他の癌の予後診断、治療決定のための開発中の試験
  • 開発中の、または医薬品研究で用いられているその他の個別化医療試験
  • 医薬品/診断薬企業の合意

第8章 専門家インタビュー

リファレンス

企業インデックス(ウェブアドレス付き)

目次

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.

The report emphasizes the market perspectives in the field. Nearly all major pharmaceutical companies have personalized medicine strategies in place. This report describes the activities of 104 pharmaceutical and diagnostic companies in the Rx/Dx space.

ABOUT THE AUTHOR

Lucy J. Sannes, PhD, MBA, is president of Sannes & Associates, a consulting firm specializing in evaluation and management of the biosciences. Before forming Sannes & Associates, she held management positions at Genetic Systems and Abbott Laboratories in product development, product support, and technical marketing. Dr. Sannes received her PhD in biological chemistry from the University of Michigan and her MBA from Seattle Pacific University.

Table of Contents

EXECUTIVE SUMMARY

CHAPTER - 1

INTRODUCTION

CHAPTER - 2

OVERVIEW OF PERSONALIZED MEDICINE

  • 2.1. What is Personalized Medicine? What are Drug/Diagnostic Combinations?
  • Drug/Diagnostic Combinations
  • 2.2. Selected 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. Estrogen 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
  • Applied Genomics‘ PulmoType
  • Aureon Laboratories' Prostate Px
  • bioTheranostics' Theros CancerTYPE ID
  • Pathwork Diagnostics' Pathwork Tissue of Origin Test
  • 3.6. Epidermal 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. BRAF 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. Biomarkers in Leukemia and Lymphoma
  • Gleevec and Other Tyrosine Kinase Inhibitors for Treatment of Philadelphia Chromosome Positive CML
  • Philadelphia Chromosome and Busulfan
  • PML/RARa 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. Selected CNS Applications of Personalized Medicine
  • HLA-B*1502 and Carbamazepine
  • PGxPredict:CLOZAPINE
  • 3.16. Selected 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
  • 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 OPPORTUNITIES 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
  • 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 ADDRESSES

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