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コンパニオン診断:創薬の合理化・オーダーメイド医療の進歩

Companion Diagnostics - Streamlining Drug Development and Advancing Personalized Medicine

発行 CBR Pharma Insights 商品コード 274482
出版日 ページ情報 英文
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コンパニオン診断:創薬の合理化・オーダーメイド医療の進歩 Companion Diagnostics - Streamlining Drug Development and Advancing Personalized Medicine
出版日: 2013年04月01日 ページ情報: 英文
概要

当レポートでは、コンパニオン診断の現在の課題と将来の機会について調査し、初期の臨床開発から製品発売までのコンパニオン診断のメリットと患者集団における現行用途の概要、個別化医療とコンパニオン診断に期待される疾病管理の変化、成功例の特定と分析、および今後の展望などを提供しており、概略以下の構成でお届けします。

エグゼクティブサマリー

調査手法

オーダーメイド医療・コンパニオン診断

  • オーダーメイド医療の概要
  • バイオマーカーとは?
  • コンパニオン診断とは?

コンパニオン診断のメリット

  • より的を絞った患者集団
  • 創薬へのフォーカス
  • 合理的な治療決定
  • ファーマコエコノミクス(医薬経済学)

コンパニオン診断の開発における課題

  • 物流の課題
  • 戦略的ビジネス課題
  • 財務リスク
  • 規制の課題

ケーススタディ

  • Roche:コンパニオン診断をリード
  • Biogen Idec:リスクを緩和するための診断
  • Xalkori:これから起こることの前兆?

将来の展望

  • コンパニオン診断:承認の必要条件
  • がんを超えた世界
  • 主要企業

付録

目次
Product Code: CBRSV044

Personalized healthcare encompasses tailored diagnostics, treatment and management of illnesses and diseases. Although the concept has been around for many years, it is only with the advent of companion diagnostics that personalized healthcare has started to gain ground. Companion diagnostics can be used in screening, monitoring, diagnosing and treating patients and can allow for stratification of patients to maximize efficacy and minimize risk

Companion diagnostics can allow for a specific patient population to be identified which will ensure those patients who are most likely to respond are recruited for clinical trials and receive the therapy once the product is launched. Companion diagnostics can help to rationalize treatment decisions, with specifics such as accurate dosing, risks of adverse events and diagnostics being made possible through these tests. Through the use of companion diagnostics, the right treatment can be delivered to the right patient at the right time, delivering greater value and optimizing healthcare resource utilization

Oncology has been the most active arena for companion diagnostics but, as research has advanced and new diagnostics developed, applications in other therapy areas are being discovered and established

The report, “Companion Diagnostics - Streamlining Drug Development and Advancing Personalized Medicine” was written to support both the biopharmaceutical and diagnostic industries better understand the current challenges involved in developing products with a companion diagnostic, as well as the opportunities that will exist in the future. Recent success stories are identified and analyzed, and insights are provided throughout the study to support pharmaceutical & diagnostic strategic planning needs.

Key Reasons to Purchase

  • This report provides an overview of advantages offered by companion diagnostics from early clinical development through to product launch and ongoing use in the patient population
  • Understand what personalized medicine and companion diagnostics are and how these are expected to change the face of disease management
  • Enables you to understand some of the key challenges faced during the development of companion diagnostics and recommendations on how to overcome them
  • Provides an in-depth analysis of key case studies highlighting the successful application of companion diagnostics and how this has impacted company activities
  • Gain insight into which pharmaceutical companies are leading the way in the development and application of companion diagnostics while assessing the key partnerships in place with diagnostics companies driving this sector forward

Table of Contents

  • Executive summary
  • Methodology
  • Personalized medicine and companion diagnostics
    • Personalized medicine overview
    • What are biomarkers?
    • What are companion diagnostics?
  • Advantages of companion diagnostics
    • A more targeted patient population
    • Focused drug development
    • Rationalized treatment decisions
    • Pharmacoeconomic advantages
  • Challenges in the development of companion diagnostics
    • Logistical challenges
    • Strategic business challenges
    • Financial risks
    • Regulatory challenges
  • Case studies
    • Roche - leading the way with companion diagnostics
    • Biogen Idec - a diagnostic to mitigate risk
    • Xalkori - a sign of things to come?
  • A look to the future
    • Companion diagnostics - a prerequisite to approval?
    • A world beyond oncology
    • Companies leading the way
  • Appendix
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