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バイオバンキング:将来に向けたスマートで持続可能かつ倫理的に適合したバイオリポジトリの構築

Biobanking: Developing Smart, Sustainable and Ethically Compliant Biorepositories for the Future

発行 CBR Pharma Insights 商品コード 348173
出版日 ページ情報 英文 118 Pages
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バイオバンキング:将来に向けたスマートで持続可能かつ倫理的に適合したバイオリポジトリの構築 Biobanking: Developing Smart, Sustainable and Ethically Compliant Biorepositories for the Future
出版日: 2015年12月02日 ページ情報: 英文 118 Pages
概要

バイオバンクはヒトの生物検体と関連するデータを収集し医療科学研究に役立てるほか、体系的に試料やデータをまとめるためのものです。ビックデータなどの新規ツールや高品質な生物検体に対するニーズの高まりから、今後も生物検体の収集は拡大し市場の成長につながるとみられています。北米、欧州が中心ですが、アジア太平洋地域ではオーストラリアが最大数のバイオバンクを有し、途上国ではインドが最大となっています。

レポートでは、バイオバンキングの概要とバイオバンクの分類と様々な用途、技術開発動向、地域別分布、現在の倫理的および法規制上の課題、市場の機会とニーズなどをまとめています。

イントロダクション

バイオバンキングの概要

  • 設計
  • 分類
  • 用途
  • 経済的課題
    • コスト管理戦略
    • コスト回収戦略
    • 基本的モデルと推奨

タイプ別バイオバンクの分類

  • 人口ベース
  • 疾患ベース
  • 試料採取別
  • 創薬および薬剤開発におけるバイオバンクの役割
  • バイオバンキングと治験

バイオバンクの地域別動向

主なバイオバンクプロファイル

バイオバンキング技術とソリューションの進歩

  • 試料採取と保管
  • 移送
  • データ処理ソフト

ビッグデータ

  • 現在の技術的、倫理的、法的課題
  • 医療におけるビッグデータの機会
  • ビッグデータ技術の統合

バイオバンキングに対する見解

  • インフォームドコンセントの問題

バイオバンキングにおける倫理と法規制

  • 現在の課題
  • 生物検体とデータの共有に関する国際的原則
  • 倫理と法規制ケーススタディ
  • バイオバンクの知的財産の機会

バイオバンキング業界のための手順と法規制整合

  • バイオバンクの整合の影響
  • 現在の整合問題
  • バイオバンクの整合における日本の取組み
  • Global Alliance for Genomics and Healthによる整合の取組み

参考文献

目次
Product Code: GBI063CBR

Summary

GBI Research's latest report, "Biobanking: Developing Smart, Sustainable and Ethically Compliant Biorepositories for the Future" discusses fundamental concepts in biobanking and recent technology advancements in the field. The report also describes ethical and regulatory concerns in biobanking as well as the economic challenges and opportunities surrounding this industry. Furthermore, this report provides strategic recommendations on how to overcome some of the most critical economic, technological and ethical challenges facing this fast-growing sector.

Biobanks collect human biospecimens and associated data for medical-scientific research, and organize samples and data in a systematic way for use by others. The importance of biobanks lies in determining the most effective way to store that information and make it available when required. Biobanks may collect different samples from diseased or healthy individuals in various settings. The integration of novel tools such as big data techniques, coupled with the increasing industry need for high-quality biospecimens for research, will lead to expanding biospecimen collections, ultimately resulting in the growth of this sector. Biobanks currently exist on every continent with most located in North America, followed by Europe. Australia has the highest number of biobanks in the Asia-Pacific region whilst India has the highest number of biobanks, when considering the developing economies only.

The development of a biobank depends upon people's willingness to donate their samples for research and to agree to sample storage. The participation and support of the public is therefore of crucial importance as their attitude towards biobanking activities will determine the success of many of these organizations.

Scope

  • What are the fundamentals of biobanking?
  • How can biobanks be classified and what are their different applications in healthcare?
  • What are the economic challenges faced by biobanks and how can these be overcome?
  • What are the most recent technology advancements in biobanking?
  • What role does biobanking play in drug discovery and clinical trials?
  • How are biobanks distributed geographically?
  • What are the prospects of Big Data and associated technologies within biobanking?
  • What are the technological and legal challenges?
  • What are the main healthcare opportunities that can be leveraged?
  • What is the public attitude towards various biobanking activities?
  • What are the challenges in obtaining informed consent from donors and what strategies can biobanks adopt to overcome these challenges?
  • What are the current ethical and regulatory challenges in biobanking?
  • What is the role and importance of the international charter of principles for data sharing between biobanks?
  • What are the main intellectual property right opportunities and challenges within biobanking? How can biobanks overcome these challenges and mitigate potential risks?
  • What is the need for process harmonization between biobanks?

Key Reasons to Purchase

This report will allow you to -

  • Gain insights in the biobanking industry: This report describes fundamental concepts in biobanking, biobank classification as well as economic, technological and ethical challenges surrounding these organizations. Learn how biobanks can overcome these challenges through best practice guidelines and strategic recommendations.
  • Understand the role of biobanks in research and development: This report demonstrates the relationship between biobanks and R&D groups.
  • Gain analysis on the distribution of biobanks in key regions and countries: This includes detailed analysis on the number of biobanks within each of the key regions and countries.
  • Review and assess recent advances in biobanking technologies: This includes technology innovations in specimen collection, storage, temperature maintenance, consumables, data handling, transportation of biospecimens, and the integration of big data technologies in biobanking activities.
  • Understand public views on biobanking activities: Learn about the various public concerns on biobanking, their attitude towards research, and how consent issues can be addressed through novel frameworks and technology adoption.
  • Assess ethics, regulations, and harmonization needs in biobanking: This in-depth report provides analysis on ethical, regulatory and harmonization requirements in the biobanking sector.

Table of Contents

  • Introduction
  • Fundamentals of Biobanking
    • Designing Biobanks
    • Classification of Biobanks
    • Applications of Biobanks
    • Economic Challenges faced by Biobanks
      • Cost-Control Strategies for Biobanks
      • Cost-Recovery Strategies for Biobanks
      • Funding Models and Recommendations for Biobanks
  • Biobank Characterization by Type
    • Population-based Biobanks
    • Disease-Based Biobanks
    • Biobanks Based on Type of Sample Collections
    • Role of Biobanks in Drug Discovery and Development
    • Biobanking and Clinical Trials
  • Regional Presence of Biobanks
  • Selected Biobank Profiles
  • Advances in Biobanking Technologies and Solutions
    • Specimen Collection and Storage
    • Transport of Specimens
    • Data Handling Software
  • Big Data
    • Current Technological, Ethical and Legal challenges
    • Big Data Opportunities in Healthcare
    • Integration of Big Data Technologies
  • Public Attitudes Towards Biobanking
    • Informed consent challenges
      • Informed Consent Strategies for Biobanks
  • Ethics and Regulations in Biobanking
    • Current Challenges
    • International Charter of Principles for Sharing Biospecimens and Data
    • Ethics and Regulations Case Studies
    • Intellectual Property Opportunities for Biobanks
      • IPRs Challenges and Risks for Biobanks
      • IPR Strategies and Recommendations for Biobanks
  • Procedure and Regulatory Harmonization for the Biobanking Industry
    • Harmonization Impact on Biobanks
    • Current Harmonization Challenges
    • Japan's Initiative in Harmonizing Biobanks
    • Harmonization Initiative by Global Alliance for Genomics and Health
  • Bibliography
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