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市場調查報告書
生物標記技術利用相關授權策略
Licensing Strategies for Accessing Biomarker Technologies
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本報告已在2011年12月21日停止出版。
藥物發現及新藥開發工作中生物標記的角色日益重要,提供生物標記相關工作及服務的企業也紛紛加入該市場。
本報告書內容包括:生物製藥企業、生物標記・發展企業、研究機構、大學等生物標記產業的利害關係人應採取的策略介紹。內容綱要摘記如下:
第1章 實施概要
第2章 醫療價値鏈中生物標記的優點
第3章 生物標記技術利用
第4章 生物製藥企業及醫療診斷企業的生物標記
- 生物製藥企業的生物標記利用
- 醫療診斷企業的生物標記利用
- IVD企業的生物標記技術提供活動
第5章 生物標記研究領域中小規模企業的角色
第6章 研究機構及大學的開發
- 生物標記技術商品化
- 營業
- 授權費率
- 目標達成補助金
- 持續支援
- 聯絡對象
- 新興診斷企業及生物科技企業的重要性
第7章 展望
Abstract
Introduction
Biomarkers play an increasingly important role in drug discovery and
development. A large number of companies have emerged that provide various
biomarker-related tools and services. The various stakeholders in the
biomarker industry-specifi cally, biopharmaceutical companies, biomarker
developers, and research institutions and universities-will need to devise
specifi c strategies to access an array of agents and technologies that are
constantly changing.
Get the Answers You Need to Shape Your Strategy
- Biopharmaceutical companies must carefully consider their options when
seeking to access specifi c biomarker technology. What single principle
should biopharmaceutical companies adhere to when seeking to secure successful
deals with potential clients in order to increase the chances of fi nding a
suitable partner?
- In today' s environment of M&As and the anticlimactic results of the
Roche-Ventana and GE Healthcare-Abbott deals, large in vitro diagnostics (IVD)
companies need to clarify their biomarker research strategies. How should a
large IVD company' s choice of commercial partners change with the company' s
goals?
- Research institutions and universities that have patented technology will
continue to rely upon licensees or commercial partners to further refi ne the
technology and perform the advanced testing that allows commercial use of the
technology. What aspect of licensing agreements do research institutions
need to be particularly wary of when negotiating agreements with commercial
partners?
- Because the bulk of new biomarker research is driven by research
institutions and universities, these parties need to continue to secure
funding for their research efforts. Why is reliance on biopharmaceutical
licensing partnerships as a source of funding for these institutions
particularly risky in today' s biomarker environment?
- Partly because of the costs associated with biomarker development, several
consortia have been set up to address biomarker use for drug discovery and
development. What specifi c biomarkers are some of these consortia seeking
to develop?
Scope
- Advantages of biomarkers across the health care value chain: benefi
ts for diagnostics companies, biopharmaceutical companies, life sciences
research tools companies, patients, caregivers, and health care payers
- Accessing biomarker technology: sources of biomarkers; determining
biomarker access strategies; validation and qualifi cation requirements
- Research institutions and universities: goals of outlicensing
biomarker technology; the transference of technology to the private sector;
patents, royalties, liabilities, and milestone payments; commercialization of
biomarker technology; importance to emerging diagnostics and biotechnology
companies
- Biopharmaceutical and diagnostics companies: the use of biomarkers
as tools for improving drug discovery and development; association with
diagnostics testing companies; biomarker licensing activities by in vitro
diagnostics companies
- Smaller companies: the role of testing laboratory companies and
biomarker research tool and service companies
- Licensing agreements: a series of 5 tables detailing more than 170
biomarker agreements
- Outlook: the engine for new biomarkers; providing critical funding;
consortia to the rescue
Table of Contents
- Executive Summary
- Strategic Considerations
- Stakeholder Implications
- Advantages of Biomarkers Across the Health Care Value Chain
- Accessing Biomarker Technology
- Where Do Novel Biomarkers Come From?
- Fitness-for-Purpose
- Biomarkers in Biopharmaceutical and Diagnostics Companies
- Biomarker Use in Biopharmaceutical Companies
- Biomarker Use in Diagnostics Companies
- Biomarker Licensing Activities by IVD Companies
- Role of Smaller Companies in Biomarker Research
- Testing Lab Companies
- Biomarker Research Tool and Service Companies
- Tapping Research Institutions and Universities
- Commercialization of Biomarker Technologies
- Operations
- Royalty Rates
- Milestone Payments
- Continuing Support
- Personal Contacts
- Importance to Emerging Diagnostics and Biotechnology Companies
- Outlook
- Engine for New Biomarkers
- Funding Is Critical
Sidebar
- Consortia Addressing Biomarker Usage for Drug Discovery and Development
Tables
- 1. Uses of Biomarkers in Drug Discovery and Development
- 2. Biomarker Defi nitions for Drug Discovery and Development
- 3. Key Biomarker Outlicensing Agreements Among Biopharmaceutical
Companies, January 2006-October 2007
- 4. Select Outlicensing Biomarker Technology Deals by IVD Companies, July
2006-October 2007
- 5. Key Biomarker Licensing Activities Among Smaller Companies, January
2007-October 2007
- 6. New Biomarker Technology Agreements with Testing Lab Companies, July
2006-October 2007
- 7. Select Biomarker Research Service and Tools Companies
- 8. Major Considerations in Technology Transfer Deals
- 9. Select Biomarker Outlicensing Activities by Research Institutions and
Universities, January 2006-October 2007
Figures
- 1. Requirements for Validation and Qualifi cation in Biomarker Discovery
and Development
- 2. Number of FDA-Approved New Molecular Entities (NMEs) (1997-2006) and
Total Global R&D Spending, PhRMA Members (1997-2005)
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