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.

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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

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)

簡介
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Licensing Strategies for Accessing Biomarker Technologies