Table of Contents
- Executive Summary
- Strategic Considerations
- Stakeholder Implications
- Academia: A Rich Source for Commercial Biomarker Development
- Creating a Win-Win for Academia and Industry
- New Heights in Biomarker Research
- Types of Academia-Industry Relationships
- Sponsorship
- Consultation
- Consortia
- Partnerships and Collaborations
- Spin-Outs
- Issues to Consider
- Identifying the Biomarker
- Government Intervention and Facilitation
- Regulatory and Reimbursement Challenges
- Surrogate End Points and the FDA
- Role of Technology Transfer Offi ces
- Advanced Planning
- Models Around the World
- Japan
- France
- The Netherlands
- Hungary
- China
- India
- Outlook
- Negotiation Process
- Caveats for Academia and Industry
- Contents (cont.)
- Expert Commentary
- Capitalizing on the Biomarker Repertoire for Drug Safety Research
- by Jack A. Reynolds, D.V.M., D.A.C.L.A.M., D.A.C.V.P., F.I.A.T.P.,
- Director of the Center for Molecular Safety Sciences and Head of
Safety Sciences and Translational Research at the Hamner Institutes for
Health Sciences
Sidebars:
- Paying the Price for Irreconcilable Differences
- Case Study:A Successful Marriage Between Academia and Industry
Tables:
- 1. Major Risks and Benefi ts of Academia-Industry Relationships for
Biomarker Development
- 2. Select Academic Technology Licensing Opportunities in the United States
- 3. Select Partnerships Between Major Industry Players and Academia
- 4. Common Models for Academic-Industry Relationships
- 5. Biomarker Defi nitions and Examples
- Appendix Table. Select Academia-Industry Biomarker and Diagnostics
Partnerships, as of March 2008
Figures:
- 1. Cycle of Funding Gained Through Academic Research
- 2. Number of Academia-Industry Relationships, 2004-2008 (as of March 2008)
- 3. Development Process for Drug, Biomarker, and Diagnostic Tests
- 4. Industry-Funded Expenditures and Research at U.S. Academic
Institutions, 2000-2006
- 5. General Path and Role of Technology Transfer Offi ces at Research
Universities
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