Harnessing Biomarker Research in Academic Institutions for Use in Industry

Harnessing Biomarker Research in Academic Institutions for Use in Industry published by Decision Resources, Inc. in April, 2008. This report consists of 36 Pages and the price starts from US $ 2250.

Introduction

Academic research institutions are a rich source of technology for commercial biomarker development. Some of today' s most dynamic biomarker discoveries originated from academic-industrial relationships, resulting in millions of dollars for universities and billions of dollars for industry. Alliances between academia and industry can be complex, but creating a win-win solution for both parties is possible and worthwhile.

• Most of the major players in the pharmaceutical industry are involved " in some type of relationship with academic partners, and many successful biomarkers ultimately derive from academic research. What are the key alliances between academia and industry relevant to biomarker discovery and diagnostic test development? What is the role of government oversight in ensuring the success of these alliances?
• Various relationships exist between academic institutions and industry engaged in biomarker development. What are the most common types of partnerships between academia and industry? What are the risks and benefi ts of each?
• Industrial science and academic science have fundamentally different orientations, as well as different cultures and rules of conduct. What are the issues to consider before embarking on a partnership? What are the ingredients for a successful industry-academia relationship? What issues can sour a relationship?

• Commercial biomarker development: creating a win-win for academia and industry; the negotiation process; caveats for successful relationships.
• Types of academia-industry relationships: sponsorship, consultation, consortia, partnerships and collaborations, and spin-outs.
• Case studies: a partnership that succeeded and another that did not. What went right and what went wrong?
• Global perspective: Select academia-industry biomarker development partnerships around the world.

• 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

• 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

• 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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