Abstract
Introduction
Biomarkers - physical characteristics that are objectively evaluated as
indicators of normal biological processes, pathogenic processes, or
pharmacological responses to therapeutic intervention - are high-valueadded
commodities in drug and diagnostics discovery and development, and
biomarker-based strategies are the key to success in personalized medicine. In
2008, these strategies were manifest in a variety of biomarkercentered
partnerships that involved pharmaceutical and biotech companies, academic
institutions, and government agencies and in several signifi cant M&As that we
examine in this report.
Get the Answers You Need to Shape Your Strategy
- The push for personalized medicine is gathering momentum. What are
the driving forces? What are the advantages and challenges of the personalized
medicine paradigm shift for pharma companies? For diagnostics companies? For
healthcare in general?
- Biomarker proponents often point to the success of
Genentech/Roche/Chugai' s Herceptin to illustrate the value of biomarker-based
drug/diagnostic development. What makes Herceptin a prime example? What
other success stories in biomarker-related research, development, partnering,
and regulatory approval can companies use as models?
- Researchers at your company have discovered a target that is amenable to
biomarker development, drug development, or both. What are your options?
When should you pursue an alliance? What are the benefi ts of partnering, or
not partnering, to realize the full potential of the discovery? What are other
companies doing? What are the pros and cons of investing in biomarkers? What
can companies do to secure their buyin?
Scope
- Key trends in biomarker partnering, November 2007 to November 2008:
biopharmaceutical and diagnostics company alliances, diagnostics company
partnerships, industry and academia collaborations, and government-sponsored,
biomarker-based product development.
- Five biomarker deal models: whole company acquisitions, asset
purchases, collaborations, licensing deals, and government-funded deals.
- Biomarker deal drivers: demand for more-precise diagnostics and
safer, more-effective drugs; lower-cost, lower-risk drug development; growth
potential of the diagnostics market.
- Expert Commentary: Spectrum Senior Program Manager Lulu Pickering,
Ph.D., offers “Ten Insights on Integrating Personalized Medicine into
Pharma Business Strategies.”
Table of Contents
- Executive Summary
- Strategic Considerations
- Stakeholder Implications
- Overview
- Biomarker Development Versus Drug Development
- Sidebar: Where Do Novel Biomarkers Come From?
- Biomarkers in Drug Development
- Model Case Studies
- Biomarker Diagnostics and Progress Indicators
- Making Strategic Partnering Decisions
- Factors That Infl uence Alliances
- Partnering.....
- .....Or Not Partnering
- Common Types of Biomarker-Centric Alliances
- Whole Company Acquisition
- Affymetrix Complements Its Product Line with the Addition of Panomics
- Johnson & Johnson Acquires Amic
- Immucor Acquires BioArray Solutions
- Asset Purchase
- Collaborations
- Roche Will Work with Arcxis on Infectious Disease and Cancer
- Rosetta Genomics Worked with Columbia University to Validate its NSCLC
Test
- The European Group for the Study of Insulin Resistance Will Contribute
Samples to Metabolon
- ApoCell Will Support Pfi zer' s Phase I Clinical Trial
- Genomic Health Is Developing a Renal Cell Carcinoma Test for Pfi zer
- Licensing Opportunities
- Ipsogen Licenses to Quest Diagnostics
- Genomic Nanosystems Licenses to Sequenom
- Johns Hopkins University Licenses to Orion Genomics
- OncoMethylome Sciences Licenses to Merck KGaA
- 20/20 GeneSystems/Ortho-Clinical Diagnostics
- Government' s Vested Interest
- Conclusions and Outlook
- Trends by Therapy Area
- “Blockbuster Diagnostic” Is an Oxymoron - for the Moment
- Drug Development Is a Driver
- Growth Comes from Undersized Sectors
- Spectrum Expert Commentary:
- Ten Insights on Integrating Personalized Medicine into Pharma Business
Strategies
Sidebar
- Where Do Novel Biomarkers Come From?
Expert Commentary
- Ten Insights on Integrating Personalized Medicine into Pharma Business
Strategies, Lulu Pickering, Ph.D., Decision Resources
Tables
- 1. Use of Biomarkers in Drug Development
- 2. Valid Genomic Biomarkers in the Context of Approved Drug Labels, for
Required and Recommended Tests
- 3. Valid Genomic Biomarkers in the Context of Approved Drug Labels, for
Information Only
- 4. Whole Company Acquisitions Related to Biomarkers and Diagnostics,
November 2007- November 2008
- 5. Asset Purchase Deals Related to Biomarkers and Diagnostics, November
2007- November 2008
- 6. Select Collaborations Related to Biomarkers and Diagnostics, November
2007- November 2008
- 7. Select Licensing Opportunities Related to Biomarkers and Diagnostics,
November 2007-November 2008
- 8. Select Government-Based Alliances Related to Biomarkers and
Diagnostics, November 2007-November 2008
Figures
- 1. Drug Discovery, Development, and Approval Process
- 2. Diagnostic Technologies Can Increase Treatment Effi cacy
- 3. Cycle of Funding Gained Through Academic Research
- 4. Payer Attitudes Toward Diagnostic Regulatory Pathways
- 5. Trends in Biomarker and Diagnostics Alliances by Therapy Area, November
2007-November 2008
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