It's All About the Biomarkers: How 2008's Biomarker-Based Partnering Is Driving Personalized Medicine

Abstract

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.

• 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?

• 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.”