Biomarkers

1
Biomarkers competitiveness in the biotechnology
industry

• AIMBE 15th annual event
• National Academy of Sciences
• Washington, DC
• March 2, 2006

2
Industry is rapidly approaching an inflection
point

• Where are we technically?
• Where are we from a business perspective?
• Challenges, opportunities
• How can biomarkers become tools for competitive
  advantage in the future?
• What is the path to commercialization?
• What obstacles remain?

3
Practical challenges are significant

• Pharma companies are still evaluating
  risk/benefit ratio
• CMS is intrigued, but issues remain
• What diseases are targets?
• Universal testing costs
• Ethical issues
• Diagnostic business has historically lacked
  economic appeal
• Convergence the new paradigm for opportunity

4
Challenges exist in the path to future
commercialization
Novel target identification
Earlier proof-of-concept
Smaller trials, more efficient development
but challenges in prime time
5
Operational components for RA biomarker strategy
are complex

• What is itprognostic, diagnostic, PGx,
  monitoring?
• Sensitivity, specificity, wet/dry chemistry,
  cost, ethical issue
• Integration into guidelines
• Physician education
• Patient education
• Early integration into development

6
Interest is increasingfollow the money!

• IPO valuations, FDA approval times
• Vioxx Celebrex
• Life Sciences VCs will need to diversify late
  1990s focus was enabling tools 2000 present
  focus is late stage therapeutics
• Future balanced and diversified portfolio
• Convergence of diagnostics, devices,
  therapeutics, biomaterials, and information
  technology
• Enabling tools
• Health Wellness
• Public demand, ready market