When a biotech or pharmaceutical company collaborates with a diagnostic partner to co-develop molecular biomarkers and other diagnostic tests that may predict effi cacy and safety for various patient populations, thorny issues arise. The time-honored research and development collaboration model, in which the parties speak with one voice to regulatory agencies and peg their respective profits to revenue streams on drug sales, work awkwardly at best. Co-labeling of the two products may indeed encourage drug sales—or not. Is it fair, then, for the diagnostic developer to share in all sales revenues? Or are there better, more creative models for capturing value for both parties? What are the pitfalls each party may face in seeking regulatory approval of the therapeutic and the diagnostic, separately or in tandem?

• Provide a forum in which thought leaders in the drug, diagnostic, regulatory and legal arenas can brainstorm about new collaboration models
• Educate about novel best practices, which are not likely to be widely used throughout the industry
• Excite about the revolutionary partnering of therapeutics and diagnostics as a tool for developing safer, more effective drugs