New molecular tests and clinical information demonstrate the utility of testing patients before prescribing both established and new therapeutics in many classes. But clinical adoption of such testing is slowed not only by the absence of standards of care, FDA requirements and payer buy-in, but also by the dearth of data demonstrating clinical utility, improved outcomes and cost-effectiveness.



Objectives:

Illustrate in concrete ways how the various sectors of the health-care system can both drive and deter approaches to personalized medicine.

Provide specific examples that the attendees can both learn from and apply to their own efforts to achieve regulatory approval and product launches in both diagnostics and therapeutics.

Identify tactical opportunities and pitfalls for developing and launching patient-specific approaches.