"Major technological advances in genomics and bioinformatics provide significant opportunities to improve the way that medical products are developed and regulated. The FDA, forward-looking companies and other stakeholders have come together to identify new and novel strategies to improve medical product development productivity and reduce the attrition. This session will provide an important update on the status of Critical Path activities, the impact of new legislation under the PDUFA IV reauthorization and perspectives from stakeholders who have taken the lead in establishing consortia that build on the promise of the Critical Path Initiative."

Objective1: Provide an understanding of Critical Path and its current state.

Objective2: Stimulate greater involvement in by biotech companies.

Objective3: Identify Critical Path opportunities of particular need for biologic therapeutics.