Over the past three decades, Congress and the FDA have put in place several programs to drive industry investment towards innovative and neglected areas of drug research. Policy-based incentive mechanisms, such as market/data exclusivity (e.g. Hatch-Waxman, Orphan Drug Act), expedited programs (e.g. breakthrough therapy designation, accelerated approval, and priority review), tax credits, and the FDA priority review voucher, have been proposed or implemented to attract investment and speed the drug development process towards priority therapeutic areas. This panel will review these programs, discuss their impact on drug development and patient wellbeing, and identify possible improvements to these programs as incentives. Panelists will represent small and large biopharmaceutical companies, and the investor community.
Ability Level: Advanced
Session ID: 503653