"The ability to obtain orphan drug approval (ODA) has been a cornerstone of biotechnology's innovative reputation. But as the regulatory landscape evolves, orphan drugs become a high-risk, potentially low-return investment, and at the end of the day, it's the patient who suffers. What does the orphan drug landscape look like today?"

Objective1: "Assess the status of orphan drugs in terms of applications and approvals from a historical and current standpoint . . . where are we trending?"

Objective2: Review the challenges of obtaining an orphan drug approval from a regulatory standpoint.

Objective3: Assess the overall risk/benefit profile of bringing an orphan drug to market and review post-approval obligations.