On the Forefront of Orphan Drug Development – Re-examining the Orphan Drug Act and Key Initiatives Impacting the Clinical, Regulatory and Reimbursement Landscape
In 2011, CBI is proud to present its 6th Annual Rare Disease Leadership Summit at a critical time for this community. Advocates of the 5,800 rare diseases that have no commercialized treatments are petitioning Congress to update the Orphan Drug Act of 1983. A guidance from the FDA is expected regarding clinical trial design with an added flexibility due to the small number of participants. What will this look like and will it aid in the use of surrogate endpoints? Additionally, a rising number of orphan drug designations, while a positive for patients, is putting pressure on payers and may alter the reimbursement landscape. What will the result be on drug utilization? On the needs for patient assistant programs?
These are just a few of the reasons why this summit is a must attend in 2011!
Read about the buzz from our 2010 event!
For more information, or to submit abstracts, please contact Amy Bensle at (339) 298-2103 or email her at firstname.lastname@example.org.