Just over 25 years ago, the U.S. Congress passed the Orphan Drug Act thanks in large part to the efforts of the National Organization for Rare Diseases (NORD).  This legislation provides financial incentives for the development of new treatments for rare diseases. Since the passage of the act in 1983, more than 300 orphan drugs and biological products have received marketing authorization and over 1000 different orphan drug designations have been granted by the FDA’s Office of Orphan Products Development.

Join the MdBio Division of the Tech Council of Maryland to celebrate the success of the Orphan Drug Act and learn how bioscience companies can access and utilize its mandated incentives to facilitate drug development programs, shape business strategies, and drive commercial success.   Our speakers are:

Moderator

Kimberley Cummings, Ph.D., RAC(US)
Associate Director, Project Management Office
Cato Research, Ltd.

Speakers

Timothy Cotè, MD, MPH
Director, Office of Orphan Products Development
US Food and Drug Administration

Diane Dorman
VP, Public Policy
National Organization for Rare Disorders (NORD)

Debra Lewis, OD, MBA
Associate Director, Office of Orphan Products Development
US Food and Drug Administration

Eugene Sullivan, MD, FCCP
Chief Medical Officer
United Therapeutics Corporation