NORD's
Corporate Council met in Washington, DC, on May 23, 2005, to hear Mark McClellen,
MD, PhD, administrator for the Centers for Medicare and Medicaid Services (CMS),
discuss plans for the transition to new Medicare prescription drug coverage
in January 2006. Dr. McClellen also fielded questions from the audience.
Following his presentation, Don Moran, an industry analyst, discussed the anticipated
impact of the transition to the new Medicare regulations on pharmaceutical and
biotechnology companies.
Maria Hardin, vice president for patient services at NORD, and Sharon Cardinale,
project outreach manager for Trailblazers, described the current Medicare Demonstration
Project, through which the new regulations are being applied for certain patient
populations.
Europe and the US
The
afternoon session focused on orphan drug initiatives in Europe and how they
parallel and complement those in the U.S. Josep Torrent-Farnell, MD, chairman
of the European Union's Committee on Orphan Medicinal Products (COMP), discussed
developments in Europe since the enactment of orphan drug legislation there.
Yann
Le Cam, executive director of EURORDIS, the European Rare Disease Organization,
described his organization's role in orphan drug development.
Marlene Haffner, MD, director of the Office of Orphan Products Development
at the U.S. Food and Drug Administration, talked about the collaborative nature
of orphan drug development activities in the U.S. and other countries around
the world.
A European case study was presented by Darlene Stevens of the Genzyme Corporation.
Members of the NORD Corporate Council represent pharmaceutical and biotechnology
companies. They meet twice a year to discuss issues, opportunities, and challenges
of common interest related to the development of orphan products. The companies
represented range from very small start-up firms working on a first product
to well-established corporations with many products.
For information on the Corporate Council and/or its next meeting, contact Jean
Campbell at NORD (jcampbell@rarediseases.org).
Read about Corporate Council.
Read about events on Capitol Hill, funding for rare-disease research, and other topics of interest from NORD's office in Washington, DC.
