DIA And NORD Hold 1st US Conference On Rare Diseases And Orphan Products

Release Groundbreaking Report on FDA Approval Process

What: Release of Report on FDA approval process of orphan drugs
When: Tuesday October 11, 2011 at 1pm
Where: Omni Shoreham Hotel / 2500 Calvert Street, NW,
Washington, DC

DIA and the National Organization for Rare Disorders (NORD) today announced the release of a new report detailing how flexible the Food and Drug Administration is in approving pharmaceuticals for rare diseases. The report will be released during the first US Conference on Rare Diseases and Orphan Products from October 11-13.

The following panel of experts will be present to discuss the report:

• Frank J. Sasinowski, Chair, NORD, and author of the report
• Janet Woodcock, Director, Center for Drug Evaluation and Research, FDA
• Christopher Paul-Milne, Associate Director, Tufts Center for the Study of Drug Development
• David P. Meeker, COO, Genzyme Corporation

A rare disease is defined Orphan Drug Act of 1983 as a disease or condition that affects fewer than 200,000 persons in the United States.

This conference will also feature panel discussions with pharmaceutical and healthcare industry leaders, patient advocacy groups and federal regulators, including: Francis S. Collins, Director, NIH; Fred Hassan, Warburg Pincus, Chairman, Bausch + Lomb; Jeffrey Shuren, Director, Center for Devices and Radiological Health, FDA; John F. Crowley, Chairman and CEO, Amicus Therapeutics; and Michael J. Astrue, Commissioner, Social Security Administration.

ABOUT DIA
DIA is a neutral, global, professional, member-driven association of nearly 18,000 professionals involved in the discovery, development, and life cycle management of pharmaceuticals, biotechnology, medical devices, and related health care products. Through our international educational offerings and myriad networking opportunities, DIA provides a global forum for knowledge exchange that fosters the innovation of products, technologies, and services to improve health and well being worldwide. Headquarters are in Horsham, PA, USA, with offices in Basel, Switzerland, Tokyo, Japan, Mumbai, India, and Beijing, China.

ABOUT NORD
NORD is a nonprofit organization representing all patients and families affected by rare diseases in the U.S. It was established in 1983 by rare disease patient organization leaders who had worked together on behalf of enactment of the Orphan Drug Act. Today, NORD provides programs and services that include advocacy, education of patients and medical professionals, support for research, and patient assistance programs to help patients access life-saving therapies.

SOURCE: DIA