The US Food and Drug Administration (FDA) recently announced an upcoming public workshop to discuss immunogenicity in therapeutic factor protein products designed to treat people with bleeding disorders.
Immunogenicity is the capacity of a substance to prompt a response from the immune system. In people with bleeding disorders, it refers to the development of inhibitors, antibodies that attack infused factor product, neutralizing their ability to prevent and/or stop bleeds. Inhibitors occur in 15%-20% of people with hemophilia A (factor VIII deficiency), and 2%-5% of people with hemophilia B (factor IX deficiency). Inhibitors can also occur in people with other types of bleeding disorders.
The workshop will include presentations and panel discussions on the scientific progress made toward a better understanding of the genetic and biological causes of immunogenicity. Expert speakers from academic institutions, industry and government agencies will also talk about novel approaches to accurately predict potential undesired immune responses.
The workshop will be held on Thursday, September 17, 2015, from 8:30am to 5pm, and on Friday, September 18, 2015, from 8:30am to 12pm. The location is the Ruth Kirschstein Auditorium, Natcher Conference Center on the National Institutes of Health (NIH) Campus in Bethesda, MD.
Learn more by accessing the full notice on the Federal Register.
The workshop has been planned in partnership with the National Heart, Lung, and Blood Institute, NIH, the National Hemophilia Foundation and the Plasma Protein Therapeutics Association.
The deadline to register is Thursday, August 27, 2015. Although there is no fee for the workshop, you are encouraged to register early because seating is limited. Registration on the days of the public workshop will be provided on a space available basis beginning at 8:15 a.m.
Source: Federal Register, July 2, 2015
