Public Workshop: New Methods to Predict the Immunogenicity of Therapeutic Coagulation Proteins

September 17, 2015
8:30 a.m. to 5:00 p.m.

September 18, 2015
8:30 a.m. to 12:00 p.m.

The Food and Drug Administration (FDA) is announcing a public workshop entitled: "New Methods to Predict the Immunogenicity of Therapeutic Coagulation Proteins."

Purpose and Scope of the MeetingThe purpose of the public workshop is to discuss recent scientific progress in identifying the genetic determinants for an unwanted immune response to therapeutic coagulation proteins (immunogenicity), and to identify and discuss potential new methods to predict such immunogenicity. Immunogenicity results in the development of antibodies that target the therapeutic protein and can affect the safety and efficacy of the biological product.

The workshop has been planned in partnership with the National Heart, Lung and Blood Institute, National Institutes of Health (NIH), the National Hemophilia Foundation, and the Plasma Protein Therapeutics Association. The workshop will include presentations and panel discussions by experts from academic institutions, industry, and government agencies.

LocationThe public workshop will be held at the following location:

National Institutes of Health Campus
Ruth Kirschstein Auditorium
Natcher Conference Center, Building 45
9000 Rockville Pike
Bethesda, MD 20892

Entrance for public workshop participants (non-NIH employees) is through the NIH Gateway Center located adjacent to the Medical Center Metro, where routine security check procedures will be performed. Please visit the following website for location, parking, security and travel information:
http://www.nih.gov/about/visitor/index.htm.

RegistrationIf you wish to attend this workshop, please visit http://methodspredictimmunogenicity.eventbrite.com.

Please register by August 27, 2015.

There is no registration fee for the public workshop. Early registration is recommended because seating is limited. Registration on the day of the public workshop will be provided on a space available basis beginning at 8:15 a.m.

If you need special accommodations due to a disability, please contact Freddy Barnes (see contact information below) at least 7 days in advance.

Contact InformationFreddy Barnes
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993
240-402-6943
E-mail: CBERPublicEvents@fda.hhs.gov (Subject Line: FDA MPICPDT Workshop)