Risk Mitigation Strategies to Address Potential Procoagulant Activity in Immune Globulin Products
May 17, 2011
8:30 a.m. – 5:00 p.m.
May 18, 2011
8:00 a.m. – 2:00 p.m.
Workshop Goals and Objectives
The Food and Drug Administration (FDA), in cooperation with the National Heart, Lung and Blood Institute, and the Plasma Protein Therapeutics Association, are jointly co-sponsoring a public workshop on risk mitigation strategies to address procoagulant activity that may be present in some Immune Globulin Intravenous (Human) (IGIV) products. The purposes of the public workshop are to identify the most likely causes of IGIV-associated thrombotic events, to determine which procoagulant proteins may be causative, and to identify relevant, feasible tests that could be used to assess levels and/or activity of these proteins in IGIV products. The public workshop will feature presentations by national and international experts from government, academic institutions, and industry.
The following topics will be discussed at the public workshop: (1) Epidemiology of thrombotic events in IGIV recipients; (2) pathophysiology of arterial and venous thrombosis in this context; (3) research to identify specific procoagulant proteins that can co-purify with IGIV; (4) partitioning of coagulation factors during IGIV purification; (5) the role of activated Coagulation Factor XIa in IGIV-associated thrombosis; (6) test methods for screening IGIV products; (7) ancillary animal models; and (8) standards development for thrombin generation tests. On the first day of the public workshop, the epidemiology and potential causes of historically observed IGIV-associated thrombotic adverse events, as well as biochemical identification of procoagulant proteins that co-purify with IGIV will be discussed. In addition, results of IGIV product testing for procoagulant activity will be presented and discussed. On the second day of the workshop, methods and relevance of both broad and specific tests to screen IGIV products for procoagulant activity will be addressed, and limitations in test methodologies and validation needs will be identified. A summary of the meeting will be presented.
The Universities at Shady Grove Conference Center
Building II, Multipurpose Room
9630 Gudelsky Drive
Rockville, MD 20850
Please visit http://www.shadygrove.umd.edu/about/visit for directions, visitor parking, and public transportation information.
There is no registration fee for the workshop. Early registration is recommended before April 26, 2011 as seating is limited. Registration on the day of the workshop will be provided on a space available basis beginning at 7:30 a.m. To register, complete the attached registration form in this announcement and mail, fax or e-mail it to Rhonda Dawson, Food and Drug Administration, HFM-302, 1401 Rockville Pike, Rockville, MD 20852; Fax: 301-827-2843; E-mail: firstname.lastname@example.org
If you need special accommodations due to a disability, please contact Rhonda Dawson at least seven days in advance of the workshop.
For Program Information Contact
Food and Drug Administration
Office of Blood Research & Review
Center for Biologics Evaluation and Research
1401 Rockville Pike, HFM-302
Rockville, MD 20852