Public Workshop
Safety of Hemoglobin-Based Oxygen Carriers (HBOCs)
April 29, 2008
8:30 a.m. - 5:00 p.m.
April 30, 2008
8:30 a.m. - 5:00 p.m.
Review of Publicly Available Reports of Adverse Events Associated with HBOC's (PDF - 144 KB)
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Workshop Goals and Objectives
The Food and Drug Administration (FDA) is announcing a public workshop entitled: "Hemoglobin Based Oxygen Carriers: Current Status and Future Directions." The purpose of the public workshop is to discuss the safety of hemoglobin-based oxygen carriers (HBOCs) as related to a variety of potential uses of these investigational products. We are having this discussion because clinical and nonclinical studies of HBOCs, as either blood substitutes or as resuscitation fluids, have raised questions about the safety of these products as a group. The public workshop will feature presentations and roundtable discussions led by experts from academic institutions, government, and industry.
Topics to be discussed include oxygen and nitric oxide physiology in relation to hemoglobin and HBOCs in general and an overview of the biochemical and physiological aspects of HBOCs with special emphasis on the strengths and limitations of animal studies. The workshop will feature presentations by manufacturers of HBOCs on their experiences gained in the course of development of these products. Roundtable discussions by experts in different disciplines will focus on organ specific adverse effects seen with a variety of HBOCs and potential underlying mechanisms. The workshop will conclude with presentations on finding ways forward in terms of biochemical mitigation strategies, animal studies and alternative focused clinical designs.
Workshop Co-Sponsors
The public workshop co-sponsors are FDA; the National Heart, Lung and Blood Institute, National Institutes of Health; and the Department of Health and Human Services’ Office of the Secretary and Office of Public Health and Science (OS/OPHS).
Location
Natcher Conference Center
Bldg. 45
National Institutes of Health
8800 Rockville Pike
Bethesda, MD 20894
Registration
There is no registration fee for the workshop. Early registration is recommended before April 11, 2008, as seating is limited to 175 attendees. 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: rhonda.dawson@fda.hhs.gov
Registration Form (PDF, 16 kb)
If you need special accommodations due to a disability, please contact Rhonda Dawson at least seven days in advance of the workshop.
Overnight Accommodations
A block of rooms has been reserved for participants requiring overnight accommodations on April 28 and April 29 at the Bethesda Marriott Hotel, 5151 Pooks Hill Road Bethesda, MD 20814. Contact the hotel @ 1-800-228-9290 or 301-564-8210 before March 28, 2008 and refer to the FDA workshop on Safety of Hemoglobin-based Oxygen Carriers to receive a discounted room rate of $201.00/night plus tax. The hotel provides a free shuttle service to the NIH campus. There are a limited number of rooms available at the discounted rate.
For Program Information Contact
Rhonda Dawson
Program Coordinator
Food and Drug Administration
Office of Blood Research & Review
Center for Biologics Evaluation and Research
1401 Rockville Pike, HFM-302
Rockville , MD 20852
Phone: 301-827-6129
Fax: 301-827-2843
e-mail: rhonda.dawson@fda.hhs.gov