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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Agenda - Safety of Hemoglobin-Based Oxygen Carriers (HBOCs)

Hemoglobin Based Oxygen Carriers:
Current Status and Future Directions

Center for Biologics Evaluation and Research, FDA
The National Heart, Lung, and Blood Institute, NIH
Office of the Secretary and Office of Public Health and Science, DHHS

Natcher Auditorium
Building 45
National Institutes of Health
Bethesda, Maryland


April 29, 2008

7:30 a.m. Registration
8:30 a.m. Opening Remarks
J. Goodman, G. Nemo, J. Holmberg

Session I: Workshop Overview & HBOCs Update

Moderator: J. Fratantoni

8:35 a.m. Overview of the Workshop
J. Fratantoni
8:40 a.m. Physiology of Oxygen Transport
H.F. Bunn
9:00 a.m. HBOCs: Biochemical & Physiological Perspectives
A. Alayash
9:20 a.m. Nitric Oxide Physiology
A. Schechter
9:40 a.m. Non-Clinical Studies
G. Biro
10:00 a.m. Questions for Faculty Members
10:20 a.m. BREAK

Session II: Clinical Experience with HBOCs

Moderator: B. Alving

10:35 a.m. Introduction to the Issues
T. Silverman
10:55 a.m. Risk: Benefit Considerations in Clinical Trials
S. Goldkind
11:15 a.m. Presentations from Industry
Sangart, Northfield, Enzon
12:45 a.m. LUNCH
1:45 p.m. Presentations from Industry
Biopure, Baxter, Apex
3:15 p.m. BREAK
3:30 p.m. Panel Discussion:
Industry Speakers
5:00 p.m. Adjournment
5:30 p.m. Social Gathering
Natcher Center Atrium

April 30, 2008

Session III: Clinical Findings & Mechanisms

Moderators: H. Klein and R. Weiskopf

8:30 a.m. Opening Remarks
H. Klein
8:45 a.m. Functional Aspects of the HBOCs as a Class
Moderator: H. Klein

Panel Discussion:
S. Cohn, D. Demetriades, M. Fink, D. Freilich, J. Holcomb, C. Natanson, E. Norris, G. Vlahakes

10:00 a.m. BREAK
10:15 a.m. Organ-Specific Aspects of Safety
Moderator: R. Weiskopf

Panel Discussion:
A. Baines, M. Fink , M. Gladwin, J. Parillo, R. Regan, D. Waltier

12:00 p.m. LUNCH

Session IV: Finding a Way Forward

Moderator: G. Biro

Biochemical Approaches and Mitigation Strategies for HBOCs

1:00 p.m. Nitrite Reductase Activity of HBOCs
M. Gladwin
1:20 p.m. Engineering of Safer and Stable HBOCs
J. Olson
1:40 p.m. Vasoactivity and Dose Optimization
M. Intaglietta
2:00 p.m. Endogenous Scavengers of Hb
D. Schaer
2:20 p.m. Animal Models and HBOCs
J. Cavagnaro
2:40 p.m. Focused Clinical Trial Design
J. Carson
3:00 p.m. BREAK
3:15 p.m. Panel Discussion: J. Carson, J. Cavagnaro, E. Emanuel, C. Fleming, M. Intaglietta, J. Olson, D. Schaer, G. Vlahakes

Closing Remarks

4:30 p.m. J. Epstein

*Agenda subject to changes