Public Workshop
Safety of Hemoglobin-Based Oxygen Carriers (HBOCs)
Hemoglobin Based Oxygen Carriers:
Current Status and Future Directions
Sponsors:
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
ABBREVIATED AGENDA*
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