Food and Drug
Administration
Blood Products Advisory Committee
May 1, 2008
SLIDES
May 2, 2008
Updates and Informational Presentations
Topic II: Lev Pharmaceuticals, Inc. Clinical Trial for the Use of Plasma-Derived C1 Esterase Inhibitor (Cinryze) for the Prophylaxis of Hereditary Angioedema Attacks
Introduction, Felice D’Agnillo, Ph.D., DH, OBRR, FDA (ppt) (htm)
Lev Pharmaceuticals, Inc Presentation: (ppt) (htm)
- Introduction, Jason Bablak, Lev Pharmaceuticals
- Unmet Need and Pathophysiology, Michael Frank, M.D., Duke University
- Clinical Program, Ira Kalfus, M.D., Lev Pharmaceuticals
- Clinical Considerations for Patient Care, Paula Busse, M.D., Mount Sinai
Medical Center
FDA Review of Clinical Data, Basil Golding, M.D., Director, DH, OBRR, FDA
(ppt) (htm)
Statistical Issues, Boris Zaslavsky, Ph.D., Dr.Sc, OBE, FDA
(distributed to Committee and public, but not presented at the meeting)
(ppt) (htm)
Topic III: Review of the Research Programs in the Laboratory of Hepatitis and Related Emerging Agents, Division of Emerging and Transfusion Transmitted Diseases, OBRR, CBER (Site Visit November 8, 2008)
Overview of CBER Research Program, Carolyn Wilson, Ph.D., Acting Associate Director for Research, CBER, FDA (ppt) (htm)
Overview of OBRR Research Program, C.D. Atreya, Ph.D., Associate Director for Research, OBRR, FDA (ppt) (htm)
Overview of the Division of Emerging and Transfusion Transmitted Diseases Research Program, Hira Nakhasi, Ph.D., Director, DETTD, OBRR, FDA (ppt) (htm)
Overview of the Laboratory of Hepatitis and Related Emerging Agents and Review of its Scientific Program, Gerardo Kaplan, Ph.D., Chief, LHREA, DETTD, OBRR, FDA (ppt) (htm)
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