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Food and Drug Administration

Blood Products Advisory Committee

May 1, 2008


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)

  1. Introduction, Jason Bablak, Lev Pharmaceuticals

-     Unmet Need and Pathophysiology, Michael Frank, M.D., Duke University

  1. 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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