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Food and Drug Administration

Oncologic Drugs Advisory Committee Meeting
May 09, 2007

Morning Section


Sponsor Presentation

Introduction, Bonnie Mills, Ph.D., IDM Pharma (PPT) (HTM)

Unmet Need, Ian J. Lewis, M.B., ChB, FRCP, FRCPH, St. James University Hospital, Leeds, UK (PPT) (HTM)

Product Characteristics, Bonnie Mills, Ph.D., IDM Pharma (PPT) (HTM)

Efficacy/Safety, Paul Meyers, M.D., Vice-Chairman, Department of Pediatrics Memorial Sloan-Kettering Cancer Center, NY (PPT) (HTM)

Statistical Interpretation, Brent Blumenstein, Ph.D., Trial Architecture Consulting (PPT) (HTM)

Tolerability and Benefit/Risk, Eugenie S. Kleinerman, M.D., Professor and Head, Division of Pediatrics, Anderson Cancer, Texas (PPT) (HTM)

Core and Back up Slides (PPT) (PDF)

Food and Drug Administration Presentation

Medical Review, Patricia Dinndorf, M.D., Medical Officer, Office of Oncology Drug Products (OODP), FDA (PPT) (HTM)

Efficacy Data for Advair Diskus 500/50, Feng Zhou, M.S., DBII/ Office of Biostatistics (PPT) (HTM)

Statistical Review, Laura Lu, Ph.D., Statistical Reviewer, Office of Biostatistics, CDER, FDA (PPT) (HTM)

Afternoon Section

Sponsor Presentation

Introduction, Christopher J. Schaber, Ph.D., DOR BioPharma (PPT) (HTM)

orBec for the Treatment of Graft-Versus-Host Disease involving the GI Tract in Conjunction with an Induction Course of High-dose Prednisone or Prednisolone, George McDonald, M.D., Professor of Medicine, University of Washington (PPT) (HTM)

Core and Back up Slides (PPT) (HTM)

Food and Drug Administration Presentation

Clinical Review, Nancy Scher, M.D., Medical Officer, Division of Drug Oncology Products, FDA (PPT) (HTM)

Statistical Considerations, Shan Sun-Mitchell, Ph.D., Statistical Reviewer, Office of Biostatistics, CDER, FDA (PPT) (HTM)

Open Public Hearing Speakers

Susan Stewart, BMT InfoNet., Steve Dugan, transplant survivor, Radnor, PA, and Diane Pearl, mother of transplant survivor, Eureka, MO, (PPT) (HTM)

Philip L. McCarthy Jr. BMT Program Roswell Park Cancer Institute, Buffalo, NY, (PPT) (HTM)

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