Pediatric Oncology Subcommittee
of the Oncologic Drugs Advisory Committee 

December 6, 2006

Slides

FDA Presentation

Opening Remarks, Karen Weiss, M.D., Deputy Director, Office of Oncology Products (OOP), CDER, FDA (PPT) (HTM)

Non-inferiority Trial Design, Rajeshwari Sridhara, Ph.D., Statistical Team Leader for Oncology Drugs, Division of Biometrics V, Office of Biostatistics, CDER, FDA (PPT) (HTM)

Sponsor Presentation

Summary of January 2006 Workshop on Clinical Trial End Points in Primary Brain Tumors, Larry Kun, M.D., Chair, Department of Radiological Sciences St. Jude Children's Research Hospital (PPT) (HTM)

Biology of Pediatric Brain Tumors and the Heterogeneity of this Disease, Mark Kieran, M.D., Ph.D., Department of Pediatric Oncology, Dana Farber Cancer Institute, Assistant Professor of Pediatrics, Harvard Medical School (PPT) (HTM)

Children's Oncology Group Experience with Pediatric Brain Tumor Clinical Trials, Ian Pollack, M.D. F.A.C.S., F.A.A.P., Walter Dandy Professor of Neurosurgery, Chief, Pediatric Neurosurgery, Children's Hospital of Pittsburgh, Director, UPCI Brain Tumor Program, University of Pittsburgh School of Medicine (PPT) (HTM)

Neurocognitive Sequelae of Pediatric Brain Tumors, Daniel Armstrong, Ph.D., Professor and Associate Chair, Department of Pediatrics. Director, Mailman Center of Child Development Associate Chief of Staff, Holtz Children's Hospital at University of Miami/Jackson Memorial Medical Center (PPT) (HTM)

Questions to the Pediatric Oncology Subcommittee and Discussion (PDF)

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