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COMBIDEX ® (ferumoxtran-10) Introduction, Combidex, Indication Mark Roessel Vice President Regulatory Affairs, Advanced Magnetics, Inc. Yoshimi Anzai, MD Associate Professor of Radiology, University of Washington

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combidex

COMBIDEX®

(ferumoxtran-10)

introduction combidex indication
Introduction, Combidex, Indication

Mark Roessel

Vice President Regulatory Affairs,

Advanced Magnetics, Inc.

consultants
Yoshimi Anzai, MDAssociate Professor of Radiology, University of Washington

Michael Bettmann, MDProfessor & Vice Chair for Interventional Services, Wake Forest University School of Medicine – Radiology

Steven Harms, MDDepartment of Radiology, University of Arkansas

Richard Wahl, MDProfessor of Radiology & Oncology, Johns Hopkins Hospital

Dror Michaelson, MD, PhDAssistant of Medicine, Massachusetts General Hospital

Consultants
consultants continued
Consultants (continued)
  • Thomas Julian, MD, FACSAssociate Professor of Human Oncology, Drexel University
  • Neal Futran, MD, DMDProfessor of Otolaryngology, University of Washington
  • Michael Manyak, MD, FACSProfessor of Urology, Microbiology and Tropical Medicine,George Washington University, VP Medical Affairs Cytogen Corporation
  • Shahin Tabatabaei, MDDepartment of Urology, Massachusetts General Hospital
  • Mack Roach, MDProfessor Radiation Oncology, Medical Oncology, and Urology,University of California San Francisco Comprehensive Cancer Center
consultants continued5
Consultants (continued)
  • William Shipley, MD, FACRAndres Soriano Professor of Radiology Oncology, Harvard Medical School
  • Michael Kaliner, MDMedical Director for the Institute for Asthma & Allergy,George Washington University School of Medicine
  • John Page, MDMedical Officer, Advanced Magnetics, Inc.
  • Richard Chiacchierini, PhDR.P. Chiacchierini Associates (statistics)
  • David Ng, PhDVice President PPD Development (statistics)
indication
Combidex® (ferumoxtran-10) is for intravenous administration as a contrast agent for use with magnetic resonance imaging (MRI). Combidex can assist in the differentiation of metastatic and non-metastatic lymph nodes in patients with confirmed primary cancer who are at risk for lymph node metastases.

The information provided by Combidex should be considered in conjunction with other diagnostic information and lymph node findings from Combidex images should be pathologically confirmed unless medically contraindicated.

Indication
agenda and key topics
Agenda and Key Topics
  • Introduction, Combidex, IndicationMark Roessel, Vice President Regulatory Affairs, Advanced Magnetics, Inc.
  • Mechanism of Action, Combidex in MR ImagingMukesh Harisinghani, MD, Department of Radiology,Massachusetts General Hospital
  • Efficacy ReviewWilliam Goeckeler, PhD, Senior Vice President, Cytogen Corporation
  • Safety ReviewGerald Faich, MD, President Pharmaceutical Safety Associates
  • Clinical Utility of Combidex in Various CancersJelle O. Barentsz, MD, Professor of Radiology,University Hospital Nijmegen, Netherlands
slide8

COMBIDEX®

(ferumoxtran-10)