1
COMBIDEX®
(ferumoxtran-10)
Introduction, Combidex, Indication
Mark Roessel
Vice President Regulatory Affairs,
Advanced Magnetics, Inc.
3
Consultants
• Yoshimi Anzai, MD
Associate Professor of Radiology, University of Washington
• Michael Bettmann, MD
Profes...
4
Consultants (continued)
• Thomas Julian, MD, FACS
Associate Professor of Human Oncology, Drexel University
• Neal Futran...
5
Consultants (continued)
• William Shipley, MD, FACR
Andres Soriano Professor of Radiology Oncology, Harvard Medical Scho...
6
Indication
Combidex®
(ferumoxtran-10) is for intravenous
administration as a contrast agent for use with
magnetic resona...
7
Agenda and Key Topics
Introduction, Combidex, Indication
Mark Roessel, Vice President Regulatory Affairs, Advanced Magne...
COMBIDEX®
(ferumoxtran-10)
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Transcript of "[PPT"

  1. 1. 1 COMBIDEX® (ferumoxtran-10)
  2. 2. Introduction, Combidex, Indication Mark Roessel Vice President Regulatory Affairs, Advanced Magnetics, Inc.
  3. 3. 3 Consultants • Yoshimi Anzai, MD Associate Professor of Radiology, University of Washington • Michael Bettmann, MD Professor & Vice Chair for Interventional Services, Wake Forest University School of Medicine – Radiology • Steven Harms, MD Department of Radiology, University of Arkansas • Richard Wahl, MD Professor of Radiology & Oncology, Johns Hopkins Hospital • Dror Michaelson, MD, PhD Assistant of Medicine, Massachusetts General Hospital
  4. 4. 4 Consultants (continued) • Thomas Julian, MD, FACS Associate Professor of Human Oncology, Drexel University • Neal Futran, MD, DMD Professor of Otolaryngology, University of Washington • Michael Manyak, MD, FACS Professor of Urology, Microbiology and Tropical Medicine, George Washington University, VP Medical Affairs Cytogen Corporation • Shahin Tabatabaei, MD Department of Urology, Massachusetts General Hospital • Mack Roach, MD Professor Radiation Oncology, Medical Oncology, and Urology, University of California San Francisco Comprehensive Cancer Center
  5. 5. 5 Consultants (continued) • William Shipley, MD, FACR Andres Soriano Professor of Radiology Oncology, Harvard Medical School • Michael Kaliner, MD Medical Director for the Institute for Asthma & Allergy, George Washington University School of Medicine • John Page, MD Medical Officer, Advanced Magnetics, Inc. • Richard Chiacchierini, PhD R.P. Chiacchierini Associates (statistics) • David Ng, PhD Vice President PPD Development (statistics)
  6. 6. 6 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.
  7. 7. 7 Agenda and Key Topics Introduction, Combidex, Indication Mark Roessel, Vice President Regulatory Affairs, Advanced Magnetics, Inc. Mechanism of Action, Combidex in MR Imaging Mukesh Harisinghani, MD, Department of Radiology, Massachusetts General Hospital Efficacy Review William Goeckeler, PhD, Senior Vice President, Cytogen Corporation Safety Review Gerald Faich, MD, President Pharmaceutical Safety Associates Clinical Utility of Combidex in Various Cancers Jelle O. Barentsz, MD, Professor of Radiology, University Hospital Nijmegen, Netherlands
  8. 8. COMBIDEX® (ferumoxtran-10)
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