Joint meeting of the Anti-Infective Drugs Advisory Committee and the Pediatric Advisory Committee

April 12, 2007



FDA Presentation

Regulatory Pathways for Products for the Prevention or Treatment of Disease Caused by Shiga Toxin-Producing Bacteria, Thomas Smith, M.D., Medical Officer Division of Anti-Infective and Ophthalmology Products (DAIOP).  (PPT) (HTML)

Epidemiology of Shiga toxin-producing E. coli infections, focusing on North America, Patricia Griffin, M.D., Chief, Enteric Diseases Epidemiology Branch, Division of Foodborne, Bacterial and Mycotic Diseases, National Center for Zoonotic, Vectorborne and Enteric Diseases. (PPT) (HTML)

Clinical course and consequences of infections with Escherichia coli O157:H7 and other Shiga toxin-producing bacteria, Phillip I. Tarr, M.D., Melvin E. Carnahan Professor of Pediatrics, Professor of Molecular Microbiology, Director, Division of Pediatric Gastroenterology and Nutrition, Washington University School of Medicine. (PPT) (HTML)

Experimental Animal Models for the Evaluation of Therapeutic Products Indicated for Shiga-toxin Producing Infections, Amy C. Nostrandt, D.V.M., Ph.D., Pharmacologist, DAIOP, CDER, FDA. (PPT) (HTML)

Study Design Issues and Considerations in HUS Trials, Yan Wang, Ph.D., Statistical Reviewer, Division of Biometrics IV, CDER, FDA. (PPT) (HTML)

STEC Disease Severity Score, Martin Bitzan, M.D., Assistant Professor, Department of Pediatrics and Pediatric Nephrology, McGill University, Montreal Children's Hospital. (PPT) (HTML)

Sponsor Presentation

Thallion Pharmaceuticals, Trial Design for Shiga Toxin-Producing Bacterial Infection, Thomas G. Cleary, M.D., Center for Infectious Diseases, University of Texas School of Public Health. (PDF)

Thallion Pharmaceuticals, backup slide. (PDF)

Teijin America, Inc., Strategy, Issues, and Alternative Approaches in Development of a Treatment for HUS Prevention - Sheldon Brookman, Ph.D. Executive Director, Clinical Research and Regulatory Affairs, Teijin America, Inc.  -  Allen Cato, M.D., Ph.D., President, Cato -  Research Myron Peterson, M.D., Ph.D. M.P.H., Acting Director, Medical Affairs, Cato Research. (PPT) (HTML)