Feb 7

Past Event

Modernizing Antibacterial Drug Development and Promoting Stewardship

Summary

Antibacterial drug resistance is a global public health threat poised to worsen due to the combination of the inappropriate use of existing drugs and a marked decline in innovative antibacterial drug development. In order to tackle this problem, stakeholders must consider comprehensive strategies that address both drug development and stewardship.

On February 7, the Engelberg Center for Health Care Reform convened an expert workshop, “Modernizing Antibacterial Drug Development and Promoting Stewardship” to explore a two-pronged approach to combating antibacterial drug resistance that includes: 1) the development of pathogen-focused antibacterial drugs that target the most serious public health threats; and 2) stewardship efforts for all antibacterial products in order to preserve their utility. Participating stakeholders included experts from the drug development and health care industries, the clinical community, government, and academia. These stakeholders shared their insights on potential frameworks and evidentiary considerations for pathogen-focused drug development, and efforts underway to promote the appropriate use of commonly used antibacterial drugs in the ambulatory care setting.

Event Agenda

  • 9:00

    Welcome and Introduction

  • 9:15

    Opening Comments

    • Edward Cox

      U.S. Food and Drug Administration

  • 9:30

    Targeting Drug Development for Patients with Serious Bacterial Diseases and Unmet Medical Needs

    • Moderator

      mmclellanimage

      Mark B. McClellan

      Director, Health Care Innovation and Value Initiative

      Senior Fellow, Economic Studies

    • Marco Cavaleri

      European Medicines Agency

    • John Rex

      AstraZeneca

    • Christine Murray

      Achaogen

    • Cheryl Bettigole

      CompleteCare Health Network, National Physicians Alliance

  • 10:30

    Break

  • 10:40

    Evidentiary Considerations for Advancing Targeted Antibacterial Drug Development

    • Moderator

      mmclellanimage

      Mark B. McClellan

      Director, Health Care Innovation and Value Initiative

      Senior Fellow, Economic Studies

    • John F. Tomayko

      GlaxoSmithKline

    • Karen C. Carroll

      The John Hopkins University School of Medicine

    • Paul G. Ambrose

      The State University of New York at Buffalo, Institute for Clinical Pharmacodynamics

    • Helen W. Boucher

      Tufts Medical Center, Tufts University School of Medicine

  • 12:00

    Lunch

  • 1:00

    Stewardship and Benefit-Risk Considerations

    • Moderator

      mmclellanimage

      Mark B. McClellan

      Director, Health Care Innovation and Value Initiative

      Senior Fellow, Economic Studies

    • Joseph Toerner

      U.S. Food and Drug Administration

    • John Powers

      George Washington University School of Medicine

    • Lauri Hicks

      Centers for Disease Control and Prevention

    • Stuart B Levy

      Tufts University School of Medicine, Alliance for the Prudent Use of Antibiotics

  • 2:15

    Recap and Closing Remarks

Details

February 7, 2014

9:00 AM - 2:30 PM EST

The Brookings Institution

1775 Massachusetts Ave., NW

Map

For More Information

Brookings Office of Communications

202.797.6105