As the prevalence of drug-resistant bacteria continues to rise, there is a pressing need for new drugs to combat infections by these organisms. However, research and development in this area has slowed, creating a public health concern that we lack the drugs necessary to treat multi-drug resistant infections. Challenges to promoting antibacterial drug development may be scientific, methodological, regulatory, or economic in nature.

On Wednesday, May 9, 2012, the Engelberg Center for Health Care Reform convened an expert workshop, "Facilitating Antibacterial Drug Development,” that explored solutions to methodological and regulatory challenges that could make the development process more efficient. This meeting brought together diverse multi-stakeholder experts—including medical product developers, health care professionals, researchers, patient advocates, representatives of the U.S. Food and Drug Administration, and other groups—to explore the following issues:

  • Existing paradigms for antibacterial drug development;
  • Novel approaches to further antibacterial drug development, including use of pharmacokinetics and pharmacodynamics, Bayesian methods, innovative clinical trial designs, new data sources, alternate clinical endpoints, and new regulatory tools; and
  • Short- and long-term opportunities to advance the antibacterial drug development enterprise through collaboration among stakeholders, improved regulatory science, and other means.

For more information on FDA’s Antibacterial Drug Development Task Force, click here.

Event Agenda

  • Welcome and Overview

  • Remarks from FDA: Current and Future Status of Antibacterial Drug Development

    • Janet Woodcock

      U.S. Food and Drug Administration

  • Existing Paradigms for Antibacterial Drug Development

    • Moderator

    • Brad Spellberg

      Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center

    • George Talbot

      Talbot Advisors LLC

    • Thomas Fleming

      University of Washington School of Public Health

    • John Powers

      National Institutes of Health and The George Washington University School of Medicine

  • Pharmacokinetics and Pharmacodynamics (PK/PD) in Antibacterial Drug Development and Bayesian Methods in Clinical Research

    • Moderator

      Rob Califf

      Duke Translational Medicine Institute, Duke University Medical Center

    • George Drusano

      University of Florida College of Medicine

    • Scott Emerson

      University of Washington

  • Novel Approaches to Further Antibacterial Drug Development: New Approaches to the Clinical Development Program

    • Moderator

      Rob Califf

      Duke Translational Medicine Institute, Duke University Medical Center

    • John Rex

      AstraZeneca Pharmaceuticals and University of Texas Medical School at Houston

    • Daniel Benjamin

      Duke Clinical Research Institute, Duke University School of Medicine

    • Richard Platt

      Harvard Pilgrim Health Care and Harvard Medical School

    • Edward Cox

      U.S. Food and Drug Administration

  • Outlining the Path Forward

    • Moderator

    • Helen Boucher

      Tufts Medical Center and Tufts University School of Medicine

    • Barry Eisenstein

      Cubist Pharmaceuticals and Harvard Medical School

    • Louis Rice

      Warren Alpert Medical School of Brown University, Rhode Island Hospital and The Miriam Hospital

    • Rachel Sherman

      U.S. Food and Drug Administration

  • Recap and Closing Remarks


May 9, 2012

8:30 AM - 2:30 PM EDT

Brookings Institution

Saul/Zilkha Rooms

1775 Massachusetts Avenue NW


For More Information

Engelberg Events