Past Event

Facilitating Antibacterial Drug Development

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.

Agenda

Welcome and Overview

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

D

Janet Woodcock

Director, Center for Drug Evaluation and Research - US Food and Drug Administration

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

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

P

Richard Platt

Professor and Chair, Department of Population Medicine - Harvard Pilgrim Health Care Institute

Outlining the Path Forward

P

Rachel Sherman

Principal, Drug and Biological Drug Products - Greenleaf Health LLC

Recap and Closing Remarks

Existing Paradigms for Antibacterial Drug Development

A

John Powers

Associate Clinical Professor of Medicine; George Washington University School of Medicine - Senior Medical Scientist; Leidos Biomedical Research

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