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Past Event

Brookings Council on Antibacterial Drug Development Meeting #1

As part of ongoing cooperative work with the U.S. Food and Drug Administration, the Engelberg Center for Health Care Reform has formed a council to bring together expert perspectives on the challenges facing antibacterial drug development. Designed to include representatives from academia, patient advocacy groups, industry, providers, and government agencies, the Brookings Council on Antibacterial Drug Development (BCADD), will convene twice a year to discuss pressing issues in the treatment of infectious diseases and potential steps to address them.  

The first BCADD meeting, held on August 30, 2012, brought stakeholders together to discuss the following:

  • Ongoing antibacterial initiatives at FDA and the Clinical Trials Transformation Initiative
  • Statistical and methodological approaches that could be harnessed to improve the efficiency of antibacterial drug development
  • Balancing benefit-risk and uncertainty considerations with public health needs
  • Next steps for council action

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

Agenda

Welcome, Introduction, Charge to the Council, and Meeting Objectives

J

Janet Woodcock

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

Session I: Addressing Statistical Challenges in Antibacterial Drug Development

L

Lisa LaVange

Director, Office of Biostatistics, Center for Drug Evaluation and Research - U.S. Food and Drug Administration

Session II: Council Discussion on Data and Statistical Issues

L

Lisa LaVange

Director, Office of Biostatistics, Center for Drug Evaluation and Research - U.S. Food and Drug Administration

Session III: Risk-Benefit and Uncertainty in Antibacterial Drug Development and its Impact on Addressing Public Health Needs

Closing Remarks

More Information

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