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.
Remarks from FDA: Current and Future Status of Antibacterial Drug Development
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
Outlining the Path Forward
Existing Paradigms for Antibacterial Drug Development