The National Institutes of Health (NIH) and the Food and Drug Administration (FDA) will host a two-day workshop, "The Development of New Antibacterial Products: Charting a Course for the Future," to explore key issues and challenges related to antibacterial product development and discuss the development of streamlined regulatory pathways for bringing new antibacterial drugs to market. The workshop aims to identify strategies for promoting clinical trials for antibacterial drugs and encouraging partnerships to accelerate the development of new antibacterial drugs.
Specific issues to be discussed include:
- Priorities and strategic approaches to conducting clinical trials for antibacterial drugs
- Regulatory pathways-including streamlined development programs for the development of antibacterial drugs for patients with limited or no treatment options
- Clinical trial design issues including: the development of a common clinical protocol; using common control groups; statistical design issues; data sharing across trials (and data standards); appropriate clinical trial endpoints; and lessons learned from other therapeutic areas
- The role of public private partnerships in advancing the scientific and clinical trials enterprises
This workshop is open to the public. Due to space limitations, pre-registration is encouraged; registration deadline is Monday, July 14, 2014. The workshop will be held at the Bethesda North Marriott Hotel & Conference Center in Bethesda, Md.