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U.S. Department of Health and Human Services

Emergency Preparedness and Response

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The Development of New Antibacterial Products: Charting a Course for the Future

 

Public Workshop

CDC microbiologist holding an opened Petri dish culture plate, demonstrating the results of a modified Hodge test, which is used to identify resistance in bacteria known as Enterobacteriaceae. Bacteria that are resistant to carbapenems (Carbapenem-Resistant Enterobacteriaceae (CRE)), which are considered “last resort” antibiotics, produce a distinctive clover-leaf shaped growth pattern, as seen in this case. Photo: CDC/James GathanyJuly 30-31, 2014

 

Presentations from Day 1 disclaimer icon

Presentations from Day 2 disclaimer icon

 

Bethesda North Marriott Hotel & Conference Center disclaimer icon
5701 Marinelli Road
North Bethesda, MD 20852

 

The National Institutes of Health (NIH) and FDA will host a two-day workshop 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

 

Registration Information

This workshop is open to the public. Due to space limitations, pre-registration is encouraged; registration deadline is Monday, July 14, 2014.

If you require assistance registering, please contact Monica Barnette at (301) 650-8660 or mbarnette@palladianpartners.com

 

Federal Register notice about this event (July 1, 2014)