Unmet Need

in Antibiotic Development

>> Project Summary

 

AB Drug Development

Unmet Need in Antibacterial Drug Development

CTTI Project Category: AB Drug Development

Project Status: Current

 

What is the issue?

Advances in clinical trial design over the past decade have offered new and accelerated pathways for drug development in general. Despite this, the development of novel antibacterial therapies is still lagging due to scientific and economic challenges. Meanwhile, resistance to currently available antibiotics is on the rise, and the absence of new antibacterial drugs has become a critical public health need. New, non-traditional approaches are needed to address this unmet need.

 

What are the objectives of this project?

  • Identify challenges and explore solutions to address serious bacterial disease for which effective antibacterial drugs are limited for patients who have an emerging bacterial pathogen with multi-drug resistance
  • Facilitate discussion among stakeholders to explore non-traditional approval pathways to streamline development of antibacterial drugs addressing unmet medical need
  • Assess patients risk, tolerance, and willingness to be treated with drugs approved through nontraditional trials, and to participate in the same (Workstream 2 - Patient Perspective)

 

What will we produce?

  • Publications/reports
  • Meeting summaries

 

What is the anticipated impact?

  • Incentivize industry investment in developing new antibacterial drugs
  • Increase public awareness about the benefits/risk considerations of new approaches to drug development