Improving Regulatory Practices to Sustain Antibiotic Innovation

Webinar for Policymakers

The final installment of our three-part webinar series focuses on antibiotic development and invites expert speakers to consider how the regulatory process impacts investment in antibiotic development and commercialization. Speakers will discuss strategies to improve clinical trials for antibiotics, the impact of international regulatory harmonization, and how real-world evidence might augment the regulatory review and clinical success of novel antibiotics. Specifically, speakers will explore:

• Challenges associated with clinical trials for antibiotics, including: 
  • Conducting robust clinical trials among small patient populations (such as those with rare drug-resistant infections);
  • Achieving adequate and meaningful clinical trial enrollment; and
  • Advancing evidence of patient outcomes;
• Strategies to incentivize clinical trials among geographies beyond the U.S. where antibiotic resistance patterns are different or result in a higher burden of disease;
• The impact of the regulatory pathway on developing antibiotics for unmet needs; and
• How advancing international harmonization for bacterial infection indications might mitigate developmental barriers.

Funding Acknowledgement & Disclosure

The AMR Action Fund provided funding for this Duke-Margolis webinar. However, the views and conclusions shared by webinar speakers are solely those of the speakers and do not reflect the official position nor endorsement of the AMR Action Fund or any organization associated with the speakers.