Improving Regulatory Practices to Sustain Antibiotic Innovation

Event

Improving Regulatory Practices to Sustain Antibiotic Innovation

Register
Improving Regulatory Practices to Sustain Antibiotic Innovation

 

New Publication

View the one-page 'takeaways' publication under the Materials section at the top of this webpage.

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.

Cover of white paper with images of a petri dish, pill bottles being filled at a factory, boxes in a warehouse, a man scanning blood collection tubes at a diagnostic device, a woman working at a pharmacy's shelves, and antibiotic capsules in the background.

RELATED REPORT | Bolstering Public Health Preparedness by Investing in Post-Market Incentives for Novel Antibiotics

Durg-resistant infections and antimicrobial resistance (AMR) threaten global public health, and access to innovative, novel antibiotics is critical to prepare for future health emergencies. On October 23, 2023, Duke-Margolis published “Bolstering Public Health Preparedness by Investing in Post-Market Incentives for Novel Antibiotics” to describe opportunities for policymakers to establish pull incentives for novel antibiotics that advance public health preparedness and the bioindustrial base.

Read More

Duke-Margolis Policy Research Team

MHL

Marianne Hamilton Lopez, PhD, MPA

Senior Research Director, Biomedical Innovation
Faculty Director of the Duke-Margolis Postdoctoral Associates & Affiliated Fellows Program
Adjunct Associate Professor
Senior Team Member
Margolis Core Faculty

Image of Nicholas Harrison

Nicholas R. Harrison, MPH, MA

Policy Research Associate

Cameron Joyce Headshot

Cameron Joyce, MPA

Senior Policy Analyst