ANTIMICROBIAL RESISTANCE SOLUTIONS
WITH DR. JOHN H. REX
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R&D Insight
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Antimicrobial resistance poses a catastrophic threat. If we don’t act now, any one of us could go into hospital in 20 years for minor surgery and die because of an ordinary infection that can’t be treated by antibiotics. And routine operations like hip replacements or organ transplants could be deadly because of the risk of infection.
Dame Sally Davies Tweet
The 37,000-year view: Infections in Eurasia
Developing systemic & inhaled antibiotics for lung infections
FDA AMDAC – Developing Single-Pathogen agents for P. aeruginosa and A. baumannii
Categories of resistance: MDR, XDR, PDR, UDR, and (new!) DTR
FDA analysis of 40-years of antibacterial development: Dheman et al.
FDA: Early endpoints and late endpoints suggest a path to global regulatory convergence (Bart et al.)
FDA workshop: Insights on inhaled antifungals and antibacterials
How hard (and how) to Pull? Net value of Pull via a Transferrable Exclusivity Extension (TEE)
Reimbursing for innovative antibiotics / Encouraging updates from the AMR conference
In Praise of Non-Inferiority
Language matters: CRE vs. CPE; SDD vs. I; and MDR, XDR, PDR, UDR vs. DTR
FDA Workshop: Animal Models To Support Antibacterial Development (5 Mar 2020, post-meeting notes)
The thoughtless person playing with penicillin treatment is morally responsible for the death of the man who succumbs to infection with the penicillin-resistant organism.
Alexander Fleming Tweet
The bipartisan PASTEUR Act is the strongest bill ever written to strengthen antibiotic development and use. It will fix our market failures, expand the pipeline for next generation antibiotics, and save lives. We can’t sit on our hands as this public health crisis arrives – we have to act now.
U.S. Senator Michael Bennet Tweet