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
In Praise of Non-Inferiority
FDA and EMA regulatory updates / Fireside chat during the 4th AMR Conference
The hunt for oral antibiotics: Beyond Lipinski’s Rule of Five
How hard (and how) to Pull? Net value of Pull via a Transferrable Exclusivity Extension (TEE)
The 6 meanings of “Lack of Access” (UNSLAP)
FDA: Early endpoints and late endpoints suggest a path to global regulatory convergence (Bart et al.)
Draft FDA guidance on anti-infectives for children: It’s (mostly) all about PK and safety
FDA analysis of 40-years of antibacterial development: Dheman et al.
New pipeline analysis: Cancer projects were funded 17x more than antibacterials during 2011-2020
FDA Workshop: Animal models in support of narrow-spectrum agents for A. baumannii and P. aeruginosa
Push! Pull! Push! Pull! / Highlights from Davos 2018
Non-traditional antibiotics: A pipeline review and an analysis of key development challenges
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