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
FDA Workshop: Animal models in support of narrow-spectrum agents for A. baumannii and P. aeruginosa
Categories of resistance: MDR, XDR, PDR, UDR, and (new!) DTR
Language matters: CRE vs. CPE; SDD vs. I; and MDR, XDR, PDR, UDR vs. DTR
New pipeline analysis: Cancer projects were funded 17x more than antibacterials during 2011-2020
IDSA White Paper on developing narrow-spectrum antimicrobials + editorial by G. Drusano
Developing antibiotics for children: There are no easy answers
Draft FDA guidance on anti-infectives for children: It’s (mostly) all about PK and safety
How hard (and how) to Pull? Net value of Pull via a Transferrable Exclusivity Extension (TEE)
Non-traditional antibiotics: A pipeline review and an analysis of key development challenges
Reimbursing for innovative antibiotics / Encouraging updates from the AMR conference
FDA: Early endpoints and late endpoints suggest a path to global regulatory convergence (Bart et al.)
FDA AMDAC – Developing Single-Pathogen agents for P. aeruginosa and A. baumannii
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