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
NIAID workshop: What is a robust PK-PD package?
FDA Workshop: Animal Models To Support Antibacterial Development (5 Mar 2020, post-meeting notes)
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
Chemical vs. drugs (Part 2): How do you discriminate? / More on halicin
FDA AMDAC – Developing Single-Pathogen agents for P. aeruginosa and A. baumannii
Developing antibiotics for children: There are no easy answers
De-risking vaccine development: Insights spanning decades of experience
Mirror Bacteria: An AMR threat of unprecedented magnitude
How hard (and how) to Pull? Net value of Pull via a Transferrable Exclusivity Extension (TEE)
DTR Gram-negative infections: Are new antibiotics making a difference?
Novel Biology, Novel Utility, & the Illusion of Skill: What to develop? What to reward?
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