R&D Insight

Help update the WHO clinical antibacterial pipeline analysis

Dear All: As you know, WHO produced a pipeline update with a cut-off date of 1 July 2018. It’s now published both as a manuscript (Theuretzbacher et al. Lancet ID 2018, link) and a set of summary tables (link). Team WHO would like to update this analysis with a cut-off date of 1 Aug 2019. They

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WHO Pipeline review / Roadmap for susceptibility testing developers

Dear All: Two useful papers have just been released — see titles and abstracts below my signature. Both are Open Access so please do download & read! And just for full disclosure, know that I’m a co-author on both. First, a working group organized by WHO has produced a comprehensive review of the clinical antimicrobial pipeline for both

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Summary of funding initiatives (Simpkin et al.) + E9(R1) Statistical methods update (FDA)

Dear All: Two updates today. First, our colleagues at London School of Economics have just published a review of antibiotic innovation incentives that includes a detailed review of some of the currently available sources of funding (Simpkin VL et al., Incentivising innovation in antibiotic drug discovery and development: progress, challenges and next steps. J Antibiot, 1 Nov 2017). As

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Modern Noninferiority Trial Designs Enable Antibiotic Development in Advance of Epidemic Bacterial Resistance

Dear All: Along with our co-authors (Mark Goldberger, Barry Eisenstein, Roger Echols, John Tomayko, Mike Dudley, and Aaron Dane), George Talbot and I delighted to be able to share the attached manuscript which was released online yesterday at Clinical Infectious Diseases (link for online access & the abstract are below my signature). We are also sharing this brief slide set summarizing the

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REVAMP, a pull incentive in the US: Time to make it happen!

Dear All: I previously wrote about the nascent REVAMP legislation that would create a Pull incentive in the US market. With everybody back from the July 4th holiday, the goal for this week is to get REVAMP into position to be offered as an amendment at the House Energy & Commerce Committee’s PAHPA mark-up (expected next week).

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Heads-up on REVAMP, a credible Pull incentive for the US!

Dear All: Incredibly exciting news! Due to the bipartisan efforts of Representatives John Shimkus (R-IL) and Tony Cardenas (D-CA), the Re-Valuing Anti-Microbial Products (REVAMP) Act of 2018 is now being introduced. This is the Pull incentive that we’ve been looking for in the US! The very short summary is that REVAMP (a) creates a new “priority antimicrobial product” category, (b) grants

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BARDA’s DRIVe goes live; FDA workshop (27 Jun!) on inhaled antibiotics

Dear All: I don’t mean to inundate your inbox (this is my 3rd email this week!), but these two things have just hit my inbox and one of them has very tight timing: First, I previously wrote about job opportunities with BARDA’s new DRIVe initiative. With the goal of revolutionizing the way we prevent, detect, and respond to major health security threats,

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14 June Duke-Margolis workshop + A taxonomy for non-traditional (non-Fleming) antimicrobials

Dear All: (18 June addendum: the materials from the meeting are now posted!) First, planning continues apace for the 14 June Duke-Margolis workshop on non-traditional products. There is now a link for registration, confirmation that the event is going to be webcast, and a draft agenda. Mark your calendar now to attend either in person or via the webcast! Second, I would like to

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