R&D Insight

PASTEUR Act (re)introduced: A delinked Pull award advances in the US!

Dear All (with thanks to Kevin Outterson for leading this note), HUGE news today: Senator Michael F. Bennet and Senator Todd Young have introduced an updated PASTEUR Act that (if enacted) would create a predictable path to rewarding new #FireExtinguishersOfMedicine for their value to society via a subscription contract (valued at $750m to $3b) that prepays

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US DoD SBIR grants to develop small molecules for MDR Pseudomonas aeruginosa

Dear All, The US Department of Defense (DoD) is offering funds through the Small Business Innovation Research (SBIR) program for a “Novel Antibiotic for the Treatment of Multidrug-Resistant Pseudomonas Aeruginosa Infections.” Antibody, phage, and vaccine approaches are out of scope and the business must be located in the United States. To find the funding offer, navigate

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FDA workshop: Revising the process for importance-ranking of human antimicrobials to guide their use in animals

Dear All, FDA have announced that they will hold a virtual public workshop on 16 Nov 2020 (9.30a-4.00p EST) entitled “Potential Approach for Ranking of Antimicrobial Drugs According to Their Importance in Human Medicine: A Risk Management Tool for Antimicrobial New Animal Drugs.” Go here for the FR notice, here for extended details, including registration, and here for

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In Praise of Non-Inferiority

Dear All (wonkish but intended for everybody to read and absorb): 27 Jan 2021 update: This topic now has its own YouTube video! As the ideas here are VERY confusing, I suggest you make the time to watch the video, read the newsletter, and then watch the video one more time. I have yet to

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FDA workshop on complex innovative trial designs / WHO consultancy

Dear All, First up today is a very interesting new workshop from FDA on 1-2 Sep entitled “Advancing the Development of Pediatric Therapeutics (ADEPT 7) Complex Innovative Trial Design.” In brief: “The Complex Innovative Trial Design Pilot Meeting Program (CID Program) facilitates and advances the use of complex and innovative trial designs that have the potential

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WHO-FAO-OIE OneHealth survey on research priorities / JPIAMR-VRI integrated resistance database

Dear All, Two brief items today: First, a survey on OneHealth research priorities from WHO/FAO/OIE: “The Tripartite collaboration between World Health Organization (WHO), Food and Agricultural Organization of the United Nations (FAO), and World Organization for Animal Health (OIE)) is joining efforts to develop a One Health priority research agenda on antimicrobial resistance (AMR). “This

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FDA-NIAID phage workshop / Social distancing in the 1800s

Dear All, This webinar merits a standalone newsletter! If you are thinking (or working on) phage, then please mark your calendar for an FDA (CBER; Center for Biologics Evaluation and Research) workshop entitled: Science and Regulation of Bacteriophage Therapy: August 30, 2021—September 1, 2021 The purpose of the public workshop is to exchange information with the

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Open call to fund an EU-based novel antibacterial to IND

Dear All, GNA NOW (part of the IMI AMR Accelerator; this 25 Mar 2021 press release is a good overview of the AMR Accelerator) has just announced an open call to identify a novel mechanism candidate antibacterial to add to its portfolio. For those not familiar with it, the IMI AMR Accelerator is a 295 m€ IMI program

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