R&D Insight

FDA-NIAID-CDC: Developing drugs for gonorrhea, 23 Apr 21 workshop

Dear All, FDA, NIAID and CDC have announced a public workshop on development considerations of antimicrobial drugs for the treatment of gonorrhea. The workshop will cover both nonclinical (preclinical) and clinical trial design considerations: Animal models Clinical pharmacology considerations Trial design considerations for gonorrhea, such as enrollment strategies, choice of comparators and site of infection.

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Updated global antibacterial pipeline review from Pew Trusts

Dear All, Pew Charitable Trusts have released an excellent update to their long-running series of pipeline reviews. Here are the links you need: (link) Pipeline of traditional products (classical small molecules) (link) Pipeline of non-traditional products (vaccines, immunotherapies, and other out-of-the-box ideas) (link) An infographic that you can use for sharing the key points (link)

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NHS England Antibiotic Procurement Pilot: Call for applications!

Dear All, As has been discussed in recent newsletters (link), the UK National Institute for Health and Care Excellence (NICE) and NHS England launched a joint project July 2019 to test a payment model for antibiotic products, based on a product’s value to the NHS, rather than how much is used. This goal of the

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Perspectives on restoring the antibiotic ecosystem: ACS ID, June 2020 issue

Dear All, The June issue of ACS Infectious Diseases (link) is entirely devoted to the perspectives on how we can restore and maintain the antibiotic ecosystem. Check it out … we have perspectives from major groups driving policy, groups doing active R&D, and the major funders. Here’s the table of contents, re-organized slightly to group

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How Italy should Push and Pull: New report as Italy takes the 2024 G7 chair

Dear All (and with thanks to Damiano for taking the lead on this newsletter): In advance of Italy assuming the G7 Presidency for 2024, The  European House – Ambrosetti (an Italian think tank and management consulting firm) published a new report on 15 November 2023 entitled “Value and sustainability of antibiotics as essential tools for the healthcare

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Fireside Chat with BARDA’s Branch Chief for Antimicrobials

Note: Be sure to take advantage of the BARDA Industry Day(s) event that occurs Monday-Tuesday of this coming week … see newsletter and forward calendar for details. Dear All, In what could be called Part 2 of Excellent 2023 ASM/ESCMID Talks (read the newsletter on Jen Cohen’s talk on how manufacturing underpins both access and

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Pan-EU/EEA Pull incentive: A proposal by DRIVE-AB alumni!

Dear All (and with thanks to Kevin for co-authoring), In a clear and compelling policy paper, a dozen of the DRIVE-AB alumni have proposed a concept for a pan-EU/EEA Pull Incentive. To follow the plot, here are the key points as a refresh: To date, the only strong, active Pull model is the UK NHS project that

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WHO Bacterial Priority Pathogen List (PPL): 2024 update

Dear All, WHO have just released a 2024 update to their 2017 (bacterial) Priority Pathogen List (PPL)! Here are the links you need: The WHO 2024 PPL. WHO’s webpage about the 2024 PPL. A PowerPoint (.pptx) deck (and there is also a .pdf version) summarizing the new PPL and all prior PPLs. 22 May 2024 post-newsletter

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