R&D Insight

Antibacterial guidance (including pediatrics): Parallel EMA+FDA updates

Dear All (Wonkish alert! Get some coffee and settle in!), Almost in parallel, EMA and FDA have released updates to key antibacterial guidance documents! Here are the links you’ll need and I’ve highlighted the key documents. To go deeper, you’ll need to pick through everything and I provide a tour further below in this newsletter:  EMA’s

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IDWeek 2022: New pipeline sessions seek presentation of therapeutics and diagnostics!

Dear All: I have learned that the program for IDWeek 2022 will have specific dedicated pipeline sessions for therapeutics and diagnostics. The online details are relatively scant, but my understanding is that the therapeutics of interest for these sessions include antibacterials, antifungals, and non-HIV, non-COVID antiviral agents. There do not appear to be any constraints

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Antibiotic supply chains: Challenges & Opportunities

Dear All, In a report entitled Understanding the Antibiotic Manufacturing Ecosystem: A view of global supply chains, pressure points, and implications for antimicrobial resistance response, the Boston Consulting Group and Wellcome Trust have examined at length the questions of (i) how the #FireExtinguishersOfMedicine are made and (ii) how they can be made with the least impact

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Outstanding discussions of Pull, the NHS Pilot, and Antibiotic value

Dear All, The BEAM Alliance, along with its partners (CARB-X, the Novo REPAIR Impact Fund, the IMI AMR Accelerator, and the European Biotechnology Magazine) converted their annual AMR conference into a virtual event held 24-26 Aug 2021. As usual, it was excellent! I know we’re all really, REALLY tired of virtual meetings but the 2h/day x 3 day themed format worked well:

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Implementing your National Action Plan: Tell your story!

Dear All, Building on the success of the previous Call to Action on Antimicrobial Resistance (AMR) conferences held in Berlin (2017) and Ghana (2018), the governments of Denmark, Colombia, Ghana and Zambia, with the International Centre for AMR Solutions (ICARS), UN Foundation, UNICEF, and the Wellcome Trust, are together organizing a follow-up Call to Action

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Beyond Pull: Maximizing availability + (appropriate!) use / Help needed!

Dear All, Today we have two interwoven topics to consider: An analysis of research priorities (not all technical!) and a triad of related initiatives, each of which comes with an opportunity for you to starting working on some of those priorities! First up, we have an excellent new paper summarizing the perspective of 32 experts

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Horizon Europe 2021-2027: Initial AMR-focused calls now posted!

Dear All (and with thanks to Arjon van Hengel for co-authoring), As was discussed in newsletters dated 28 Nov 2020 (a general announcement) and 29 Apr 2021 (comments by Stella Kyriakides), the EU has announced an ambitious Pharmaceutical Strategy with initiatives that includes development of Pull incentives for antimicrobials among a number of other topics (see the 28

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BARDA Medical Countermeasures BAA: Substantial updates

Dear All (and yes, back-to-back newsletters … lots of action this week!): BARDA have today released a new version of their long-running BAA (Broad Agency Announcement, formerly BAA-18-100-SOL-00003) that seeks medical countermeasures (MCMs) for chemical, biological, radiological, and nuclear (CBRN) threats, pandemic influenza, and emerging infectious diseases. The new BAA is BAA-23-100-SOL-00004 and has been completely reorganized and

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