14 June Duke-Margolis workshop on non-traditional products: Post-meeting materials

Dear All:

wrote previously about the Duke-Margolis workshop done in collaboration with FDA on the challenges of developing non-traditional antimicrobial products. We’re now back from that workshop and I can report that it was excellent. We covered an array of strategies for non-traditional products and heard an exceptional series of company case vignettes. I’ll say that I was very impressed by the day’s content.

If you missed it, Duke-Margolis has now posted the meeting materials and made the entire meeting available for streaming. I encourage you to make time to listen to the video. Please note that the video as currently posted starts with ~35 minutes of a message advising you to “Wait for the meeting to start.” It’s easy to skip over this to the beginning of the presentations.

I hope that at some point the slides will also be posted, but at least for now here’s the deck that Kevin Outterson and I used to give a scene-setting talk. It includes our ideas on product archetypes, a summary by Kevin of the current CARB-X portfolio, a discussion of the need for Pull incentives, and some ideas we’d propose for ways to go forward.

All best wishes, –jr

John H. Rex, MD | Chief Medical Officer, F2G Ltd. | Expert-in-Residence, Wellcome Trust. Follow me on Twitter: @JohnRex_NewAbx. See past newsletters and subscribe for the future: https://13.43.35.2/blog/

Upcoming meetings of interest to the AMR community:

  • [OLD MEETING, detailed summary now out] 14-15 Jun 2017: NIAID PK-PD workshop. A detailed summary document is now available. See also my prior blog on this meeting.
  • 21-22 Jun 2018 (London): joint EMA-FDA-PMDA workshop on pediatric development of antibacterial agents.
  • 22-26 Jun 2018 (Saskatoon, Canada): 5th International One Health Congress, including a dedicated AMR track
  • 26 June 2018 (CDD-sponsored webinar at 11a EST): “SAR data in Drug Discovery”. Andrew Leach (ChEMBL) and Evan Bolton (PubChem) will discuss drug discovery informatics and ways to use the freely available PubChem and ChEMBL SAR data.
  • [NEW] 27 June 2018 (Washington): FDA workshop on inhaled antibacterial drugs for Cystic Fibrosis and Non-Cystic Fibrosis Bronchiectasis
  • 22-27 Jul 2018 (Bryant University, Smithfield, RI): Gordon Research Conference on Drug Resistance for Cancer, Infectious Disease and Agriculture
  • 21-22 Aug 2018 (Rockville, MD): NIAID-NINDS-DTRA workshop entitled “Infectious Disease in The CNS and Therapeutic Strategies to Cross the Blood-Brain Barrier”
  • 21-23 Aug 2018 (Cardiff, UK): BSAC Standardized Susceptibility Testing Residential Workshop. Register here.
  • [UPDATED with full program] 4-7 Sep 2018 ESCMID-ASM Conference (#3) on Drug Development for AMR (Lisbon, Portugal). Full program is now posted.
  • 24-28 Sep 2018 (Big Sky, Montana): MSG-ERC (Mycoses Study Group) Biennal meeting
  • 3-7 Oct 2018 (San Francisco): ID Week
  • 6-14 Oct 2018 International Course on Antibiotics and Resistance (ICARe, Les Pensières, Annecy, France) 
  • 26 Oct 2018 (London): EMA information day for SMEs: “Regulatory toolbox for medicines and combined devices developers”. Here is the current agenda. Webcast will be available. More details from sme@ema.europa.eu.
  • 7-9 Nov 2018 (Seville, Spain): Better Methods for Clinical Studies in Infectious Diseases and Clinical Microbiology: A Hands-on Workshop

EPA (Part 4): Further resources

This is the fourth of a 5-part newsletter series. There is an initial 27 Sep 2023 newsletter introducing the EPA concept note, a second (28 Sep 2023) newsletter that expands on

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