Listen & learn: A pair of FDA Advisory committees and a webinar on PK-PD

Dear All: New things continue to appear at a furious pace! Here are 3 excellent opportunities to listen and learn. Even if you can’t be there in person, the first is a webinar and the other two are (in my experience) very likely to be webcast:

  1. On 26 June, there will be a webinar sponsored by GARDP and CARB-X in which William Hope will reprise his excellent lecture from ECCMID entitled “PK-PD: How much is enough?” Register for the webinar here.
  2. On 7 Aug, FDA will have an Advisory Committee on an inhaled amikacin product for Mycobacterium avium complex (MAC).
  3. On 8 Aug, FDA will have an Advisory Committee on omadacycline, their modified tetracycline developed for community-acquired bacterial pneumonia and bacterial skin infections.

We’re all busy, but I strongly, strongly, STRONGLY encourage you to make every effort to read the briefing books (usually released 2 days before the meeting) and at least listen to the advisory committee meetings. There is simply no substitute for watching the advisory committee process yourself. These are free master classes … please avail yourself of the opportunity!

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:

  • 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
  • [NEW] 26 June 2018 (webinar at 11a EST): GARDP- and CARB-X-sponsored webinar on PK-PD: How much is enough? William Hope will reprise and take Q&A on his excellent talk from ECCMID 2018 (see here for the full symposium)
  • 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.
  • 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
  • [NEW] 7-8 Aug 2018: A pair of FDA Advisory Committees:
  • [NEW] 21-22 Aug 2018 (FDA White Oak Campus, Silver Spring, MD): workshop entitled “Development of Non-Traditional Therapies for Bacterial Infections”. Meeting notice is here.
  • 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.
  • [Don’t miss this one!] 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

Share

Conflict-Borne XDR Superbugs: It’s Time for the PASTEUR Act!

Dear All: The recent publication of an exceptionally good plain-language summary of the AMR problem in Rolling Stone (yes, you read that correctly!) prompts today’s 3-part journey into the way(s) that war contributes to the threat of resistant superbugs. We’ve summarized the story in outline form — please explore the references for further details. And

ENABLE-2 funding now includes Hit Identification & Validation

23 July 2024 addenda x 2:  Mark Blaskovich let me know that the CO-ADD project is still offering a free in vitro screening service. See https://www.co-add.org/ to submit compounds for free testing vs 5 bacteria and 2 fungi; see https://db.co-add.org/ for structures and screening data on >100K compounds. The GHIT Fund has announced its 21st Request for Proposals for its Hit-to-Lead Platform to

NIAID/DMID thinking for FY2026: Antibacterials, Phage, and Antifungals

Dear All, NIAID’s DMID (Division of Microbiology and Infectious Diseases) recently held a council meeting during which they proposed program concepts that encompassed both antibacterial therapies (including phage) as well as antifungal therapies for funding in FY 2026 (the year that would run from 1 Oct 2025 to 30 Sep 2026). There is no guarantee that

WHO Antibacterial Pipeline Review: Update thru 31 Dec 2023

Dear All, WHO have released an update through 31 Dec 2023 of their ongoing series of antibacterial pipeline reviews! Here are the links you need: The report: 2023 Antibacterial agents in clinical and preclinical development: an overview and analysis and a press release about the report. Infographics: Key facts and recommendations from the 2023 antibacterial agents in clinical

Scroll to Top