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

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