21-22 Aug 2018 FDA workshop: Development of Non-Traditional Therapies for Bacterial Infections

Dear All:

Following hard on the heels of yesterday’s note about the 14 June 2018 Duke-Margolis workshop on development of non-traditional products, we now have a notice regarding a 21-22 Aug FDA workshop on that same topic!

The meeting will be on FDA’s White Oak Campus from 8.30a-4.30p (21 Aug) and 8.30a-noon (22 Aug). From the notice: “The purpose of the public workshop is to discuss the general development considerations of non-traditional therapies, including pre-clinical development, early clinical studies, and phase 3 clinical trial designs to evaluate safety and efficacy.”

This is exciting to see and will be a good way to build on the conversations that began last week. Hopefully, this is a next step towards a draft guidance on this topic from FDA. 

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: http://amr.solutions/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
  • 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] 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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