Save the date: 18-19 Nov 2019 FDA-IDSA-NIAID-Pew-sponsored workshop: “How can we improve antibacterial development?”

Dear All,

Please mark your calendar now to be in the Washington, DC area on 18-19 Nov 2019 for a 2-day workshop at FDA’s White Oak Campus focused on enhancing the clinical trial enterprise for antibacterial drug development.

Jointly co-sponsored by FDA, IDSA, NIAID, and Pew Trusts, this meeting will have a particular focus on (a) multi-stakeholder challenges and (b) changes that could be made in the United States to enhance the development of antibacterial drugs.

The program is expected to cover these topics:

  • What data do various stakeholders (clinicians, patients, developers, FDA) need?
  • Where there are gaps in data, what data are possible?
  • How can we use innovative trial design elements (e.g., novel statistical methods) to generate better data?
  • Can we facilitate trial conduct via such tools as trial networks?
  • What is the role of scientific journals in spreading the word on what is known, not known, and possible to know?
  • Likewise, what is the role of scientific societies educating the community? Can guideline updates be more frequent and timely?

I think this will be an important meeting and I would encourage the developer community to make every effort to attend either in person or by webcast. The general webpage for the meeting is here and the registration page is here. The meeting to runs 8.30a-5.30p on Day 1 and then 8.30a-1.00p on Day 2.

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:

  • 8 Oct 2019 (London): Launch of “Reviewing Antimicrobial Resistance: Where Are We Now and What Needs to Be Done?”, a follow-up to the UK AMR Review‘s report and recommendations. Go here to register. 
  • 10 Oct 2019 (online): Deadline for feedback to the Global AMR R&D Hub on their draft Collaboration Framework. Go here to tell them what you think! 
  • 11 Oct 2019 (online): Deadline for Novo REPAIR’s 2019 US-Canada investment round. Go here for details — you need to dig all the way to the bottom of the web page.
  • 16 Oct 2019 (FDA, White Oak): Advisory Committee for NDA 209445, cefiderocol lyophilized powder for intravenous administration, submitted by Shionogi Inc., for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis due to gram-negative bacteria in patients with limited or no alternative treatment options. Go here for details.
  • 19-27 Oct 2019 (Annecy, France): International Course on Antibiotics and Resistance (ICARe) – A soup-to-nuts intensive residential training program on all things AMR, especially R&D for new antibiotics. See this link for details.
  • 4 Nov 2019 (FDA, White Oak): Public hearing on FDA’s proposed rules for “Use of Fecal Microbiota for Transplantation to Treat Clostridioides (Clostridium) difficile.” Go here for the online FR notice and here for the .pdf version.
  • 7 Nov 2019 (webinar, 17:00-18:30 CEST): REVIVE webinar entitled “Converting Gram-positive-only compounds into broad-spectrum antibiotics.” Go here to register.
  • 14-15 Nov 2019 (Hamilton, Ontario): “Fueling the Fight Against Antimicrobial Resistance”, a 2-day Gairdner Foundation-sponsored symposium in collaboration with the Michael G. DeGroote Institute for Infectious Disease Research and the David Braley Centre for Antibiotic Discovery at McMaster University. Go here for details.
  • [NEW] 18-19 Nov 2019 (FDA, White Oak Campus): FDA-IDSA-NIAID-Pew-sponsored workshop: “Enhancing the Clinical Trial Enterprise for Antibacterial Drug Development in the United States.” Mark your calendar now, details to follow.
  • 19 Nov 2019 (London): BSAC seminar entitled “Into clinical practice: Meeting the challenges of Gram-negative infection management”. A one-day conference on treatments for Gram-negative infections. Go here for details.
  • 28-29 Nov 2019 (Birmingham, UK): BSAC workshop entitled “ARM (Antibiotic Resistance & Mechanisms)”. This meeting is a research forum for UK-based researchers at all levels, including PhD students and technicians. Go here for details.
  • 16-18 Dec 2019 (Bangkok, Thailand): 3rd International Symposium on Alternatives to Antibiotics in Animal Production. Go here for details: https://www.ars.usda.gov/alternativestoantibiotics/
  • 21 Jan 2020 (London): BSAC’s 2nd Antimicrobial Chemotherapy Conference – An ABC for everyone involved in developing new antimicrobials. Go here for details.
  • 20 Feb 2020 (London, UK): Westminster Health Forum conference entitled “Antimicrobial resistance – coordinating a global response and progress on the UK strategy.” Go here for details.
  • 26-27 Feb 2020 (Washington, DC): US PACCARB public meeting. Go here for details.
  • 1-6 Mar 2020 (Il Ciocco, Tuscany, Italy): GRC on Antibacterial Discovery and Development: “Now is the time to re-boot antibiotic R&D before it’s too little, too late.” Go here for details.
  • 12-13 Mar 2020 (Basel, I’m told): BEAM-, Novo REPAIR-, CARB-X-, DZIF-, ND4BB-, ENABLE-supported (among a long list!) Conference on Novel Antimicrobials and AMR Diagnostics. Final location is TBD, details will appear here, and you should mark your calendar now. 
  • 16-17 Mar 2020 (London): BSAC Spring Conference entitled: “Bridging the gap between science, policy and effective antimicrobial use.” Go here for details. 
  • 18-21 Apr 2020 (Paris): Annual ECCMID meeting (#30)
  • 25-30 May 2020 (Rotterdam), Annual ESPID meeting (European Society for Pediatric ID, #38)
  • 10-13 Apr 2021 (Vienna): Annual ECCMID meeting (#31)
  • 1-4 Sep 2020 (Dublin): Annual ASM-ESCMID Conference on Antibiotic Development #5! Mark your calendar now and go here for details.
  • 9-10 Sep 2020 (Washington, DC): US PACCARB public meeting. Go here for details.

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