Pew’s SPARK goes live / FDA on Master Protocols and Adaptive Designs / CDC’s Fungal Awareness Week

Dear All: Potpourri! Four things of note…

First, Pew’s SPARK (Shared Platform for Antibiotic Research and Knowledge) has now gone live. Seeking to address a core issue in Pew’s Scientific Roadmap for Antibiotic Discovery, SPARK is a cloud-based sharing tool for data on how molecules enter and stay inside of Gram-negative bacteria. To learn more, mark your calendar for a 23 Oct webinar on the SPARK.

Second and third, FDA has released draft guidance documents on the design of both Master Protocols for Expedited Development of Oncology Drugs and of Adaptive Clinical Trials. Personally, I find both of these ideas to represent tantalizing ways that we as a community might design more efficient trial programs and networks.

  • Master Protocols have been used in Oncology to permit one protocol to to be used to study a test agent against multiple diseases (so-called “Basket Trials”) and to allow multiple drugs to be studied simultaneously against a specific disease (“Umbrella Trials”). We’ve not yet seen use of an Umbrella Trial for antibacterials, but the Basket Trial concept sounds a lot like the idea from FDA’s Unmet Need Guidance on how data on infections at more than one body site could be pooled. 
  • Adaptive Clinical Trial Designs offer the potential to adjust the size of a trial, drop study arms, change randomization between study arms, and more. But, there are also many pitfalls in the design of same and I’ve not seen them used for antibacterials. It’s something we should explore further, I think.
  • Both guidance documents are in draft with comments requested. Our statistical colleagues need to get busy reading! 

Finally, CDC’s first post-UNGA activity is Fungal Disease Awareness Week. At that link, you’ll find data types of fungal infections, environmental mould challenges after a disaster, CDC’s outbreak investigations, and much more. But, please do keep in mind that not all fungi are bad … Tom Volk’s discussions of the fungi necessary for a merry Christmas reminds us of the ways fungi are also useful.

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/

Opportunities of interest for the AMR community

  • 11 Oct 2018 deadline: Novo’s REPAIR Impact fund has re-opened for proposals during the window 4 Sep – 11 Oct. Read more and apply here.
  • 24 Oct 2018 deadline: IMI AMR Accelerator programme Pillar A within IMI Call 15: Capability-building network to manage the whole accelerator and strengthen AMR science. This is a two-stage call, with letter of intent from applicants expected on 24 Oct 2018.
  • 24 Oct 2018 deadline: IMI AMR Accelerator programme Pillar B: Tuberculosis drug development network within IMI Call 15: Tuberculosis drug development network to collaboratively progress TB compounds and validate new tools for TB drug development. This is a two-stage call, with letter of intent from applicants expected on 24 Oct 2018.
  • 24 Oct 2018 deadline: IMI Call 16: A series of individual programs where a single EFPIA partner works with a consortium to progress compounds for for TB, non-tuberculous mycobacteria, and Gram-negatives. This is a one-stage call, with full proposal from the EFPIA and applicant consortium expected on 24 Oct 2018.

Upcoming meetings of interest to the AMR community:

  • [NEW and ONGOING] 1-5 Oct 2018 (CDC): Fungal Disease Awareness Week
  • 3-7 Oct 2018 (San Francisco): ID Week
  • 6-14 Oct 2018 International Course on Antibiotics and Resistance (ICARe, Les Pensières, Annecy, France) 
  • [NEW] 23 Oct 2018 (online webinar): Introduction to Pew’s SPARK platform (Shared Platform for Antibiotic Research and Knowledge)
  • 23 Oct 2018 (New York City): New York Academy of Sciences workshop entitled “New Therapeutic Strategies to Combat Antibacterial Resistance
  • 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.
  • 29-30 Oct 2018 (Washington: BARDA Industry Days, a 2-day conference on countermeasure development for the US Government
  • 7-9 Nov 2018 (Seville, Spain): Better Methods for Clinical Studies in Infectious Diseases and Clinical Microbiology: A Hands-on Workshop
  • 8 Nov 2018 (Alderley Park, UK): Bionow’s 1-day Bioinfect conference
  • 13 Nov 2018 (London): All-Parties Parliamentary Working Group on AMR meeting. Online materials here
  • 16 Nov 2018 (Berlin): Max Planck Institute for Innovation and Competition is organizing a conference on life sciences and innovation. Online materials here.
  • 21 Nov 2018 (London): NICE- & APBI-sponsored masterclass: “Using non randomised data to estimate treatment effects in NICE submissions”. Details here.
  • 29-30 Nov 2018 (Birmingham, UK): BSAC (British Society Antimicrobial Chemotherapy): Antibiotic Resistance Mechanisms Workshop for Researchers
  • 7 Dec 2018 (Boston, MA) BAARN, Boston Area Antimicrobial Resistance Network 2018 symposium, 8:30am to 7pm at The Starr Center (185 Cambridge Street, Boston, MA). This is an excellent networking opportunity, especially for those based in the Boston area. Details not yet online.
  • 14-15 Mar 2019 (Berlin): BEAM– and ND4BB-ENABLE-sponsored Berlin Conference on Novel Antimicrobials and AMR Diagnostics. Details here.
  • 21-22 Mar 2019 (Birmingham, UK): BSAC Spring Conference.

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