Sunday 10 Jan: UCSF-Stanford regulatory conference with FDA

Dear All,

New on the meetings calendar today is the 10 Jan 2021 UCSF-Stanford Innovations in Regulatory Science Summit. Per the meeting website:

  • “It is a gathering of leaders in the academia, industry and regulatory sectors to discuss the role of regulatory science in medical product development.  
  • “The 2021 Summit will have a major focus on the COVID19 pandemic including panel discussions on infectious disease and pandemic preparedness as well as how the pandemic continues to affect the development and approval of medical products targeted to other diseases.  
  • “It will also include a panel focused on the development of innovative medical products for cancer.
  • “The goal of the summit is to stimulate discussion across sectors and to critically consider lessons learned and scientific issues that need addressing to expeditiously and safely advance the development, approval and monitoring of medical products, particularly for infectious disease but also for oncology and other diseases.  “

The agenda looks excellent and includes an all-star cast:

  • Janet Woodcock, MD: Director, Center for Drug Evaluation and Research at FDA (YouTube: keynote talk entitled “The US Clinical Trial Ecosystem is Deficient”)
  • Rob Califf, MD: former FDA commissioner (YouTube: co-moderator of a panel discussion entitled “Scientific Issues That Underlie the Development, Assessment and Repurposing Of Medical Products for Infectious Diseases”)
  • Peter Marks, MD, PhD: Director, Center for Biologics Evaluation and Research at FDA (YouTube: keynote talk entitled “Advancing Bespoke Therapeutics”) 
  • Jeffrey Shuren, MD, JD: Director, Center for Devices and Radiological Health at FDA (YouTube: keynote talk entitled “Update from CDRH”)

18 Jan 2021 update: All the talks are now available on YouTube. If your time is limited, then Panel 1 (11.50a-1p EST, YouTube) entitled “Scientific Issues That Underlie the Development, Assessment and Repurposing Of Medical Products For Infectious Diseases” looks to be especially relevant to antibiotic R&D.

All best wishes, –jr

John H. Rex, MD | Chief Medical Officer, F2G Ltd. | Operating Partner, Advent Life Sciences. Follow me on Twitter: @JohnRex_NewAbx. See past newsletters and subscribe for the future: https://amr.solutions/blog/. All opinions are my own.

Current funding opportunities (most current list is here):

  • CDC has released a Broad Agency Announcement with that includes multiple opportunities for AMR-related work. See this newsletter for details. The deadline is 13 Jan 2021.
  • The US Department of Defense is funding pre-clinical research on small molecules vs. P. aeruginosa. See this newsletter for details. The deadline is 18 Feb 2021.
  • CDC has released an RFP entitled “Safe Healthcare, Epidemiology, and Prevention Research Development (SHEPheRD)” that seeks support for a broad range of healthcare epidemiology projects. See this newsletter for details. The deadline is 3 Mar 2021.
  • The National Institute of Allergy and Infectious Diseases (NIAID) Applicant Assistance Program (AAP) provides no cost support for companies planning to apply for a Phase II, Fast Track, or Direct-to-Phase II SBIR or STTR Award. Go here for details.
  • Novo REPAIR Impact Fund closed its most recent round on 31 Jul 2020. Go here for current details.
  • CARB-X recently announced that their existing resources will be reserved to fund their existing portfolio (75 total awards, and counting and they conclude contracting on prior rounds), including future options on those awards. New rounds from CARB-X will occur only after new funding is obtained in 2021.
  • The Global AMR R&D Hub’s dynamic dashboard (link) summarizes funders and projects by geography, stage, and more.
  • It’s not a funder, but AiCuris’ AiCubator offers incubator support to very early stage projects. Read more about it here.
  • Finally, you might also be interested in the most current lists of R&D incentives (link) and priority pathogens (link)


Upcoming meetings of interest to the AMR community (most current list is here):

  • 5-8 Jan 2021 (online, from 11a EST each day): Meeting #3 of the project entitled “Examining the Long-term Health and Economic Effects of Antimicrobial Resistance in the United States” sponsored by the National Academies of Science, Engineering, and Medicine. This project was described in a previous newsletter and appears to be part of the run-up to creating the next iteration of the US National Action Plan (NAP) for Combatting Antimicrobial Resistant Bacteria (CARB). Go here for more details and to register.
  • 14 Jan 2021 (online, 5-6.30p CET): GARDP-sponsored webinar entitled “Manipulating the host response to treat infections,” moderated by Neeloffer Mookherjee. Go here to register.
  • [NEW] 10 Jan 2021 (online, 11a-6p EST): Sponsored by UCSF-Stanford, the 2nd Innovations in Regulatory Science Summit. Featuring talks by three FDA Center directors (Peter Marks of CBER, Jeffrey Shugren of CDRH, Janet Woodcock of CDER), the program includes panel discussions on infectious disease and pandemic preparedness. It’s heavily virus oriented, but I anticipate useful perspectives that could be relevant to antibacterials. Its free — go here for details and to register.
  • 18-20 Jan 2021 (online, 10.00a EST to ???): A pair of virtual Keystone Symposia entitled “Harnessing the Microbiome for Disease Prevention and Therapy” and “The Microbiome: From Mother to Child”. Not a lot specifically on infection, but the deep biology typical of Keystone’s programs looks fascinating. Go here and here to register. 
  • 26-28 Jan 2021 (online, runs ~7.30a-5.00p Central each day): 4th Annual Texas Medical Center Antimicrobial Resistance and Stewardship Conference. Sponsored by McGovern Medical School, ARLG, and the Gulf Coast Consortia, the agenda includes both poster sessions and keynotes. The call for abstracts closes 18 Dec 2020. Go here for more details.
  • 2-3 Feb 2021 (online, 1-5p GMT): Antimicrobial Chemotherapy Conference 2021 sponsored by BSAC and GARDP in collaboration with the Helmholtz Institute for Pharmaceutical Sciences (HIPS), the German Center for Infection Research (DZIF) and the International Research Alliance for Antibiotic Discovery and Development (IRAADD, a JPIAMR-funded network). Go here for details and to register.
  • 10-11 Feb 2021 (online, 10a-4p EST): Virtual public meeting of PACCARB (US Presidential Advisory Council on Combatting Antimicrobial Resistant Bacteria). Go here for details.
  • [TITLE AMENDED] 25 Feb 2021 (online, 5-6.30p CET): GARDP-sponsored webinar entitled “From discovery to the pre-clinical antimicrobial candidate,” moderated by Michael Mourez. Go here to register.
  • 10-12 Mar 2021 (Stellenbosch, South Africa): The University of Cape Town’s H3D Research Centre will celebrate its 10th anniversary with a symposium covering the Centre’s research on Malaria, TB, Neglected Tropical Diseases, and AMR. Go here to register; abstract deadline is 15 Nov 2020.
  • 9-12 Jul 2021 (Vienna): Annual ECCMID meeting (#31)
  • 18-21 May 2021 (Albuquerque, New Mexico): Biannual meeting of the MSGERC (Mycoses Study Group Education and Research Consortium). Save-the-date announcement is here, details to follow.
  • 24-29 May 2021 (online and in Geneva): ESPID 2021, the 39th Annual Meeting of the European Society for Paediatric Infectious Diseases. Save-the-date announcement is here, details to follow. 
  • 20-24 June 2021 (Toronto): International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD-12). Go here for details.
  • 3-7 Jun 2021 (Anaheim), ASM Microbe 2021. Go here for details.
  • 27 Jun-2 Jul 2021 (Ventura, CA): Gordon Research Conference entitled “Antimicrobial Peptides”. Go here for details, go here for the linked 26-27 Jun Gordon Research Seminar that precedes it.
  • 5-21 Aug 2021 (Marine Biology Laboratory, Woods Hole, MA): Residential course entitled “Molecular Mycology: Current Approaches to Fungal Pathogenesis.” This 2-week intensive training program has run annually for many years and gets outstanding reviews. Go here for details.
  • 8-11 Oct 2021 (Aberdeen, Scotland): 10th Trends in Medical Mycology. Go here for details.
  • 16-24 Oct 2021 (Annecy, France): Interdisciplinary Course on Antibiotics and Resistance (ICARe). This is a soup-to-nuts residential course on antibiotics, antibiotic resistance, and antibiotic R&D. The course is very intense, very detailed, and gets rave reviews. Registration is here and is limited to 40 students. Bonus feature: For obvious reasons, the course didn’t happen in 2020! But as a celebration of the course’s 5th year, a webinar version was held on 29 Oct 2020: go here to stream it. 
  • 6-11 Mar 2022 (Il Ciocco, Tuscany): Gordon Research Conference entitled “New Antibacterial Discovery and Development”. Go here for details, go here for the linked 5-6 Mar Gordon Research Seminar that precedes it.

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