ASM-ESCMID (3-6 Sep 2019, Boston): Post-meeting notes and annotated presentations

Dear All,

Apologies for the delay, but I’ve held off on this note until the majority of the presentations from the 3-6 Sep 2019 ASM-ESCMID meeting (Boston) were online. You can now access the program, most of the presentations, and the meeting abstracts here. It was a wonderful meeting with over 400 attendees. And, please be sure to mark your calendar now for the 1-4 Sep 2020 meeting in Dublin (link)!

To help in navigating the presentation decks, I have organized ASM-ESCMID’s links to the talks in the list just below my signature. Where the title is not self-explanatory, I’ve added some commentary. If other materials are added (a notable gap right now are the Bootcamp decks and videos), I’ll update this summary and send around a note.

There’s some great material here … many thanks to the presenters for sharing their decks! 

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/

Day 1: General Regulatory Updates

1. Overview of the regulatory presentations: link
2. Update from FDA (US, Sumati Nambiar): link
3. Update from EMA (EU, Marco Cavaleri): link
4. Update from PMDA (Japan, Junk Sato): link
5. Update from CDSCO (India, Arun Pradha): link
6. CMC Issues (FDA, Balajee Shanmugam): link
7. Clinical Pharmacology Issues (FDA, Seong Jang): link

• We continue to see strong global efforts to harmonize guidelines. As a significant example of cross-agency discussions, we had the Indian agency joining PMDA, EMA and FDA at this meeting.

Day 1: Keynote lecture on beta-lactamases and their inhbitors

• Beta-Lactamase Inhibitors: A Journey of Discovery (Robert Bonomo): link
• A tour de force summary of the BL-BLI landscape …  how we get here, where we are, where we’re going. 

Day 1: Strategies for Developing Beta-Lactamase Inhibitors

1. Can a BLI be a standalone product? (David Livermore): link. That’s not exactly the title, but it is the theme of the talk.
2. Dose selection for BLIs: PK-PD and resistance suppression (Brian VanScoy): link
3. Experience with developing a standalone BLI (Jeff Loutit): link
4. Regulatory perspectives from FDA (Sumati Nambiar: link
5. Regulatory perspectives from EMA (Marco Cavaleri): link

• A standalone BLI seems possible but requires careful work.

Day 2: Panel on CARB-X and the experience of funded companies

1. CARB-X overview (Kevin Outterson): link
2. Antabio (Martin Everett): link
3. Amicrobe (Michael Bevliacqua): link
4. Bugworks (Anand Anandkumar): link
5. SciBac (Jeanette Mucha): link

Day 2: Panel on CARB-X’s Accelerator Network. Who are they? What do they do?

1. Overview of CARB-X’s Accelerators (Rich Lawson): link
2. DZIF (Germany, Ailke Alt): link
3. RTI International (US, Chris George): link
4. Wellcome Trust (UK, Joanna Wiecek): link
5. FIND (US, Jennifer Osborn): link. FIND is Foundation for Innovative New Diagnostics
6. NIAID (US, Anita Sheoran): link

Day 2: Keynote on Combination Therapy

• Combination Therapy for Serious Gram‐Negative Bacterial Infections is (sometimes) the Future (George Drusano): link
• A classic Drusano lecture! Key quote: “What’s REALLY missing for ComboRx in the Hospital‐Acquired infection realm is adequately sized prospective randomized trials examining patients who actually are sick (APACHE II score >17) and where there is a large bacterial burden so that there is a high likelihood of resistance emergence to test the hypotheses”

Day 2: Considerations for Antifungal Agents

1. FDA overview (Sumati Nambiar): link
2. EMA overview (Marco Cavaleri): link
3. Use of biomarkers in antifungal development (Francisco Marty): link
4. Experimental animal models for antifungal agents (Tom Patterson): link
5. Challenges in developing antifungal agents for drug-resistant infection (David Angulo): link

• Antifungal and antibacterial development share many similar features. EMA’s guidance is almost a decade old and perhaps due for a update. Both agencies indicate a willingness to apply regulatory flexibility in this domain. 

Day 2: Young Investigator Lecture:

• Geographical Differences in Enrollment and Microbial Etiology in Clinical Trials of Antibacterial Agents, 2001-2017 (Stephen Bart): link.
• This presentation shows the result of a major FDA study that sought to determine whether or not data were generalizable across regions. Fortunately, the answer is (mostly) YES!

Day 3: Strategic Perspectives

1. The Role of WHO in Setting R&D Priorities (Sarah Paulin, WHO): link
2. Creating a Sustainable Antibiotic R&D Ecosystem (Jeremy Knox, Wellcome Trust): link

• If you only look at a limited number of talks, put these high on your list. The views of major government groups and large funders will shape many things!

Day 3: Non-Traditional Therapeutics

1. CAL02 (Combioxin, Samareh Azeredo da Silveira Lajaunias): link
2. ABX01 (Centauri Therapeutics, Mike Westby): link
3. MEDI3902 (AstraZeneca, Antonio DeGiandomenico): link

• Non-traditional therapies are intriguing but have distinctive challenges. See this blog for two papers that survey this area at length.

Upcoming meetings of interest to the AMR community:

• 3 Oct 2019 (webinar, 17:00-18:30 CEST): REVIVE webinar entitled “Natural product antibiotics: from traditional screening to novel discovery approaches.” Go here to register.
• 2-6 Oct 2019 (Washington, DC): IDSA’s annual IDWeek meeting.
• 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.
• 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! Go here for details.
• 9-10 Sep 2020 (Washington, DC): US PACCARB public meeting. Go here for details.