New YouTube videos! Cost of R&D, Antibiotic value, and Lessons from COVID

Dear All,

For those of you who enjoy listening to learn, here are some updates to recent newsletters that you might enjoy:

  • 9 Jan 2021 (newsletter): “All-In Cost of a New Antibiotic From Discovery to 10 Years on Market
    • As you’ll recall, the key point is that the all-in cost is ~$1.7b per new molecule after 10-20 years of work! 
    • The talks (~25 minutes each) that Kevin Krause and I gave are now available on YouTube:
      • (YouTube) Krause: “The Post-Approval Challenges of Antimicrobial Development” (.pdf) (.pptx)
      • (YouTube) Rex: “Pricing of Antibiotics & Proposals to Strengthen the Pipeline” (.pdf) (.pptx)
  • 5 Jan 2021 (newsletter): “UCSF-Stanford Regulatory Conference With FDA
    • Video from the entire meeting is available on YouTube. The meeting’s focus was heavily on lessons learned from COVID about the clinical trials enterprise, but antibiotics do emerge from time to time (e.g., see below).
    • If your time is limited, the 90-minute sequence of the keynote by Janet Woodcock and then a panel chaired by Rob Califf is very instructive (YouTube link to Janet’s talk; the panel starts here).
    • During that panel, Peter Kim introduces the problem of the broken economics of antibiotics in a very clear way (go here to jump straight to those comments).
    • Intriguingly, the idea of progressive/adaptive approval also comes up at this point in the panel discussion (see the references below my signature if you want to learn more about this idea).
  • No prior newsletter, but over the weekend I posted video from a fireside chat that Kevin Outterson and I recently had
    • We discussed the origins of the fire extinguisher analogy, reward structures for antibiotics, and points in between
    • The full chat (~50 minutes) is on YouTube and links to specific parts of the conversation are shown below the video
    • If your time is limited, you might want to jump straight to these segments


Shameless plug and request for feedback: I’m working steadily on the amr.solutions YouTube channel as a different way to communicate. As a Baby Boomer, this is not my native style but I know that the Millennials and GenXers often really prefer this approach. I would love to hear your thoughts about the channel – please reach out with your comments, feedback, or any topics you’d like to see covered in the future!

 

Stay safe! –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.

References on Adaptive Licensing, Real-World Evidence, and Pragmatic Clinical Trials

  • Eichler HG, Oye K, Baird LG, et al. Adaptive licensing: taking the next step in the evolution of drug approval. Clin Pharmacol Ther, 91(3): 426-37, 2012 (https://doi.org/10.1038/clpt.2011.345).
  • Woodcock J. Evidence vs. Access: Can Twenty-First-Century Drug Regulation Refine the Tradeoffs? Clin Pharmacol Ther, 91(3): 378-80, 2012 (https://doi.org/10.1038/clpt.2011.337).
  • Eichler HG, Baird LG, Barker R, et al. From adaptive licensing to adaptive pathways: delivering a flexible life-span approach to bring new drugs to patients. Clin Pharmacol Ther, 97(3): 234-46, 2015 (https://doi.org/10.1002/cpt.59).
  • Califf RM, Sugarman J. Exploring the ethical and regulatory issues in pragmatic clinical trials. Clin Trials, 12(5): 436-41, 2015 (https://doi.org/10.1177/1740774515598334)
  • Sherman RE, Anderson SA, Dal Pan GJ, et al. Real-World Evidence – What Is It and What Can It Tell Us? N Engl J Med, 375(23): 2293-7, 2016 (https://doi.org/10.1056/nejmsb1609216).
  • Califf RM, Robb MA, Bindman AB, et al. Transforming Evidence Generation to Support Health and Health Care Decisions. N Engl J Med, 375(24): 2395-400, 2016 (https://doi.org/10.1056/nejmsb1610128).
  • Eichler HG, Bedlington N, Boudes M, et al. Medicines Adaptive Pathways to Patients: Why, When, and How to Engage? Clin Pharmacol Ther, 105(5): 1148-55, 2019 (https://doi.org/10.1002/cpt.1121).

Current funding opportunities (most current list is here):

  • FDA have released RFPs for work on breakpoint updates, impact of extended duration infusion beta-lactam therapy, and development of PROs for NTM, ABPA, and coccidioidomycosis. All have 28 Jan 2021 deadlines for an initial Quad Chart and White Paper. See this newsletter for more details.
  • 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.
  • FDA have announced two fellowship opportunities (one for research on ordinal endpoints, one for research on endpoints in cUTI), both with a 26 Feb 2021 deadline. See this newsletter for more details.
  • 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.
  • JPIAMR has an open research call entitled “One Health interventions to prevent or reduce the development and transmission of AMR.” More details on the call are here; the deadline for pre-proposals is 16 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):

  • 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. 
  • 25 Jan 2021 (online, 2-4p UK): Update webinar by the NHS England and NHS Improvement team who are running the UK Antibiotic Subscription pilot. Go 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.
  • 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.
  • 15-18 Mar 2021 (virtual, EU afternoon timing): The Uppsala Health Summit is focusing this year on “Managing Antimicrobial Resistance through Behaviour Change.” This is a multi-disciplinary and multi-stakeholder (policy, industry, academia, civil society) program that focuses on a different topic each year. Go here to for more details.
  • 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. 
  • 3-7 Jun 2021 (Anaheim), ASM Microbe 2021. Go here for details.
  • 20-24 June 2021 (Toronto): International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD-12). Go here for details.
  • [NEW] 20-24 Jun 2021 (virtual, various times): World Microbe Forum sponsored by the American Society for Microbiology (ASM) and the Federation of European Microbiological Societies (FEMS). Go here for more details and to register.
  • 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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