Heads-up … numerous changes in the meeting calendar: Lots of new events as well as rescheduling of previously announced events.
Dear All, A busy start to the week!
First, I’ve received notes expressing concern regarding news that Glaxo is trying to find a buyer for (some of) its antibiotics. With all the angst about the exit of large pharma from the area, this news item looks disturbing on initial glance. But, the news is not what it seems:
- Here’s a typical version of the news story (link): “Glaxo Revives Sale of Some Antibiotic Treatments”
- Reading closely, here’s what happening:
- Glaxo (GSK) has two off-patent cephalosporins (ceftazidime, cefuroxime) for which a buyer has been sought since 2017 (link).
- GSK is not seeking a buyer for Augmentin.
- GSK is not stopping its Phase 3 program for gepotidacin: Per clinicaltrials.gov (link), the gepotidacin Phase 3 program started 2H19 with a 1200-patient uncomplicated UTI trial (NCT04020341, link) and a 600-patient uncomplicated gonorrhea trial (NCT04010539, link). There is also a 2nd 1200-patient uUTI trial shown starting this month (NCT04187144, link)
- Putting it all together with a bit of personal speculation:
- Those two cephalosporins are likely suffering from generic entry.
- At a corporate level, these two antibiotics are selling at ~$200m/year, an amount that is ~0.5% of GSK’s annual sales of ca. $40b.
- At a societal level, these two antibiotics are fading in utility due to the rise of resistance (ESBLs in particular)
- So, this is not a major retreat but rather the kind of business decision that needs to be made on a regular basis.
- No panic or alarm is needed!
- But, we can have a good discussion about maintaining supply chain continuity for older antibiotics. I don’t want to go further on this today, but supply chain continuity is one of the 4 incentives proposed by the DRIVE-AB project (link).
Second, the Uppsala Antibiotic Center (UAC, https://www.uac.uu.se/) started a podcast series on AMR about 18 months ago. I recorded an interview for their series during the 2019 ICARe course with Eva Garmendia (the coordinator for UAC as a whole) and the podcast has just gone live here. Eva and her colleague Jenny Jagdmann gave me room to talk for about 20 minutes on everything from fire extinguishers (no surprise there!) to non-inferiority trials, after which the two of them carry on a lively 40-minute discussion of both the interview and some relevant current papers.
But my podcast is not the point … rather, I’d draw your eye (rather, ear) to the UAC project’s very multidisciplinary perspective and its messages for the broader antibiotic R&D community. As I have learned time and time again, the best insights come from debates that cross boundaries: learning to see through other eyes is incredibly powerful! My favorite personal example of this is that the phrase “antibiotics are the fire extinguishers of medicine” arose during a spirited hallway discussion between a lawyer (Kevin Outterson) and a medic (me) at a DRIVE-AB meeting in Sweden.
Thus, I was delighted to see that UAC’s podcast episodes have featured a wide array of disciplines: lawyers, scientists, historians, economists, ethicists, and more. Go to https://www.uac.uu.se/the-amr-studio/ for a full list of prior episodes and have fun broadening your horizons.
And if you want to dig even more deeply into the social science aspects of addressing the problem of AMR, check out the International Network for AMR Social Science (INAMRSS), an open consortium of international academic centers focused on social science research and policy on AMR (link). INAMRSS is a network of networks and seeks to foster international research collaboration by tying together research leaders from diverse regional, national, and international AMR research centers. Perhaps you can join them … see the link above for more details.
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/
Current funding opportunities:
- Open now through 16 Mar 2020: CC4CARB, NIAID’s call for applications to fund an innovative Chemistry Center for Combating Antibiotic-Resistant Bacteria (CC4CARB). Go here for details.
- Open now through 9 Apr 2020: NIAID Broad Agency Announcement (BAA) soliciting contract proposals for preclinical and clinical development of vaccines, therapeutic, and diagnostics for microbial pathogens. Go here for more.
- Dates for the 2020 funding rounds for Novo REPAIR Impact Fund will be announced May 2020. Go here for current details.
- 2020 funding rounds for CARB-X have not been announced.
Upcoming meetings of interest to the AMR community:
- 5 Mar 2020 (FDA, White Oak Campus, 8.30a-5.00p EST): FDA workshop entitled “Advancing Animal Models for Antibacterial Drug Development.” FR notice is here and registration is here. The workshop will be webcast.
- 16-17 Mar 2020 (London): BSAC Spring Conference entitled: “Bridging the gap between science, policy and effective antimicrobial use.” Go here for details.
- 20 Mar 2020 (Boston, MA): 7th annual BAARN (Boston Area Antimicrobial Resistance Network) Meeting. Chaired by Lawson Ung and Michael Gilmore, talks start at 9 am and end with a reception at the Harvard Museum of Natural History. Go here to register; you can also contact Lawson Ung (firstname.lastname@example.org) for other inquiries.
- [NEW] 26 Mar 2020 (online, 17:00-18:30 CET): GARDP REVIVE webinar. Title: “Probability of target attainment analyses for dose selection in antimicrobial drug development,” Speaker: Shampa Das. Go here to register.
- 26-30 Mar 2020 (Atlanta, GA): CDC- and SHEA-sponsored 6th International Conference on Healthcare Associated Infections. Go here for details.
- 30 Mar 2020 (everywhere): Deadline for applications for the Molecular Mycology pathogenesis course at Marine Biological Laboratory, Woods Hole. Now in its 24th year, the hands-on residential course runs 17 July to 2 Aug and gets rave reviews. Go here for more.
- 9 Apr 2020 (everywhere): Final date for applications for NIAID/DMID call (link) for AMR-related vaccines, therapeutics, and diagnostics.
- 17 Apr 2020 (Paris): Pre-ECCMID workshop entitled “Machine Learning for Clinical Microbiology”. Go here for details.
- 18-21 Apr 2020 (Paris): Annual ECCMID meeting (#30)
- [NEW] 28 Apr 2020 (online, 17:00-18:30 CEST): GARDP REVIVE webinar. Title: “Inhaled antimicrobials: Do we get the drug to the bug?” Speaker: Harm A. W. M. Tiddens. Go here to register.
- [NEW] 5 May 2020 (online, 09:00-10:30 CEST): GARDP REVIVE webinar. Title: “The challenges and opportunities for antimicrobial R&D in low- and middle-income countries – India case study.” Speaker: Anand Anandkumar. Go here to register.
- [NEW] 8 May 2020 (Silver Spring): FDA workshop entitled “Developing Antifungal Drugs for the Treatment of Coccidiodomycosis (Valley Fever) Infection.” Go here to register.
- 25-30 May 2020 (Rotterdam), Annual ESPID meeting (European Society for Pediatric ID, #38)
- 18-22 Jun 2020 (Chicago), ASM Microbe 2020. Go here for details.
- 27-28 Jun 2020 (Bryant University, Rhode Island): Drug Resistance Gordon Research Seminar entitled “Mechanisms and Approaches to Overcoming Drug Resistance in Cancer, Infectious Disease and Agriculture” for graduate students and postdoctoral scientists. Go here for details … this immediately precedes the GRC listed just next
- 28 Jun-3 Jul 2020 (Bryant University, Rhode Island): Gordon Research Conference (GRC) entitled “Strategies to Disrupt Drug Resistance in Infectious Disease, Cancer and Agriculture.” Go here for details.
- [RESCHEDULED] 2-7 Aug 2020 (Il Ciocco, Tuscany, Italy): Gordon Research Conference (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.
- [RESCHEDULED] 24-25 Aug 2020 (Basel): BEAM-, Novo REPAIR-, CARB-X-, DZIF-, ND4BB-, ENABLE-supported (among a long list!) Conference on Novel Antimicrobials and AMR Diagnostics. Details are here.
- [UPDATED] September 2020. University of Sheffield (UK). Applications are being taken for a new 1-year (full-time) or 2-year (part-time) Masters of Science course in Antimicrobial Resistance. The program runs annually from September and covers microbiology, clinical practice and policy. The course webpage is here.
- 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.
- 22-25 Sep 2020 (Albuquerque, New Mexico): Biannual meeting of the MSGERC (Mycoses Study Group Education and Research Consortium). Save-the-date announcement is here, details to follow.
- 17-25 Oct 2020 (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. The date is set for 2020 and the program will ultimately appear here. Registration is limited to 40 students and opens 15 Mar 2020.
- 10-13 Apr 2021 (Vienna): Annual ECCMID meeting (#31)
- 3-7 Jun 2021 (Anaheim), ASM Microbe 2021. Go here for details.