Dear All, The high-value webinars below have just crossed my radar.
First up, we have a very important 2-part webinar on pediatric antibacterial drug development entitled “Improving the Investigation of New Antibacterial Agents for Use in Children: Ensuring That Our Youngest Patients Also Benefit from Innovative Treatments of Infections Caused by Multi-Drug Resistant Bacteria.” Here are the details you need:
- Part 1: 27 Jan 2023 (virtual, 10.00-14.00 ET): “The Challenges.”
- Part 2: 2 Feb 2023 (virtual, 10.00-14.00 ET): “Addressing the Challenges.”
- The series is convened by I-ACT (Institute for Advanced Clinical Trials for Children) and chaired by I-ACT’s Chief Medical Officer (Gary Noel).
- Agenda: This is a soup-to-nuts tour of pediatric antibacterial drug development:
- Top-notch faculty from Industry, Academia, and Regulatory (both FDA and EMA).
- Lots of time for discussion … it will be a great deep dive!
- Go here for details and to register.
Given the faculty, this will be an outstanding, not-to-be-missed series. Developing antibiotics for children is amazingly difficult … and a puzzle we really must solve! As a warm-up for the webinars, you can find useful further background in these two newsletters:
- 7 April 2021: “Developing Antibiotics For Children: There Are No Easy Answers”
- 27 May 2022: “Antibacterial Guidance (Including Pediatrics): Parallel EMA+FDA Updates”
Second, we have an intriguing webinar on drug delivery systems from GARDP. Running live on 24 Jan 2023 (17.00-18.30 CET), the webinar is entitled “Delivery systems in antibacterial drug discovery” and will survey the use of phage, DNA nanostructures, and nanocarriers for drug delivery. Go here for details.
Great stuff all around … many thanks to the organizers of these events! I look forward to (virtually) seeing you there!
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)
- FDA have announced five RFPs spanning antifungal animal models, usability of antimicrobial drug labeling, urine PK-PD, and interpretive breakpoints. Applications are due dates of 23 Jan 2023 — see this newsletter for more details.
- CDC have announced a very eclectic BAA that covers topics as diverse as surveillance and novel endpoints! White papers are due 3 Feb 2020 — see this newsletter for more details.
- Current funding rounds from CARB-X are as described in this newsletter!
- The AMR Action Fund is now open to proposals for funding of Phase 2 / Phase 3 antibacterial therapeutics. Per its charter, the fund prioritizes investment in treatments that address a pathogen prioritized by the WHO, the CDC and/or other public health entities that: (i) are novel (e.g., absence of known cross-resistance, novel targets, new chemical classes, or new mechanisms of action); and/or (ii) have significant differentiated clinical utility (e.g., differentiated innovation that provides clinical value versus standard of care to prescribers and patients, such as safety/tolerability, oral formulation, different spectrum of activity); and (iii) reduce patient mortality. It is also expected that such agents would have the potential to strongly address the likely requirements for delinked Pull incentives such as the UK (NHS England) subscription pilot and the PASTEUR Act in the US. Submit queries to email@example.com.
- BARDA’s long-running BAA-18-100-SOL-00003 offers support for both antibacterial and antifungal agents. This BAA has offered 4 deadlines/year since 2018 … check the most current amendment for details.
- INCATE (Incubator for Antibacterial Therapies in Europe) is an early-stage funding vehicle supporting innovation vs. drug-resistant bacterial infections. The fund provides advice, community, and non-dilutive funding (€10k in Stage I and up to €250k in Stage II) to support early-stage ventures in creating the evidence and building the team needed to get next-level funding. Details and contacts on their website (https://www.incate.net/).
- It’s not a funder, but AiCuris’ AiCubator offers incubator support to very early stage projects. Read more about it here.
- The Global AMR R&D Hub’s dynamic dashboard (link) summarizes the global clinical development pipeline, incentives for AMR R&D, and investors/investments in AMR R&D.
- In addition to the lists provided by the Global AMR R&D Hub, you might also be interested in my 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):
- [NEW] 24 Jan 2023 (virtual, 17.00-18.30 CET) Webinar entitled “Delivery systems in antibacterial drug discovery.” Sponsored by GARDP, this webinar will survey the use of phage, DNA nanostructures, and nanocarriers for drug delivery. Go here for details.
- [NEW] 27 Jan 2023 (virtual, 10.00-14.00 ET): “The Challenges,” part 1 of a 2-part series entitled “Improving the Investigation of New Antibacterial Agents.” Sponsored jointly by PhRMA, Pfizer, and Shionogi and chaired by Gary Noel (Chief Medical Officer for I-ACT, the Institute for Advanced Clinical Trials for Children), this webinar features an outstanding faculty from Industry, Academia, and Regulatory (both FDA and EMA). Go here for details and to register.
- 1-2 Feb 2023 (virtual): Antimicrobial Chemotherapy Conference by GARDP and BSAC in collaboration with ReAct Africa and Africa CDC. Go here for details.
- [NEW] 2 Feb 2023 (virtual, 10.00-14.00 ET): “Addressing The Challenges,” part 2 of a 2-part series entitled “Improving the Investigation of New Antibacterial Agents.” Sponsored jointly by PhRMA, Pfizer, and Shionogi and chaired by Gary Noel (Chief Medical Officer for I-ACT, the Institute for Advanced Clinical Trials for Children), this webinar features an outstanding faculty from Industry, Academia, and Regulatory (both EMA and FDA). Go here for details and to register.
- 16-17 Mar 2023 (timings suggest hybrid EU-US): 7th AMR Conference, hosted by the BEAM Alliance with many co-sponsors. This has historically been a very good networking event. Go here for details.
- 14 Apr 2023 (Copenhagen, Denmark; 3-6.30p CEST): ECCMID and the Global Leaders Group on AMR will jointly sponsor a symposium entitled “Forging partnerships between science and policy in Antimicrobial Resistance (AMR).” Go here to register.
- 15-18 Apr 2023 (Copenhagen, Denmark): 33rd ECCMID. Go here for details and to register.
- 8-12 May 2023 (Lisbon, Portugal): 41st Annual Meeting of the European Society for Paediatric Infectious Diseases. Go here for details.
- [UPDATED DATES] 7-15 Oct 2023 (residential, Annecy, France): ICARe, the Interdisciplinary Course on Antibiotics and Resistance. Now in its 7th year, this course is a deep-dive into the world of antibiotic development. Intense, rigorous, and HIGHLY recommended. Seats are always limited … apply sooner rather than later! Go here for details.
- 20-23 Oct 2023 (Athens, Greece): 11th TIMM (Trends in Medical Mycology). Go here for details.