Dear All,
BARDA has released a fascinating Sources Sought Notice (SSN) seeking data on antibacterials near, at, or beyond Phase 2. I’ve never seen one before, but an SSN is market research with which BARDA will “collect feedback from current and prospective antibiotic development partners” that will “serve as continued market research for potential future acquisitions and programs.”
While this might sound like just another pipeline review, we’ll see in a moment that the query goes well beyond the relatively high-level pipeline reviews maintained by WHO (see the Bugs & Drugs webpage). Here is the link to the SSN along with its title, lightly broken up for ease of reading:
- SSN No.: BARDA-CBRN-11042024
- “Antimicrobial Resistance Project BioShield:
- “BARDA Antibiotic for Treatment of Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia or Bloodstream Infections
- “Caused by Drug-Resistant Bacteria or Biothreat Pathogens.”
The mention in the title of the SSN of “Project BioShield“ is our further clue that this is part of BARDA’s goal of having at least one MCM for all CBRN threats (translation: one Medical Counter-Measure for all Chemical, Biological, Radiological, and Nuclear threats) as part of their 2022-2026 Strategic Plan. To follow this in more detail, see the 4 Jun 2022 newsletter for more on BARDA’s strategic plan and the 12 Nov 2023 newsletter + excellent Fireside Chat with Mark Albrecht, Antimicrobials Program Director at BARDA.
What is being sought? Here it is best just to read the text of the SSN (again, lightly broken up with bullets):
- “The subject of this Sources Sought Notice is to gain information regarding antibiotics in development for the treatment of
- “hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) and bloodstream infections (BSI)
- “caused by drug-resistant bacterial infections.
- “Proposed antibiotics may also be developed for post-exposure prophylaxis and/or treatment of biothreat pathogens (Yersinia pestis, Francisella tularensis, Burkholderia pseudomallei, and Bacillus anthracis).”
Within this framework, BARDA lays out 4 possible criteria for a product of interest. Note that 3 of the criteria are for products in development but the 4th is for approved products:
- Antibiotic programs that already have or expect to hold their end-of-Phase 2 meeting with the FDA by May 1, 2025, with an intended indication for the treatment of HABP/VABP
- Antibiotic programs that already have or expect to hold their end-of-Phase 2 meeting with the FDA by May 1, 2025, with an intended indication for the treatment of BSI.
- Antibiotic programs that already have or expect to hold their end-of-Phase 2 meeting with the FDA by May 1, 2025, with an intended indication for the treatment of HABP/VABP or BSI that could also be developed for a biothreat indication.
- Antibiotics that are (already) approved for HABP/VABP and/or BSI that have sufficient data to warrant development for a biothreat indication.
Fascinating! The SSN takes pains to say that BARDA is not promising to procure anything right now, but you can easily see how the information being sought could lead to procurement in the not too far distant future. To give you a feel for this, I have reproduced below my signature the substantial descriptive information being sought in a 15-page (max!) summary — it covers spectrum, IP, the clinical trials program, manufacturing, and more!
Wow! The deadline for submissions is Noon EST on November 29, 2025. Submissions, along with questions, comments, or concerns go to erin.greninger@hhs.gov or audrey.glover@hhs.gov
Go Team BARDA! Procure those MCMs vs. CBRN threats! Hooray for acronymics! 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.
== Information sought by BARDA in a 15-page (maximum length) summary
- Overview of the antibiotic candidate:
- Pathogens targeted.
- Clinical indication(s) sought or approval date (if applicable)
- Commercial formulation (IV, PO)
- FDA correspondences and future FDA meeting plans
- If targeting a biothreat pathogen, summary of discussions with the FDA on the biothreat development program to achieve an sNDA
- Status of the IP
- Proposed timeline for sNDA or NDA submission
- Overview of nonclinical studies and status:
- In vitro and in vivo efficacy
- In vitro activity against pathogens with key resistant phenotypes
- In vivo pharmacology/pharmacodynamics and ADME studies
- Toxicology and safety data
- Overview of clinical development status:
- Phase 1 trial(s)
- Trial design and endpoints
- Safety data summary
- Final CSR – date completed and summary of data.
- Phase 2 trial(s)
- Trial design and endpoints summary
- Enrollment target and date completed (or target completion)
- Interim analysis – date completed (or target completion) and summary of data (if available)
- Final CSR – date completed (or target completion) and summary of data (if available)
- Phase 3 trial(s)
- Trial design and endpoints summary
- Enrollment target and date completed (or target completion)
- Interim analysis – date completed (or target completion) and summary of data (if available)
- Final CSR – date completed (or target completion) and summary of data (if available)
- Black Box Warnings or anticipation of a Black Box Warning with a risk-benefit assessment to justify the products use during a public health emergency.
- Phase 1 trial(s)
- Manufacturing:
- Registration/primary batches – summary of the current status and plans, with timelines
- Process validation – summary of current status and plans, with timelines
- Stability testing – summary of stability data for drug substance (DS) and drug product (DP) and plans to achieve 5 years of product shelf-life for the DS and DP
- Summary of current demonstrated and planned manufacturing scale
- Status of contract manufacturing organization (CMO), including location, and whether any US domestic capacity currently exists for both DS and fill/finish of DP. If US domestic capacity does not yet exist, provide a timeline and summary of the approach to onshore both DS manufacturing and fill-finish of DP.
- Procurement:
- If procured, the USG-owned product must be able to be 1) delivered as final drug product (FDP) to the ASPR/SNS or; 2) maintained as FDP by the sponsor as vendor-managed inventory. Provide a summary of how the Respondent would meet both of these requirements should BARDA procure the antibiotic for stockpiling.
- Commercialization Plan:
- A summary of the commercialization strategy for the proposed product and a corporate sustainability strategy.
And as a bit more food for thought, I highly recommend the Fireside Chat with Mark from the 2023 ASM-ESCMID Developer’s Meeting (YouTube below, 12 Nov 2023 newsletter):
- NIAID’s RFA-AI-24-069 is a notice of funding opportunity (NOFO) soliciting applications to establish Centers for Accelerating Phage Therapy to Combat ESKAPE Pathogens (CAPT-CEP). The CAPT-CEPs will focus on developing preclinical assays, tools, and models for robust phage therapy research and development (R&D) and advancing phage clinical research. Applications are due by 28 Jan 2025; letters of intent must be received 30 days prior to the due date.
- ENABLE-2 has continuously open calls for both its Hit-to-Lead program as well as its Hit Identification/Validation incubator. Applicants must be academics and non-profits in Europe due to restrictions from the funders. Applications are evaluated in cycles … see the website for details on current timing for reviews.
- CARB-X has open calls at intervals that span four areas: (i) Therapeutics for Gram-Negatives, (ii) Prevention for Invasive Disease, (iii) Diagnostics for Neonatal Sepsis, and (iv) Proof-Of-Concept for Diagnosing Lower-Respiratory-Tract Infections. See this 6 Mar 2024 newsletter for a discussion of the call and go here for the CARB-X webpage on the call. There are multiple opportunities to submit — see the CARB-X webpage for details.
- BARDA’s long-running BAA (Broad Agency Announcement) for medical countermeasures (MCMs) for chemical, biological, radiological, and nuclear (CBRN) threats, pandemic influenza, and emerging infectious diseases is now BAA-23-100-SOL-00004 and offers support for both antibacterial and antifungal agents (as well as antivirals, antitoxins, diagnostics, and more). Note especially these Areas of Interest: Area 3.1 (MDR Bacteria and Biothreat Pathogens), Area 3.2 (MDR Fungal Infections), and Area 7.2 (Antibiotic Resistance Diagnostics for Priority Bacterial Pathogens). Although prior BAAs used a rolling cycle of 4 deadlines/year, the updated BAA released 26 Sep 2023 has a 5-year application period that ends 25 Sep 2028 and is open to applicants regardless of location: BARDA seeks the best science from anywhere in the world! See also this newsletter for further comments on the BAA and its areas of interest.
- HERA Invest was launched August 2023 with €100 million to support innovative EU-based SMEs in the early and late phases of clinical trials. Part of the InvestEU program supporting sustainable investment, innovation, and job creation in Europe, HERA Invest is open for application to companies developing medical countermeasures that address one of the following cross-border health threats: (i) Pathogens with pandemic or epidemic potential, (ii) Chemical, biological, radiological and nuclear (CBRN) threats originating from accidental or deliberate release, and (iii) Antimicrobial resistance (AMR). Non-dilutive venture loans covering up to 50% of investment costs are available. A closing date is not posted insofar as I can see — applications are accepted on a rolling basis; go here for more details.
- The AMR Action Fund is open on an ongoing basis 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 contact@amractionfund.com.
- 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/).
- These things aren’t sources of funds but would help you develop funding applications
- 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.
- Diagnostic developers would find valuable guidance in this 6-part series on in vitro diagnostic (IVD) development. Sponsored by CARB-X, C-CAMP, and FIND, it pulls together real-life insights into a succinct set of tutorials.
- 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).
John’s Top Recurring Meetings
Virtual meetings are easy to attend, but regular attendance at annual in-person events is the key to building your network and gaining deeper insight. My personal favorites for such in-person meetings are below. Of particular value for developers are the AMR Conference and the ASM-ESCMID conference. Hope to see you there!
- 25-26 February 2025 (Basel, Switzerland): The 9th AMR Conference 2025. Go here to register!
- 11-15 April 2025 (Vienna, Austria): ESCMID Global 2025, the annual meeting of the European Society for Clinical Microbiology and Infectious Diseases. Go here for details.
- (no date as yet) 2025 ASM/ESCMID Joint Conference on Drug Development to Meet the Challenge of Antimicrobial Resistance. Go here to see details of the outstanding 2024 meeting!
- 19-22 Oct 2025 (Georgia, USA): IDWeek 2025, the annual meeting of the Infectious Diseases Society of America. Details pending; go here for the general meeting website.
Upcoming meetings of interest to the AMR community:
- [NEW] 18-24 Nov 2024 (everywhere): World AMR/Antibiotic Awareness Week. Events are happening globally. I can’t show them all … you should do a search of the form “MyCountry World AMR Awareness week.” As examples, see the summary webpages from WHO, the US CDC, the European CDC, and the Australian Safety and Quality Commission!
- 4-5 Dec 2024 (in person, Washington, DC): “Fungal Dx 2024: Fungal Diagnostics in Clinical Practice” is a 2-day in-person workshop organized by ISHAM‘s Fungal Diagnostics Working Group. The program and registration links are available at https://fungaldx.com/; the agenda is comprehensive and features an all-star global list of speakers.
- 28-29 Jan 2025 (online and in-person, Washington, DC): PACCARB (US Presidential Advisory Council on Combatting Antimicrobial Resistant Bacteria): This particular meeting of PACCARB is unusually important as it will seek (i) public input into NAP for CARB 2025-2030 and (ii) work to sustain the momentum regarding the commitments at the High-Level Meeting on AMR at the 2024 UN General Assembly (UNGA HLM AMR). Go to http://hhs.gov/paccarb for details and to register.
- 25-26 February 2025 (Basel, Switzerland): The 9th AMR Conference 2025. See list of Top Recurring meetings, above.
- 11-15 April 2025 (Vienna, Austria): ESCMID Global 2025. See list of Top Recurring meetings, above.
- [NEW] 30 June-1 July 2025 (virtual and in Washington, DC): BID2025: BARDA Industry Days — Enhancing Health Security With a Sustainable Future. BID provides the opportunity to discuss U.S. government medical countermeasure (MCM) priorities, provide the private sector an informal opportunity to interact with BARDA and ASPR teams, and identify potential areas of collaboration in the field of MCM research and development. Go here for details.
- 19-22 Oct 2025 (Georgia, USA): IDWeek 2025. See list of Top Recurring meetings, above.
- 4-5 Feb 2025 (online, 1-5p GMT timing on both days): Antimicrobial Chemotherapy Conference by GARDP and BSAC in collaboration with CEPID-ARIES and Fiocruz. Now in its 6th year, the free program offers a good review of antimicrobial R&D, ranging from drug discovery to preclinical and clinical activities. Go here to register; the abstract deadline is 15 Nov 2024.
- 25-26 February 2025 (Basel, Switzerland): The 9th AMR Conference 2025. See list of Top Recurring meetings, above.
- 11-15 April 2025 (Vienna, Austria): ESCMID Global 2025, the annual meeting of the European Society for Clinical Microbiology and Infectious Diseases. See Recurring Meetings list, above.
- 19-22 Oct 2025 (Georgia, USA): IDWeek 2025, the annual meeting of the Infectious Diseases Society
- 11-15 April 2025 (Vienna, Austria): ESCMID Global 2025. See list of Top Recurring meetings, above.
- [NEW] 30 June-1 July 2025 (virtual and in Washington, DC): BID2025: BARDA Industry Days — Enhancing Health Security With a Sustainable Future. BID provides the opportunity to discuss U.S. government medical countermeasure (MCM) priorities, provide the private sector an informal opportunity to interact with BARDA and ASPR teams, and identify potential areas of collaboration in the field of MCM research and development. Go here for details.
- 19-22 Oct 2025 (Georgia, USA): IDWeek 2025. See list of Top Recurring meetings, above.
- OpenWHO: “Antimicrobial Resistance in the environment: key concepts and interventions.” Per the webpage for the course, it will teach you “…why addressing AMR in the environment is essential and gain insights into how action can be taken to prevent and control AMR in the environment at the national level.” This course builds on WHO’s 2024 Guidance on wastewater and solid waste management for manufacturing of antibiotics. For further reading, see also the 25 Sep 2023 newsletter entitled “Manufacturing underpins both access and stewardship: Cefiderocol as a case study” and the 28 Jan 2024 newsletter entitled “EMA Concept Paper: Guidance on manufacturing of phage products”.