How to apply for CARB-X funding and support
CARB-X welcomes applications from around the world for funding and support for the early development of antibiotics, diagnostics, vaccines, devices and other products to combat the most serious drug-resistant bacteria. Please read the sections below carefully to find out what CARB-X funds and how to apply for funding and support.
What CARB-X funds
The scope of CARB-X funding is restricted to projects that target drug-resistant bacteria highlighted on the ‘Antibiotic Resistant Threats in the United States’ report published by the Centers for Disease Control and Prevention (CDC) in 2013 or the Priority Bacterial Pathogens list published by the World Health Organization (WHO) in 2017 – with a priority on those pathogens deemed Serious or Urgent on the CDC list or Critical or High on the WHO list.
CARB-X supports early development of innovative products within the following categories in descending priority: direct-acting therapeutics for Gram-negative infections, diagnostics, prevention (includes vaccines, antibodies, microbiome, devices, etc.), indirect acting therapeutics, and direct-acting therapeutics for Gram-positive infections.
For antibiotics, other therapeutics and preventatives, CARB-X funds projects from Hit-to-Lead into Phase 1, generally restricting CARB-X support for clinical evaluation to include Phase 1 single ascending dose/multiple ascending dose evaluations in healthy volunteers (and in certain situations, patients). Click here for a description of development phases in scope.
For diagnostics and devices, CARB-X funds projects from Feasibility Demonstration to System Integration and Testing. Click here for a description of development phases in scope.
Part of CARB-X’s funding is available through our partnership with the UK’s Global AMR Innovation Fund (GAMRIF) to support the economic development and welfare of developing countries through the ‘Official Development Act’ (ODA) program. If your program is selected by the JOC for investment, part of the funding for your project could come from our UK GAMRIF investment funds which will be focused on those projects which 1) comply with ODA eligibility requirements and 2) meet the following GAMRIF scope: development of alternatives to traditional antibiotics (as defined in Czaplewski et al, Lancet 2016) including vaccines for infection prevention. The scope of the UK GAMRIF funds does not include diagnostics/devices. In the EOI form, applicants will be requested to indicate whether the intent of their project, or a portion of it, aligns with the ODA requirements and a detailed justification of the rationale for the eligibility is to be provided at the Short Form stage.
Who can apply for CARB-X funding?
To be considered for funding:
- Projects must be in CARB-X’s scope. CARB-X focuses on the treatment and prevention of high priority drug-resistant bacteria, primarily Gram-negative, and limits its support to antibiotics and other therapeutics, vaccines, rapid diagnostics and devices which are in early development.
- Projects must also be within the scope of the specific funding round for which the application is made. Specific funding scope can vary from round to round.
- Applicants must have a legal entity and be considered a going concern – financially solvent (funded) with funding in place for operations for at least 12 months.
- Commercial drug developers must have an appropriate operations or capabilities in place to support product development, particularly through the development stages in scope for CARB-X.
- Applicants from noncommercial drug development centers or academic institutions must meet additional requirements. See Special Message at the bottom of this page.
- Applicants must own or have rights to the intellectual property and have reasonable expectation of freedom to operate required to carry out the project.
- Applicants must be able to contribute at least 30% of the cost of the program/project (“cost share”). Applicants from better-resourced companies are encouraged to propose higher amounts of cost share where feasible, as this demonstrates financial commitment to the project. Higher cost share proposals are viewed favorably.
2018 Funding rounds and how to apply
- Round 1 EOI –The application period is now closed.
- Round 1 Short Form: The selected applicants must submit their Short Forms using the on-line application tool by 5pm EST on May 21, 2018. Please note that only products developers who are selected from the EOI application process are asked to submit a confidential Short Form application. To view the Short Form FAQ, click here. To view the Short Form instruction guide, click here.To view the Short Form Budget Template example, click here.
- Round 1 Long Form: The selected applicants must submit their Long Forms using the on-line application tool by 5pm EST on August 9, 2018. The Long Form Instruction document, budget workbook and other guidance documents will be posted when available.
- Round 2 EOI – Round 2 applicants must submit an Expression of Interest (EOI) between June 1, 2018 through June 8, 2018, 5pm EST, to be considered for CARB-X funding. The EOI must be submitted using the on-line application tool below using this link which will ONLY BE ACTIVE during the submission window. Only on-line applications will be considered. The sample EOI form can be found here. The Round 2 FAQ can be found here. The scope of Round 2 is broad – therapeutics, vaccines and other preventatives, diagnostics and devices. Click here to see the scope of Round 2.
- Round 2 Short Form: The selected applicants must submit their Short Forms using the on-line application tool by 5pm EST on July 30, 2018.
- Round 2 Long Form: The selected applicants must submit their Long Forms using the on-line application tool by 5pm EST on October 19, 2018.
For additional information about CARB-X’s funding rounds, please watch the webinar on CARB-X’s 2018 Funding Rounds hosted by Kevin Outterson on March 12, 2018.
For more information about the Scope and Application process, please contact email@example.com
How the CARB-X application process works
CARB-X projects are selected through a global competitive process. Applications are vetted by the CARB-X Advisory Board, comprised of leading antibiotic and diagnostic professionals as well as experts in other modalities, when needed, including vaccines, microbiome, phage and immunology. The Advisory Board operates under non-disclosure agreements. Funding of applications is decided by CARB-X’s governing board, the Joint Oversight Committee (JOC), taking into account the recommendations from the Advisory Board. Projects must be in scope, and CARB-X reserves the right to use its judgment in determining whether an applicant has the necessary scientific, business and operational capabilities. CARB-X receives many applications and we strive to make the best decisions as quickly as possible at each stage of the process. The entire process – from Expression of Interest (EOI) to a final funding decision – will take approximately eight months, followed by negotiation of a final award contract.
Special message for academic institutions and non-commercial drug developers
CARB-X can support products under development in academic or non-commercial drug development centers, but organizations with a track record of transitioning products from pre-clinical development to clinical research are of particular interest.
If you are submitting an application from an academic institute or non-commercial drug development center, it is the responsibility of the applicant and any host organization to demonstrate to CARB-X reviewers that it has:
- Capabilities similar to those expected of a drug development industry partner, particularly through the development stages in scope for CARB-X.
- Access to and use of a range of relevant experts (internal and/or external) to inform and advance projects toward clinical investigation within the framework of a major regulatory agency, e.g., US FDA, EMA
- Active management of the IP portfolio supporting the project
- A well-developed strategy for advancement to early clinical development with options for ‘exit strategy’ from your organization (e.g., spin out, licensure to biotech)
- Capabilities in commercial (business) development and technology transfer (if IP is controlled by a university, is the project supported by the Technology Transfer office?)
- Financial commitment and stability to cover cost share of at least 30% of the total cost of the project CARB-X does not provide funding and support for basic research (drug discovery) projects, including screening for novel antibacterials.
CARB-X does not provide funding and support for basic research (drug discovery) projects, including screening for novel antibacterials.
Working in early discovery? A message for academic researchers working on antibacterial discovery projects:
Check out CHEAD at The Broad Institute of MIT and Harvard.
As a CARB-X partner, the Broad Institute has created the Collaborative Hub for Early Antibiotic Discovery (CHEAD) to accelerate the development of small molecule compounds into clinical therapeutics, with the goal of engaging academic investigators to help progress their hits that have emerged from innovative biology, targets, platforms or approaches.
CHEAD is an inter-disciplinary center providing medicinal chemistry and protein biochemistry/structural biology capabilities, biochemistry and biophysics expertise, and in vitro ADME/PK services. For more information about our hub and the application process, click here.