How the CARB-X process works
CARB-X welcomes applications from around the world for funding and support for the early development of antibiotics and other non-traditional treatment approaches, vaccines and other prevention approaches including phage and microbiome and diagnostics to address the bacterial pathogens deemed by the CDC and WHO to represent the most significant risk to humans (excluding the new CDC ‘Watch List’ category and TB):
Project development stages supported by CARB-X
Antibiotics, other therapeutics and vaccines, 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). For a description of the development phases in scope for antibiotics and therapeutics, please click Development Stages in Scope – Therapeutics For a description of development phases in scope for vaccines and biotherapeutics, please click Development Stages in Scope – Vaccine and Antibodies.
Diagnostics, CARB-X funds projects from Feasibility Demonstration to Verification/Validation. For a description of the development phases in scope for diagnostics, please click Development Stages in Scope – Diagnostics.
How the CARB-X application process works
CARB-X projects are selected through a competitive process. Applications are vetted by the CARB-X Advisory Board, comprised of leading antibiotic drug development, vaccine, antibody and diagnostic professionals including experts in other modalities such as phage, microbiome and other non-traditional approaches. The Advisory Board operates under non-disclosure agreements.
Sample application instructions can be found here (note these are from the 2019 Funding round and subject to modification in any new funding round/process including scope definitions):
- Please click here to view a sample EOI
- Please click here to view a sample Short Form
- Please click here to view a sample Long Form
Applicants are requested to develop TPPs for their projects according to the following templates (used in the 2019 Funding rounds, subject to change):
- CARB-X Therapeutic TPP and Competitive Analysis
- CARB-X Vaccines and Antibodies TPP and Competitive Analysis
- CARB-X Diagnostic Target Product Profile and Competitive Analysis
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.
Sample of contractual agreement for recipients of CARB-X awards:
- CARB-X Research Subaward Agreement – for-profit recipients
- CARB-X Research Subaward Agreement – non-profit recipients
The contracts are administered through Boston University.
How CARB-X project support works
CARB-X provides financial, scientific and business support to accelerate the development of products focused on the most serious drug-resistant bacteria identified by the WHO and CDC. The goal is to support the funded product and team through the early stages of product development and Phase 1 (or verification/validation in the case of diagnostics) so they can attract private or public investment for further clinical stage development.
CARB-X is unique in that, in addition to funding, it provides scientific and business support through the CARB-X Global Accelerator Network, a group of accelerators from around the world each specialized in areas that are essential to product development as well as via the internal CARB-X R&D team’s experience and diverse team of external Subject Matter Experts through establishment of a Company Support Team for each product. These services are provided free of charge to the product developer. For more information about the Global Accelerator Network, and the services they provide, please click here. CARB-X funded product developers also have accelerated access to NIAID Pre-clinical Services, a description of which can be found here.
Funded companies are required to meet high standards in all their research and business activities, including in animal and human testing, reporting and compliance. For more information about Research Compliance, please click here.