All ToolsTarget Identification(Pre)-Hit to LeadLead OptimisationLead to CandidateCandidate to ClinicalClinicalApproval
AB-Direct
PBPK models
Physiologically based pharmacokinetic (PBPK) models allow between-species extrapolations to predict gepotidacin exposure in various tissues of patients with various pathophysiological characteristics and treated with various dosing regimens.
PK/PD models
Pharmacokinetic/Pharmacodynamic (PK/PD) models to relate gepotidacin tissue concentrations versus time profiles to the kinetics of effect and eventually select the best dosing regimens to reach optimal antimicrobial efficacy.
COMBINE
FAIR data templates
Tools for standardisation of data sets to allow for FAIR working and data reuse.
Download the Data Survey, the Lab Data templates, the Data dictionary, and the FAIR assessments from Zenodo.
Bacterial strain repository
Preclinical repository with bacterial strains found to be reproducibly virulent and fulfilling performance criteria in the COMBINE standardised pneumonia mouse model. Discover strain characterisation data on the Paul-Ehrlich-Institut website.
Bioassay Protocol Ontology
A new bioassay protocol ontology enables the conversion of unstructured bioassay protocol data into structured, machine-readable formats that promote reusability and allow an accurate description of in vivo efficacy study metadata for antibiotic agents.
Download the ontology from GitHub.
Algorithm
A machine learning algorithm for predicting whether a compound will be active against broad spectrum (Gram-positive, Gram-negative, and acid-fast) bacterial strains. Explore the experimentally validated antibacterial chemicals on the AMR-KG Database.
Read more about the source code and data repository on GitHub.
Recommendations
Recurring issues and mitigation strategies for the (clinical) development of vaccines and monoclonal antibodies against ESCAPE infections.
Coming in 2024.
Animal infection model
Standardised in vivo pneumonia mouse model to test small molecule antibiotics.
Coming in 2025.
ERA4TB
Repositories
TB-PACTS—Platform for Aggregation of Clinical TB Studies (TB-PACTS, part of the C-Path Data Archive) contains data from TB clinical trials. An application is required to gain access.
Apply to access the database at the C-Path Institute website.
TB-APEX — Platform for the Aggregation of Preclinical Experiments Data (part of the C-Path Data Archive) catalogues preclinical trial data sets. Application required to gain access.
Apply to access the database at the C-Path Institute website..
Platforms
C-Path Data Archive provides access to databases/repositories containing multiple legacy TB clinical trials and preclinical experiments for ERA4TB partners, other TB consortia and qualified researchers.
Apply to access the ERA4TB data archive at the C-Path Institute website.
Drug Development Information Management (DDIM) System with procedures for acquiring, curating, and integrating internally and externally generated tuberculosis (TB) specific data sets.
Apply to access the DDIM portal services.
Hollow Fiber Infection Model
Hollow fiber system for tuberculosis: PK/PD technology implemented to work with BSL3 pathogens.
Read more about the tool at the ARAID agency website.
Protocols
Implementation of epidemiological cut-off (ECOFF) and clinical breakpoints (CBs) following the EUCAST reference method for any newly approved agents.
Read more about the protocol at the EUCAST website.
Standardised time-kill assay protocol with the most replicable and efficient plating methods, increased throughput and structured data reporting.
Read the published protocol in open access: doi:10.1016/j.isci.2023.106411.
Animal Infection Models
Mouse and non-human primate TB infection models have been implemented, and a set of non-invasive biomarkers (PET/CT imaging, cellular, cytokines, molecular biomarkers) and models to follow disease evolution and response to treatment is in development.
Coming in 2025.
Development Infrastructure
Preclinical and Phase I European Open Platform to accelerate the development of new regimens for the treatment of TB.
Coming in 2025.
GNA NOW
Protocols
Development of bioanalytical methods to quantify cationic peptides, such as antibiotic odilorhabdin derivatives, in various types of body fluids.
Design and generation of a biosynthetic gene cluster for heterologous production of odilorhabdin.
Assays
Ex vivo culture of rat mast cells to anticipate the risk of pseudo-allergic reaction for cationic peptides.
UpMIC is a combined MIC and uptake determination assay.
Target Product Profile
Consensus target product profile (TPP) for antibiotic treatment of severe (paediatric) enteric bacterial infection in low- and middle-income countries.
Coming in 2024.
Bacterial Strain Repository
Collection of Gram-negative pathogens relevant to severe diarrhoea in low- and middle-income countries.
Coming in 2025.
Quality Management System
Establishment of standards and consensus protocols of in vitro PK/PD data determination to allow inter-laboratory comparisons.
Coming in 2025.
PrIMAVeRa
Data Repository
Epidemiological repository of patient-level data on frequency measures, clinical outcomes, mortality and economic impact associated with the most common pathogens.
Coming in 2025.
Mathematical Models
Open source, open access cost-effectiveness models to inform public health officials, policymakers, and the wider scientific community about the net benefits to public health when applying vaccines and monoclonal antibodies against AMR.
Coming in 2026.
RespiriNTM
Animal Infection Model
Development of novel mouse model for Mycobacterium abscessus infection.
Coming in 2025.
Bacterial Strain Repository
Collection of clinical isolates of Mycobacterium avium and M. abscessus, including multi-drug and extensively drug-resistant isolates.
Coming in 2025.
RespiriTB
Bacterial Strain Repository
Collection of clinical isolates of Mycobacterium tuberculosis, including multi-drug and extensively drug-resistant isolates.
Coming in 2025.
TRIC-TB
Protocols
Development of bioanalytical techniques to quantify alpibectir and ethionamide levels in cerebrospinal fluid (CSF). CSF concentrations can be used as a surrogate measure for assessment of central nervous system (CNS) drug delivery in early preclinical drug development.
Coming in 2025.
Development of a microbiological assay to assess the minimal inhibitory concentration of the alpibectir/ethionamide combination in vitro.
Coming in 2025.
UNITE4TB
Protocol
The development of a MAMS seamless trial design with EMA feedback that may be utilised beyond the PARADIGM4TB trial.
Coming in 2024.
Biomarkers
Novel microbiological and immunological biomarkers were evaluated as alternative clinical endpoints in mid-stage TB trials.
Coming in 2027.
Machine Learning Model
The development and assessment of a machine learning model to incorporate multiple data sets (clinical, biomarkers, PK) to predict a relapse-free cure for TB.
Coming in 2027.
Clinical Trial Network
Establishment of a new global clinical trial network, with sites across four continents for mid/late-stage evaluation of anti-TB regimens comprising new chemical entities. Selection of one or more regimens for subsequent Phase III evaluation.
Coming in 2028.
Data Repository
Development and management of data, human samples and bacterial strain repositories. The data repository will contain de-identified patient-level data, and access will be secured through a data collaboration platform. The human sample biobank will contain sputum, blood, and urine samples with accompanying metadata for future research use. The bacterial strain biobank will incorporate strains isolated from participants within UNITE4TB trials.
Coming in 2028.
FAIR Data Templates
COMBINE
Tools for standardisation of data sets to allow for FAIR working and data reuse.
Download the Data Survey, the Lab Data templates, the Data dictionary, and the FAIR assessments from Zenodo.
Machine Learning
COMBINE
A machine learning algorithm for predicting whether a compound will be active against broad spectrum (Gram-positive, Gram-negative, and acid-fast) bacterial strains. Explore the experimentally validated antibacterial chemicals on the AMR-KG Database.
Read more about the source code and data repository on GitHub
ERA4TB
The development and assessment of a machine learning model to incorporate multiple data sets (clinical, biomarkers, PK) to predict relapse-free cure of TB.
Coming in 2027.
Platform
ERA4TB
C-Path Data Archive provides access to databases/repositories containing multiple legacy TB clinical trials and preclinical experiments for ERA4TB partners, other TB consortia and qualified researchers.
Apply to access the ERA4TB data archive at the C-Path Institute website.
Drug Development Information Management (DDIM) System with procedures for acquiring, curating, and integrating internally and externally generated tuberculosis (TB) specific data sets.
Apply to access the DDIM portal services.
Protocol
GNA NOW
Design and generation of a biosynthetic gene cluster for heterologous production of odilorhabdin.
UpMIC is a combined MIC and uptake determination assay.
Repository
ERA4TB
TB-PACTS—Platform for Aggregation of Clinical TB Studies (TB-PACTS, part of the C-Path Data Archive) contains data from TB clinical trials. An application is required to gain access.
Apply to access the database at the C-Path Institute website.
TB-APEX — Platform for the Aggregation of Preclinical Experiments Data (part of the C-Path Data Archive) catalogues preclinical trial data sets. Application required to gain access.
Apply to access the database at the C-Path Institute website..
UNITE4TB
Development and management of data, human sample and bacterial strain repositories. The data repository will contain de-identified patient-level data and access will be secured through a data collaboration platform. The human sample biobank will contain sputum, blood and urine samples will accompanying metadata for future research use. The bacterial strain biobank will incorporate strains isolated from participants within UNITE4TB trials.
Bacterial Strain Repository
GNA NOW
Collection of Gram-negative pathogens relevant to severe diarrhoea in low- and middle-income countries.
Coming in 2025.
RespiriNTM
Collection of clinical isolates of Mycobacterium avium and M. abscessus, including multi-drug and extensively drug resistant isolates.
Coming in 2025.
RespiriTB
Collection of clinical isolates of Mycobacterium tuberculosis, including multi-drug and extensively drug-resistant isolates.
Coming in 2025.
FAIR Data Templates
COMBINE
Tools for standardisation of data sets to allow for FAIR working and data reuse.
Download the Data Survey, the Lab Data templates, the Data dictionary, and the FAIR assessments from Zenodo.
Infection Models
ERA4TB
Hollow fiber system for tuberculosis: PK/PD technology implemented to work with BSL3 pathogens.
Read more about the tool at the ARAID agency website.
Platform
ERA4TB
Drug Development Information Management (DDIM) System with procedures for acquiring, curating, and integrating internally and externally generated tuberculosis (TB) specific data sets.
Apply to access the DDIM portal services.
Protocols
ERA4TB
Implementation of epidemiological cut-off (ECOFF) and clinical breakpoints (CBs) following the EUCAST reference method for any newly approved agents.
Read more about the protocol at the EUCAST website.
GNA NOW
Development of bioanalytical methods to quantify cationic peptides, such as antibiotic odilorhabdin derivatives, in various types of body fluids.
COMBINE
A new bioassay protocol ontology enables the conversion of unstructured bioassay protocol data into structured, machine-readable formats that promote reusability and allow an accurate description of in vivo efficacy study metadata for antibiotic agents.
Download the ontology from GitHub.
Target Product Profile
GNA NOW
Consensus target product profile (TPP) for antibiotic treatment of severe (paediatric) enteric bacterial infection in low- and middle-income countries.
Coming in 2024.
Bacterial strain repository
COMBINE
Preclinical repository with bacterial strains found to be reproducibly virulent and fulfilling performance criteria in the COMBINE standardised pneumonia mouse model. Discover strain characterisation data on the Paul-Ehrlich-Institut website.
FAIR Data Templates
COMBINE
Tools for standardisation of data sets to allow for FAIR working and data reuse.
Download the Data Survey, the Lab Data templates, the Data dictionary, and the FAIR assessments from Zenodo.
Infection Models
COMBINE
Standardised in vivo pneumonia mouse model to test small molecule antibiotics.
Coming in 2025.
Platform
ERA4TB
Drug Development Information Management (DDIM) System with procedures for acquiring, curating, and integrating internally and externally generated tuberculosis (TB) specific data sets.
Apply to access the DDIM portal services.
Animal Infection Models
COMBINE
Standardised in vivo pneumonia mouse model to test small molecule antibiotics.
Coming in 2025.
ERA4TB
Mouse and non-human primate TB infection models implemented, set of non-invasive biomarkers (PET/CT imaging, cellular, cytokines, molecular biomarkers) and models to follow disease evolution and response to treatment in development.
Coming in 2025.
RespiriNTM
Development of novel mouse model for Mycobacterium abscessus infection.
Coming in 2025.
Bacterial strain repository
COMBINE
Preclinical repository with bacterial strains found to be reproducibly virulent and fulfilling performance criteria in the COMBINE standardised pneumonia mouse model. Discover strain characterisation data on the Paul-Ehrlich-Institut website.
FAIR Data Templates
COMBINE
Tools for standardisation of data sets to allow for FAIR working and data reuse.
Download the Data Survey, the Lab Data templates, the Data dictionary, and the FAIR assessments from Zenodo.
Protocols
GNA NOW
Ex vivo culture of rat mast cells to anticipate the risk of pseudo-allergic reaction for cationic peptides.
TRIC-TB
Development of a microbiological assay to assess the minimal inhibitory concentration of the alpibectir/ethionamide combination in vitro.
Quality Management System
GNA NOW
Establishment of standards and consensus protocols of in vitro PK/PD data determination to allow inter-laboratory comparisons.
Coming in 2025.
Platform
ERA4TB
Drug Development Information Management (DDIM) System with procedures for acquiring, curating, and integrating internally and externally generated tuberculosis (TB) specific data sets.
Apply to access the DDIM portal services.
Animal Infection Models
COMBINE
Standardised in vivo pneumonia mouse model to test small molecule antibiotics.
Coming in 2025.
Bacterial strain repository
COMBINE
Preclinical repository with bacterial strains found to be reproducibly virulent and fulfilling performance criteria in the COMBINE standardised pneumonia mouse model. Discover strain characterisation data on the Paul-Ehrlich-Institut website.
Development Infrastructure
ERA4TB
Preclinical and Phase I European Open Platform to accelerate the development of new regimens for the treatment of TB.
Coming in 2025.
FAIR Data Templates
COMBINE
Tools for standardisation of data sets to allow for FAIR working and data reuse.
Download the Data Survey, the Lab Data templates, the Data dictionary, and the FAIR assessments from Zenodo.
Pharmacokinetic Models
AB-Direct
Physiologically based pharmacokinetic (PBPK) models allow between-species extrapolations to predict gepotidacin exposure in various tissues of patients with various pathophysiological characteristics and treated with various dosing regimens.
Pharmacokinetic/Pharmacodynamic (PK/PD) models to relate gepotidacin tissue concentrations versus time profiles to the kinetics of effect and eventually select the best dosing regimens to reach optimal antimicrobial efficacy.
Platform
ERA4TB
Drug Development Information Management (DDIM) System with procedures for acquiring, curating, and integrating internally and externally generated tuberculosis (TB) specific data sets. Apply to access the DDIM portal services.
Protocols
TRIC-TB
Development of bioanalytical techniques to quantify alpibectir and ethionamide levels in cerebrospinal fluid (CSF). CSF concentrations can be used as a surrogate measure for assessment of central nervous system (CNS) drug delivery in early preclinical drug development. Coming in 2025.
Development of a microbiological assay to assess the minimal inhibitory concentration of the alpibectir/ethionamide combination in vitro. Coming in 2025.
Clinical Trial Network
UNITE4TB
Establishment of a new global clinical trial network, with sites across four continents for mid/late-stage evaluation of anti-TB regimens comprising new chemical entities. Selection of one or more regimens for subsequent Phase III evaluation.
Coming in 2028.
Development Infrastructure
ERA4TB
Preclinical and Phase I European Open Platform to accelerate the development of new regimens for the treatment of TB.
Coming in 2025.
FAIR Data Templates
COMBINE
Tools for standardisation of data sets to allow for FAIR working and data reuse.
Download the Data Survey, the Lab Data templates, the Data dictionary, and the FAIR assessments from Zenodo.
Protocol
UNITE4TB
The development of a MAMS seamless trial design with EMA feedback that may be utilised beyond the PARADIGM4TB trial.
Coming in 2024.
Platform
ERA4TB
Drug Development Information Management (DDIM) System with procedures for acquiring, curating, and integrating internally and externally generated tuberculosis (TB) specific data sets.
Apply to access the DDIM portal services.
Data Repository
PrIMAVeRa
Epidemiological repository of patient-level data on frequency measures, clinical outcomes, mortality and economic impact associated with the most common pathogens.
Coming in 2025.
Mathematical Models
PrIMAVeRa
Open source, open access cost-effectiveness models to inform public health officials, policymakers, and the wider scientific community about the net benefits to public health when applying vaccines and monoclonal antibodies against AMR.
Coming in 2026.
