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From discovery to IND: Roadmap to a successful antibacterial project
No observed adverse effect level (NOAEL)
No observed effect level (NOEL)
Good Laboratory Practice (GLP)
Brazilian Association of Pharmaceutical Sciences
Top 10 mistakes in antibacterial development
Resistance testing – beyond serial passage experiments
Bootcamp: Preclinical Toxicology (ESCMID/ASM 2018)
Coping with Preclinical Toxicology Challenges
Clinical Microbiology for a Development Program
European Gram Negative AntiBacterial Engine (ENABLE)
European Commission: Funding opportunities
NIAID: Opportunities & Announcements
REPAIR Impact Fund
CARB-X
Drug Development Process
Tackling the drug-resistance pandemic – 2020 and beyond
Why we need to prioritize developing antibiotics for children
Bringing antimicrobial research and development to Africa – the time is now
The REPAIR Impact Fund: Reflections from the first year
Time to pull out all the stops in the fight against superbugs
Discovery of new antibacterials using artificial intelligence (computational chemoinformatics)
Building better breakpoints: data and methods needed to determine breakpoints for new agents
Exploring safety issues in antimicrobial drug development
Moving from preclinical to clinical-stage: Challenges and opportunities
The challenges and opportunities for antimicrobial R&D in low- and middle-income countries – India case study
Clinical development of antimicrobials – Phase 1 development challenges
Test tube to patient: PK/PD of fixed dose beta-lactam/beta-lactamase inhibitor combinations
Probability of target attainment analyses for dose selection in antimicrobial drug development
PK/PD murine infection models: Focus on study elements, variability, and interpretation of results
Non-traditional antibacterial therapeutic options and challenges
Testing for the potential of emergence of antimicrobial resistance
Converting Gram-positive-only compounds into broad-spectrum antibiotics
Models for antimicrobial R&D: Advanced and complex in vivo models for infectious disease research
Models for antimicrobial R&D: Computational modelling for population PK and PKPD
Enabling academia to fill the discovery gap – Learnings from industry and funders
Infection models for antimicrobial R&D: Intracellular models
Models for antimicrobial R&D: Development and use of in vivo models for infectious disease research
NIAID Resources to Facilitate Discovery & Development of Anti-Infectives
Minimum inhibitory concentration (MIC)
Maximum tolerated dose (MTD)
Investigational new drug (IND)
Epidemiological cut-off value (ECOFF)
Pharmacokinetics-pharmacodynamics (PK/PD)
Tissue concentration
Intracellular concentration
Preclinical development
Median effective dose (ED50)
Toxicity
Target product profile (TPP)
Target candidate profile (TCP)
Pro-drug
Median lethal dose (LD50)
Mechanism of action (MoA)
Cmax
Absorption, distribution, metabolism, elimination (ADME)
Antimicrobial susceptibility testing (AST), resistance testing
Pharmacokinetics (PK)
Pharmacodynamics (PD)
Candidate