Planning a clinical development programme requires defining a clear path from preclinical development through first‑in‑human studies to later‑stage trials and product registration, with study designs matched to the product, pathogen, indication and specific patient population. The resources in this section cover traditional, pathogen-specific and non-traditional antibacterial development, alongside innovative and adaptive trial designs and clinical trial platforms. They also address clinical microbiology, breakpoint setting, quality-by-design, regulatory engagement and practical approaches to reducing development risk.
Resources
13 resourcesFeatures case studies from multiple developers, highlighting the regulatory value of early FDA engagement and the unique challenges and strategies involved in advancing non-traditional antimicrobials, microbiome therapeutics, vaccines, and diagnostics through clinical and regulatory pathways.
Explores innovative and adaptive clinical trial designs for antimicrobials and vaccines, highlighting the potential of platforms like MAMS, DOOR, and PRACTical, while addressing decision-making, implementation challenges, and maintaining trial integrity.
Highlights innovative clinical trial approaches for infectious diseases, including new designs for complicated UTI trials through POS-cUTI/ECRAID, and the SNIP-AFRICA platform—a flexible research architecture addressing neonatal sepsis in LMICs with a focus on integrating new antibiotic interventions.
PART 1: introduces the relationship between the discovery phase and later clinical development. Discusses traditional clinical development pathways (tiers A and B) focusing on non-inferiority trial design.
PART 1: In this presentation we introduce the relationship between the discovery phase and later clinical development. We discuss in some depth traditional clinical development pathways (tiers A and B) focusing on the non-inferiority trial design.
PART 2: focuses on the challenges of developing antibacterial therapies targeting single bacterial species, particularly for rare but urgent infections, highlighting the higher development risks and complexities compared to more traditional, broad-spectrum approaches.
PART 3: aims to help non-clinical developers understand the varied risks in antibacterial product development. Here, non-traditional antibiotic development pathways are discussed.
Explains how breakpoints for new antimicrobial agents are determined using preclinical data (e.g., MICs, PK/PD models) and clinical methods (e.g., human PK, Monte Carlo simulations, and clinical outcomes).
Addresses the essential role of clinical microbiology in antibiotic development programmes, including pathogen identification, susceptibility testing, and microbiological endpoints for regulatory success.
Explores India’s AMR crisis, government initiatives, a growing R&D ecosystem, emerging clinical trial networks, and evolving regulations aimed at accelerating antimicrobial product approvals.
Provides guidance on the clinical development lifecycle, including designing quality into clinical studies, considering the broad range of clinical study designs and data sources used.
Access and search for registered clinical trials around the world for insights and learnings.
Discusses how to de-risk your clinical development plan through strategic planning, good clinical trial design, risk assessment, regulatory planning, and adding innovative solutions.