Clinical positioning is a critical early step and should underpin all subsequent R&D decisions. Defining the intended patient population, indication and unmet need establishes the products value proposition, including its potential clinical impact, relevance within the current pipeline and treatment landscape, and helps demonstrate why there is a market need for the proposed product. A well-defined Target Product Profile translates this clinical positioning into a structured set of desired product characteristics. By clearly defining the desired attributes of a new antimicrobial agent, TPPs guide research and development efforts, facilitate regulatory approval, and ensure that the final product meets clinical and market needs. Utilising available guidance documents and resources can aid in the effective creation and implementation of TPPs.
Resources
13 resourcesExplores how to define and apply target candidate and product profiles in antibacterial drug development, featuring academic, industry, and WHO perspectives on aligning product goals with clinical and public health value.
Discusses the complexities of developing Target Product Profiles (TPPs) for antibiotics, highlighting insights from CARB-X, Evotec, and GSK on aligning TPPs with patient, regulatory, and market needs across the drug development lifecycle.
This follow-on webinar explores how to select an appropriate in vivo model and conduct studies based on a specific TPP.
Highlights antibiotic-resistant bacteria of greatest public health concern, grouping 15 pathogen families into critical, high and medium priority categories. It is intended to guide antibacterial research, development, investment and public health action.
WHO’s 2025 update of the global review of antibacterial therapeutic products in preclinical development includes 232 antibacterial products in development as of 15 February 2025. The dashboard provides an interactive overview of products in development against priority bacterial pathogens, with filters by development stage, pathogen, treatment type and developer.
Provides an overview of antibacterial products in clinical development (Phase I-III) as of 15 February 2025, helping developers understand the pipeline, identify unmet needs and consider how their product could be positioned and differentiated.
Offers guidance on desired characteristics for new antibacterial agents to address global health priorities.
Provides TPPs for new antibacterial therapeutics for enteric fever, gonorrhoea, neonatal sepsis and urinary tract infections. Each profile sets out the minimum and preferred characteristics of a future treatment, helping developers, funders and regulators align product development with priority public health needs.
Provides TPPs for new antibacterial agents to treat severe multidrug-resistant Gram-negative infections, resistant Gram-positive infections in immunosuppressed and critically ill patients, and bacterial meningitis. The profiles set out desired characteristics covering efficacy, safety, pharmacokinetics, administration, stability, access and affordability to guide development towards urgent public health needs.
Provides target product profiles for new oral antibacterial treatments for acute uncomplicated urinary tract infections (cystitis) and acute pyelonephritis. It sets out minimum and preferred characteristics—including target populations, activity against multidrug-resistant Gram-negative pathogens, efficacy, safety, dosing and formulation—to guide developers towards therapies that address priority clinical needs.
Presents patient-focused TPPs for cystic fibrosis-related infections, emphasising stakeholder engagement.
NHS England’s antimicrobial subscription model guidance. Contracts are awarded following strict eligibility and assessment criteria, focusing on priority-resistant pathogens.
Open-access database that catalogues and describes known antibacterial agents, consolidating data from diverse sources that include the primary research literature, patents and conference abstracts.