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
4 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.
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