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OUTCOMES & IMPACT

pMedGR aims to:

Strengthen basic research

Harness the “big data” and informatics revolution that is underway

Move regulatory science forward

Revise clinical trial designs

Foster collaboration to enable and reduce the risk of translational research

Enhance patient access to innovative medicines and health innovation

Key outcomes include the development of "stratified medicines": therapeutics combined with companion diagnostics that target specific patient subpopulations on the basis of a clinical or molecular characteristic, such as a biomarker that predicts treatment response. Such therapeutics that target patients on the basis of distinctive biological characteristics, lead to enrichment of subpopulations that respond differently to treatment, thus generating more favorable benefit–risk profiles than with traditional approaches. Beyond the considerable benefits for patient outcomes, these approaches also have positive economic benefits, as well as higher success and reduced attrition rates, thus achieving premium pricing, improving market uptake, market size and market share hence maintaining revenues to the benefit of all stakeholders including patients, national health authorities, the pharmaceutical industry and diagnostics developers. Drug-diagnostic co-development programs are now becoming the norm and provide significant economic benefits towards increased net present value of stratified medicines.

Key Outcomes:

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