Biomarker-guided drug development provides value for patients, payers and drug developers: lessons learned from 25 years in the biomarker industry.

Alexander Lynge Reese-PetersenHelene W BreisnesDaniel GaborSarah R RønnowBruna ManoelMayuur BajajClaus S von ArenstorffElijah AighobahiRune VestermarkMorten A Karsdal

Published in: Biomarkers : biochemical indicators of exposure, response, and susceptibility to chemicals (2024)

Biomarkers may guide drug developers in selecting the optimal projects to progress, when designing clinical studies and development paths. Biomarkers may aid in the diagnosis and prognostic assessment of patients and assist in matching the molecular endotype to the selected treatment, which improves the success rate of clinical development progression. The aim of this paper is to provide a comprehensive ideation framework for how to utilize biomarkers in clinical development, with a focus on utility for patients, payers and drug developers.

Keyphrases

end stage renal disease
ejection fraction
newly diagnosed
prognostic factors
peritoneal dialysis
patient reported outcomes
quality improvement
single molecule