Digitally Enhanced Life Cycle Management for a Blockbuster Prescription Drug

Life Cycle Management of pharmaceutical products consists of many measures aiming to speed up time to and on the market and clinical use while the drug enjoys patent protection. Among many other factors, LCM decisions ought to consider technology changes that affect diagnostic or clinical pathways in indications covered by the approved pharmaceutical drug. The current paper discusses an Investigator Sponsored Research (ISR) activity financially supported by the manufacturer of an oral anticoagulant drug. It was a randomized, double-blind siteless clinical trial that successfully established feasibility and effectiveness of a digitally enabled innovative diagnostic pathway. Tools and pathways tested in the trial greatly facilitated detection and subsequent treatment of patients with Atrial Fibrillation which is the main indication of the oral anticoagulant marketed by the pharmaceutical company. Therefore, the tool and pathway researched in the trial have become a relevant factor in the life cycle management of this prescription drug. Using this study as an example the paper comprehensively discusses circumstances and conditions needed to successfully leverage external factors like digital technologies for the life cycle management of a classic prescription drug.