From Biomarkers to Approvals: How Digital Tools Are Accelerating Drug Development
Drug development has historically been famously slow, expensive, and complex. On average, it can take over a decade and billions of dollars to bring a new therapy to market. For patients with urgent needs (especially in rare or life-threatening diseases) and in the light of “personalised medicine” becoming reality — that requires acceleration. This is where digital tools, particularly digital biomarkers and digital endpoints, are beginning to change the game.
From Biomarkers to Digital Biomarkers
Traditionally, biomarkers have been lab tests, imaging results, or clinical measures that provide insight into disease state or treatment effect. Digital biomarkers build on this idea, but are collected using wearables, sensors, smartphones, or connected devices.
Examples include:
Gait speed and mobility patterns from wearable accelerometers in multiple sclerosis
Voice and speech analysis in Parkinson’s disease
Continuous glucose monitoring in diabetes
These measurements are objective, continuous, and often captured in real-world settings — a huge step forward compared to infrequent clinic visits.
When a Biomarker Becomes an Endpoint
The key distinction to be made is this: a biomarker is a measurement, but an endpoint is a clinically validated measure used to judge whether a treatment works. For example:
Digital biomarker: Step count from a smartwatch.
Digital endpoint: A validated reduction in step count decline, accepted by regulators as evidence of slowing disease progression.
This transition — from measurement to endpoint — requires rigorous validation, regulatory dialogue, and demonstration of clinical relevance. But once achieved, it opens the door to faster and more sensitive ways to measure drug impact.
Why Digital Endpoints Matter
For life sciences and pharma, digital endpoints offer three major advantages:
Speed: Continuous real-world data can reveal changes sooner than traditional clinic-based endpoints.
Sensitivity: Subtle signals (like micro-changes in gait or speech) may capture disease progression earlier.
Patient-Centricity: Data is collected unobtrusively in daily life, reducing trial burden and reflecting what matters to patients.
This is particularly powerful in rare diseases and neurodegenerative conditions, where traditional endpoints can take years to show meaningful change.
The Link to Conditional Approvals
Regulators like the FDA and EMA are increasingly open to innovative endpoints that can support accelerated or conditional approvals — provided there is a commitment to collect confirmatory evidence later.
For example:
In Duchenne muscular dystrophy, video analysis and smartphone data are being explored as digital endpoints of motor function.
In oncology, wearable-derived activity levels may complement traditional survival endpoints to demonstrate early benefit.
While not all digital endpoints are yet fully accepted, the trajectory is clear: they are moving from experimental to essential.
Challenges to Overcome
Of course, adoption isn’t without hurdles:
Validation and standardization are critical — not every app or wearable is trial-ready.
Regulatory frameworks are evolving but still cautious. Like any rapidly emerging modality or treatment, regulatory frameworks often lag significantly behind the pace of scientific innovation.
Data privacy and interoperability remain hot topics, especially in global trials.
While these barriers very much exist, industry momentum, patient demand, and regulatory dialogue are all pushing digital endpoints forward at a pace.
A Final Thought
Digital biomarkers and endpoints will not replace traditional measures overnight, but they are becoming vital accelerators in drug development. For patients, that means faster access to life-changing therapies. For companies, it means smarter, more efficient and potentially cheaper trials. For the system itself, it means progress toward a more modern, patient-centred model of evidence.
What’s your view — are digital endpoints the future of drug development, or still too early in their journey to reshape approvals?
Dr. Ivan Fisher