Our mission at Regeneron is to push the boundaries of science to make life-changing medicines for patients in need. This philosophy is what inspires us to harmonize biology and technology, marrying the best of both to revolutionize the drug development process.
In my role at Regeneron, I am responsible for overseeing how Regeneron executes our clinical research. Since I started my career over 30 years ago, there have been incremental improvements in the way clinical trials are conducted, but today we are on the cusp of a monumental shift in the modernization of clinical trials. As we look toward clinical trials of the future, one of the most transformational areas in clinical research, in my opinion, is the advent of digital health technologies (DHTs) and digital biomarkers.
TRADITIONAL VS. DIGITAL BIOMARKERS
Clinical trials have traditionally relied on subjective measures, such as patient-reported outcomes or PROs, to assess how patients are feeling and functioning during a clinical trial. These PROs complement the physician’s assessment, imaging, and lab results to determine the viability of the investigational therapy.
Digital biomarkers are objective, quantifiable physiological or behavioral data measured using wearable, mobile, and digestible DHTs, like watches, insoles, eyeglasses, and even home-based Wi-Fi boxes. These devices and the data they collect can provide unbiased information directly from a patient to a clinical trial site continuously during a study. This continuous monitoring, in comparison to the traditional methods that typically measure a moment in time and require clinical or laboratory settings, allows us to collect real-time data in real-world settings.
This continuous, objective data collection offers the potential to increase reliability and reduce variability – this may lead to better quality data over longer periods which could help remove barriers making it easier for patients to participate in clinical trials since data can be collected where the patient is.
And the work for this is already happening at Regeneron. Two areas we are working to develop digital endpoints are our auditory and neurological early clinical trials. Introducing more objective measures collected remotely can provide us with a better understanding of the impact of the disease, and the patients living with the conditions, and looking further into the future the benefits of potential therapeutics, potentially reducing the study sample size required to detect signals.
GOING FAR, TOGETHER
We believe that using DHTs and adopting digital biomarkers as endpoints will be a seismic shift in how the industry studies drugs. Gaining confidence in a new way of collecting data, within the high-stakes world of drug development that could be viewed as risky, is imperative. That said, the upside to digital biomarkers and their application in clinical trials has the opportunity to revolutionize drug development.
This is why we hosted the Digital Biomarker Summit USA, which brought together a mix of industry leaders in May 2023, including representatives from sponsors, vendors, academic industry, to think about how we advance digital biomarkers. Throughout the day, speakers covered a range of topics in a pre-competitive forum including working with regulators on accepting digital endpoints, insights on the development and validation of digital biomarkers, case studies on how to implement them into clinical research, and the future of wearables.
Information is power, and together we can go far. Insights shared during the Summit underscore the importance of a collaborative approach in this space, showcase Regeneron’s commitment to innovation in everything we do, and offer the hope of a new way of collecting data that improves clinical development and helps us find potential new therapies for patients faster.