BOSTON, November 16, 2023 – An industry report released today forecasts that digital endpoints will see broader adoption in supporting pharmaceutical and life science label claims in the years ahead—but only after industry-wide, pre-competitive collaboration aimed at standardization and proactive sharing of data around clinically validated patient-centric outcomes. This is one of the main findings presented in a report by Biofourmis, a leading global technology-enabled clinical research and care delivery company, and HealthXL, a leading market intelligence platform and community for health technology and digital health globally.
The full report is available here.
The report, “Unlocking the Value of DigitalMeasures in Drug Development,” delves deep into the trends and opportunities of using digital measures in pharmaceutical R&D. The report is based on an exclusive survey and one-on-one interviews with experts and executives within the pharmaceutical and life science research and development sector. Additionally, the report draws insights from recent trends and developments in digital endpoints and biomarkers analyzed by Biofourmis and HealthXL. As of November 1, the Digital Medicine Society’s Crowdsourced Library of Digital Endpoints had reached 430, with nearly 80% of the listings added in 2019 or later.
“We have seen remarkable interest and momentum in recent years toward the incorporation of digital measures and endpoints throughout the drug development lifecycle,” said Biofourmis Chief Medical Officer and Co-Founder Maulik Majmudar, MD, who is one of the authors of the report. “The use of digital measures is primarily aimed at accelerating R&D timelines, reducing clinical trial related costs, and deepening our understanding of disease pathways and outcomes. However, for broad, real-world adoption of digital endpoints, the experts and insiders surveyed revealed that a consolidated approach is essential, encompassing standardized definitions, as well as use of digital health technologies used to capture, share, and analyze these measures.”
The report describes the progress of employing digital biomarkers and endpoints in drug development, the challenges of unlocking their true value, and outlines a rationale of how pharmaceutical companies will benefit from a solid digital measurement strategy. The benefits of incorporating digital measures cited most often by digital R&D leaders were improving clinical trial efficiency and lower costs, according to the report’s survey results.
To achieve those goals, the report emphasizes the importance of pre-competitive collaboration between pharmaceutical and life sciences companies to establish an impartial consensus around a set of clinically validated digital endpoints and biomarkers. Experts also conveyed to the report’s authors, Dr. Majmudar and Tessy Huss, Director of Community Strategy for HealthXL, that industry consortia advocating for regulatory clarity and the sharing of validation data will expedite the process of achieving consensus on digital endpoints.
“Numerous experts and senior executives stressed the importance of open-source collaboration on digital endpoint development. This is a challenge considering the fierce scientific and business competition within the industry, along with the financial constraints that researchers face in their study of novel therapies,” Huss said. “Yet by prioritizing collective action and a unified effort toward more clearly defined regulatory approval criteria, these companies can usher in a new era of medicine, in which highly effective therapies arrive sooner and outcomes are evaluated with greater precision and reliability.”
All digital measures or endpoints, experts and insiders said, need to be guided by patient preferences. For instance, the report cites the FDA’s rejection of a proposed digital biomarker for Parkinson’s Disease in 2021, contending that “rigidity or finger tapping” was a measurable biomarker but not “directly meaningful” to patients. Conversely, in 2023, the FDA approved a digital actigraphy device-derived change in moderate-to-vigorous physical activity as a relevant primary endpoint in a Phase III clinical trial for a drug treating pulmonary hypertension associated with pulmonary fibrosis.
“Progress in building industry consensus and securing regulatory approval around digital biomarkers and endpoints is still in its early stages, but it is progressing rapidly despite the high regulatory burden and rigorous clinical requirements,” said Jaydev Thakkar, COO of Biofourmis. “Our report, produced in collaboration with HealthXL, summarizes the progress achieved so far and suggests a path forward to help the industry maintain the momentum that is likely to yield greater ROI for pharmaceutical and life sciences companies and improved therapies for patients.”
Biofourmis brings the right care to every person, no matter where they are. The company's AI-driven solution collects and analyzes patient data in real time and identifies shifts that require proactive interventions. This vital innovation provides people everywhere with connected access to hospital-level services, virtual provider networks for remote care, in-home services, and life-changing clinical trials—all without leaving their homes. Trusted by leading health systems, payers, biopharma companies and patients alike, Biofourmis' connected platform improves patient outcomes, prevents hospital readmissions, accelerates drug development, and closes critical gaps in care—ultimately making science smarter, healthcare simpler, and patients healthier. Biofourmis is a global technology company enabling care delivery, with headquarters in Boston and key offices in Singapore and India. For more information, visit biofourmis.com and follow Biofourmis on LinkedIn, Twitter and YouTube.
HealthXL (headquarters in Dublin, Ireland) is a global community of senior leaders from the biggest healthcare brands. HealthXL combines the power of their specialized advisory team, their member platform and the intelligence of their expert community to get real-world insights to clients' questions. The HealthXL community is composed of over 2000 leaders in healthcare including entrepreneurs, investors, researchers, healthcare professionals, and life sciences executives. For more information, visit HealthXL.com and follow HealthXL on LinkedIn.
Amendola Communications for Biofourmis