In this conversation with Christine Guo, Chief Scientific Officer at ActiGraph, we explored the impact of Actigraph’s acquisition of Biofourmis Connect. Christine shared insights on how this integration will enhance AI-driven analytics, modernize clinical trials, and reinforce ActiGraph’s commitment to patient-centricity.
Moe: How will AI-driven analytics enhance ActiGraph’s digital health ecosystem post-acquisition?
The acquisition of Biofourmis Connect significantly broadens our platform capabilities, allowing us to integrate a broader range of sensor data modalities. AI thrives on high-quality, diverse data, and this acquisition enables us to collect essential data from sources like ECG patches and continuous high-frequency blood pressure measurements. These data points are crucial for building robust AI models to predict and monitor patient health more effectively. For instance, we acquired 21 algorithms from Biofourmis, including FDA-cleared ones like Biovitals and RhythmAnalytics. These algorithms enhance our ability to monitor safety in clinical
trials by detecting deviations from normal health patterns, which can indicate medical crises. This capability is particularly valuable in oncology, where managing adverse events like cytokine release syndrome (CRS) is critical. By leveraging these advanced analytics, we can improve patient monitoring and potentially decentralize trials, reducing the need for hospital stays and alleviating resource strains.
Moe: How will ActiGraph and Biofourmis Connect modernize clinical trials with remote monitoring?
Integrating Biofourmis Connect with ActiGraph’s existing platform is a game-changer for clinical trials. Traditionally, trials are complex and require a cohesive platform to manage various data elements. With this acquisition, we can offer a comprehensive solution that supports multiple aspects of a trial, from wearables to eConsent and virtual visits. This reduces the operational burden on sponsors and ensures a seamless data collection process. For example, we were limited to supporting specific data elements like wearables before this integration. Now, we can manage a broader range of digital solutions, streamlining the trial process and enhancing data coherence. This holistic approach accelerates trials and improves the quality and reliability of the collected data, ultimately leading to faster and more accurate trial outcomes.
Moe: How does the acquisition align with ActiGraph’s commitment to patient centricity?
Patient centricity is at the core of ActiGraph’s mission, and this acquisition aligns perfectly with that commitment. By expanding our capabilities to collect patient-generated data in home environments, we can significantly reduce the burden on patients who would otherwise need to visit clinics for data collection. Previously, our technology was primarily used to assess drug efficacy, such as physical activity or sleep improvements. However, with the new capabilities from Biofourmis, we can also focus on safety profiles, allowing us to monitor patients remotely and identify potential adverse events without requiring them to stay in clinics. This enhances the patient experience by making participation in trials more convenient and broadens our ability to collect comprehensive data that reflects real-world patient experiences.
Moe: How is ActiGraph ensuring compliance with FDA guidelines on digital health technologies?
Compliance with regulatory guidelines is paramount, and acquiring Biofourmis Connect strengthens our regulatory capabilities. The Biofourmis platform is built around necessary regulatory compliance for clinical trials, and many of their devices and algorithms are already FDA-cleared. For instance, some of our acquired algorithms have been cleared through the FDA’s 510(k) pathway. Additionally, Biofourmis has been proactive in engaging with the FDA, using pre-submission mechanisms to discuss advanced solutions like early detection algorithms for adverse events. This proactive approach enhances our regulatory portfolio and ensures that we remain at the forefront of compliance as digital health technologies evolve.
Moe: What are ActiGraph’s plans for leveraging synergies from this acquisition?
Moving forward, we will focus on oncology and immunotherapy, areas with a significant unmet need. The integration is already yielding results; just weeks after the acquisition, we’ve had client inquiries where the Biofourmis Connect platform perfectly addresses their needs. For example, we’ve been able to offer solutions that meet client requirements and save costs by reusing wearables. This rapid integration demonstrates the potential for developing new digital biomarkers and expanding into therapeutic areas where advanced monitoring and data collection can make a substantial impact.
Moe Alsumidaie is Chief Editor of The Clinical Trial Vanguard. Moe holds decades of experience in the clinical trials industry. Moe also serves as Head of Research at CliniBiz and Chief Data Scientist at Annex Clinical Corporation.
