February 27, 2020 | February was full of exciting news in the clinical trial and healthcare community, including partnerships, products, and promotions from ICER, TrialScope, ClinOne, and more.

The Institute for Clinical and Economic Review (ICER) announced it has selected Aetion as a preferred partner and platform to generate decision-grade real-world evidence (RWE). The announcement comes on the heels of ICER's commitment to expand their use of RWE to complement other sources of information used in its value assessments, and it furthers ICER's mission of catalyzing a movement toward fair pricing, fair access, and future innovation across the entire U.S. health system. ICER independently evaluates how well new medical interventions improve patients’ lives, and proposes benchmark prices that fairly align with each intervention's added benefit to patients and the health system. In its updated 2020 Value Assessment Framework, ICER committed to generating new RWE for its assessment process, and to piloting a formal process for using RWE in 24-month re-evaluations of drugs approved by the FDA under accelerated approval pathways. As Aetion partners with global regulators and biopharma manufacturers to advance RWE standards, its technology will help inform where RWE can support ICER's assessments. The partnership will advance methods and processes to generate relevant, decision-grade RWE, and ICER will use the Aetion Evidence Platform® to generate RWE for select upcoming assessments and 24-month re-evaluations. The protocols developed will be included in the assessments that ICER releases to the public, enabling other stakeholders to replicate the studies. Press release

ClinOne announced its strategic collaboration with BioIntelliSense to combine continuous health monitoring and clinical intelligence with  the ClinOne ClinTrialConnect patient portal platform. The addition of the FDA-cleared BioSticker single-use device provides an effortless trial participant experience enabling 30-days of continuous vital sign monitoring. “With BioIntelliSense, we will be able to capture a wide array of medical-grade biosensor data and offer our enterprise clients a new standard for Remote Patient Monitoring (RPM), resulting in more efficient and scalable virtual clinical trials,” Rob Bohacs, ClinOne CEO, said in a press release. The introduction of the BioIntelliSense Data-as-a-Service platform and BioSticker device closes the real-world data (RWD) gap in clinical trials by providing a comprehensive view of a patients’ health status. The BioSticker device enables medical-grade remote data capture of vital signs that are wirelessly and securely transmitted to the BioIntelliSense BioCloud and ClinOne ClinTrialConnect platform for high-resolution patient trending and reporting. ClinOne and BioIntelliSense make medical grade monitoring and clinical trial experiences simple. The cost-effective BioSticker medical device and data services provides clinical trial sites and principal investigators with an algorithmic fusion of vital sign data and physiological biosignals including respiratory rate at rest, heart rate at rest, skin temperature, body position, activity level, sleep status, fall detection and gait analysis. Press release

TrialScope announced the appointment of Craig Lipset and Scott Ballenger to the TrialScope Connect advisory board. TrialScope Connect is an online clinical trial recruitment collective designed address the challenges stakeholders face in accurately matching patients to trials. In advance of the platform’s launch, TrialScope is accepting partner applications from sponsors, healthcare data companies and patient advocacy groups. Lipset, former head of Clinical Innovation and venture partner at Pfizer, is a recognized leader in clinical research and medicine development. He is an advisor to technology and biopharmaceutical companies, leading universities and the venture community. He serves on numerous boards, including the MedStar Health Research Institute, the People-Centered Research Foundation (the central office for PCORnet) and the Editorial Board for Therapeutic Innovation & Regulatory Science. Ballenger is president of the Trial Acceleration Institute, a consultancy serving start-ups to Fortune 50 in the creation and monetization of new solutions for the healthcare market. He has been a founding team member of several start-up companies; contributed to three venture capital rounds, two IPOs, one turnaround, and multiple acquisitions; and has propelled two companies from early-stage to industry leader in fewer than three years. He has advised more than 60 pharmaceutical and biotech companies In addition, Ballenger himself has been a volunteer in several clinical trials. Press release

Shimmer Research announced that the Open Wearables Initiative (OWEAR) is now actively soliciting open source software and datasets from wearable sensors and other connected health technologies. OWEAR is a collaboration designed to promote the effective use of high-quality, sensor-generated measures of health in clinical research through the open sharing and benchmarking of algorithms and datasets. OWEAR has also expanded its Working Group to include executives from four major global pharmaceutical companies, a major clinical research organization (CRO), Sage Bionetworks and the Digital Medicine Society (DiMe). Wearables, ingestible sensors and in-home monitoring technologies offer the opportunity to assess an individual’s health continuously, objectively and in real time. As a result, they hold the potential to revolutionize health, healthcare, and health research. However, the lack of accepted endpoints is proving to be a major impediment to the adoption of these digital measures in clinical trials. OWEAR will leverage the work of thousands of researchers from academia, pharma, and other organizations during the past decade to facilitate the development of those requisite endpoints. OWEAR will serve as a community hub, indexing, distributing and benchmarking algorithms openly and transparently. It will act as a neutral broker, conducting formal, objective benchmarking processes and identifying high-performing algorithms in selected domains. Its goal is to provide the industry with a searchable database of benchmarked algorithms and source code that can be freely used by everyone. This new resource will help to streamline drug development and enable digital medicine. Press release

Spring Bank announced a new clinical collaboration with Roche to explore the co-administration of SB 11285, Spring Bank’s intravenously (IV)-administered STING (STimulator of INterferon Gene) agonist with Roche’s PD-L1 checkpoint inhibitor atezolizumab (Tecentriq) in patients with advanced solid tumors. During the fourth quarter of 2019, Spring Bank dosed the first patient in the monotherapy dose escalation component of the intravenously-administered SB 11285 Phase 1a trial. This monotherapy dose escalation component will be followed by a combination dose escalation of IV SB 11285 with a checkpoint inhibitor (nivolumab) and with atezolizumab (Tecentriq) as an additional arm added to the combination dose escalation segment of the Phase 1a trial. By the end of 2020, Spring Bank plans to generate sufficient data from its Phase 1a/1b IV STING agonist program to enable advancement into a Phase 2 clinical trial. “We are thrilled to announce a new clinical collaboration to explore our SB 11285 IV STING agonist in combination with atezolizumab (Tecentriq) in patients with advanced solid tumors,” said Atif Abbas, Vice President & Head of Oncology/Immunology Development at Spring Bank, in a press release. “We believe our IV-administered STING agonist has the ability to treat a broader range of cancers and patients when used in combination with checkpoint inhibitors by potentially enhancing their potency and effectiveness, and we look forward to being able to examine this effect with atezolizumab (Tecentriq) as well as other checkpoint inhibitors.” Press release