September 26, 2019 | September was full of exciting news in the clinical trial and healthcare community, including partnerships, products, and promotions from Shimmer, IQVIA, Certara, and more.

Shimmer Research announced the launch of a healthcare industry open source initiative for wearable sensor algorithms. The initiative is being co-founded by Shimmer, Vincent van Hees, author of the GGIR software and algorithms for movement sensor calibration, sensor wear detection, and signal aggregation, and Nextbridge Health, which is developing the Nextbridge Exchange, an online marketplace and discovery platform for the clinical research community. This new initiative seeks to develop a curated set of open source algorithms and software tools for analyzing wearable sensor data that will be available to all medical device and pharmaceutical companies in a pre-competitive environment as a service to the industry. It will allow the work conducted by thousands of researchers during the past decade to be leveraged to create commonly-accepted de facto industry standards. Press release

IQVIA announced its collaboration with Friends of Cancer Research in a cross-industry effort to advance acceptance and drive future uses of real world evidence (RWE). This research helps confirm that clinical benefits seen for therapies in clinical trials were consistent with the benefits of those treatments within real world settings. RWE comprises dynamic data including assets such as EMR, hospital, pharmacy, and claims sources, as well as genomics, mobile health, and patient reported outcomes. The project is part of a Friends of Cancer Research initiative that is working to demonstrate the application of real world evidence in oncology research. As part of this project, a recent study involving six research centers in the U.S. followed a common protocol to assess real world endpoints among cancer patients, including overall survival, time to next treatment, time to treatment discontinuation, time to progression and progression-free survival. Results from the collaborative project, An Exploratory Analysis of Real-World End Points for Assessing Outcomes Among Immunotherapy-Treated Patients With Advanced Non–Small-Cell Lung Cancer, were recently published in JCO Clinical Cancer Informatics. Press release

Certara announced the launch of Hasharc, its decentralized application (DApp) for healthcare, built in conjunction with the Hedera public Distributed Ledger Technology (DLT). Hasharc has been built on Certara’s OpenPharma technology platform. The need for increased traceability and security in the life science industry is rapidly increasing, as evidenced by regulations including FDA’s Drug Supply Chain Security Act and the EU’s General Data Protection Regulation (GDPR), along with several clinical trials transparency regulations. Certara’s OpenPharma is being leveraged to address these challenges, especially as they impact patient safety and privacy protections. Current examples include pharmacovigilance, compliant supply chain tracking, patient engagement in clinical trials, and the use of real-world evidence to inform the pharmaceutical life cycle. The release of Hasharc coincided with Hedera’s own major milestone release of Open Access for the mainnet network and the introduction of the mirrornet. Hasharc leverages both the mainnet and the mirrornet and builds on other key technological advances of the Hedera platform as well. Certara has been a Hedera user and partner since its infancy. “We are proud of our association and collaboration with Hedera,” Jim Nasr, VP of Technology and Innovation, and Head of Certara’s OpenPharma innovation unit, said in a press release. “Hedera’s next-generation DLT moves beyond traditional blockchain, providing Certara with a real-time, public, scalable platform to address key clinical research, regulatory reporting, and supply chain challenges.” Press release

The partnership between Clinerion and OncologyInformationService (O.I.s) will create a platform for oncology which integrates O.I.s)’s real-world databases with Clinerion’s patient data network, via Clinerion’s patented patient data analytics technologies. The partners aim to establish a real-world evidence (RWE) database from a network of cancer treating institutions which will also allow real-time query of the participating institutions’ electronic medical records (EMRs). This platform will leverage the aggregated data to deliver: epidemiological, clinical and health care research analyses, real world data comparison of treatment algorithms, health economic analyses, identification of target patient groups as requested from pharmaceutical companies for value dossiers and HTAs; an estimation of eligible patients for clinical trial design, identification of sites treating targeted patients, and identification of eligible patients for CROs; real world data analyses for quality of care assessment and epidemiological analysis for medical associations and working groups; quality measurement in cancer care referring to clinical outcomes for treating institutions; and integration of genomic data to complete the clinical data collected in the network. Press release

Life Image announced the launch of its new Real World Imaging (RWI) offering to respond to researcher needs for maturing insights and accelerating drug development decisions. With its digital platform that is powered by industry-leading interoperability standards, Life Image specializes in “living” or evolving data sets of novel imaging that’s linkable to other clinical information. Life Image’s RWI will also be used to train artificial intelligence (AI) models demanding deeper accuracy and sensitivity across diverse data sets. Life Image’s RWI “living” data sets represent hundreds of thousands of patients, tens of millions of images and hundreds of thousands of associated reports and studies categorized by more than 25 anatomical parts including head, lung, breast, chest and more. This heterogeneous and continuously growing data represents an expanding variety of demographics, temporal data, linked longitudinal records and virtually every global manufacturer across all modalities. Imaging data, especially for Real World Evidence (RWE), has historically been difficult, if not impossible, to access, retrieve, view, de-identify and normalize at-scale, even though it provides clinically material insights for a growing number of therapies. Since 2008, Life Image has been the market leader using common interoperability standards to solve the many technical, procedural and structural barriers that have effectively segregated imaging data into unconnected data silos. Press release

GenSight Biologics reported the first set of results from Week 96 of the RESCUE Phase III clinical trial. The trial evaluated the efficacy and safety of a single intravitreal injection of GS010 (rAAV2/2-ND4) in 39 subjects whose visual loss due to 11778-ND4 Leber Hereditary Optic Neuropathy (LHON) commenced up to 6 months prior to study treatment. Week 96, which marks the time when individual patient profiles can be analyzed, is the last of the scheduled readouts for the RESCUE trial and completes the data collection from GS010’s pivotal trials in Europe. The results point to continued efficacy of GS010 two years past injection, with best-corrected visual acuity (BCVA) sustaining a clinically meaningful improvement over nadir. Having been treated early in the course of the disease, RESCUE patients’ vision initially deteriorated to a worst point, or nadir, before beginning to recover. Press release