September 1, 2021 | New video eConsent capabilities from Medidata, Kaia Health revamps C-Suite to expand clinical capabilities, clinical trial partnerships for Curebase, Adagene, and Telix Pharmaceuticals, and Clinerion expands global hospital network. Plus new products from Smart Meter, Digital Science, and Elsevier.

FDB (First Databank), has announced the results of a study by FDB pharmacists that sheds new light on information from the U.S. Food and Drug Administration (FDA) on how patients’ genes affect their response to prescribed medications. The study, "Characterization of Pharmacogenetic Information in Food and Drug Administration Drug Labeling and the Table of Pharmacogenetic Associations," was published in the peer-reviewed journal Annals of Pharmacotherapy. The authors created a new categorization schema for pharmacogenetic information and clinical outcomes associated with drug-gene pairs recognized in the FDA resources. Press release.

GNDI of Brazil has joined Clinerion’s global network of hospitals on Patient Network Explorer. Grupo NotreDame Intermédica (GNDI) is the largest healthcare operator in Brazil, with 6.4 million members. Founded in 1968, it is a pioneer in preventive medicine. GNDI has a wide offer, comprising 29 hospitals, 88 clinical centers, 23 autonomous emergency rooms, 15 preventive medicine centers and 2 health centers exclusively dedicated to the over-fifties. Joining Patient Network Explorer, GNDI patients and their treating physicians gain increased treatment options and quicker access to new medical interventions. Patients are matched to academic and sponsored clinical studies according to their electronic health records, ensuring better screening when recruiting for clinical trials. Trial managers gain the ability to include eligible patients for trials more quickly and efficiently than before. Physicians gain tools to better stratify patient care, including the identification of hard-to-diagnose rare disease patients. Press release.

Foundation Medicine has announced a partnership to integrate its comprehensive genomic profiling (CGP) and other testing services with Epic’s electronic medical record (EMR) system. Once completed, all providers who use Foundation Medicine’s instance of Epic will be able to electronically order Foundation Medicine tests within the Epic network. The integration is designed to support oncology practices, academic medical centers and other health systems by providing easy access to clinical and genomic information in one place to better enable more streamlined clinical decision making. This integration is one of many updates Foundation Medicine is making across its portfolio to help expand precision oncology through efficient and high-quality, data-driven insights. This integration will enable clinical teams to place orders for Foundation Medicine’s CGP tests, and receive and view results directly within their existing workflow in Epic’s EMR platform. The enhancement will also target to reduce data entry with the aim of accelerating delivery of actionable insights to physicians to help guide treatment planning. Press release.

Kaia Health has recently revamped its C-suite, adding Gemma Wenstrom as Chief Operations Officer, CJ Mark as Chief Revenue Officer, Manu Diwakar as Chief Financial Officer, Sanid Khilnani as Vice President of Product, and Justin Yang, M.D., as Chief Medical Officer, US Commercial. The hiring announcements follow Kaia Health’s recent $75 million Series C round ($125 million raised to date) to expand clinical capabilities, heavily invest in computer vision technology, and transform the treatment pathways for MSK in the U.S. and Europe. Website.

Curebase and AppliedVR have announced a one-year partnership where AppliedVR will deploy the Curebase platform to run five clinical trials assessing the effectiveness of virtual reality-based (VR) therapy to treat chronic pain. The clinical trials with Curebase will focus onstudying a self-administered, at-home VR therapyprogram, with Curebase software managingonline patient recruitment, consent,participant engagement, and collecting patient reported outcomes. The Curebase platform also will support clinical workflows, including randomization schema, research coordinator communication, PI oversight, and coordination of VR headset and trial kit distribution. Press release.

UT Southwestern has become a founding member of the new Sickle Cell Disease Clinical Trials Network (SCD CTN) to bring treatments and curative options to people suffering from this potentially life-shortening red blood-cell disorder. The American Society of Hematology (ASH), which created the network, is the world’s largest professional society of clinicians and researchers who focus on blood diseases. UT Southwestern’s inclusion in the national network underscores its commitment as an academic medical center to bring the latest treatments to underserved populations. Sickle cell disease hits Black Americans the hardest, with the genetic disease occurring in 1 out of every 365 African American births. Press release.

Smart Meter, the leader in cellular-connected remote patient monitoring (RPM) devices, data, and services, has announced the availability of its iGlucose monitor for managing gestational diabetes. iGlucose provides those with gestational diabetes an easy and reliable way to test, monitor and manage their blood glucose levels, ensuring that all care providers have immediate access to testing results. Key benefits of iGlucose in gestational diabetes include immediate transmission of BG data through cellular connectivity with AutoShare, improved visibility to patient results, critical high and low readings delivered in real-time, improved patient experience through a cellular-enabled device, and more. Press release.

Boston Healthcare is now a part of Veranex, a new global solutions provider for MedTech and Life Sciences innovators, bringing together four complementary solution providers: Ximedica, Quartesian, Experien Group, and Boston Healthcare Associates. The combined company brings deep experience in the areas of devices, in vitro diagnostics, precision medicine, digital health, and combination products/drug delivery among other technology areas. Disease areas of focus include cardiovascular, orthopedic, women’s health, wound care, ophthalmology, neurology, oncology, and gastrointestinal among others. Veranex is the first concept-to-commercialization global service provider built for medical technology innovators. The Veranex platform is designed to provide the global medical technology industry with comprehensive, integrated, and technology-enabled product development and commercialization solutions. Press release.

Clinerion has published its European patent for the technology underpinning Patient Network Explorer. The Clinerion patent underpins any medical EHR database infrastructure that incorporates a hybrid model of cloud-and-local server node installations at individual hospitals, as well as any method for search of patient cohort care metrics across such a platform. This allows real-time search at each individual hospital across the entire network at once, returning aggregate metrics from the entire network. The patent builds in data protection as it incorporates restrictions to data transfer from the local server to outbound connections, while having no inbound ports, thereby preventing hacking of the local server. The patent also describes a firewall, encryption, and/or additional protective components, as well as the use of an anonymization module on patient data before a request may be initiated. The patent further introduces a reverse identification process crucial to clinical research outreach processes, such as patient engagement. Press release.

Optellum has entered a strategic collaboration with the Lung Cancer Initiative at Johnson & Johnson. Through the collaboration, Optellum will apply its AI-powered clinical decision support platform with the goal of increasing lung cancer survival rates through early intervention and prevention. At the core of the collaboration is Optellum's commercial software, Virtual Nodule Clinic, including an AI-powered digital biomarker based on neural networks and imaging analytics. It identifies and tracks at-risk patients and assigns a Lung Cancer Prediction score to lung nodules; small lesions, frequently detected in chest Computed Tomography (CT) scans, that may or may not be cancerous. The Optellum AI will be used to drive accurate early diagnosis and optimal treatment decisions with the aim of treating patients earlier, potentially at a pre-cancerous stage, increasing survival rates. Press release.

Adagene has entered into a third clinical trial collaboration and supply agreement with Merck. The agreement includes an open-label, dose escalation and expansion clinical study of ADG106 in combination with Merck’s anti-PD-1 KEYTRUDA (pembrolizumab) in advanced or metastatic solid and/or hematological malignancies (ADG106-P2001/KEYNOTE-D12). This clinical study builds on the promising monotherapy and combination therapy data from a Phase I trial of ADG106. Engineered using Adagene’s proprietary NEObody platform technology, ADG106 is a fully human, ligand-blocking, agonistic anti-CD137 immunoglobulin G4 (IgG4) monoclonal antibody (mAb). Press release.

Global Kinetics has entered the Remote Physiologic Monitoring (RPM) space in the U.S. market with its unique system for monitoring Parkinson’s disease (PD), the Personal KinetiGraph (PKG). The PKG system is an FDA 510(k) cleared system that features a wearable biosensor for patients to use in their home environment which collects movement data over a continuous period of time and transmits data via a cellular connection. An easy to review report is produced for the clinician to enable more personalized treatment and management decisions ultimately leading to a higher quality of life for persons living with PD. Global Kinetics provides device fulfillment directly to the patient’s home and delivers comprehensive annotated reports via a clinic-facing portal. Patients can be monitored in their own home while going about normal activities of daily living; clinic staff can review monitoring progress including effects of medication changes and adjustments to advanced therapy settings on an ongoing basis to fulfill the RPM reimbursement coding guidelines. Press release.

Digital Science has launched a new version of its popular Dimensions platform—Dimensions Life Sciences & Chemistry (Dimensions L&C)—focused on life sciences and chemistry research activities. Dimensions L&C analyzes more than 120 million scientific publications, millions of patents, grants and clinical trial documents. It is both larger than other databases, and unlike traditional manually-curated tools, applies up-to-the-minute semantic text analysis tools and ontologies, providing powerful up-to-date discovery functionality previously unavailable at such scale. Press release.
Telix Pharmaceuticals has entered a pan-cancer clinical collaboration with Merck KGaA to conduct combination studies with one of Merck’s investigational proprietary DNA Damage Response Inhibitor (DDRi) molecules in combination with each of Telix’s TLX591 (177Lu-rosopatamab) and TLX250 (177Lu-girentuximab) molecularly targeted radiation (MTR) therapeutic programs. This clinical collaboration builds on the success of a strategic research collaboration agreement between Telix and Merck announced in August 2019. TLX591 and TLX250 are late-stage products in development for prostate and renal cancer therapy, respectively. Under the terms of the collaboration and based on encouraging pre-clinical data derived from the initial strategic research collaboration, the two parties have agreed to investigate the synergy of these investigational assets with Merck’s DDRi compound across a wide variety of oncology indications in the clinic. Press release.

Medidata has enhanced myMedidata eConsent to enable video visits with patients and study staff. With video eConsent, trial participants can engage in remote, face-to-face, live conversation between patients and clinical trial site staff during the informed consent process. Building upon existing eConsent functionality, video eConsent represents yet another step in the revolutionary changes being brought about by decentralized clinical trial (DCT) technology. This expansion of the company’s telemedicine/video visit capability is the most recent addition to the myMedidata portal designed to be a single patient platform for all patient-centered technology. Medidata eConsent is an innovative, regulatory-compliant, patient-friendly, electronic consent system for clinical trials. Whether onsite or remote, eConsent simplifies the consent learning process for patients, digitizes the enrollment process, and onboards patients directly into Medidata’s industry-leading electronic data capture platform, Rave EDC. With myMedidata eConsent, patients can remotely access the same great eConsent tool through their web-based myMedidata portal. Using video eConsent, the patient consent process is further enhanced with the ability to connect individuals with real-time video to clinical trial staff, boosting knowledge, compliance, and engagement. Press release.

Avera Health, an integrated regional health care system that serves 300 locations across the Upper Midwest, and Sema4, a patient-centered health intelligence company, have announced a new collaboration launching a precision medicine initiative. This initiative will initially focus on advancing oncology care, enabling Avera Health’s providers and patients to benefit from data-driven insights that inform targeted cancer treatments. Avera Cancer Institute has had a robust precision oncology program for several years in which the patient’s tumor has been genetically sequenced to guide individualized cancer treatment. This collaboration will take that a step further by leveraging Centrellis, Sema4’s health intelligence platform, to curate, structure and integrate clinical and genomic data to support both cancer research and clinical care at Avera Health. Sema4 will deliver predictive disease network models and clinically actionable insights, empowering Avera Health’s providers to further improve the prevention, detection, and treatment of cancer for their patients. Sema4 will also offer digital tools, which give Avera Health’s providers the ability to readily search for cohorts of patients based on clinical criteria, view a patient’s treatment history that is contained in the curated data as an interactive timeline, and more systematically match patients to clinical trials. Press release.

MedAware, a medication safety monitoring technology, has announced a partnership with athenahealth through the company’s Marketplace program. As part of the athenahealth Marketplace, this newly integrated application is now available to athenahealth's growing network of healthcare providers to help identify potential adverse drug events, analyze a patient’s risk of opioid dependency, alert providers to dangerous drug interactions, and more. Press release.

Elsevier has launched an enhanced version of ClinicalKey, which will provide physicians with quick access to Elsevier’s trusted medical resources in addition to clinical decision support at the point of care. The new ClinicalKey for physicians in the U.S. and various international markets will help them diagnose and treat patients faster, and more effectively, based on the latest evidence. Elsevier conducted extensive research with hundreds of clinicians and leveraged global insights to inform the development of a solution that would support them with patient care in an environment where evidence-based data and guidance changes quickly. Elsevier also partnered with institutional leaders to evolve ClinicalKey and help address these challenges. Press release.