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Roche Announces IMPACT Trial Results, RWE Acquisitions, More

Acquisitions for THREAD, Elsevier, and Global Healthcare Opportunities. Partnerships for international trials and AI-based clinical trial acceleration software. Plus new products from Intuity Medical, Florence, uMotif, and more.

Elsevier has acquired Osmosis, a US-based visual learning platform that has simplified the complex learning journey for millions of current and future healthcare professionals and their patients around the world. Osmosis utilizes evidence-based learning science to create distinct microcontent that turn complex medical concepts into easy-to-follow learning modules.

With a broad reach in 195 countries, Osmosis has more than two million subscribers on its YouTube channel, 150+ partnerships with institutions ranging from medical schools to digital health companies, and over a quarter-of-a-billion views of its content. Osmosis will join Elsevier’s Global Medical Education portfolio, complementing its advanced digital solutions, which enable students and healthcare professionals to learn and apply complex healthcare information more effectively.

Elsevier intends to enhance other segments across healthcare with the effective microcontent capabilities provided by Osmosis, including supporting the learning needs of medical students and healthcare professionals, nursing students and eventually patients. Press release. NEXT Oncology has entered into an agreement with the Quirónsalud Group to open two new phase I clinical trial centers in Spain.

The venture increases global access to new agents and anticancer therapies for cancer patients. NEXT Oncology’s phase I centers provide patients with advanced cancer who have exhausted all other treatment options access to the newest cancer treatments available. According to the company, the global expansion into Spain is another step in a series of planned collaborations to bring NEXT Oncology’s proprietary model of Phase I clinical trials to cities all over the U.S. as well as other parts of the world.

Press release. Clinerion was selected by the Swiss Personalized Health Network (SPHN) to be the backbone of its Federated Query System (FQS) due to the unique nature of its patented federated cloud infrastructure, which allows patient data to remain inside the IT infrastructure and under the control of each hospital, while still allowing queries of anonymized and obfuscated patient data from other hospitals in the network. The FQS allows researchers to verify the feasibility of their project by assessing whether suitable patient data for specific research questions exist at Swiss university hospitals.

The available information in the system, currently more than 70 million data elements from over 450’000 patients, who have consented to the further use of their data for research purposes, is a subset of the clinical data of all five university hospitals. The platform includes demographic data (age and gender), diagnosis (coded in ICD-10), procedures (coded in CHOP), medication (coded in ATC), laboratory tests (coded in LOINC) and laboratory test results with units (according to UCUM). Under the project lead of the SPHN Data Coordination Center (DCC) managed by the SIB Swiss Institute of Bioinformatics, the clinical partners harmonized and standardized the anonymized clinical information, making it available for federated queries via a common front-end.

Press release. uMotif and researchers at The University of Manchester are investigating the real-world usability of uMotif’s digital body mapping tool in a feasibility study in people living with musculoskeletal conditions. The University’s Manchester Digital Pain Manikin (MDPM) app has been developed by uMotif and utilizes its body mapping technology, making it faster and easier for patients to accurately report the location of their pain to study teams via their smartphone.

Findings from the study are shedding new light on how a digital body map can improve pain reporting, which in turn can enhance the support and care of individuals who experience long-term pain. The design of uMotif’s body mapping technology implements an easy-to-use interface that enables people to quickly capture the location and intensity of their pain by drawing on a digital body map. Data collection for The University of Manchester’s feasibility study is currently underway, with nearly 100 patients taking part through a decentralized and bring-your-own-device (BYOD) research design.

A series of workshops have also taken place to gather user feedback and better understand the influence of ethnicity and cultural background on pain reporting behavior. Future studies will focus on further evaluating the tool’s validity as a research-quality pain measurement instrument. It is anticipated that this opportunity will contribute to the technology becoming a new standard for how long-term pain can be measured, analyzed, and reported. Press release.Leon Health has selected HEALTHsuite Advantage from RAM Technologies to administer their new Medicare Advantage business in south Florida.

The RAM solution suite will provide Leon Health with an end-to-end solution to manage their Medicare Advantage offerings while providing complete integration with CMS. Leon Health, Inc. is a new Medicare Advantage health plan based in Hialeah, Florida. They will be working in conjunction with Leon Medical Centers, a recognized leader providing primary care, preventative care and ambulatory services to thousands of Medicare beneficiaries in south Florida since 1996.

The available offerings from Leon Health, Inc. will include an MAPD product; a D-SNP product and a Part B Premium Giveback offering. Press release. Global Healthcare Opportunities, or GHO Capital Partners LLP, the European specialist investor in global healthcare, announces the acquisition of Genesis Research, a leading provider of tech-enabled Real-World Evidence (RWE) and Health Economics and Outcomes Research (HEOR) services. Founded in 2009 and headquartered in Hoboken, New Jersey, Genesis is a pioneer in RWE and HEOR services via tech-enabled data and science-first solutions, servicing market leading innovators across the Life Sciences industry. Genesis optimizes drug development and evidences the clinical and commercial value of products via expert analysis, synthesis, communication, and utilization of integrated Real-World Data (RWD).

Press release. Emmes, a global, full-service Clinical Research Organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation, has announced a partnership with MedGenome aimed at accelerating breakthrough treatments, powered by human genomics, for rare disease patients. The two companies will collaborate to combine patients’ epidemiologic, phenotypic, and genomic data into custom disease registries to enhance study design, support patient recruitment, and create standard control arms for advanced statistical models of treatment effect. Press release.

ICON has announced that its Accellacare Site Network has expanded in reach and capabilities through new partnerships with six research sites across four countries. Agreements with Asclepes Research and Olympian Clinical Research in the United States, Curiositas ad Sanum and Intermed in Germany, Quironsalud in Spain, and KO-MED in Poland brings the Accellacare network to 112 active locations across eight countries and the entry to two new U.S. states – Florida and California.

Through these new partnerships, Accellacare is also enhancing its already-strong capability in the central nervous system (CNS) and immune-inflammation therapeutic areas. The expansion of the Accellacare Site Network increases access and engagement with investigative sites and its patients, supporting faster recruitment and reducing the overall time and cost associated with drug development for customers. Accellacare now has access to more than 9 million patients. Press release.

Louisville, Kentucky-based Baptist Health has selected Sepio Systems’ HAC-1 solution to add a new layer of defense against rogue devices used by cybercriminals to evade traditional threat detection tools. The health system will integrate Sepio’s HAC-1 system with existing network security controls to defend its more than 400 locations in Kentucky and southern Indiana against a multitude of proximity-based attack vectors. Sepio also adds additional protections for its home-based workers. Press release.

TARA Biosystems and Scipher Medicine are collaborating to address a critical unmet need for effective therapeutics in cardiac laminopathies. Cardiac laminopathies, associated with mutations in the LMNA gene, can result in electrical and mechanical changes in the heart that can have profound clinical consequences. Scipher will leverage human molecular data analyzed by its Spectra platform, which includes data from TARA’s Biowire II LMNA disease models, to identify novel targets for a stratified disease population. This approach aims to identify proteins upstream and downstream of LMNA signaling within the Spectra network model.

The identified targets will be evaluated in TARA’s Biowire II platform, which consists of induced pluripotent stem cell-derived human cardiac tissue models, including a repertoire of healthy, gene-edited, patient-derived, and drug-induced phenotypes of human disease. Press release. Genomenon has announced a proof-of-concept agreement with Deep 6 AI, the leader in artificial intelligence (AI)-based clinical trial acceleration software (CTAS).

The collaboration offers significant value to disease researchers, clinical operations, and precision matched recruitment, accelerating the identification and treatment of diseases such as cancer, Parkinson, and Wilson disease. Deep 6 CTAS integrates into multiple, disparate hospital environments, accessing both structured and unstructured EMR, genomics and pathology data, which supports trial feasibility site selection and patient recruitment. When partnered with Genomenon’s Genomic Landscapes—which enable more efficacious clinical trials with curated, evidence-driven data that provides precision matching protocols—the two companies will mine data that is traditionally distributed across systems and hospitals.

The result will take inclusion/exclusion information in a clinical trial, match it to a patient, then score/rank the patient based off the matching percentage. Press release. THREAD has acquired Modus Outcomes to combine high-technology and high-science in one platform designed to achieve higher-quality outcomes for research sponsors. Headquartered in Cambridge, Mass., Modus Outcomes is a research consultancy that supports the design and selection of electronic clinical outcome assessments (eCOA), participant-focused trial design and scientific delivery of DCTs.

With this acquisition, THREAD will bring together its eCOA technology platform with Modus’ services to provide global biopharma and contract research organizations (CROs) with a unique solution that optimizes their decision-making for developing and commercializing new therapies. Modus brings a team of 40 experts and offices in London and Lyon, France, expanding THREAD’s worldwide presence to six global offices. Press release. Intuity Medical has announced the availability of the POGO Automatic Blood Glucose Monitoring System in the U.S.

The product is the first and only FDA-cleared blood glucose monitor whose 10-test cartridge technology makes a glucose test possible with only the press of a button and without needing to carry separate test strips and lancets. POGO Automatic is the first and only FDA-cleared ABGM whose 10-test cartridge technology makes it possible to lance and collect blood and produce a glucose result in just one step, without the need to individually load lancets or test strips.

With One-Step testing, POGO Automatic delivers a greatly simplified and discreet blood glucose testing experience that is less disruptive to the user’s everyday life. Once the 10-test cartridge is loaded and the monitor turned on, the user only has to press their finger on a button to activate POGO Automatic, which then automatically does all the work of lancing and blood collection, followed by a four-second countdown and a result. This single-step test greatly simplifies blood glucose testing compared to using a traditional blood glucose meter, which can require as many as 15 or more steps to conduct a blood glucose test. Press release. Florence Healthcare’s digital research platform, Florence eBinders, will support clinical trial operations for SWOG Clinical Trials Partnerships.

SWOG CTP is an independent company formed by The Hope Foundation, the public charity of the SWOG Cancer Research Network. SWOG CTP conducts non-federally funded trials with sites that are members of SWOG’s network of nearly 12,000 researchers at over 1,300 hospitals, clinics, and cancer centers in 47 states. SWOG CTP will benefit from Florence’s integrated digital research hub, Florence eBinders, to streamline regulatory operations, study-startup, and remote site monitoring in their multi-center studies. Press release. Roche announced that results from the IMPACT (IMproving Primary screening And Colposcopy Triage) trial demonstrate clear patient benefit in using Roche’s CINtec PLUS Cytology dual-stain biomarker technology as a triage test for women who test positive for high-risk human papillomavirus (HPV). The data from the trial, established from a study cohort of more than 35,000 women aged 25-65 years, was published recently in the International Journal of Cancer.

In the IMPACT trial, women who were positive for high-risk HPV received a follow-up triage test to help determine if their cervical cells were transforming to cervical pre-cancer. The biomarker-based CINtec PLUS Cytology test showed a significantly higher sensitivity in detecting cervical pre-cancers, compared to Pap cytology. The Roche test aids clinicians in more confidently determining which women are at increased risk for high-grade cervical pre-cancer and require immediate further diagnostic procedures, and which women may need repeat testing or routine screening. Press release. Better Therapeutics, a prescription digital therapeutics (PDT) company delivering cognitive behavioral therapy to address the root causes of cardiometabolic diseases, has completed its business combination with Mountain Crest Acquisition Corp II, a publicly traded special purpose acquisition corporation or SPAC. The resulting combined company will commence trading its shares on Nasdaq under the ticker symbol “BTTX” on October 29, 2021.

The shareholders of Mountain Crest Acquisition Corp II approved the transaction at a special meeting held on October 27, 2021, and the transaction was previously approved by Better Therapeutics’ stockholders. Better Therapeutics’ management team, led by Co-Founder and Chief Executive Officer, Kevin Appelbaum, will lead the combined company along with Dr. Mark Berman, Chief Medical Officer, Kristin Wynholds, Chief Product Officer, and Mark Heinen, Interim Chief Financial Officer. Press release.

Florence has launched its Digital Research Certification program. Professionals in the clinical research field can now enroll in a complementary introductory course on digital clinical trials. Study sites in 44 countries use Florence’s digital research software to manage their content creation and management workflows and facilitate 3 million remote monitoring and source data verification actions every month. Press release.Kaia Health, the next-generation solution for musculoskeletal (MSK) care covering 60 million lives globally, has unveiled an industry-first partnership with Luna On-Demand Physical Therapy to further extend access to high-quality care for MSK patients by delivering physical therapy to a patient’s doorstep.

This unique online-offline partnership will expand access to care for more members, including high-risk patients, and advance the Kaia Health mission to make effective therapies accessible to patients anywhere and at any time. Using a multimodal approach, Kaia Health provides a holistic MSK pain rehabilitation program that reduces the likelihood of inconsistencies, incomplete care, and duplicative services. Kaia Health is now the only digital MSK pain solution to provide clinically validated digital therapy complemented by in-person, at-home intervention at the right points in a patient’s care journey. Press release.

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