June 30, 2022 | Artificial intelligence capabilities design potentially more precise and efficient clinical trials for Bristol Myers Squibb; a natural language generation platform accelerates clinical study submission processes; The University of Chicago Medicine helms a nationwide cancer study with 50,000 participants; a one-of-a-kind online tool for sharing, collecting, and analyzing data specifically about Down syndrome; and more. 

Canada’s largest dementia research initiative, the Canadian Consortium on Neurodegeneration in Aging, launched an innovative online program that offers older adults the opportunity to increase their knowledge of dementia, improve lifestyle risk factors, and engage with researchers. Brain Health PRO program offers interactive digital educational modules to empower older adults to improve their physical and mental health and modify their risk factors for dementia. The bilingual program focuses on seven modifiable dementia risk domains: exercise, nutrition, sleep, psychological and social health, cognitive engagement, heart health, and vision and hearing. With the rise of dementia anticipated to reach nearly 1 million Canadians over the next 12 years, dementia prevention is becoming an increasingly urgent national health priority. Press release.

PerkinElmer announced three new research use-only library preparation kits: NEXTFLEX Small RNA-Seq Kit v4, NEXTFLEX Rapid XP V2 DNA-Seq Kit, and PG-Seq Rapid Kit v2. The NEXTFLEX Small RNA-Seq Kit v4 delivers gel-free library prep from purified miRNA or 1ng of total RNA and exceptional miRNA discovery rates. The kit produces sequence-ready small-RNA libraries in approximately six hours and allows multiplexing of 384 samples per run using unique dual-index barcodes. The NEXTFLEX Rapid XP V2 DNA-Seq Kit includes proprietary NEXTFLEX normalization beads that shorten the time needed for quantification and pooling preparation for sequencing by up to 3 hours per 96 samples. The PG-Seq Rapid Kit v2 analyzes picogram quantities of DNA from an embryo biopsy for preimplantation genetic research with enhanced whole-genome coverage and accuracy. Press release.

Medidata, a Dassault Systèmes company, announced enhancements to Medidata Detect and Rave Clinical Trial Management System (CTMS) to improve data oversight and reporting for sponsors and contract research organizations. Medidata Detect provides end-to-end data and risk surveillance, allowing cross-functional operational teams to monitor and mitigate risks to patient safety and data integrity. Visual Analytics for Rave CTMS is a powerful new data visualization tool that allows users to quickly and easily navigate, explore, and combine data through intuitive visuals, charts, and tables. Both offerings are part of Medidata’s award-winning Digital Oversight Solution, which reduces on-site monitoring days by 33% per site/year (a total of four monitoring days), with no impact to study quality. These unified solutions support the execution of decentralized and hybrid trials by ensuring no information is lost, dropped, or without clinical context. Press release. 

The University of Texas MD Anderson Cancer Center and Turning Point Therapeutics announced a strategic alliance to expand the evaluation of two investigational small molecules focusing on oncology precision medicine targets. The initial focus will be Turning Point’s lead drug candidate, repotrectinib–a next-generation kinase inhibitor targeting the ROS1 and NTRK oncogenic drivers of non-small cell lung cancer and advanced solid tumors–that is currently in a registrational Phase I/II study. Alliance studies also will include elzovantinib, a kinase inhibitor targeting MET, CSF1R, and SRC, which is currently in a Phase I trial of patients with advanced solid tumors harboring genetic alterations in MET. The alliance combines MD Anderson's clinical trial infrastructure and expertise with Turning Point's differentiated, targeted oncology pipeline. Under the alliance’s five-year agreement, the teams will conduct collaborative preclinical and clinical studies on several solid tumors. Press release. 

TrialX launched a new Diversity, Equity, and Inclusion toolkit in iConnect, an award-winning patient recruitment management platform. Using the toolkit, patient recruitment teams will be able to create study websites, pre-screeners, and patient notifications in multiple languages, thereby expanding the potential reach of the study to a wide range of patient populations in different geographic regions and ethnic communities. Additionally, the iConnect volunteer registry provides the ability to collect race, ethnicity, and preferred language information from volunteers and an outreach system based on their preferences and demographics. Press release. 

New Mountain Capital, a growth-oriented investment firm with more than $37 billion in assets under management, and Emmes, a global tech-enabled full-service clinical research organization dedicated to advancing public health and biopharmaceutical innovation, announced their partnership to support and accelerate Emmes’ next phase of growth. Emmes sits at the intersection of the public and private healthcare sectors. It is proud to support the research efforts of agencies such as the National Institutes of Health, Food and Drug Administration, Department of Defense, Department of Health and Human Services, and the Biomedical Advanced Research and Development Authority. Emmes’ five acquisitions since December 2020 complemented the company’s core operations in the greater Washington, D.C. area, Canada, and India while expanding its international presence throughout Europe. Press release. 

SAS, a clinical research analytics company, announced the SAS Life Science Analytics Framework on Azure–a single, open, cloud-native statistical computing environment for clinical trial analysis and submission–that helps pharmaceutical companies navigate clinical research analytics and bring new therapies to the world faster. Gunvatta USA, a contract research organization, headquartered in Washington, DC, helps clients collect, manage, analyze and visualize the terabytes of clinical and healthcare data. With the SAS Life Science Analytics Framework, Gunvatta modernized how it approaches clinical trials. SAS also announced the Clinical Enrollment Simulation Cloud–a cloud-native solution available later this year on the Microsoft Azure Marketplace. It uses a powerful discrete event simulation analytical engine to model the clinical trial enrollment process as it evolves, facilitating improved insights to guide enrollment strategy and meet contracted patient targets. Press release. 

ObvioHealth has signed a new global licensing agreement with healthcare and diagnostic software solutions provider Dedalus Group to access the latter’s data mining technology. Their previous partnership permitted ObvioHealth to assess anonymized analytics of healthcare records of Dedalus. This technology will provide access to ObvioHealth’s multi-source healthcare data analytics to offer improved clinical trial design, recruitment, and longitudinal disease and therapies trends. In addition, this data will aid them in training artificial intelligence-powered digital and diagnostic instruments to offer an in-depth assessment of disease states. The latest agreement will bolster the expertise of ObvioHealth in detecting and assessing disease, comorbidity, and therapy patterns. Press release. 

Parexel, a global contract research organization, announced the launch of its Community Alliance Network, a novel program further integrating clinical research into the community healthcare setting to serve patients better and create further opportunities for increased diversity in clinical trials. CVS Health, a health care solutions company, and Javara, an Integrated Research Organization, have joined the network as inaugural members, opening the door to community-based research sites and increasing access to new patient populations to support trial delivery for Parexel’s biopharmaceutical customers. The Community Alliance Network builds alliances with healthcare and research organizations that have close relationships with patients who previously had no or little ability to participate in clinical research. Press release. 

Koneksa, a healthcare technology company pioneering digital biomarkers, announced that it was awarded a research grant from The Michael J. Fox Foundation for Parkinson’s Research in collaboration with Northwestern University. The research will evaluate a measurement concept to objectively quantify the severity of symptoms related to Parkinson’s disease and vocal abnormalities associated with the initial stages of disease progression. In parallel, Koneksa recently announced a partnership with Aural Analytics, a clinical-grade speech analytics company, to further strengthen its platform and research capabilities using Aural Analytics’ technology, which will be part of this research collaboration with Northwestern University. Press release. 

Sanofi has chosen to scale its natural language generation (NLG) capabilities with Yseop, the AI software and Natural Language Processing company. Sanofi will use the platform to accelerate its clinical study submission processes and bring new treatments to patients faster. Sanofi is one of the first pharmaceutical firms to leverage NLG in their clinical trial documents authoring workflows and is a pioneer in artificial intelligence use for faster drug development. Sanofi plans to expand the Yseop platform to a wide range of therapeutic and vaccine use cases this year. Press release. 

Withings Health Solutions, a remote patient monitoring (RPM) solution provider and a complete ecosystem of connected devices serving healthcare professionals across chronic disease prevention, announced a partnership with athenahealth through the company's Marketplace program. As part of the partnership, athenahealth users can place standard orders for RPM services from the athenahealth electronic health records solution. Withings will ship cellular devices directly to the patients' homes, including the Withings Body Pro scale and Withings BPM Connect Pro blood pressure monitor. The devices connect directly to cellular networks and seamlessly transmit data in a frictionless patient experience straight into their athenahealth patient chart. Press release. 

Calyx, the eClinical and regulatory solutions and services provider solving complex data challenges in clinical research, was named an approved provider of centralized medical imaging services by Clinscience, a full-service contract research organization (CRO) offering smart, end-to-end clinical trial services to the global pharmaceutical industry. Clinscience joins an extensive list of international pharmaceutical companies and CROs who repeatedly leverage Calyx’s scientific expertise and experience to assess their compounds' safety, efficacy, and effectiveness. To date, Calyx Medical Imaging has been used in over 2,600 clinical trials worldwide and has supported the approvals of over 270 medical treatments across a broad range of therapeutic areas. Press release. 

The University of Chicago Medicine hopes to recruit 50,000 people to participate in a new national study designed to explore the causes of cancer and learn more about how to prevent it. The academic health system has partnered with the National Cancer Institute, a part of the National Institutes of Health, for the Connect for Cancer Prevention Study (Connect). Connect will track participants over time to identify factors that could impact a person’s cancer risk and other health outcomes. The team says the findings can influence public health and cancer prevention guidance for years. People who join will be asked to complete online health surveys several times a year and to donate samples of blood, urine, and saliva every two to three years. Safeguards for privacy and confidentiality will be in place to protect participants’ data and biological samples. Press release. 

Owkin has entered into a multi-year, strategic collaboration with Bristol Myers Squibb to apply Owkin’s artificial intelligence capabilities to design potentially more precise and efficient clinical trials for Bristol Myers Squibb. The partnership will initially focus on cardiovascular diseases with the potential to extend into other therapeutic areas. Under the terms of the agreements, Owkin will receive $80 million in aggregate for the upfront payment and the Series B-1 equity investment by Bristol Myers Squibb and potentially further payments above $100 million contingent on the collaboration achieving certain success-based milestones in conjunction with regulatory processes. Owkin will use the equity investment to support its ambitious data generation strategy in multiple therapeutic areas, focusing on multimodal and rich biological data, including the most advanced spatial single-cell omics technologies. Press release. 

10x Genomics, a life sciences company focused on mastering biology to advance human health, announced a series of product updates previously previewed at the J.P. Morgan Healthcare Conference in January. The new Chromium Fixed RNA Profiling Kit enables single-cell transcriptomics on dissociated formalin-fixed, paraffin-embedded (FFPE) tissues and allows for single-cell analysis on preserved biobank samples for the first time. In addition, Visium CytAssis–the company's first spatial instrument and compact benchtop system simplifies sample processing by facilitating the transfer of analytes from tissue sections. Visium for FFPE v2 is the second version of its spatial FFPE workflow that profiles RNA and dozens of proteins simultaneously in the same FFPE tissue section at high spatial resolution. A Xenium platform for in situ analysis is also launching later this year. Xenium is expected to offer single-molecule RNA analysis at subcellular resolution and be compatible with fresh, frozen, and FFPE tissues. Press release. 

Entos Pharmaceuticals, a clinical-stage biotechnology company developing genetic medicines with its Fusogenix proteolipid vehicle (PLV) nucleic acid delivery platform, announced the opening of its new 9,600 square-foot research and development facility in the Torrey Pines community of San Diego, California. This collaborative space will be shared with Entos’ sister companies, Oisín Biotechnologies, OncoSenX, and Aegis Life, allowing the companies to expand their team and infrastructure and support continued growth. Entos’ proprietary Fusogenix PLV drug delivery system is formulated with FAST proteins to deliver nucleic acid cargo, such as DNA and RNA, directly into target cells. Press release. 

Fisher Scientific announced an In Vitro Diagnostic Requirements (IVDR) version of the Applied Biosystems QuantStudio 5 Dx Real-Time PCR System to help molecular diagnostic manufacturers and clinical testing laboratories adapt to the higher-standard IVDR in effect in the European Union. The innovative qPCR system simplifies molecular diagnostic workflows for infectious disease and oncology. Furthermore, the qPCR system has an intuitive touchscreen and simplified, efficient workflow that minimizes steps to deliver quality results in as little as 30 minutes. Press release. 

MMS Holdings, a data-focused contract research organization, announced a strategic partnership with Medidata, a Dassault Systèmes company, to provide clients with a full range of solutions for clinical data management and decentralized clinical trial technologies, including Medidata’s unified platform and Rave Electronic Data Capture (EDC). The partnership with Medidata provides MMS with greater flexibility to work with sponsors using their preferred database platform and expands its capacity to work with any data management system. In addition, Medidata’s Rave EDC forms the cornerstone of the Medidata Clinical Cloud–the unified clinical research platform that connects processes, eliminates data reconciliation, and delivers cross-functional and cross-study data insights. Press release. 

The Society for Clinical Research Sites (SCRS) announced yesterday that Clinerion joined the organization as a Global Impact Partner (GIP). SCRS’ GIP Program provides a unique opportunity for sponsors, clinical research organizations, and solution providers to engage and collaborate with SCRS and its site members. Becoming a GIP demonstrates Clinerion’s commitment to developing a deeper understanding of sites' needs and contributing to developing solutions in the clinical research marketplace. Clinerion accelerates clinical research and medical access to treatments for patients at its core. SCRS is a global organization that unifies the voice of the clinical research site community to create greater site sustainability. Press release. 

The University of Texas MD Anderson Cancer Center presented two studies in the Journal of Clinical Oncology that shed new light on the potential of the gut microbiome as a targetable biomarker to improve responses to immunotherapy. One study (DOI: 10.1200/JCO.2022.40.16_suppl.2006) reported gut microbiome associations with immunotherapy response in newly diagnosed glioblastoma patients. As a result, many clinical trials for glioblastoma at MD Anderson routinely include stool sample collection to enable correlative gut microbiome studies. The second study (DOI: 10.1200/JCO.2022.40.16_suppl.2511) found a link between gut microbiome signatures, immune cells in the tumor microenvironment, and immune checkpoint blockade responses in melanoma, non-small cell lung cancer, and sarcoma. Press release. 

The INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Project Data Coordinating Center launched the INCLUDE Data Hub, a free-to-use, one-of-a-kind online tool for sharing, collecting, and analyzing data specifically about Down syndrome. The INCLUDE Data Hub provides centralized access to large-scale research resources, including a biospecimen library and clinical and multi-omics datasets, as part of the National Institutes of Health-funded INCLUDE Project, a research effort to advance our understanding of health and quality-of-life needs of people with Down syndrome. The Data Hub currently features data from more than 8,000 study participants and almost 30,000 biospecimens collected exclusively from people with Down syndrome. Press release. 

Lento Bio announced its launch as a preclinical pharmaceutical company focused on developing small-molecule therapeutics for age-related diseases. The company will focus on developing pharmaceutical eye drops to treat presbyopia, also known as age-related farsightedness. Support comes from Ichor Life Sciences, a preclinical contract research organization at Clarkson University's Peyton Hall Biotechnology Incubator. Lento Bio is the first startup company to join Ichor in establishing a North Country biotechnology cluster. Press release. 

Waters Corporation recently unveiled new instruments, software, and product enhancements to drive drug discovery and development. New products include the Xevo G3 quadrupole time-of-flight (QTof) mass spectrometer, CONFIRM Sequence app, and an electrospray ionization source for the high-resolution Waters SELECT SERIES Multi-Reflecting Time of Flight (MRT) mass spectrometer. The new Xevo G3 QTof system is a high-performance, benchtop mass spectrometer for characterizing and quantifying thermally fragile molecules in biotherapeutics, forensics, metabolite identification, metabolomics, extractables, and leachables. The CONFIRM Sequence app on the waters_connect software platform helps scientists confirm the nucleic acid sequence of therapeutics and identify impurities that could compromise product safety and efficacy. The Waters SELECT SERIES MRT System enables scientists to measure low (<200 ppb) concentrations of sample analytes for metabolomics, metabolite identification, or peptide mapping applications. Press release. 

PerkinElmer announced the launch of the research-use-only BioQule Next-Generation Sequencing (NGS) System–an automated benchtop solution for NGS library preparation of up to eight samples. By incorporating automated thermocycling, integrated quality control through optical quantification, and robust liquid handling technology into a single device, the BioQule NGS System enables researchers to produce high-quality NGS libraries that yield reliable and reproducible results in a variety of genomic analysis applications. In addition to its straightforward design and walk-away automation capabilities, the BioQule NGS System expands opportunities in NGS library preparation by requiring as little as 10 ng of starting material to create libraries. In comparison, other systems require 50 ng or more. Press release. 

Foundation Medicine, a cancer molecular profiling company, announced its participation in a neoadjuvant screening trial with the Lung Cancer Research Foundation and Lung Cancer Mutation Consortium (LCMC). This screening trial, entitled “LCMC4 Evaluation of Actionable Drivers in EaRly Stage Lung Cancer” (LEADER), is the fourth study conducted through the LCMC and is a collaborative effort involving numerous academic study sites and pharmaceutical supporters. Foundation Medicine will be the sole provider of comprehensive genomic profiling in the LEADER trial, which uses an umbrella trial design to screen for 11 actionable driver mutations in 1,000 patients with high-risk, resectable non-small cell lung cancer to develop essential data that supports oncologists in their personalized treatment planning for cancer patients before surgery. Press release. 

Becton, Dickinson, and Company (BD), a global medical technology company, announced a new cell sorting technology that enables researchers to see and sort cells at unprecedented speeds. This technology transforms research and cell-based therapeutic development across various fields, such as virology, oncology, and other disease states. The new BD FACSDiscover S8 Cell Sorter features the breakthrough BD CellView Image Technology profiled earlier this year on the cover of the journal Science (DOI: 10.1126/science.abj3013). It is the world’s first cell sorter to combine advanced spectral flow cytometry with sort-capable image analysis. This will enable researchers to yield more accurate data and sort cells that previously were not identifiable. Press release. 

Avera Health, an integrated regional health care system, and Sema4, an AI-driven genomic and clinical data intelligence platform company, announced the Avera/Sema4 Oncology and Analytics Protocol (ASAP) study–a five-year commitment to population health for precision oncology care. The ASAP study will enroll 3,000 patients annually, including those with cancer or at risk for developing cancer. Study participants will receive genomic sequencing of their tumor and hereditary cancer and pharmacogenomics testing to identify targeted, personalized treatment options. Furthermore, participants will receive pharmacogenomics testing to study how variations in some genes may affect medication efficacy and safety. Press release. 

Median Technologies announced that the company is expanding its portfolio of services with Imaging Lab, a new entity whose mission is to leverage AI, data mining, and radiomics technologies to exploit imaging data from clinical trials in oncology. The creation of Imaging Lab materializes the convergence of iCRO's activities for image management in the development of new oncologic drugs and iBiopsy's activities for the development of software as a medical device targeting early diagnosis of cancers, especially lung cancer. In addition, the Imaging Lab will provide new answers in four areas that determine the success of clinical trials: selection of patients included in trials, prediction of response to therapy, measurement of disease progression, and evaluation of the safety of drug candidates. Press release. 

Bezyl, a global digital mental health company, is collaborating with THREAD to provide a mental health digital app and support system to patients participating in clinical trials. Grounded within a secure communications platform, the Bezyl app makes it easier for patients to ask for help from friends, family, and caregivers. Additionally, it provides access to valuable and easy-to-navigate resources specific to the patients' needs. As a peer-support tool, the Bezyl app aims to help patients eliminate anxiety, retain their participation in clinical trials, maintain treatment compliance, and, most importantly, build their mental strength. Press release.