October 27, 2022 | A new application that enables real-time data access for sponsors and clinical research sites; a first-of-its-kind solution for aggregating, cleaning, and transforming clinical data; two new applications to help clinical teams improve site selection and optimize trial design; and more. 

ObvioHealth is collaborating with Oracle in Asia Pacific to help get breakthrough therapies to market faster through more efficient integration of diverse data sets. The alliance will enable the rapid collection, integration, and analysis of multi-source data collected from sites, patients, devices, and labs. This announcement comes on the heels of ObvioHealth’s launch of ObvioGo, a next-generation decentralized clinical trial platform and mobile app. The platform’s capabilities will fully integrate into the Oracle Clinical One Cloud Service (Clinical One), facilitating pharma-grade analytics and reporting that can deliver more timely patient insights. ObvioHealth is also partnered with Novotech, the leading Asia-Pacific biotech specialist CRO. Press release. 

The European Organization for Research and Treatment of Cancer found that liquid biopsies, which are increasingly used in the routine care of patients to identify and monitor cancer progress, can also detect a disorder of blood cells that places patients at higher risk of developing blood cancers. Researchers took liquid biopsies from 1416 patients with a range of solid tumors who had enrolled in the Gustave Roussy Cancer Profiling study. They believe that when liquid biopsies reveal a high-risk clonal hematopoiesis feature—a condition characterized by the hyper-replication of hematopoietic stem cells with the same genetic mutation—this should trigger further hematological evaluation to determine if the patient is at risk for cancer or should receive a diagnosis. Press release. 

The Predi-COVID Cohort study (PLoS Digital Health, DOI: 10.1371/journal.pdig.0000112), a project led by the Luxembourg Institute of Health, demonstrated that vocal recordings of COVID-19-affected people could monitor related symptoms of the disease. This new biomarker-based technology could become a novel and easy way for healthcare practitioners to provide at-risk patients with immediate help and relieve some burdens on the healthcare system. In the future, healthcare practitioners could track the progression of symptoms via remote monitoring using non-invasive tools like smartphones. It could also be a practical solution for monitoring Long COVID patients over an extended period to anticipate the evolution of their symptoms. Press release. 

Calyx announced a significant enhancement to its advanced interactive response technology (IRT) system. The company expanded its self-service IRT tools, which enable clinical trial sponsors and CROs to quickly adapt to trial needs without reprogramming. With the ability to easily add countries and depots to Calyx IRT’s customizable platform, sponsors can react to the inevitable changing needs of their trials and quickly have medication available for patient enrollments at new sites worldwide. Press release. 

The American Heart Association created the Cardiogenic Shock Registry powered by Get With The Guidelines. The new registry will help researchers, clinicians, and regulators to better understand the clinical symptoms of cardiogenic shock types, treatment patterns, and outcomes. Data from this no-cost registry will help inform the larger medical community on how best to treat cardiogenic shock. The American Heart Association will use its Precision Medicine Platform, a secure cloud-computing platform, to facilitate the research. Powered by Amazon Web Services, the Precision Medicine Platform provides streamlined data access and cloud-based workspaces, removing traditional barriers researchers often face when approaching challenging scientific questions. Press release. 

Cleveland Clinic and IBM have begun deployment of the first private sector onsite IBM-managed quantum computer in the United States. Anticipated to be completed in early 2023, the first quantum computer in healthcare was built to fundamentally advance the pace of biomedical research through high-performance computing. Additionally, both companies have launched the Cleveland Clinic-IBM Discovery Accelerator, where teams have already begun several collaborative projects. These projects include a research study developing a quantum computing method to screen and optimize drugs targeted to specific proteins; improving a prediction model for cardiovascular risk following non-cardiac surgery; and using artificial intelligence to search genome sequencing findings and large drug-target databases to find effective, existing drugs that could help patients with Alzheimer’s and other diseases. Press release. 

Veeva Systems announced the availability of Veeva ePRO. The application makes it easier for patients to complete assessments on a mobile device or web browser and enables real-time data access for sponsors and clinical research sites. Veeva ePRO improves the patient experience by providing a modern, user-friendly application for completing patient-reported outcomes (PRO). Sponsors can configure studies using survey and instrument libraries and push ePRO and schedule definitions to research sites. Research sites can then easily assign activities, automatically receive updates, and track patient progress without needing other systems or applications. Press release. 

Veeva Systems announced the availability of Veeva CDB, a first-of-its-kind solution for aggregating, cleaning, and transforming clinical data. With Veeva CDB, sponsors and data providers can view and resolve data queries centrally to minimize quality risks, provide better data visibility, and speed trial execution. Veeva CDB’s automated ingestion engine combines data from various external sources, including EDC, RTSM, ePRO, eCOA, and lab data. In addition, for the first time, the Veeva CDB Data Provider Program will provide qualified data providers with tools, training, and support to supply data using a standardized and streamlined method for Veeva CDB customers. Press release. 

Phesi launched its AI-driven Trial Accelerator platform to facilitate real-time scenario modeling across patient, endpoint, country, key opinion leader, and investigator site allocation. Underpinned by the world's largest, most dynamic clinical trial database, the SaaS platform enables clinical development personnel to optimize study design and simulate trial outcomes. The Trial Accelerator leverages clinical study data, including control arm data, to accelerate product development and commercialization. The platform powers clinical development decision-making by connecting the design to execution and allowing study teams to design smarter trials to develop faster cures. Phesi partners will also benefit from access to real-world data by being able to create digital patient profiles, digital twins, and digital control arms, including external control arms. Press release. 

Critical Path Institute’s Transplant Therapeutics Consortium received a draft qualification opinion for the iBox Scoring System as a novel secondary efficacy endpoint for kidney transplant trials. This was achieved through the European Medicines Agency’s qualification of novel methodologies for drug development. The iBox Scoring System is a composite biomarker that uses multiple clinically relevant patient features to fully reflect the heterogeneity of graft failure, including measures of renal function and immunologic response to the graft, with or without direct assessment of allograft health through histopathology. Press release. 

Veeva Systems announced two new Veeva Link applications to help clinical teams improve site selection and optimize trial design: Link SiteBase and Link TrialBase. Link SiteBase identifies, filters, and ranks research sites. Link TrialBase delivers clinical trial intelligence, including current status, inclusion criteria, protocol design, and endpoints. These applications are created by a modern data platform that combines intelligent software automation with human curation to ensure accuracy and depth. This combination allows Veeva Link to deliver real-time intelligence across many areas, including sales, marketing, market access, medical, and clinical. Press release. 

Cambridge Cognition agreed to acquire eClinicalHealth (eCH). Catalyzed by the pandemic, the overall virtual clinical trials market has grown rapidly and is now valued at $7.8 billion, with a projected growth of 14% per annum. By integrating eCH’s patient-centric Clinpal platform, Cambridge Cognition will be able to offer clients a fully integrated solution covering all trial modules—from recruitment to clinical reporting. The eCH acquisition now enables Cambridge Cognition to complete its offering with a patient-centric platform that connects patients, sites, and pharmaceutical companies to coordinate and manage all the essential steps in a virtual clinical trial. Press release. 

Experts on an international panel convened by the DAIDS Cross-Network TB Vaccine Working Group—comprised of the HIV Vaccine Trials Network, the AIDS Clinical Trials Group, and the International Maternal Pediatric Adolescent AIDS Clinical Trials Network—have mandated that people living with HIV must be included in clinical trials for new tuberculosis vaccine candidates currently in the development pipeline. Their recommendations, which appear in a recent paper in The Lancet HIV (DOI: 10.1016/S2352-3018(22)00255-7), are designed to shape the future of TB vaccine development and help ensure people living with HIV have access to safe and effective TB vaccines like those for the general population. The three networks worked collaboratively with the National Institutes of Health, the National Institute of Allergy and Infectious Diseases, and its Division of AIDS. Press release. 

Ultrahuman announced the creation of a medical and sports science advisory board which globally renowned medical and med-tech experts will lead. The company is launching clinical trials of its continuous glucose monitoring (CGM) health platform with non-diabetics and pre-diabetics. The clinical trials have been designed in-house with leading global metabolic health experts. This study's metabolic biomarker data will correlate to various CGM parameters. These correlations will be used to construct a scoring system using CGM data to indicate an individual's metabolic health. Press release. 

Phesi has published its latest update on the significant impact of the war in Ukraine on clinical development in the region. From January until October 1, 2022, the number of recruiting sites fell from 1,814 to 940 (48%) in Ukraine. In Russia, recruiting sites fell from 3,412 to 1,638 (52%) and from 84 to 33 (55%) in Belarus. Neighboring Poland has increased from 3,473 to 3,829 (10%), indicating that Poland can fill some of the gaps caused by the war. More than a quarter (26%) of all trials in schizophrenia takes place in Ukraine and Russia, as well as a high proportion of gastrointestinal disease studies. Ethical issues are associated with suddenly discontinuing treatment and wider medicine availability during a crisis. Real-time predictive analytics solutions can help sponsors optimize site, country, and investigator selection to minimize the negative impact of events on cost and cycle time. Press release. 

A clinical trial coordinated by researchers from the Universitat Oberta de Catalunya, University of Barcelona (UB) Psychology Department, and UB Institute of Neurosciences will examine new tools to improve the psychological treatment of young people with depression. The study will examine the usefulness of personal construct therapy in people between 18 and 29 years old with mild or moderate symptoms of depression. It will also explore whether it is more effective when implemented with a new and pioneering virtual reality application. The app, called EYME, uses an initial interview to transform the meanings and important people in the individual's identity into a 3D space in the form of spheres and words. Volunteers can sign up at the project website. Press release. 

Critical Path Institute announced that it has recently launched a pre-consortium collaboration with the U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research and Center for Drug Evaluation and Research, focused on accelerating medical product development in alpha-1 antitrypsin deficiency (AATD). The pre-consortium, Critical Path for alpha-1 antitrypsin deficiency, will work in partnership with AATD stakeholders to define tangible unmet needs in drug development and lay the groundwork for specific solutions to these needs, to be generated through the envisioned full consortium. Improving the quantitative understanding of actionable biomarkers and clinically meaningful endpoints will accelerate medical product development for this condition. Press release. 

Amphista Therapeutics has selected Domainex as a trusted partner to provide integrated drug discovery services to support its research programs. Domainex will provide protein production, assay biology, and medicinal chemistry expertise. Domainex has experience in targeted protein degradation with knowledge in designing, synthesizing, and profiling targeted heterobifunctional protein degraders. Domainex has established in vitro binary and ternary complex formation assays to confirm target engagement using its suite of biophysical technologies. This expertise makes Domainex an ideal partner to support Amphista’s targeted protein degradation programs. Press release. 

Massive Bio announced a strategic partnership with Perthera.ai to empower more cancer patients to find an appropriate clinical trial. Perthera.ai’s patented ranked therapy recommendations complement Massive Bio’s screening and analysis. Less than three percent of cancer patients today are matched and enrolled in a clinical trial. By combining both companies' advanced computational methods and artificial intelligence capabilities, more physicians and patients can confidently access the benefits of investigational precision oncology treatments from FDA-approved and novel therapies specific to patients’ unique molecular and genetic biomarkers. Perthera.ai combines multi-omics testing results to simplify the decision-making process to increase the chance that the best treatment is used the first time. Press release. 

The European Organisation for Research and Treatment of Cancer (EORTC) and Walgreens Boots Alliance announced the next phase of their partnership in support of the organization’s E²-RADIatE platform, the only radiation oncology platform in Europe. The E²-RADIatE platform—a joint scientific collaboration between the EORTC and the European Society of Radiation Oncology—and downstream clinical research projects aim to make it easier to document new clinical indications treated with radiotherapy appropriately and to monitor the impact of new radiation treatments, techniques, and technologies, while new standards of care are developing in parallel. Press release. 

The Antibacterial Resistance Leadership Group, funded by the National Institute of Allergy and Infectious Diseases, will enroll up to 72 adults at 16 cystic fibrosis (CF) centers across the United States in an early-stage clinical trial evaluating bacteriophage therapy in adults with CF who carry Pseudomonas aeruginosa in their lungs. The study estimates whether the bacteriophage or “phage” therapy is safe and can reduce the number of bacteria in the lungs. Researchers have considered the potential use of phages as therapeutics, theorizing that mixtures of bacteriophages might be used on their own or in conjunction with antibiotics to treat bacterial infections—especially those resistant to antibiotics. Press release. 

Curavit Clinical Research announced that it is partnering with 1nHealth to speed up patient recruitment digitally for decentralized clinical trials (DCTs). 1nHealth integrates with Curavit’s DCT platform, speeding trial enrollment and improving retention. Curavit and 1nHealth’s first collaboration is for Lark Health’s trial of an investigational digital therapeutic for chronic cardiovascular disease. The smartphone-based program uses conversational AI, connected devices, and remote patient monitoring to activate and engage patients by addressing CVD risk factors such as diet, exercise, and tobacco use. Together, Curavit and 1nHealth are working to overcome recruitment challenges and help usher in the next generation of decentralized clinical trials. Press release. 

iSpecimen launched its new Marketplace Onsite program that embeds a coordinator at select partner sites to facilitate fulfillment of incoming sample and data requests from the proprietary iSpecimen Marketplace platform. With this extra support layer, iSpecimen and its partners can expand and streamline access to biospecimens for research. The Marketplace Onsite coordinator will field all requests and submit proposals on behalf of the provider, streamlining sample-related management and reducing strain on existing staff and product pipelines. It will also help with building and contracting with a network of researchers, providing remuneration for biospecimens and data, offering IT assistance for data management needs, and covering the expenses of the iSpecimen Onsite employee. Press release. 

SEQSTER PDM and PatientsLikeMe have collaborated to launch one of the first rare-disease studies focused on Alpha-1 Antitrypsin Deficiency (AATD). The study aims to better understand how to reduce diagnosis delays, decrease disparities in care, and improve outcomes in patients with AATD through enhanced digital real-time data, peer support, and real-world evidence. Participants living with AATD can now consent, share, and engage with all their data in one place, leading to a seamless longitudinal patient journey. Press release. 

Celltrion USA announced that the U.S. Food and Drug Administration approved Vegzelma (bevacizumab-adcd), a biosimilar to Avastin (bevacizumab), for the treatment of six types of cancer: metastatic colorectal cancer; recurrent or metastatic non-squamous non-small cell lung cancer; recurrent glioblastoma; metastatic renal cell carcinoma; persistent, recurrent, or metastatic cervical cancer; and epithelial ovarian, fallopian tube, or primary peritoneal cancer. Results showed that as a first-line treatment, Vegzelma is highly similar to the reference product in terms of efficacy, safety, and pharmacokinetics. Vegzelma is Celltrion’s third oncology biosimilar approved for use in the U.S. It was approved in the EU in August 2022 and UK and Japan in September 2022. Press release. 

Gladstone Institutes has partnered with the Parker Institute for Cancer Immunotherapy (PICI) to establish a new research center focused on using genomics and CRISPR technology to program the human immune system to treat cancer. Through the partnership, Gladstone scientists will collaborate with other preeminent research centers in the PICI Network to explore how genome editing could accelerate fundamental insights into how immune cells are “wired,” potentially leading to a new generation of cell-based cancer immunotherapies. PICI also facilitates access to advanced bioinformatics, intellectual property, sequencing, immune monitoring, industry-owned drugs, cell manufacturing, genetic engineering, and clinical trial management. Press release. 

The National Human Genome Research Institute (NHGRI), part of the National Institutes of Health, launched The Democratizing Education for Sickle Cell Disease Gene Therapy Project. NHGRI researchers developed materials for individuals living with sickle cell disease to learn about the gene therapy clinical trial process, its benefits and risks, mental health considerations, and the science behind different treatment options. The project seeks to help the sickle cell disease community understand new therapies and facilitate engagement between this community and those conducting relevant clinical trials. Researchers are looking for ways to cure sickle cell disease at the DNA level by altering the genes that play a role in sickle cell disease. Press release.