By Clinical Research News Staff 

October 26, 2023 | Mayo Clinic and Oxford Nanopore Technologies unveils a multi-year joint development collaboration to develop new clinical tests for diseases and improve patient care; Walgreens and the Cardiovascular Research Foundation (CRF) announces a collaboration to drive forward the PREVUE-VALVE study, a population-based clinical trial to quantify the prevalence of valvular heart disease (VHD) among older Americans; Qnovia enters a drug development collaboration with the University of Virginia (UVA) to advance novel inhaled-drug candidates for treating bacterial infections in the lungs; and more. 

Mayo Clinic and Oxford Nanopore Technologies unveiled a multi-year joint development collaboration to develop new clinical tests for diseases and improve patient care. Mayo Clinic and Oxford Nanopore have identified several areas of development, spanning a wide breadth of applications from translational research in human genetics to detection of genetic predisposition to cancer. Press release. 

Walgreens and the Cardiovascular Research Foundation (CRF) announced a collaboration to drive forward the PREVUE-VALVE study, a groundbreaking population-based clinical trial that aims to quantify the prevalence of valvular heart disease (VHD) among older Americans and pave the way for the development of new therapies and tools for VHD detection and diagnosis. Press release. 

PicnicHealth has acquired AllStripes, a platform dedicated to generating evidence about the rare disease community. This strategic consolidation establishes PicnicHealth as the leading patient-centric evidence generation partner within a rapidly evolving life sciences landscape. PicnicHealth engages directly with patients to collect and curate comprehensive clinical data and patient-reported outcomes (PROs) to generate rich insights across patient healthcare journeys. Historically, generating such evidence has required the establishment of a network of clinical sites, which are expensive to operate, burdensome to patients and sites, and often lead to delays. PicnicHealth and AllStripes pioneered a new model by working directly with patients, which enables a deeper view of each patient's health and experience while reducing the challenges of traditional site-based studies. Press release. 

Aspen Neuroscience announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for ANPD001 for the treatment of Parkinson's disease (PD) to improve motor function. ANPD001, is a personalized (autologous) cell therapy under investigation to treat PD by replacing lost dopamine neurons. The purpose of Fast Track Designation is to get important new drugs to patients earlier. FDA grants Fast Track Designation (FTD) to facilitate development, and to expedite the review of medicines to treat serious conditions and fill an unmet medical need. Benefits of FTD include early and frequent interactions with FDA during the clinical development process, as well as eligibility for accelerated approval and priority review. Press release. 

Qnovia has entered a drug development collaboration with the University of Virginia (UVA) to advance novel inhaled-drug candidates for treating bacterial infections in the lungs. Qnovia will work with UVA School of Medicine investigators Dr. Molly Hughes and Dr. Matthew Crawford to combine Qnovia’s RespiRx inhaled drug delivery platform and UVA’s proprietary portfolio of antimicrobial peptides to kill antibiotic-resistant and biodefense bacteria that can cause life-threatening infections. As a result of this agreement, Qnovia will add two new assets to its development pipeline: QN-05 for the treatment of pneumonia and QN-06 for the treatment of pulmonary infection for individuals exposed to the biodefense agent B. anthracis, the causative agent of anthrax. Press release. 

JPA Health has acquired True North Solutions, a consulting firm based in Cambridge, Mass. True North specializes in commercial, clinical, and medical affairs, with expertise in digital acceleration and customized predictive analytics, as well as solutions powered by AI and natural language processing. This acquisition, the first for JPA Health, will further expand JPA's strategic offerings providing end-to-end integrated medical affairs, clinical development, commercial strategy, creative marketing, public relations, and patient advocacy solutions to clients. Press release. 

C2i Genomics and Gustave Roussy announced a new collaborative trial, 'The UMBRELLA Trial,' aimed at establishing the clinical utility of circulating tumor DNA (ctDNA) based molecular residual disease (MRD) testing in guiding immunotherapy escalation in the post-definitive care setting across early-stage solid tumors. The collaboration brings together the expertise and resources of each organization to perform a randomized multicenter clinical trial across multiple hospitals in France. Gustave Roussy will act as a central clinical partner in France throughout the research process. Press release. 

Saama announced a multi-year agreement with global biopharmaceutical leader AstraZeneca. The agreement is designed to streamline and facilitate AstraZeneca’s clinical data management and medical review processes using Saama’s AI-enabled technology platform and aims to set a new industry standard for accelerating clinical development. Press release. 

Integrated DNA Technologies (IDT) announced the completion of its new Therapeutic Oligonucleotide Manufacturing facility in Coralville, Iowa. The milestone marks a significant achievement in the company’s 35-year-history—its entrance into the therapeutics space—and enables IDT to manufacture products for research use through to current good manufacturing practice (cGMP) grade cell and gene therapy reagents to provide researchers with a single partner that can help them rapidly transition from the lab to therapeutic development. Press release. 

M42 has unveiled an advancement in healthcare technology with the launch of Med42, a new open-access Clinical Large Language Model (LLM). The 70 billion parameter, generative AI model is poised to transform the future of AI across the healthcare sector and create a direct impact on patient care outcomes. Med42 has the potential to revolutionize the pace of clinical decision-making, acting as an AI assistant for healthcare professionals. The capability of the model extends to developing personalized treatment plans by analyzing a patient's medical history to identify the best course of treatment. Press release. 

Elsevier has launched the new PharmaPendium, sharpening the translational view of a platform that combines extensive preclinical and clinical data, including complete Food and Drug Administration (FDA) and European Medicines Agency (EMA) approval packages, with predictive tools to accelerate drug development. PharmaPendium enables companies to make faster, more informed decisions about what drug candidates to advance. Pharma professionals and researchers can use the tool to benchmark against competitors, prioritize safety and efficacy, and develop effective strategies for regulatory submissions. Press release. 

H1 announced the launch of GenosAI, a new generative AI tool seamlessly embedded into its clinical trial intelligence platform, Trial Landscape, to analyze and respond to all types of complex inquiries. Trial Landscape allows sponsors to identify new sites, centers of excellence, and investigators with diverse patients; evaluate site and PI patient recruitment strategies; and gauge competition across trials. GenosAI is a significant leap forward in enhancing efficiency, diversity, and innovation in the pharmaceutical industry. It improves clinical research in the following ways: competitive intelligence and trial design, site selection and feasibility, diversity and inclusion, clinical trial design, and unlocking internal clinical trial data silos. Press release. 

Emmes has acquired VaxTRIALS. Headquartered in Panama City, Panama, VaxTRIALS' 160+ staff members manage and monitor vaccine clinical trial activities throughout Latin America. VaxTRIALS' vaccine-related clinical trials have been conducted in 11 Latin American countries, as well as the Philippines. VaxTRIALS' staff members have supported clinical trials aimed at preventing diseases, such as influenza, dengue, chikungunya, hepatitis A, meningitis, norovirus, herpes zoster, pertussis, respiratory syncytial virus (RSV), polio, and COVID-19. Press release. 

Advarra announced new technology functionality designed to improve all stakeholders' clinical trial experiences. Longboat, an established platform used in more than 70 countries and by nearly 20,000 sites, now features an online patient portal with a comprehensive set of engagement tools, including a simple document exchange that enables transparent collaboration between patients, sites, and sponsors or clinical research organizations (CROs) without adding technology burden. The new Advarra Longboat patient portal provides key features that align the patient, site, and sponsor. Notable advancements include: sites being able to share important documents such as signed informed consent forms and lab results with patients; patients are able access all important documents and communications, as well as educational videos, study information, key study contacts, and quick links to other study tools in one easy-to-use portal; and sites are notified via email with information attached when the sponsor or CRO provides study newsletters and other information directly to the patient, allowing them to stay in the loop on communications. Press release. 

Sengenics Corporation has launched i-Ome Discovery, a comprehensive protein microarray platform for the analysis of autoantibodies associated with disease diagnosis and therapeutic intervention. The i-Ome Discovery platform was developed to support academic and clinical biopharmaceutical research teams who are seeking to better understand the dynamic interactions and relationships between proteins, the immune system, and disease. i-Ome Discovery leverages Sengenics’ patented KREX technology, which presents full-length autoantigen proteins that are properly folded and fully functional, allowing for highly sensitive, specific, and reproducible autoantibody detection. I-Ome Discovery provides over 1,800 autoantigens that were selected for their biological relevance to several diseases, including cancer, autoimmune, and neurodegenerative disorders. Press release. 

Quris-AI has extended its collaboration with Merck KGaA, Darmstadt, Germany, a leading science and technology company. This follows the successful initial collaboration, a preclinical study to assess Quris-AI’s ability to predict drug toxicity in comparison to traditional in vitro and in vivo approaches. Merck KGaA, Darmstadt, Germany will now further leverage Quris-AI platform’s ability to effectively identify liver toxicity risks in a selection of drug candidates. Press release. 

DNAnexus announced that the UK Biobank Research Analysis Platform (UKB-RAP) community has grown to more than 5,000 users around the world. The UKB-RAP was designed to allow researchers to access and analyze the exponentially increasing scale of the UK Biobank (UKB) dataset, which now contains more than 28 petabytes (PB) of biomedical data, making it the world’s largest and most comprehensive resource for researchers looking to advance the understanding of human disease. Press release. 

Viz.ai announced the expansion into outpatient ambulatory centers to accelerate clinical trial recruitment. Amavita Heart and Vascular Health, with facilities spanning four locations in Miami-Dade County, has taken a pioneering step by integrating Viz.ai technology into their outpatient ambulatory centers to screen and recruit patients in a clinical study on heart failure, sponsored by a leading, global biopharma company. Viz.ai’s expansion into outpatient clinics allows both ambulatory and hospital-based research sites to access the artificial intelligence (AI)-powered platform, Viz RECRUIT, to aid with patient identification and patient recruitment for clinical research. Press release. 

Omixon Biocomputing launched NanoTYPE MONO and MONO all - RUO, a single locus human leukocyte antigen (HLA) amplification kit compatible with Oxford Nanopore's MinION platform. NanoTYPE MONO is designed to empower clinical laboratories by offering the ability to retype, confirm, and analyze single HLA genes with exceptional precision using high-resolution typing. This technology is set to help clinical laboratories in the field of genetic marker assessment, providing an unprecedented level of accuracy at a competitive pricing structure. Press release.