May 26, 2022 | NIAID awards $577 million to establish nine Antiviral Drug Discovery Centers; Allelica and Invitae build clinical artificial intelligence architecture for breast cancer; a new COVID-19 antibody test is used in vital pandemic research; next-generation gene and cell therapy research promote more efficient clinical trials; and more. 

The HIV Vaccine Trials Network, funded by the National Institute of Allergy and Infectious Diseases, a part of the National Institutes of Health (NIH), launched a new human immunodeficiency virus (HIV) awareness campaign and the Red Ribbon Registry to help end HIV. Built by Oracle, the unique cloud-based registry makes it easy for anyone to be considered for an HIV clinical study. The registry expands on Oracle’s work with the NIH and Fred Hutchinson Cancer Center throughout the COVID-19 pandemic. In addition, Oracle developed the COVID-19 Prevention Network Volunteer Screening Registry to capture and analyze nearly 700,000 participant registrations for COVID-19 vaccine and therapeutics clinical studies in just six months. Press release. 

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has awarded approximately $577 million to establish nine Antiviral Drug Discovery (AViDD) Centers for Pathogens of Pandemic Concern. The awards are a part of the Antiviral Program for Pandemics, an intensive research program designed to speed the development of therapeutics for COVID-19. The AViDD award recipients are The Center for Antiviral Medicines & Pandemic Preparedness (Scripps Research Institute), UTMB-Novartis Alliance for Pandemic Preparedness (The University of Texas Medical Branch), Rapidly Emerging Antiviral Drug Development Initiative—AViDD Center (The University of North Carolina at Chapel Hill), Development of Outpatient Antiviral Cocktails against SARS-CoV-2 and other Potential Pandemic RNA Viruses (Stanford University School of Medicine), Antiviral Countermeasures Development Center (Emory University and Georgia State University), Metropolitan AntiViral Drug Accelerator (Hackensack University Medical Center), QBI Coronavirus Research Group Pandemic Response Program (University of California, San Francisco), Midwest AViDD Center (University of Minnesota, Minneapolis), and AI-Driven Structure-Enabled Antiviral Platform (Drugs for Neglected Diseases Initiative, PostEra, and Sloan Kettering Institute and Memorial Sloan Kettering Cancer Center). Press release. 

Curebase, a company committed to democratizing access to clinical studies, and Flow Neuroscience, the creator of Europe’s only medically approved transcranial direct current stimulation device and behavioral therapy app for depression, is launching a clinical trial in which participants will test the effectiveness of Flow’s at-home headset in reducing depressive symptoms. Providing a non-pharmaceutical alternative, the Flow headset works by delivering gentle electrical currents to the dorsolateral prefrontal cortex to restore activity usually lowered in those with depression. Press release. 

Proscia, a digital and computational pathology solutions company, introduced an automated quality control application that leverages artificial intelligence (AI) to improve quality and efficiency in data-driven drug development. The company has also released an updated version of its Concentriq for Research platform to unify global pathology operations further and centralize data across the connected enterprise. Automated quality control leverages AI that has been trained and tested on thousands of samples to identify commonly occurring quality issues in every image of H&E stained slides. Reducing the need to review these images manually drives significant productivity and quality gains that may enable research teams to start studies faster, increase the reproducibility of results, and reduce technician burnout. Press release. 

NetScientific, the international life sciences, sustainability technology investment, and commercialization group, announces that its wholly-owned subsidiary ProAxsis has completed the development and validation of the AstraZeneca COVID-19 antibody test. The independent performance evaluation study by Prof. Tara Moore of Ulster University analyzed over 1,100 clinical serology samples. The assay detected IgG antibodies in blood samples from previously infected and vaccinated individuals and detected IgG from those infected by the different SARS-CoV-2 variants—Alpha, Delta, and Omicron. This test’s accuracy and ability to detect multiple assay variants make it a valuable tool for vital research, supporting ongoing and future pandemic response strategies and the individual. Press release. 

GenScript USA, a life-science research tools and services provider, announced the availability of new GMP-grade GenExact single-stranded DNA and GenWand closed-end linear double-stranded DNA services. These services will enable next-generation gene and cell therapy research and development programs to advance to investigational new drug filing and clinical trials faster and more efficiently. In addition, non-viral homology-directed repair templates, in combination with CRISPR technology, can accelerate cell engineering compared to traditional GMP virus-based engineering, delivering results faster than alternate techniques. Press release. 

VIDA Diagnostics, a lung and respiratory intelligence data company, is introducing a new suite of retrospective data analysis services for clinical trial sponsors in response to the growing demand for precision data to optimize lung treatment trials. This suite of services empowers sponsors to leverage VIDA’s unique AI-enabled biomarker generation services and decades of validated techniques with previously generated imaging cohorts. In addition, VIDA’s retrospective data analysis services uncover new insights about therapeutic mechanisms of action and the characteristics of a responder population. Press release. 

Paradigm4 unveiled REVEAL: Proteomics, the newest use case-specific app powered by the Paradigm4 FLASH high-performance bioinformatics platform. Proteomics unlocks the power of advanced mass spec proteomics by simplifying cross-sample and cross-study searching for protein isoforms as potential biomarkers for drug response and disease progression. The new application aims to streamline disease research by integrating protein-gene mappings between HUGO and ENSEMBL, enabling analysis in an ad hoc manner without connecting to external websites. Press release. 

The U.S. National Institutes of Health licensed 11 COVID-19 research tools and early-stage vaccine and diagnostic candidates to the Medicines Patent Pool (MPP) through the World Health Organization’s COVID-19 Technology Access Pool (C-TAP). The licenses will allow manufacturers worldwide to work with MPP and C-TAP to use these technologies for the potential development of COVID-19 vaccines, treatments, and diagnostics to benefit people living in low- and middle-income countries. Included in the technologies licensed is the SARS-CoV-2 stabilized spike protein—a patented invention included in multiple COVID-19 vaccines. Press release. 

Suvoda, a global clinical trial technology company specializing in complex studies in therapeutic areas such as oncology, central nervous system, and rare diseases, announced they agreed to partner with N-SIDE. This deep tech company empowers organizations in the clinical trials industry to make better decisions and optimize the use of critical resources. Suvoda’s IRT enables the implementation of optimized resupply strategies with adapted IRT algorithms that seamlessly integrate N-SIDE’s forecasting and mathematical optimization recommendations. This integration results in significant cost savings through reduced drug wastage and accelerated trial timelines. Press release. 

SCIEX, a global life science analytical technologies company, launched the RNA 9000 Purity & Integrity kit for the BioPhase 8800 and PA 800 Plus systems. This kit is a purpose-built, high-resolution analysis method for mRNA therapeutics. It was specifically designed to provide higher resolution for mRNA therapeutics from 50 to 9,000 bases. As a result, scientists could minimize time to market with exceptional reproducibility and detect low-level impurities in samples. Press release. 

ArisGlobal has acquired Boehringer Ingelheim’s Benefit-Risk Analytic System. The engine will operate under the name of LifeSphere Clarity. It will play a key role in driving industry-wide pharmacovigilance and patient safety advancement. LifeSphere Clarity is a digital engine that leverages automation and artificial intelligence to consolidate patient safety data, reveals possible reasons why things happened, and allows modeling the potential impact of different influences. Press release. 

Ochre Bio, a biotech company developing RNA medicines for chronic liver diseases, announced the launch of their ‘Liver ICU.’ Housed in BioLabs@NYULangone, a biopharma incubator in New York City, this research site will evaluate the efficacy of new RNA therapeutics on whole human livers maintained on machines. The use of discarded donor livers for research is expected to enhance the timelines and accuracy of liver medicine research by testing interventions directly in human livers maintained under conditions mimicking human physiology. Ochre Bio is also announcing a partnership with OrganOx, a donor liver preservation company and one of the first to have a liver perfusion device approved by the Food and Drug Administration. Press release. 

Strata Oncology, a precision oncology company, announced the enrollment of the first patient in the Strata Precision Indications for Approved THerapies (Strata PATH) trial, a prospective pan-tumor therapeutic trial designed to evaluate the efficacy and safety of multiple FDA-approved cancer therapies in new, biomarker-guided patient populations. The database includes both DNA mutation profiles and quantitative RNA expression data from tens of thousands of patients coupled with detailed treatment history and outcomes data. Strata PATH will enroll patients with advanced and early-stage cancer who have evidence of micrometastatic disease after initial treatment. Press release. 

ObvioHealth, a global Virtual Research Organization for end-to-end decentralized clinical trial solutions, announces the development of two digital instruments to increase accuracy and reduce patient/caregiver burden in pediatric clinical trials. The pediatric GI instrument uses AI to guide caregivers through capturing high-quality, privacy-compliant photos of infant stools. The pediatric cry capture instrument enables effortless recording of crying episodes, collecting data such as duration, type, and crying sounds. Both tools include sending the captured data—whether image or audio—to the expert rater platform for scoring, streamlining the workflow for raters, and alerting them to variability in their scores. Press release. 

Arcadia, a data analytics platform for healthcare and life sciences, and Datavant, a company that helps organizations securely connect health data, announced a partnership to enable de-identified connectivity of Arcadia’s electronic health record data for life sciences research and commercial analytics. Using Datavant, life sciences and research organizations will be able to leverage Arcadia’s data for health economics and outcomes research, medical affairs, and commercial analyses. Press release. 

AliveCor announced the launch of KardiaComplete, a comprehensive heart health enterprise solution designed to drive improved health outcomes and reduce the cost of cardiac care. The service will be available to people diagnosed with hypertension and arrhythmias, like atrial fibrillation, through their self-insured employers, health insurance plans, and health systems. KardiaComplete also addresses the urgent need to democratize heart care as the United States faces a significant cardiologist shortage. By leveraging data from AliveCor’s KardiaMobile 6L and Omron’s Evolv, KardiaComplete meets people’s need for coaching and care in the moments that matter. Press Release. 

Allelica formalized a partnership with Invitae Corporation, a medical genetics company, to build a clinical artificial intelligence architecture for breast cancer polygenic risk score (PRS) development and clinical implementation in multiple ancestries. The partnership will accelerate clinical applications of PRS for individuals of diverse ancestries by combining Invitae's wealth of high-quality genomics data with Allelica's innovative genomics analytics and predictive software tools. With this collaboration, Allelica and Invitae aim to decrease the gap in PRS performance in individuals from diverse genetic ancestries, ensuring that the lifesaving integration of genomic information into breast cancer risk assessments can benefit all women. Press release. 

Scribe Therapeutics, a molecular engineering company for CRISPR-based genetic medicine, announced that Biogen exercised an option for an additional disease target in gene therapy as part of the company’s ongoing research collaboration to develop and commercialize CRISPR-based medicines. This collaboration further validates Scribe’s position as a leading organization driving the development of novel CRISPR-based therapeutics that treat the underlying cause of disease. Press release. 

eClinical Solutions, a digital clinical software company, launched and demonstrated the elluminate Statistical Computing Environment (SCE). SCE is a validated environment for statistical analysis and reporting. Integrated with the elluminate Clinical Data Cloud, the SCE provides one centralized place for all data, metadata, programs, and results, increasing statistical analyses' efficiency, traceability, and visibility. With elluminate SCE, programmers and statisticians can develop and maintain programs and scripts from popular programming languages and execute those programs against data within the platform. Press release.