ArisGlobal’s FDA Rollout, Science 37 in China, Russia, More

December 22, 2021 | ArisGlobal announces FDA go-live for adverse event reporting, Metabolon plans collaborations with Boston hospitals for lactation research, THREAD names Amazon-alum to Chief Product Officer role, and Science 37 expands to China and Russia. Plus new products from Certara, Leica Microsystems, and more.

 

BioLife Solutions has announced a partnership with UNICEF to extend thermal stability of temperature-sensitive COVID-19 vaccines in developing communities in Africa, the Middle East and South America where limited power infrastructure and extreme environmental conditions make it difficult for most ULT freezers to remain operational. As part of this program, UNICEF has approved Stirling's upright SU780XLE freezers and first-of-its-kind, portable UL25NEU freezer models for country specific selection. Press release.

SureClinical has launched their new Eclinical Ecosystem ECO Applications and Platform Bundle. Designed for the unique needs of Clinical Research Organizations, the ECO Bundle connects people, programs, projects and processes everywhere for a singular view of clinical data. The ECO Bundle centralizes clinical intelligence and reporting across multiple applications, data points and systems, allowing distributed clinical research teams to collaborate within a single, modern, easy to use application experience. Press release.

Ichor Life Sciences, a premium preclinical contract research organization offering services in discovery through pharmacology, has formally completed the acquisition of Woodland Biosciences, Inc. The in vivo services for the study of metabolic diseases and oncology provided by the former Woodland Biosciences are now available through Ichor’s Pharmacology division. A preclinical contract research organization, Woodland Biosciences was previously located on the campus of Tufts Veterinary Medicine School. Woodland’s R&D facilities have fully relocated from Tufts University to Ichor’s facilities in LaFayette, New York. Dr. Michael Briggs, the President and CSO of Woodland Biosciences, continues as part of Ichor’s scientific leadership in pharmacology. Dr. Briggs has deep expertise and experience in pharmacology and has worked on several preclinical and clinical programs in hepatitis, liver fibrosis and oncology, among others. Ichor Life Sciences’ clients and partners will continue to benefit from Dr. Briggs’ involvement in study designs and insights that can progress their preclinical programs. Press release.   

The U.S. Food and Drug Administration (FDA) has renewed and expanded its licenses of Certara’s proprietary biosimulation software, with more than 400 user licenses of Simcyp and Phoenix software. In total, there are 12 divisions and offices of the FDA using Certara’s software for internal research and to independently analyze, verify and review regulatory submissions. Certara’s Simcyp Simulator, an industry-leading platform for physiologically-based pharmacokinetic (PBPK) modeling and simulation, is used throughout the drug development process to evaluate new drug formulations, determine first-in-human dosing, optimize clinical study design and predict drug-drug interactions. The FDA has renewed its licenses for the Simcyp Simulator, Simcyp Paediatric and Simcyp Cardiac Safety Simulator, which the agency uses to independently analyze, verify and review investigational therapies, new drug applications and generic drug applications. Press Release.

Metabolon will collaborate with Brigham and Women’s Hospital and Beth Israel Deaconess Medical Center (BIDMC) in a first-of-its-kind Lactation Lab, providing comprehensive metabolomic profiles to enhance understanding of the biology underlying lactation to identify solutions to improve maternal and infant health. The value of this work is two-fold. In the short-term, the findings will generate fundamental knowledge required for the discovery of interventions to improve maternal and infant health outcomes. In the long-term, the development of the Lactation Lab will provide a model for discovery in the field of lactation science, bringing much-needed scientific rigor to investigations during this critical period that influences the lifelong health of two generations. Press release.

ArisGlobal has announced the go-live of the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS II), an electronic safety reporting platform, powered by ArisGlobal’s LifeSphere MultiVigilance. The successful go-live marks a key milestone in the FDA's Technology Modernization Action Plan, and the culmination of its efforts to adopt a cutting-edge platform to automate the intake and processing of adverse event reports. Designated a modernization priority by the United States Department of Health and Human Services, FAERS II is a mission critical platform for the FDA's Centers of Drug and Biologic Evaluation and Research (CDER/CBER), providing a modern, all-in-one solution for collection, triage and processing of adverse event reports. With safety case volumes growing amid a global public health crisis, the platform will leverage the flagship safety product of ArisGlobal's LifeSphere R&D technology suite, LifeSphere MultiVigilance, to increase efficiency and improve data quality. A proven and scalable solution already adopted by many of the largest global biopharmaceutical companies, LifeSphere MultiVigilance is the only safety system in production that uses AI and machine learning to automate the end-to-end processing of adverse event reports in the industry for market authorization holders. Press release.

Brain signal recording with the Wyss Center for Bio and Neuroengineering’s subscalp Epios sensing electrodes (leads) is being carried out for the first time in patients at the University Hospital Bern, Inselspital. The clinical trial is the first step towards the validation of Epios, a minimally invasive, long-term brain monitoring system intended for people with drug resistant epilepsy. The trial will assess the feasibility, safety and recording ability of the electrodes and will test the tools developed to insert the leads based on required locations and patient specific anatomy. Press release.

Certara has released Pinnacle 21 Enterprise 5.1.0, which updates the Company’s flagship software for preparing clinical trial data for biosimulation and regulatory submission. Pinnacle 21 Enterprise validates data quality and compliance with Clinical Data Interchange Standards Consortium (CDISC) standards, enabling a clean data pipeline from worldwide sponsors to health authorities. Pinnacle 21 Enterprise 5.1.0 includes new and advanced capabilities, such as: support for recently released Define-XML 2.1 standard, new analytics module for portfolio-wide summary statistics and insights, highlighting performance by asset or therapeutic area and identifying frequent unresolved validation issues, and automation and intuitive capabilities with auto set-up of latest dictionaries, alignment of upload sources over time, simplified roles and assignments, and bulk-actions for user management and company-specific settings. Press release.

Akoya Biosciences, The Spatial Biology Company, and PathAI, a global leader in artificial intelligence (AI)-powered technology for pathology, have announced a collaboration to advance the discovery and validation of novel predictive biomarkers for immunotherapies. The partners will leverage their industry leading capabilities in spatial biology and deep data mining using Phenoptics, Akoya’s high throughput spatial phenotyping platform, and PathAI’s artificial intelligence tools and algorithms to enhance their shared biopharmaceutical partners’ ability to identify patients most likely to respond to drugs in clinical trials. Akoya will work with PathAI to create a seamless interface between the Advanced Biopharma Solutions (ABS) service offerings and PathAI’s analytical capabilities to provide a powerful and complete solution for biopharma partners. This partnership and ABS’ recent CLIA certification represent significant milestones in advancing Akoya’s ability to serve the growing demand for spatial biomarkers in clinical trials. Press release.

Leica Microsystems, a leading manufacturer of microscopes and scientific instruments, has released the ARveo 8, a digital visualization neurosurgery microscope with ultra-fast processing speeds. Through the use of advanced augmented reality (AR) visualization, ARveo 8 enables the entire neurosurgical team to benefit from an improved level of AR visualization by utilizing AR fluorescence imaging, IGS information, and endoscopic imaging. The ultra-fast processing capabilities of the ARveo 8 delivers visual information to users with a more natural, real-time feel to help them make informed and precise decisions during surgery. ARveo 8 helps increase efficiency in the OR, improves system accessibility for the entire team with its new graphical user interface, and provides the freedom to adopt more new technologies and AR applications as they become available. Press release.

Science 37 has added capability to meet regulatory requirements and deploy its full-stack, end-to-end technology platform into China and Russia—further extending penetration into the Asia-Pacific market and providing sponsors the ability to more effectively run global decentralized clinical trials. In addition to expanding global capacity, Science 37 continues to enhance its purpose-built technology platform to support more agile clinical trials now available in nearly 95 countries and in more than 45 languages—ensuring a seamless user experience for a myriad of international stakeholders. Press release.

THREAD, a leading technology and service provider enabling decentralized clinical trials (DCTs), has appointed Scott Pearson as chief product officer (CPO). An Army veteran, Pearson has a proven track record in leading innovation and technology development, having held product leadership roles at Amazon, GE and Nike. Prior to joining THREAD, Pearson served as head of product for life sciences, biotech and pharma at Amazon, where he co-developed products for large biopharma customers to offer complex solutions in the form of computational pathology, cloud infrastructure and AI. As chief product officer, Pearson will lead THREAD’s product teams to advance the company’s mission of providing customers with one comprehensive global platform, delivering products to support research that is five times more inclusive and enabling decentralized clinical trials that are 30% more efficient. Press release.

Insilico Medicine has announced that the first healthy volunteer has been dosed in a first-in-human microdose trial of ISM001-055. ISM001-055 is a potentially first-in-class small molecule inhibitor of a novel biological target discovered by Pharma.AI, Insilico Medicine’s end-to-end AI-powered drug discovery platform. It is being developed for the treatment of idiopathic pulmonary fibrosis (IPF), a chronic lung disease that results in progressive and irreversible decline in lung function. After completing IND-enabling studies, Insilico Medicine has initiated the microdose trial to begin characterizing the pharmacokinetic profile in humans. The trial, administering ISM001-055 intravenously in healthy volunteers, is being conducted in Australia. ISM001-055 demonstrated highly promising results in multiple preclinical studies including in vitro biological studies, pharmacokinetic and safety studies. The compound significantly improved myofibroblast activation which contributes to the development of fibrosis. ISM001-055’s novel target is potentially relevant to a broad range of fibrotic indications. Press release.

Albert Einstein College of Medicine and Montefiore Health System have been awarded a National Institutes of Health (NIH) grant to establish a multidisciplinary research center focused on treatments for people with both chronic pain and opioid use disorder (OUD). The Integrative Management of Chronic Pain and OUD for Whole Recovery Research Center at Montefiore Einstein (IMPOWR-ME) will receive $5.1 million for its first two years; additional funding at the same level is expected for the following three years. The grant is part of the NIH's Helping to End Addiction Long-term Initiative, or HEAL Initiative, which aims to accelerate the pace of scientific solutions to stem the national opioid public health crisis. Press release.

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