March 30, 2023 | A clinical trial supply forecasting service helps inform decision-making related to the quantity of medication produced for use in clinical development; a new innate immune biology lab to study the innate immune system and its cells; a post-stroke atrial fibrillation (AF) platform collects real-time imaging data and securely transfers it to the central investigators to improve the detection of AF; and more. 

A research team from Syracuse University, SUNY Upstate Medical University, and Seattle Children’s Research Institute presented an injectable drug that mimics the benefits of gastric bypass surgery at the spring meeting of the American Chemical Society. The drug, GEP44, caused obese rats to eat up to 80% less than they would typically and to lose an average of 12% of their weight without any signs of nausea or vomiting. GEP44 also initiated a higher energy expenditure, which can manifest as increased movement, heart rate, or body temperature. The drug also reduced blood sugar by pulling glucose into muscle tissue for fuel and converted specific cells in the pancreas into insulin-producing cells, replacing those damaged by diabetes. GEP44 also reduced the craving for opioids such as fentanyl in rats. If that also works in humans, it could help addicts quit illicit drugs or fend off a relapse. Press release. 

Innovators at the U.S. Department of Energy’s Thomas Jefferson National Accelerator Facility formed the lab’s new Biomedical Research & Innovation Center (BRIC). The more than 1,850 scientists conducting their research there focus on what the lab’s particle accelerator can do to uncover new information about the atom's nucleus and enable a better understanding of our universe. Jefferson Lab’s experts develop, build, test, and improve detector technologies that can be used to better image plants in the lab, find hidden tumors in a woman’s breast, or catch radiation and stop it before it reaches groundwater. More efficient particle accelerators can sterilize medical instruments or remove forever chemicals from wastewater with a single zap. The new center aims to help these innovators come together with like-minded colleagues. BRIC members remain dedicated to their current departments, with their BRIC membership as an added activity to boost their innovation efforts. Press release. 

Greenphire unveiled the addition of the Patient-Powered Registry, designed to help foundations more effectively engage and support patient communities. The comprehensive mobile and web-based registry will allow disease-specific organizations to communicate with members—delivering patient insights such as condition-specific health information, employing interactive tools such as virtual surveys, and connecting and matching members with clinical trials. Foundations can create and manage registry content quickly and easily, streamlining operations and improving analytics to enhance patient support and provide value-added data to key stakeholders such as their boards of directors. The Patient-Powered Registry allows foundations to easily identify potential participants based on their medical history, geographic location, and other criteria. It also helps keep patients engaged throughout the trial by providing real-time updates on progress and results from an interactive and helpful app. Press release. 

Benchling announced new products and services focused on driving long-term success in the modern R&D lab. Benchling’s Solution Accelerators address the industry-specific digital requirements of biotechs with pre-built data models, templates, dashboards, and end-to-end workflows alongside capabilities for experimental tracking, sample management, and process modeling. The result is accelerated time to value, with up to 50% faster delivery timelines, increased data consistency, and operational efficiency gains. Benchling Learning Labs and Success Packages improve digital skills in the lab, provide expert support from trained scientists and technologists, and ensure the highest quality outcomes for customers. Benchling Learning Labs offers flexible, on-demand training for Benchling users. Individuals can skill up and get certified on topics ranging from conducting essential R&D in Benchling to performing administration tasks. Press release. 

FutureNeuro announced two collaborative research projects with IQVIA and Novartis Ireland to advance the use of data in healthcare research and clinical care delivery. The DataScape project, in collaboration with IQVIA, explores key stakeholders' attitudes, expectations, and concerns on using health data for healthcare improvement and research. The Learning Health System in a Digital hospital project focuses on developing a prototype Learning Health System that will integrate patient data from clinical dashboards with research analytics. Through industry partnerships, FutureNeuro aims to create new technologies and solutions for treating, diagnosing, and monitoring chronic and rare neurological diseases. Press release. 

Aman Chauhan, M.D., and Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine have embarked on a mission to make Sylvester a top-level research center for neuroendocrine tumors and to make Miami a first-choice destination for patients seeking treatment for these complex cancers. They are currently conducting two trials in first-in-human phase 1 studies. One is looking at adding a drug called triapine—a radiation sensitizer—to a standard-of-care radioactive drug, lutetium Lu 177 dotatate (Lutathera), to manage neuroendocrine tumors. That trial is moving to an NCI-funded national randomized phase 2 study, on which Chauhan is co-PI. The other phase 1 study is looking at combining a drug called peposertib—a DNA-dependent protein kinase inhibitor—with a radiation-based drug. Press release. 

The European Platform for Neurodegenerative Diseases (EPND) launched its Cohort Catalogue, a central, open, accessible repository for researchers to discover ongoing studies and search metadata by disease area, biosample availability, imaging and cognitive data, and more. The EPND consortium brings neurodegeneration research, data science, diagnosis, and treatment experts from 29 public and private organizations. EPND aims to accelerate the identification, development, and validation of biomarkers for neurodegenerative diseases by establishing a data- and sample-sharing platform for collaborative, large-scale research. Using the Catalogue, researchers can search and filter cohorts by metadata characteristics to discover cohorts useful in their research. Additional features and benefits are currently under development to extend the size and scope of the catalog. Press release. 

Mural Health and ProofPilot announced a strategic partnership to advance clinical trial operations for life science customers. Through this partnership, Mural Health's Mural Link platform and ProofPilot's digital protocol automation platform will work together to progress clinical operations, streamline payments, and materially improve the efficiency and outcomes of global clinical trials. Adding to the growing list of partners brought into ProofPilot's digital protocol automation platform, Mural Health provides sponsors and sites another automated, turnkey capability, further reducing site burden while providing more optionality for patients. Press release. 

Emory University announced an agreement with Pfizer to advance research addressing the need for additional effective COVID-19 treatment options to save patients’ lives. Under the terms of the deal, Emory University’s Schinazi Laboratory and Pfizer will work together to identify and evaluate potential antiviral compounds for the treatment of COVID-19. If this collaboration advances the preclinical development of these compounds, Pfizer will have the option to exercise exclusive rights to the leading clinical candidates and be solely responsible for further development activities. Press release. 

Neogap and Simsen Diagnostics initiated a collaboration to improve personalized cancer diagnostics by examining circulating tumor DNA in the blood of patients participating in Neogap's phase I/II clinical trial. The goal is to develop more precise and effective diagnostic tools for cancer. Neogap's personalized Trained Tumour Lymphocytes cell therapy is an immunotherapy designed to treat solid tumors by training the immune system to recognize and attack cancer cells using specific altered proteins called neoantigens. Neogap has commissioned Simsen Diagnostics to measure the circulating tumor DNA levels in the blood of patients participating in Neogap's upcoming immunotherapy trial. These measurements will be used to evaluate the therapy's effect by comparing the development and survival of tumor cells over time. Neogap's proprietary PIOR software will analyze the data collected during the trial. Press release. 

Charles River Laboratories International launched Apollo, a secure, cloud-based platform for drug developers that provides access to study data, study milestones, documents, cost estimates, and program planning tools to save time and enhance the client experience. The platform’s capabilities are designed to support clients with safety assessment and toxicology studies. Using the cloud-based platform, clients now have access to self-service tools designed to reduce barriers, access the status of studies, data insights and analysis, and download study documents immediately. Additionally, Apollo offers access to a self-service quoting tool, allowing enhanced budget forecasting. Press release. 

Greenphire announced expanding its agreement with Merck, known as MSD outside the United States and Canada. This expanded agreement now includes using Greenphire's ClinCard with rideshare integration for participants across Merck's clinical development network. Research from Tufts University identified that expense reimbursement and transportation assistance are the top two enhancements to increase patient participation in clinical trials. Greenphire's ClinCard with rideshare integration is designed to help alleviate financial and logistical burdens on participants. ClinCard does not impose costs on sites and helps ensure patients are reimbursed quickly so research sites can focus on the important work of conducting clinical trials. Press release. 

LEO Pharma and ICON plc announced a strategic partnership that will enable LEO Pharma to scale clinical trial execution that is patient-centric and cost-effective. The partnership's mission is to improve dermatology patients' lives with access to innovative clinical trials and the launch of new medicines. The partnership will operate under the acronym of PACE, representing LEO Pharma and ICON’s shared values of Passion, Agility, Communication, and Excellence in delivery. LEO Pharma plans to achieve the following while remaining a patient-centric company: drive efficiencies in clinical trials, scale in all areas of expertise within clinical development, co-investment within the area of decentralized clinical trials, access a significant number of ICON in-house ancillary services, access external data, knowledge, and expertise as well as technologies, and partner with a company that shares similar core values. Press release. 

The National Cancer Institute (NCI), part of the National Institutes of Health and Cancer Research UK, announced nine new research challenges to tackle some of the most profound problems in cancer research. The research initiative aims to inspire bold new ideas with the greatest potential for advancing cancer research and improving patient outcomes. The nine new challenges are as follows: solid tumors in children, cancer inequities, obesity, physical activity, aging and cancer, T-cell receptors, early-onset cancers, cancer cell plasticity, retrotransposable elements, and chemotherapy-induced neurotoxicities. Interested teams should submit an expression of interest by June 22, 2023. The final determinations of short-listed teams will be announced in August 2023. In March 2024, NCI and Cancer Research UK expect to announce the selection of up to four winning teams. For more information about the Cancer Grand Challenges program, visit https://cancergrandchallenges.org/. Press release. 

The Pistoia Alliance launched the Pistoia Alliance Pharma Innovation Council. The 13 next-generation leaders from large global pharmaceutical companies reflect the diversity of membership viewpoints. The Council will explore common challenges at a grassroots level and seed ideas for new pre-competitive projects aligned with the Alliance’s strategic themes: emerging sciences and technology, improving the efficiency and effectiveness of R&D, and empowering the patient. The Pharma Innovation Council aims to produce one new project idea per theme and will bring together interested parties from member companies. New projects will sit alongside the Alliance’s current portfolio, including the IDMP Ontology Project, DataFAIRy Bioassay Annotation Project, and Diversity & Inclusion in STEM Leadership program. The Council will meet again on April 25th to discuss their new project proposals. Press release.  

Calyx announced the availability of Calyx Supply Simulation, a clinical trial supply forecasting service available through Calyx's in-house expert statistical design and trial supplies consultants. Clinical trial sponsors can leverage the simulation service to inform decision-making about the quantity of medication produced for clinical development. The service helps sponsors improve clinical trial efficiencies by evaluating the medication required to start and maintain clinical trial enrollment, predicting how long an existing amount of study medication will last, and determining the optimal site and depot buffer stock quantities required while reducing excessive drug wastage. Calyx Supply Simulation considers multiple, real-life fixed and variable domains and the “what if” scenarios that often occur during clinical trials. Press release. 

The Patient-Centered Outcomes Research Institute (PCORI) has chosen Cleveland Clinic for a nationwide initiative to improve how healthcare systems translate research findings to clinical practice. PCORI’s Health Systems Implementation Initiative connects 42 healthcare systems to reduce the time it takes to move a discovery in research to a new treatment for patients, an estimated 17-year lag. PCORI is offering a first phase of funding to build capacity for upcoming implementation projects—up to $500,000 per health system. Healthcare systems will then pitch implementation projects for the second funding phase, ranging from $500,000 to $5 million per project. In 2019, Cleveland Clinic launched the Healthcare Delivery and Implementation Science Center, a systemwide resource for research implementation, connecting researchers with operations leadership. The center offers consultation and education programs and funds implementation projects through grants. Press release. 

Curavit Clinical Research announced the appointment of Jackie Kent to the Curavit Board of Directors. Ms. Kent is the first external fiduciary, independent life sciences industry veteran member on the Curavit Board. She spent more than two decades at Eli Lilly and Company, including five years as Lilly’s TransCelerate BioPharma representative, where she served in various capacities. Later, Kent accepted a position as head of product and then chief customer officer at Medidata. While at Medidata, Kent also served as vice chairperson (2021) and chairperson (2022) of the Association of Clinical Research Organizations. Today, she is working independently to help drive change across the industry, focusing on the Society of Clinical Research Sites’ diversity program and sitting on various industry boards. Press release. 

The Patient-Centered Outcomes Research Institute (PCORI) kicked off a multiyear initiative with an initial investment of $50 million to advance the uptake of practice-changing comparative clinical effectiveness research results into healthcare practice with the selection of 42 U.S. health systems to participate in its groundbreaking Health Systems Implementation Initiative (HSII). The array of participating health systems representing a wide range of care settings and populations will develop and implement viable strategies to actively advance the adoption of new evidence in healthcare delivery. In addition to announcing participants, PCORI has opened the first HSII funding opportunity for participating health systems to propose capacity-building projects, with awards up to $500,000. Subsequent HSII funding opportunities will support innovative implementation projects that promote the uptake of specific evidence from PCORI-funded research studies within the health systems, with funds ranging from $500,000 to $5 million per project. HSII participants collectively represent 800 hospitals serving 79 million unique patients—nearly a quarter of the U.S. population—across 41 states and the District of Columbia. Press release. 

Jumo Health announced with the I Choose Life Foundation (ICLF) that they expanded their health equity service line to include recruiting and retaining people of color in clinical trials. To guide their pharmaceutical and biotech customers as they endeavor to develop culturally responsible medications, Jumo Health and ICLF have amassed a national network of more than 2,000 churches primarily serving Black congregations historically underrepresented in clinical trials totaling more than 500,000 members. Working together, Jumo Health, ICLF, and the CARES Council seek to ensure that Black participants are appropriately represented in future clinical trials. Press release. 

mdgroup opened its latest medical distribution center in Amsterdam. One of three hubs worldwide, mdgroup’s Horreum distribution center—named after the Latin horrea meaning “storage warehouses”—provides European sponsors with clinical trial supply procurement, storage, logistics, and delivery. mdgroup specialist teams link the dots between stakeholders by bringing study-critical elements in-house to secure critical clinical supply chain management. The horreum network services include clinical trial consumables and equipment procurement, storage, distribution, clinical trial supplies logistics, laboratory kit assembly, management, and patient pack printing and delivery. Press release. 

Greenphire announced significant expansion and growth of ConneX upon its in-market resources in key regions, including Japan, Central and Southern Europe, Scandinavia, and Southeast Asia. With the largest international network of localized travel agents supporting clinical trials, ConneX removes administrative burdens for research sites and eliminates logistical and financial barriers for participants. In support of global trial retention, ConneX offers personalized concierge services, including air, train, hotel, car services and rideshare, ambulatory care, and specialty services. This includes travel visa support, with successful applications recently processed for patients traveling from Jordan to Germany and Iraq to the USA. The service eliminates out-of-pocket costs and travel complexities for participants across protocols and therapeutic areas, including rare diseases, oncology, and more. In addition, its integration with ClinCard, Greenphire's leading participant payment automation software, ensures that any expense incurred can be quickly reimbursed in real-time. Press release. 

Yale School of Medicine scientists conducted a cross-sectional study (DOI:10.1001/jamanetworkopen.2023.0855) to examine the gender, racial, and ethnic diversity of elite National Institutes of Health (NIH) investigators from 1991 to 2020. The researchers found a growing gap among NIH investigators, creating a cohort of highly funded NIH investigators. Notably, there were persistent gender, ethnic, and racial inequities among this elite class of super principal investigators receiving three or more research project grants. As the NIH develops critical initiatives and reforms to promote equity among its investigators, consideration of the persistent gender, ethnic, and racial gaps in this elite class and their influence is critical for meaningful reform. Press release. 

Brainomix announced its involvement in a new study sponsored by the University of Liverpool focused on post-stroke atrial fibrillation (AF). Sites with existing clinical deployments of Brainomix’s e-Stroke platform will utilize the AI system to collect real-time imaging data and securely transfer it to the central investigators. The Liverpool-Huawei Stroke Study aims to determine the clinical effectiveness, cost-effectiveness, and acceptability of Huawei Smartwear to detect AF in patients following an acute ischemic stroke. Ultimately, the aim is to improve the detection of AF to initiate earlier treatment and reduce the risk of recurrent stroke in populations post-stroke. Its detection is critical to begin appropriate monitoring and treatment to reduce the risk of recurrent stroke. Press release. 

A University of Southern California-led research consortium is launching a massive data-gathering initiative in India to address a diversity crisis in brain research. The India ENIGMA Initiative for Global Aging and Mental Health research project was launched at the National Institute of Mental Health and Neurosciences (NIMHANS) in Bangalore, India. The five-year project aims to bridge the knowledge gap around the various factors influencing the acceleration of brain aging. To do this, a team of experts will leverage their global working group, the ENIGMA Consortium, to partner with dementia research pioneers in India, creating new links between international biobanks and building research capacity. This study will use novel machine learning methods to hypothesize how brain aging depends on lifestyle and psychosocial factors such as diet, family support, literacy, sleep, education, genetic risks, and more. This collaborative India-US initiative will enable future science initiatives and equip the NIMHANS team with the necessary tools to train new scientists. Press release. 

The Institute for Research in Biomedicine, Barcelona, opened a new Innate Immune Biology lab to study the innate immune system—our body's first defense system—and the cells that make it up, such as macrophages, dendritic cells, and neutrophils. The laboratory will center on the functions of these cells in different tissues, how they work to keep the body healthy, and how they react during non-infectious diseases and other aggressions, such as cancer, aging, wounds, or obesity. The lab will work with the Translational Research and Innovation Programme (TRIP), promoting emerging research areas such as immuno-oncology, inflammation, and cellular senescence. TRIP promotes basic and clinical research activities in the same environment and facilitates joint access to knowledge, technologies, and applications. Press release.