December 27, 2022 | A 16-gene molecular signature investigation based on gene expression differences between patients with and without local recurrence after breast-conserving surgery; analytically sensitive infectious disease panels to support laboratory research; eClinical solutions to make clinical research processes more efficient and compliant; and more. 

The European Medicines Agency (EMA) issued a letter of support for the Critical Path for Parkinson’s (CPP) Consortium’s Model-based Clinical Trial Simulation Platform to Optimize Design of Efficacy Evaluation Studies in Parkinson’s Disease (PD). The CPP Consortium has developed three clinical trial simulators with EMA endorsement. The first one helps sponsors deploy molecular dopamine neuroimaging to optimize patient selection for PD clinical trials targeting the early stages of the disease. The second and third help sponsors optimize the design of PD trials that intend to use the Movement Disorder Society-Unified Parkinson’s Disease Rating Scale Part II or Part III as primary endpoints. This regulatory achievement for CPP is one of 10 letters of support from EMA across various disease conditions that aim to streamline the path to the regulatory endorsement of novel tools to enhance drug development. Press release. 

Critical Path Institute announced that its Transplant Therapeutics Consortium (TTC) received a qualification opinion for the iBox Scoring System as a secondary efficacy endpoint in clinical trials investigating novel immunosuppressive medicines in kidney transplant patients. This regulatory milestone was achieved through the European Medicines Agency’s qualification of novel methodologies for drug development and is the first qualified endpoint for any transplant indication. Sponsors can apply various inclusion/exclusion criteria and other specifications to better understand how group differences in iBOX parameters translate to a difference in iBOX scores. TTC is also working on the regulatory endorsement of the iBox Scoring System as a reasonably likely surrogate endpoint by the U.S. Food and Drug Administration, to whom the Qualification Plan has been submitted and is under review. Press release. 

The Children’s National Hospital and the National Capital Consortium for Pediatric Device Innovation announced the opening of a request for proposal to solicit companies interested in obtaining pediatric labeling for medical devices that may address an unmet need in the pediatric population and that already have clearance or approval for adult use by the U.S. Food & Drug Administration. This program aims to generate real-world evidence to facilitate the pediatric regulatory pathway for U.S. market clearance. The deadline to apply is 5 p.m. EST on Feb. 9. To learn more and apply, visit http://www.innovate4kids.org. Press release. 

The Lee Kong Chian School of Medicine at Nanyang Technological University, Singapore, in collaboration with other healthcare institutions, has embarked on a landmark comprehensive health study of 100,000 Singaporeans to identify the social, environmental, lifestyle, and genetic factors associated with diseases prevalent in Singapore, such as diabetes, hypertension, and cancer. Throughout the study, SG100K participants will be monitored for their long-term health outcomes through various approaches, including electronic medical records, disease registries, and invitations for further follow-up. SG100K will also analyze blood samples to assess the population's genomic and other relevant molecular variations. Participants will be offered a detailed health report, which they can use for discussion with their doctors at no charge. Press release. 

PhoreMost and ThinkCyte K.K. announced a strategic research partnership to advance modern phenotypic drug screening using artificial intelligence. The partnership leverages both companies’ distinctive technologies in high-throughput drug discovery, PhoreMost’s next-generation phenotypic screening platform, SITESEEKER, and ThinkCyte’s AI-driven cell characterization and sorting platform, Ghost Cytometry, to develop differentiated therapies for a range of diseases with an unmet clinical need. By combining SITESEEKER to identify novel druggable targets with Ghost Cytometry to identify subtle phenotypic changes in living cells, the partnership aims to develop a unique approach to high-content phenotypic screening. The research partnership will drive ThinkCyte deeper into early drug discovery and contribute to PhoreMost’s mission of “Drugging the Undruggable.” Press release. 

Curebase announced the release of an integrated, plug-and-play software and full trial services offering that allows sponsors of diagnostic studies to accelerate enrollment and launch their trials more quickly as the sole execution partner. This comprehensive solution includes everything a sponsor needs: no scrambling for sites or PIs, no need to start from scratch in configuring software, no lengthy, costly recruitment process, and no multi-vendor management for contract research organization services. The Curebase offering is beneficial for at-home, in vitro, and liquid biopsy diagnostics in infectious disease and oncology—all of which struggle to get products to market faster because their studies typically require enrolling thousands of patients. Curebase's decentralized clinical trial approach opens enrollment to a broader group of patients who can participate in a study with their local providers or virtually. Press release. 

Syneos Health has extended its strategic partnership with Medable as part of the Company’s commitment to bring clinical trials closer to the patient. Syneos Health and Medable will continue reducing site and patient burden, improving enrollment and retention, and increasing patient access and diversity through innovative decentralized clinical trial solutions. Syneos Health and Medable have made significant progress in adopting new tools and creating a scalable operational model for decentralized and hybrid studies. Syneos Health’s deep therapeutic knowledge, experience in managing global clinical trials, and operational excellence across the product development lifecycle, combined with Medable’s leading digital trial platform, is benefitting patients, sites, and sponsors and transforming biopharmaceutical product development. Press release. 

Scientists from the Sahlgrenska Comprehensive Cancer Center and the University of Gothenburg in Sweden evaluated the predictive potential of Profile for the Omission of Local Adjuvant Radiotherapy (POLAR). This investigational 16-gene molecular signature was developed based on gene expression differences between patients with and without local recurrence after breast-conserving surgery. Among the 429 patients with high POLAR scores, those who received adjuvant radiation therapy after breast-conserving surgery had a 63 percent reduction of local recurrence compared with those who did not receive adjuvant radiation therapy. After 10 years, 5% of patients who received radiation therapy experienced a local recurrence, compared with 7% of those who did not. Future research from Karlsson and colleagues will examine whether the POLAR gene profile can also identify patients who could safely avoid regional radiation therapy. Press release. 

IllumiCare partnered with MultiCare Health System to allow providers to recommend clinical trials as a therapeutic option at the point of care using its Trials App on the Smart Ribbon. This is the first time the Trials App has been deployed in a clinical setting. It nudges providers in real time if the patient they are seeing meets the referral criteria for an institutional clinical trial, as established by the local research team. It’s the only technology directly connecting patients to trial coordinators for follow-up and tracks a patient’s journey within the recruitment and trial process, enabled by one simple click. MultiCare has introduced the Trials App to its oncology and pediatric providers, with plans to roll it out across other specialties next. Press release. 

SomaLogic announced the full-scale global launch of the SomaLogic Certified Site program, allowing institutions worldwide to run the 7,000-plex SomaScan Assay in their own labs. By becoming a SomaLogic Certified Site, labs can run assays on SomaLogic’s SomaScan Platform—the largest commercially available proteomics platform—and accelerate their own research and generate revenue as a service provider. SomaLogic Certified Sites receive support services, on-site training, and equipment servicing. SomaLogic’s proprietary SomaScan Platform was designed to be a universal platform that can be applied across research and discovery, translational research, biopharmaceutical development, and clinical applications. SomaLogic can run approximately 7,000 protein measurements on a single 55-microliter plasma or serum sample. Press release. 

RealTime Software Solutions is pleased to announce the acquisition of Complion. The partnership of RealTime and Complion bolsters the combined organization’s position as a provider of eClinical solutions to make clinical research processes more efficient and compliant. Complion’s eReg offering adds another best-of-breed product to RealTime’s Site Operations Management System, a fully integrated suite of products that include CTMS, eRegulatory, eSource, Pay, Text, eConsent, participant engagement, and other eClinical solutions and services. Complion’s eRegulatory solutions automate investigator regulatory compliance, eliminate paper, redundancies, and manual processes, and alleviate the site monitoring burden to facilitate faster study startup. Press release. 

Thermo Fisher Scientific announced the launch of the TrueMark Infectious Disease Research Panels designed to enable rapid and accurate detection and categorization for investigating microorganisms that cause respiratory, vaginal, urinary, gastrointestinal, and sexually transmitted diseases. To effectively study outbreaks and determine disease etiology where pathogens are similar, analytically sensitive panels are needed to support laboratory research. TrueMark Infectious Disease Research Panels are analytically sensitive, real-time polymerase chain reaction syndromic panels for analyzing various infectious disease pathogens. Testing can be done from nasopharyngeal swabs, nasopharyngeal aspirate, vaginal, genital, and lesion swabs, or urine samples. These samples can also be prepared using workflows currently in most labs. For Research Use Only. Not for use in diagnostic procedures. Press release.  

RedHill Biopharma announced that the U.S. Food and Drug Administration’s Exclusivity Board had granted Aemcolo five years’ exclusivity under the Generating Antibiotic Incentives Now Act Qualified Infectious Disease Product designation, in addition to the five years of data exclusivity granted as a new chemical entity for the treatment of travelers’ diarrhea caused by non-invasive strains of Escherichia coli in adults. Aemcolo, containing 194 mg of rifamycin as delayed-release tablets, is an orally-administered, non-systemic antibiotic employing MMX technology, a proprietary drug delivery system that distributes rifamycin in a controlled manner to the lower intestine. Due to its non-systemic delivery, Aemcolo is associated with limited side effects and minimal potential for interactions with other medications. Press release. 

Scientists at Klick Applied Sciences have discovered a way to transform a continuous glucose monitor (CGM) into a powerful diabetes screening and prevention tool using artificial intelligence. The team revealed how they used machine learning and just 12 hours of data from CGMs to determine whether a patient was prediabetic or diabetic. They discovered their 12-hour model correctly identified two-thirds of patients with prediabetes and showed high accuracy in identifying healthy patients and those with Type 2 diabetes. Their study—published in Nature (DOI: 10.1038/s41746-020-0283-x)—was based on mathematical modeling to determine how some underlying changes in glucose regulation cause diabetes. Press release. 

A think tank convened by the Association of Clinical Research Professionals (ACRP)—titled “From Trepidation to Trust: Documenting the Realities of Hybrid and Decentralized Clinical Trials (DCTs) Adoption”—included 42 participants from multiple clinical trial stakeholder groups. The think tank was conducted with educational sponsorship funding from Medable, Advanced Clinical, and Syneos Health. The findings add to data from a newly published ACRP membership survey focused on DCTs—entitled “Delivering on the Promise of Decentralized Trials: Unexpected Perspectives from Clinical Research Professionals”—and provide a new, broader perspective of the many challenges that must be addressed at the site level, where day-to-day trial activities take place, to accelerate DCT adoption. Holding the think tank and fielding the new survey advances the ACRP mission to promote professionalism and the vision that clinical research must be performed ethically, responsibly, and professionally everywhere in the world. Press release. 

The University of North Carolina at Chapel Hill, through the Eshelman Institute for Innovation, announced a collaboration with Amazon Web Services to build an environment for startup creation that uses cloud technology to translate UNC-Chapel Hill's digital health research expertise into commercialized solutions. The partnership will support 25 projects over three years, aiming to create, fund, and build 10 successful start-up companies based out of UNC-Chapel Hill. The focus is software-forward digital technologies to advance health and wellness, enhance patient and provider experience, and improve healthcare access across five areas: enterprise systems and support, clinician services and support, patient-facing wellness and support, patient-facing diagnostic and monitoring, and patient-facing therapeutic interventions. For more information, visit UNC’s Eshleman Institute for Innovation’s website or contact the team. Press release. 

A survey by University of California, Irvine (UCI) neuroscientists found that the U.S. Food and Drug Administration’s controversial accelerated approval of the first Alzheimer’s drug in nearly 20 years has made the public less willing to volunteer for Alzheimer’s pharmaceutical trials. The study was conducted by the UCI Institute for Memory Impairments and Neurological Disorders (UCI MIND) and appeared in the Journal of Alzheimer’s Disease (DOI: 10.3233/JAD-220801). The UCI team performed the survey in tandem with the FDA’s spring 2021 consideration of aducanumab. The monoclonal antibody reduces brain plaques, an Alzheimer’s hallmark, in people with the condition. The survey’s findings show researchers need to be aware of sample bias. The UCI MIND team plans to conduct further research into the issue, emphasizing learning how to ensure diverse populations are part of Alzheimer’s clinical trials. Press release. 

uMotif continues its transformation of the eCOA/DCT market by announcing that its proprietary Motif data capture interface offers a validated alternative to text-based instruments for clinical, post-marketing, and real-world research. The Motif is a patented, flower-like graphical user interface. Each petal represents a different question, such as an Outcome Measure, symptom, or eDiary entry. Patients simply swipe on each petal to capture their data. The highly visual and easy-to-use interface is faster and more engaging for patients, leading to higher data capture compliance rates. uMotif’s highly scalable eCOA/ePRO platform combines deep clinical knowledge and consumer design expertise to deliver unprecedented levels of patient compliance, regularly achieving >90% compliance in real-world studies. uMotif meets clinical and RWE market needs in any country, language, therapeutic area, and participant population, supporting site-based, hybrid, and fully virtual decentralized trials. Press release.