- Alimentiv, AcelaBio and PharmaNest join forces to revolutionize precision medicine and AI digital pathology for NASH/MASH clinical trials
LONDON, ON, Nov. 8, 2023/PRNewswire/ -- Alimentiv Inc., AcelaBio Inc. and PharmaNest Inc. are pleased to announce their collaborative effort to revolutionize precision medicine and AI-enabled digital pathology solutions (IA) for steatohepatitis associated with metabolic dysfunction (MASH), formerly known as nonalcoholic steatohepatitis. (NASH) clinical trials. This collaboration will enable clinical trial sponsors to quantify the histological effects of compounds and gain deeper insight into the underlying mechanisms in MASH-targeting therapies using next-generation spatial transcriptomics and AI-driven single-cell and single-fiber digital pathology. Leveraging the collective expertise of Alimentiv, AcelaBio and PharmaNest, this collaboration will establish an integrated ecosystem that seamlessly combines high-throughput specialized anatomical and molecular pathology, precision medicine technologies, bioinformatics and digital pathology image analysis powered by artificial intelligence. The integration of these cutting-edge solutions is a significant advance in the application of novel technologies to enable high-quality, end-to-end tissue assays, which will enable clinical trial sponsors to drive scientific discoveries and accelerate drug development in MASH. , a disease with a growing impact and currently without approved therapies.
AcelaBio, a CAP/CLIA-certified clinical research laboratory known for its end-to-end digital pathology workflows, will perform analysis of tissue samples to generate whole-slide images and molecular data. "Our collaboration has great potential to advance MASH clinical research to advance the identification and quantification of digital pathology biomarker data and improve clinical development," explained Niels Vande Casteele, Ph.D., CEO of AcelaBio. "By creating seamless workflows that integrate advanced sample analysis, digital pathology, bioinformatics and AI-driven analysis, we can unlock new opportunities to identify biomarker signatures within the spatial context of tissue."
The collaborative efforts of Alimentiv, AcelaBio and PharmaNest will facilitate the seamless integration of robust digital pathology operational workflows and artificial intelligence into MASH clinical trials, ultimately leading to the development of personalized therapies and improving patient outcomes.
"Alimentiv prioritizes scientific leadership through our commitment to developing innovative early clinical trial designs and outcome assessments. Our expertise in endpoint assessments and precision medicine analytics, including bioinformatics and digital-driven pathology biomarker quantification by AI, positions us together with our collaborative partners to innovate and transform the MASH clinical trials landscape," said Wendy Teft, Ph.D., vice president of Precision Medicine at Alimentiv. "Through the integration of our respective technologies and expertise, we aim to provide clinical trial sponsors with the tools necessary to improve the quality of histological endpoints, discover new biomarkers and accelerate drug development timelines by obtaining comprehensive knowledge about the mechanisms of action underlying MASH targeted therapies.
PharmaNest, recognized for its excellence in MASH digital pathology and artificial intelligence analysis services, will play a key role in this collaboration by providing high-resolution, quantitative, single-fiber and single-cell image analysis and AI-powered biomarkers from the same images reviewed by pathologists for critical endpoint evaluations. Together, these organizations will improve the quality of current histologic endpoints required for interim approval of therapies in MASH by the FDA and enable analysis of complex data sets, leading to a comprehensive understanding of MASH pathology. and the discovery of new biomarkers.
"Using our FibroNest digital pathology platform, automated high-resolution quantification of fibrosis severity phenotype and related tissue injury from the same pathologist-reviewed slides offers a robust and scalable method to generate continuous scores that resolve changes." slight differences in fibrosis severity and disease activity and can be used in MASH trials to assist pathologists and enrich the quantification of the effect of an intervention. Our digital fibrosis pathology biomarker, Ph-FCS, offers exceptional performance as diagnostic tool for early and severe fibrosis. The recently published results show that the fact that it can also predict liver-related events and outcomes paves the way for its future qualification as a possible surrogate endpoint in MASH studies," he commented Mathieu Petitjean, Ph.D., CEO of PharmaNest. "The partnership with Alimentiv and AcelaBio will ensure that sponsors receive an excellent end-to-end digital tissue pathology assay where pre-analytical conditions are well controlled for the duration of a study.
The collaboration between Alimentiv, AcelaBio and PharmaNest represents a substantial advance in the integration of precision medicine and digital pathology solutions for MASH clinical trials. By pooling their expertise, these organizations aim to further improve the efficiency of early drug development to provide safe and effective treatments to patients in a more convenient way.
Clinical trial sponsors interested in accessing the benefits of this service collaboration are encouraged to contact the respective organizations for more information.
About Alimentiv Inc.
Alimentiv is a global contract research organization (CRO) focused on gastroenterology providing clinical trials, central image management, precision medicine and real-world evidence services to the pharmaceutical and biotechnology industries. Headquartered in London, Ontario, Alimentiv employs more than 500 people across operations in Canada, the United States, Europe, Asia-Pacific and Latin America. The organization's unique model combines the efforts of academic researchers and internationally recognized operational experts to deliver integrated solutions to clients. Over the past 20 years, Alimentiv has become a recognized expert in clinical trial design, central image management solutions, outcome measures development, and precision medicine for gastrointestinal drug development. Today, Alimentiv serves more than 50 countries worldwide, collaborates with leading universities and academic institutions around the world, and works with many leading pharmaceutical and biotechnology organizations to provide new and improved treatment options to patients. Alimentiv is committed to investing in medical research and development, focusing on identifying barriers to drug development and finding solutions that advance gastrointestinal research. Research findings are put into practice in an efficient clinical trial methodology for clients that aligns with emerging regulatory standards. In collaboration with leading experts, Alimentiv has pioneered the development, validation and standardization of technologies and outcome measures, shaping the evolving landscape of clinical trials for multiple indications and providing significant long-term consequences for patients, their treatment and society. For more information visit: www.alimentiv.com
About AcelaBio (US) Inc.
AcelaBio is a state-of-the-art, CAP/CLIA-accredited contract research organization providing comprehensive histopathology and precision medicine services to pharmaceutical, biotechnology and academic institutions. AcelaBio provides high-throughput digital pathology services to support global multicenter clinical trials and has the flexibility to develop and validate biomarker assays for new or existing molecular or protein targets. To discover new biomarker signatures and interrogate the spatial biology of tissues, AcelaBio implemented 10X Genomics Visium Spatial Transcriptomics into its workflows. AcelaBio's laboratory capabilities are applicable across a wide range of therapeutic indications, including gastroenterology, oncology and dermatology. AcelaBio is highly specialized in testing gastrointestinal tissues from patients with inflammatory bowel diseases (e.g., Crohn's disease and ulcerative colitis), eosinophilic gastrointestinal diseases (e.g., eosinophilic esophagitis), and liver diseases (steatohepatitis associated with metabolic dysfunction). AcelaBio employs operational, scientific and medical experts, including US board-certified pathologists, who are dedicated to providing high-quality, reliable data and images. For more information, visit: www.acelabio.com
About PharmaNest
PharmaNest is a Digital Pathology and Artificial Intelligence company focused on the development and validation of new histological standards for the quantification of inflammation and fibrosis. Its multi-vendor platform, FibroNest, is delivered worldwide via the cloud and is used in multiple preclinical and clinical studies in various fibrotic conditions, including MASH, PBC, PSC, IBD, EoE, Sjogren's, Fibro-Immuno- oncology and more.
For more information about FibroNest and PharmaNest, visit www.pharmanest.com and www.fibronest.com
Fern Livingstone, Tel: 519.639.3205, E-mail: fern.livingstone@alimentiv.com
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