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Evolving Concept of Value in Health Economics and Outcomes Research: Emerging Tools for Innovation and Access to Cell and Gene Therapies for Rare Diseases.
Value Health
December 2024
CHOICE Institute, School of Pharmacy, University of Washington, Seattle, WA, USA.
Objective: Recent scientific breakthroughs have propelled the development of disease-modifying and potentially curative cell and gene therapies (CGTs) for rare diseases, including those diseases previously considered untreatable. However, the unique characteristics of CGTs pose challenges for the traditional methods of therapy value determination, reimbursement, and outcome evaluation used by regulatory and assessment agencies for product approval and market access. Notably, CGTs are one-time or short-course treatments, often first-in-class (precluding direct comparisons with effective alternatives), and have health benefits that are largely realized over time.
View Article and Find Full Text PDFTumour purity assessment with deep learning in colorectal cancer and impact on molecular analysis.
J Pathol
February 2025
Department of Pathology and Molecular Pathology, University Hospital and University of Zurich, Zurich, Switzerland.
Tumour content plays a pivotal role in directing the bioinformatic analysis of molecular profiles such as copy number variation (CNV). In clinical application, tumour purity estimation (TPE) is achieved either through visual pathological review [conventional pathology (CP)] or the deconvolution of molecular data. While CP provides a direct measurement, it demonstrates modest reproducibility and lacks standardisation.
View Article and Find Full Text PDFQuantifying Biomass and Visualizing Cell Coverage on Fibrous Scaffolds for Cultivated Meat Production.
Curr Protoc
December 2024
Department of Biomedical Engineering, Tufts University, Medford, Massachusetts.
Article Synopsis
- * The article discusses methods to analyze how these scaffolds interact with cells, focusing on how they degrade and how cell growth (biomass) can be measured through various metrics like cell weight and extracellular matrix (ECM) deposition.
- * It presents detailed protocols for creating silk fiber scaffolds, cultivating specific mouse cells (C2C12), and monitoring key parameters, contributing to the development of more efficient cellular agriculture techniques.
Article Synopsis
- The World Health Assembly set six global nutrition targets (GNTs) in 2012 to improve maternal and child health, but there has been no comprehensive report detailing progress from 2012 to 2021.
- A study evaluated the prevalence and impact of these nutrition targets across 204 countries using data from the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) 2021 and projected future trends up to 2050.
- By 2021, only a few countries met some GNTs; most showed increased child overweight and notable decreases in female anaemia, highlighting a connection between societal development status and nutritional challenges.
Reconciling predicted and measured viscosity parameters in high concentration therapeutic antibody solutions.
MAbs
December 2024
Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, Glasgow, UK.
Monoclonal antibody (mAb) solution viscosity in ultra-high concentration formulations is a key developability consideration in mAb development risk mitigation strategies that has implications for downstream processing and patient safety. Predicting viscosity at therapeutically relevant concentrations remains critical, despite the need for large mAb quantities for viscosity measurement being prohibitive. Using a panel of IgG1s, we examined the suitability of viscosity prediction and fitting models at different mAb test concentration regimes.
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