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The 18 Workshop on Recent Issues in Bioanalysis (18 WRIB) took place in San Antonio, TX, USA on May 6-10, 2024. Over 1100 professionals representing pharma/biotech companies, CROs, and multiple regulatory agencies convened to actively discuss the most current topics of interest in bioanalysis. The 18 WRIB included 3 Main Workshops and 7 Specialized Workshops that together spanned 1 week to allow an exhaustive and thorough coverage of all major issues in bioanalysis of biomarkers, immunogenicity, gene therapy, cell therapy and vaccines.
View Article and Find Full Text PDF2024 White paper on recent issues in bioanalysis: Impact of LDT in US and IVDR in EU; AI/ML for High Parameter Flow Cytometry; The rise of Olink Technology; CDx for AAV Gene Therapies; Integrative Bioanalysis by Multiple Platforms; Super Sensitive ADA/NAb LBA ( - Recommendations on Advanced Strategies for Biomarkers, IVD/CDx Assays (BAV), Cell Based Assays (CBA), and Ligand-Binding Assays (LBA) - Regulatory Agencies' Input on Biomarkers, IVD/CDx, and Biomarker Assay Validation).
Bioanalysis
January 2025
Eli Lilly and Company, Indianapolis, IN, USA.
The 18th Workshop on Recent Issues in Bioanalysis (18th WRIB) took place in San Antonio, TX, USA on May 6-10, 2024. Over 1100 professionals representing pharma/biotech companies, CROs, and multiple regulatory agencies convened to actively discuss the most current topics of interest in bioanalysis. The 18th WRIB included 3 Main Workshops and 7 Specialized Workshops that together spanned 1 week to allow an exhaustive and thorough coverage of all major issues in bioanalysis of biomarkers, immunogenicity, gene therapy, cell therapy and vaccines.
View Article and Find Full Text PDFBayesian Borrowing With Multiple Heterogeneous Historical Studies Using Order Restricted Normalized Power Prior.
Stat Med
February 2025
U.S. Food and Drug Administration, Silver Spring, Maryland.
The recent U.S. Food and Drug Administration guidance on complex innovative trial designs acknowledges the use of Bayesian strategies to incorporate historical information based on clinical expertise and data similarity.
View Article and Find Full Text PDFSynthesis of Arginase Inhibitors: An Overview.
Pharmaceutics
January 2025
Department of Pharmacy, "Federico II" University of Naples, 80131 Naples, Italy.
Arginase (ARG) is a binuclear manganese-containing metalloenzyme that can convert L-arginine to L-ornithine and urea and plays a key role in the urea cycle. It also mediates different cellular functions and processes such as proliferation, senescence, apoptosis, autophagy, and inflammatory responses in various cell types. In mammals, there are two isoenzymes, ARG-1 and ARG-2; they are functionally similar, but their coding genes, tissue distribution, subcellular localization, and molecular regulation are distinct.
View Article and Find Full Text PDFAn Overview of Potential Applications of Environmentally Friendly Hybrid Polymeric Materials.
Polymers (Basel)
January 2025
Faculty of Environmental Engineering, University of Science and Technology, 50-013 Wrocław, Poland.
The applications of polymeric materials are being constantly reviewed and improved. In the present world, the word hybrid, and the general idea of combining two or more inherently different approaches, designs, and materials is gaining significant attention. The area of sustainable materials with a low environmental impact is also rapidly evolving with many new discoveries, including the use of materials of a natural origin and countless combinations thereof.
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