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| http://dx.doi.org/10.3389/fpls.2020.01293 | DOI Listing |
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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 PDFImplications and Lessons from the Withdrawal of Sacituzumab Govitecan for Treating Advanced Urothelial Carcinoma.
Eur Urol Oncol
January 2025
Division of Hematology and Oncology, Department of Medicine, University of California, Irvine Orange CA USA.
The recent withdrawal of sacituzumab govitecan for advanced urothelial carcinoma has revealed several implications, including concerns over a lack of remaining effective treatment options, reimbursement, supportive care measures (such as granulocyte-colony stimulating factor), dose reductions, and inconsistencies with related historical regulatory decisions.
View Article and Find Full Text PDFESAT-6 protein suppresses allograft rejection by inducing CD4Foxp3 regulatory T cells through IκBα/cRel pathway.
Front Immunol
January 2025
Section of Immunology, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China.
Background: Maintenance immunosuppression is required for suppression of alloimmunity or allograft rejection. However, continuous use of immunosuppressants may lead to various side effects, necessitating the use of alternative immunosuppressive drugs. The early secreted antigenic target of 6 kDa (ESAT-6) is a virulence factor and immunoregulatory protein of mycobacterium tuberculosis (Mtb), which alters host immunity through dually regulating development or activation of various immune cells.
View Article and Find Full Text PDFEvidence for direct dopaminergic connections between substantia nigra pars compacta and thalamus in young healthy humans.
Front Neural Circuits
January 2025
Department of Advanced Medical and Surgical Sciences, Advanced MRI Research Center, University of Campania "Luigi Vanvitelli", Naples, Italy.
The substantia nigra pars compacta (SNc), one of the main dopaminergic nuclei of the brain, exerts a regulatory function on the basal ganglia circuitry via the nigro-striatal pathway but its possible dopaminergic innervation of the thalamus has been only investigated in non-human primates. The impossibility of tract-tracing studies in humans has boosted advanced MRI techniques and multi-shell high-angular resolution diffusion MRI (MS-HARDI) has promised to shed more light on the structural connectivity of subcortical structures. Here, we estimated the possible dopaminergic innervation of the human thalamus via an MS-HARDI tractography of the SNc in healthy human young adults.
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