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2021 White Paper on Recent Issues in Bioanalysis: ISR for Biomarkers, Liquid Biopsies, Spectral Cytometry, Inhalation/Oral & Multispecific Biotherapeutics, Accuracy/LLOQ for Flow Cytometry (Part 2 - Recommendations on Biomarkers/CDx Assays Development & Validation, Cytometry Validation & Innovation, Biotherapeutics PK LBA Regulated Bioanalysis, Critical Reagents & Positive Controls Generation).
Hersey S, Keller S, Mathews J, King L, Bandukwala A, Berisha F, Birchler M, Bower J, Clausen V, Duarte J, Garofolo F, Hopper S, Kar S, Mabrouk O, Marshall JC, McGuire K, Naughton M, Saito Y, Schuhmann I, Sperinde G, Teixeira P, Vitaliti A, Wang YM, Wnek R, Zhang Y, Spitz S, Decman V, Eck S, Estevam J, Goihberg P, Alcaide EG, Gonneau C, Hedrick MN, Hopkins G, Junker F, Nuti S, Sommer U, Standifer N, Stevens C, Stevens E, Hendricks C, Wadhwa M, Torri A, Ma M, Harris S, Kumar S, Partridge MA, Caiazzo T, Chilewski S, Cludts I, Coble K, Gorovits B, Grimaldi C, Jordan G, Kamerud J, Leary B, Liang M, Lim H, Mayer A, O'Connor E, Palackal N, Poetzl J, Prior S, Abhari MR, Savoie N, Soo C, Ware M, Wu B, Xu Y, Yang TY, Zoghbi J. Hersey S, et al. Bioanalysis. 2022 May;14(10):627-692. doi: 10.4155/bio-2022-0080. Epub 2022 May 17. Bioanalysis. 2022. PMID: 35578974
Urinary Proteomics and Outcomes in Heart Failure With Preserved Ejection Fraction.
Carland C, Zhao L, Salman O, Cohen JB, Zamani P, Xiao Q, Dongre A, Wang Z, Ebert C, Greenawalt D, van Empel V, Richards AM, Doughty RN, Rietzschel E, Javaheri A, Wang Y, Schafer PH, Hersey S, Carayannopoulos LN, Seiffert D, Chang CP, Gordon DA, Ramirez-Valle F, Mann DL, Cappola TP, Chirinos JA. Carland C, et al. Among authors: hersey s. J Am Heart Assoc. 2024 May 7;13(9):e033410. doi: 10.1161/JAHA.123.033410. Epub 2024 Apr 19. J Am Heart Assoc. 2024. PMID: 38639358 Free PMC article. Clinical Trial.
2023 White Paper on Recent Issues in Bioanalysis: EU IVDR 2017/746 Implementation/Impact, IVD/CDx/CLIA Approved Assays, High Dimensional Cytometry, Multiplexing Technologies, LBA Tissue Analysis, Vaccine Study Endpoints, Cell-Based Assays for Biomarkers, Cell Therapy and Vaccines (PART 2 - Recommendations on Development & Validation of Biomarkers, IVD, CDx, Cell-Based, Flow Cytometry, Ligand-Binding and Enzyme Assays; Advanced Critical Reagents Strategies).
Kholmanskikh O, Wang YM, Hersey S, Wadhwa M, Block K, Bandukwala A, Szapacs M, Weiner R, Awwad K, Dessy F, Downing S, Du X, Garofolo F, Harris S, Hou V, Jones J, Kar S, Kinhikar A, Li M, Mathews J, Meissen J, Sumner GO, Pan L, Sanderink G, Scully I, Stanta J, Tanaka Y, Vauleon S, Wagner L, Wang K, Zhu L, Eck S, Lin YD, Azadeh M, Decman V, Diebold S, Du X, Goihberg P, Alcaide EG, Gonneau C, Hedrick MN, Hopkins G, Kar S, Loschko J, McCausland M, Mendez L, Sehra S, Stevens E, Sun YS, Tangri S, Trampont PC, Cludts I, Dysinger M, Kavita U, Sugimoto H, Chilewski S, Grimaldi C, Jiang Y, Kamerud J, Liu S, Owen C, Palackal N, Petit-Frere C, Pine S, Abhari MR, Scheibner K, Williams L, Xu T, Zhang G. Kholmanskikh O, et al. Among authors: hersey s. Bioanalysis. 2024;16(8):179-220. doi: 10.1080/17576180.2024.2340961. Epub 2024 May 22. Bioanalysis. 2024. PMID: 38899739
A call to adapt the regulation of HLA testing for T cell receptor-based therapeutics.
Meyer M, Mahr A, Brewer J, Daniel V, Dell'Aringa J, Goldstone T, Hersey S, Johnston I, Larson P, Loveridge M, MacBeath G, Moyer M, Nagorsen D, Papa S, Peiser L, Ranade K, Rizzi R, Roers A, Schendel D, Sivakumar P, Tran E, Türeci Ö, Weigand L, Wennborg A, Williams D, Yee C, Britten CM. Meyer M, et al. Among authors: hersey s. Nat Rev Drug Discov. 2024 Jan;23(1):1-2. doi: 10.1038/d41573-023-00189-4. Nat Rev Drug Discov. 2024. PMID: 38030734 No abstract available.
138 results