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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. Among authors: stevens c, stevens e. Bioanalysis. 2022 May;14(10):627-692. doi: 10.4155/bio-2022-0080. Epub 2022 May 17. Bioanalysis. 2022. PMID: 35578974
2022 White Paper on Recent Issues in Bioanalysis: Enzyme Assay Validation, BAV for Primary End Points, Vaccine Functional Assays, Cytometry in Tissue, LBA in Rare Matrices, Complex NAb Assays, Spectral Cytometry, Endogenous Analytes, Extracellular Vesicles Part 2 - Recommendations on Biomarkers/CDx, Flow Cytometry, Ligand-Binding Assays Development & Validation; Emerging Technologies; Critical Reagents Deep Characterization.
Sumner G, Keller S, Huleatt J, Staack RF, Wagner L, Azadeh M, Bandukwala A, Cao L, Du X, Salinas GF, Garofolo F, Harris S, Hopper S, Irwin C, Ji Q, Joseph J, King L, Kinhikar A, Lu Y, Luo R, Mabrouk O, Malvaux L, Marshall JC, McGuire K, Mikol V, Neely R, Qiu X, Saito Y, Salaun B, Scully I, Smeraglia J, Solstad T, Stoop J, Tang H, Teixeira P, Wang Y, Wright M, Mendez L, Beaver C, Eacret J, Au-Yeung A, Decman V, Dessy F, Eck S, Goihberg P, Alcaide EG, Gonneau C, Grugan K, Hedrick MN, Kar S, Sehra S, Stevens E, Stevens C, Sun Y, McCush F, Williams L, Fischer S, Wu B, Jordan G, Burns C, Cludts I, Coble K, Grimaldi C, Henderson N, Joyce A, Lotz G, Lu Y, Luo L, Neff F, Sperinde G, Stubenrauch KG, Wang Y, Ware M, Xu W. Sumner G, et al. Among authors: stevens c, stevens e. Bioanalysis. 2023 Aug;15(15):861-903. doi: 10.4155/bio-2023-0151. Epub 2023 Aug 16. Bioanalysis. 2023. PMID: 37584363
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: stevens e. Bioanalysis. 2024;16(8):179-220. doi: 10.1080/17576180.2024.2340961. Epub 2024 May 22. Bioanalysis. 2024. PMID: 38899739
Target Occupancy and Functional Inhibition of JAK3 and TEC Family Kinases by Ritlecitinib in Healthy Adults: An Open-Label, Phase 1 Study.
Martin DA, Telliez JB, Pleasic-Williams S, Zhang Y, Tierney B, Blatnik M, Gale JD, Banfield C, Zhou Y, Lejeune A, Zwillich SH, Stevens E, Tiwari N, Kieras E, Karanam A. Martin DA, et al. Among authors: stevens e. J Clin Pharmacol. 2024 Jan;64(1):67-79. doi: 10.1002/jcph.2347. Epub 2023 Sep 29. J Clin Pharmacol. 2024. PMID: 37691236 Clinical Trial.
A Phase 1, randomized, double-blind, placebo-controlled, single- and multiple-dose escalation study to evaluate the safety and pharmacokinetics/pharmacodynamics of PF-06835375, a C-X-C chemokine receptor type 5 directed antibody, in patients with systemic lupus erythematosus or rheumatoid arthritis.
Cohen S, Beebe JS, Chindalore V, Guan S, Hassan-Zahraee M, Saxena M, Xi L, Hyde C, Koride S, Levin R, Lubaczewski S, Salganik M, Sloan A, Stevens E, Peeva E, Vincent MS, Martin DA, Chu M. Cohen S, et al. Among authors: stevens e. Arthritis Res Ther. 2024 Jun 6;26(1):117. doi: 10.1186/s13075-024-03337-2. Arthritis Res Ther. 2024. PMID: 38845046 Free PMC article. Clinical Trial.
1,027 results