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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: mcguire k. Bioanalysis. 2022 May;14(10):627-692. doi: 10.4155/bio-2022-0080. Epub 2022 May 17. Bioanalysis. 2022. PMID: 35578974
2020 White Paper on Recent Issues in Bioanalysis: BAV Guidance, CLSI H62, Biotherapeutics Stability, Parallelism Testing, CyTOF and Regulatory Feedback (Part 2A - Recommendations on Biotherapeutics Stability, PK LBA Regulated Bioanalysis, Biomarkers Assays, Cytometry Validation & Innovation Part 2B - Regulatory Agencies' Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine).
Spitz S, Zhang Y, Fischer S, McGuire K, Sommer U, Amaravadi L, Bandukwala A, Eck S, Garofolo F, Islam R, Jordan G, King L, Saito Y, Sumner G, Terry L, Vitaliti A, Wang YM, Grimaldi C, Joyce A, Palmer R, Andisik M, Araya M, Azadeh M, Baltrukonis D, Elliott R, Haidar S, Kumar S, Mayer A, Neff F, Palackal N, Peng K, Abhari MR, Satterwhite C, Savoie N, Soo C, Vinter S, Welink J, Yan W, Maher K, Lanham D, Bertholet S, Dakappagari N, Gonneau C, Green C, Junker F, Kar S, Patti-Diaz L, Sarikonda S, McCausland M, Teixeira PC, Decman V, Estevam J, Hedrick M, Robert AH, Hopkins G, Nuti S, Tangri S, Wnek R, Dandamudi S, Dasgupta A, Edmison A, Faustino P, McGuinness M, Lima Santos GM, Mirza T, Shakleya D, Stojdl S, Tampal N, Zhang J, Cherry E, Cludts I, Exley A, Ishii-Watabe A, Kirshner S, Pedras-Vasconcelos J, Shen M, Siggers R, Solstad T, Verthelyi D, Yan H, Zhang L. Spitz S, et al. Among authors: mcguire k. Bioanalysis. 2021 Mar;13(5):295-361. doi: 10.4155/bio-2021-0005. Epub 2021 Jan 29. Bioanalysis. 2021. PMID: 33511867
2021 White Paper on Recent Issues in Bioanalysis: TAb/NAb, Viral Vector CDx, Shedding Assays; CRISPR/Cas9 & CAR-T Immunogenicity; PCR & Vaccine Assay Performance; ADA Assay Comparability & Cut Point Appropriateness (Part 3 - Recommendations on Gene Therapy, Cell Therapy, Vaccine Assays; Immunogenicity of Biotherapeutics and Novel Modalities; Integrated Summary of Immunogenicity Harmonization).
Loo L, Harris S, Milton M, Meena, Lembke W, Berisha F, Bertholet S, Dessy F, Dodge R, Fang X, Fiscella M, Garofolo F, Gorovits B, Gupta S, Jawa V, Ishii-Watabe A, Long B, Lu Y, Mack T, McGuire K, Nolan K, Pan L, Potthoff B, Purushothama S, Smith D, Solstad T, Sonderegger I, Taddeo F, Tangri S, Wagner L, Wu B, Xu Y, Kirshner S, Verthelyi D, Yan H, Maxfield K, Pedras-Vasconcelos J, Abhari MR, Gupta S, Wu Y, Rajadhyaksha M, Andisik M, Baltrukonis D, Cherry E, Cludts I, Gunn G, Millner AH, Jordan G, Kar S, Kubiak R, Lotz GP, Palmer R, Peng K, Poetzl J, Richards S, Savoie N, Staack RF, Stubenrauch K, Wadhwa M, Waxenecker G, Yang TY, Zhang L. Loo L, et al. Among authors: mcguire k. Bioanalysis. 2022 Jun;14(11):737-793. doi: 10.4155/bio-2022-0081. Epub 2022 May 17. Bioanalysis. 2022. PMID: 35578991
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: mcguire k. Bioanalysis. 2023 Aug;15(15):861-903. doi: 10.4155/bio-2023-0151. Epub 2023 Aug 16. Bioanalysis. 2023. PMID: 37584363
Regulatory interactions between APOBEC3B N- and C-terminal domains.
Braza MKE, Demir Ö, Ahn SH, Morris CK, Calvó-Tusell C, McGuire KL, de la Peña Avalos B, Carpenter MA, Chen Y, Casalino L, Aihara H, Herzik MA, Harris RS, Amaro RE. Braza MKE, et al. Among authors: mcguire kl. bioRxiv [Preprint]. 2024 Dec 12:2024.12.11.628032. doi: 10.1101/2024.12.11.628032. bioRxiv. 2024. PMID: 39713448 Free PMC article. Preprint.
Patient-Reported Outcomes for Low-Risk Ductal Carcinoma In Situ: A Secondary Analysis of the COMET Randomized Clinical Trial.
Partridge AH, Hyslop T, Rosenberg SM, Bennett AV, Drier S, Jonsson M, Shimada A, Li Y, Li Y, Lynch T, Frank E, Collyar D, Basila D, Pinto D, Weiss A, Wolf A, Norris K, Witten M, Boisvert M, Giuliano A, Larson KE, Yost K, McAuliffe PF, Krie A, Tamirisa N, Darai S, Carey L, Thompson A, Hwang ES; COMET Study Consortium. Partridge AH, et al. JAMA Oncol. 2024 Dec 12. doi: 10.1001/jamaoncol.2024.6556. Online ahead of print. JAMA Oncol. 2024. PMID: 39665588
Active Monitoring With or Without Endocrine Therapy for Low-Risk Ductal Carcinoma In Situ: The COMET Randomized Clinical Trial.
Hwang ES, Hyslop T, Lynch T, Ryser MD, Weiss A, Wolf A, Norris K, Witten M, Grimm L, Schnitt S, Badve S, Factor R, Frank E, Collyar D, Basila D, Pinto D, Watson MA, West R, Davies L, Donovan JL, Shimada A, Li Y, Li Y, Bennett AV, Rosenberg S, Marks J, Winer E, Boisvert M, Giuliano A, Larson KE, Yost K, McAuliffe PF, Krie A, Tamirisa N, Carey LA, Thompson AM, Partridge AH; COMET Study Investigators. Hwang ES, et al. JAMA. 2024 Dec 12. doi: 10.1001/jama.2024.26698. Online ahead of print. JAMA. 2024. PMID: 39665585
Enhancing reproducibility in single cell research with biocytometry: An inter-laboratory study.
Fikar P, Alvarez L, Berne L, Cienciala M, Kan C, Kasl H, Luo M, Novackova Z, Ordonez S, Sramkova Z, Holubova M, Lysak D, Avery L, Caro AA, Crowder RN, Diaz-Martinez LA, Donley DW, Giorno RR, Reed IKG, Hensley LL, Johnson KC, Kim AY, Kim P, LaGier AJ, Newman JJ, Padilla-Crespo E, Reyna NS, Tsotakos N, Al-Saadi NN, Appleton T, Arosemena-Pickett A, Bell BA, Bing G, Bishop B, Forde C, Foster MJ, Gray K, Hasley BL, Johnson K, Jones DJ, LaShall AC, McGuire K, McNaughton N, Morgan AM, Norris L, Ossman LA, Rivera-Torres PA, Robison ME, Thibodaux K, Valmond L, Georgiev D. Fikar P, et al. Among authors: mcguire k. PLoS One. 2024 Dec 9;19(12):e0314992. doi: 10.1371/journal.pone.0314992. eCollection 2024. PLoS One. 2024. PMID: 39652549 Free PMC article.
431 results