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Page 1
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: standifer n. Bioanalysis. 2022 May;14(10):627-692. doi: 10.4155/bio-2022-0080. Epub 2022 May 17. Bioanalysis. 2022. PMID: 35578974
Evaluation of assay interference and interpretation of CXCR4 receptor occupancy results in a preclinical study with MEDI3185, a fully human antibody to CXCR4.
Schwickart M, Chavez C, Henderson S, Vainshtein I, Standifer N, DelNagro C, Mehrzai F, Schneider A, Roskos L, Liang M. Schwickart M, et al. Among authors: standifer n. Cytometry B Clin Cytom. 2016 Mar;90(2):209-19. doi: 10.1002/cyto.b.21327. Epub 2015 Dec 15. Cytometry B Clin Cytom. 2016. PMID: 26384735 Free PMC article.
Moxetumomab pasudotox in relapsed/refractory hairy cell leukemia.
Kreitman RJ, Dearden C, Zinzani PL, Delgado J, Karlin L, Robak T, Gladstone DE, le Coutre P, Dietrich S, Gotic M, Larratt L, Offner F, Schiller G, Swords R, Bacon L, Bocchia M, Bouabdallah K, Breems DA, Cortelezzi A, Dinner S, Doubek M, Gjertsen BT, Gobbi M, Hellmann A, Lepretre S, Maloisel F, Ravandi F, Rousselot P, Rummel M, Siddiqi T, Tadmor T, Troussard X, Yi CA, Saglio G, Roboz GJ, Balic K, Standifer N, He P, Marshall S, Wilson W, Pastan I, Yao NS, Giles F. Kreitman RJ, et al. Among authors: standifer n. Leukemia. 2018 Aug;32(8):1768-1777. doi: 10.1038/s41375-018-0210-1. Epub 2018 Jul 20. Leukemia. 2018. PMID: 30030507 Free PMC article.
Safety, Efficacy, and Pharmacodynamics of Tremelimumab Plus Durvalumab for Patients With Unresectable Hepatocellular Carcinoma: Randomized Expansion of a Phase I/II Study.
Kelley RK, Sangro B, Harris W, Ikeda M, Okusaka T, Kang YK, Qin S, Tai DW, Lim HY, Yau T, Yong WP, Cheng AL, Gasbarrini A, Damian S, Bruix J, Borad M, Bendell J, Kim TY, Standifer N, He P, Makowsky M, Negro A, Kudo M, Abou-Alfa GK. Kelley RK, et al. Among authors: standifer n. J Clin Oncol. 2021 Sep 20;39(27):2991-3001. doi: 10.1200/JCO.20.03555. Epub 2021 Jul 22. J Clin Oncol. 2021. PMID: 34292792 Free PMC article. Clinical Trial.
Safety and Clinical Activity of MEDI1873, a Novel GITR Agonist, in Advanced Solid Tumors.
Balmanoukian AS, Infante JR, Aljumaily R, Naing A, Chintakuntlawar AV, Rizvi NA, Ross HJ, Gordon M, Mallinder PR, Elgeioushi N, González-García I, Standifer N, Cann J, Durham N, Rahimian S, Kumar R, Denlinger CS. Balmanoukian AS, et al. Among authors: standifer n. Clin Cancer Res. 2020 Dec 1;26(23):6196-6203. doi: 10.1158/1078-0432.CCR-20-0452. Epub 2020 Sep 4. Clin Cancer Res. 2020. PMID: 32887725 Clinical Trial.
A Consideration of Fixed Dosing Versus Body Size-Based Dosing Strategies for Chimeric Antigen Receptor T-Cell Therapies.
He JZ, Wang H, Lim K, Ren S, Rollins F, Vallaster M, Wong R, Stebbings R, Standifer N, Keefe R, Phipps A, Gibbs M. He JZ, et al. Among authors: standifer n. Clin Pharmacol Drug Dev. 2022 Oct;11(10):1130-1135. doi: 10.1002/cpdd.1171. Epub 2022 Sep 12. Clin Pharmacol Drug Dev. 2022. PMID: 36094760 Free PMC article. No abstract available.
Circulating Immune Cell and Outcome Analysis from the Phase II Study of PD-L1 Blockade with Durvalumab for Newly Diagnosed and Recurrent Glioblastoma.
Nayak L, Standifer N, Dietrich J, Clarke JL, Dunn GP, Lim M, Cloughesy T, Gan HK, Flagg E, George E, Gaffey S, Hayden J, Holcroft C, Wen PY, Macri M, Park AJ, Ricciardi T, Ryan A, Schwarzenberger P, Venhaus R, Reyes ML, Durham NM, Creasy T, Huang RY, Kaley T, Reardon DA. Nayak L, et al. Among authors: standifer n. Clin Cancer Res. 2022 Jun 13;28(12):2567-2578. doi: 10.1158/1078-0432.CCR-21-4064. Clin Cancer Res. 2022. PMID: 35395080 Free PMC article. Clinical Trial.
34 results