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2025 White Paper on Recent Issues in Bioanalysis: Biomarkers Calibrators & Stability; Evaluation of NULISA; Neurofilament & Autoantibody Biomarker Assays; Removing IgM Interference; ELISpot & FluoroSpot Best Practices; Modular HD Cytometry; Single-cell Analysis Imaging Cytometry (PART 2A-Recommendations on Biomarkers Discovery, Development, Validation & Regulatory Approval, Ligand-Binding Assays (LBA) and Cell-Based Assays (CBA) PART 2B-Regulatory Agencies' Input on Biomarkers, IVD/CDx and Biomarker Assay Validation (BAV)) 2025年生物分析近期问题白皮书：生物标志物校准与稳定性；NULISA评估；神经丝蛋白与自身抗体生物标志物检测；去除IgM干扰；ELISpot与FluoroSpot最佳实践；模块化高维度细胞计数；单细胞分析成像细胞计数（第二部分A-关于生物标志物发现、开发、验证与监管批准、配体结合检测（LBA）和细胞基础检测（CBA）的建议；第二部分B-监管机构对生物标志物、体外诊断（IVD）/伴随诊断（CDx）和生物标志物检测验证（BAV）的反馈） Hersey, Sarah; McGuire, Kristina; Kholmanskikh, Olga; Bivi, Nicoletta; Bandukwala, Abbas; Gong, Binsheng; Irwin, Chad; Ray, Soma; Gunsior, Michele; Avanesov, Andrei; Baker, Brian; Bond, Sarah; Braun, Alexander; Buoninfante, Alessandra; Dessy, Francis; Fang, Xiaodong; Garofolo, Fabio; Gomme, Emily; Hays, Amanda; King, Lindsay; Mayer, Christian; McGregor, Jessica; McHenry, Melis; Nowocin, Anna; Rubel, Carrie; Sanderink, Gerard; Scott, Bradley; Scully, Ingrid; Seyda, Agnes; Stoop, Jeroen; Tang, Huaping; Tavares Neto, Joao; Walravens, Karl; Wang, Kai; Wassmer, Sarah; Xiao, Wenming; Zhu, Liang; Zoghbi, Jad; Brockus, Catherine; Petit-Frere, Corinne; Coble, Kelly; Fischer, Sally; Yearwood, Graham; Cao, Liching; Dysinger, Mark; Grimaldi, Christine; Jiang, Yong; Joyce, Alison; Kerridge, Claire; Lu, Kun; McCush, Fred; Nolan, Katrina; O'Connor, Ellen; Palmer, Rachel; Reese, Kimberly; Stubenrauch, Kay-Gunnar; Verch, Thorsten; Beaver, Christopher; Mendez, Luis; Decman, Vilma; Bhavaraju, Kamala; Huleatt, James; Trampont, Paul C.; Eck, Steven; Goihberg, Polina; Alcaide, Enrique Gomez; Hedrick, Michael Nathan; Jalah, Rashmi; McGrath, Shannon; Ogorman, William; Prior, Sandra; Sehra, Sarita; Shaik, Saleem; Standifer, Nathan; Stevens, Chad; Stevens, Erin; Sun, Yongliang (Steve) 分享 收藏
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Therapeutic Drug Monitoring of Biologics: Current Practice, Challenges and Opportunities - a Workshop Report Shubow, Sophie; Gunsior, Michele; Rosenberg, Amy; Wang, Yow-Ming; Altepeter, Tara; Guinn, Daphne; Rajabiabhari, Mohsen; Kotarek, Joseph; Mould, Diane R.; Zhou, Honghui; Cheifetz, Adam S.; Garces, Sandra; Chevalier, Rachel; Gavan, Sean; Trusheim, Mark R.; Rispens, Theo; Bray, Kurtis; Partridge, Michael A. 分享 收藏
Neutralizing Antibody Sample Testing and Report Harmonization (vol 26, 80, 2024) Jani, Darshana; Gunsior, Michele; Marsden, Robin; Cowan, Kyra J.; Irvin, Susan C.; Hay, Laura Schild; Ward, Bethany; Armstrong, Luke; Azadeh, Mitra; Cao, Liching; Carmean, Rebecca; Delcarpini, Jason; Dholakiya, Sanjay L.; Hays, Amanda; Hosback, Sarah; Hu, Zheng; Kulagina, Nadia; Kumar, Seema; Lai, Ching Ha; Lichtfuss, Marit; Liu, Hsing-Yin; Liu, Susana; Mozaffari, Reza; Pan, Luying; Pennucci, Jason; Poupart, Marie-Eve; Saini, Gurleen; Snoeck, Veerle; Storey, Kristine; Turner, Amy; Vainshtein, Inna; Verthelyi, Daniela; Wala, Iwona; Yang, Lili; Yang, Lin 分享 收藏
B cell and aquaporin-4 antibody relationships with neuromyelitis optica spectrum disorder activity Bennett, Jeffrey L.; Pittock, Sean J.; Paul, Friedemann; Kim, Ho Jin; Irani, Sarosh R.; O'Connor, Kevin C.; Patterson, Kristina R.; Smith, Michael A.; Gunsior, Michele; Mittereder, Nanette; Rees, William A.; Cimbora, Daniel; Cree, Bruce A. C. 分享 收藏
Best Practices for Development and Validation of Enzymatic Activity Assays to Support Drug Development for Inborn Errors of Metabolism and Biomarker Assessment Azadeh, Mitra; Good, Jeremy; Gunsior, Michele; Kulagina, Nadia; Lu, Yanmei; McNally, Jim; Myler, Heather; Ni, Yan G.; Pelto, Ryan; Quadrini, Karen J.; Vrentas, Catherine; Yang, Lin 分享 收藏
Neutralizing Antibody Sample Testing and Report Harmonization Jani, Darshana; Gunsior, Michele; Marsden, Robin; Cowan, Kyra J.; Irvin, Susan C.; Hay, Laura Schild; Ward, Bethany; Armstrong, Luke; Azadeh, Mitra; Cao, Liching; Carmean, Rebecca; DelCarpini, Jason; Dholakiya, Sanjay L.; Hays, Amanda; Hosback, Sarah; Hu, Zheng; Kulagina, Nadia; Kumar, Seema; Lai, Ching Ha; Lichtfuss, Marit; Liu, Hsing-Yin; Liu, Susana; Mozaffari, Reza; Pan, Luying; Pennucci, Jason; Poupart, Marie-Eve; Saini, Gurleen; Snoeck, Veerle; Storey, Kristine; Turner, Amy; Vainshtein, Inna; Verthelyi, Daniela; Wala, Iwona; Yang, Lili; Yang, Lin 分享 收藏
Serum neurofilament light chain levels at attack predict post-attack disability worsening and are mitigated by inebilizumab: analysis of four potential biomarkers in neuromyelitis optica spectrum disorder 发作时的血清神经丝轻链水平可预测发作后残疾的恶化，并通过inebilizumab缓解: 视神经脊髓炎谱系障碍的四种潜在生物标志物分析 Aktas, Orhan; Hartung, Hans-Peter; Smith, Michael A.; Rees, William A.; Fujihara, Kazuo; Paul, Friedemann; Marignier, Romain; Bennett, Jeffrey L.; Kim, Ho Jin; Weinshenker, Brian G.; Pittock, Sean J.; Wingerchuk, Dean M.; Cutter, Gary; She, Dewei; Gunsior, Michele; Cimbora, Daniel; Katz, Eliezer; Cree, Bruce A.; N-MOmentum Study Investigators 分享 收藏
Association between B-cell depletion and attack risk in neuromyelitis optica spectrum disorder: An exploratory analysis from N-MOmentum, a double-blind, randomised, placebo-controlled, multicentre phase 2/3 trial Bennett, Jeffrey L.; Aktas, Orhan; Rees, William A.; Smith, Michael A.; Gunsior, Michele; Yan, Li; She, Dewei; Cimbora, Daniel; Pittock, Sean J.; Weinshenker, Brian G.; Paul, Friedemann; Marignier, Romain; Wingerchuk, Dean; Cutter, Gary; Green, Ari; Hartung, Hans-Peter; Kim, Ho Jin; Fujihara, Kazuo; Levy, Michael; Katz, Eliezer; Cree, Bruce A. C.; N-MOmentum Study Investigator 分享 收藏
Anti-drug Antibody Sample Testing and Reporting Harmonization Jani, Darshana; Marsden, Robin; Gunsior, Michele; Hay, Laura Schild; Ward, Bethany; Cowan, Kyra J.; Azadeh, Mitra; Barker, Breann; Cao, Liching; Closson, Kristin R.; Coble, Kelly; Dholakiya, Sanjay L.; Dusseault, Julie; Hays, Amanda; Herl, Carina; Hodsdon, Michael E.; Irvin, Susan C.; Kirshner, Susan; Kolaitis, Gerry; Kulagina, Nadia; Kumar, Seema; Lai, Ching Ha; Lipari, Francesco; Liu, Susana; Merdek, Keith D.; Moldovan, Ioana R.; Mozaffari, Reza; Pan, Luying; Place, Corina; Snoeck, Veerle; Manning, Marta Starcevic; Stocker, Dennis; Tary-Lehmann, Magdalena; Turner, Amy; Vainshtein, Inna; Verthelyi, Daniela; Williams, William T.; Yan, Haoheng; Yan, Weili; Yang, Lili; Yang, Lin; Zemo, Jennifer; Zhong, Zhandong Don 分享 收藏
Depleting plasmacytoid dendritic cells reduces local type I interferon responses and disease activity in patients with cutaneous lupus Karnell, Jodi L.; Wu, Yanping; Mittereder, Nanette; Smith, Michael A.; Gunsior, Michele; Yan, Li; Casey, Kerry A.; Henault, Jill; Riggs, Jeffrey M.; Nicholson, Simone M.; Sanjuan, Miguel A.; Vousden, Katherine A.; Werth, Victoria P.; Drappa, Jorn; Illei, Gabor G.; Rees, William A.; Ratchford, John N. 分享 收藏
The enhanced immunopharmacology of VIB4920, a novel Tn3 fusion protein and CD40L antagonist, and assessment of its safety profile in cynomolgus monkeys Nicholson, Simone M.; Casey, Kerry A.; Gunsior, Michele; Drabic, Stacey; Iverson, William; Cook, Halie; Scott, Stephen; O'Day, Terry; Karanth, Subramanya; Dixit, Rakesh; Ryan, Patricia C. 分享 收藏
A CD40L-targeting protein reduces autoantibodies and improves disease activity in patients with autoimmunity Karnell, Jodi L.; Albulescu, Marius; Drabic, Stacey; Wang, Liangwei; Moate, Rachel; Baca, Manuel; Oganesyan, Vaheh; Gunsior, Michele; Thisted, Thomas; Yan, Li; Li, Jing; Xiong, Ximing; Eck, Steven C.; de los Reyes, Melissa; Yusuf, Isharat; Streicher, Katie; Mueller-Ladner, Ulf; Howe, David; Ettinger, Rachel; Herbst, Ronald; Drappa, Jorn 分享 收藏
SAFETY, PHARMACOKINETICS, PHARMACODYNAMICS AND INHIBITION OF T-CELL DEPENDENT ANTIBODY RESPONSE (TDAR) WITH MEDI4920, A NOVEL, ENGINEERED CD40 LIGAND (CD40L) ANTAGONIST: RESULTS OF A FIRST-TIME-IN-HUMAN STUDY Albulescu, M. G.; Gunsior, M.; Li, J.; Bush, J.; Godwood, A.; Miday, R.; Grant, E.; Howe, D.; Faggioni, R.; Roskos, L. 分享 收藏
Highly homologous hS100A15 and hS100A7 proteins are distinctly expressed in normal breast tissue and breast cancer Wolf, Ronald; Voscopoulos, Christopher; Winston, Jason; Dharamsi, Alif; Goldsmith, Paul; Gunsior, Michele; Vonderhaar, Barbara K.; Olson, Melanie; Watson, Peter H.; Yuspa, Stuart H. 分享 收藏
Asparagine synthetase is a predictive biomarker of L-asparaginase activity in ovarian cancer cell lines Lorenzi, Philip L.; Llamas, Jenny; Gunsior, Michele; Ozbun, Laurent; Reinhold, William C.; Varma, Sudhir; Ji, Helen; Kim, Hijoo; Hutchinson, Amy A.; Kohn, Elise C.; Goldsmith, Paul K.; Birrer, Michael J.; Weinstein, John N. 分享 收藏
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