日期:
2020 年 — 2026 年
2020
2021
2022
2023
2024
2025
2026
影响因子:

2024 White Paper on Recent Issues in Bioanalysis: Evolution of Immunogenicity Assessment beyond ADA/NAb; Regulated Genomic/NGS Assays; Hypersensitivity Reactions; Minimum Noise Reduction; False Positive Range; Modernized Vaccine Approaches; NAb/TAb Correlation (PART 3A - Recommendations on Advanced Strategies for Molecular Assays and Immunogenicity of Gene Therapy, Cell Therapy, Vaccine; Biotherapeutics Immunogenicity Assessment & Clinical Relevance PART 3B - Regulatory Agencies' Input on Immun

2024 年生物分析最新问题白皮书:免疫原性评估超越 ADA/NAb 的演变;受监管的基因组/NGS 检测;超敏反应;最小噪声抑制;假阳性范围;现代化疫苗方法;NAb/TAb 相关性(第 3A 部分 - 关于基因治疗、细胞治疗、疫苗的分子检测和免疫原性的高级策略建议;生物治疗免疫原性评估和临床相关性;第 3B 部分 - 监管机构对免疫原性评估的意见)

Tounekti, Omar; Prior, Sandra; Wassmer, Sarah; Xu, Joshua; Wong, Adrian; Fang, Xiaodong; Sonderegger, Ivo; Smeraglia, John; Huleatt, James; Loo, LiNa; Beaver, Christopher; DelCarpini, Jason; Dessy, Francis; Diebold, Sandra; Fiscella, Michele; Garofolo, Fabio; Grimaldi, Christine; Gupta, Swati; Hou, Victor; Irwin, Chad; Jani, Dewal; Joseph, Julie; Kalina, Warren; Kar, Sumit; Kavita, Uma; Lu, Yanmei; Marshall, Jean-Claude; Mayer, Christian; Mora, Johanna; Nolan, Katrina; Peng, Kun; Riccitelli, Nathan; Scully, Ingrid; Seitzer, Jessica; Stern, Mark; Wadhwa, Meenu; Xu, Yuanxin; Verthelyi, Daniela; Sumner, Giane; Clements-Egan, Adrienne; Chen, Cecil; Gorovits, Boris; Torri, Albert; Baltrukonis, Daniel; Gunn, George; Ishii-Watabe, Akiko; Kramer, Daniel; Kubiak, Robert J; Mullins, Garrett; Pan, Luying; Partridge, Michael A; Poetzl, Johann; Rasamoelisolo, Michele; Sirtori, Federico Riccardi; Richards, Susan; Saad, Ola M; Shao, Weiping; Song, Yuan; Song, Sam; Staack, Roland F; Wu, Bonnie; Manangeeswaran, Mohanraj; Thacker, Seth

Field Study and Correlative Studies of Factor IX Variant FIX-R338L in Participants Treated with Fidanacogene Elaparvovec

接受菲达那基因埃拉帕沃韦治疗的参与者中因子IX变异体FIX-R338L的现场研究和相关性研究

Pittman, Debra D; Carrieri, Charles; Soares, Holly; McKay, John; Tan, Charles Y; Liang, John Z; Rakhe, Swapnil; Marshall, Jean-Claude; Murphy, John E; Gaitonde, Puneet; Rupon, Jeremy

2023 White Paper on Recent Issues in Bioanalysis: ISR for ADA Assays, the Rise of dPCR vs qPCR, International Reference Standards for Vaccine Assays, Anti-AAV TAb Post-Dose Assessment, NanoString Validation, ELISpot as Gold Standard (Part 3 - Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Biotherapeutics Immunogenicity & Risk Assessment; ADA/NAb Assay/Reporting Harmonization)

2023 年生物分析最新问题白皮书:ADA 检测的 ISR、dPCR 与 qPCR 的兴起、疫苗检测的国际参考标准、抗 AAV TAb 给药后评估、NanoString 验证、ELISpot 作为金标准(第三部分 - 关于基因治疗、细胞治疗、疫苗免疫原性和技术的建议;生物治疗免疫原性和风险评估;ADA/NAb 检测/报告协调)

Mora, Johanna; Palmer, Rachel; Wagner, Leslie; Wu, Bonnie; Partridge, Michael; Meena; Sonderegger, Ivo; Smeraglia, John; Bivi, Nicoletta; Dakappagari, Naveen; Diebold, Sandra; Garofolo, Fabio; Grimaldi, Christine; Kalina, Warren; Kamerud, John; Kar, Sumit; Marshall, Jean-Claude; Mayer, Christian; Melton, Andrew; Merdek, Keith; Nolan, Katrina; Picard, Serge; Shao, Weiping; Seitzer, Jessica; Tanaka, Yoichi; Tounekti, Omar; Vigil, Adam; Walravens, Karl; Xu, Joshua; Xu, Weifeng; Xu, Yuanxin; Yang, Lin; Zhu, Liang; Verthelyi, Daniela; Kubiak, Robert J; Coble, Kelly; Gupta, Swati; Abhari, Mohsen Rajabi; Richards, Susan; Song, Yuan; Ullmann, Martin; Calderon, Boris; Cludts, Isabelle; Gunn, George R; Gupta, Shalini; Ishii-Watabe, Akiko; Manangeeswaran, Mohanraj; Maxfield, Kimberly; McCush, Fred; O'Day, Christine; Peng, Kate; Poetzl, Johann; Rasamoelisolo, Michele; Saad, Ola M; Scheibner, Kara; Shubow, Sophie; Song, Sam; Thacker, Seth

Harmonization of Vaccine Ligand Binding Assays Validation

疫苗配体结合试验验证的协调统一

Dessy, Francis; Sonderegger, Ivo; Wagner, Leslie; Buoninfante, Alessandra; Wadhwa, Meenu; Agnes, Joseph; Aksyuk, Anastasia; Baclin, Angelique; Bonhomme, Marie; Cloney-Clark, Shane; Corsaro, Bart; Neto, João Tavares; Fries, Louis; Gagnon, Luc; Garofolo, Fabio; Giardina, Peter; Green, Tina; Guimera, Nuria; Harris, Shannon; Helmy, Roy; Huleatt, James; Ishii-Watabe, Akiko; Jaeger, Ralf; Jani, Dewal; Janssen, Sarah; Kierstead, Lisa; Makar, Karen; Marshall, Jean-Claude; Mayer, Christian; Mendes, Dulcyane Neiva; Murphy, Rocio; Nadarajah, Sankeetha; Nolan, Katrina; Plested, Joyce; Scully, Ingrid; Solstad, Therese; Stoop, Jeroen; Tan, Charles; Verch, Thorsten; Wilkins, Deidre; Xu, Arron; Zheng, Lingyi; Zhu, Mingzhu

Current challenges and opportunities for pharmacogenomics: perspective of the Industry Pharmacogenomics Working Group (I-PWG)

药物基因组学的当前挑战与机遇:产业药物基因组学工作组(I-PWG)的视角

Bienfait, Karina; Chhibber, Aparna; Marshall, Jean-Claude; Armstrong, Martin; Cox, Charles; Shaw, Peter M; Paulding, Charles

Evaluation of the Association of Polymorphisms With Palbociclib-Induced Neutropenia: Pharmacogenetic Analysis of PALOMA-2/-3

评估多态性与帕博西尼诱导的中性粒细胞减少症的关联性:PALOMA-2/-3 的药物遗传学分析

Iwata, Hiroji; Umeyama, Yoshiko; Liu, Yuan; Zhang, Zhe; Schnell, Patrick; Mori, Yuko; Fletcher, Olivia; Marshall, Jean-Claude; Johnson, Jillian G; Wood, Linda S; Toi, Masakazu; Finn, Richard S; Turner, Nicholas C; Bartlett, Cynthia Huang; Cristofanilli, Massimo

Meta-Analysis of Noncompartmental Pharmacokinetic Parameters of Ertugliflozin to Evaluate Dose Proportionality and UGT1A9 Polymorphism Effect on Exposure.

对 Ertugliflozin 非房室药代动力学参数进行荟萃分析,以评估剂量比例性和 UGT1A9 多态性对暴露的影响

Marshall Jean-Claude, Liang Yali, Sahasrabudhe Vaishali, Tensfeldt Thomas, Fediuk Daryl J, Zhou Susan, Krishna Rajesh, Dawra Vikas Kumar, Wood Linda S, Sweeney Kevin

The role of ADME pharmacogenomics in early clinical trials: perspective of the Industry Pharmacogenomics Working Group (I-PWG)

ADME药物基因组学在早期临床试验中的作用:产业药物基因组学工作组(I-PWG)的视角

Tremaine, Larry; Brian, William; DelMonte, Terrye; Francke, Stephan; Groenen, Peter; Johnson, Keith; Li, Lei; Pearson, Kimberly; Marshall, Jean-Claude

Toward more transparent and reproducible omics studies through a common metadata checklist and data publications

通过通用元数据清单和数据发布,实现更透明、更可重复的组学研究

Kolker, Eugene; Özdemir, Vural; Martens, Lennart; Hancock, William; Anderson, Gordon; Anderson, Nathaniel; Aynacioglu, Sukru; Baranova, Ancha; Campagna, Shawn R; Chen, Rui; Choiniere, John; Dearth, Stephen P; Feng, Wu-Chun; Ferguson, Lynnette; Fox, Geoffrey; Frishman, Dmitrij; Grossman, Robert; Heath, Allison; Higdon, Roger; Hutz, Mara H; Janko, Imre; Jiang, Lihua; Joshi, Sanjay; Kel, Alexander; Kemnitz, Joseph W; Kohane, Isaac S; Kolker, Natali; Lancet, Doron; Lee, Elaine; Li, Weizhong; Lisitsa, Andrey; Llerena, Adrian; Macnealy-Koch, Courtney; Marshall, Jean-Claude; Masuzzo, Paola; May, Amanda; Mias, George; Monroe, Matthew; Montague, Elizabeth; Mooney, Sean; Nesvizhskii, Alexey; Noronha, Santosh; Omenn, Gilbert; Rajasimha, Harsha; Ramamoorthy, Preveen; Sheehan, Jerry; Smarr, Larry; Smith, Charles V; Smith, Todd; Snyder, Michael; Rapole, Srikanth; Srivastava, Sanjeeva; Stanberry, Larissa; Stewart, Elizabeth; Toppo, Stefano; Uetz, Peter; Verheggen, Kenneth; Voy, Brynn H; Warnich, Louise; Wilhelm, Steven W; Yandl, Gregory

Massively parallel sequencing reveals an accumulation of de novo mutations and an activating mutation of LPAR1 in a patient with metastatic neuroblastoma

大规模平行测序揭示了转移性神经母细胞瘤患者体内存在大量新生突变和LPAR1激活突变。

Wei, Jun S; Johansson, Peter; Chen, Li; Song, Young K; Tolman, Catherine; Li, Samuel; Hurd, Laura; Patidar, Rajesh; Wen, Xinyu; Badgett, Thomas C; Cheuk, Adam T C; Marshall, Jean-Claude; Steeg, Patricia S; Vaqué Díez, José P; Yu, Yanlin; Gutkind, J Silvio; Khan, Javed