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论文共 20 篇作者统计合作学者相似作者

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CAMPSIITE™ Phase I/II/III: an Interim Clinical Study Update of RGX-121, an Investigational Gene Therapy for the Treatment of Neuronopathic Mucopolysaccharidosis Type II (MPS II)

Paul Harmatz,Can Ficicioglu,Roberto Giugliani,Deepa Rajan,Joseph Hagood,Michele Fiscella,Lin Yang,Michelle Gilmor,Yoonjin Cho,Caroline Mulatya,Dawn Phillips,Nidal Boulos,Paulo Falabella,Laura Pisani

MOLECULAR GENETICS AND METABOLISMno. 2 (2024)

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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; ..

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

Bioanalysisno. 7 (2024): 77-119

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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 Immunoge..

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

BIOANALYSIS（2024）

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Neutralizing Antibody Sample Testing and Report Harmonization

Darshana Jani,Michele Gunsior,Robin Marsden,Kyra J. Cowan,Susan C. Irvin, Laura Schild Hay, Bethany Ward, Luke Armstrong,Mitra Azadeh,Liching Cao,Rebecca Carmean,Jason DelCarpini,Sanjay L. Dholakiya,Amanda Hays, Sarah Hosback,Zheng Hu,Nadia Kulagina,Seema Kumar,Ching Ha Lai, Marit Lichtfuss, Hsing-Yin Liu,Susana Liu, Reza Mozaffari,Luying Pan,Jason Pennucci, Marie-Eve Poupart, Gurleen Saini,Veerle Snoeck,Kristine Storey, Amy Turner,Inna Vainshtein,Daniela Verthelyi, Iwona Wala,Lili Yang,Lin Yang

The AAPS Journal（2024）

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Best Practices for Development and Validation of Enzymatic Activity Assays to Support Drug Development for Inborn Errors of Metabolism and Biomarker Assessment

Mitra Azadeh, Jeremy Good,Michele Gunsior,Nadia Kulagina, Yanmei Lu,Jim McNally,Heather Myler,Yan G. Ni,Ryan Pelto, Karen J. Quadrini,Catherine Vrentas,Lin Yang

The AAPS Journalno. 5 (2024): 1-16

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RGX-202, an Investigational Gene Therapy for the Treatment of Duchenne Muscular Dystrophy: Interim Clinical Data (S21.005)

Aravindhan Veerapandiyan,Vamshi Rao,Jahannaz Dastgir,Paulo Falabella, Steve Pakola, Sarang Rastogi,Dawn Phillips, Catherine Wilson,Nidal Boulos,Michelle Gilmor,Lin Yang,Hiren Patel,Michele Fiscella,Olivier Danos

Neurologyno. 17_supplement_1 (2024)

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2022 White Paper on Recent Issues in Bioanalysis: FDA Draft Guidance on Immunogenicity Information in Prescription Drug Labeling, LNP & Viral Vectors Therapeutics/Vaccines Immunogenicity, Prolongation Effect, ADA Affinity, Risk-based Approaches, NGS, Qpcr, Ddpcr Assays (part 3-Recommendations on Gene Therapy, Cell Therapy, Vacci..

Luying Pan,Johanna Mora,Karl Walravens,Leslie Wagner,Shirley Hopper,Lina Loo, David Bettoun, Sarah Bond,Francis Dessy,Sean Downing,Fabio Garofolo,Soumi Gupta,Neil Henderson,Chad Irwin,Akiko Ishii-Watabe,Sumit Kar,Vibha Jawa,Julie Joseph,Ludovic Malvaux,Jean-Claude Marshall,Jessica McDevitt, Susovan Mohapatra,Jessica Seitzer,Justin Smith,Therese Solstad,Hiroshi Sugimoto,Omar Tounekti,Bonnie Wu,Yuling Wu,Yuanxin Xu,Joshua Xu,Takenori Yamamoto,Lin Yang,Albert Torri,Susan Kirshner,Kimberly Maxfield,Joao Pedras Vasconcelos,Mohsen Rajabi Abhari,Daniela Verthelyi,Eric Brodsky,Montserrat Carrasco-Triguero,John Kamerud,Matthew Andisik,Daniel Baltrukonis,Nicoletta Bivi,Isabelle Cludts,Kelly Coble,Boris Gorovits,George R. Gunn,Swati Gupta,Anders Holm Millner,Alison Joyce,Robert J. Kubiak,Seema Kumar,Karen Liao,Mohanraj Manangeeswaran,Michael Partridge,Samuel Pine,Johann Poetzl,Manoj Rajadhyaksha,Michele Rasamoelisolo,Susan Richards, Yuan Song,Steven Swanson,Seth Thacker,Meenu Wadhwa, Andreas Wolf,Lucia Zhang, Lin Zhou

Bioanalysisno. 14 (2023): 773-814

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RGX-111 Gene Therapy for the Treatment of Severe Mucopolysaccharidosis Type I (MPS I): Interim Analysis of Data from the First in Human Study

Raymond Y. Wang,Can H. Ficicioglu,Roberto Giugliani,Jenna Burke, Michele Fiscella,Lin Yang,Michelle Gilmor, Yoonjin Cho,Dawn Phillips,Paulo Falabella

Molecular Genetics and Metabolismno. 2 (2023): 107354-107354

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Anti-drug Antibody Sample Testing and Reporting Harmonization

Darshana Jani,Robin Marsden,Michele Gunsior, Laura Schild Hay, Bethany Ward,Kyra J. Cowan,Mitra Azadeh,Breann Barker,Liching Cao,Kristin R. Closson,Kelly Coble,Sanjay L. Dholakiya, Julie Dusseault,Amanda Hays, Carina Herl,Michael E. Hodsdon,Susan C. Irvin,Susan Kirshner,Gerry Kolaitis,Nadia Kulagina,Seema Kumar,Ching Ha Lai, Francesco Lipari,Susana Liu, Keith D. Merdek,Ioana R. Moldovan, Reza Mozaffari,Luying Pan,Corina Place,Veerle Snoeck,Marta Starcevic Manning,Dennis Stocker,Magdalena Tary-Lehmann, Amy Turner,Inna Vainshtein,Daniela Verthelyi,William T. Williams,Haoheng Yan,Weili Yan,Lili Yang,Lin Yang,Jennifer Zemo,Zhandong Don Zhong

The AAPS Journal（2022）

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