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 <u>(Part 3</u> – Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Biotherapeutics Immunogenicity & Risk Assessment; ADA/NAb Assay/Reporting Harmonization)
Johanna Mora(Bristol-Myers Squibb (United States)), Christine O’Day(Seagen (Canada)), Kimberly Maxfield(Southwestern Medical Center), Karl Walravens(GlaxoSmithKline (Belgium)), Swati Gupta(AbbVie (United States)), Jessica Seitzer(Intellia Therapeutics (United States)), Katrina M. Nolan(Merck & Co., Inc., Rahway, NJ, USA (United States)), Boris Calderón(Eli Lilly (United States)), Bonnie Wu(Janssen (United States)), Ivo Sonderegger(Takeda (Switzerland)), Serge Picard(Bristol-Myers Squibb (Germany)), Weifeng Xu(Merck & Co., Inc., Rahway, NJ, USA (United States)), Mohsen Rajabi Abhari(United States Food and Drug Administration), Mohanraj Manangeeswaran(Center for Drug Evaluation and Research), Christian Mayer(Austrian Agency for Health and Food Safety), Joshua Xu(National Center for Toxicological Research), John Kamerud(Pfizer (United States)), Fred McCush(Pfizer (United States)), Daniela Verthelyi(Center for Drug Evaluation and Research), John Smeraglia(AstraZeneca (United Kingdom)), Lin Yang(Regenxbio (United States)), Adam Vigil(Boehringer Ingelheim (United States)), Yuanxin Xu(Nanjing University of Chinese Medicine), Kelly Coble(Boehringer Ingelheim (United States)), Akiko Ishii‐Watabe(National Institute of Health Sciences), Liang Zhu(Moderna Therapeutics (United States)), Yoïchi Tanaka(Mercy Willard Hospital), Naveen Dakappagari(Navidea Biopharmaceuticals (United States)), Sumit Kar, Martin Ullmann(Fresenius (Germany)), Shalini Gupta(Amgen (United States)), Keith D. Merdek(University of Massachusetts Chan Medical School), George R. Gunn(GlaxoSmithKline (United States)), Fabio Garofolo(Vancouver Native Health Society), Warren V. Kalina(Pfizer (United States)), Sandra S. Diebold(Montana Health Research Institute), Omar Tounekti(Centre National de la Recherche Scientifique), Weiping Shao(AstraZeneca (United Kingdom)), Nicoletta Bivi(Eli Lilly (United States)), Isabelle Cludts(NIHR Research Delivery Network), Yuan Song(Nanchang University), Michael A. Partridge(Regeneron (United States)), Susan Richards(MRC Clinical Trials Unit at UCL), Jean‐Claude Marshall(Pfizer (United States)), Leslie Wagner(United States Food and Drug Administration), Andrew C. Melton(BioMarin (United States)), Christine Grimaldi(Boehringer Ingelheim (United States)), Meena Meena, Rachel Palmer(Sanofi (United States))
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