2021 White Paper on Recent Issues in Bioanalysis: TAb/NAb, Viral Vector CDx, Shedding Assays; CRISPR/Cas9 & CAR-T Immunogenicity; PCR & Vaccine Assay Performance; ADA Assay Comparability & Cut Point Appropriateness ( <u>Part 3</u> – Recommendations on Gene Therapy, Cell Therapy, Vaccine Assays; Immunogenicity of Biotherapeutics and Novel Modalities; Integrated Summary of Immunogenicity Harmonization)
LiNa Loo(Vertex Pharmaceuticals (United States)), Robert Kubiak(Boehringer Ingelheim (Germany)), Katrina M. Nolan(United States Military Academy), Therese Solstad(Direktoratet for medisinske produkter), Wibke Lembke, Bonnie Wu(Janssen (United States)), Ivo Sonderegger(Takeda (Switzerland)), Luying Pan(Takeda (United States)), Gregor Jordan(Roche Pharma AG (Germany)), Kristina McGuire(Regeneron (United States)), Mohsen Rajabi Abhari(United States Food and Drug Administration), Dean Smith(Health Canada), Vibha Jawa(Bristol-Myers Squibb (Germany)), Daniel Baltrukonis(Pfizer (United States)), Sylvie Bertholet(GlaxoSmithKline (United States)), Shobha Purushothama(Biogen (United States)), Daniela Verthelyi(Center for Drug Evaluation and Research), Manoj Rajadhyaksha(Regeneron (United States)), Bernd Potthoff(Novartis (Switzerland)), Shabnam Tangri(Navidea Biopharmaceuticals (United States)), Shannon Harris, Matthew Andisik(Regeneron (United States)), Yuanxin Xu(Alnylam Pharmaceuticals (United States)), Anders Millner(Novo Nordisk (Denmark)), Akiko Ishii‐Watabe(National Institute of Health Sciences), Xiaodong Fang(BGI Group (China)), João Pedras-Vasconcelos(United States Food and Drug Administration), Sumit Kar, Haoheng Yan(United States Food and Drug Administration), George R. Gunn(GlaxoSmithKline (United States)), Fabio Garofolo(Angelini Pharma (Italy)), Robert Dodge(Novartis (United States)), Michele Fiscella(Regenxbio (United States)), Boris Gorovits(Pfizer (United States)), Frank J. Taddeo(Takeda (United States)), Flora Berisha(Janssen (United States)), Mark Milton(Novartis (United States)), Susan Kirshner(United States Food and Drug Administration), Isabelle Cludts(NIHR Research Delivery Network), Elana Cherry(Health Canada), Yanmei Lu, Yuling Wu(AstraZeneca (United States)), Francis Dessy(GlaxoSmithKline (Belgium)), Timothy R. Mack(Bristol-Myers Squibb (United States)), Leslie Wagner(United States Food and Drug Administration), Meena Meena, Soumi Gupta(AbbVie (United States)), Kimberly Maxfield(Southwestern Medical Center), Brian Long(BioMarin (United States)), Swati Gupta(AbbVie (United States))
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