2022 White Paper on Recent Issues in Bioanalysis: Fda Draft Guidance on Immunogenicity Information in Prescription Drug Labeling, Lnp & Viral Vectors Therapeutics/Vaccines Immunogenicity, Prolongation Effect, Ada Affinity,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 ( <u>Part 3</u> – Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Immunogenicity & Risk Assessment of Biotherapeutics and Novel Modalities; NAb Assays Integrated Approach)
Luying Pan(Takeda (United States)), Swati Gupta(AbbVie (United States)), Karl Walravens(GlaxoSmithKline (Belgium)), Jessica Seitzer(Intellia Therapeutics (United States)), Eric Brodsky(United States Food and Drug Administration), Jessica McDevitt(Bristol-Myers Squibb (United States)), Therese Solstad(Direktoratet for medisinske produkter), Bonnie Wu(Janssen (United States)), Mohsen Rajabi Abhari(United States Food and Drug Administration), LiNa Loo(Vertex Pharmaceuticals (United States)), Joshua Xu(National Center for Toxicological Research), John Kamerud(Pfizer (United States)), Vibha Jawa(Bristol-Myers Squibb (Germany)), Daniel Baltrukonis(Pfizer (United States)), Daniela Verthelyi(Center for Drug Evaluation and Research), Albert Torri(Regeneron (United States)), Lin Yang(Regenxbio (United States)), Matthew Andisik(Regeneron (United States)), Yuanxin Xu(Alnylam Pharmaceuticals (United States)), Kelly Coble(Boehringer Ingelheim (United States)), Akiko Ishii‐Watabe(National Institute of Health Sciences), Shirley Hopper, Ludovic Malvaux(GlaxoSmithKline (Belgium)), Johanna Mora(Bristol-Myers Squibb (United States)), Sumit Kar, Sarah Bond(Alnylam Pharmaceuticals (United States)), David Bettoun, George R. Gunn(GlaxoSmithKline (United States)), Fabio Garofolo(Angelini Pharma (Italy)), Susovan Mohapatra, Julie Joseph(University of Ottawa), Omar Tounekti(Centre National de la Recherche Scientifique), Boris Gorovits(Pfizer (United States)), Joao Pedras Vasconcelos(United States Food and Drug Administration), Nicoletta Bivi(Eli Lilly (United States)), Hiroshi Sugimoto(Takeda (United States)), Susan Kirshner(United States Food and Drug Administration), Isabelle Cludts(NIHR Research Delivery Network), Chad R. Irwin(Health Canada), Sean Downing(Takeda (United States)), Takenori Yamamoto, Neil Henderson(AstraZeneca (Sweden)), Yuling Wu(AstraZeneca (United States)), Francis Dessy(GlaxoSmithKline (Belgium)), Jean‐Claude Marshall(Pfizer (United States)), Leslie Wagner(United States Food and Drug Administration), Justin Smith(Pfizer (United States)), Kimberly Maxfield(Southwestern Medical Center), Soumi Gupta(AbbVie (United States)), Montserrat Carrasco‐Triguero(Sangamo BioSciences (United States))
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