2020 White Paper on Recent Issues in Bioanalysis: Vaccine Assay Validation, qPCR Assay Validation, QC for CAR-T Flow Cytometry, NAb Assay Harmonization and ELISpot Validation ( <u>Part 3</u> –Recommendations on Immunogenicity Assay Strategies, NAb Assays, Biosimilars and FDA/EMA Immunogenicity Guidance/Guideline, Gene & Cell Therapy and Vaccine Assays)
Bart Corsaro(GlaxoSmithKline (United States)), Meina Liang(AstraZeneca (United States)), Robert Kubiak(Boehringer Ingelheim (Germany)), Swati Gupta(AbbVie (United States)), Rocio Murphy(United States Military Academy), Therese Solstad(Direktoratet for medisinske produkter), Bonnie Wu(Janssen (United States)), Ivo Sonderegger(Takeda (Switzerland)), Natasha Savoie, Richard Siggers(Health Canada), Arno Kromminga, Ghanashyam Sarikonda(Novartis (United States)), John Kamerud(Pfizer (United States)), Vibha Jawa(Bristol-Myers Squibb (Germany)), Sylvie Bertholet(GlaxoSmithKline (United States)), Daniela Verthelyi(Center for Drug Evaluation and Research), Marco Petrillo(Biogen (United States)), Manoj Rajadhyaksha(Regeneron (United States)), Lisa Kierstead(United States Military Academy), Lucia Zhang(Health Canada), Jim McNally, Akiko Ishii‐Watabe(National Institute of Health Sciences), João Pedras-Vasconcelos(United States Food and Drug Administration), Naveen Dakappagari(Navidea Biopharmaceuticals (United States)), Roland F. Staack(Roche Pharma AG (Germany)), Chris Stebbins, Sumit Kar, Haoheng Yan(United States Food and Drug Administration), George R. Gunn(GlaxoSmithKline (United States)), Fabio Garofolo(Angelini Pharma (Italy)), Madeleine Dahlbäck(University of Copenhagen), Johann Poetzl(Hexal (Germany)), Tong‐Yuan Yang(Janssen (United States)), Boris Gorovits(Pfizer (United States)), Sam Song(Takeda (United States)), Lynne Jesaitis(BioMarin (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, Michael A. Partridge(Regeneron (United States)), Yuling Wu(AstraZeneca (United States)), Andrew Exley, Francis Dessy(GlaxoSmithKline (Belgium)), Anna Ma, Samuel Pine(Ablynx (Belgium)), Jean‐Claude Marshall(Pfizer (United States)), Jason DelCarpini(Bluebird Bio (United States))
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