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White Paper

2022 White Paper on Recent Issues in Bioanalysis: Fda Draft Guidance on Immunogenicity Information in Prescription Drug Labeling, Lnp & Viral Vectors Therapeutics/Vaccines Immunogenicity, Prolongation Effect, Ada Affinity,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, Vaccines Immunogenicity & Technologies; Immunogenicity & Risk Assessment of Biotherapeutics and Novel Modalities; NAb Assays Integrated Approach)

Luying Pan1 Takeda, Cambridge, MA, USA
,
Johanna Mora13 Bristol Myers Squibb, Lawrenceville, NJ, USA
,
Karl Walravens3 GlaxoSmithKline, Rixensart, Belgium
,
Leslie Wagner19 US FDA, Silver Spring, MD, USA
,
Shirley Hopper9 UK MHRA, London, UK
,
Lina Loo2 Vertex, Boston, MA, USA
,
David Bettoun4 Larimar, Bala-Cynwyd, PA, USA
,
Sarah Bond5 Alnylam, Cambridge, MA, USA
,
Francis Dessy3 GlaxoSmithKline, Rixensart, Belgium
,
Sean Downing1 Takeda, Cambridge, MA, USA
,
Fabio Garofolo6 BRI Frontage, Vancouver, BC, CanadaCorrespondence[email protected]
,
Soumi Gupta7 BioMarin, Novato, CA, USA
,
Neil Henderson8 AstraZeneca, Gothenburg, Sweden
,
Chad Irwin10 Health Canada, Ottawa, ON, Canada
,
Akiko Ishii-Watabe11 Japan MHLW, Tokyo, Japan
,
Sumit Kar12 WRIB, Montreal, QC, Canada
,
Vibha Jawa13 Bristol Myers Squibb, Lawrenceville, NJ, USA
,
Julie Joseph10 Health Canada, Ottawa, ON, Canada
,
Ludovic Malvaux3 GlaxoSmithKline, Rixensart, Belgium
,
Jean-Claude Marshall14 Moderna, Mystic, CT, USA
,
Jessica McDevitt13 Bristol Myers Squibb, Lawrenceville, NJ, USA
,
Susovan Mohapatra15 Stoke, Cambridge, MA, USA
,
Jessica Seitzer16 Intellia, Cambridge, MA, USA
,
Justin Smith17 Pfizer, Groton, CT, USA
,
Therese Solstad18 Norway NoMA, Oslo, Norway
,
Hiroshi Sugimoto1 Takeda, Cambridge, MA, USA
,
Omar Tounekti10 Health Canada, Ottawa, ON, Canada
,
Bonnie Wu20 Janssen R&D, Spring House, PA, USA
,
Yuling Wu21 AstraZeneca, Gaithersburg, MD, USA
,
Yuanxin Xu16 Intellia, Cambridge, MA, USA
,
Joshua Xu22 US FDA, Jefferson, AR, USA
,
Takenori Yamamoto11 Japan MHLW, Tokyo, Japan
,
Lin Yang23 REGENXBIO, Rockville, MD, USA
,
Albert Torri24 Regeneron, Tarrytown, NY, USA
,
Susan Kirshner19 US FDA, Silver Spring, MD, USA
,
Kimberly Maxfield19 US FDA, Silver Spring, MD, USA
,
Joao Pedras Vasconcelos19 US FDA, Silver Spring, MD, USA
,
Mohsen Rajabi Abhari19 US FDA, Silver Spring, MD, USA
,
Daniela Verthelyi19 US FDA, Silver Spring, MD, USA
,
Eric Brodsky19 US FDA, Silver Spring, MD, USA
,
Montserrat Carrasco-Triguero25 Sangamo, Brisbane, CA, USA
,
John Kamerud17 Pfizer, Groton, CT, USA
,
Matthew Andisik24 Regeneron, Tarrytown, NY, USA
,
Daniel Baltrukonis17 Pfizer, Groton, CT, USA
,
Nicoletta Bivi26 Lilly, Indianapolis, IN, USA
,
Isabelle Cludts9 UK MHRA, London, UK
,
Kelly Coble27 Boehringer Ingelheim, Danbury, CT, USA
,
Boris Gorovits28 Sana Bio, Cambridge, MA, USA
,
George R Gunn29 GSK, Collegeville, PA, USA
,
Swati Gupta30 AbbVie, Irvine, CA, USA
,
Anders Holm Millner31 Novo Nordisk, Maaloev, Denmark
,
Alison Joyce17 Pfizer, Groton, CT, USA
,
Robert J Kubiak21 AstraZeneca, Gaithersburg, MD, USA
,
Seema Kumar32 EMD Serono, Boston, MA, USA
,
Karen Liao33 Merck, West Point, PA, USA
,
Mohanraj Manangeeswaran19 US FDA, Silver Spring, MD, USA
,
Michael Partridge24 Regeneron, Tarrytown, NY, USA
,
Samuel Pine34 Sanofi, Ghent, Belgium
,
Johann Poetzl35 Sandoz, Oberhaching, Germany
,
Manoj Rajadhyaksha36 Alexion, New Haven, CT, USA
,
Michele Rasamoelisolo37 Teva, West Chester, PA, USA
,
Susan Richards38 Sanofi, Framingham, MA, USA
,
Yuan Song39 Genentech, South San Francisco, CA, USA
,
Steven Swanson39 Genentech, South San Francisco, CA, USA
,
Seth Thacker19 US FDA, Silver Spring, MD, USA
,
Meenu Wadhwa9 UK MHRA, London, UK
,
Andreas Wolf40 Amgen, Munich, Germany
,
Lucia Zhang10 Health Canada, Ottawa, ON, Canada
&
Lin Zhou19 US FDA, Silver Spring, MD, USA
 show all
Pages 773-814 | Received 08 Jul 2023, Accepted 11 Jul 2023, Published online: 01 Aug 2023

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