2025 White Paper on Recent Issues in Bioanalysis: Redosing Patients with AAV Gene Therapy; CRS Immunogenicity Risk; Shedding Assays; NHP Studies Immunogenicity; CMC vs Bioanalytical Assays; Artificial Intelligence-Powered Genomic Pipelines for NGS ( <u>PART 3A</u> – Recommendations on Gene, Cell, and Vaccine Therapies Immunogenicity & Technologies; Biotherapeutics & Biosimilars Immunogenicity Assessment & Clinical Relevance <u>PART 3B</u> – Regulatory Agencies’ Input on Immunogenicity/Technologies of Biotherapeutics, Gene, Cell & Vaccine Therapies)
Omar Tounekti(Centre National de la Recherche Scientifique), Maria Jadhav(Novartis (China)), Jessica Seitzer(Intellia Therapeutics (United States)), Jasdeep S. Nanra(GlaxoSmithKline (India)), Rocio Murphy(Merck & Co., Inc., Rahway, NJ, USA (United States)), Adrian Wong(Vrije Universiteit Brussel), Anna Nowocin(Montana Health Research Institute), Sanjay L. Dholakiya(Bristol-Myers Squibb (Germany)), Mohsen Rajabi Abhari(United States Food and Drug Administration), Sandra Prior(Montana Health Research Institute), Hatice Karaüzüm(Pfizer (United States)), Bradley J. Scott(Health Canada), R Kubiak(Gwynedd Council), Vibha Jawa(EpiVax (United States)), Sophie Shubow(United States Food and Drug Administration), Theingi M. Thway(Eisai (Japan)), Daniel Baltrukonis(Pfizer (United States)), Daisy Yuill(The Francis Crick Institute), Binsheng Gong(Harbin Medical University), Mark Stern(Bristol-Myers Squibb (United States)), Fabio Garofolo(Vancouver Native Health Society), Shannon Dogmanits(Glaxosmithkline (Finland)), Michele Fiscella(Regenxbio (United States)), Tong‐Yuan Yang(Johnson & Johnson (United States)), Warren V. Kalina(Pfizer (United States)), Boris Gorovits(Pfizer (United States)), Heather Myler(Pharmaceutical Product Development (United States)), Claire Kerridge(Montana Health Research Institute), Sarah Wassmer(Health Canada), Hiroshi Sugimoto(Takeda (United States)), Andrea Van Tuyl(AstraZeneca (Brazil)), W C Xiao(United States Food and Drug Administration), Chad R. Irwin(Health Canada), Zuben E. Sauna(Center for Biologics Evaluation and Research), Yuanxin Xu(Intellia Therapeutics (United States)), Michael Taylor(Moderna Therapeutics (United States)), Michael A. Partridge(Regeneron (United States)), Wojciech Jankowski(United States Food and Drug Administration), Giane Sumner(Regeneron (United States)), Susan C. Irvin(Regeneron (United States)), Andrew C. Melton(BioMarin (United States)), David Coronado Escobar(Institute of Navigation), Yanmei Lu(Sangamo BioSciences (United States)), Christian Mayer(Austrian Energy Agency), Jessica McGregor(Esri (Canada)), Ryan Pelto(Alexion Pharma (Switzerland)), George Gunn(Glaxosmithkline (Finland)), Jason DelCarpini(Bluebird Bio (United States)), Lin Yang(BioMarin (United States)), Swati Gupta(AbbVie (United States))
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