2023 White Paper on Recent Issues in Bioanalysis: ISR for ADA Assays, the Rise of dPCR vs qPCR, International Reference Standards for Vaccine Assays, Anti-AAV TAb Post-Dose Assessment, NanoString Validation, ELISpot as Gold Standard (Part 3 – Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Biotherapeutics Immunogenicity & Risk Assessment; ADA/NAb Assay/Reporting Harmonization)

US FDA, EU EMA, UK MHRA, Austria AGES, Belgium FAMHP, Netherlands IGJ, Brazil ANVISA, Health Canada, Japan MHLW, and WHO for supporting this workshopAll Session Chairs & Working Dinner Facilitators for chairing the workshops and the White Paper discussions: Dr. Mitra Azadeh (Ultragenyx), Mr. Mike Baratta (Takeda), Dr. Gopa Biswas (US FDA), Dr. Katherine Block (Genentech), Dr. Mark Dysinger (Alexion), Dr. Seongeun Julia Cho (US FDA), Dr. Isabelle Cludts (UK MHRA), Ms. Kelly Coble (Boehringer Ingelheim), Dr. Vilma Decman (GSK), Dr. Steven Eck (AstraZeneca), Dr. Anna Edmison (Health Canada), Dr. Fabio Garofolo (BRI Frontage), Dr. Swati Gupta (AbbVie), Dr. Shawna Hengel (Seattle Genetics), Ms. Sarah Hersey (BMS), Dr. Allena Ji (Chiesi), Dr. Wenying Jian (Janssen), Dr. Surinder Kaur (Genentech), Dr. Uma Kavita (Spark Therapeutics), Dr. Christopher Kochansky (Exelixis) Dr. Yi-Dong Lin (Takeda), Dr. Meena (Stoke), Dr. Johanna Mora (BMS), Dr. Rachel Palmer (Sanofi), Dr. Susan Richards (Sanofi) Dr. John Smeraglia (AstraZeneca), Dr. Ivo Sonderegger (Takeda), Dr. Yuan Song (Genentech), Dr. Hiroshi Sugimoto (Takeda), Dr. Matthew Szapacs (AbbVie), Dr. Martin Ullmann (Fresenius Kabi), Dr. Meenu Wadhwa (UK MHRA), Dr. Jian Wang (Crinetics), Dr. Russell Weiner (Takeda), Dr. Long Yuan (Biogen), Dr. Yiyue (Cynthia) Zhang (US FDA)All the workshop attendees and members of the Global Bioanalytical Community who have sent comments and suggestions to the workshop to complete this White PaperFuture Science Group as a trusted partner

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