2024 White Paper on Recent Issues in Bioanalysis: Evolution of Immunogenicity Assessment beyond ADA/NAb; Regulated Genomic/NGS Assays; Hypersensitivity Reactions; Minimum Noise Reduction; False Positive Range; Modernized Vaccine Approaches; NAb/TAb Correlation <u>(PART 3A</u> – Recommendations on Advanced Strategies for Molecular Assays and Immunogenicity of Gene Therapy, Cell Therapy, Vaccine; Biotherapeutics 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), Luying Pan(Takeda (United States)), Nathan Riccitelli(Novartis (United States)), Swati Gupta(AbbVie (United States)), Jessica Seitzer(Intellia Therapeutics (United States)), Adrienne Clements‐Egan(Cyprus College of Art), Katrina M. Nolan(Merck & Co., Inc., Rahway, NJ, USA (United States)), Ivo Sonderegger(Takeda (Switzerland)), Adrian Wong(Chinese University of Hong Kong), James W. Huleatt(Gates (United States)), Sandra Prior(Montana Health Research Institute), Christian Mayer(Austrian Agency for Health and Food Safety), LiNa Loo(Vertex Pharmaceuticals (United States)), Joshua Xu(National Center for Toxicological Research), Christopher Beaver(Takeda (United States)), Victor Hou(Mystic Seaport), Daniel Baltrukonis(Pfizer (United States)), Uma Kavita(Spark Therapeutics (United States)), Daniela Verthelyi(Center for Drug Evaluation and Research), Daniel Kramer(Sanofi (Germany)), Albert Torri(Regeneron (United States)), John Smeraglia(AstraZeneca (United Kingdom)), Cecil Chen(AstraZeneca (Australia)), Yuanxin Xu(Nanjing University of Chinese Medicine), Akiko Ishii‐Watabe(National Institute of Health Sciences), Xiaodong Fang(BGI Group (China)), Johanna Mora(Bristol-Myers Squibb (United States)), Sumit Kar, Mark Stern(Bristol-Myers Squibb (United States)), Garrett R. Mullins(Eli Lilly (United States)), Ingrid L. Scully(Pfizer (United States)), George R. Gunn(GlaxoSmithKline (United States)), Fabio Garofolo(Vancouver Native Health Society), Meenu Wadhwa(Montana Health Research Institute), Michele Fiscella(Regenxbio (United States)), Warren V. Kalina(Pfizer (United States)), Sandra S. Diebold(Montana Health Research Institute), Julie Joseph(University of Ottawa), Boris Gorovits(Pfizer (United States)), Sarah Wassmer(Health Canada), Yanmei Lu, Kun Peng(Roche (United States)), Chad R. Irwin(Health Canada), Francis Dessy(GlaxoSmithKline (Belgium)), Giane Sumner(Regeneron (United States)), Dewal Jani(Takeda (United States)), Christine Grimaldi(Boehringer Ingelheim (United States)), Jean‐Claude Marshall(Pfizer (United States)), Jason DelCarpini(Bluebird Bio (United States))
Cited by 10
Related Papers
A global reference for human genetic variation
|Nature|2015|19.9k
Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine
|New England Journal of Medicine|2020|15.7k
Safety and Immunogenicity of Two RNA-Based Covid-19 Vaccine Candidates
|New England Journal of Medicine|2020|2.7k