2018 White Paper on Recent Issues in Bioanalysis: Focus on Flow Cytometry, Gene Therapy, Cut Points and Key Clarifications on Bav (Part 3 – Lba/Cell-Based Assays: Immunogenicity, Biomarkers and Pk Assays)
Lauren Stevenson(University of Dundee), Nisha Palackal(Regeneron (United States)), Lorella Di Donato(Caprion (Canada)), Ian M. Catlett(Bristol-Myers Squibb (United States)), Sam Haidar(United States Food and Drug Administration), Cherie Green, John Kamerud(Pfizer (United States)), Vibha Jawa(Bristol-Myers Squibb (Germany)), Joseph C. Marini(Thomas Jefferson University), Catherine Fleener(Pfizer (United States)), Rafiq Islam(Celerion (United States)), Yongchang Qiu, Daniel Baltrukonis(Pfizer (United States)), Szilard Kamondi(Roche (Switzerland)), Shobha Purushothama(Biogen (United States)), Gerry Kolaitis(Bristol-Myers Squibb (United States)), Saloumeh K Fischer(Roche (United States)), Brian Janelsins(United States Food and Drug Administration), Albert Torri(Regeneron (United States)), Stephanie Fraser(Pfizer (United States)), Renuka Pillutla(Bristol-Myers Squibb (United States)), Shan Chung, Jonathan Haulenbeek(Bristol-Myers Squibb (United States)), Gizette Sperinde, Akiko Ishii‐Watabe(National Institute of Health Sciences), Lakshmi Amaravadi(Takeda (United States)), Shirley Hopper, Christopher Stebbins(University of Illinois Chicago), Roland F. Staack(Roche Pharma AG (Germany)), Virginia Litwin(Caprion (Canada)), Chris Beaver(Syneos Health (United States)), George R. Gunn(GlaxoSmithKline (United States)), Fabio Garofolo(Angelini Pharma (Italy)), Meina Liang(AstraZeneca (United States)), Patrick Liu(Institute for Health Metrics and Evaluation), V.N. Kakkanaiah(Pharmaceutical Product Development (United States)), Patricia Siguenza, Boris Gorovits(Pfizer (United States)), Heather Myler(Pharmaceutical Product Development (United States)), Shashi Amur(United States Food and Drug Administration), Isabelle Cludts(NIHR Research Delivery Network), Elana Cherry(Health Canada), Neil Henderson(AstraZeneca (Sweden)), Seema Kumar(Merck & Co., Inc., Rahway, NJ, USA (United States)), Stephen Keller(AbbVie (United States)), Susan Richards(MRC Clinical Trials Unit at UCL), Kimberly Maxfield(Southwestern Medical Center), Devangi Mehta(Biogen (United States)), Pekka Kurki(Fimet (Finland))
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