2019 White Paper on Recent Issues in Bioanalysis: FDA Immunogenicity Guidance, Gene Therapy, Critical Reagents, Biomarkers and Flow Cytometry Validation (Part 3 – Recommendations on 2019 FDA Immunogenicity Guidance, Gene Therapy Bioanalytical Challenges, Strategies for Critical Reagent Management, Biomarker Assay Validation, Flow Cytometry Validation & CLSI H62)
Steven P. Piccoli(GlaxoSmithKline (United States)), Susan Kirshner(United States Food and Drug Administration), Joel Mathews(Ionis Pharmaceuticals (United States)), Andrew P. Mayer(GlaxoSmithKline (United States)), Thomas Emrich(Roche Pharma AG (Germany)), Cherie Green, Alison Joyce(Pfizer (United States)), John Allinson, David Lanham(Eurofins (United Kingdom)), Nisha Palackal(Regeneron (United States)), Catherine Fleener(Pfizer (United States)), Daniel Baltrukonis(Pfizer (United States)), Shobha Purushothama(Biogen (United States)), Sai Thankamony(Bristol-Myers Squibb (United States)), Paul C. Trampont(Covance (United States)), Manoj Rajadhyaksha(Regeneron (United States)), Shabnam Tangri(Navidea Biopharmaceuticals (United States)), Jochen Brumm(Roche (Switzerland)), Alessandra Vitaliti(Novartis (Switzerland)), Carol Gleason(Bristol-Myers Squibb (United States)), Jonathan Haulenbeek(Bristol-Myers Squibb (United States)), Yuanxin Xu(Alnylam Pharmaceuticals (United States)), Lakshmi Amaravadi(Takeda (United States)), Shirley Hopper, Laurent Vermet(Sanofi (France)), Michael N. Hedrick(Bristol-Myers Squibb (United States)), Steve Eck(AstraZeneca (United States)), Eris Bame(Biogen (United States)), Naveen Dakappagari(Navidea Biopharmaceuticals (United States)), Virginia Litwin(Caprion (Canada)), Chris Beaver(Syneos Health (United States)), Fabio Garofolo(Angelini Pharma (Italy)), Meina Liang(AstraZeneca (United States)), V.N. Kakkanaiah(Pharmaceutical Product Development (United States)), Kevin Maher(United States Food and Drug Administration), Becky Schweighardt(BioMarin (United States)), Shashi Amur(United States Food and Drug Administration), Jason A DelCarpini(Celldex Therapeutics (United States)), Elana Cherry(Health Canada), Kun Peng(Roche (United States)), Yow‐Ming Wang(United States Food and Drug Administration), Yan Zhang(Jiangsu University), Afshin Safavi, Cynthia Rogers(Bluebird Bio (United States)), Susan Richards(MRC Clinical Trials Unit at UCL), Allena Ji(Sanofi (United States)), Devangi Mehta(Biogen (United States)), Christine Grimaldi(Boehringer Ingelheim (United States))
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