Part One: IMMUNOGENICITY ASSESSMENT AND CLINICAL RELEVANCE
Melissa Cheu, Senior Research Associate, Bioanalytical Assays, Genentech, Inc.
Deborah Finco, Ph.D., Immunogenicity Lead, Immunotoxicology COE, Drug Safety R&D, Pfizer, Inc.
Robert G. Hamilton, Ph.D., D.ABMLI, Professor, Medicine and Pathology, Johns Hopkins University School of Medicine, and Director, Johns Hopkins Dermatology, Allergy and Clinical Immunology Reference Laboratory
Kristina Howard, Therapeutic Proteins, FDA
Steve Keller, Ph.D., Director, Bioanalytical Sciences, Abbott Biotherapeutics
Susan Richards, Ph.D., Group Vice President, Clinical Laboratory Science, Biologics R&D, Genzyme Corp.
Holly W. Smith, B.A., Senior Research Scientist, Investigative Toxicology, Eli Lilly and Company
Meena Subramanyam, Ph.D., Senior Director, Clinical Science & Technology, Biogen Idec, Inc.
Albert Torri, Ph.D., Senior Director, Bioanalytical Sciences, Regeneron Pharmaceuticals
Michael Tovey, Ph.D., Director, Research, Biotechnology & Applied Pharmacology, ENS Cachan
Marie T. Rock, Ph.D., Vice President, Protein Bioanalysis, Midwest BioResearch LLC, a Wil Research Company
Sam Song, M.D., Senior Scientist, Immunoassay Development, Merrimack Pharmaceuticals, Inc.
Tobias Manigold, M.D., Lab Head, Immunosafety, Hoffmann-La Roche
Jörgen Dahlström, Ph.D., Scientific Director, Phadia
Matthias Hofmann, Ph.D., Senior Investigator, Bioanalytics, Novartis Institutes for Biomedical Research
Daniel T. Mytych, Ph.D., Principal Scientist, Clinical Immunology, Amgen, Inc.
Marie T. Rock, Ph.D., Vice President, Immunoassays, Midwest BioResearch, a Wil Research Company
Stephen Keller, Ph.D., Associate Director, Pre-Clinical and Clinical Development Sciences, Abbott Biotherapeutics Corp.
Sally Fischer, Ph.D., Senior Scientist & Group Leader, Bioanalytical Research and Development (BARD), Genentech, Inc.
Pankaj Oberoi, Ph.D., Director, Scientific Services and Research & Development, Meso Scale Discovery
Brian Schlain, Lead, Non-Clinical Statistician, Biostatistics, Biogen Idec, Inc.
Combined Session
Susan Kirshner, Associate Chief, Laboratory of Immunology, Office of Biotechnology, FDA
Robin Thorpe, Ph.D., FRCPath., Head, Biotherapeutics Group, NIBSC
Meena Subramanyam, Ph.D., Senior Director, Clinical Science & Technology, Biogen Idec, Inc.
Ethan M. Shevach, M.D., Chief, Cellular Immunology Section, Laboratory of Immunology, National Institute of Allergy and Infectious Diseases, National Institutes of Health
Part Two: IMMUNOGENICITY PREDICTION AND MITIGATION
Michel Awwad, Senior Director, PDM-NBE, Pfizer, Inc.
Matthew Baker, Ph.D., CSO, Antitope Ltd.
Mary Cromwell, Ph.D., Senior Scientist & Associate Director, Protein Analytical Chemistry, Genentech, Inc.
John Den Engelsman, Merck, Sharpe & Dohme
Fiona A. Harding, Ph.D., Senior Principal Research Scientist, Biologics Technologies, Abbott Biotherapeutics Corp.
Sandeep Kumar, Principal Scientist, Biotherapeutics Pharmaceutical Sciences, Pfizer, Inc.
Nadine Ritter, Ph.D., Senior CMC Consultant, Biologics Consulting Group, Inc.
David W. Scott, Ph.D., Professor and Vice Chair for Research, Department of Medicine, Uniformed Services University of Health Sciences, Bethesda
Daniela Verthelyi, M.D., Ph.D., Chief, Laboratory of Immunology, Therapeutic Proteins, CDER, FDA
Susan Kirshner, Ph.D., Associate Chief, Laboratory of Immunology, Therapeutic Proteins, Biotechnology, FDA
Kristina Howard, D.V.M., Ph.D., FDA Commissioner’s Fellow, Therapeutic Proteins, Pharmaceutical Sciences, CDER, FDA
Melody Sauerborn. Ph.D., Pharmaceutical Sciences, University of Utrecht, and CEO, ADA InVivo BV
Miranda van Beers, Ph.D., Research Scientist, Analytics, Bioprocessing Technology Institute, A*STAR