Immunogenicity Summit
Immunogenicity and Bioassay Summit

Speaker Listing

Immunogenicity Assessment & Strategies (Nov. 11-12) 

  • Lieselot Bontinck, M.Sc., Scientist, Pharmacology, Bioanalytics & Immunogenicity, Ablynx N.V 
  • Marie-Paule Bouche, Ph.D., Section Head, Pharmacology – Bioanalytics and Immunogenicity, GLP Test Facility Manager, Ablynx BV 
  • Francesca Civoli, Ph.D., Principal Scientist, Clinical Immunology, Amgen, Inc. 
  • Kathleen Clouse, Ph.D., Director, Division of Monoclonal Antibodies, CDER/FDA 
  • Jill B. Conner, Ph.D., Director, Global Specialty Medicines, Teva Pharmaceuticals 
  • Kyra J. Cowan, Ph.D., Scientist, BioAnalytical Sciences, Genentech, Inc. 
  • Deborah Finco, Ph.D., Senior Principal Scientist, Drug Safety R&D, Pfizer, Inc. 
  • Martin Gleeson, Ph.D., CSO, Genalyte, Inc. 
  • Claire Holland, Ph.D., Senior Manager, Biopharm R&D, Clinical Immunology, GlaxoSmithKline 
  • Kyung-Jin Jung, Ph.D., Senior Researcher, Analytical Center, Korean Institute of Toxicology 
  • Marta Starcevic Manning, Ph.D., Principal Scientist, Clinical Immunology, Amgen, Inc. 
  • Jim McNally, Ph.D., Senior Principal Scientist, Biotherapeutics Research, Pfizer, Inc. 
  • Laura Salazar-Fontana, Ph.D., Reviewer, Quality & Immunogenicity, Therapeutic Proteins, CDER/FDA 
  • Melody Sauderborn, Senior Expert Immunogenicity and Bioanalysis, TNO, a Netherlands Applied Research Center 
  • Manju Saxena, Ph.D., Group Leader, Principal Scientist, Tandem Labs, a LabCorp Company
  • Martin Schwickart, Ph.D., Scientist, Clinical Pharmacology and DMPK, MedImmune, Inc. 
  • Eric Shaw, Senior Director, Nonclinical and Clinical Assays, Nuron Biotech 
  • Noel Smith Ph.D., Lead Scientist, Lonza Biologics
  • Steven J. Swanson, Ph.D., Executive Director, Medical Sciences (Clinical Immunology), Amgen, Inc. 
  • Robin Thorpe, Ph.D., FRCPath, Head, Biotherapeutics Group, National Institute for Biological Standards and Control 

PK/PD of Novel Constructs (Nov. 11-12) 

  • Ranjana Advani, M.D., Saul A. Rosenberg Professor of Lymphoma, Professor of Medicine/Oncology, Stanford Cancer Institute 
  • Balaji Agoram, Ph.D., Director, PKPD and Bioanalysis, MedImmune, Inc. 
  • Changshou Gao, Ph.D., Fellow, Antibody Discovery & Antibody Engineering, MedImmune 
  • Nahor Haddish-Berhane, Ph.D., Senior Principal Scientist, Pfizer 
  • Yuki Iwayanagi, Ph.D., Research Scientist, Preclinical Research, Chugai Pharmaceutical Co., Ltd. 
  • Syd Johnson, Ph.D., Vice President, Antibody Engineering, MacroGenics, Inc. 
  • Guozheng Liu, Ph.D., Research Associate Professor, Division of Nuclear Medicine, Department of Radiology, University of Massachusetts Medical Center 
  • Timothy B. Lowinger, Ph.D., CSO, Mersana Therapeutics 
  • Chris Macaraeg, Senior Associate Scientist, PKDM, Amgen
  • Jan Pinkas, Ph.D., Director, Pharmacology, ImmunoGen, Inc. 
  • Benno Rattel, Ph.D., Executive Director, Nonclinical Development ARM, AMGEN Research Center (Munich) GmbH 
  • Marjorie A. Shapiro, Ph.D., Chief, Laboratory of Molecular and Developmental Immunology, Division of Monoclonal Antibodies, FDA/CER 
  • Rakesh Sindhi, M.D., Professor of Surgery, Co-Director, FACS, Pediatric Transplantation, Children's Hospital of Pittsburgh 
  • Tamara Van Steeg, Ph.D., Senior Consultant, PK/PD, LAP&P Consultants BV 

Immunogenicity Risk Assessment & Mitigation (Nov. 12-13) 

  • Gary Bembridge, Ph.D., Business Development Manager, Antitope (Polytherics Company)
  • Briana Betz, Ph.D., Immunology Sales Specialist, ProImmune, Inc.
  • Vera Brinks, Ph.D., Postdoctoral Researcher, Utrecht University, Utrecht Institute for Pharmaceutical Sciences; Currently Visiting Scientist, Laboratory of Immunology, Therapeutic Proteins, CDER/FDA 
  • Sally Fischer, Ph.D., Senior Scientist and Group Leader, Bioanalytical Sciences, Genentech, Inc. 
  • Haiyan Jiang, Ph.D., Senior Director, Preclinical and Clinical Research, Biogen Idec Hemophilia 
  • Larry Kauvar, Ph.D., Senior Vice President & CSO, Trellis Bioscience 
  • Takashi Kishimoto, Ph.D., Chief Science Officer, R&D, Selecta Biosciences 
  • Herald Kropshofer, Ph.D., Senior Personalized Healthcare Leader, Pharmaceutical Development, F. Hoffmann-La Roche Ltd. 
  • Ira Pastan, M.D., NIH Distinguished Investigator, Co-Chief, Laboratory of Molecular Biology, National Cancer Institute, National Institutes of Health 
  • Jack Ragheb, Ph.D., Principal Investigator, Therapeutic Proteins, CDER/FDA 
  • Zuben E. Sauna, Principal Investigator, Haematology, CDER/FDA 
  • David W. Scott, Ph.D., Professor and Vice Chair, Research, Medicine, Uniformed Services University of Health Sciences, Bethesda 
  • Alessandro Sette, Ph.D., Principal Investigator, Center for Infectious Diseases, La Jolla Institute for Allergy & Immunology 
  • Steve Swanson, Ph.D., Executive Director, Medical Sciences, Amgen, Inc. 
  • Li Xue, Ph.D., Principal Scientist, Pharmacokinetics Dynamics & Metabolism, NBE, Pfizer, Inc. 

Optimizing Bioassays for Biologics (Nov. 12-13) 

  • Xiao-Yan Cai, Ph.D., Director, Biologics Bioanalytical Development, Merck Research Laboratories 
  • M.N. Dixit, Ph.D., Assistant General Manager & Head, Bioanalytical Laboratory, Clinigene International 
  • Shawn Fernando, Senior Researcher, Morphotek, Inc. (tentative) 
  • Brad Greenfield, Scientist, Theraclone Sciences 
  • Cecile Geuijen, Ph.D., Director, Oncology, Merus BV 
  • Lea Hagigi, Scientist, Bioassay Analytical Development, Biogen Idec 
  • Barbara Hebeis, Ph.D., Principal Scientist, CMC Bioassay and Genomics, NDA Analytics 
  • Jenny Hu, ATO Clinical Immunology, Medical Science, Amgen, Inc. 
  • Janet L. Lathey, Ph.D., Director, Immunology and Assay Development, BioDefense Division, Emergent BioSolutions 
  • Patrick Liu, M.D., Ph.D., Senior Director and Global Head of Bioassays, Teva Pharmaceuticals, Inc. 
  • Tina S. Morris, Ph.D., Vice President, Biologics & Biotechnology, United States Pharmacopeial Convention, Global Sciences & Standards Division 
  • Surendran Rajendran, Ph.D., Senior Research Investigator, BAS-Biologics, Bristol-Myers Squibb 
  • Jane Robinson, Ph.D., Principal Scientist, Biotherapeutics, National Institute for Biological Standards and Control, UK 
  • Alexis Rossignol, Ph.D., R&D Project Manager, Clean Cells SAS 
  • Timothy Schofield, Senior Fellow, MedImmune 
  • Jennifer Swisher, Ph.D., Senior Staff Fellow, Laboratory of Molecular and Developmental Immunology, Division of Monoclonal Antibodies, CDER/FDA 
  • Max L. Tejada, Ph.D., Senior Scientist, Biological Technologies, Genentech, Inc. 
  • Baolin Zhang, Ph.D., Senior Investigator, Division of Therapeutic Proteins, Office of Biotechnology Products, Food and Drug Administration 
  • Xianzhi Zhou, Ph.D., Senior Scientist, MedImmune, Inc. 

 

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2016 Immunogenicity and Bioassay Summit Brochure


2016 Immunogenicity and Bioassay Summit Brochure  

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