Speakers

Symposium: Immunology for Biotherapeutics

  • Rakesh Dixit, PhD, Vice President, R&D, Global Head, Biologics Safety Assessment, MedImmune, Inc.
  • Michael Lacy, PhD, Lead Scientist, Non-Clinical Development, Emergent BioSolutions
  • David H. Margulies, MD, PhD, Chief, Molecular Biology, Immunology Lab, NIAID, National Institutes of Health
  • Paul Moore, PhD, Vice President, Immunology and Cell Biology, Macrogenics,Inc.
  • Bonita (Bonnie) Rup, PhD, Biopharmaceutical Consultant, Bonnie Rup Consulting
  • Ethan Shevach, MD, Senior Investigator, Laboratory of Immunology, National Institute of Allergy and Infectious Diseases, NIH
  • Han-Yu Shih, PhD, MS, Research Fellow, National Institute of Arthritis and Musculoskeletal and
  • Skin Disease, (NIAMS), NIH

Immunogenicity Assessment & Clinical Relevance

  • Mitra Azadeh, PhD, Principal Scientist, Bioanalytical & Biomarker Development, Shire
  • Terry P. Combs, PhD, Senior Scientist, BioMedicine Design, Pfizer, Inc.
  • Jochem Gokemeijer, PhD, Associate Director, Molecular Discovery Technology, Bristol-Myers Squibb
  • Theresa J. Goletz, PhD, Global Head, New Biological Entities and Drug Disposition, EMD Serono Research & Development Institute, Inc.
  • William Hallett, PhD, Biologist, OPQ/OBP, CDER, FDA
  • Zhihua Jiang, PhD, Senior Scientist, BioMedicine Design, Pfizer, Inc.
  • Kevin Larimore, PhD, Senior Scientist, Bioanalytical Sciences, BioMarin Pharmaceutical, Inc.
  • Mauricio Maia, PhD, Senior Scientist, BioAnalytical Sciences, Genentech, Inc.
  • Devangi Mehta, PhD, Associate Director, Development Biomarkers and Bioanalytical Sciences, Biogen, Inc.
  • Lilia Macovei, PhD, Senior Scientist, BioMedicine Design, Pfizer, Inc.
  • Michael Partridge, PhD, Senior Staff Scientist, Bioanalytical Sciences, Regeneron Pharmaceuticals, Inc.
  • Christian Ruzanski, PhD, Senior Scientist, Bioanalysis, Novo Nordisk A/S
  • Chris Stebbins, PhD, Principal Scientist, Translational Medicine, Biogen, Inc.
  • Lauren Stevenson, PhD, Director, Development Biomarkers and Bioanalytical Sciences, Biogen, Inc.
  • Weifeng Xu, PhD, Senior Research Investigator, Bioanalytical Science, Bristol-Myers Squibb
  • Haoheng Yan, PhD, MD, Chemist, OPQ/OBP, CDER, FDA

Immunogenicity Prediction & Control

  • Steve Bowen, PhD, Team Leader, Chemist, Office of Biotechnology Products, CDER, FDA
  • Sivan Cohen, PhD, Scientist, BioAnalytical Sciences, Genentech, Inc.
  • Mark Fogg, PhD, Head, Immunology, Biology, Abzena
  • Timothy Hickling, PhD, Immunogenicity Sciences Lead, Biomedicine Design, Pfizer, Inc.
  • Indigo King, PhD, Scientist, Immunology, Cyrus Biotechnology
  • Kei Kishimoto, PhD, CSO, Selecta Biosciences
  • Karen Liao, MD, Investigator, GSK Associate Fellow, Immunogenicity and Clinical Immunology, GlaxoSmithKline
  • Jad Maamary, PhD, Senior Scientist, Merck and Co., Inc.
  • Mohanraj Manangeeswaran, PhD, Therapeutic Proteins, FDA/CDER
  • Ronit Mazor, PhD, Scientist, Antibody Discovery & Protein Engineering (ADPE), MedImmune, Inc.
  • Jad Maamary, PhD, Senior Scientist, Merck and Co., Inc.
  • Valerie Quarmby, PhD, Staff Scientist, BioAnalytical Sciences, Genentech, Inc.
  • Zuben E. Sauna, PhD, Principal Investigator, Plasma Protein Therapeutics, CBER, FDA
  • Renu Singh-Dhanikula, PhD, Senior Research Investigator, Metabolism & Pharmacokinetics, Bristol-Myers Squibb
  • Noel Smith, PhD, Senior Group Leader, Applied Protein Services, Lonza Pharma & Biotech
  • Daniela Verthelyi, PhD, Chief, Immunology Lab, Therapeutic Proteins, CDER, FDA
  • Joleen T. White, PhD, Director, Head of Project Support, NBE Drug Disposition, EMD Serono
  • Li Xue, PhD, Senior Principal Scientist, BioMedicine Design, Pfizer, Inc.

Optimizing Bioassays for Biologics

  • Robyn Beckwith, PhD, Technical Development Scientist, Analytical Development and Quality Control, Genentech
  • Keith M. Bower, Principal CMC Statistician, Process Sciences, Seattle Genetics
  • Stephen Hartman, PhD, Senior Scientist III, AbbVie
  • Samantha Jeshonek, PhD, Research Informatics Analyst, Research Informatics, Collaborative Drug Discovery
  • Martin Kane, MS, CRE, Managing Data Scientist, Statistical and Data Sciences Practice, Exponent
  • Thomas Little, PhD, President and CEO, Bioassay Sciences, Thomas A. Little Consulting
  • Steven Novick, PhD, Director, Statistical Sciences, MedImmune
  • Brian R. Peterson, PhD, President, Bioassay Solutions LLC
  • Timothy Schofield, Senior Advisor, Technical Research & Development, GSK
  • Mingfang Shen, Principal Development Associate, Translational Research, ImmunoGen, Inc.
  • Perceval Sondag, Senior Manager, Statistics, PharmaLex

Training Seminar: Introduction to Design of Experiments (DoE)

  • Perceval Sondag, Senior Manager, Statistics, PharmaLex

Short Courses

SC1: Mechanism of Action and Risk-Based Approach for Developing Neutralizing Ab Assays
  • Jim McNally, PhD, Senior Director, Therapeutic Area Lead, Non-Clinical Development, Shire
  • Weifeng Xu, PhD, Senior Research Investigator, Bioanalytical Science, Bristol-Myers Squibb
SC2: Overcoming Drug Target Interference in ADA Assays
  • Jim McNally, PhD, Senior Director, Therapeutic Area Lead, Non-Clinical Development, Shire
  • Lilia Macovei, PhD, Senior Scientist, BioMedicine Design, Pfizer, Inc.
Dinner SC3: Validation of ADA Assays and Cut Point Calculations
  • Jim McNally, PhD, Senior Director, Therapeutic Area Lead, Non-Clinical Development, Shire
  • Michael Partridge, PhD, Senior Staff Scientist, Bioanalytical Sciences, Regeneron
  • Pharmaceuticals, Inc.
Dinner SC4: Immunology for Immuno-Oncology
  • Jochem Gokemeijer, PhD, Associate Director, Molecular Discovery Technology, Bristol-Myers Squibb
  • J. Joseph (Jos) Melenhorst, PhD, Director, Product Development & Correlative Sciences, Cellular Immunotherapies, University of Pennsylvania
Dinner SC5: Back to Basics: Optimizing Bioassay Design and Analysis
  • Sofie Pattijn, CTO, ImmunXperts
  • Annemie Wielant, Senior Scientist, Bioassay Development, UCB
  • Sylvia Janetzki, MD, President, ZellNet Consulting
Dinner SC6: Advice on Putting Together an Integrated Summary of Immunogenicity
  • Joao Pedras-Vasconcelos, PhD, Biotech Quality and Immunogenicity Reviewer, Office of Biotechnology Products, CDER, FDA
  • Bonnie Rup, PhD, Bonnie Rup Consulting LLC

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