Speakers - Immunogenicity & Bioassay Summit

2018 Archived Content

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

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

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.

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, Principal Scientist, 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, 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

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

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

CONFERENCE PROGRAMS