Distinguished Faculty


Emily ShacterEmily Shacter, Ph.D., Chief, Laboratory of Biochemistry, Division of Therapeutic Proteins, Office of Biotechnology Products, FDA/CDER/OPS, FDA




Graham McCartneyR. Graham McCartney, Ph.D., Technical Lead, Biotechnology, Eli Lilly





Jane RobinsonJane Robinson, Ph.D., Principal Scientist, Biotherapeutics, National Institute for Biological Standards and Control (NIBSC)




Ruth RodriguezRuth Cordoba–Rodriguez, Division of Monoclonal Antibodies, Office of Biotechnology Products, Center for Drug Evaluation and Research, FDA




Igor KaltashovIgor Kaltashov, Ph.D., Associate Professor, Chemistry, University of Massachusetts and Shire Human Genetic Therapies




Nadine RitterNadine M. Ritter, Ph.D., Senior CMC Consultant, Biologics Consulting Group, Inc.





Ewa MarszalEwa Marszal, Ph.D., Chemist, Laboratory of Plasma Derivatives, Division of Hematology, CBER, FDA




XuRong JiangXu-Rong Jiang, Ph.D., M.D., Associate Director, Analytical Biochemistry, MedImmune, LLC





Stacey TravigliaStacey Traviglia, Ph.D., Senior Scientist, Analytical Technology, Biogen Idec, Inc.





Marco ThomannMarco Thomann, Ph.D., Group Leader, Development Analytics, Roche Diagnostics GmbH





Philippe GilbertPhilippe-Alexandre Gilbert, Senior Scientist, MedImmune, Inc.





Gillian WoollettGillian R. Woollett, M.A., D.Phil., Chief Scientist, Engel & Novitt, LLP





Liming ShiLiming Shi, M.A., M.Sc., Senior Scientist, Bioanalytical Chemistry, Amylin Pharmaceuticals, Inc.




Chris HollowayChris Holloway, Ph.D., Group Director, Regulatory Affairs, ERA Consulting Group





Alain BeckAlain Beck, Ph.D., Head, Physico-Chemistry, Centre d'Immunologie, Pierre Fabre





Ron TaticekRon Taticek, Ph.D., Senior Director and Head, Commercial Product Quality Stewards, Biologics, Genentech, Inc.




Tina MorrisTina S. Morris, Ph.D., Vice President, Biologics and Biotechnology, USP





Aimee Cossins, Ph.D., Group Leader, Analytical & Formulation Development, Syntaxin Ltd.


Ziping WeiZiping Wei, Ph.D., Fellow, Analytical Biochemistry, MedImmune, Inc.





Pat CashPat Cash, Senior Director, Analytical Biochemistry, MedImmune, Inc.





Qin ZouQin Zou, Ph.D., Senior Principal Scientist, Analytical Research & Development, Pfizer, Inc.





Michele DoughertyMichele K. Dougherty, Ph.D., Product Quality Reviewer, Division of Monoclonal Antibodies, OBP/CDER/FDA




Alain BernardAlain Bernard, Ph.D., Vice President, Biopharmaceutical Process Sciences, UCB Group





John O'HararJohn O'Hara, Ph.D., Associate Director, Analytical Development, Biologicals, UCB-Celltech





Kathleen WilliamsKathleen M. Williams, Ph.D., Partner, Intellectual Property, Edwards, Angell, Palmer & Dodge LLP




Brian HarveyBrian Harvey, M.D., Ph.D., Vice President, US Regulatory Policy, Global Regulatory Affairs, Sanofi-Aventis




Yung HsiangYung-Hsiang Kao, Ph.D., Senior Scientist & Group Leader, Protein Analytical Chemistry, Genentech, Inc.




Christian ClaussLouis-Christian Clauss, Phar.D., IAE, RACS, Antheln Biomed, USA





John StultsJohn T. Stults, Ph.D., Director, Protein Analytical Chemistry-2, Genentech, Inc., a member of the Roche Group




Daniel HigaziDaniel Higazi, Ph.D., Scientist, Analytical Biochemistry, MedImmune Ltd.





Jette Wypych, Ph.D., Principal Scientist, Process and Product Development, Amgen, Inc.

Alfred PanAlfred Pan, Ph.D., Associate Director, Analytical and Process Technologies, MedImmune, LLC





Paul GilPaul J. Gil, Ph.D., Deputy Director, Global Regulatory Affairs, Bayer HealthCare





Kirstin Bislev Hansen, M.SC., Senior Regulatory Project Manager, Regulatory Affairs, Marketed Products, Novo Nordisk A/S

Keith Chidwick Keith Chidwick, Ph.D., Senior Pharmaceutical Assessor, Biologicals Unit, MHRA


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