September 26-27, 2018, Washington, DC
Stephan O. Krause is AstraZenca's Director of QA Technology. Stephan has published many articles in respected industry journals in the US, Europe, and Asia. His bestseller book on risk-based method validation strategies (PDA/DHI Publications, April 2007) won the 2007 PDA Distinguished Author Award. This award recognizes significant contributions to improve industry standards. Stephan won PDA's Fred Simon Award in 2017 for the best article published in 2016, and, won PDA’s Distinguished Service Award in 2018
Stephan is the primary author and task force leader of PDA TR 57 (2012). He is co-author of PDA TR 65 for Tech Transfer (2014), PCMO's task force leader for IMP Specification Setting (2015), and co-chair of PDA’s Biosimilar Conference/Workshops (2016-18). He is a member of PDA's BioAB, RQAB, EAB, and TRI. In 2012 and 2015, Stephan was invited by the OBP/FDA to present industry perspectives to the OBP CMC reviewer teams at FDA's headquarters.
Emanuela is currently the Associate Director for Biosimilars and Biologics Policy in the Office of Biotechnology Products in CDER. Emanuela joined the Office of Biotechnology Products, Division of Therapeutic Proteins, at FDA in 2001. Prior to her appointment at the FDA, Emanuela worked at Georgetown University and at NIH.
Emanuela earned her PhD in Biotechnology and MS/BS in Molecular and Cellular Biology from the University of Milano, Italy.
Dr. Bev Ingram is a Senior Director within the Global Regulatory Affairs team supporting the biosimilar products portfolio at Pfizer Inc. She is located at the Manufacturing and Pharmaceutical Science R&D facility in Massachusetts USA where she has a global portfolio development role and global regulatory lead. Bev has been working in the area of biosimilars since 2010 and has engaged with regulatory agencies including FDA, EMA and PMDA regarding a range of biosimilar development topics. She is a highly experienced Regulatory professional with over 20 years industry experience, managing full product life-cycle for small and large molecules and preparing global regulatory submissions including biosimilars, monoclonal antibodies and antibody drug conjugates. She has previously worked for GlaxoSmithKline and Wyeth. She started her scientific career in the pharmaceutical industry supporting development of cell culture processes for the production of therapeutic macromolecules by mammalian and microbial cells, having gained her PhD at the University of Manchester Institute of Science & Technology (UK).
Dr. Polozova has been with Amgen, Inc. since 2013 in the Process Development / Attribute Sciences department. She served as Attribute Sciences Team Leader for commercial and late stage protein therapeutics and managed a group within Pivotal Attribute Sciences supporting characterization testing, as well as methods development, qualification, transfer and validation. Most recently Dr. Polozova led preparation of CMC analytical characterization packages for marketing applications of two Amgen biosimilar candidates. Prior to joining Amgen, Dr. Polozova held positions in MedImmune/AstraZeneca, NIH and Liposome Company/Elan.
Dr. Rellahan holds a MS in Cell Biology, a PhD in Immunology and performed a post-doctoral fellowship in the Laboratory of Immune Cell Biology, National Cancer Institute, NIH. Dr. Rellahan joined the Division of Monoclonal Antibodies (DMA), Office of Biotechnology Products (OBP), FDA in 1995. She began her career with the FDA as a research/review scientist, was converted to a Staff Scientist in 1998, and a Principle Investigator in 2004. She subsequently became a Product Quality Team Leader in DMA and supervised a team of regulator scientists with responsibility for review of CMC sections of regulatory filings including assessment of product comparability, manufacturing and testing. In 2013 she joined Amgen as a Director of Product Quality and manages a group of Product Quality Leaders who have product quality oversight of Amgen's biosimilar products including the establishment of specification, comparability and stability strategies.
Joel Welch is a review chief in the Office of Biotechnology Products in the Center for Drug Evaluation and Research at FDA. In this role, he oversees 12 reviewers who evaluate CMC information for monoclonal antibodies and therapeutic proteins from pre-clinical development through licensure, including both novel products and biosimilars. Joel is a trained chemist, and spent six years in industry supporting late state analytical development of small molecules prior to joining FDA in 2010. In his time at FDA, he has worked as a regulatory project manager, a product quality reviewer, and was most recently a product quality/CMC team leader.
Richard (Rick) K. Burdick is an Emeritus Professor of Statistics, Arizona State University (ASU) and former Quality Engineering Director for Amgen, Inc. for 10 years. He presently serves as Chief Statistician for Elion Labs, a division of KBI Biopharma, Inc.
His research and consulting interests consider several CMC statistical applications including comparability studies, stability data analysis, analytical method validation, quality by design process characterization, and analytical similarity for biosimilar products. He has written over 70 journal articles and four books.
Burdick is a Fellow of the American Statistical Association (ASA) and a member of the American Society for Quality (ASQ) and the American Association of Pharmaceutical Scientists (AAPS). He has served on the USP Statistics Expert Committee since 2010. He received his Bachelor’s Degree in Statistics from the University of Wyoming. He received his Masters and Doctorate degrees in Statistics from Texas A&M University.
Dr. Choi has been working at CELLTRION since 2015 in the Regulatory Affairs team, responsible for the preparation and submission of regulatory dossiers, in particular CMC documents, of biosimilars, and communication with the agencies including FDA. He has been involved in the preparation and review of module 3 documents and responses to the agency’s questions, and dedicated himself for the approval of a infliximab biosimilar, Inflectra in US and a trastuzumab biosimilar, Herzuma in Europe. Today, Dr. Choi manages the group responsible for regulatory activities to seek the approval of Herzuma in US.
Dr. Chung is a senior biologist in the Office of Biotechnology Products in the Center for Drug Evaluation and Research at FDA. In this role, Dr. Chung reviews product quality data for biotechnology products submitted in support of therapeutic drug development such as Investigational New Drug Applications and Biologics License Applications for both new molecular entities and biosimilar products. Dr. Chung holds a Bachelor of Science degree in Biological Chemistry from University of Chicago and a Doctorate degree in Cellular and Molecular Pharmacology from Rutgers University/University of Medicine and Dentistry of New Jersey. Prior to joining the FDA, Dr. Chung completed her research fellowship at Weill Medical College of Cornell University where she trained as a protein crystallographer to determine structural information of downstream TNF-alpha signaling mediators.
Chantal Depatie is a Senior Biologist/Scientific Evaluator in the Hormones and Enzymes Division of the Centre for the Evaluation of Radiopharmaceuticals and Biologics (CERB), Biologics and Genetic Therapies Directorate (BGTD), Health Products and Food Branch (HPFB), Health Canada. Chantal graduated with a PhD in Biochemistry from McGill University (Montreal, Canada) in 1999. Over the next 13 years, she continued in research as a post-doctoral fellow at the Sidney Kimmel Cancer Center in San Diego, and later, a research associate at the Children’s Hospital of Eastern Ontario in Ottawa. Chantal joined Health Canada in 2015.
Dr. Marjorie Shapiro received her Ph.D. in immunology from the University of Pennsylvania where she studied molecular mechanisms underlying antibody diversity. She joined the Division of Monoclonal Antibodies/FDA in 1993 and is currently a Lab Chief in the Division of Biotechnology Review and Research 1, Office of Biotechnology Products. She is known for her expertise in therapeutic monoclonal antibodies and related products such as antibody-drug conjugates, bispecific antibodies, antibody cocktails, Fc-fusion proteins, as well as biosimilars.
Catherine is the Senior Director for the Pfizer Biosimilars Analytical R&D group. She joined Pfizer as part of the Hospira acquisition in September 2015. Catherine’s Pfizer team is responsible for definition and implementation of strategies for demonstration of analytical similarity between Pfizer biosimilar products and on-market originator products. Additional responsibilities include analytical method development, qualification/validation and definition/implementation of analytical control strategies for biosimilar products. She is actively involved in the preparation of global regulatory submissions and meetings with Global Health Authorities in support of Pfizer’s biosimilar programs.
Prior to joining Hospira in 2012, Catherine held a number of roles in the Bioproduct Development organization at Eli Lilly and Company, including Director, Bioproduct Analytical Development and Director, Bioprocess Purification Development and Viral Safety. As Director, Bioproduct Analytical Development, Catherine led a group of scientists responsible for overseeing the development of analytical methods and control strategies for therapeutic proteins and peptides. As Director, Bioprocess Purification Development and Viral Safety at Lilly, Catherine led a group of scientists and engineers responsible for overseeing purification process development/optimization and technology transfer activities for biotechnology products in clinical and commercial development.
Catherine has a B.S. in Chemistry (West Virginia University, U.S.A.) and a Ph.D. in Analytical Chemistry (Indiana University, U.S.A).
Thomas Stangler is a Regulatory CMC team lead for Biosimilars at Novartis. Thomas has > 10 years of experience in the development of Biosimilars for Novartis’ Sandoz division. He is a physicist by training and has professional experience in analytical characterization, process development & characterization, QbD implementation and the use of statistics in CMC development.
Dr. R.M. van der Plas is senior assessor for biological products at the Medicines Evaluation Board, and previously RIVM where he started working as assessor in 2000. His fields of attention include biosimilars, monoclonal antibodies, recombinant proteins and plasma-derived products in general.
He obtained a Ph.D. degree in 1999, with the thesis ‘Structure and Function of Human von Willebrand Factor’. He obtained a ‘doctorandus’ (M.Sc) degree in 1994 with a major in Molecular Pharmacology.
Dr. Qing Zhou is a review chief in the Office of Biotechnology Products (OBP) at FDA’s Center for Drug Evaluation and Research (CDER). Dr. Zhou joined the FDA in 2010 as an Interagency Oncology Taskforce (IOTF) fellow. She became a product quality reviewer in the Division of Monoclonal Antibody (DMA), OBP/CDER/FDA, in 2012 and was selected to serve as a team leader in 2015. Dr. Zhou has extensive research experience in the areas of tumor and transplantation immunology and immunotherapy. Currently, she supervises a group of primary reviewers and team leaders to perform the review of regulatory submissions at the FDA for a wide range of novel and biosimilar biotechnology products.