SC 1: MEASUREMENT, CHARACTERIZATION AND IMPACT OF IMPURITIES
Pat Cash, Ph.D., Senior Director, Analytical Biochemistry, MedImmune, Inc.
Dr. Patricia Cash is Senior Director in the Analytical Biochemistry Department at MedImmune. Her group is responsible for developing and implementing analytical methods used for characterization, lot release, and in-process testing of all protein projects at various stages of development. Dr. Cash worked as Director of Biochemical Methods at Sanofi Pasteur (1999-2007), a Senior Research Investigator at Bristol-Myers Squibb (1993-1999), and a Principal Scientist at Cytogen (1990-1993). She received her PhD from Rutgers University in Newark, NJ and an MBA from the University of Phoenix.
Nadine M. Ritter, Ph.D., Senior CMC Consultant, Biologics Consulting Group, Inc.
Nadine Ritter has been a protein scientist for over 25 yrs, first as funded academic research in bone biology, followed by a move to the biotechnology industry in 1998. There she acquired direct experiences as a senior scientist in large pharma organization, conducting analytical studies to support product quality testing and regulatory filings. She was then recruited to become director of the analytical services division of a major biotech contract lab performing R&D, GLP and GMP studies and tests. During her tenure, her lab generated product characterization, comparability, release and stability data to support the development and commercialization of a wide array of biotechnology products. Currently, she is a CMC technical, regulatory and quality consultant in the biopharmaceutical industry, and is an instructor in post-graduate academic programs for biotechnology education. Dr. Ritter is on the board of several biotechnology professional organizations, academic institutions and journals. She has given invited presentations around the world, and has written numerous articles and book chapters as a subject matter expert. She is a recognized leader in the technical, quality and regulatory elements of analytics for a variety of biotechnology, biological and biosimilar products. Nadine has been a popular and highly-rated PTI trainer since 2001.
SC 2: SETTING UP A COMPARABILITY PROTOCOL FOR INNOVATOR PRODUCTS AND BIOSIMILARS
Chris Holloway, Ph.D., Group Director, Regulatory Affairs, ERA Consulting Group
For the past 23 years, Chris has held the position of Group Director of Regulatory Affairs of the ERA Consulting Group, during which time he has been involved in projects on the development of more than 400 biological medicinal products, ranging from natural products to advanced therapy medicinal products (gene, cell and tissue engineered products). Previously, he was Professor of Clinical Biochemistry and Physiological Chemistry at Hannover Medical School in Germany, where, in the early 1980s, he became involved in the evolving evaluation process for products of recombinant DNA products, which at that time were in their infancy. He remains a member of the teaching faculty of Hannover Medical School. Apart from his expertise in regulatory strategies for novel biopharmaceutical products in Europe and the US, and work on issues relating to comparability of biologicals, Chris has a particular interest in the challenge and needs of evaluating complex medicines in emerging countries and the developing world, to which end he has provided training sessions for regulators of those jurisdictions.
Michael Tovey, Ph.D., Director, Research, Laboratory of Biotechnology & Applied Pharmacology, ENS Cachan
Michael G. TOVEY, Ph.D, is INSERM Director of Research, Laboratory of Biotechnology and Applied Pharmacology at the Ecole Normale Supérieure de Cachan, Cachan, France. He is the author of more than 200 articles on interferon, cytokines, biotechnology, and immunogenicity. He is a member of numerous scientific boards and is French representative for the ISICR International Council. He is chair of the International Cytokine Standards Committee, a member of the ISICR Meetings Committee, and a member of the European Adjuvant Advisory Committee. He is editor-in-chief of Detection and Quantification of Antibodies to Biopharmaceuticals:Practical and Applied Considerations, and Associate Editor of the Journal of Interferon and Cytokine Research.