A special session: Meet the regulator
 Meet the regulator in a special session, interact with FDA specialist and receive insightful answers regarding FDA initiatives
Dr. Steven Kozlowski,
CDER, FDA, Silver Spring, MD USA
Quality, Quality by Design, Biotechnology Products and US FDA Initiatives
Steven Kozlowski is the Director of the Office of Biotechnology Products, Office of Pharmaceutical Science, at the Center for Drugs Evaluation and Research (CDER), FDA. He received his medical degree from Northwestern University and trained in Pediatrics at the University of Illinois. Prior to joining the FDA, Dr. Kozlowski worked as a staff fellow in the Molecular Biology Section of the Laboratory of Immunology, NIAID, NIH. He studied the immune responses to proteins and peptides during his fellowship. Dr. Kozlowski joined the Division of Monoclonal Antibodies in 1993 and was tenured as a Senior Investigator in 2000. He has been involved in all phases of the regulatory process as a reviewer, from pre-IND product development through inspections, licensing and post approval supplements. Dr. Kozlowski served as the acting Director of the Division of Monoclonal Antibodies from 2004-2005. He has also served as an instructor and as an adjunct clinical reviewer at FDA. Dr. Kozlowski’s research interests include the effects of drugs on the immune system. He has been very involved in promoting Quality-by-Design approaches for the manufacture of biopharmaceutical products.
Chair Person and Discussion Moderator: Dr. Raphy Bar
A Special Afternoon Workshop With Cocktail Reception
on
Pharmacopoeial Chromatography:
Revising USP Chapter <621>
with Karen A. Russo, Ph.D. 
Vice President, Small Molecules, United States Pharmacopeia
 For presentation of Dr. Karen Russo please click here
Karen joined USP in 2002 and has developed public standards for various drug substances and dosages forms. She serves USP in a coordinating role with the pharmaceutical industry for monograph development and acquisition efforts. Karen oversees a staff of scientific liaisons working with the USP Council of Experts to provide the scientific content for monographs. She is also responsible for oversight of databases and applications that manage the monograph acquisition and revision workflow.
Karen worked at Midwest Research Institute (Kansas City, MO) for 12 years and gained experience in project management involving method development and validation of drugs from various therapeutic categories. She also managed projects involving chemical characterization of drug substances and stability studies for dosage forms. Karen also worked at Regulatory and Clinical Consultants, Inc. as a clinical research associate responsible for monitoring human Phase II and Phase III clinical trials. She is a member of the American Association of Pharmaceutical Scientists.
Workshop Moderated by: Bianca Avramovitch, Ph.D.
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