Isabel Drzewiecki owns and operates her own consulting company, JID Consulting, LLC, specializing in Regulatory Affairs. She retired as Vice President of Regulatory Affairs for Barrier Therapeutics in Princeton, NJ at the end of January 2009. She has served in the Regulatory field for over four decades and has participated in the development and approval of many products in the reproductive medicine, dermatological, and anti-infective drugs therapeutic areas. She has prepared and served as DIA faculty for several regulatory courses. Isabel earned her BS in Chemistry from Douglass College, Rutgers University, where she serves on the Dean’s Committee for Women in Engineering, Science and Mathematics.

Dr. Michael R. Hamrell is the President of MORIAH Consultants, a Regulatory Affairs/Clinical Research consulting firm located near Los Angeles, CA. He has worked in pharmaceuticals, contract research, government and biotech industries, in domestic and international regulatory affairs and clinical research. He also worked in the Division of AIDS in NIAID at NIH and as a reviewer at CDER at the FDA. Dr. Hamrell has published numerous papers in pharmacology, regulatory affairs, product development, clinical research, computers and information systems.

Ms Carol H. Danielson, Dr PH, RAC has provided regulatory expertise and leadership for more than twenty five years for drugs, biologics and medical devices from discovery through post-marketing. Her areas of specialization include regulatory strategy and submissions, clinical affairs and compliance, and quality assurance and control. Her background includes both extensive “hands on” experience and corporate level strategy activities from partnering due diligence to serving as an expert witness in the drug development process.