Dana Bell, PhD, is an RA Consultant specializing in the development of the registration strategies for the drugs, biologics and devices. Previously, she was a Senior Director of Global Regulatory Affairs at Baxter Healthcare Corporation. Dr Bell is a part time professor at the USC School of Pharmacy. She holds an MS in Pharmacy and a PhD in Pharmacology and Biochemistry.

Dr. Smerkanich has her doctorate and is an Assistant Professor in the Department of Regulatory and Quality Sciences at the University of Southern California. She leads the clinical/regulatory courses while continuing to provide regulatory knowledge support to her academic and industry peers. In her role at USC, she brings many years of practical regulatory knowledge and experience to academia with a focus on clinical translational science. With over 30 years of experience, Dr. Smerkanich has participated in all regulatory aspects of drug development, having served as Regulatory Liaison, US Agent, and Global Regulatory Lead across all therapeutic areas.

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.