Dr. Scott has more than 30 years of experience in drug regulatory affairs in the pharmaceutical industry, and is currently at Sobi, a specialty pharmaceutical company that is building a portfolio of differentiated medicines for patients with rare conditions. She has served in a number of companies, including BDSI, Cempra, EMD, Pfizer and Parke-Davis, as a principal in constructing clinical regulatory strategies and submissions for the development of products across a range of therapeutic areas, with a focus on anti-infective drugs. She is also a certified paralegal with primary interests in administrative law and intellectual property.

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.