Carol H. Danielson, DrPH, MS, RAC is the President of Regulatory Advantage International, LLC. She has provided regulatory expertise and strategy for more than twenty five years for drugs, biologics, and combination products from discovery through post-marketing. Dr. Danielson has an MS in Biology from Samford University and a Doctorate in Public Health from the University of Alabama. She has worked extensively with both large Pharma and virtual start ups in therapeutic proteins, vaccines, and cellular therapies. She received the DIA 2011 award for excellence in science and medicine, is a reviewer for the California Institute of Regenerative Medicine, and an adjunct professor in clinical and regulatory affairs.