Elliott T. Berger, PhD, is President of ETB Regulatory Consulting, LLC. He recently retired from BioCryst Pharmaceuticals, Inc., where he held the position of Senior Vice President of Regulatory Affairs for 14 years. He has frequently served as speaker and session chair at numerous meetings and workshops for DIA and for the Pharmaceutical Research & Manufacturers of America (PhRMA). He serves as an instructor for the DIA Regulatory Affairs: The IND, NDA, and Post-Marketing training course and is a member of the DIA Regulatory Training Committee.