Allison Wolf is a Principal Research Scientist in Global Regulatory Affairs CMC at Eli Lilly in Indianapolis, Indiana. She has been a regulatory scientist for over 16 years and has worked on small molecules, peptides, oligonucleotides, therapeutic proteins, and monoclonal antibodies. Her experience spans clinical development, commercialization, and post approval. Allison started her career as a medicinal chemist at Pharmacia and Upjohn after graduating from the University of Notre Dame with a M.S. degree in organic chemistry. In 2001, she moved into Regulatory CMC at Pharmacia and later joined Lilly as a regulatory scientist in 2003. In her current role, she leads a group of regulatory scientists responsible for the development and implementation of CMC regulatory strategies for therapeutic peptides, proteins, and monoclonal antibodies in all phases of clinical development and commercialization.