BIO
Liz Spehalski, Ph.D.
Senior Consultant, Regulatory Consulting
Work Experience
Prior to joining Parexel, Liz worked for over 6 years as a pharmacology/toxicology reviewer at the FDA in the Center for Drug Evaluation and Research’s (CDER’s) Division of Hematology Oncology Toxicology (DHOT). Liz has expertise in FDA regulations and review processes in early-stage nonclinical development including IND- enabling preclinical proof-of-principle study and GLP toxicology study design requirements, as well as in mid- to late- stage nonclinical development including chronic toxicology, DART, and carcinogenicity study design requirements. Since joining Parexel she has gained significant experience with the nonclinical development of cell and gene therapy (CGT) applications, including Initial Targeted Engagement for Regulatory Advice on CBER Products (INTERACT), pre-IND meetings, and IND applications.
Education
Liz holds a Ph.D. in cell and molecular pathology from the University of Michigan. She also holds a bachelor's degree in biology from Villanova University.