Julie Tripp
Scientific Advisor
Is an American Board of Toxicology diplomate, senior level toxicologist and nonclinical regulatory leader with extensive experience advancing CNS, addiction, and psychiatric therapeutics from pre–first-in-human development through post-marketing support. She has led or served as primary toxicologist for successful NDA, MAA, CTA, and IND-enabling programs, contributing to global approvals for extended-release and nasal products. She has directed comprehensive nonclinical safety strategies, including pivotal toxicology, genetic toxicology, reproductive toxicology, safety pharmacology, carcinogenicity, ADME, and impurity assessments, while integrating pharmacology, pharmacokinetic, and toxicology data into regulatory-ready submissions. Her accomplishments include leading modern nonclinical programs for small-molecule candidates, authoring and reviewing major regulatory documents, supporting successful health authority interactions, and contributing as Co-PI and lead toxicologist to a funded NIH HEAL grant. Across programs, she has enabled efficient go/no-go decisions, managed safety risks, and delivered scientifically rigorous nonclinical packages supporting clinical development and regulatory approvals