scientific operations

Craig Trost

With more than 15 years of experience in nonclinical drug development, Craig has built a career leading toxicology and IND-enabling programs across gene therapy, neuroscience, and ocular therapeutics. As a consultant and former Nonclinical Study Monitor at REGENXBIO, Craig has served as the nonclinical lead for successful IND submissions supporting two neuroscience small molecules currently in clinical development. His expertise includes developing nonclinical strategies, overseeing outsourced studies and CRO partnerships, interpreting study data, and authoring regulatory documentation including IND Section 2.6 and CTD summaries. He has also participated directly in FDA interactions, including pre-IND and designated meetings.

Previously, Craig spent over a decade at Covance Laboratories, progressing from Study Technician to Study Director. In these roles, he led global, cross-functional teams managing multifaceted GLP toxicology studies for pharmaceutical sponsors worldwide, with particular specialization in ocular toxicology. Craig’s experience spans study design, operational oversight, regulatory compliance, risk mitigation, data interpretation, and stakeholder communication across all phases of preclinical development.

Combining scientific expertise with strategic support, Craig is recognized for the ability to guide development
programs while balancing regulatory requirements, timelines, and business objectives. Craig holds a Master of
Science in Pharmacology and Toxicology from Michigan State University and a Bachelor of Science in Genetics
from University of Wisconsin.