I was selected to receive a Supplemental Training for Education Program (STEP) Award from the Society of Toxicology this past year where I could participate in a proposed career development activity of my choice. I chose to attend a Continuing Education course at the American College of Toxicology (ACT) Annual Meeting in Phoenix, Arizona.
In November 2025, I attended the ACT Continuing Education course “Strategies for Successful Nonclinical Studies: Study Director and Study Monitor Workshop”, which was a full-day workshop focused on the design, conduct, and interpretation of IND-enabling nonclinical programs. The course was taught by senior toxicologists and regulatory leaders across industry, consulting firms, and contract research organizations with significant experience in nonclinical safety. At the start of the course, we were assigned to small groups with meeting attendees that included graduate students like myself, early-career to senior-career study directors, and scientists that worked as consultants for regulatory submissions. Throughout the session, I engaged in discussions with course faculty and participants on practical study design, regulatory expectations, and real-world case studies to help us understand the challenges of building a robust nonclinical package for FDA submission. Overall, I had a great time connecting with and learning from the course attendees and instructors.
After completion of the course, I was able to attend the remaining meeting activities where I was able to learn about topics such as the involvement of new approach methodologies in the pharmaceutical industry and the interactions between the FDA and pharmaceutical companies in the regulatory process. I also attended the Early Career Professional Night where we participated in speed-networking with scientists working at small and large pharma companies, consulting firms, contract research organizations, and government agencies.
My primary objective in participating in this course at ACT was to strengthen my understanding of nonclinical safety assessment and deepen my insight into how early decision-making influences the success of regulatory submissions. As a trainee interested in a career in drug safety and regulatory toxicology, I selected this CE course as my desired training activity so that I could learn more about the specific roles and responsibilities of study directors and study monitors, the decision-making process they take when interpreting study data, and how their position fits into the drug development process.
Overall, the course strengthened my ability to interpret preclinical findings in a translational context and enhanced my understanding of the role of a toxicologist at contract research organizations and pharmaceutical companies. In addition, I had the opportunity to meet with multiple toxicologists in these roles that were attending the course as well. It was an amazing opportunity to connect with scientists in my desired field and learn how they approach common challenges in their role. Together, my participation in the course provided me with a critical foundation on nonclinical drug safety, and I was able to build meaningful connections with professionals in my field of interest. Over the next year, I plan to attend activities at the SOT Annual Meeting on nonclinical drug safety, and I will follow up with my ACT connections who are current study monitors/directors to learn more about their c areer paths and specific advice for finding their first role as study director.
