Preparing to “STEP” into the Pharmaceutical Industry


By Lauren Lewis posted 07-02-2019 13:58


In April, I traveled to Gaithersburg, Maryland, to participate in the American College of Toxicology (ACT) educational course, “Toxicology for Pharmaceutical and Regulatory Scientists.” This was a weeklong course that provided an overview of toxicology and nonclinical safety evaluations. My participation in this course was made possible by the financial support of the Society of Toxicology and the Supplemental Training for Education Program (STEP) award. My goal for participating in this ACT course was to learn more about the pharmaceutical industry and the drug development process.

Apply Now for STEP Award Funding.pngThe course structure fostered a great environment for learning. There were approximately 80 attendees from around the world. Participants came from diverse backgrounds, such as CROs, regulatory agencies, and biotechnology and pharmaceutical companies, which created dynamic discussions. The guest speakers for each lecture were expert toxicologists and regulatory scientists who were eager to share their knowledge and professional experience.

The course started with topics such as general toxicology, pharmacology, and pathology. As the course progressed, we listened to detailed lectures on nonclinical safety study requirements and considerations. The course finished with the preparation of nonclinical documents for regulatory submission. In addition to lectures, networking breaks were included in the schedule to allow for professional development. This provided me with the opportunity to learn about many different career options in the pharmaceutical industry and make valuable connections.

My favorite part of the course was applying concepts from the lectures to regulatory case studies and reviewing “real-world” nonclinical data. Participants were divided into breakout groups and worked through exercises such as calculating safety factors and determining the maximum safe starting dose. In addition, we had the opportunity to practice evaluating Investigational New Drug (IND) submissions that had been previously reviewed by the US Food and Drug Administration (US FDA). Our assignment as a group was to determine if the submitted data were sufficient for the approval of the IND or if it needed to be placed on hold until the sponsor conducted additional experiments, which we practiced recommending to them. For our final case study of the course, US FDA reviewers joined in on our discussions and provided their insight. Conducting these analyses reinforced what we learned throughout the course.

Overall, my experience at the “Toxicology for Pharmaceutical and Regulatory Scientists” course was excellent. As a fourth-year PhD candidate in toxicology, I believed that attending this course would provide valuable insight into the drug development process and help prepare me for a career in the pharmaceutical industry. Although my graduate coursework has covered some of the material that was presented, this course provided in-depth information about nonclinical safety evaluations and hands-on analyses of nonclinical data.

Thank you to the Society of Toxicology for their support of graduate student career development. I appreciate the opportunity to expand my toxicology training, and by participating in this course, I am one “STEP” closer to becoming a toxicologist in the pharmaceutical industry.

The next STEP application date is October 9.