Class of 2023

Applied Experience: FDA Center for Drug Evaluation Research

Briefly describe what you did for your Applied Experience and any highlights.

In my AE at the United States Food and Drug Administration’s Center for Drug Evaluation Research (or USFDA CDER), I uncovered and evaluated potential DDTs, which are “methods, materials, or measures that have the potential to facilitate drug development.” The majority of technologies encountered were applicable to data science and computational modeling. These include AIs and simulations. There were also tools for managing the overall workflow of drug development, and a number of physical models, including a ‘liver-on-a-chip’! We presented our findings at the FDA Annual Summer Student Scientific Poster Day 2021. Finally, we formulated a set of policy recommendations for the Innovative Science and Technology Approaches for New Drugs (ISTAND) pilot program to guide their evaluation of these novel tools.

How has your experience informed your understanding of public health?

I don’t think it’s possible to fully appreciate the importance of government in public health until one experiences the lengths to which FDA goes to ensure that their messaging is clear.

In the world of drugs, FDA is the rule maker. Thus, every statement made by the Administration must mean only what the FDA wants it to mean. To ensure this, each publication goes through a painstaking revision and review process. My poster, for example, was edited a half-dozen times to ensure that I was using certain terminology, that these words were used their correct contexts, and that the poster format adhered to FDA standards. Only then was it accepted for presentation.

How do you think your time at JHU prepared you for this work?

The crux of my work at FDA was to characterize and evaluate an assortment of unique potential DDTs. To do this, it was critical to understand what each tool did, and how they were applicable to human health. Thankfully, my coursework in my second major, biomedical engineering (BME), gave me the skills to quickly understand what each tool does.

Many potential DDTs involve novel mechanisms and intriguing materials. However, they are not of interest unless they help solve an issue in drug development. My public health education enabled me to understand the challenges that confront our well-being. These are the areas in which we need DDTs most urgently, and were the areas that I emphasized during my evaluation of potential DDTs.

* Update April 2022: During the summer of 2022, Lucas will be a Fellow at the CDC. He writes “I will be developing methods to analyze toxic and essential compounds. These methods will improve the overall detection and treatment of conditions related to the environment, nutrition, tobacco, and chronic and infectious diseases.”