The Biotechnology Training Program is pleased to present the following seminar by Julie Fogarty:

A Case Study in Using Pre-Clinical Tool to Predict Clinical Performance

In this Tom and Jerry-themed lecture, we will explore the range of pre-clinical tools used to screen small-molecule pharmaceutical formulations. Using a real-world case study, we will examine the strengths and limitations of commonly employed pre-clinical approaches and discuss how these tools can be further developed and strategically leveraged when unexpected clinical data emerge. Building on this foundation, the lecture will highlight formulation strategies that can be deployed in response to unanticipated clinical outcomes. We will then reassess the previously developed pre-clinical tools by applying them to these new formulations and comparing the results with subsequent clinical data. Finally, we will demonstrate how these tools can be used to generate informed predictions about potential future products.

Julie Fogarty is a Principal Scientist in Formulation and Process Development at Gilead Sciences, where she focuses on the development of impactful medicines scross Gileads three therapeutic areas. She received her academic training at the University of Texas at Austin and Stanford University, providing her with a background rooted in chemical engineering and drug product development. In her current role, Julie works at the interface of science, manufacturing, and patient impact, translating fundamental engineering principles into real-world therapies. She is passionate about mentorship, industry-academia engagement, and helping students understand the many pathways a chemical engineering education can open.