The development of ophthalmic drug products is challenging due to the complexity of the ocular system, the lack of sensitive testing to evaluate the interplay of its physiology with ophthalmic drugs, and measurement limitations associated with ocular pharmacokinetics.

In this webinar, Drs. Hovik Gukasyan (University of Southern California) and Maxime le Merdy (Simulations Plus) will discuss how modeling and simulation platforms—and the GastroPlus® ocular physiologically based pharmacokinetic (PBPK) model in particular—are supporting researchers in overcoming these challenges.

In part 1 of the webinar, Hovik will provide an overview of several prior reports which describe bioinformatics and cheminformatics-based approaches supporting ocular development, using progressive modeling and simulation methods, i.e., the mechanistic ocular absorption and transit (OCAT™) model in GastroPlus®. He will then present a case study focused on the application of machine learning and PBPK approaches to support a comprehensive analysis of all molecules published on Boehringer Ingelheim’s opnMe.com database to find solutions specific to ophthalmic pharmacology and therapeutic questions with major unmet need through complete early drug candidate repositioning research.

In part 2 of the webinar, Maxime will introduce the mechanistic OCAT model in GastroPlus and explain how it provides insight into drug partitioning in eye tissues that are usually not accessible and/or are challenging to sample in humans. He will share use cases developed in collaboration with the U.S. FDA which illustrate how the validated preclinical model in animals is translated to predicts human exposure and PD outcomes following the administration of ophthalmic formulations.

Attendees will learn how model-informed drug development (MIDD) can be used to establish and increase confidence for ocular presence of drug targets. Participants will also have the chance to ask questions during our live Q&A.

Presenters:

• Dr. Hovhannes (Hovik) Gukasyan, Associate Professor of Pharmacology and Pharmaceutical Sciences, USC Alfred E. Mann School of Pharmacy and Pharmaceutical Sciences
• Dr. Maxime le Merdy, Associate Director, Research and Collaborations, Simulations Plus