Modelling biologics: Challenges and opportunities, with Dr Dhaval Shah

Advanced simulation and modelling is already making huge waves in how we develop small molecule drugs, but when it comes to gene and antibody-based therapies, there are new technological and data challenges.

At the recent AAPS National Biotech Conference 2025, pharmaphorum editor-in-chief Jonah Comstock caught up with Dr Dhaval Shah, a professor of pharmaceutical sciences at the University of Buffalo and former Pfizer researcher who specialises in simulation and modelling for biologics.

In the segment below, the two discuss the biggest challenge of using simulation and modelling for biologics: access to high quality data. But they also get into other important challenges, including a lack of understanding on the part of regulators, model trustworthiness, the compute power required, and the many variables that an in silico model has to account for to be effective.

Shah also discusses what makes gene therapy in particular so hard to model and goes into the nitty gritty of how these models work. Check out the full conversation below.