There is a strong need to move from a reactive stance to proactively embedding Inclusive Research from the earliest stages of development. This comprehensive, end-to-end approach mandates early consideration of all potential patient populations our medicines could serve. It is imperative to thoroughly characterize drug behaviors, safety profiles, pharmacology, and pharmacodynamic effects across diverse subpopulations. This is achieved by leveraging innovative experimental work such as organoids and advanced modeling techniques like Model-Informed Precision Dosing, critically enhanced by Artificial Intelligence and Machine Learning. While broadening studies to encompass more populations can be resource-intensive, scientific innovations, including AI are actively lowering barriers. This makes inclusive research achievable, enhances R&D productivity and promotes health equity.
Learning Objectives:
Explain the critical need to transition from a reactive to a proactive approach in embedding Inclusive Research from the earliest stages of drug development
Understand the opportunities and benefits of investing early in addressing population heterogeneity
Understand the business impact of addresssing population heterogeneity in research and early development