Model-informed drug discovery and development approaches to inform clinical trial design and regulatory decisions: A primer for the MENA region

Model-Informed Drug Discovery and Development (MID3) represents a transformative approach in pharmaceutical research, integrating quantitative models to inform and optimize decision-making throughout the drug development process. This review explores the current applications, challenges, and future prospects of MID3 within the Middle East and North Africa (MENA) region. By leveraging local data and advanced computational techniques, MID3 has the potential to significantly enhance the efficiency and success rates of drug development tailored to regional health priorities. We discussed successful case studies of applying MID3 at different phases of drug development and clinical trials. Furthermore, we emphasized the critical need for MENA countries to embrace MID3 by investing in workforce training, aligning regulatory frameworks, and fostering collaborative research initiatives. This call to action underscores the importance of a robust MID3 ecosystem, urging policymakers, academic institutions, and industry stakeholders to prioritize and support its integration into the MENA region’s healthcare.