Integrating Patient-Centric Clinical Pharmacology and MID3 to Advance Biologic Development in Immune-Mediated Inflammatory Diseases.

Advances in biologics and model-informed drug discovery and development (MID3) are transforming the treatment of immune-mediated inflammatory diseases (IMIDs). By integrating pharmacokinetics and pharmacodynamics, MID3 enables mechanism-based, patient-centered strategies to optimize therapies, strengthen benefit-risk assessment, and advance precision medicine. Innovations such as cytokine inhibitors, bispecific antibodies, antibody-drug conjugates, and mRNA therapies have expanded treatment options across dermatology, rheumatology, gastroenterology, and respiratory medicine. The rapid development of JAK- and interleukin-targeted agents underscores the shift toward individualized, mechanistically driven therapies. At ASCPT 2025, the session "Transformative Advancements in the Treatment of IMIDs: Integrating Patient-Centric Clinical Pharmacology with Translational MID3 for Biologics" brought together experts from academia, industry, and regulatory agencies and emphasized how translational MID3 and precision pharmacology are accelerating the next generation of patient-tailored biologic therapies, with case studies in inflammatory bowel disease, systemic lupus erythematosus, and rheumatology.