Transformative Advancements in the Treatment of Immune-Mediated Diseases: Integrating Patient-Centric Clinical Pharmacology with Translational MID3 for Biologics

Session Description

The field of immunology has seen remarkable advancements, particularly with the emergence of novel biologics capable of multiple therapeutic applications. Central to these innovations is translational model-informed drug discovery and development (TMID3), an approach that integrates pharmacokinetics (PK) and pharmacodynamics (PD) to optimize therapeutic strategies. TMID3 has been instrumental in identifying effective combination therapies and establishing a new paradigm in treating immune-mediated diseases, enhancing efficacy while minimizing safety risks.

Novel biological modalities, including immune cytokines, cyclic peptides, bispecific antibodies, antibody-drug conjugates, mRNA therapies, cell therapy and vaccines, have become essential components of the immunology armamentarium. Each modality presents unique advantages and broad potential for treating various immune-mediated diseases. Through the application of TMID3, these innovative therapies are developed, optimized, and brought to clinical use, with advanced PK/PD modeling playing a crucial role in expediting the drug development process and enhancing safety and efficacy profiles.

Leveraging the latest advancements in TMID3, this scientific session offers a comprehensive overview of the transformative potential of these novel biologics. Detailed analysis and discussion will underscore the importance of a patient-centric approach in clinical pharmacology, prioritizing individual patient needs and responses in developing new therapies.

This session aims to illuminate the future direction of immunology, emphasizing how these groundbreaking biologics can address unmet medical needs and significantly improve patient outcomes.

Learning Objectives

1. Understand the significance of TMID3 in optimizing therapeutic strategies for immune-mediated diseases.
   Explore the role of advanced PK-PD modeling in identifying effective combination therapies and minimizing safety risks.
2. Examine various innovative biological modalities (cytokines, cyclic peptides, bispecifics, ADC, mRNA therapies, cell therapy and vaccines). Learn utility of TMID3 in Biologics development and importance of patient centricity in clinical pharmacology.
3. Recognize the transformative potential of these novel biologics in addressing unmet medical needs and significantly improving patient outcomes in immunological disorders.

Session Schedule

Introduction
Sihem Bihorel, MSc, PharmD, PhD and Li Zhang, PhD

Personalized Treatment for Inflammatory Bowel Disease: Leveraging Translational MID3 and Patient-Centric Pharmacology
Sihem Bihorel, MSc, PharmD, PhD

Towards Precision Medicine in Systemic Lupus Erythematosus
Li Zhang, PhD

Model Informed Drug Development Based Approval of Intravenous Secukinumab for the Treatment of Multiple Rheumatology Indications
Dipak Pisal, MS, PhD

Panel Discussion
Brian Cicali, MS, PhD