The ISoP QSP SIG is hosting its annual fully-student-focused Virtual Student QSP Symposium on Sep 8th, 2026. This event allowed current students and trainees to learn about training and career paths and share their work with each other and professionals in the field. The Symposium featured a stellar line-up of speakers and panelists from industry and academia.

IVIG co-administration with monoclonal-antibodies/bispecifics is common across autoimmunity, immunodeficiencies, and transplantation. These therapies undergo FcRn-mediated recycling, raising potential for PK-PD interactions. Mechanistic IgG-disposition model utilized to investigate how IVIG dose/timing, and IgG dynamics influence IgG behavior and PK/PD outcomes. Model well-described total/endogenous-IgG kinetics across autoimmune/transplantation. It recapitulated reduced tesidolumab exposure with IVIG in transplantation, explaining associated PD alterations. Model examined IVIG supplementation in multiple-myeloma receiving teclistamab, and rituximab-IVIG co-therapy for transplant desensitization. Simulations revealed IVIG co-therapy alters mAb PK-PD depending on IVIG-regimen, IgG-pool and exposure-response-relationship of the mAb. Model provides mechanistic framework for MIDD and prospective management of IgG interactions. The MIDD Webinar Series, coordinated by Yash Kapoor and Fulya Akpinar Singh, is a series of webinars focused on shaping the future of drug development and regulatory decision-making sponsored by the ISoP Education Committee. Topics range from MIDD approaches in regulatory submission to pharmacometrics topics that are at the core of model development.

The ICH M15 Guideline “General Principles for MIDD” stresses the importance of performing model evaluation targeting the Question of Interest (QoI) that model is intended to help to answer. In this presentation we elaborate on how reference corrected visual predictive check (rcVPC) methodology can be used for this purpose. The rcVPC can provide an efficient and more easily communicable tool to validate models, increasing confidence in model-informed decision-making among broader, non-modeling stakeholders. The MIDD Webinar Series, coordinated by Yash Kapoor and Fulya Akpinar Singh, is a series of webinars focused on shaping the future of drug development and regulatory decision-making sponsored by the ISoP Education Committee. Topics range from MIDD approaches in regulatory submission to pharmacometrics topics that are at the core of model development.