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Roller Coaster 3

Advancing Drug Development through Model Informed Drug Development: Insights from the ICH M15 MIDD Guidance Working Group

Wednesday, November 13, 2024
10:50 AM – 11:05 AM MST
Location: Sonoran Sky Ballroom 5 - 8

    Speaker(s)

  • JC

    Jenny Chien, PhD

    Associate Vice President
    Eli Lilly and Company
    Indianapolis, Indiana, United States

    Disclosure(s): Eli Lilly and Company: Employment (Ongoing), Ownership Interest (stocks, stock options, patent or other intellectual property or other ownership interest excluding diversified mutual funds) (Ongoing)

Disclosure(s):
Jenny Chien, PhD: Eli Lilly and Company: Employment (Ongoing), Ownership Interest (stocks, stock options, patent or other intellectual property or other ownership interest excluding diversified mutual funds) (Ongoing)
Description: M15 is a new multidisciplinary guideline endorsed for development by ICH in November 2022. Once complete, it will provide over-arching general principles and good-practices guidance for model-informed drug development (MIDD) applicable to all current modeling and simulation (M&S) approaches, including QSP, AI/ML and integrated approaches that span disciplines (doi:10.1002/cpt.3006).
MIDD is defined as a quantitative framework in which mathematical models are used to predict drug concentrations and/or pharmacologic effects on disease pathology or clinical outcomes. When utilized appropriately, MIDD can inform optimized trial designs, therapeutic advancement decision-making, efficiency in drug development and regulatory reviews. Therefore, harmonization in the regulatory review, interactions, assessments and reporting of MIDD results and removal of inconsistencies has potential to greatly reduce wasted resources, inefficiencies and missed opportunities in the development and delivery of medicines to patients across geographies.
The guideline introduces the concept of a risk-based assessment, and advocates for upfront cross-functional strategic planning and more multidisciplinary communications within and between regulatory agencies and industry scientists to improve efficiency of drug development and regulatory decision-making.
In this session, regulatory and industry members of the ICH M15 MIDD Working Group will present and lead a panel discussion on challenges and opportunities for M&S in drug development and regulatory decision-making globally and how they can be addressed by the guidance.

Learning Objectives:

  • Upon completion, participants • will be introduced to the newly proposed ICH M15 guideline and its forward-looking objectives, expectations, and prioritizations. • gain a better appreciation of the challenges and opportunities for MIDD for novel approaches and applications in context of regulatory decision-making globally. • as members of the scientific community, have an opportunity to provide feedback to ICH expert working group members for the draft guideline (through the panel discussion)