A Modern Curriculum for Training Scientists in Model-Informed Drug Development: Progress Report on FDA Grant to Train...

Area of Science:

• Drug Development
• Regulatory Science
• Pharmacometrics

Background:

• The Critical Path Institute (C-Path) and industry partners created e-learning materials on model-informed drug development (MIDD).
• Existing training often falls short for non-modeling professionals in regulatory and industry settings.
• Multinational pharmaceutical companies provided case studies for practical application examples.

Purpose of the Study:

• To develop accessible e-learning video modules on MIDD topics for a non-modeling audience.
• To bridge the gap between academic knowledge and practical application in drug development and regulatory science.
• To provide valuable insights for both modelers and non-modelers involved in reviewing modeling and simulation work.

Main Methods:

• Creation of didactic video materials in an e-learning format covering various MIDD topics.
• Inclusion of case studies from pharmaceutical companies illustrating MIDD applications.
• Development of modules on the MIDD landscape, model types, decision-making, future goals, and model interconnectedness.

Main Results:

• Approximately 13 hours of video content on MIDD is now available.
• The e-learning materials are designed to benefit regulators, academic scientists, and industry professionals.
• A learning management system (LMS) is being beta-tested by FDA reviewers.

Conclusions:

• The developed MIDD e-learning resources address a critical training gap.
• Future plans include expanding content, faculty, mentorship, and broader access.
• The MIDD training LMS is adaptable for diverse learning needs and future audience expansion.