Model-Informed Drug Development (MIDD) Applications in Advancing Patient Care

Includes a Live Web Event on 08/27/2025 at 12:00 PM (EDT)

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Model-Informed Drug Development (MIDD) can be a valuable tool to support drug development and advance patient care, especially in assessing benefit-risk of different dosing regimens, bridging between different routes of administration, or when considering dosing recommendations in specific situations not specifically evaluated in clinical trials. For example, by leveraging available clinical data to assess alternative dosing intervals, MIIDD approaches can potentially inform treatment options that reduce frequency or number of patients visits or inform handing of missed/interrupted dosing without the need of additional clinical trials.

In this webinar, we will discuss several case examples where MIDD approaches were used to support the approval of dosing regimens or dosing strategies not directly studied in clinical studies. Some of the specific examples will include use of MIDD approaches to guide dosing recommendations following dosing holidays for bispecific therapeutics and to guide dose selection during clinical development of an ocular implant designed to reduce patient treatment burden. Each of the examples will highlight the question that the MIDD approach was intended to answer, the role of the model in addressing the question, interactions between groups to achieve alignment on the approach and interpretation of the modeling, and overall outcome of the effort.

Jeffrey Florian

Associate Director

FDA/CDER/OTS/OCP

Jeffry Florian serves as an Associate Director in the Division of Applied Regulatory Science (DARS), Office of Clinical Pharmacology, Office of Translational Sciences at CDER/FDA and has worked at FDA for 15 years spanning multiple roles. In his current role, he supervises DARS teams involve in clinical and computational applied research. Activities include using in silico tools to explain emerging safety signals based on both known and predicted mechanisms, developing text-mining algorithms to quickly identify information to support labeling and policy development, and application of systems modeling approaches for topics such as CiPA (Comprehensive in vitro Proarrhythmia Assay), opioid overdose, and cannabidiol liver safety. Jeffry received his PhD in Chemical Engineering from the University of Pittsburgh in 2007.

Katie Maass

Senior Principal Scientist

Genentech

Katie Maass is a Senior Principal Scientist in the Clinical Pharmacology department at Genentech, focusing on ophthalmology programs. She has experience on cross-functional drug development teams supporting programs in the pre-IND stage through post-approval. She has contributed to clinical study designs, regulatory interactions, clinical study data analysis and interpretation, pharmacokinetic and pharmacodynamics modeling and simulation, and project team decision making. Katie received her BS in chemical engineering at the University of Texas at Austin and PhD in chemical engineering at MIT.

Lauren Price, PharmD

Clinical Pharmacology Team Lead

FDA/CDER/OTS/OCP

Lauren Price, PharmD, is a Clinical Pharmacology Team Lead in the Office of Cancer Pharmacology II, Office of Clinical Pharmacology, US Food & Drug Administration. She obtained a PharmD from the University of Washington School of Pharmacy and subsequently completed an oncology fellowship at the University of North Carolina Eshelman School of Pharmacy. Lauren joined the FDA in 2018 where she reviews and provides regulatory and scientific advice on IND, NDA, and BLA submissions for oncology products.