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# ACMD Seminar: Standards for model evaluation applied to systems pharmacology models: Focus on sensitivity analysis

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Helen Moore*Laboratory for Systems Medicine, University of Florida College of Medicine*

Tuesday, March 29, 2022, 3:00 PM EDT (1:00 PM MDT)

**A video of this talk is available to NIST staff in the Math channel on NISTube, which is accessible from the NIST internal home page.**

**Abstract:**  Quantitative systems pharmacology (QSP) models are often systems of ordinary differential equations, with a dozen or more nonlinear equations, and many more parameters. A QSP model is a mechanistic representation of a patient’s disease and therapy dynamics. Although QSP models have been used to save substantial time and money in drug development, their use is not as widespread as might be expected from these benefits. Lack of buy-in from stakeholders is a major hurdle to adoption and can, in part, be attributed to lack of confidence in QSP models and their predictions. In this talk, I will make the case that standardization of model evaluation methods, either within the biotechnology/pharmaceutical (biopharma) community or more broadly, would support more extensive use of QSP models, and would reduce the resources needed for drug development.

I will then focus on sensitivity analysis, as a paradigm for model evaluation methods. The International Society of Pharmacometrics has a special interest group (SIG), the Mathematical and Computational Sciences (MCS) SIG, that is interested in sensitivity analysis (SA) and uncertainty quantification (UQ). The MCS SAUQ working group is developing standards for which SA methods and settings are most appropriate for various types of QSP models. I will present several examples of methods and models.

**Bio:**  Dr. Helen Moore graduated from the North Carolina School of Science and Mathematics and the University of North Carolina at Chapel Hill. She received her PhD in mathematics in 1995 from Stony Brook University in New York. Her original work in differential geometry focused on shapes that minimize volume under certain constraints. While in academia, she won two teaching awards and received a National Science Foundation grant for her research. At Stanford University, she began collaborating with faculty in the medical school, and shifted her use of optimization techniques to apply them to therapies for cancer, HIV, and hepatitis C.

In 2006, Dr. Moore entered the biopharma industry as a mathematical modeler. She worked at Genentech, Certara, Bristol-Myers Squibb, AstraZeneca, and Applied BioMath. Dr. Moore was named a Fellow of the Society for Industrial and Applied Mathematics in 2018. She returned to academia in 2021, joining the Laboratory for Systems Medicine in the University of Florida College of Medicine. Her three main areas of research are mathematical optimization of combination drug regimens, model evaluation methods, and systems modeling and analysis to determine potential therapeutic targets. Outside of work, she enjoys cycling, backpacking, and frisbee.

**Note:** This talk will be recorded to provide access to NIST staff and associates who could not be present to the time of the seminar. The recording will be made available in the Math channel on NISTube, which is accessible only on the NIST internal network. This recording could be released to the public through a Freedom of Information Act (FOIA) request. Do not discuss or visually present any sensitive (CUI/PII/BII) material. Ensure that no inappropriate material or any minors are contained within the background of any recording. (To facilitate this, we request that cameras of attendees are muted except when asking questions.)

**Host:** Tony Kearsley

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                -  Anthony J. Kearsley  anthony.kearsley@nist.gov      (301) 975-6103   
                -  Stephen Langer  stephen.langer@nist.gov      (301) 975-5423   
                -  Lochi Orr  lochi.orr@nist.gov      (410) 598-6986   

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