Creating a Roadmap to Quantitative Systems Pharmacology-informed Rare Disease Drug Development

Thursday, May 11, 2023
10:00 a.m.-5:00 p.m.

The U.S. Food and Drug Administration (FDA)- in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI)- will host a one-day virtual public workshop entitled “Creating a Roadmap to Quantitative Systems Pharmacology-informed Rare Disease Drug Development” on Thursday, May 11, 2023.

The purpose of this workshop is to discuss the potential utility of QSP in rare disease drug development and brainstorm the potential path to address the challenges and facilitate its use. 

This workshop is open to the public with no cost to attend.

About the Event

There are approximately 7,000 rare diseases. There is a public heath need to develop safe and efficacious drugs to treat these conditions. However, there are many challenges in developing drugs for rare diseases, including the small number of patients available for clinical trials to optimize the dosing regimen and demonstrate safety and efficacy of the drug, inter-individual variation in the course of disease, and a lack of well-characterized biomarkers to inform drug effects. Quantitative systems pharmacology (QSP) modeling can mechanistically, quantitatively link a drug candidate’s target, via the pharmacological network, to model and simulate drug responses and the extent of response variability to inform drug development decisions. 

Meeting Information & Registration

The workshop which is jointly sponsored by the University of Maryland Center for Excellence in Regulatory Science and Innovation (M-CERSI) and the FDA, will be open to the public. 

To register, use this link

To view the agenda, use this link 

To view the speaker bios, use this link

This workshop is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award U01FD005946 with 100 percent funded by FDA/HHS. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.

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