- November 19, 2021
The Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) are announcing a virtual public workshop entitled "Best Practices for Development and Application of Disease Progression Models." The purpose of this public workshop is to discuss the best practices for developing disease progression models and their application to support drug development decisions, share experiences and case studies that highlight the opportunities and limitations in the development and application of disease progression models including models for natural history of disease and clinical trial simulations, and discuss the knowledge gaps and research needed to advance the development and use of disease progression models.
- Agenda (PDF - 192 KB)
- Meeting Recording
Topics for discussion:
- Role of disease models in drug development and regulatory review
- Lessons learned from past experiences of applying disease models in drug development
- Best practice considerations for disease modeling to support drug development and regulatory decisions
- Best practice considerations for clinical trial simulations based on disease progression/natural history models to support drug development and regulatory decisions
Meeting Information and Registration:
This workshop is open to the public; however, registration is required. Persons interested in attending this public workshop must register by November 16, 2021, at: https://www.eventbrite.com/e/best-practices-for-development-application-of-disease-progression-models-tickets-166318875233.
If you are having troubles connecting to Zoom (after registering), please email Virtual-WOCC-Support@fda.hhs.gov.
If you have any additional questions about this workshop, please contact:
Office of Clinical Pharmacology
Center for Drug Evaluation and Research
Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002