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# Serono Comments on Planned FDA Disease Progression Workshop
- URL: https://www.fdaweb.com/serono-comments-on-planned-fda-disease-progression-workshop/
- Published: 2021-03-25T12:00:00.000Z
- Updated: 2026-09-14T16:52:15.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148970

EMD Serono says there are several things FDA should consider as it continues planning a workshop on “Best Practices for Development and Application of Disease Progression Models.” In a 3/22 comment [letter](https://downloads.regulations.gov/FDA-2021-N-0031-0003/attachment%5F1.pdf?ref=fdaweb.com), the company asks the agency to consider: 

- best practices for machine learning and artificial intelligence in the development of disease progression models with multi-dimensional covariates;
- application of disease trajectory models in regulatory decision-making; and
- challenges in longitudinal exposure-response analyses of survival outcomes in oncology immunotherapy development.