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# Stakeholder Suggestions for Upcoming Disease Progression Workshop
- URL: https://www.fdaweb.com/stakeholder-suggestions-for-upcoming-disease-progression-workshop/
- Published: 2021-03-30T12:00:00.000Z
- Updated: 2026-09-14T16:52:50.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148993

The Biotechnology Innovation Organization (BIO) says it encourages FDA to include case study examples in an upcoming public workshop on best practices for the development and application of disease progression models. In a comment [letter](https://www.regulations.gov/comment/FDA-2021-N-0031-0006?ref=fdaweb.com), BIO says its members are willing to offer case study examples for inclusion in meeting agenda topics. The association also asks FDA to develop hypothetical case examples based on agency experience that illustrate key issues and can generate discussion on how obstacles may be overcome. It also recommends additional topics to be considered for the agenda.

In its [response](https://www.regulations.gov/comment/FDA-2021-N-0031-0007?ref=fdaweb.com), Novartis provides a technical discussion of the three questions FDA posed in soliciting public comment on the workshop — what to model, how to model, and questions on specific modeling.

The Critical Path Institute [says](https://www.regulations.gov/comment/FDA-2021-N-0031-0009?ref=fdaweb.com) that several factors should be considered in articulating a fit-for-purpose context for using drug progression models in drug development. The factors it suggests are **(1)** the intended application of the disease progression model in a specific stage of drug development; **(2)** a clinically relevant outcome to describe disease progression; **(3)** the definition of the target population; **(4)** detailed description of data sources, and **(5)** clinically relevant sources of variability to account for.

Finally, Genentech [says](https://www.regulations.gov/comment/FDA-2021-N-0031-0005?ref=fdaweb.com) it hopes the workshop will be the first of many such public discussions on the topic. “We request FDA to dedicate time during the workshop to consider how sponsors, FDA, and other relevant stakeholders (e.g., academics, other health authorities) can continue engaging to share knowledge, resolve challenges, and develop solutions that are applicable and acceptable globally,” it says.