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# Marks Wants ‘Project Orbis’ for Cell/Gene Therapies
- URL: https://www.fdaweb.com/marks-wants-project-orbis-for-cell-gene-therapies/
- Published: 2023-02-14T12:00:00.000Z
- Updated: 2026-09-14T18:15:48.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5153778

CBER director **Peter Marks** told the Biopharma Congress on 2/13 that he wants to see something similar to the agency’s Project Orbis cancer program developed for cell and gene therapies as the involvement of other “high-income countries” could help attract developers. The FDA Oncology Center of Excellence launched Project Orbis in 2019 to provide applicants with a framework for concurrent submissions and review of oncology products with other regulators, according to a Regulatory Affairs Professionals Society [post](https://www.raps.org/news-and-articles/news-articles/2023/2/top-fda-official-interested-in-project-orbis-for-c?ref=fdaweb.com) on the conference.

Marks said that to spur the development of cell and gene therapies, it may be best to pool resources and expertise from other regulators in reviewing and approving projects such as Project Orbis has done.

“A lot of these gene therapies have such small populations that are applicable to the U.S. that if we can expand those markets to other high-income countries, you would attract more developers and cover more diseases,” he said.

In other comments, Marks said FDA would soon announce a new pilot program that would be akin to Operation Warp Speed for rare diseases.

Asked whether CBER is tightening its approval standards for cell and gene therapies, as reflected in an increasing number of clinical holds on the products, he said that some INDs are “missing major pieces” and that “there are cases where we have bona fide companies coming in” that have problems with their submissions that could be resolved by a simple interactive meeting. But, he said, the Center doesn’t have the “bandwidth” to support such discussions.