A top official from the US Food and Drug Administration (FDA) said he wants to see something similar to the agency’s Project Orbis program developed for cell and gene therapies, as the involvement of other “high-income countries” could help attract developers, asserted Peter Marks, director of FDA’s Center for Biologics Evaluation and Research (CBER), at the Biopharma Congress on 13 February.
At the meeting, FDA officials offered their perspectives on other policy areas, such as the use of accelerated approval for cell and gene therapies and whether the agency is raising its approval standards for new cell and gene therapies.
The officials were asked to discuss whether there have been any of lessons learned in developing cell and gene therapy products from the oncology field, and asked to comment on whether cell and gene therapies are now at a similar place where the oncology field was 40 years ago.
Marks said that one lessons learned is 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 products, similar to what Project Orbis has done in the oncology space…
