Commentary|Videos|September 10, 2025

How Recent Policy Changes Could Impact Clinical Research

Kate Gallin Heffernan, life sciences attorney at Epstein Becker Green, and Jim Kremidas, executive director, Association for MultiSite Research Corporations (AMRC), discuss how proposed policy changes could limit federal research funding, create uncertainty for clinical trial organizations, and slow the development of future therapies.

Heffernan: They really are more of a statement of the administration's policy, direction, and the way in which the administration would like to see agencies and congress, and other parts of the government carry out that policy. Many of them are limited as far as their immediate enforceability. However, we've seen a number of them obviously direct the agencies that fund a lot of our clients’ research to take certain steps to ensure that that federal funding is not being used in furtherance of aims that are not aligned with the administration's policy. I think that has put many of our clients, clinical trial researchers, and the organizations that they work for in a little bit of limbo.
Kremidas: It could have a detrimental effect on future therapies, because there may be less money to invest in developing those therapies, so that's a concern. The other piece of that, which we didn't really touch on is a lot of the funding being cut on NIH studies, because that's where most of the early discovery takes place, and unfortunately, cutting those funds could eat into the development of new scientific concepts that would lead to new therapies, so we're kind of getting hit with a double whammy if this Most Favored Nations project or concept goes through.

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