Reagan-Udall Foundation
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Search complete. 8 mentions across 6 episodes found for "Reagan-Udall Foundation".
Oct 28, 2026
John CarlinHOST
to solicit feedback on the Rare Disease Framework Initiative from patients and disease advocates, industry, and others.
John CarlinHOST
The FDA is hosting a meeting in late October, which probably will have passed by the time you're listening to this, and it'll happen at the FDA's White Oak campus, and that will be facilitated by the Reagan-Udall Foundation for the FDA.
John CarlinHOST
And so we've got a quote here from HHS Secretary Robert F. Kennedy.
John CarlinHOST
It says, And he continues, Under President Trump, He says we'll remove any unnecessary barriers, embrace cutting-edge science, and accelerate promising treatments while upholding FDA's rigorous standards.
Phil NewmanHOST
And I guess that the obvious question is measurement within the trial period, but of course, the trajectory to the equivalent of 10, 15, 20 years of decline.
Phil NewmanHOST
I know that XPRIZE was part of the Reagan-Udall Foundation at the FDA.
Phil NewmanHOST
And that was obviously a really interesting meeting from a lot of perspectives about obviously FDA engagement and what's happening with Operation Prosper.
Phil NewmanHOST
What is your confidence level, both of you really, I guess, about where we can get to from those measurements over that short period of time and that demonstration of that trajectory in those years restored? I mean, it is the big one, right?
Alex MercerHOST
Several of this episode's stories, including the FOP trial and the ultra-rare cholestatic liver diseases, rested on small studies, which is the situation the initiative is about.
Alex MercerHOST
The next date is an October 28th feedback meeting at FDA's White Oak campus, facilitated by the Reagan-Udall Foundation.
Maya PatelHOST
One date for the days ahead.
Maya PatelHOST
On Friday, October 23, Marengo Therapeutics is scheduled to present updated Phase 2 data from its START-001 study of Invicafusp-alpha, an investigational cancer drug.
Matt DuckworthHOST
An accompanying white paper and press release describes how the FDA will develop a, quote, optimized fit-for-purpose framework that reflects the realities of rare disease drug development by considering the nuances of each disease, patient needs, product type, and the evidence that can be realistically generated in small patient populations, unquote.
Matt DuckworthHOST
The FDA plans to solicit feedback from patients, industry, and other stakeholders at an October 28th meeting led by the Reagan-Udall Foundation for the FDA.
speaker_4SOUNDBITE_SPEAKER
Before becoming HHS secretary for years, you have been one of the leading voices questioning the efficacy of vaccines.
speaker_4SOUNDBITE_SPEAKER
Do you accept some responsibility for this measles outbreak?
Derrick GingeryHOST
A- and that's certainly become a priority issue, um, in this administration.
Derrick GingeryHOST
I mean, we saw that with the leukovorin labeling change, and there was a big meeting a couple weeks a- a couple months ago with the Reagan-Udall Foundation on, um, repurposing efforts.
Derrick GingeryHOST
That, that's something that could not only provide access to people with rare diseases who don't have other options.
Derrick GingeryHOST
It's also, um...
19 MINS LATER
Sue SutterPANELIST
But, um, they really need that, the input from the patient voice, you know, earlier at the beginning of development and throughout development to help nail down those endpoints and what's important.
Sue SutterPANELIST
So, um, that's gonna be a big aspect of this framework.
Sue SutterPANELIST
In fact, there's a meeting later today, a Reagan-Udall Foundation meeting later today at the FDA on, um, integrating the patient voice throughout development in rare diseases.
Derrick GingeryHOST
Well, that's something that they've tried various things to, you know, introduce patient-
Derrick GingeryHOST
A- and that's certainly become a priority issue, um, in this administration.
Derrick GingeryHOST
I mean, we saw that with the leukovorin labeling change, and there was a big meeting a couple weeks a- a couple months ago with the Reagan-Udall Foundation on, um, repurposing efforts.
Derrick GingeryHOST
That, that's something that could not only provide access to people with rare diseases who don't have other options, it's also, um...
Derrick GingeryHOST
I see it also as a, uh, drug cost, drug pricing, um, approach, [clears throat] especially if you can repurpose generic drugs, uh, for people who, who currently don't have any, uh, on-label treatment options.
19 MINS LATER
Sue SutterPANELIST
But, um, they really need that, the input from the patient voice, you know, earlier at the beginning of development and throughout development to help nail down those endpoints and what's important.
Sue SutterPANELIST
So, um, that's gonna be a big aspect of this framework.
Sue SutterPANELIST
In fact, there's a meeting later today, a Reagan-Udall Foundation meeting later today at the FDA on, um, integrating the patient voice throughout development in rare diseases.
Derrick GingeryHOST
Well, that's something that they've tried various things to, you know, introduce patient-