Center for Drug Evaluation and Research
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Search complete. 30 mentions across 22 episodes found for "Center for Drug Evaluation and Research".
Sep 25, 2026
Brian SkorneyHOST
Um, so look, overall, whether she's ultimately confirmed or not, I think you can kind of take away the message that the administration is really, um, trying to calm the chaos of the FDA, whether it's through, you know, DeMontes, who's, who, who's been acting again.
Brian SkorneyHOST
Um, certainly the-- we talked about the appointment of the permanent CDER, CBER, um, directors, which I think is, is a positive, and it's hard to imagine that Overton didn't have some say in that, um, even though she's not, not confirmed yet.
Brian SkorneyHOST
So I don't know.
Brian SkorneyHOST
My takeaway was i-i- you know, there wasn't clear opinion, and I think the process kind of j-jumped on that, that she didn't really offer a lot in terms of like what her opinions on things were.
Rebecca CoombsHOST
But if both mRNA vaccines elevated the risk of an adverse event like myocarditis in roughly equal amounts, the observed frequency and the expected frequency would be similar, resulting in no automated alert.
David WillmanSOUNDBITE_SPEAKER
An FDA medical officer, a woman, a PhD MD medical officer named Anna Scharfman, who had been principally involved with the long-used algorithm at FDA Center for Drug Evaluation and Research, She spotted this masking very early in February 2021 and said, let's use the statistician that we have worked with all these years, a fellow named William Dumochel, who is from Oracle Health Systems, and let's update and perfect our algorithm.
David WillmanSOUNDBITE_SPEAKER
Because unfortunately, what was happening during the pandemic was, in other words, PRR, If they were going to rely on that, it's hard to tell what's real and what isn't.
David WillmanSOUNDBITE_SPEAKER
But with empirical Bayesian, it turned out they had blind spots.
Ava TemkinGUEST
I was in the chief counsel's office there, where I was a drugs counselor, meaning I liaised with the Center for Drugs and the Center for Biologics who are my clients inside FDA.
Ava TemkinGUEST
Um, and I also spent a number of years in CDER's Office of New Drugs, where I worked in the Office of New Drugs policy, and I ran the, uh, policy staff that oversaw biologics policy, the Office of Therapeutic Biologics and Biosimilars.
Ava TemkinGUEST
Um, I was a litigator in private practice before that, so I do sort of a mix of things that run the gamut from litigation, pure FDA regulatory work, and transactional.
Ava TemkinGUEST
Um, and Elizabeth, I'll pass it to you.
Susie ScherbGUEST
Janet created accelerated approval, just the regulatory pathway during the HIV crisis.
Susie ScherbGUEST
And she was... head of CDER.
Susie ScherbGUEST
And at the time, you know, there was a massive HIV outbreak and people were dying that it was spreading and no one really know what to do.
Susie ScherbGUEST
There wasn't any medications for it at all.
Jeff CranmerHOST
Before we get into today's episode, a quick heads-up.
Jeff CranmerHOST
Last week, episode 387, uh, Psychedelics at FDA, Mike Davis' CDER, and tRNAs had an upload error where an earlier episode briefly showed up in its place.
Jeff CranmerHOST
We caught it early thanks to one of our listeners who used fan mail to point this out to us.
Jeff CranmerHOST
Our production engineer quickly fixed it.
Wayne PinesHOST
And if she is, hopefully she will continue the stability that we are seeing.
Wayne PinesHOST
It's a good sign that Mike Davis has been named as permanent director of CDER because we need a permanent director there.
Wayne PinesHOST
We've gone through so many directors there.
Wayne PinesHOST
I want to switch to real world evidence.
22 MINS LATER
Bethany HillsGUEST
That would make engaging with the FDA a lot easier.
Bethany HillsGUEST
In fact, that would be a dream.
Bethany HillsGUEST
A rare disease drug is going to either be reviewed in CDER or CBER, and I think Dilesh mentioned this earlier, each center is has programs that have specialized offices.
Bethany HillsGUEST
They have different review divisions.
Jeff AxtHOST
All right, so as I said at the top, we're gonna start with the FDA this week.
Jeff AxtHOST
In addition to some of the news I teased in the intro, last week, shortly after recording this podcast in fact, we learned from the FDA that it was making the acting directors of CBER and CDER, those are its two main drug and biologics review units, along with the acting director of the Center for Tobacco Products, made all three of those men permanent in their positions.
Jeff AxtHOST
I can't really speak directly to Bhet Kapila's work at the tobacco unit, but I have heard Kareem McAleer and Michael Davis speak at BIO.
Jeff AxtHOST
At the international convention in June they spoke, and I, I honestly was impressed.
Jeff AxtHOST
So just to recap a little bit, McAleer and Davis have led CBER and CDER since mid-May.
Jeff AxtHOST
They stepped into those roles on an acting basis after former division heads Vinay Prasad and Tracy Beth Hogue left the agency.
Jeff AxtHOST
And as we know, we've discussed a lot here on this podcast, Prasad and Hogue, along with former commissioner Marty Makary, were closely tied to several controversial regulatory decisions.
Tess CameronHOST
Um, we can start with regulatory policy.
Tess CameronHOST
Uh, HHS appointments were announced earlier this week for directors of CDER and CBER.
Tess CameronHOST
Um, and, uh, uh, HHS announced that, uh, you know, Kareem is, is going to keep his place as, uh, director of CBER, so making a, a temporary appointment permanent.
Tess CameronHOST
Um, and also that Michael Davis, uh, would be selected as director for CDER, so, so also making this permanent.
Tess CameronHOST
So, um, Brian, maybe we can, we can go back to you and just, um, uh, you know, comment on, uh, any of the other-- You know, I think those are the two, uh, you know, main appointments that, that really have read through to biotech.
Tess CameronHOST
There were also, uh, you know, there were also appointments in, uh, you know, for Center of Tobacco Products and, uh, you know, a new, um, a new appointment as Deputy Commissioner for, uh, Technology and Artificial Intelligence, uh, to Jared Seehofer.
Brian SkorneyHOST
Um, right.
Brian SkorneyHOST
That's been just, like, a lot of chaos.
speaker_0HOST
On a similar note, Takeda undergoes organizational changes amid potential strategic shifts following its CEO appointment, demonstrating volatility within companies striving for competitive advantage through effective leadership.
speaker_0HOST
Promising developments at the FDA include solidifying leadership with Kareem Mikhail at CBER and Michael Davis at CDER, crucial appointments ensuring operational stability amidst past disruptions under former commissioner Marty Makary, and appointing Jared Seehofer as deputy commissioner focusing on AI integration into regulatory processes.
speaker_0HOST
Significant financial movements continue highlighting investor interest.
speaker_0HOST
Frazier adds over one billion dollars targeting small mid-sized biotech firms, while Samsung Biologics secures manufacturing deals emphasizing strategic partnerships importance globally.
Derrick GingeryHOST
First up is FDA leadership.
Derrick GingeryHOST
The agency announced this week that the directors of the Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research were no longer temporary leaders.
Derrick GingeryHOST
Sue, what do we know about this at this point?
Sue SutterPANELIST
Well, Kareem McHale and Mike Davis were named permanent directors of Center for Biologics and Center for Drugs, respectively.
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