December 15, 2025 • 32 mins
Obesity readouts continue to be hot for biotech with new top-line data from both injectable and oral therapies pushing the boundaries on efficacy. On the latest BioCentury This Week podcast, BioCentury’s analysts break down last week’s readouts from Eli Lilly, Structure and Wave Life Sciences, and discuss a deal in the space by Pfizer.
Lilly reported the latest for its triple agonist contender retatrutide for best-in-class weight loss, while strong Phase IIb data put Structure back in the oral GLP-1 race. Meanwhile, Pfizer added an oral GLP-1R agonist via a deal). Structure and Wave parlayed their data into follow-on cash, as did Kymera after posting data for its STAT6 program KT-621 that hints at a new era for degraders in immunology.
The analysts then detailed the results of BioCentury’s industry sentiment survey on FDA, which found that politicization of the agency’s leadership, volatility and uncertainty are casting a long shadow over investor and drug developer sentiment. Finally, they discuss the impact of the congressional stalemate over the U.S. Small Business Innovation Research (SBIR) program.
View full story: https://www.biocentury.com/article/657880
#ObesityDrugDevelopment #TargetedProteinDegradation #STAT6 #FDARegulation #SBIRFunding
00:00 - Introduction
01:45 - Obesity Data
12:17 - Kymera's Breakthrough
21:45 - FDA Survey Results
29:41 - SBIR Funding Stalemate
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
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Transcript
Episode Transcript
Available transcripts are automatically generated. Complete accuracy is not guaranteed.
(00:00):
[AI-generated transcript.]
Jeff Cranmer (00:01):
Obesity stays hot with top line data
for both injectable andoral therapies pushing the
boundaries on efficacy.
Kymera had a readout thathints at a new era for
degraders in immunology.
And we have the results,BioCentury's FDA survey reflects
(00:26):
an industry in distress.
Plus critical funding forU.S. biotechs caught in a
congressional stalemate.
And wowee what a weekfor Biotech fundraising.
We'll discuss all of thisand more on the latest
BioCentury This Week.
I'm Jeff Cranmer, oneof the executive editors
(00:48):
here at BioCentury.
And joining me today onthe pod are my colleagues,
Simone Fishburn (00:54):
Simone Fishburn, Editor in Chief.
Stephen Hansen (00:57):
Stephen Hansen, Director of
Biopharma Intelligence.
Selina Koch (00:59):
Selina Koch, Executive Editor.
Steve Usdin (01:03):
And, Steve Usdin, Washington Editor.
Jeff Cranmer (01:04):
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(01:25):
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Okay.
(01:45):
obesity, it's the storythat won't quit this year.
We had data out of Lilly forthe company's triple agonist.
it showed best inclass weight loss.
Structure, got back intothe oral GLP-1 race with
some strong Phase IIb data.
(02:06):
And Pfizer, back in the raceand making yet another deal.
Stephen is followingall of this, Stephen.
Stephen Hans (02:15):
Yeah thanks, Jeff.
going on, I guess.
Um, but, uh, yeah.
So Lily's, uh,
Jeff Cranmer (02:21):
We're doing a very racy podcast.
Stephen Hansen (02:23):
oh, okay.
Uh, so I think we shouldstart with Lily's, uh,
Retatrutide, as you said,they're triple agonist,
which is a GLP-1, uh, GIP andglucagon, uh, receptor agonist.
Sort, I've always beensort of hyped as being the,
one that would probablydrive the biggest efficacy.
And, you know, I, I, Idon't think it disappointed
(02:43):
from, from that respect.
it had already shown, you know,pretty compelling efficacy
in Phase II, where it showedabout a 22% weight loss at
I think it was 40 weeks.
And here this is thefirst Phase III readout.
And of note, this wasn't justobese patients, these were obese
patients with osteoarthritis.
At 68 weeks, there was, asyou said, the largest weight
(03:05):
loss we've seen thus far,26.6% placebo adjusted weight
loss, in this patient set.
I mean 40% of patientsachieved more than 30% weight
loss, nearly a quarter 35%.
And the thing that stuckout to me most was the first
time that I've seen a companyinclude in their reasons for
treatment discontinuation,as being this a perception
(03:27):
of excessive weight loss.
That was one I had not, uh,had not come across before.
The thing with this programthough, is, it drives so
much weight loss that, thatit really is probably gonna
be limited to sort of thehighest BMI sort of patients.
It doesn't mean that that's asmall group, but I'm sure there,
there's still a very healthymarket for that out there.
But this is not probably gonnabe as widely used in my opinion
(03:51):
as, you know, the Wegovy or thetirzepatide that are out there,
which, you know, give anywherefrom 15 to 20% weight loss.
This is really for the sortof severe obese population
and sort of serving thathigher, higher population.
Selina Koch (04:05):
but Steven, so if you look at the very
early data, like the weightloss is pretty quick.
With this drug candidatecompared to others, right?
So couldn't you just like takeit for a while, lose the weight?
I, I don't know,like why wouldn't you
try to go for some bigweight loss kind of quickly?
Stephen Hansen (04:23):
you could.
Um, I, I think first off, weprobably wanna spend a bit of
time doing some work on howhealthy that level of weight
loss is for an individualdropping that much that quickly.
I don't think we actually havea good sense of what that is.
And then on top of it, theadverse event profile for
Retatrutide, you know, incomparison to the other
ones is a bit worse.
(04:44):
I mean, there's more of thenausea, there's more of the
vomiting, there's more ofthat stuff that comes with it.
Simone Fishburn (04:49):
Steven, can you talk a little bit about
the mechanism, because thisis a triple agonist, right?
It's GLP-1/GIP/GCG, glucagonreceptor, and it doesn't have
an amylin component, which islike some of the other ones
that you compared it with.
So going back to yourand Selina's question,
or points rather.
(05:11):
Do we know anything about whythis extra, the triple agonism
either weighs in to the sideeffects or to the rapid weight
loss or to Selina's point, likeat the end of the day, you've
really just added, let's say,an extra agonist, what if you
switch to another one, it's notreally clear to me how much we
(05:31):
know mechanistically about this.
Stephen Hansen (05:33):
So, these three, the, GLP-1, GIP and
GCGR, as you said, the glucagon.
So these are your sortof three traditional sort
of incretin mechanisms.
There's always beeninterest in this.
I know that, Novo pursued onefor a while, but all have the
same sort of issue in thatthey have this gastrointestinal
side effect profile foreach of them individually.
(05:56):
And so the problem is as youstack them, you can potentially
have additive side effectprofiles that add on that just
simply make it intolerable.
And that's been a problem fora lot of the previous triple
agonists that have been trialedearly in clinical trials, is
they've just hit thresholdsthat the companies deemed to
be sort of unacceptable froma tolerability perspective.
(06:16):
Now, Lilly obviously seems tothink that there's a market,
even if they have these highlevels of adverse events.
Which they may be right, butI think it, it just, it's not
surprising that we're seeinghigher levels with this.
Selina Koch (06:29):
So is that the main reason for the increased
discontinuations then?
At the top you talked aboutexcess weight loss, but.
Stephen Hansen (06:35):
So yeah, the main reason I think
was still the tolerability.
Um, I mean, they did note thatin patients with higher BMI's,
I think the discontinuationweight rate dropped from 20%
for the entire population,but it was down to about 12%
at the high dose for likea high BMI population where
you kind of cut out thatmaybe perception of excessive
(06:57):
weight loss sort of cohort.
I think it's still, I don'tthink this is gonna be one where
I I wouldn't think that thisis gonna run away and sort of
dominate the obesity market.
Cause as I said, and I thinkwe've talked about this
podcast before, I think we'retransitioning to a point to
where we're kind of beyond the,the weight loss Olympics where
you have to just get a superhigh amount of weight loss.
(07:18):
And so I think this, thiswill definitely target a
certain section of the obesitypopulation, but I don't think
this is gonna be as widely takenup, you know, by everyone as
as some of the other ones have.
Simone Fishburn (07:29):
So one, one last question because, what
you've done very nicely on thechart is sort of color code,
the Novo ones, the Lilly ones.
It seems that each one has sortof a obviously a portfolio.
And it is really such a very,very large patient population
that don't you feel there's justroom for all of these products.
Stephen Hans (07:47):
Oh yeah, for sure.
No, I, I think there is, becauseI mean, the existing ones are,
are pulling in, you know, 20billion, you know, close to
that in revenue a year andwe've barely hit 1% of the
population, you know, in termsof being able to get into it,
1% of the patient population.
So there's, I think there'sstill a lot of room for
other players to come in.
And, you know, with thatnote, I think that's a good
(08:08):
lead into the other big dataannouncement, which was the
Structure data for their oralGLP-1 Aleniglipron, which had
kind of fallen I think by thewayside a little bit in terms
of like companies that investorswere talking a lot about.
Because they'd had some,maybe less than stellar
early data, uh, that hadpeople a bit worried.
But they reported Phase IIBdata, from a couple trials.
(08:31):
One where they dosed up to120 milligrams that basically
showed about 11% placeboadjusted efficacy, which
kind of puts it on par withLilly's Orforglipron, which
is the most advanced oralsmall molecule GLP-1 agonist.
But then they had a secondstudy that dosed up higher
to 240 milligrams, wherethey showed up to 15% placebo
(08:52):
adjusted weight loss, whichis really what people were
hoping to see from Orforglipronin their Phase III studies.
It looks like theymight have a potential
advantage of going higher.
The big question thoughis we don't know what the
adverse event profile lookslike for that higher dose.
Now structure has been talkingabout, titration sort of
strategies they can use,starting with a much lower
(09:13):
dose and some more slowlytitrating patients up to try
and sort of you know, optimizethat tolerability profile.
that's sort of a key outstandingquestion here for this.
But, think it brings structuresort of back into the frame
with regard to if there's apharma company out there that
wants to get kinda leapfrogback into the oral GLP-1 race
structure looks like a prettyattractive candidate right now.
Jeff Cranmer (09:35):
Yeah, and this is the company, uh,
launched by Raymond Stevens,he's, still the CEO.
He uh sold his priorcompany Receptos for
multi-billion dollars to BMSCelgene, back in the day.
So certainly one to watch.
Uh, quickly, Stephen, speakingof doing deals, Pfizer again,
(09:57):
after they did their bigdeal, now they've kind of
tacked one on out of Fosun.
Stephen Hansen (10:03):
Yeah, so they obviously, everyone,
you know, we spent many,many minutes talking about
their, uh, deal with Metsera.
That basically got them intothe sort of, largely into the
injectable sort of peptide,part of the obesity race.
Well, now they've done adeal with Fosun to sort of
come back in on, on the smallmolecule side, so something
that would be competitive withthe Structure and the lily
uh small molecule programs.
(10:25):
We don't really know alot about the molecule.
We don't think we'veseen any data yet.
But obviously, you know,Pfizer has a history here.
They had two prior smallmolecule GLP-1 programs,
that ended up beingdiscontinued either for
efficacy or for liver issues.
Um, so I think they're verymuch hoping that third time
is a charm here and they can,uh, you know, be back in this
(10:46):
race, which, you know, as Simonealready pointed out, I mean,
it's such a massive market.
I think there's plenty of roomfor multiple small molecule
programs to be effective here.
Whether they're positionedas frontline therapies or
as maintenance therapies.
Once people come off theseinjectables, I think there's
gonna be a lot of opportunityfor these GLP-1 small molecules.
Selina Koch (11:04):
What about wave life sciences?
Stephen Hansen (11:06):
that was.
Selina Koch (11:08):
So I mean, okay, you talk about
differentiators, right?
And you're like, okay, well justa little bit more weight loss
is no longer a differentiator.
You want something long acting,you want something oral,
or you want muscle sparing.
Stephen Hansen (11:18):
Wave definitely showed that.
I mean, they have, lookslike they have the muscle
sparing thing in hand.
So I've spoken to a coupleinvestors that thought maybe
that was the, um, so they,they were up pretty big on
their early Phase I data to fortheir INHBE antisense program.
Think there were some investorsthat thought maybe it was
a bit too much excitementfrom investors on that.
I mean, look, I mean, the waythey're looking to position
(11:40):
it is something that youcan basically transition off
of a once weekly injectableonto something that you could
take maybe once a yearly.
And if you can maintain thatweight loss while potentially
either maintaining musclemass or even maybe, I don't
know if you could even startbuilding a little bit of
muscles, having muscle comeback, seems like a pretty
compelling product profileto me, even if you're not
(12:02):
getting additional weight loss.
'Cause I think the idea thereis that you've already done
the weight loss bit and nowyou just want to keep it off.
Yeah, it's pretty exciting,but as, as you said, it's
very, very early data, so wewill, we'll see what, we'll
see what comes from that.
Jeff Cranmer (12:15):
All righty.
Thanks for that, Stephen.
More data Kymera has takenthe next step toward its goal
of bringing oral drugs withbiologics like activity to
autoimmune disease patients.
the company had a PhaseIB readout for its STAT6
degrader in atopic dermatitis.
(12:37):
The data sent sharesup more than 40%.
Selina, you wrote alittle piece on this.
What'd you find?
Selina Koch (12:45):
Yeah.
first I think it's worth notingthis is a needed win for Kymera.
This is a platform companythat's now a decade old.
So at this stage of thegame, you need some positive
clinical readouts, right.
Um, it was initially like dualtracking cancer and immunology
and then regrouped at somepoint and said, putting all
our chips on immunology.
It had an IRAK4 program thatwith Sanofi, Sanofi decided not
(13:09):
to take it forward, althoughthat partnership does progress
with the backup compound.
So in that contextthis was important.
Kymera is one of the leadersin one of the hottest new
therapeutic modalitiesin the industry, right,
targeted protein degradation.
Often these molecules arejust referred to as degraders.
And one of the promises ofdegraders is to have a way
(13:30):
to get at difficult targetsthat you know are historically
undruggable, because they don'thave a good binding pocket for
a small molecule inhibitor.
Or the target's not on thesurface, it's not accessible to
antibodies, that kind of thing.
So STAT6 is one of theseundruggable targets cause
it is a transcriptionfactor, so that puts it in
a, a class of notoriouslydifficult to drug targets.
(13:52):
It appealed to Kymera whoobviously, you know, they have
a new technology, so they havesome technology risk and they've
had some kind of setbacks,right, because it kind of
minimizes biology risk whilealso showcasing the ability to
go after an undruggable target.
So STAT6 sits downstream ofthe same receptors hit by
(14:14):
Dupixent, so that's IL4 and IL3.
So Dupixent obviously bigmulti blockbuster biologic
for inflammatory conditions.
So the way Kymera saw thiswas that, the biology risk
would be reasonably low,but there's a massive market
opportunity here because theseare chronic conditions, right.
Patients are treated for longperiods of time, and many
(14:35):
of them would prefer an oralalternative, if you could get
that same sort of selectivityand efficacy that you could
get with biologic, which hasbeen historically very hard.
So it's a problem a lot of, alot of companies want to solve,
including a lot of pharmas.
Although right now this programremains unpartnered, I'll say.
So yeah, this is, this is stillan early stage, still a small
trial, but what they did seewas 94% degradation of STAT6 in
(15:00):
skin reaching 98% in blood, sothat's very deep degradation.
And then importantly, thattranslated to changes in
biomarkers that are keyones commonly used to track
therapeutic activity inatopic dermatitis and some
other, conditions thatinvolve type 2 inflammation.
So this could, this therapycould work, you know, much more
broadly than just atopic derm.
(15:21):
Those include the Chemokine(TARC), IL31, Eotaxin-3
Simone Fishburn (15:25):
Selina, I mean, I think this
is really interesting.
As you pointed out, Dupixentis such a blockbuster, and
there are a few competitors,most of which I think
are biologics, right?
So here you're going inwith a small molecule or
small molecule modality, buteffectively an oral agent.
I'm sort of wonderingwhat the path is gonna be.
Are they gonna go for peoplewho've cycled off Dupixent
(15:48):
or do you think they'll, youknow, I, you know, Paul Hudson,
the CEO of Sanofi has severaltimes talked about the fact
that I think, under 10% ofatopic dermatitis patients are
actually accessing treatmentor receiving treatment.
And then even within those,they cycle on and off of
these therapies, with thecourse of the disease.
(16:11):
So I'm sort of wondering howyou see this fitting into the
landscape or, or if it's, ifwe're able to talk about that?
Selina Koch (16:18):
Well, I do believe the com is keeping their
options open to some extent.
So they're running aPhase IIB trial right now,
it's ongoing, it's calledBROADEN2 for, moderate to
severe atopic dermatitis,so not the mildest patients.
And they are enrolling, youknow, I believe patients
who are biologic naive andthose with prior exposure.
But, the exclusion criteria,I believe does not allow for
(16:40):
patients to enter if theyhave been non-responders in
the past to Dupixent a JAKinhibitor, things like that.
So that that's where it's, youknow, initially this mid-stage,
fitting into the landscape.
Simone Fishburn (16:54):
And like you said, I mean, I think it's
a pretty important proof ofprinciple as we start to knock
off these undruggable, butI think now they like to call
them hard to drug targets as weknock them off one by one, they
no longer become undruggable.
So, you know, getting STAT6in there, probably open
the door to a few othertranscription factors.
Wouldn't you think?
Selina Koch (17:13):
I would think, yeah, that's the hope.
Jeff Cranmer (17:15):
All right, and if you'd like to learn
more about Kymera and itstechnology, uh, Selina sat down
with company Nello Mainolfi,in October on our sister
podcast the BioCentury Show.
And you can find that on Apple,Spotify, YouTube, you name it.
(17:36):
While you're there, likeus, subscribe to us.
We're wrapping up our sixthseason of BioCentury's This
Week, and we're very gratefulto you, our listeners for
supporting us along the wayand making us one of the top
biotech podcasts out there,couldn't do it without you.
Okay, Kymera, Structureand Wave, were among eight
(18:00):
biotechs raising more than3.2 billion total between
Tuesdays closed last weekand Wednesday's morning bell.
And if that doesn't signalstrength in the marketplace
for follow-ons in the sector,well, I don't know what would.
More followed later in theweek, bringing the weekly
total to nearly 4.5 billion.
(18:23):
And how did that lookcompared with the rest
of the year, Selina?
Selina Koch (18:29):
Yeah, we did calculate the weekly totals
for follow on financingthis year, and it was triple
the next biggest week.
So a bigbump to finish the year, uh,
strong.
Jeff Cranmer (18:40):
Yeah.
The top weeks from earlier,we had two weeks, I think
at about 1.4 billion, oneit 1.3 billion and the rest
were uh, kind of meh as,
Simone Fishburn (18:50):
Yeah, but I mean, I gotta tell you,
if you look at this chart,there's a very clear pattern.
The first half of the yearwas very, very dismal.
Just a few little spikes thereon the weekly amount, but this
last quarter has been, as oneperson can't remember if the
words they used were gangbustersor you know, the follow on
market being very, very healthy.
(19:12):
And then as you say, this hugespike in the 50th week of the
year, according to the chart.
So, uh, the Jubilee orwhatever, the Jubilee week.
certainly.
Good to have some good.
Selina Koch (19:24):
Maybe a little, maybe a little sneak peek
because we've also beenlooking at new venture
funds raised this year.
The, you know, announcedones and the pattern
looks very similar.
You see very few new fundsbeing announced in the
first half of the year,and, and it has picked up.
So that'll come out.
Jeff Cranmer (19:41):
Yeah, indeed.
And, our one listener who tellsus to talk more about Japan,
uh, he will be pleased to knowthat, uh, think there were more
venture funds raised in Japanthis year than China or Korea.
We're still digginginto that to confirm.
Simone Fishburn (19:57):
I just wanna know, is that one listener
our colleague Matt Krebs?
Jeff Cranmer (20:01):
It's not actually, it's not.
Um, uh, Matt though, Mattis a big, big supporter,
of the podcast.
Just a few numbers.
Structure raised $650million, Kymera $ 602
million, Wave at $350.
(20:21):
The other big, big one camefrom Turns, at $650 million.
So, congrats to allthose companies.
It's, certainly great to seeand to do it right before JPM.
Maybe the sun will finally shinein San Francisco during JPM.
Alright, we're gonna takea quick break and we're
gonna turn to Washington.
Alanna Farro (20:44):
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Jeff Cranmer (21:31):
Okay.
And I am recruiting, presentingcompanies for the conference.
If you're interested oryou know, a company that
I should check out, dropme a line The results of
our survey are in here totell you about it, Simone.
Simone Fishb (21:51):
Well, thanks Jeff.
I really wanna pick up fromthe very positive sentiment
that seems to be happeningin the capital markets.
I don't think the IPO marketshave, uh, picked up yet,
but it's really good tosee the secondaries or the
follow ones as we call them,and venture going well.
And I say that because on theregulatory front and generally
(22:15):
there is a very big shadowover biotech, caused by the
uncertainty, the volatility,and in particular the
politicization of FDA accordingto the survey that we ran.
And why did I tie it tothe markets because really
(22:37):
there's still a feelingthat it is very hard for
investors to engage and to getexcited about about biotech.
So obviously we see that'shappening to some degree, but I
wanna go into some of the issuesthat came up in our survey.
So I think that there arethree principle points.
One of them is, is a fairlypositive one, which is that
(22:58):
the people who engage withthe survey, which are mostly
biotechs, about two thirdsbiotech, uh, and about one third
investors, and then there area few other stakeholders, but
they really say that this year,their interactions with FDA
have mostly continued with thesame kind of efficiency as last
year, productive interactions,that's about two thirds of them.
(23:21):
And so I feel that there'svery broad support inside the
industry for the staff at FDA.
And we've talked about thisbefore, the staff at FDA are
working incredibly hard, andthat actually is why companies
are able to move ahead, generatepositive clinical data and raise
on the back of that, right.
But it's not clear thatpast is gonna be prologue.
(23:45):
The second thing that isclear from this survey is
there are huge concernsabout the leadership.
So the biopharma industry isquite sophisticated and they
know how to distinguish betweenthe leadership of FDA and
the staff and the operations.
And they have huge concernsover the leadership.
Even the respondents whoare quite, there are a
(24:07):
few respondents who arequite supportive of FDA
Commissioner, Marty Makary.
Although he and the Head ofCBER Vinay Prasad caught quite a
lot of harsh criticism as well.
But even the people who aresupportive of Makary and some
of his initiatives really and,every single comment, but one,
(24:27):
questioned whether they havethe competence to actually
execute on what they thinkmight be good initiatives.
So if the first main twofindings are that the
FDA staff retain broadsupport from the industry.
And the second being thatthe leadership has got really
overwhelmingly negative ratings.
I think the third partis this uncertainty
(24:50):
and the inconsistencybeing this huge shadow.
The consequences are notonly chilling investment,
but many people, whoresponded as saying they are
moving their clinical trialsoutside of US territories.
And this won't surpriseanybody completely abandoning
vaccine programs andinvestment in vaccines.
Selina Koch (25:13):
Yeah, Simone, along those lines, I thought
it was kind of interestingthat 20% of respondents say
they had personally throughtheir companies, or if it
was an investor one of theirportfolio companies experienced
a reversal of an FDA positionor of earlier guidance on trial
design, that sort of thing.
And there's this perception thatthat's becoming more common.
Simone Fishburn (25:34):
Right, so.
That's correct.
So about 20%.
As you point out, we did askpeople whether they had had,
FDA change its guidance tothem or its instructions to
them, reverse a position thatit had taken previous to 2025.
So under the previousleadership, 20% said yes.
(25:55):
We also asked whether therewas a perception whether
they believe that FDArehearsals on trial design
are becoming more common.
And a large majority,like 85%, think that it's
becoming more common.
We don't have the numbers totell you whether it's becoming
more common, but most peoplebelieve it is, and most people
(26:15):
believe that's a bad thing.
And Steve, I expect youwanna comment in a minute.
Let me just add one morepoint because I, I'd like
you to answer this as well.
We also asked about acceleratedapproval, most people think that
that is going to get harder.
many think that it will beeasier in some indications
and harder in others, butacross the board about, more
than half I think, believethat it's going to get
(26:36):
harder in some indications.
So, do you wanna address acouple of those things, Steve?
Steve Usdin (26:40):
Yeah.
Yeah.
so, so I think well look,the critical thing to.
Point out is that the surveywas done when Richard Pazdur
was CDER director and nobodyknew at that time that he
was planning to retire.
I think if we were to do thesurvey again now, results
would be more negative,than they were especially
about political influenceand ideological influence
(27:01):
on FDA regulatory decisions.
I think the other thing that'sreally important to point
out, it's really interesting.
All of us have been outthere talking biotech
CEOs, to investors,to other stakeholders.
And there's exactly twothings that everybody
wants to talk about.
The first is what's happeningat FDA, and the second is
what's happening in China.
(27:21):
And I think that thetwo things are linked.
Right.
One of the things that's beena competitive advantage for the
United States over the yearshas been an innovative, science
driven regulatory environment.
The sense now is thatwe're losing that, that
that's being degraded.
And it is happening inconjunction, with a rise
(27:42):
in, China and biotechecosystem, which is being
facilitated in part by theirown innovative, science-driven
regulatory environment.
You know, it's not acoincidence that, we're seeing,
those two things happen inconjunction with each other.
Simone Fishburn (27:57):
Right.
I just wanna end with,one quote from somebody.
So, as I pointed out, manyof the quotes were quite
caustic and negative.
Absolutely you are right thatthere's, some people who were
literally wrote in the words.
thank goodness for Pazdurthis, this, uh, this survey
was conducted while he wasstill, at the top of CDER.
But here's a quote that Ijust thought really, really
(28:20):
represents across theboard what people think.
Even those who agree thatFDA could use some fixing.
One person wrote, "Getyour act together.
The headlines are terrible.
The infighting is disheartening.
Personnel decisions are awful.
You are seriously jeopardizingyour credibility and this
industry, right When weare in a race with China.
(28:43):
Get a meeting with the topleadership of FDA along with
RFK Jr. and get alignment,then speak with one voice,
give clarity, uncertaintyis the death nail to this
industry." That's fromone respondent, as I said.
So I think there'sjust a feeling that FDA
needs to fix itself.
And on that note, I'll, I'llpass it back to you, Jeff.
Selina Koch (29:08):
I can say for folks out there, who haven't
looked at it yet, there is boththe quantitative side of the
survey and as Simone was justreading the qualitative, um, we
did let people speak in theirown words and it was anonymous,
but we put a bunch of theirown words in there as well.
So that's available our website.
Jeff Cranmer (29:24):
Go to BioCentury.com.
BioCenturypodcast.com and you'llbe able to find it there, and
we'll create a link if you'renot a subscriber, that allows
you to, to get your hands onthis very interesting, uh,
somewhat depressing survey.
All right, apparently I'm toldby my colleagues that I'm the
(29:45):
only person in the world whocalls SBIR Grants siber Grants.
And well, my mom alwaystold me I was special.
I guess that's why.
Um, so, you know, this fundingis critical for biotechs and it
just happens to be caught up.
One of the many things caughtup in a stalemate in Congress,
(30:06):
and Steve took a look at this,um, Steve, what's the word?
Steve Usdin (30:10):
Yeah, SBIR, the Small Business Innovation
Research Program does reallya cornerstone of early stage
funding biotech startups.
Expired on September 30, andcutting off a major source
of non-dilutive capital forsmall life sciences companies.
As you said, Congress isdeadlocked over its future.
Basically there's adisagreement, uh, between
(30:32):
parties in Congresswho wanted to simply
reauthorize it, at least toreauthorize it for a year.
Well, there's discussion about,reforms and, well, in basically
Senator Joni Ernst, who wantsto change the SBIR program in
a lot of very significant ways.
Many of those ways thatthe biotech industry,
(30:53):
and small businesses andother industries oppose.
So the deadlock has not beenbroken and right now, to be
honest, there isn't a clearsight to how that might
happen, is really unfortunate.
And it's, also interestingbecause this is one of the
very few, government programsI think that has, nearly
(31:14):
unanimous bipartisan support,it's been really important.
And if we're gonna talk aboutChina, because we always
talk about China these days,it seems, it's also another
area where there's a contrastbecause, China learned from
the success of the US SBIRprogram and put in place
similar programs, programsthat were modeled on SBIR
(31:34):
but are much larger scale.
And, they've beenreally important in
helping them ramp up.
Selina Koch (31:40):
Yeah.
I mean, if we stop fundingthese ideas, early stage ideas,
through that so-called Valleyof Death, we do risk falling
behind in an area where we wereleading.
Simone Fishburn (31:53):
You know, I think most people who've
started a company have atsome point entertained the
idea of having an SBIR, ifnot actively sought one.
So I think we allacknowledge how important
they are for the industry.
Jeff Cranmer (32:04):
All right.
And you can check out Steve'sstory at BioCentury.com.
That's it for this week.
We're taking a break nextweek, we'll be back on
the 29th of December.
And we wish everyone out therea happy holiday season, however
you roll, and we'll be talkingabout some year end stuff and
(32:24):
some 2026 2026 preview stuffwhen we come back December 29th
Kendall Square Orchestraprovides the music for
BioCentury This Week.
The group connects scienceand technology professionals
and other members of theGreater Boston community
to collaborate innovate andinspire through music, while
(32:45):
supporting causes relatedto healthcare and education.
[AI-generated transcript.]
Jeff Cranmer (00:01):
Obesity stays hot with top line data
for both injectable andoral therapies pushing the
boundaries on efficacy.
Kymera had a readout thathints at a new era for
degraders in immunology.
And we have the results,BioCentury's FDA survey reflects
(00:26):
an industry in distress.
Plus critical funding forU.S. biotechs caught in a
congressional stalemate.
And wowee what a weekfor Biotech fundraising.
We'll discuss all of thisand more on the latest
BioCentury This Week.
I'm Jeff Cranmer, oneof the executive editors
(00:48):
here at BioCentury.
And joining me today onthe pod are my colleagues,
Simone Fishburn (00:54):
Simone Fishburn, Editor in Chief.
Stephen Hansen (00:57):
Stephen Hansen, Director of
Biopharma Intelligence.
Selina Koch (00:59):
Selina Koch, Executive Editor.
Steve Usdin (01:03):
And, Steve Usdin, Washington Editor.
Jeff Cranmer (01:04):
Hey, hey, hey, J.P. Morgan 2026, like it or
not, it's around the cornerin BioCentury's, JPM Guide
is here to help you out.
Head to jpmguide.com tobrowse the lineup of sideline
(01:25):
events and receptionsplanned across San Francisco.
And if you're hosting somethingspecial, you can use the
online form to make sure yourevent appears in our guide.
Again, head to jpmguide.com tomake the most of JPM 2026 week.
Okay.
(01:45):
obesity, it's the storythat won't quit this year.
We had data out of Lilly forthe company's triple agonist.
it showed best inclass weight loss.
Structure, got back intothe oral GLP-1 race with
some strong Phase IIb data.
(02:06):
And Pfizer, back in the raceand making yet another deal.
Stephen is followingall of this, Stephen.
Stephen Hans (02:15):
Yeah thanks, Jeff.
going on, I guess.
Um, but, uh, yeah.
So Lily's, uh,
Jeff Cranmer (02:21):
We're doing a very racy podcast.
Stephen Hansen (02:23):
oh, okay.
Uh, so I think we shouldstart with Lily's, uh,
Retatrutide, as you said,they're triple agonist,
which is a GLP-1, uh, GIP andglucagon, uh, receptor agonist.
Sort, I've always beensort of hyped as being the,
one that would probablydrive the biggest efficacy.
And, you know, I, I, Idon't think it disappointed
(02:43):
from, from that respect.
it had already shown, you know,pretty compelling efficacy
in Phase II, where it showedabout a 22% weight loss at
I think it was 40 weeks.
And here this is thefirst Phase III readout.
And of note, this wasn't justobese patients, these were obese
patients with osteoarthritis.
At 68 weeks, there was, asyou said, the largest weight
(03:05):
loss we've seen thus far,26.6% placebo adjusted weight
loss, in this patient set.
I mean 40% of patientsachieved more than 30% weight
loss, nearly a quarter 35%.
And the thing that stuckout to me most was the first
time that I've seen a companyinclude in their reasons for
treatment discontinuation,as being this a perception
(03:27):
of excessive weight loss.
That was one I had not, uh,had not come across before.
The thing with this programthough, is, it drives so
much weight loss that, thatit really is probably gonna
be limited to sort of thehighest BMI sort of patients.
It doesn't mean that that's asmall group, but I'm sure there,
there's still a very healthymarket for that out there.
But this is not probably gonnabe as widely used in my opinion
(03:51):
as, you know, the Wegovy or thetirzepatide that are out there,
which, you know, give anywherefrom 15 to 20% weight loss.
This is really for the sortof severe obese population
and sort of serving thathigher, higher population.
Selina Koch (04:05):
but Steven, so if you look at the very
early data, like the weightloss is pretty quick.
With this drug candidatecompared to others, right?
So couldn't you just like takeit for a while, lose the weight?
I, I don't know,like why wouldn't you
try to go for some bigweight loss kind of quickly?
Stephen Hansen (04:23):
you could.
Um, I, I think first off, weprobably wanna spend a bit of
time doing some work on howhealthy that level of weight
loss is for an individualdropping that much that quickly.
I don't think we actually havea good sense of what that is.
And then on top of it, theadverse event profile for
Retatrutide, you know, incomparison to the other
ones is a bit worse.
(04:44):
I mean, there's more of thenausea, there's more of the
vomiting, there's more ofthat stuff that comes with it.
Simone Fishburn (04:49):
Steven, can you talk a little bit about
the mechanism, because thisis a triple agonist, right?
It's GLP-1/GIP/GCG, glucagonreceptor, and it doesn't have
an amylin component, which islike some of the other ones
that you compared it with.
So going back to yourand Selina's question,
or points rather.
(05:11):
Do we know anything about whythis extra, the triple agonism
either weighs in to the sideeffects or to the rapid weight
loss or to Selina's point, likeat the end of the day, you've
really just added, let's say,an extra agonist, what if you
switch to another one, it's notreally clear to me how much we
(05:31):
know mechanistically about this.
Stephen Hansen (05:33):
So, these three, the, GLP-1, GIP and
GCGR, as you said, the glucagon.
So these are your sortof three traditional sort
of incretin mechanisms.
There's always beeninterest in this.
I know that, Novo pursued onefor a while, but all have the
same sort of issue in thatthey have this gastrointestinal
side effect profile foreach of them individually.
(05:56):
And so the problem is as youstack them, you can potentially
have additive side effectprofiles that add on that just
simply make it intolerable.
And that's been a problem fora lot of the previous triple
agonists that have been trialedearly in clinical trials, is
they've just hit thresholdsthat the companies deemed to
be sort of unacceptable froma tolerability perspective.
(06:16):
Now, Lilly obviously seems tothink that there's a market,
even if they have these highlevels of adverse events.
Which they may be right, butI think it, it just, it's not
surprising that we're seeinghigher levels with this.
Selina Koch (06:29):
So is that the main reason for the increased
discontinuations then?
At the top you talked aboutexcess weight loss, but.
Stephen Hansen (06:35):
So yeah, the main reason I think
was still the tolerability.
Um, I mean, they did note thatin patients with higher BMI's,
I think the discontinuationweight rate dropped from 20%
for the entire population,but it was down to about 12%
at the high dose for likea high BMI population where
you kind of cut out thatmaybe perception of excessive
(06:57):
weight loss sort of cohort.
I think it's still, I don'tthink this is gonna be one where
I I wouldn't think that thisis gonna run away and sort of
dominate the obesity market.
Cause as I said, and I thinkwe've talked about this
podcast before, I think we'retransitioning to a point to
where we're kind of beyond the,the weight loss Olympics where
you have to just get a superhigh amount of weight loss.
(07:18):
And so I think this, thiswill definitely target a
certain section of the obesitypopulation, but I don't think
this is gonna be as widely takenup, you know, by everyone as
as some of the other ones have.
Simone Fishburn (07:29):
So one, one last question because, what
you've done very nicely on thechart is sort of color code,
the Novo ones, the Lilly ones.
It seems that each one has sortof a obviously a portfolio.
And it is really such a very,very large patient population
that don't you feel there's justroom for all of these products.
Stephen Hans (07:47):
Oh yeah, for sure.
No, I, I think there is, becauseI mean, the existing ones are,
are pulling in, you know, 20billion, you know, close to
that in revenue a year andwe've barely hit 1% of the
population, you know, in termsof being able to get into it,
1% of the patient population.
So there's, I think there'sstill a lot of room for
other players to come in.
And, you know, with thatnote, I think that's a good
(08:08):
lead into the other big dataannouncement, which was the
Structure data for their oralGLP-1 Aleniglipron, which had
kind of fallen I think by thewayside a little bit in terms
of like companies that investorswere talking a lot about.
Because they'd had some,maybe less than stellar
early data, uh, that hadpeople a bit worried.
But they reported Phase IIBdata, from a couple trials.
(08:31):
One where they dosed up to120 milligrams that basically
showed about 11% placeboadjusted efficacy, which
kind of puts it on par withLilly's Orforglipron, which
is the most advanced oralsmall molecule GLP-1 agonist.
But then they had a secondstudy that dosed up higher
to 240 milligrams, wherethey showed up to 15% placebo
(08:52):
adjusted weight loss, whichis really what people were
hoping to see from Orforglipronin their Phase III studies.
It looks like theymight have a potential
advantage of going higher.
The big question thoughis we don't know what the
adverse event profile lookslike for that higher dose.
Now structure has been talkingabout, titration sort of
strategies they can use,starting with a much lower
(09:13):
dose and some more slowlytitrating patients up to try
and sort of you know, optimizethat tolerability profile.
that's sort of a key outstandingquestion here for this.
But, think it brings structuresort of back into the frame
with regard to if there's apharma company out there that
wants to get kinda leapfrogback into the oral GLP-1 race
structure looks like a prettyattractive candidate right now.
Jeff Cranmer (09:35):
Yeah, and this is the company, uh,
launched by Raymond Stevens,he's, still the CEO.
He uh sold his priorcompany Receptos for
multi-billion dollars to BMSCelgene, back in the day.
So certainly one to watch.
Uh, quickly, Stephen, speakingof doing deals, Pfizer again,
(09:57):
after they did their bigdeal, now they've kind of
tacked one on out of Fosun.
Stephen Hansen (10:03):
Yeah, so they obviously, everyone,
you know, we spent many,many minutes talking about
their, uh, deal with Metsera.
That basically got them intothe sort of, largely into the
injectable sort of peptide,part of the obesity race.
Well, now they've done adeal with Fosun to sort of
come back in on, on the smallmolecule side, so something
that would be competitive withthe Structure and the lily
uh small molecule programs.
(10:25):
We don't really know alot about the molecule.
We don't think we'veseen any data yet.
But obviously, you know,Pfizer has a history here.
They had two prior smallmolecule GLP-1 programs,
that ended up beingdiscontinued either for
efficacy or for liver issues.
Um, so I think they're verymuch hoping that third time
is a charm here and they can,uh, you know, be back in this
(10:46):
race, which, you know, as Simonealready pointed out, I mean,
it's such a massive market.
I think there's plenty of roomfor multiple small molecule
programs to be effective here.
Whether they're positionedas frontline therapies or
as maintenance therapies.
Once people come off theseinjectables, I think there's
gonna be a lot of opportunityfor these GLP-1 small molecules.
Selina Koch (11:04):
What about wave life sciences?
Stephen Hansen (11:06):
that was.
Selina Koch (11:08):
So I mean, okay, you talk about
differentiators, right?
And you're like, okay, well justa little bit more weight loss
is no longer a differentiator.
You want something long acting,you want something oral,
or you want muscle sparing.
Stephen Hansen (11:18):
Wave definitely showed that.
I mean, they have, lookslike they have the muscle
sparing thing in hand.
So I've spoken to a coupleinvestors that thought maybe
that was the, um, so they,they were up pretty big on
their early Phase I data to fortheir INHBE antisense program.
Think there were some investorsthat thought maybe it was
a bit too much excitementfrom investors on that.
I mean, look, I mean, the waythey're looking to position
(11:40):
it is something that youcan basically transition off
of a once weekly injectableonto something that you could
take maybe once a yearly.
And if you can maintain thatweight loss while potentially
either maintaining musclemass or even maybe, I don't
know if you could even startbuilding a little bit of
muscles, having muscle comeback, seems like a pretty
compelling product profileto me, even if you're not
(12:02):
getting additional weight loss.
'Cause I think the idea thereis that you've already done
the weight loss bit and nowyou just want to keep it off.
Yeah, it's pretty exciting,but as, as you said, it's
very, very early data, so wewill, we'll see what, we'll
see what comes from that.
Jeff Cranmer (12:15):
All righty.
Thanks for that, Stephen.
More data Kymera has takenthe next step toward its goal
of bringing oral drugs withbiologics like activity to
autoimmune disease patients.
the company had a PhaseIB readout for its STAT6
degrader in atopic dermatitis.
(12:37):
The data sent sharesup more than 40%.
Selina, you wrote alittle piece on this.
What'd you find?
Selina Koch (12:45):
Yeah.
first I think it's worth notingthis is a needed win for Kymera.
This is a platform companythat's now a decade old.
So at this stage of thegame, you need some positive
clinical readouts, right.
Um, it was initially like dualtracking cancer and immunology
and then regrouped at somepoint and said, putting all
our chips on immunology.
It had an IRAK4 program thatwith Sanofi, Sanofi decided not
(13:09):
to take it forward, althoughthat partnership does progress
with the backup compound.
So in that contextthis was important.
Kymera is one of the leadersin one of the hottest new
therapeutic modalitiesin the industry, right,
targeted protein degradation.
Often these molecules arejust referred to as degraders.
And one of the promises ofdegraders is to have a way
(13:30):
to get at difficult targetsthat you know are historically
undruggable, because they don'thave a good binding pocket for
a small molecule inhibitor.
Or the target's not on thesurface, it's not accessible to
antibodies, that kind of thing.
So STAT6 is one of theseundruggable targets cause
it is a transcriptionfactor, so that puts it in
a, a class of notoriouslydifficult to drug targets.
(13:52):
It appealed to Kymera whoobviously, you know, they have
a new technology, so they havesome technology risk and they've
had some kind of setbacks,right, because it kind of
minimizes biology risk whilealso showcasing the ability to
go after an undruggable target.
So STAT6 sits downstream ofthe same receptors hit by
(14:14):
Dupixent, so that's IL4 and IL3.
So Dupixent obviously bigmulti blockbuster biologic
for inflammatory conditions.
So the way Kymera saw thiswas that, the biology risk
would be reasonably low,but there's a massive market
opportunity here because theseare chronic conditions, right.
Patients are treated for longperiods of time, and many
(14:35):
of them would prefer an oralalternative, if you could get
that same sort of selectivityand efficacy that you could
get with biologic, which hasbeen historically very hard.
So it's a problem a lot of, alot of companies want to solve,
including a lot of pharmas.
Although right now this programremains unpartnered, I'll say.
So yeah, this is, this is stillan early stage, still a small
trial, but what they did seewas 94% degradation of STAT6 in
(15:00):
skin reaching 98% in blood, sothat's very deep degradation.
And then importantly, thattranslated to changes in
biomarkers that are keyones commonly used to track
therapeutic activity inatopic dermatitis and some
other, conditions thatinvolve type 2 inflammation.
So this could, this therapycould work, you know, much more
broadly than just atopic derm.
(15:21):
Those include the Chemokine(TARC), IL31, Eotaxin-3
Simone Fishburn (15:25):
Selina, I mean, I think this
is really interesting.
As you pointed out, Dupixentis such a blockbuster, and
there are a few competitors,most of which I think
are biologics, right?
So here you're going inwith a small molecule or
small molecule modality, buteffectively an oral agent.
I'm sort of wonderingwhat the path is gonna be.
Are they gonna go for peoplewho've cycled off Dupixent
(15:48):
or do you think they'll, youknow, I, you know, Paul Hudson,
the CEO of Sanofi has severaltimes talked about the fact
that I think, under 10% ofatopic dermatitis patients are
actually accessing treatmentor receiving treatment.
And then even within those,they cycle on and off of
these therapies, with thecourse of the disease.
(16:11):
So I'm sort of wondering howyou see this fitting into the
landscape or, or if it's, ifwe're able to talk about that?
Selina Koch (16:18):
Well, I do believe the com is keeping their
options open to some extent.
So they're running aPhase IIB trial right now,
it's ongoing, it's calledBROADEN2 for, moderate to
severe atopic dermatitis,so not the mildest patients.
And they are enrolling, youknow, I believe patients
who are biologic naive andthose with prior exposure.
But, the exclusion criteria,I believe does not allow for
(16:40):
patients to enter if theyhave been non-responders in
the past to Dupixent a JAKinhibitor, things like that.
So that that's where it's, youknow, initially this mid-stage,
fitting into the landscape.
Simone Fishburn (16:54):
And like you said, I mean, I think it's
a pretty important proof ofprinciple as we start to knock
off these undruggable, butI think now they like to call
them hard to drug targets as weknock them off one by one, they
no longer become undruggable.
So, you know, getting STAT6in there, probably open
the door to a few othertranscription factors.
Wouldn't you think?
Selina Koch (17:13):
I would think, yeah, that's the hope.
Jeff Cranmer (17:15):
All right, and if you'd like to learn
more about Kymera and itstechnology, uh, Selina sat down
with company Nello Mainolfi,in October on our sister
podcast the BioCentury Show.
And you can find that on Apple,Spotify, YouTube, you name it.
(17:36):
While you're there, likeus, subscribe to us.
We're wrapping up our sixthseason of BioCentury's This
Week, and we're very gratefulto you, our listeners for
supporting us along the wayand making us one of the top
biotech podcasts out there,couldn't do it without you.
Okay, Kymera, Structureand Wave, were among eight
(18:00):
biotechs raising more than3.2 billion total between
Tuesdays closed last weekand Wednesday's morning bell.
And if that doesn't signalstrength in the marketplace
for follow-ons in the sector,well, I don't know what would.
More followed later in theweek, bringing the weekly
total to nearly 4.5 billion.
(18:23):
And how did that lookcompared with the rest
of the year, Selina?
Selina Koch (18:29):
Yeah, we did calculate the weekly totals
for follow on financingthis year, and it was triple
the next biggest week.
So a bigbump to finish the year, uh,
strong.
Jeff Cranmer (18:40):
Yeah.
The top weeks from earlier,we had two weeks, I think
at about 1.4 billion, oneit 1.3 billion and the rest
were uh, kind of meh as,
Simone Fishburn (18:50):
Yeah, but I mean, I gotta tell you,
if you look at this chart,there's a very clear pattern.
The first half of the yearwas very, very dismal.
Just a few little spikes thereon the weekly amount, but this
last quarter has been, as oneperson can't remember if the
words they used were gangbustersor you know, the follow on
market being very, very healthy.
(19:12):
And then as you say, this hugespike in the 50th week of the
year, according to the chart.
So, uh, the Jubilee orwhatever, the Jubilee week.
certainly.
Good to have some good.
Selina Koch (19:24):
Maybe a little, maybe a little sneak peek
because we've also beenlooking at new venture
funds raised this year.
The, you know, announcedones and the pattern
looks very similar.
You see very few new fundsbeing announced in the
first half of the year,and, and it has picked up.
So that'll come out.
Jeff Cranmer (19:41):
Yeah, indeed.
And, our one listener who tellsus to talk more about Japan,
uh, he will be pleased to knowthat, uh, think there were more
venture funds raised in Japanthis year than China or Korea.
We're still digginginto that to confirm.
Simone Fishburn (19:57):
I just wanna know, is that one listener
our colleague Matt Krebs?
Jeff Cranmer (20:01):
It's not actually, it's not.
Um, uh, Matt though, Mattis a big, big supporter,
of the podcast.
Just a few numbers.
Structure raised $650million, Kymera $ 602
million, Wave at $350.
(20:21):
The other big, big one camefrom Turns, at $650 million.
So, congrats to allthose companies.
It's, certainly great to seeand to do it right before JPM.
Maybe the sun will finally shinein San Francisco during JPM.
Alright, we're gonna takea quick break and we're
gonna turn to Washington.
Alanna Farro (20:44):
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Jeff Cranmer (21:31):
Okay.
And I am recruiting, presentingcompanies for the conference.
If you're interested oryou know, a company that
I should check out, dropme a line The results of
our survey are in here totell you about it, Simone.
Simone Fishb (21:51):
Well, thanks Jeff.
I really wanna pick up fromthe very positive sentiment
that seems to be happeningin the capital markets.
I don't think the IPO marketshave, uh, picked up yet,
but it's really good tosee the secondaries or the
follow ones as we call them,and venture going well.
And I say that because on theregulatory front and generally
(22:15):
there is a very big shadowover biotech, caused by the
uncertainty, the volatility,and in particular the
politicization of FDA accordingto the survey that we ran.
And why did I tie it tothe markets because really
(22:37):
there's still a feelingthat it is very hard for
investors to engage and to getexcited about about biotech.
So obviously we see that'shappening to some degree, but I
wanna go into some of the issuesthat came up in our survey.
So I think that there arethree principle points.
One of them is, is a fairlypositive one, which is that
(22:58):
the people who engage withthe survey, which are mostly
biotechs, about two thirdsbiotech, uh, and about one third
investors, and then there area few other stakeholders, but
they really say that this year,their interactions with FDA
have mostly continued with thesame kind of efficiency as last
year, productive interactions,that's about two thirds of them.
(23:21):
And so I feel that there'svery broad support inside the
industry for the staff at FDA.
And we've talked about thisbefore, the staff at FDA are
working incredibly hard, andthat actually is why companies
are able to move ahead, generatepositive clinical data and raise
on the back of that, right.
But it's not clear thatpast is gonna be prologue.
(23:45):
The second thing that isclear from this survey is
there are huge concernsabout the leadership.
So the biopharma industry isquite sophisticated and they
know how to distinguish betweenthe leadership of FDA and
the staff and the operations.
And they have huge concernsover the leadership.
Even the respondents whoare quite, there are a
(24:07):
few respondents who arequite supportive of FDA
Commissioner, Marty Makary.
Although he and the Head ofCBER Vinay Prasad caught quite a
lot of harsh criticism as well.
But even the people who aresupportive of Makary and some
of his initiatives really and,every single comment, but one,
(24:27):
questioned whether they havethe competence to actually
execute on what they thinkmight be good initiatives.
So if the first main twofindings are that the
FDA staff retain broadsupport from the industry.
And the second being thatthe leadership has got really
overwhelmingly negative ratings.
I think the third partis this uncertainty
(24:50):
and the inconsistencybeing this huge shadow.
The consequences are notonly chilling investment,
but many people, whoresponded as saying they are
moving their clinical trialsoutside of US territories.
And this won't surpriseanybody completely abandoning
vaccine programs andinvestment in vaccines.
Selina Koch (25:13):
Yeah, Simone, along those lines, I thought
it was kind of interestingthat 20% of respondents say
they had personally throughtheir companies, or if it
was an investor one of theirportfolio companies experienced
a reversal of an FDA positionor of earlier guidance on trial
design, that sort of thing.
And there's this perception thatthat's becoming more common.
Simone Fishburn (25:34):
Right, so.
That's correct.
So about 20%.
As you point out, we did askpeople whether they had had,
FDA change its guidance tothem or its instructions to
them, reverse a position thatit had taken previous to 2025.
So under the previousleadership, 20% said yes.
(25:55):
We also asked whether therewas a perception whether
they believe that FDArehearsals on trial design
are becoming more common.
And a large majority,like 85%, think that it's
becoming more common.
We don't have the numbers totell you whether it's becoming
more common, but most peoplebelieve it is, and most people
(26:15):
believe that's a bad thing.
And Steve, I expect youwanna comment in a minute.
Let me just add one morepoint because I, I'd like
you to answer this as well.
We also asked about acceleratedapproval, most people think that
that is going to get harder.
many think that it will beeasier in some indications
and harder in others, butacross the board about, more
than half I think, believethat it's going to get
(26:36):
harder in some indications.
So, do you wanna address acouple of those things, Steve?
Steve Usdin (26:40):
Yeah.
Yeah.
so, so I think well look,the critical thing to.
Point out is that the surveywas done when Richard Pazdur
was CDER director and nobodyknew at that time that he
was planning to retire.
I think if we were to do thesurvey again now, results
would be more negative,than they were especially
about political influenceand ideological influence
(27:01):
on FDA regulatory decisions.
I think the other thing that'sreally important to point
out, it's really interesting.
All of us have been outthere talking biotech
CEOs, to investors,to other stakeholders.
And there's exactly twothings that everybody
wants to talk about.
The first is what's happeningat FDA, and the second is
what's happening in China.
(27:21):
And I think that thetwo things are linked.
Right.
One of the things that's beena competitive advantage for the
United States over the yearshas been an innovative, science
driven regulatory environment.
The sense now is thatwe're losing that, that
that's being degraded.
And it is happening inconjunction, with a rise
(27:42):
in, China and biotechecosystem, which is being
facilitated in part by theirown innovative, science-driven
regulatory environment.
You know, it's not acoincidence that, we're seeing,
those two things happen inconjunction with each other.
Simone Fishburn (27:57):
Right.
I just wanna end with,one quote from somebody.
So, as I pointed out, manyof the quotes were quite
caustic and negative.
Absolutely you are right thatthere's, some people who were
literally wrote in the words.
thank goodness for Pazdurthis, this, uh, this survey
was conducted while he wasstill, at the top of CDER.
But here's a quote that Ijust thought really, really
(28:20):
represents across theboard what people think.
Even those who agree thatFDA could use some fixing.
One person wrote, "Getyour act together.
The headlines are terrible.
The infighting is disheartening.
Personnel decisions are awful.
You are seriously jeopardizingyour credibility and this
industry, right When weare in a race with China.
(28:43):
Get a meeting with the topleadership of FDA along with
RFK Jr. and get alignment,then speak with one voice,
give clarity, uncertaintyis the death nail to this
industry." That's fromone respondent, as I said.
So I think there'sjust a feeling that FDA
needs to fix itself.
And on that note, I'll, I'llpass it back to you, Jeff.
Selina Koch (29:08):
I can say for folks out there, who haven't
looked at it yet, there is boththe quantitative side of the
survey and as Simone was justreading the qualitative, um, we
did let people speak in theirown words and it was anonymous,
but we put a bunch of theirown words in there as well.
So that's available our website.
Jeff Cranmer (29:24):
Go to BioCentury.com.
BioCenturypodcast.com and you'llbe able to find it there, and
we'll create a link if you'renot a subscriber, that allows
you to, to get your hands onthis very interesting, uh,
somewhat depressing survey.
All right, apparently I'm toldby my colleagues that I'm the
(29:45):
only person in the world whocalls SBIR Grants siber Grants.
And well, my mom alwaystold me I was special.
I guess that's why.
Um, so, you know, this fundingis critical for biotechs and it
just happens to be caught up.
One of the many things caughtup in a stalemate in Congress,
(30:06):
and Steve took a look at this,um, Steve, what's the word?
Steve Usdin (30:10):
Yeah, SBIR, the Small Business Innovation
Research Program does reallya cornerstone of early stage
funding biotech startups.
Expired on September 30, andcutting off a major source
of non-dilutive capital forsmall life sciences companies.
As you said, Congress isdeadlocked over its future.
Basically there's adisagreement, uh, between
(30:32):
parties in Congresswho wanted to simply
reauthorize it, at least toreauthorize it for a year.
Well, there's discussion about,reforms and, well, in basically
Senator Joni Ernst, who wantsto change the SBIR program in
a lot of very significant ways.
Many of those ways thatthe biotech industry,
(30:53):
and small businesses andother industries oppose.
So the deadlock has not beenbroken and right now, to be
honest, there isn't a clearsight to how that might
happen, is really unfortunate.
And it's, also interestingbecause this is one of the
very few, government programsI think that has, nearly
(31:14):
unanimous bipartisan support,it's been really important.
And if we're gonna talk aboutChina, because we always
talk about China these days,it seems, it's also another
area where there's a contrastbecause, China learned from
the success of the US SBIRprogram and put in place
similar programs, programsthat were modeled on SBIR
(31:34):
but are much larger scale.
And, they've beenreally important in
helping them ramp up.
Selina Koch (31:40):
Yeah.
I mean, if we stop fundingthese ideas, early stage ideas,
through that so-called Valleyof Death, we do risk falling
behind in an area where we wereleading.
Simone Fishburn (31:53):
You know, I think most people who've
started a company have atsome point entertained the
idea of having an SBIR, ifnot actively sought one.
So I think we allacknowledge how important
they are for the industry.
Jeff Cranmer (32:04):
All right.
And you can check out Steve'sstory at BioCentury.com.
That's it for this week.
We're taking a break nextweek, we'll be back on
the 29th of December.
And we wish everyone out therea happy holiday season, however
you roll, and we'll be talkingabout some year end stuff and
(32:24):
some 2026 2026 preview stuffwhen we come back December 29th
Kendall Square Orchestraprovides the music for
BioCentury This Week.
The group connects scienceand technology professionals
and other members of theGreater Boston community
to collaborate innovate andinspire through music, while
(32:45):
supporting causes relatedto healthcare and education.
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