November 10, 2025 • 28 mins
With ObesityWeek yielding eye-catching amylin data and a bidding war that ran to $10 billion for Metsera, weight loss companies were center stage in biotech last week. On the latest edition of the BioCentury This Week podcast, BioCentury’s analysts explained why Pfizer's victory for the start-up over European rival Novo Nordisk doesn’t necessarily mean a broader U.S. policy shift against foreign acquisitions of domestic biotechs.
Turning to ObesityWeek readouts, they discuss Eli Lilly's data for amylin monotherapy eloralintide, arguing that just as Lilly did with GLP-1 agonists, the company is again setting the benchmark by which all other molecules in the class will be measured.
BioCentury's analysts also discuss takeaways from Washington Editor Steve Usdin's Commentary, which finds FDA in a crisis of politicized decisions, plummeting morale, and a hollowed workforce, and highlights from BioCentury's interview with gene therapy pioneer Jim Wilson as he rethinks the funding model for ultrarare disease therapies to keep his mission on track. This episode of the BioCentury This Week podcast is brought to you by Voyager Therapeutics.
View full story: https://www.biocentury.com/article/657545
#ObesityWeek #Amylin #GLP1 #Eloralintide #DrugMechanism #FDA #RareDisease #GeneTherapy
00:01 - Sponsor Message: Voyager Therapeutics
01:53 - Pfizer Wins Metsera
08:48 - Lilly's Amylin Data
13:06 - Funding Ultrarare Therapies
20:51 - What's Next for FDA
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
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Episode Transcript
Available transcripts are automatically generated. Complete accuracy is not guaranteed.
(00:00):
[AI-generated transcript.]
Eric Pierce (00:03):
BioCentury This Week is brought to you
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Jeff Cranmer (00:49):
Pfizer has won the bidding war for Metsera.
What can we learn from the weeklong wrangling between Pfizer
and Novo for Metsera and whatit means for cross-border M&A.
Staying with obesity, apair of amylin data sets
made for an interestingObesityWeek in Atlanta.
(01:14):
Plus Jim Wilson, isrethinking the funding model
for ultra rare therapies.
P lus more leadership turmoilat FDA as Richard Pazdur
declines the CDER job.
But what's FDA going tolook like moving forward?
I'm Jeff Cranmer, andthis is the BioCentury
(01:37):
This Week podcast.
Joining me are my colleagues.
Simone Fishburn (01:43):
Simon Fishburn, editor in chief.
Stephen Hansen (01:45):
Stephen Hansen, director of
Biopharma Intelligence.
Lauren Martz (01:48):
Lauren Martz, executive Director
of Biopharm Intelligence.
Steve Usdin (01:51):
And Steve Oden, Washington editor.
Jeff Cranmer (01:53):
All right, guys.
Thanks for joining me.
You all have quite differentthings to talk about, Stephen.
I guess maybe you're gladthat this, uh, week long,
uh, bidding war is over.
What, uh, where didthe ball last bounce?
Stephen Hansen (02:07):
I think so it's been, uh, quite a wild week.
So just, I mean, if youheard last week's podcast,
we talked about this fairlyextensively, but, um, if you
recall, Pfizer, was set toacquire, Metsera in a deal they
announced in late September.
Then, on October 30th, Novo camein with a bid, arrival bid to
acquire Metsera and sort of thebidding war started from there.
(02:28):
in the intervening period wehad Pfizer suing Novo and suing
Metsera for breach of contract.
there was, talk about, Americafirst and these sorts of things.
There's all this sort of dramathat was happening in between,
but kind of where it alllanded was over the weekend.
Pfizer announced that ithad, again, increased its
bid for Metsera, to whatamounted to, 7.6, billion
(02:50):
dollars upfront, plus a CVRworth up to 2.4 billion.
So overall 10 billion,that basically equaled what
Novo's final bid had been.
then Novo announced overthe weekend that it was,
uh, basically pulling outthat it was no longer gonna
offer any, any new bids.
So kind of where things standis now Pfizer Metsera are, now
(03:10):
looking to go forward for a$10 billion overall, acquisition
price on Metsera rather thanthe roughly seven and a half
is kind of where it stood,before Novo got involved.
So, quite the sweetened dealfrom, where things stood.
Steve Usdin (03:23):
I'm wondering how much you mentioned the America
first thing, you know, I'mreally curious, how much do
you think that played into it?
How much did the FTCsintervention in making
it seem like the Novo bidwas gonna be disadvantaged
compared to Pfizer?
Simone Fishbur (03:37):
So let me answer
Steve Usdin (03:38):
was that.
Simone Fish (03:39):
The answer's a ton.
Okay, so Stephen and I havebeen talking about this.
I think it is not possible tolook at this course of events.
We know they said that FTCbasically called up Metsera and
said this offer is questionable,Novo, even the offer of money
upfront might get reversed.
(04:00):
I believe this was donewhile the government
shut down was still on.
There's clearly a, a lotof FTC hand in this all I
can say is, Lina Khan couldhave done this herself.
Steve Usdin (04:13):
So the, the, the question I guess that has going
forward is, is, this one off?
It seems, seems like thesethings are, are never one off.
People always say they're gonnabe one off, but I think that
people are gonna have to thinkabout this when you're talking
about these kinds of deals.
going forward for the remainderof this administration.
Simone Fishburn (04:30):
think I, sorry, Steven, I know
you wanna come into this,but I wanna add to that.
I mean, there's that generally.
But that's what you are callingthe America first thing, Steve.
But you know, you've got Bourlahaving cozied up to Trump.
But there's another partof this, which Steven maybe
you can talk about, whichis whether other obesity
companies should be thinking,I'm not gonna be able to
(04:51):
partner with Lilly or Novo.
Stephen Hansen (04:53):
Yeah.
So here's what I think Ithink there was a clear
argument that this would'vebreached the antitrust.
laws in the U.S. I mean, Ithink for one sense, I think
that's exactly why Novo choseto pursue such a unique deal
structure was because theyprobably knew this was gonna be
hard, very hard to get through.
And so why they went afterthis, you know, very unique
structure that would putso much money up front.
(05:14):
secondly, I mean, Novo itselfreports that they, hold 48% of
the market share for the GLP-1market in the U.S. in diabetes.
And based on sales of Lilly'sdrugs, I'm pretty confident
that we can say that Lillyprobably holds another 48% in
the U.S. And so when you lookat, definitions of dominant
market position in antitrust,you know, legislation, I
(05:36):
think this clearly fits.
You know, when you're talkingabout GLP-1s, I think Metsera
and Novo kind of clearlyfit into that dominant
market position a rgument.
And so I, I actually thinkPfizer had a pretty good
case to say that thiswasn't gonna make it by.
And so while I think it's veryconvenient that Novo was a
Danish company, for Bourla,in terms of using that America
(05:57):
first argument, I would arguethat if you took Novo out
and you inserted Lilly, Ithink the FTC would've had
a similar approach here.
I don't think Lilly couldhave gotten t his deal
done with Metsera, withthe same deal structure.
I think the America firsthelped just from a optics kind
of being able to like leanon them and maybe to get it
(06:17):
done a little bit quicker.
But I, I think justfrom an antitrust
perspective, I think both Lilly
Simone (06:22):
Stephen, what about the,
Stephe (06:23):
would've had a hard time
Simone Fishburn (06:24):
What about the argument that I've read
in the Journal and in my ownSlack messages to you, about
the number of other pharmaswith activity in this space?
You've got Amgen and youcan name them, and this is
a molecule that's not yet onthe market, so you know, it's.
Stephen Hans (06:41):
yeah, that's true.
And, you know what, I thinkin five years time, you
probably could easily makethe argument that Novo could
buy, a next gen GLP-1 andprobably be in a position to
do that because there wouldbe four or five other GLP-1s
out there and they wouldn'thave as dominant a position.
But I think atthis point in time.
you know, few conversationsI've had with some
M&A lawyers as well.
(07:01):
they think there's a prettystrong argument to say that
as of right now, Novo hasthat dominant position, and
therefore, when you're talkingabout GLP-1s, this would be a
hard one to push forward with.
Doesn't mean to say theycan't do deals elsewhere.
Like we've, we've seen theLilly do and Novo obviously
do due deal with obesity.
Novo bought, youknow, CB1, inhibitor.
Which was, a different,molecule, different class.
(07:21):
Lilly's done deals forbimagrumab you know, which is
sort of the, activin antibodySo there are deals to be done.
I just think very narrowly inthis GLP-1 class, this is one
where it would be harder toforward from an
antitrust position.
Simone Fishburn (07:34):
Okay.
Last thing then.
If they had this strongantitrust position, was
sure of it and actually gotthat verified by Metsera
in their announcement.
Why did they have to up the bid?
That's Pfizer.
Why did Pfizer up the bid?
Stephen Hansen (07:48):
I've been thinking about this since
you originally put thisto me earlier, I think the
reason you upped the bid isbecause you take the decision
out of Metsera's hands.
When you match Novo's offerand you have the clear runway
from a regulatory perspective,there's no decision to be made
by Metsera's board, it's clearlythe better offer to take.
I think if you try to go in witha lower offer, you make it much
(08:11):
harder on Metsera to decide.
And so I think, Pfizer's boardwas just finally like, you
know what, whatever, just upthe offer, make it an offer.
They can, you know, this is likethe, the Godfather offer, make
'em an offer They can't refuse.
And let's just move on with it.
Simone Fishburn (08:24):
Uh, all right.
So I think that we can agreethat basically they listened
to our podcast last weekand decided what's another
billion between friends.
And I also agree with youthat from Metsera's point of
view, it makes complete sense.
Stephen Hansen (08:36):
that's right.
Jeff Cranmer (08:38):
All righty.
Thanks for that, Stephen.
You were, uh, certainlyon top of that.
we didn't get you outta bedfor anything, but, uh, you sort
of waited to make your nextstory, make your next move.
Okay.
Well, Lilly sat on the sidelinesof the Metsera madness, but it
was making its mark in Hotlanta.
For ObesityWeek, whichwrapped up on Friday.
(09:01):
SITC fans, we knowyou're out there, we'll
get to you next week.
but we're gonna stay withthe obesity theme here.
Lilly, set the bar for amylinwith weight loss data, but
we also saw two data setsthat called into question
the quality of weightloss, and how folks were
thinking about it for amylin.
Stephen, break this down for us.
Stephen Hansen (09:23):
Yeah, sure.
Thanks Jeff.
So the, as you mentioned, sothis past week was ObesityWeek
and for those that aren't, Iguess, big on nightclubs and
things in Atlanta, Georgia.
and yeah, I mean, I guessthe most impressive data
out of the conference frommy perspective, was the
eloralintide, data from Lilly.
It is an amylin receptorbiased, agonist.
and it was pretty impressive.
(09:44):
So this was 48 week data.
we already kind of knew this,that this molecule was pretty
good because at ADA earlierthis year, we saw 12 week data
that showed 11.5% weight loss.
and now the 48 week datashowed nearly 20% placebo
adjusted weight loss.
I mean, that's prettymuch on par with
Lilly's Tirzepatide, so.
Very impressive data.
(10:05):
and then on, on the safety side,I mean, across all the doses, it
looked better than what we wouldtypically see with an incretin.
But then when they had a, um,a titration cohort that showed
weight loss of it to 16%, Imean, the, the, the GI side
effects were very mild, just, Afew percentage points above what
they were seeing with placebo.
So it was a verypromising sort of profile
(10:26):
for, um, that program.
To get what you were saying,Jeff, about the weight
loss quality, so peoplehad previously, you know,
been telling me that amylinmonotherapy could reach kind
of the high teens in terms ofweight loss, but I was always
kind of skeptical of that.
that was primarily because.
Everyone had been talkingabout this preclinical data
that they'd seen for amylinand how that, weight loss was
(10:46):
predominantly driven by fatmass loss and that it was a
muscle sparing mechanism andall these things, and sort
of by definition, if you'reonly losing weight from fat
and not other parts of leanmass, well it is just harder to
lose more than what you wouldtypically see with the GLP-1.
So I was always quite skepticalof the idea that you could get
kind of GLP-1 like weight lossfrom an amylin monotherapy.
(11:09):
Now we know why we can seethe size of weight loss is
because, we got data forCagriSema from their, REDEFINE
1 Phase III study where theyalso have Cagrilintide and
Semaglutide, monotherapy arms.
And when they looked at bodycomposition, essentially there
was no difference in weightloss between the amylin and the
GLP-1 actually in that trial.
(11:30):
There was a bit more weightloss from fat for Semaglutide
than there was from theamylin arm of that study.
And then on top of that, forthe eloralintide data, they
also had a body composition,subset of the data.
And that also showed basicallyweight loss where you get 60 to
70% weight loss from fat, andthen around 30 to 40% from lean
(11:50):
mass, which again, is basicallywhat we would expect to see
from an incretin based therapy.
So.
It's essentially two fairly,sizable knocks against amylin
being a muscle sparing,mechanism, which was one of
the potential benefits of thisclass in terms of it being
able to, you know, be a core,obesity therapy going forward.
(12:12):
So right now, the way I wouldthink about it is, unless
we see data, otherwise, I'msort of, in my mind, I'm
kind of removing that musclesparing benefit from amylin.
I mean, the rest of thedata still looks great.
It still is, GLP-1 likeweight loss with better
side effect profile.
I think there's still a realrole for amylin to play as
a core obesity treatment.
(12:32):
But, as of right now, I thinkwe have to cut out the, uh,
the muscle sparing mechanism.
Jeff Cranmer (12:38):
Well, thanks for the update, Stephen.
What's next for you?
What are you watching for?
Stephen Hansen (12:42):
Well, we're gonna have a look at, uh, there
was some NLRP3 data in obesityrecently, so I'm gonna have a
take a bit of a deeper dive intothat and kind of where things
stand and then, uh, who knows?
I'm sure there's plentyof directions that,
we can go from there.
So,
Jeff Cranmer (12:55):
thanks for that, Stephen.
I'm looking forward tothat piece for sure.
All right.
Enjoy your evening, suspect it'sdinner time for you right now.
Well, let's turn to Lauren.
Lauren, had the pleasure ofspeaking to Jim Wilson recently,
and, she wrote, about what hehas been up to since he left
(13:16):
Penn. And, you know, she foundFDA, has been trying to find
ways to ease the regulatorypath for ultra rare disease
drugs, VCs, uh, not, not reallytaking the bait just yet.
largely uninterestedin the space.
And so that sort of set thestage for, Jim Wilson as
(13:38):
he set out to develop andfund gene therapies for
ultra orphan indications.
Little more than a yearin, uh, the hurdles he
encountered, prompted himto, rethink the funding model
to keep his mission alive.
Lauren, what did you learn?
Lauren Martz (13:55):
Yeah, thanks Jeff.
So a few weeks ago we learnedthat Jim Wilson, who left his
longstanding position at Pennto found Gemma Therapeutics,
was launching a new companyfocused on AAV gene therapies
for ultra rare diseasescalled Rare Therapeutics.
So ultra rare diseases, werereally at the center of the
(14:16):
mission of Gemma, which launcheda year ago when he left Penn.
I spoke with Jim Wilsonabout, you know, why he was
launching this new companythat was focused on what I
thought the original companywas focused on, and he was
very transparent, as you said.
There was a lack of interestfrom the VCs that, he
approached in funding theultra orphan, programs that
(14:37):
he was trying to develop.
So the whole idea behindGemma was that the company
would license later stage genetherapies for ultra orphan
diseases that wouldn't requirevery much investment to get
to the first approvals, thenThe company would use the
Priority Review Vouchers andwhatever sales were generated
to fund future programs.
(14:58):
You know, this didrequire some VC funding,
especially at the beginning.
And, interest from VCsimply wasn't there.
that's, of course something thatwe've been observing when we've
been talking about gene therapydevelopment over the course
of this year and many yearsbefore that, you know, interest
in gene therapy in general isdeclining for various reasons.
Um.
There just isn't really aline of sight to how to make
(15:20):
these types of therapiesfor the rarest diseases,
something that, that peoplethink can be very profitable.
The outcome is that GemmaTherapeutics is sticking with
its earlier stage programs forthe less rare, rare diseases
in order to get VC backing.
And then the ultra rare programswere spun out into this new
company, Rare Therapeutics.
Steve Usdin (15:40):
How much of this is a consequence of the of sun
setting, of the Priority ReviewVoucher, and how important
would it be if the PriorityReview Voucher came back?
Lauren Martz (15:50):
So that was a core part of the original model.
you know, there is thisexpectation that those programs
when approved would get PriorityReview Vouchers that was just
built into the funding model.
And so without that, I thinkthat that is a big component to
why this may not have worked.
developing these ultra rareprograms really does depend
(16:11):
on the government, theFDA regulatory incentive.
So there were the PriorityReview Vouchers, which, you
know, we still have vouchers.
They're not as predictable.
They're not gonna be or theymay not be for these, these
types of indications aswe've seen
Steve Usdin (16:24):
they're, and they, they're, they call 'em vouchers.
They're not vouchers becausethey can't be transferred,
they can't be sold.
The, the key thing about thePriority Review Voucher wasn't
that it sped up the developmentprogram, which is what the new
Commissioner National PriorityVoucher is supposed to do.
The key thing about that wasthat they were, um, you know,
Willy Wonka's magic ticket.
You, you could, transfer themor you could sell them, for,
(16:46):
you know, north of a hundredmillion dollars usually.
that's a powerful incentive fordeveloping these kinds of drugs.
In the absence of that,it's gonna be a struggle to
see how companies are gonnabe able to come up with
the investment to do it.
Lauren Martz (16:58):
Exactly.
I think this is ademonstration of that.
And I think there are sortof other incentives that
this was depending on.
So there's also this platformtechnology designation, which
we have been seeing rollouts.
You know, there have beentwo companies at this
point that have receivedthis designation, but.
(17:18):
Again, that's somethingthat's unpredictable.
So the idea there is that ifyou have a therapy approved
based on an underlyingplatform technology here, it
would be the same AAV vector.
There would be fewerrequirements, fewer, as you
know, you don't have to repeatsome of the requirements,
and that would streamlinedevelopment and cut the costs.
And so again, that'ssomething, there's not a
ton of certainty around whenthat can be available and
(17:41):
if it will be available.
When I spoke with Jim Wilson,he also cited some potentially
more reliable incentives.
There's the Rare DiseaseEvidence Principles Program,
which is focused specificallyon the ultra rare diseases,
and that's where RareTherapeutics is focused.
So I think this is a storythat we'll continue to
(18:02):
follow as an example ofhow regulatory incentives
can impact development ofgene therapies for rare
and ultra rare diseases.
Steve Usdin (18:11):
And we're also gonna be seeing the
plausible mechanism pathway,at least that's what
it's been called to date.
Some kind of a, a new pathwaythat FDA is creating for ultra.
Rare diseases that's gonnabe announced, I think, uh,
probably this week, but ifnot this week, then next week.
Jeff Cranmer (18:28):
Okay, thanks for that, Lauren.
Lauren, specializes incovering, gene therapy new
modalities, and she'll stayon top of this space for us,
and you can read her piece atbiocenturypodcast.com and I'll
drop a link to the show notes.
And speaking of.
The show notes while you're,uh, checking those out.
(18:51):
Uh, don't forget to like andsubscribe BioCentury This W
eek and check out our sisterpodcast, The BioCentury Show.
Steve, you, uh, arelooking very dapper today.
You've got a greenscreen behind you.
What's, what's on your agenda?
Steve Usdin (19:05):
yeah, I, I dressed up just for the podcast so
people can hear me, uh, whatI I sound like in a suit.
No, I, I'm going to be doingan interview later this
afternoon with, former NIHdirector and former Head of
R&D at Sanofi, Elias Zerhouni.
Jeff Cranmer (19:19):
Alright.
I'm looking forward to that.
Yes, Simone did, uh, announcea new editorial policy where
one of us has to wear a suit.
every day.
So, uh,
Simone Fishburn (19:29):
to see how this plays out, you know?
Jeff Cranmer (19:31):
yeah, me, me too.
I mean, today, Eagles attire.
Big, big Monday night game.
But, uh, hey, we'regonna get back to Steve
and what's happening inWashington, right after this.
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And I have already begun recruiting,
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Alright, uh, Steve, FDACommissioner, Marty Makary,
(20:54):
as you reported last week,had asked Richard Pazdur to
serve as CDER director in thewake of George Tidmarsh's we
talked about on that on lastweek's pod, so we won't need
to dwell on the things aroundthat, but you can check out
last week's pod, get caught up.
What is going on withleadership at FDA right now?
Steve Usdin (21:15):
Well, so here's what we know when
we're talking about CDER.
Um.
We know, and you know, as Imentioned last week of George
Tidmarsh is not coming back.
Yeah, FDA Commissioner Makaryasked Oncology Center of
Excellence Director RichardHHS Secretary Robert F. Kennedy
Jr., interviewed Pazdur.
And I think it's importantto point out that
this is unprecedented.
It's unprecedented foran HHS secretary to vet
(21:37):
an FDA center director.
But here's what I think, Ithink the job of the center
director has become politicized.
In the best of times, it's areally difficult job, and in
the current administration ithas become much more difficult.
Whoever takes the positionwill have to be aligned with
Kennedy's MAHA movement.
They're gonna have to bewilling to accept political
interference and routineregulatory decisions, and
(21:59):
they're gonna have to understandthat they may not last longer
than the current administration.
Previous CDER directors andCBER directors have had the
confidence that since they'recivil servants, that they will.
stay in the position for,a lengthy period of time.
I'm not convinced that that'sthe case now, and whoever comes
into the job is gonna have todeal with plummeting morale,
depleted staffing, and kindof toxic pandemic politics.
(22:22):
So it's gonna be tough to findsomebody, to do the job who
will do it with the same kindof, expertise and same kind
of excellence as, previousCDER e directors have done it.
And you can't really emphasizehow important for the biopharm
industry and for patients,the CDER director role is.
in many ways it's more importantthan the FDA Commissioner
Simone Fishburn (22:46):
So Steve, Obviously there was Janet
Woodcock for a very long time.
Then Patrizia Cavazzoni Janetwas there for so long, Dr.
Woodcock, that I'm not actuallysure to be honest, Steve, I
don't remember who was beforeher, I'm sort of wondering
whether there isn't scope.
I mean, if there were somebodygood and competent, is there not
scope for somebody to think, I,I have to survive one year, two
(23:10):
year, three years, and this,how, how much does somebody
think about just survivalin a role like that versus
walking in with an agenda?
I'm really gonna do,you know, big things.
think that's one of my concernsis the risk aversion that
people at FDA will have,despite many things that.
Makary is talking aboutin terms of making drug
(23:31):
development easier, thereseems to be a concern about
sticking your head out.
Steve Usdin (23:37):
Yeah.
So look, I think that whoevercomes into this position is
gonna have to come into theposition realizing, all the
things that I mentioned earlierand, um, they're gonna have
to be comfortable with that.
They're gonna have to be,it's gonna have to be somebody
who's comfortable in a morepoliticized environment, in
an environment where the HHSsecretary can decide that
(23:57):
Tylenol, is no longer safe for,pregnant women or for, children,
without any kind of processaround it that is, is normal or
that leucovorin is, uh, is aneffective treatment for, autism.
There's gonna be moreand more of those things.
So whoever comes into theposition is gonna have to be.
Comfortable dealingwith, that environment?
(24:17):
What does that mean?
Yeah.
One of the things that we'regoing to see, regardless
of who's the CDER directorgoing forward is, we're gonna
see, more risk aversion.
we're going to see lesspredictability, and
we're gonna see moreerratic decision making.
And by erratic decision making,I mean decisions that are made.
(24:38):
Then there's political blowbackand FDA changing its mind.
There have been severalinstances of that already in
this administration, and Ithink, we're going to see more.
There's quite a bit ofconcern about some of the
complete response lettersthat have been issued in
recent weeks and months.
The patient groups and thecompanies and the investors
(24:59):
are organizing politicalresponses to try to pressure,
FDA to reverse the completeresponses or to define paths
forward, to get those, some ofthose drugs out to patients.
So I think that's the kind ofthing that we're gonna see.
And you know, as I, I wrotethis big piece last week,
kind of trying to lookforward at what FDA is going
(25:19):
to be like in the future.
And those were some ofthe themes, you know, risk
aversion, erratic decisionmaking, less predictability
at the same time, There's, areally, dedicated staff there.
in many cases, people whohave been there for a decade
or more who are going to dotheir utmost to keep the ship.
(25:39):
You know, going to keep theship afloat and, and, and
going in the right direction.
So there are gonna be a lot ofthings that are gonna happen,
um, relationships and, um,interactions, engagements
between companies, sponsorsand FDA that are going to move
forward just as they shouldand as they have in the past.
The problem, I think, amongother problems is that it's
(26:01):
unpredictable when thingswill, blow off course.
You know, everything.
It's gonna be goingalong just as you expect.
And then for some reason,things aren't going along the
way that you expect anymore.
that's gotta be in theback of, everybody's mind.
Jeff Cranmer (26:16):
Alright, thanks for that update, Steve.
yeah, definitely, uh, muchgratitude to those people.
keeping the light onmoving, applications,
giving companies advice.
we need it.
for those of you doingthat, hang in there.
Okay.
Well, don't forget to turn intoThe BioCentury Show this week.
(26:37):
we'll also have another specialpod for you, Simone and Josh.
we're up in Boston at theVenture Café Cambridge last
week, a really good podcastfocused on, all things Korea.
one can only hope thatJosh has finally seen,
K-pop demon hunters.
I know Simone, uh,lives it basically.
(26:59):
So.
on my to-do list.
It is on my to-do list.
I have to tell you, myhusband cannot believe it is
on my to-do list, but it is.
Just as soon as I finishShogun, I gotta
finish Shogun, first.
Oh, yeah.
Yeah.
I
Simone Fishburn (27:11):
Yeah.
Yeah.
Jeff Cranmer (27:13):
Yeah.
All right.
All right.
Well, you got some plane ridesahead of you, so hopefully
you can make some, uh, someheadway on both fronts.
Okay.
thanks for tuning in.
We will catch you for ourregular pod, next week.
Kendall Square Orchestraprovides the music for
BioCentury's Podcasts.
Tickets are now on sale forthe Group's eighth season.
(27:35):
The group connects scienceand technology professionals
and other members of theGreater Boston community
to collaborate innovate andInspire through music, while
supporting causes relatedto healthcare and education.
Eric Pierce (27:48):
BioCentury would like to thank Voyager
Therapeutics for supporting theBioCentury This Week podcast.
To learn more aboutVoyager's programs advancing
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voyagertherapeutics.com.
[AI-generated transcript.]
Eric Pierce (00:03):
BioCentury This Week is brought to you
by Voyager Therapeutics.
Voyager Therapeutics isdedicated to leveraging
the power of human geneticsto modify the course
of – and ultimately cure– neurological diseases.
Voyager addresses the challengeof delivering novel treatments
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Jeff Cranmer (00:49):
Pfizer has won the bidding war for Metsera.
What can we learn from the weeklong wrangling between Pfizer
and Novo for Metsera and whatit means for cross-border M&A.
Staying with obesity, apair of amylin data sets
made for an interestingObesityWeek in Atlanta.
(01:14):
Plus Jim Wilson, isrethinking the funding model
for ultra rare therapies.
P lus more leadership turmoilat FDA as Richard Pazdur
declines the CDER job.
But what's FDA going tolook like moving forward?
I'm Jeff Cranmer, andthis is the BioCentury
(01:37):
This Week podcast.
Joining me are my colleagues.
Simone Fishburn (01:43):
Simon Fishburn, editor in chief.
Stephen Hansen (01:45):
Stephen Hansen, director of
Biopharma Intelligence.
Lauren Martz (01:48):
Lauren Martz, executive Director
of Biopharm Intelligence.
Steve Usdin (01:51):
And Steve Oden, Washington editor.
Jeff Cranmer (01:53):
All right, guys.
Thanks for joining me.
You all have quite differentthings to talk about, Stephen.
I guess maybe you're gladthat this, uh, week long,
uh, bidding war is over.
What, uh, where didthe ball last bounce?
Stephen Hansen (02:07):
I think so it's been, uh, quite a wild week.
So just, I mean, if youheard last week's podcast,
we talked about this fairlyextensively, but, um, if you
recall, Pfizer, was set toacquire, Metsera in a deal they
announced in late September.
Then, on October 30th, Novo camein with a bid, arrival bid to
acquire Metsera and sort of thebidding war started from there.
(02:28):
in the intervening period wehad Pfizer suing Novo and suing
Metsera for breach of contract.
there was, talk about, Americafirst and these sorts of things.
There's all this sort of dramathat was happening in between,
but kind of where it alllanded was over the weekend.
Pfizer announced that ithad, again, increased its
bid for Metsera, to whatamounted to, 7.6, billion
(02:50):
dollars upfront, plus a CVRworth up to 2.4 billion.
So overall 10 billion,that basically equaled what
Novo's final bid had been.
then Novo announced overthe weekend that it was,
uh, basically pulling outthat it was no longer gonna
offer any, any new bids.
So kind of where things standis now Pfizer Metsera are, now
(03:10):
looking to go forward for a$10 billion overall, acquisition
price on Metsera rather thanthe roughly seven and a half
is kind of where it stood,before Novo got involved.
So, quite the sweetened dealfrom, where things stood.
Steve Usdin (03:23):
I'm wondering how much you mentioned the America
first thing, you know, I'mreally curious, how much do
you think that played into it?
How much did the FTCsintervention in making
it seem like the Novo bidwas gonna be disadvantaged
compared to Pfizer?
Simone Fishbur (03:37):
So let me answer
Steve Usdin (03:38):
was that.
Simone Fish (03:39):
The answer's a ton.
Okay, so Stephen and I havebeen talking about this.
I think it is not possible tolook at this course of events.
We know they said that FTCbasically called up Metsera and
said this offer is questionable,Novo, even the offer of money
upfront might get reversed.
(04:00):
I believe this was donewhile the government
shut down was still on.
There's clearly a, a lotof FTC hand in this all I
can say is, Lina Khan couldhave done this herself.
Steve Usdin (04:13):
So the, the, the question I guess that has going
forward is, is, this one off?
It seems, seems like thesethings are, are never one off.
People always say they're gonnabe one off, but I think that
people are gonna have to thinkabout this when you're talking
about these kinds of deals.
going forward for the remainderof this administration.
Simone Fishburn (04:30):
think I, sorry, Steven, I know
you wanna come into this,but I wanna add to that.
I mean, there's that generally.
But that's what you are callingthe America first thing, Steve.
But you know, you've got Bourlahaving cozied up to Trump.
But there's another partof this, which Steven maybe
you can talk about, whichis whether other obesity
companies should be thinking,I'm not gonna be able to
(04:51):
partner with Lilly or Novo.
Stephen Hansen (04:53):
Yeah.
So here's what I think Ithink there was a clear
argument that this would'vebreached the antitrust.
laws in the U.S. I mean, Ithink for one sense, I think
that's exactly why Novo choseto pursue such a unique deal
structure was because theyprobably knew this was gonna be
hard, very hard to get through.
And so why they went afterthis, you know, very unique
structure that would putso much money up front.
(05:14):
secondly, I mean, Novo itselfreports that they, hold 48% of
the market share for the GLP-1market in the U.S. in diabetes.
And based on sales of Lilly'sdrugs, I'm pretty confident
that we can say that Lillyprobably holds another 48% in
the U.S. And so when you lookat, definitions of dominant
market position in antitrust,you know, legislation, I
(05:36):
think this clearly fits.
You know, when you're talkingabout GLP-1s, I think Metsera
and Novo kind of clearlyfit into that dominant
market position a rgument.
And so I, I actually thinkPfizer had a pretty good
case to say that thiswasn't gonna make it by.
And so while I think it's veryconvenient that Novo was a
Danish company, for Bourla,in terms of using that America
(05:57):
first argument, I would arguethat if you took Novo out
and you inserted Lilly, Ithink the FTC would've had
a similar approach here.
I don't think Lilly couldhave gotten t his deal
done with Metsera, withthe same deal structure.
I think the America firsthelped just from a optics kind
of being able to like leanon them and maybe to get it
(06:17):
done a little bit quicker.
But I, I think justfrom an antitrust
perspective, I think both Lilly
Simone (06:22):
Stephen, what about the,
Stephe (06:23):
would've had a hard time
Simone Fishburn (06:24):
What about the argument that I've read
in the Journal and in my ownSlack messages to you, about
the number of other pharmaswith activity in this space?
You've got Amgen and youcan name them, and this is
a molecule that's not yet onthe market, so you know, it's.
Stephen Hans (06:41):
yeah, that's true.
And, you know what, I thinkin five years time, you
probably could easily makethe argument that Novo could
buy, a next gen GLP-1 andprobably be in a position to
do that because there wouldbe four or five other GLP-1s
out there and they wouldn'thave as dominant a position.
But I think atthis point in time.
you know, few conversationsI've had with some
M&A lawyers as well.
(07:01):
they think there's a prettystrong argument to say that
as of right now, Novo hasthat dominant position, and
therefore, when you're talkingabout GLP-1s, this would be a
hard one to push forward with.
Doesn't mean to say theycan't do deals elsewhere.
Like we've, we've seen theLilly do and Novo obviously
do due deal with obesity.
Novo bought, youknow, CB1, inhibitor.
Which was, a different,molecule, different class.
(07:21):
Lilly's done deals forbimagrumab you know, which is
sort of the, activin antibodySo there are deals to be done.
I just think very narrowly inthis GLP-1 class, this is one
where it would be harder toforward from an
antitrust position.
Simone Fishburn (07:34):
Okay.
Last thing then.
If they had this strongantitrust position, was
sure of it and actually gotthat verified by Metsera
in their announcement.
Why did they have to up the bid?
That's Pfizer.
Why did Pfizer up the bid?
Stephen Hansen (07:48):
I've been thinking about this since
you originally put thisto me earlier, I think the
reason you upped the bid isbecause you take the decision
out of Metsera's hands.
When you match Novo's offerand you have the clear runway
from a regulatory perspective,there's no decision to be made
by Metsera's board, it's clearlythe better offer to take.
I think if you try to go in witha lower offer, you make it much
(08:11):
harder on Metsera to decide.
And so I think, Pfizer's boardwas just finally like, you
know what, whatever, just upthe offer, make it an offer.
They can, you know, this is likethe, the Godfather offer, make
'em an offer They can't refuse.
And let's just move on with it.
Simone Fishburn (08:24):
Uh, all right.
So I think that we can agreethat basically they listened
to our podcast last weekand decided what's another
billion between friends.
And I also agree with youthat from Metsera's point of
view, it makes complete sense.
Stephen Hansen (08:36):
that's right.
Jeff Cranmer (08:38):
All righty.
Thanks for that, Stephen.
You were, uh, certainlyon top of that.
we didn't get you outta bedfor anything, but, uh, you sort
of waited to make your nextstory, make your next move.
Okay.
Well, Lilly sat on the sidelinesof the Metsera madness, but it
was making its mark in Hotlanta.
For ObesityWeek, whichwrapped up on Friday.
(09:01):
SITC fans, we knowyou're out there, we'll
get to you next week.
but we're gonna stay withthe obesity theme here.
Lilly, set the bar for amylinwith weight loss data, but
we also saw two data setsthat called into question
the quality of weightloss, and how folks were
thinking about it for amylin.
Stephen, break this down for us.
Stephen Hansen (09:23):
Yeah, sure.
Thanks Jeff.
So the, as you mentioned, sothis past week was ObesityWeek
and for those that aren't, Iguess, big on nightclubs and
things in Atlanta, Georgia.
and yeah, I mean, I guessthe most impressive data
out of the conference frommy perspective, was the
eloralintide, data from Lilly.
It is an amylin receptorbiased, agonist.
and it was pretty impressive.
(09:44):
So this was 48 week data.
we already kind of knew this,that this molecule was pretty
good because at ADA earlierthis year, we saw 12 week data
that showed 11.5% weight loss.
and now the 48 week datashowed nearly 20% placebo
adjusted weight loss.
I mean, that's prettymuch on par with
Lilly's Tirzepatide, so.
Very impressive data.
(10:05):
and then on, on the safety side,I mean, across all the doses, it
looked better than what we wouldtypically see with an incretin.
But then when they had a, um,a titration cohort that showed
weight loss of it to 16%, Imean, the, the, the GI side
effects were very mild, just, Afew percentage points above what
they were seeing with placebo.
So it was a verypromising sort of profile
(10:26):
for, um, that program.
To get what you were saying,Jeff, about the weight
loss quality, so peoplehad previously, you know,
been telling me that amylinmonotherapy could reach kind
of the high teens in terms ofweight loss, but I was always
kind of skeptical of that.
that was primarily because.
Everyone had been talkingabout this preclinical data
that they'd seen for amylinand how that, weight loss was
(10:46):
predominantly driven by fatmass loss and that it was a
muscle sparing mechanism andall these things, and sort
of by definition, if you'reonly losing weight from fat
and not other parts of leanmass, well it is just harder to
lose more than what you wouldtypically see with the GLP-1.
So I was always quite skepticalof the idea that you could get
kind of GLP-1 like weight lossfrom an amylin monotherapy.
(11:09):
Now we know why we can seethe size of weight loss is
because, we got data forCagriSema from their, REDEFINE
1 Phase III study where theyalso have Cagrilintide and
Semaglutide, monotherapy arms.
And when they looked at bodycomposition, essentially there
was no difference in weightloss between the amylin and the
GLP-1 actually in that trial.
(11:30):
There was a bit more weightloss from fat for Semaglutide
than there was from theamylin arm of that study.
And then on top of that, forthe eloralintide data, they
also had a body composition,subset of the data.
And that also showed basicallyweight loss where you get 60 to
70% weight loss from fat, andthen around 30 to 40% from lean
(11:50):
mass, which again, is basicallywhat we would expect to see
from an incretin based therapy.
So.
It's essentially two fairly,sizable knocks against amylin
being a muscle sparing,mechanism, which was one of
the potential benefits of thisclass in terms of it being
able to, you know, be a core,obesity therapy going forward.
(12:12):
So right now, the way I wouldthink about it is, unless
we see data, otherwise, I'msort of, in my mind, I'm
kind of removing that musclesparing benefit from amylin.
I mean, the rest of thedata still looks great.
It still is, GLP-1 likeweight loss with better
side effect profile.
I think there's still a realrole for amylin to play as
a core obesity treatment.
(12:32):
But, as of right now, I thinkwe have to cut out the, uh,
the muscle sparing mechanism.
Jeff Cranmer (12:38):
Well, thanks for the update, Stephen.
What's next for you?
What are you watching for?
Stephen Hansen (12:42):
Well, we're gonna have a look at, uh, there
was some NLRP3 data in obesityrecently, so I'm gonna have a
take a bit of a deeper dive intothat and kind of where things
stand and then, uh, who knows?
I'm sure there's plentyof directions that,
we can go from there.
So,
Jeff Cranmer (12:55):
thanks for that, Stephen.
I'm looking forward tothat piece for sure.
All right.
Enjoy your evening, suspect it'sdinner time for you right now.
Well, let's turn to Lauren.
Lauren, had the pleasure ofspeaking to Jim Wilson recently,
and, she wrote, about what hehas been up to since he left
(13:16):
Penn. And, you know, she foundFDA, has been trying to find
ways to ease the regulatorypath for ultra rare disease
drugs, VCs, uh, not, not reallytaking the bait just yet.
largely uninterestedin the space.
And so that sort of set thestage for, Jim Wilson as
(13:38):
he set out to develop andfund gene therapies for
ultra orphan indications.
Little more than a yearin, uh, the hurdles he
encountered, prompted himto, rethink the funding model
to keep his mission alive.
Lauren, what did you learn?
Lauren Martz (13:55):
Yeah, thanks Jeff.
So a few weeks ago we learnedthat Jim Wilson, who left his
longstanding position at Pennto found Gemma Therapeutics,
was launching a new companyfocused on AAV gene therapies
for ultra rare diseasescalled Rare Therapeutics.
So ultra rare diseases, werereally at the center of the
(14:16):
mission of Gemma, which launcheda year ago when he left Penn.
I spoke with Jim Wilsonabout, you know, why he was
launching this new companythat was focused on what I
thought the original companywas focused on, and he was
very transparent, as you said.
There was a lack of interestfrom the VCs that, he
approached in funding theultra orphan, programs that
(14:37):
he was trying to develop.
So the whole idea behindGemma was that the company
would license later stage genetherapies for ultra orphan
diseases that wouldn't requirevery much investment to get
to the first approvals, thenThe company would use the
Priority Review Vouchers andwhatever sales were generated
to fund future programs.
(14:58):
You know, this didrequire some VC funding,
especially at the beginning.
And, interest from VCsimply wasn't there.
that's, of course something thatwe've been observing when we've
been talking about gene therapydevelopment over the course
of this year and many yearsbefore that, you know, interest
in gene therapy in general isdeclining for various reasons.
Um.
There just isn't really aline of sight to how to make
(15:20):
these types of therapiesfor the rarest diseases,
something that, that peoplethink can be very profitable.
The outcome is that GemmaTherapeutics is sticking with
its earlier stage programs forthe less rare, rare diseases
in order to get VC backing.
And then the ultra rare programswere spun out into this new
company, Rare Therapeutics.
Steve Usdin (15:40):
How much of this is a consequence of the of sun
setting, of the Priority ReviewVoucher, and how important
would it be if the PriorityReview Voucher came back?
Lauren Martz (15:50):
So that was a core part of the original model.
you know, there is thisexpectation that those programs
when approved would get PriorityReview Vouchers that was just
built into the funding model.
And so without that, I thinkthat that is a big component to
why this may not have worked.
developing these ultra rareprograms really does depend
(16:11):
on the government, theFDA regulatory incentive.
So there were the PriorityReview Vouchers, which, you
know, we still have vouchers.
They're not as predictable.
They're not gonna be or theymay not be for these, these
types of indications aswe've seen
Steve Usdin (16:24):
they're, and they, they're, they call 'em vouchers.
They're not vouchers becausethey can't be transferred,
they can't be sold.
The, the key thing about thePriority Review Voucher wasn't
that it sped up the developmentprogram, which is what the new
Commissioner National PriorityVoucher is supposed to do.
The key thing about that wasthat they were, um, you know,
Willy Wonka's magic ticket.
You, you could, transfer themor you could sell them, for,
(16:46):
you know, north of a hundredmillion dollars usually.
that's a powerful incentive fordeveloping these kinds of drugs.
In the absence of that,it's gonna be a struggle to
see how companies are gonnabe able to come up with
the investment to do it.
Lauren Martz (16:58):
Exactly.
I think this is ademonstration of that.
And I think there are sortof other incentives that
this was depending on.
So there's also this platformtechnology designation, which
we have been seeing rollouts.
You know, there have beentwo companies at this
point that have receivedthis designation, but.
(17:18):
Again, that's somethingthat's unpredictable.
So the idea there is that ifyou have a therapy approved
based on an underlyingplatform technology here, it
would be the same AAV vector.
There would be fewerrequirements, fewer, as you
know, you don't have to repeatsome of the requirements,
and that would streamlinedevelopment and cut the costs.
And so again, that'ssomething, there's not a
ton of certainty around whenthat can be available and
(17:41):
if it will be available.
When I spoke with Jim Wilson,he also cited some potentially
more reliable incentives.
There's the Rare DiseaseEvidence Principles Program,
which is focused specificallyon the ultra rare diseases,
and that's where RareTherapeutics is focused.
So I think this is a storythat we'll continue to
(18:02):
follow as an example ofhow regulatory incentives
can impact development ofgene therapies for rare
and ultra rare diseases.
Steve Usdin (18:11):
And we're also gonna be seeing the
plausible mechanism pathway,at least that's what
it's been called to date.
Some kind of a, a new pathwaythat FDA is creating for ultra.
Rare diseases that's gonnabe announced, I think, uh,
probably this week, but ifnot this week, then next week.
Jeff Cranmer (18:28):
Okay, thanks for that, Lauren.
Lauren, specializes incovering, gene therapy new
modalities, and she'll stayon top of this space for us,
and you can read her piece atbiocenturypodcast.com and I'll
drop a link to the show notes.
And speaking of.
The show notes while you're,uh, checking those out.
(18:51):
Uh, don't forget to like andsubscribe BioCentury This W
eek and check out our sisterpodcast, The BioCentury Show.
Steve, you, uh, arelooking very dapper today.
You've got a greenscreen behind you.
What's, what's on your agenda?
Steve Usdin (19:05):
yeah, I, I dressed up just for the podcast so
people can hear me, uh, whatI I sound like in a suit.
No, I, I'm going to be doingan interview later this
afternoon with, former NIHdirector and former Head of
R&D at Sanofi, Elias Zerhouni.
Jeff Cranmer (19:19):
Alright.
I'm looking forward to that.
Yes, Simone did, uh, announcea new editorial policy where
one of us has to wear a suit.
every day.
So, uh,
Simone Fishburn (19:29):
to see how this plays out, you know?
Jeff Cranmer (19:31):
yeah, me, me too.
I mean, today, Eagles attire.
Big, big Monday night game.
But, uh, hey, we'regonna get back to Steve
and what's happening inWashington, right after this.
Alanna Farro (19:42):
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Jeff Cranmer (20:31):
And I have already begun recruiting,
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You can register now,to be a delegate.
take advantage ofthat early bird rate.
You'll wanna lock in yourschedule once JP Morgan happens.
we know how that is.
it's, uh, hold onto your hats.
Alright, uh, Steve, FDACommissioner, Marty Makary,
(20:54):
as you reported last week,had asked Richard Pazdur to
serve as CDER director in thewake of George Tidmarsh's we
talked about on that on lastweek's pod, so we won't need
to dwell on the things aroundthat, but you can check out
last week's pod, get caught up.
What is going on withleadership at FDA right now?
Steve Usdin (21:15):
Well, so here's what we know when
we're talking about CDER.
Um.
We know, and you know, as Imentioned last week of George
Tidmarsh is not coming back.
Yeah, FDA Commissioner Makaryasked Oncology Center of
Excellence Director RichardHHS Secretary Robert F. Kennedy
Jr., interviewed Pazdur.
And I think it's importantto point out that
this is unprecedented.
It's unprecedented foran HHS secretary to vet
(21:37):
an FDA center director.
But here's what I think, Ithink the job of the center
director has become politicized.
In the best of times, it's areally difficult job, and in
the current administration ithas become much more difficult.
Whoever takes the positionwill have to be aligned with
Kennedy's MAHA movement.
They're gonna have to bewilling to accept political
interference and routineregulatory decisions, and
(21:59):
they're gonna have to understandthat they may not last longer
than the current administration.
Previous CDER directors andCBER directors have had the
confidence that since they'recivil servants, that they will.
stay in the position for,a lengthy period of time.
I'm not convinced that that'sthe case now, and whoever comes
into the job is gonna have todeal with plummeting morale,
depleted staffing, and kindof toxic pandemic politics.
(22:22):
So it's gonna be tough to findsomebody, to do the job who
will do it with the same kindof, expertise and same kind
of excellence as, previousCDER e directors have done it.
And you can't really emphasizehow important for the biopharm
industry and for patients,the CDER director role is.
in many ways it's more importantthan the FDA Commissioner
Simone Fishburn (22:46):
So Steve, Obviously there was Janet
Woodcock for a very long time.
Then Patrizia Cavazzoni Janetwas there for so long, Dr.
Woodcock, that I'm not actuallysure to be honest, Steve, I
don't remember who was beforeher, I'm sort of wondering
whether there isn't scope.
I mean, if there were somebodygood and competent, is there not
scope for somebody to think, I,I have to survive one year, two
(23:10):
year, three years, and this,how, how much does somebody
think about just survivalin a role like that versus
walking in with an agenda?
I'm really gonna do,you know, big things.
think that's one of my concernsis the risk aversion that
people at FDA will have,despite many things that.
Makary is talking aboutin terms of making drug
(23:31):
development easier, thereseems to be a concern about
sticking your head out.
Steve Usdin (23:37):
Yeah.
So look, I think that whoevercomes into this position is
gonna have to come into theposition realizing, all the
things that I mentioned earlierand, um, they're gonna have
to be comfortable with that.
They're gonna have to be,it's gonna have to be somebody
who's comfortable in a morepoliticized environment, in
an environment where the HHSsecretary can decide that
(23:57):
Tylenol, is no longer safe for,pregnant women or for, children,
without any kind of processaround it that is, is normal or
that leucovorin is, uh, is aneffective treatment for, autism.
There's gonna be moreand more of those things.
So whoever comes into theposition is gonna have to be.
Comfortable dealingwith, that environment?
(24:17):
What does that mean?
Yeah.
One of the things that we'regoing to see, regardless
of who's the CDER directorgoing forward is, we're gonna
see, more risk aversion.
we're going to see lesspredictability, and
we're gonna see moreerratic decision making.
And by erratic decision making,I mean decisions that are made.
(24:38):
Then there's political blowbackand FDA changing its mind.
There have been severalinstances of that already in
this administration, and Ithink, we're going to see more.
There's quite a bit ofconcern about some of the
complete response lettersthat have been issued in
recent weeks and months.
The patient groups and thecompanies and the investors
(24:59):
are organizing politicalresponses to try to pressure,
FDA to reverse the completeresponses or to define paths
forward, to get those, some ofthose drugs out to patients.
So I think that's the kind ofthing that we're gonna see.
And you know, as I, I wrotethis big piece last week,
kind of trying to lookforward at what FDA is going
(25:19):
to be like in the future.
And those were some ofthe themes, you know, risk
aversion, erratic decisionmaking, less predictability
at the same time, There's, areally, dedicated staff there.
in many cases, people whohave been there for a decade
or more who are going to dotheir utmost to keep the ship.
(25:39):
You know, going to keep theship afloat and, and, and
going in the right direction.
So there are gonna be a lot ofthings that are gonna happen,
um, relationships and, um,interactions, engagements
between companies, sponsorsand FDA that are going to move
forward just as they shouldand as they have in the past.
The problem, I think, amongother problems is that it's
(26:01):
unpredictable when thingswill, blow off course.
You know, everything.
It's gonna be goingalong just as you expect.
And then for some reason,things aren't going along the
way that you expect anymore.
that's gotta be in theback of, everybody's mind.
Jeff Cranmer (26:16):
Alright, thanks for that update, Steve.
yeah, definitely, uh, muchgratitude to those people.
keeping the light onmoving, applications,
giving companies advice.
we need it.
for those of you doingthat, hang in there.
Okay.
Well, don't forget to turn intoThe BioCentury Show this week.
(26:37):
we'll also have another specialpod for you, Simone and Josh.
we're up in Boston at theVenture Café Cambridge last
week, a really good podcastfocused on, all things Korea.
one can only hope thatJosh has finally seen,
K-pop demon hunters.
I know Simone, uh,lives it basically.
(26:59):
So.
on my to-do list.
It is on my to-do list.
I have to tell you, myhusband cannot believe it is
on my to-do list, but it is.
Just as soon as I finishShogun, I gotta
finish Shogun, first.
Oh, yeah.
Yeah.
I
Simone Fishburn (27:11):
Yeah.
Yeah.
Jeff Cranmer (27:13):
Yeah.
All right.
All right.
Well, you got some plane ridesahead of you, so hopefully
you can make some, uh, someheadway on both fronts.
Okay.
thanks for tuning in.
We will catch you for ourregular pod, next week.
Kendall Square Orchestraprovides the music for
BioCentury's Podcasts.
Tickets are now on sale forthe Group's eighth season.
(27:35):
The group connects scienceand technology professionals
and other members of theGreater Boston community
to collaborate innovate andInspire through music, while
supporting causes relatedto healthcare and education.
Eric Pierce (27:48):
BioCentury would like to thank Voyager
Therapeutics for supporting theBioCentury This Week podcast.
To learn more aboutVoyager's programs advancing
transformative medicines forneurological diseases, visit
voyagertherapeutics.com.
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