July 29, 2024 • 31 mins
Steve Uden, co-founder and CEO of RallyBio, shares his insights about leadership in biopharma and how Rallybio is working to to profoundly change the odds for patients living with rare diseases.
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John Simboli (00:00):
Today I'm speaking with Steve Uden, CEO of
Rallybio, headquartered in NewHaven. Welcome to BioBoss.
Steve.
Steve Uden (00:09):
Thanks, John. It's great to join you. I'm really
looking forward to theconversation.
John Simboli (00:12):
Steve, what led to your role as co-founder and CEO
at Rallybio?
Steve Uden (00:17):
Like so many things in life, it's a mixture of the
poetic and the prosaic, really.
On the prosaic side, I wasworking with Martin Mackay, the
other co-founder and Jeff fryerat Alexion, and Alexion went
through some big changes. So werealized it was you know, we
were, time to go and dosomething different. So that's
the sort of the prosaic. Youknow, so often in life
circumstances sort of move youin a particular direction. The
(00:38):
other side of that coin is I'vesort of made a point in my
career, in my life, quitefrankly, of always taking on a
new challenge, I've had the goodfortune to work right across the
entire spectrum of the R&D spacefor everything from sort of
discovery research all the waythrough to setting up Medical
Affairs, I've worked all aroundthe world. As you know, I've
(01:00):
worked in Japan, I've worked inthe United States. So to some
extent, this was the next bigchallenge, create your own
company and build it in your ownvision. But I think everybody in
the company, actually, becausemany of us were from Alexion,
had been bitten by this idea oftreating rare disease. So you
know, a bunch of things all cametogether, you know,
circumstances that were makingme think where to go next, a
desire to try a new challengeevery time and then there's sort
(01:22):
of interest and passion aroundrare disease and the opportunity
to make huge differences forpatients for whom there are no
therapies at the moment. Allsort of linking back to my
origins as a physician, andgoing to medical school, because
I wanted to sort of improvepeople's health.
John Simboli (01:40):
What were you hoping to achieve at Rallybio
that you might not have beenable to do, really, anyplace
else, just because of thefactors of what you were looking
to create?
Steve Uden (01:48):
I mean, fundamentally, you know, you're
creating your own company fromthe ground up. And it's sort of
an opportunity to sort of bringall of that together, the best
of drug development, the best,you know, the best therapies for
patients, the best group ofpeople, create the right
culture, and do it, you know,from the ground up. And so that
was really what the attractionwas, to be able to apply all of
(02:11):
this experience that I have, andMartin and the other colleagues
who joined us to really sort ofthen create a company that was
going to be passionate aboutgreat science, great drugs,
doing things the right way.
John Simboli (02:23):
Did you and Martin and Jeff, at any point, say, we
have an idea for a reallyinteresting approach, perhaps
we'll find an existing pharmacompany that will allow us to
build this within? Or did youknow, from the beginning, it had
to be built from scratch?
Steve Uden (02:36):
The issue is always the culture of the place you're
going to go and the sort ofpolitical dynamics, I think the
idea that, you know, you couldgo in and change anything that's
. . . and to create what we'vecreated here is, would just
never happen. But I've neverbeen naive enough to go in and
think you can change, you know,50-60 years of what's gone
(02:59):
before.
John Simboli (03:00):
When I talk with people about the work we do in
biopharma, what people oftenjump to is Big Pharma, and
selling a product, as opposed tothe idea of developing an idea
and the science that leads tothat. So in one, they kind of
picture someone in office and inanother one, it may be hard to
(03:21):
picture exactly what a CEO does,and it may be hard (of a
biopharma company), it may behard to explain to others, "What
do you do all day?"
Steve Uden (03:29):
I think if I'm explaining to somebody for the
first time, as you say, thefirst thing is you got to really
go right back and talk aboutwhat is different between
biopharma and pharmaceuticals. Ithink, you know, most people
have a vague idea of Pfizer orBristol Myers Squibb. But even
though they think of themusually as sort of large
marketing organizations and youoften have to go right back and
say, Look, you know, the drugscome from somewhere. And despite
(03:51):
what the press would have youbelieve, that the vast majority
of drugs are invented incompanies. But they're not all
invented in big companies. Veryoften, it's small groups of
people, like Rallybio, who takegreat ideas from other
scientists and put them togetherinto a plan and a package that
people find interesting enoughthat they'll invest in you. So
(04:14):
you know, what do I do all daylong? I work with our team of
people. If we're not thinkingabout the science and the
minute-by-minute stuff to movethe program forward, we're
thinking about how can we raisemoney to keep doing that? What
is the right company strategy?
How do we sort of work well withour stakeholders, that's
obviously the board, obviouslyinvestors or potential
(04:35):
investors, obviously, thescientists and the academics who
are interested in our space.
Then we've got all of ourpartners who help us get the
work done. I mean, you know,these clinical trials, employ
armies of people to actuallymake them happen. We don't
employ them in Rallybio, we usethird parties, so you know,
you're working with those. So alot of my job is really just
(04:57):
sort of stakeholderinteractions, thinking about the
company's strategy, making surethat the teams have got
everything they need to get thejob done. We're really lucky,
you know, we've got a verymature group of people. So very
rarely, if ever, am I having todeal with sort of human
interactions, Fred doesn't geton with Mary. But, you know,
we've been very careful aboutwho we chose. And we're very
(05:18):
privileged in leading a veryexperienced team. Many of us
have worked together in thepast. But it's all around, you
know, finding a way to takegreat science, turn it into a
drug that could potentiallychange the world.
John Simboli (05:29):
What have you found about your management
approach or your way that youdeal with people that works for
you?
Steve Uden (05:34):
I think number one is being very clear about what
it is that we set out toachieve. I think that this sort
of concept of how, you know,selection and maintenance of the
aim, as they say, in themilitary, what is it you're
actually trying to achieve, andlet's get everybody, make that
really, really clear. I thinkthat's the most important thing
that one can do as a leader,which is set the goal, set the
vision, set the direction ofwhere you want to go, then
(05:56):
everyone's aligned. The secondthing is, I think it's important
that you actually know yourpeople. I mean, genuinely know
them, you know, what sort ofpeople are they? How do they
like to work? Are they, youknow, extroverted? Not through
sort of Myers Briggs, just bysort of human interaction. What
about their families? You know,what do they do when they're not
at work? What what is it thatsort of makes them tick, I think
(06:18):
is also important. I prefer towork by setting goals, and then
sort of leaving people to get onwith the job in the way that
they think is best. I trustpeople but then make sure that I
do check in with them on aregular basis. One of the habits
I've got into over the years isI tend to meet with everybody
(06:38):
who reports to me directly oneon one. But I do think it's good
to check in, partly, to reallyunderstand the work that they're
doing, partly to reassure them,that you respect them, and want
to work with them. And just tomake sure that, you know, there
aren't course correctionsneeded, or, you know, people are
over-engineering something ormissing the point. So, close
interaction with the team isimportant, I think. So those are
(07:00):
the fundamentals for me.
John Simboli (07:01):
As you recall, as a young person, eight, nine,
ten, whatever the age may be,your interests, how you thought
your life might go, and perhapswhat you perceived your parents
thought was in your future. Whatdid you see, as you recall it,
and how does it connect, if atall, to your professional life?
Steve Uden (07:17):
Even by that age, looking back, it was beginning
to become clear where my careerwould go. So I'd already got
sort of an interest in science,you know, as best as one can
have as an eight year old, but Istill love when we did, like,
you know, general science.
Secondly, I wasn't I wasn't aweakly child, I had a couple of
sort of health issues, minorhealth issues that required me
to go into hospital and maybe goto the doctor a bit more often
(07:39):
than your average sort of eight,nine, ten year olds, so sort of
medicine began to intrigue mejust working with, with other
physicians. And then my fatherwas relatively older, he was of
the war generation. So he'd beenan officer and sort of risen up
through the ranks. So about thatage, he was the founding
(08:00):
headmaster, school principal, ofa brand new school in London,
where I was growing up. So Isort of saw him as, he was a
leader, a great leader, a greatmanager. So you know, those
those three factors all comingtogether–an interest in science,
even at that young age, I'dinteracted with the healthcare
system and found it really kindof inspirational in a kind of a
(08:20):
way and then having a fatherwho, you know, was clearly a
leader in his own right, andfascinated by what he'd done
during his life. And here weare, you know, 50-60 years
later, and it's all sort of cometogether.
John Simboli (08:35):
When people say, Steve, who is Rallybio, how do
you like to answer that?
Steve Uden (08:40):
I like to answer by saying that we are a biopharma
company, our mission is to takedevastating diseases and
devastate them. We arepassionate about working on
therapeutics that in one way oranother, will transform people's
lives. We're what's known as aportfolio company, we're built
around the team of people ratherthan the platform technology.
(09:01):
And you're probably aware, thereare sort of two flavors of
biotech, there's the platform,gene therapy, antibodies, what
have you. And then there's theportfolio where you build a
strong team and then bring ideasin. So that's our business
model. There's about 25 of us,all of whom have had an amazing
track record. And with thatstrong group of people, we were
able to attract the financingand then bring in the programs
(09:23):
on which we're working. So we'rea portfolio company, we're
focused on rare disease, ourmantra is devastating diseases
and devastate them. And that canbe anything from, if you like,
our lead program where thevision is to eliminate a
disease, or a preventativeapproach, all the way through to
our programs in complement wherewe are wanting to have a
therapeutic that will not be atall burdensome for patients, and
(09:47):
enable us to apply that sort ofpharmacology to a vast range of
diseases which currently, wherewe know complement almost
certainly has a role butcurrently, there's no drugs.
John Simboli (09:56):
In the time that I've known you, I've known the
work that you've done in termsof rare disease and complement
and many other things as well.
But I want to ask you about therare disease part of it. When I
first worked for a company thatwas focused on rare disease,
working with Alexion, it was sodifferent than anything I've
ever experienced because of theproximity of the science team to
the people that they werehelping. I can't think of a
(10:18):
better way to say it thanproximity. But at what point in
your training and your workexperience did you first
encounter the rare diseasecomponent? And and how did it
affect you?
Steve Uden (10:30):
Probably my first foray into rare disease in its
broadest sense, was just priorto working at Alexion, when I
was working at NovartisOncology, and I was there at the
time that, you know, this sortof patient-specific therapy was
now really beginning to takeoff, that you're not just sort
(10:51):
of blasting patients withchemotherapy, but you're finding
the subtle mutation and tryingto, alter how small subgroup of
patients interact. But it wasprobably, in a more traditional
sense, which is the sort ofnon-oncological, it was my time
at Alexion. And, as you say, youcan see the impact much more
(11:12):
clearly. One of the theinteresting things is, of
course, that, typically, yourunderstanding of the disease
itself is much greater, because,typically, rare diseases are due
to discrete genetic differences.
And if you can fix that, you canthen trace back from that
genetic component, you can traceall the way back through to
(11:33):
describe and understand thepathology etc. Whereas when
you're dealing with these moresort of public health type
problems, diabetes, what haveyou, it is multifactorial, and
what might have made youdiabetic could be very different
from me and from the guy downthe street. So it started at
Novartis Oncology, seeing theway that understanding genetics
(11:53):
could really sort of helpsimplify, if you like, the the
pharmacological approach, thenat Alexion, on how to take it to
the next degree. You can get toclear go/no, go pretty quickly.
Now, having said that, with ourlead program, it's a different
approach to prevention. Sothat's quite a monster. But we
once we get into patients, Ithink we're going to know pretty
quickly whether or not the drugworks. The issue, of course, is
(12:16):
bearing in mind that we're goingto be treating pregnant mothers.
The journey there is not asquick, simply because there's no
room for error. Not that there'sany room for error when you're
developing a drug, but with ahealthy mum, there's zero.
John Simboli (12:30):
Steve, can tell me something about Rallybio's lead
drug candidates and why, whatthe need is?
Steve Uden (12:36):
Our lead program is an approach to prevent something
called fetal and neonatalalloimmune thrombocytopenia,
FNAIT. Now, what FNAIT is, it'sdue to a genetic mismatch
between a protein on the surfaceof the mother's platelet and a
protein on the surface of herfetal platelet. There's an
(13:00):
antigen called human plateletantigen, while we all have it on
our platelets, in a small numberof people there's a single amino
acid change. The protein stillworks, but there's a shape
change, hence it'simmunologically active. So if
the mom has this rare mutation,if at any time, but the baby's
platelets get into acirculation, bleeds from the
(13:21):
baby into the mom are quitefrequent during pregnancy, and
certainly at delivery. And if atany time that happens, the
mother's immune system willrecognize these platelets as
foreign. They've got the normalprotein, she's got this slightly
abnormal protein, her plateletshere will make antibodies
against this protein. Antibodiesreadily cross the placenta so
(13:42):
now they're these antibodiesflood into the baby and destroy
the platelets. The antibody nowfinds the platelets inside the
fetus, but the level of theantibodies can be so high that
the destruction of the plateletsoverwhelms the ability of the
little fetal bone marrow toreplace the platelets. Now,
although the baby is all wrappedup inside the mother's womb, if
(14:04):
there's no platelets, thesmallest bleed will just bleed
and bleed and bleed. So henceyou get intracranial hemorrhage.
It's the most common cause ofintracranial hemorrhage. It can
cause miscarriage, majorproblems with delivery, etc. And
of course, because it's animmunological phenomenon, once
the mum's mounted theseantibodies, all future
pregnancies will be at risk, notjust that pregnancy, but the
(14:26):
next one and the one after that.
Our approach is going to be toprevent this. In other words,
identify the mums where thismismatch occurs, and treat them
during pregnancy to inhibit themhaving this immune response.
Now, the good news is thatthere's a much more prevalent
red blood cell mismatch. That'ssomething called Rhesus disease
(14:47):
of the newborn. Now many peoplehave never heard of this. Now
when I was a medical studentthis was the big breakthrough
that had occurred in the decadebefore I went to medical school.
If you think about your bloodgroup, this positive-negative
thing is due to something calledRhesus. Now Rhesus negativity is
very common, 17% of the world.
(15:09):
So this mismatch between redblood cells was quite prevalent
back in the day. Now instead ofcausing no platelets, it would
destroy the red blood cells, sothe baby would be
catastrophically anemic insidethe mother and go into heart
failure. Now, the interestingthing is that we speak to
people, even people of ourgeneration, John, they've never
heard of this syndrome. It wasthe scourge of obstetrics up
(15:31):
until the 50s and 60s, and thetreatment approach is exactly
the same as we're doing. Inother words, check the mum for
risk when she first turns up, ifshe's at risk, give a small dose
of an antibody during pregnancyand delivery to prevent the
immune reaction and get rid ofthe disease. Now, the difference
is that this mutation onplatelet is much rarer than the
(15:54):
Rhesus red blood cell platelet.
So, it's only recently that thebiology was worked out. But our
lead program, so to get rightthe way back, in our lead
program is to identify mums atrisk of causing this
catastrophic loss of plateletsin their fetus, Identify early
during pregnancy, treat the mumduring the pregnancy with an
(16:14):
incredibly small dose of anantibody—a naturally occurring
antibody—prevent her from havingan immune reaction. So the baby
comes out healthy, she hasn'thad an immune response. So the
next pregnancy will be fine, etcetera. I can think of nothing
more inspiring, quite frankly,than, if this works, to have a
therapy that tackles acatastrophic rare disease, but
(16:36):
it doesn't tackle it by treatingit. It tackles it by just
preventing it from everhappening. And my vision for the
future is that 30 years fromnow, people will be on a
podcast, and they'll be saying,well, there's this thing called
FNAIT, which has completelydisappeared. So I'll have to
tell you what it is, because,you know, when I was a medical
student, this was the terriblething. And now all due to this
(16:58):
company Rallybio, it'sdisappeared. So that's what it
is, an approach to prevent arare disease, that if don't
prevent it, can end up with achild that grows into an adult
with lifelong disability. Backto your earlier point around
you're much more intimate withthe patients in rare disease
(17:19):
than other diseases, there's amother who lives on Long Island,
who has visited the company whohad a child with FNAIT. We've
met the patient support group,this is a mum, who's had a
grandmother who had a familywith this syndrome. So, you get
to know these people and justhear the stories. It's really
(17:41):
quite awful. So that's our leadprogram. If it works, we will
actually eradicate this disease.
Can't wait.
John Simboli (17:49):
How do your choices about the pipeline
express your vision for thecompany?
Steve Uden (17:52):
Two things drove the pipeline. Number one is would
the therapy have atransformative effect, the
potential for a totallytransformative effect in a rare
disease? And secondly, is thescience that underpins the idea
strong? We've looked at whenlooked at, it must be 1000s of
potential opportunities. Andthey often failed most, usually,
(18:15):
most typically, because thescience was pretty weak, one way
or another. So with our leadprogram, we found it in a very
small, what I would callacademic startup. It was in a
company based of all places inTromso in Norway. The mutation
that causes this plateletproblem is, the further north
you go, the more prevalent. Sothere is nowhere further north
(18:39):
than Tromso. So that's probablywhy. But great academics, they
worked out the fundamentalbiology, they've worked out the
approach, how you could preventit, but they didn't know how to
move a drug forward and do thetesting to be confident, as one
can be, that you can treatmothers. That's where we stepped
in, we brought our expertise tobear to say right, take it to
(19:01):
the next step, because then wecan work out how you can do the
safety testing and create animalmodels, how we can work with
investigators to be confidentthat we can take this into
mothers, etc. If I look at thecomplement assets, great drugs,
I mean, if this drug works, itwill mean the patient can treat
themselves with a smallinjection, like giving
themselves an insulin shot oncea week. Low cost of goods. So
(19:24):
you know, you could explore theentire gamut of rare disease.
The problem had been that thedrug was produced in E. coli,
like a lot of biologics, butthere'd been some sort of
problem with the manufacturingthat was causing major side
effects. But everybody thoughtit was the drug itself. It
wasn't. it turned out itimpurities that were leaking
(19:45):
from the manufacturing processinto the drug product. And we
were able to work with thecompany that had the original
technology to fix that. Youknow, our approach in
hypophosphatasia. We looked atsome some work that had been
done in what's called a doubleknockout mouse and we realized
that maybe you could treat thiswith a pill once a day.
John Simboli (20:03):
When people hear the Rallybio story, what do they
get right? What do they getwrong? How do you help them get
onto the track that as you seethe company?
Steve Uden (20:11):
I think early in the days of the Rallybio story, this
whole concept of this FNAIT wasvery difficult for people to get
their heads around—prevention.
What you're going to treatpregnant mothers with? Like many
rare diseases, no one had everheard of it. Now, through a lot
of hard work, we've educatedvast numbers of stakeholders in
(20:31):
what is FNAIT. And so,increasingly, people come to us
knowing what we're trying to do.
The next bit of the story that'stough to tell is that these are
pregnant mums, we've got to bevery step-wise. We're having to
be, for obvious reasons, verymethodical, I think most of them
pretty quickly get to understandthat this is a really
experienced team of people. Oneof my colleagues, Amanda, our
(20:54):
Head of Business Development,she was at Bio, the big
partnering meeting. And she wastalking about our portfolio to
many companies, who might wantto partner with us, and feedback
from big players, big, crediblepharma companies, and gosh, the
science that comes out of yourteam is the best we've ever
(21:15):
seen. That's one thing, theypretty quickly realized that
this is a team of people whoreally knows what it's doing.
Early this year, J&J got into acollaboration with us. We're
trying to prevent the mum everhaving this immune response,
their approach will be to findthe mums who sadly had this
immune response, and then tryand damp down, in future
(21:36):
pregnancies, the impact on thefetus. Totally synergistic
approaches. I think, for me, thebest bit of news was, look, you
know, we're not the only peopleworrying about this, there's
another big credible player outthere. We're not in competition
with them, we are workingtogether in a collaboration to
cover the whole waterfront. Incomplement, there's a lot of
people's playing in the space.
Explaining why we're going to dosomething very, very different.
(21:59):
The good bit is they veryquickly get the science we're
doing is first class and theteam really knows what he's
doing.
John Simboli (22:07):
The word partner can have many different meanings
for a biopharma company likeRallybio, but let me just ask,
broadly, who is a good partnerfor Ralybio?
Steve Uden (22:16):
If I'm thinking about investigators, and people
are working with us on ourclinical trials, these are
obstetricians who are passionateabout making a big difference in
their practice. And then amongstthose, obviously, some people
have really given their life toFNAIT. I was on a call with an
obstetrician a few weeks ago,who said, I've divided my career
(22:39):
into three epochs, or decades,I'm in the final epoch. And what
I want to do is work with youguys to eliminate FNAIT, it has
been the scourge of my practice.
So people who are really keen toget involved in research. If I
think about investors, it's gotto be people who really
understand FNAIT and areprepared to be in for the long
(23:00):
game. And then we've got all ofour partners, because to get the
work done, we need a lot of youknow, CROs and CMOS. So again,
we take great care to selectpeople both their scientific
prowess and the quality of thework that they do. So it sort of
depends on the stakeholder, butfundamentally good science and
good quality underpinningeverything they want to do,
(23:21):
we'll get on with it very, verywell.
John Simboli (23:24):
Steve can you bring me up to date on where the
progress is with your lead assetand what you anticipate in the
coming weeks or months?
Steve Uden (23:33):
I think we've done everything, we need to get ready
to start phase two, whetherthat's talking to regulators to
agree on the package of datathat would satisfy them. We are
now getting ready to start thephase two study. We're going to
start screening mothers for ourphase two. Now, screening is the
key word because earlier on, wetalked about prevention. So if
you're in prevention, whatyou'll need to be doing is
(23:55):
testing. It will become standardpractice as it is today. You
know, when a mum goes to thedoctor, the first time and says
I'm pregnant, the doctor runs aseries of blood tests. Is she
diabetic, is she Rhesusnegative, what's her blood
group, etc. So the first thingwill be to screen all of the
mums going to the doctor to seewhether they have this mutation,
and whether they are at risk ofcausing this problem in the
(24:16):
baby. Now, the goal is by theend of this year, all of the
centers that are going to beinvolved in the studyhave
started to screen mums to find amum who may have this mutation,
who we could then treat to tryand prevent her from having this
immune response. I think it'sgoing to de-risk three big
things for us. Number one is theregulatory risk. So that's the
(24:39):
first bit of de-risking. And thenext bit of de-risking, of
course, will be, will motherstake part in a clinical trial?
We spent a lot of time talkingto investigators and doctors who
look after patients and it'sbeen a consistent feedback that
once a mom knows that the babyis at risk, they will do
whatever it takes, but we needto de risk that. And then the
third thing, how does pregnancyimpact the pharmacokinetics. We
(25:03):
all know that over the ninemonths of pregnancy, the mom's
blood volume goes up by 40%, hermetabolism changes, etc.. So
will the dose that worked wellin the phase 1 proof of concept
studies provide adequate druglevel when the blood volume has
gone up 40% Or will you have toadjust the dose for the mom
during the pregnancy or, if atall, et
John Simboli (25:26):
How did Rallybio choose to start off in New
Haven?
Steve Uden (25:31):
Many of us were at Alexion. And many of the people
at Alexion had worked in one orother of the big pharma
companies that had in theirheyday, major research
facilities in and aroundsouthern Connecticut. Pfizer up
in Groton, Bayer, in West Haven,BMS at Wallingford, and of
(25:53):
course, stillBoehringer-Ingleheim. Now, the
good news is two things, thereis a sort of nascent
biotechnology hub here. There isa commitment to try and make
Connecticut a place for biotech.
There's a huge pool of talent,there's a huge number of people
here who are very experiencedand know the space well. So it
was sort of we were here, it's agreat place to be, the state is
(26:13):
trying to support us. Andthere's just so much talent that
we could tap into who waspassionate about rare disease.
There is a benefit, I think, inbeing able to just walk across
the green to a lab in Yale or upto Science Park.
John Simboli (26:30):
What areas of thought leadership regarding the
future of biopharma arecurrently the most engaging for
you personally?
Steve Uden (26:37):
I think there are two actually, they're almost at
the sort of opposite ends of thespectrum. The first is how will
artificial intelligence changewhat we do? And how can it be
best employed? There are someobvious possibilities around
helping out with a drugdiscovery process. In fact, use
of computer models, andcomputational chemistry has
(26:59):
actually been around for quite along time, particularly in
Connecticut. But will the impactbe as revolutionary as people
predict? Or will it beincremental? Or, would it not
make a huge difference? Andwe've been through a number of
these big, this is going tochange the face of our work,
whether it was high throughputscreening, or now we've got the
(27:20):
human genome and what has tendedto happen is they're all
incremental, rather thanrevolutionary. And in fact, one
of our projects, this pill totreat hypophosphatasia, is in
collaboration with a companythat has for about the last five
or six years been usingartificial intelligence to them
in medicinal chemistry. Sothat's one end, AI, is how much
(27:41):
of a there is there there? Theother end actually is sustaining
our industry. How are we goingto train, develop, educate the
next group of biopharma leadersand innovators? I didn't know it
at the time, but I had the hugegood fortune and luck to start
my career at Pfizer. I mean, notonly was it, and it still is, a
(28:05):
great company, but it was justsuch a great place to learn the
ropes of drug development andhow the industry works and
interact with colleagues fromall different fields. If you go
straight from academia into asmall company, you're never
going to get that experience.
And how do we prepare the nextgeneration of leaders? And I
think people sort of despai,well, you know, you can't do it
(28:28):
working hybridly. I sort ofapproach it differently. Our
challenge is to make it work,bearing in mind that the future
of work could well be hybrid. Sowe're not always going to be
able to sort of stand by thewater cooler or sit somebody on
your knee and sort of teach themfrom the master. So the question
is, how can we do that? But I doworry about that, because it's
(28:49):
such a great industry, greatwork that we do. How are we
going to make sure the nextgeneration is best prepared to
do that?
John Simboli (28:57):
Steve, thanks for speaking with me today.
Steve Uden (28:59):
Quite searching questions, John. It's quite nice
to sit back and actually reflecton how one got here in the first
place. I hope some people findit interesting. I've certainly
really enjoyed talking to you.
Today I'm speaking with Steve Uden, CEO of
Rallybio, headquartered in NewHaven. Welcome to BioBoss.
Steve.
Steve Uden (00:09):
Thanks, John. It's great to join you. I'm really
looking forward to theconversation.
John Simboli (00:12):
Steve, what led to your role as co-founder and CEO
at Rallybio?
Steve Uden (00:17):
Like so many things in life, it's a mixture of the
poetic and the prosaic, really.
On the prosaic side, I wasworking with Martin Mackay, the
other co-founder and Jeff fryerat Alexion, and Alexion went
through some big changes. So werealized it was you know, we
were, time to go and dosomething different. So that's
the sort of the prosaic. Youknow, so often in life
circumstances sort of move youin a particular direction. The
(00:38):
other side of that coin is I'vesort of made a point in my
career, in my life, quitefrankly, of always taking on a
new challenge, I've had the goodfortune to work right across the
entire spectrum of the R&D spacefor everything from sort of
discovery research all the waythrough to setting up Medical
Affairs, I've worked all aroundthe world. As you know, I've
(01:00):
worked in Japan, I've worked inthe United States. So to some
extent, this was the next bigchallenge, create your own
company and build it in your ownvision. But I think everybody in
the company, actually, becausemany of us were from Alexion,
had been bitten by this idea oftreating rare disease. So you
know, a bunch of things all cametogether, you know,
circumstances that were makingme think where to go next, a
desire to try a new challengeevery time and then there's sort
(01:22):
of interest and passion aroundrare disease and the opportunity
to make huge differences forpatients for whom there are no
therapies at the moment. Allsort of linking back to my
origins as a physician, andgoing to medical school, because
I wanted to sort of improvepeople's health.
John Simboli (01:40):
What were you hoping to achieve at Rallybio
that you might not have beenable to do, really, anyplace
else, just because of thefactors of what you were looking
to create?
Steve Uden (01:48):
I mean, fundamentally, you know, you're
creating your own company fromthe ground up. And it's sort of
an opportunity to sort of bringall of that together, the best
of drug development, the best,you know, the best therapies for
patients, the best group ofpeople, create the right
culture, and do it, you know,from the ground up. And so that
was really what the attractionwas, to be able to apply all of
(02:11):
this experience that I have, andMartin and the other colleagues
who joined us to really sort ofthen create a company that was
going to be passionate aboutgreat science, great drugs,
doing things the right way.
John Simboli (02:23):
Did you and Martin and Jeff, at any point, say, we
have an idea for a reallyinteresting approach, perhaps
we'll find an existing pharmacompany that will allow us to
build this within? Or did youknow, from the beginning, it had
to be built from scratch?
Steve Uden (02:36):
The issue is always the culture of the place you're
going to go and the sort ofpolitical dynamics, I think the
idea that, you know, you couldgo in and change anything that's
. . . and to create what we'vecreated here is, would just
never happen. But I've neverbeen naive enough to go in and
think you can change, you know,50-60 years of what's gone
(02:59):
before.
John Simboli (03:00):
When I talk with people about the work we do in
biopharma, what people oftenjump to is Big Pharma, and
selling a product, as opposed tothe idea of developing an idea
and the science that leads tothat. So in one, they kind of
picture someone in office and inanother one, it may be hard to
(03:21):
picture exactly what a CEO does,and it may be hard (of a
biopharma company), it may behard to explain to others, "What
do you do all day?"
Steve Uden (03:29):
I think if I'm explaining to somebody for the
first time, as you say, thefirst thing is you got to really
go right back and talk aboutwhat is different between
biopharma and pharmaceuticals. Ithink, you know, most people
have a vague idea of Pfizer orBristol Myers Squibb. But even
though they think of themusually as sort of large
marketing organizations and youoften have to go right back and
say, Look, you know, the drugscome from somewhere. And despite
(03:51):
what the press would have youbelieve, that the vast majority
of drugs are invented incompanies. But they're not all
invented in big companies. Veryoften, it's small groups of
people, like Rallybio, who takegreat ideas from other
scientists and put them togetherinto a plan and a package that
people find interesting enoughthat they'll invest in you. So
(04:14):
you know, what do I do all daylong? I work with our team of
people. If we're not thinkingabout the science and the
minute-by-minute stuff to movethe program forward, we're
thinking about how can we raisemoney to keep doing that? What
is the right company strategy?
How do we sort of work well withour stakeholders, that's
obviously the board, obviouslyinvestors or potential
(04:35):
investors, obviously, thescientists and the academics who
are interested in our space.
Then we've got all of ourpartners who help us get the
work done. I mean, you know,these clinical trials, employ
armies of people to actuallymake them happen. We don't
employ them in Rallybio, we usethird parties, so you know,
you're working with those. So alot of my job is really just
(04:57):
sort of stakeholderinteractions, thinking about the
company's strategy, making surethat the teams have got
everything they need to get thejob done. We're really lucky,
you know, we've got a verymature group of people. So very
rarely, if ever, am I having todeal with sort of human
interactions, Fred doesn't geton with Mary. But, you know,
we've been very careful aboutwho we chose. And we're very
(05:18):
privileged in leading a veryexperienced team. Many of us
have worked together in thepast. But it's all around, you
know, finding a way to takegreat science, turn it into a
drug that could potentiallychange the world.
John Simboli (05:29):
What have you found about your management
approach or your way that youdeal with people that works for
you?
Steve Uden (05:34):
I think number one is being very clear about what
it is that we set out toachieve. I think that this sort
of concept of how, you know,selection and maintenance of the
aim, as they say, in themilitary, what is it you're
actually trying to achieve, andlet's get everybody, make that
really, really clear. I thinkthat's the most important thing
that one can do as a leader,which is set the goal, set the
vision, set the direction ofwhere you want to go, then
(05:56):
everyone's aligned. The secondthing is, I think it's important
that you actually know yourpeople. I mean, genuinely know
them, you know, what sort ofpeople are they? How do they
like to work? Are they, youknow, extroverted? Not through
sort of Myers Briggs, just bysort of human interaction. What
about their families? You know,what do they do when they're not
at work? What what is it thatsort of makes them tick, I think
(06:18):
is also important. I prefer towork by setting goals, and then
sort of leaving people to get onwith the job in the way that
they think is best. I trustpeople but then make sure that I
do check in with them on aregular basis. One of the habits
I've got into over the years isI tend to meet with everybody
(06:38):
who reports to me directly oneon one. But I do think it's good
to check in, partly, to reallyunderstand the work that they're
doing, partly to reassure them,that you respect them, and want
to work with them. And just tomake sure that, you know, there
aren't course correctionsneeded, or, you know, people are
over-engineering something ormissing the point. So, close
interaction with the team isimportant, I think. So those are
(07:00):
the fundamentals for me.
John Simboli (07:01):
As you recall, as a young person, eight, nine,
ten, whatever the age may be,your interests, how you thought
your life might go, and perhapswhat you perceived your parents
thought was in your future. Whatdid you see, as you recall it,
and how does it connect, if atall, to your professional life?
Steve Uden (07:17):
Even by that age, looking back, it was beginning
to become clear where my careerwould go. So I'd already got
sort of an interest in science,you know, as best as one can
have as an eight year old, but Istill love when we did, like,
you know, general science.
Secondly, I wasn't I wasn't aweakly child, I had a couple of
sort of health issues, minorhealth issues that required me
to go into hospital and maybe goto the doctor a bit more often
(07:39):
than your average sort of eight,nine, ten year olds, so sort of
medicine began to intrigue mejust working with, with other
physicians. And then my fatherwas relatively older, he was of
the war generation. So he'd beenan officer and sort of risen up
through the ranks. So about thatage, he was the founding
(08:00):
headmaster, school principal, ofa brand new school in London,
where I was growing up. So Isort of saw him as, he was a
leader, a great leader, a greatmanager. So you know, those
those three factors all comingtogether–an interest in science,
even at that young age, I'dinteracted with the healthcare
system and found it really kindof inspirational in a kind of a
(08:20):
way and then having a fatherwho, you know, was clearly a
leader in his own right, andfascinated by what he'd done
during his life. And here weare, you know, 50-60 years
later, and it's all sort of cometogether.
John Simboli (08:35):
When people say, Steve, who is Rallybio, how do
you like to answer that?
Steve Uden (08:40):
I like to answer by saying that we are a biopharma
company, our mission is to takedevastating diseases and
devastate them. We arepassionate about working on
therapeutics that in one way oranother, will transform people's
lives. We're what's known as aportfolio company, we're built
around the team of people ratherthan the platform technology.
(09:01):
And you're probably aware, thereare sort of two flavors of
biotech, there's the platform,gene therapy, antibodies, what
have you. And then there's theportfolio where you build a
strong team and then bring ideasin. So that's our business
model. There's about 25 of us,all of whom have had an amazing
track record. And with thatstrong group of people, we were
able to attract the financingand then bring in the programs
(09:23):
on which we're working. So we'rea portfolio company, we're
focused on rare disease, ourmantra is devastating diseases
and devastate them. And that canbe anything from, if you like,
our lead program where thevision is to eliminate a
disease, or a preventativeapproach, all the way through to
our programs in complement wherewe are wanting to have a
therapeutic that will not be atall burdensome for patients, and
(09:47):
enable us to apply that sort ofpharmacology to a vast range of
diseases which currently, wherewe know complement almost
certainly has a role butcurrently, there's no drugs.
John Simboli (09:56):
In the time that I've known you, I've known the
work that you've done in termsof rare disease and complement
and many other things as well.
But I want to ask you about therare disease part of it. When I
first worked for a company thatwas focused on rare disease,
working with Alexion, it was sodifferent than anything I've
ever experienced because of theproximity of the science team to
the people that they werehelping. I can't think of a
(10:18):
better way to say it thanproximity. But at what point in
your training and your workexperience did you first
encounter the rare diseasecomponent? And and how did it
affect you?
Steve Uden (10:30):
Probably my first foray into rare disease in its
broadest sense, was just priorto working at Alexion, when I
was working at NovartisOncology, and I was there at the
time that, you know, this sortof patient-specific therapy was
now really beginning to takeoff, that you're not just sort
(10:51):
of blasting patients withchemotherapy, but you're finding
the subtle mutation and tryingto, alter how small subgroup of
patients interact. But it wasprobably, in a more traditional
sense, which is the sort ofnon-oncological, it was my time
at Alexion. And, as you say, youcan see the impact much more
(11:12):
clearly. One of the theinteresting things is, of
course, that, typically, yourunderstanding of the disease
itself is much greater, because,typically, rare diseases are due
to discrete genetic differences.
And if you can fix that, you canthen trace back from that
genetic component, you can traceall the way back through to
(11:33):
describe and understand thepathology etc. Whereas when
you're dealing with these moresort of public health type
problems, diabetes, what haveyou, it is multifactorial, and
what might have made youdiabetic could be very different
from me and from the guy downthe street. So it started at
Novartis Oncology, seeing theway that understanding genetics
(11:53):
could really sort of helpsimplify, if you like, the the
pharmacological approach, thenat Alexion, on how to take it to
the next degree. You can get toclear go/no, go pretty quickly.
Now, having said that, with ourlead program, it's a different
approach to prevention. Sothat's quite a monster. But we
once we get into patients, Ithink we're going to know pretty
quickly whether or not the drugworks. The issue, of course, is
(12:16):
bearing in mind that we're goingto be treating pregnant mothers.
The journey there is not asquick, simply because there's no
room for error. Not that there'sany room for error when you're
developing a drug, but with ahealthy mum, there's zero.
John Simboli (12:30):
Steve, can tell me something about Rallybio's lead
drug candidates and why, whatthe need is?
Steve Uden (12:36):
Our lead program is an approach to prevent something
called fetal and neonatalalloimmune thrombocytopenia,
FNAIT. Now, what FNAIT is, it'sdue to a genetic mismatch
between a protein on the surfaceof the mother's platelet and a
protein on the surface of herfetal platelet. There's an
(13:00):
antigen called human plateletantigen, while we all have it on
our platelets, in a small numberof people there's a single amino
acid change. The protein stillworks, but there's a shape
change, hence it'simmunologically active. So if
the mom has this rare mutation,if at any time, but the baby's
platelets get into acirculation, bleeds from the
(13:21):
baby into the mom are quitefrequent during pregnancy, and
certainly at delivery. And if atany time that happens, the
mother's immune system willrecognize these platelets as
foreign. They've got the normalprotein, she's got this slightly
abnormal protein, her plateletshere will make antibodies
against this protein. Antibodiesreadily cross the placenta so
(13:42):
now they're these antibodiesflood into the baby and destroy
the platelets. The antibody nowfinds the platelets inside the
fetus, but the level of theantibodies can be so high that
the destruction of the plateletsoverwhelms the ability of the
little fetal bone marrow toreplace the platelets. Now,
although the baby is all wrappedup inside the mother's womb, if
(14:04):
there's no platelets, thesmallest bleed will just bleed
and bleed and bleed. So henceyou get intracranial hemorrhage.
It's the most common cause ofintracranial hemorrhage. It can
cause miscarriage, majorproblems with delivery, etc. And
of course, because it's animmunological phenomenon, once
the mum's mounted theseantibodies, all future
pregnancies will be at risk, notjust that pregnancy, but the
(14:26):
next one and the one after that.
Our approach is going to be toprevent this. In other words,
identify the mums where thismismatch occurs, and treat them
during pregnancy to inhibit themhaving this immune response.
Now, the good news is thatthere's a much more prevalent
red blood cell mismatch. That'ssomething called Rhesus disease
(14:47):
of the newborn. Now many peoplehave never heard of this. Now
when I was a medical studentthis was the big breakthrough
that had occurred in the decadebefore I went to medical school.
If you think about your bloodgroup, this positive-negative
thing is due to something calledRhesus. Now Rhesus negativity is
very common, 17% of the world.
(15:09):
So this mismatch between redblood cells was quite prevalent
back in the day. Now instead ofcausing no platelets, it would
destroy the red blood cells, sothe baby would be
catastrophically anemic insidethe mother and go into heart
failure. Now, the interestingthing is that we speak to
people, even people of ourgeneration, John, they've never
heard of this syndrome. It wasthe scourge of obstetrics up
(15:31):
until the 50s and 60s, and thetreatment approach is exactly
the same as we're doing. Inother words, check the mum for
risk when she first turns up, ifshe's at risk, give a small dose
of an antibody during pregnancyand delivery to prevent the
immune reaction and get rid ofthe disease. Now, the difference
is that this mutation onplatelet is much rarer than the
(15:54):
Rhesus red blood cell platelet.
So, it's only recently that thebiology was worked out. But our
lead program, so to get rightthe way back, in our lead
program is to identify mums atrisk of causing this
catastrophic loss of plateletsin their fetus, Identify early
during pregnancy, treat the mumduring the pregnancy with an
(16:14):
incredibly small dose of anantibody—a naturally occurring
antibody—prevent her from havingan immune reaction. So the baby
comes out healthy, she hasn'thad an immune response. So the
next pregnancy will be fine, etcetera. I can think of nothing
more inspiring, quite frankly,than, if this works, to have a
therapy that tackles acatastrophic rare disease, but
(16:36):
it doesn't tackle it by treatingit. It tackles it by just
preventing it from everhappening. And my vision for the
future is that 30 years fromnow, people will be on a
podcast, and they'll be saying,well, there's this thing called
FNAIT, which has completelydisappeared. So I'll have to
tell you what it is, because,you know, when I was a medical
student, this was the terriblething. And now all due to this
(16:58):
company Rallybio, it'sdisappeared. So that's what it
is, an approach to prevent arare disease, that if don't
prevent it, can end up with achild that grows into an adult
with lifelong disability. Backto your earlier point around
you're much more intimate withthe patients in rare disease
(17:19):
than other diseases, there's amother who lives on Long Island,
who has visited the company whohad a child with FNAIT. We've
met the patient support group,this is a mum, who's had a
grandmother who had a familywith this syndrome. So, you get
to know these people and justhear the stories. It's really
(17:41):
quite awful. So that's our leadprogram. If it works, we will
actually eradicate this disease.
Can't wait.
John Simboli (17:49):
How do your choices about the pipeline
express your vision for thecompany?
Steve Uden (17:52):
Two things drove the pipeline. Number one is would
the therapy have atransformative effect, the
potential for a totallytransformative effect in a rare
disease? And secondly, is thescience that underpins the idea
strong? We've looked at whenlooked at, it must be 1000s of
potential opportunities. Andthey often failed most, usually,
(18:15):
most typically, because thescience was pretty weak, one way
or another. So with our leadprogram, we found it in a very
small, what I would callacademic startup. It was in a
company based of all places inTromso in Norway. The mutation
that causes this plateletproblem is, the further north
you go, the more prevalent. Sothere is nowhere further north
(18:39):
than Tromso. So that's probablywhy. But great academics, they
worked out the fundamentalbiology, they've worked out the
approach, how you could preventit, but they didn't know how to
move a drug forward and do thetesting to be confident, as one
can be, that you can treatmothers. That's where we stepped
in, we brought our expertise tobear to say right, take it to
(19:01):
the next step, because then wecan work out how you can do the
safety testing and create animalmodels, how we can work with
investigators to be confidentthat we can take this into
mothers, etc. If I look at thecomplement assets, great drugs,
I mean, if this drug works, itwill mean the patient can treat
themselves with a smallinjection, like giving
themselves an insulin shot oncea week. Low cost of goods. So
(19:24):
you know, you could explore theentire gamut of rare disease.
The problem had been that thedrug was produced in E. coli,
like a lot of biologics, butthere'd been some sort of
problem with the manufacturingthat was causing major side
effects. But everybody thoughtit was the drug itself. It
wasn't. it turned out itimpurities that were leaking
(19:45):
from the manufacturing processinto the drug product. And we
were able to work with thecompany that had the original
technology to fix that. Youknow, our approach in
hypophosphatasia. We looked atsome some work that had been
done in what's called a doubleknockout mouse and we realized
that maybe you could treat thiswith a pill once a day.
John Simboli (20:03):
When people hear the Rallybio story, what do they
get right? What do they getwrong? How do you help them get
onto the track that as you seethe company?
Steve Uden (20:11):
I think early in the days of the Rallybio story, this
whole concept of this FNAIT wasvery difficult for people to get
their heads around—prevention.
What you're going to treatpregnant mothers with? Like many
rare diseases, no one had everheard of it. Now, through a lot
of hard work, we've educatedvast numbers of stakeholders in
(20:31):
what is FNAIT. And so,increasingly, people come to us
knowing what we're trying to do.
The next bit of the story that'stough to tell is that these are
pregnant mums, we've got to bevery step-wise. We're having to
be, for obvious reasons, verymethodical, I think most of them
pretty quickly get to understandthat this is a really
experienced team of people. Oneof my colleagues, Amanda, our
(20:54):
Head of Business Development,she was at Bio, the big
partnering meeting. And she wastalking about our portfolio to
many companies, who might wantto partner with us, and feedback
from big players, big, crediblepharma companies, and gosh, the
science that comes out of yourteam is the best we've ever
(21:15):
seen. That's one thing, theypretty quickly realized that
this is a team of people whoreally knows what it's doing.
Early this year, J&J got into acollaboration with us. We're
trying to prevent the mum everhaving this immune response,
their approach will be to findthe mums who sadly had this
immune response, and then tryand damp down, in future
(21:36):
pregnancies, the impact on thefetus. Totally synergistic
approaches. I think, for me, thebest bit of news was, look, you
know, we're not the only peopleworrying about this, there's
another big credible player outthere. We're not in competition
with them, we are workingtogether in a collaboration to
cover the whole waterfront. Incomplement, there's a lot of
people's playing in the space.
Explaining why we're going to dosomething very, very different.
(21:59):
The good bit is they veryquickly get the science we're
doing is first class and theteam really knows what he's
doing.
John Simboli (22:07):
The word partner can have many different meanings
for a biopharma company likeRallybio, but let me just ask,
broadly, who is a good partnerfor Ralybio?
Steve Uden (22:16):
If I'm thinking about investigators, and people
are working with us on ourclinical trials, these are
obstetricians who are passionateabout making a big difference in
their practice. And then amongstthose, obviously, some people
have really given their life toFNAIT. I was on a call with an
obstetrician a few weeks ago,who said, I've divided my career
(22:39):
into three epochs, or decades,I'm in the final epoch. And what
I want to do is work with youguys to eliminate FNAIT, it has
been the scourge of my practice.
So people who are really keen toget involved in research. If I
think about investors, it's gotto be people who really
understand FNAIT and areprepared to be in for the long
(23:00):
game. And then we've got all ofour partners, because to get the
work done, we need a lot of youknow, CROs and CMOS. So again,
we take great care to selectpeople both their scientific
prowess and the quality of thework that they do. So it sort of
depends on the stakeholder, butfundamentally good science and
good quality underpinningeverything they want to do,
(23:21):
we'll get on with it very, verywell.
John Simboli (23:24):
Steve can you bring me up to date on where the
progress is with your lead assetand what you anticipate in the
coming weeks or months?
Steve Uden (23:33):
I think we've done everything, we need to get ready
to start phase two, whetherthat's talking to regulators to
agree on the package of datathat would satisfy them. We are
now getting ready to start thephase two study. We're going to
start screening mothers for ourphase two. Now, screening is the
key word because earlier on, wetalked about prevention. So if
you're in prevention, whatyou'll need to be doing is
(23:55):
testing. It will become standardpractice as it is today. You
know, when a mum goes to thedoctor, the first time and says
I'm pregnant, the doctor runs aseries of blood tests. Is she
diabetic, is she Rhesusnegative, what's her blood
group, etc. So the first thingwill be to screen all of the
mums going to the doctor to seewhether they have this mutation,
and whether they are at risk ofcausing this problem in the
(24:16):
baby. Now, the goal is by theend of this year, all of the
centers that are going to beinvolved in the studyhave
started to screen mums to find amum who may have this mutation,
who we could then treat to tryand prevent her from having this
immune response. I think it'sgoing to de-risk three big
things for us. Number one is theregulatory risk. So that's the
(24:39):
first bit of de-risking. And thenext bit of de-risking, of
course, will be, will motherstake part in a clinical trial?
We spent a lot of time talkingto investigators and doctors who
look after patients and it'sbeen a consistent feedback that
once a mom knows that the babyis at risk, they will do
whatever it takes, but we needto de risk that. And then the
third thing, how does pregnancyimpact the pharmacokinetics. We
(25:03):
all know that over the ninemonths of pregnancy, the mom's
blood volume goes up by 40%, hermetabolism changes, etc.. So
will the dose that worked wellin the phase 1 proof of concept
studies provide adequate druglevel when the blood volume has
gone up 40% Or will you have toadjust the dose for the mom
during the pregnancy or, if atall, et
John Simboli (25:26):
How did Rallybio choose to start off in New
Haven?
Steve Uden (25:31):
Many of us were at Alexion. And many of the people
at Alexion had worked in one orother of the big pharma
companies that had in theirheyday, major research
facilities in and aroundsouthern Connecticut. Pfizer up
in Groton, Bayer, in West Haven,BMS at Wallingford, and of
(25:53):
course, stillBoehringer-Ingleheim. Now, the
good news is two things, thereis a sort of nascent
biotechnology hub here. There isa commitment to try and make
Connecticut a place for biotech.
There's a huge pool of talent,there's a huge number of people
here who are very experiencedand know the space well. So it
was sort of we were here, it's agreat place to be, the state is
(26:13):
trying to support us. Andthere's just so much talent that
we could tap into who waspassionate about rare disease.
There is a benefit, I think, inbeing able to just walk across
the green to a lab in Yale or upto Science Park.
John Simboli (26:30):
What areas of thought leadership regarding the
future of biopharma arecurrently the most engaging for
you personally?
Steve Uden (26:37):
I think there are two actually, they're almost at
the sort of opposite ends of thespectrum. The first is how will
artificial intelligence changewhat we do? And how can it be
best employed? There are someobvious possibilities around
helping out with a drugdiscovery process. In fact, use
of computer models, andcomputational chemistry has
(26:59):
actually been around for quite along time, particularly in
Connecticut. But will the impactbe as revolutionary as people
predict? Or will it beincremental? Or, would it not
make a huge difference? Andwe've been through a number of
these big, this is going tochange the face of our work,
whether it was high throughputscreening, or now we've got the
(27:20):
human genome and what has tendedto happen is they're all
incremental, rather thanrevolutionary. And in fact, one
of our projects, this pill totreat hypophosphatasia, is in
collaboration with a companythat has for about the last five
or six years been usingartificial intelligence to them
in medicinal chemistry. Sothat's one end, AI, is how much
(27:41):
of a there is there there? Theother end actually is sustaining
our industry. How are we goingto train, develop, educate the
next group of biopharma leadersand innovators? I didn't know it
at the time, but I had the hugegood fortune and luck to start
my career at Pfizer. I mean, notonly was it, and it still is, a
(28:05):
great company, but it was justsuch a great place to learn the
ropes of drug development andhow the industry works and
interact with colleagues fromall different fields. If you go
straight from academia into asmall company, you're never
going to get that experience.
And how do we prepare the nextgeneration of leaders? And I
think people sort of despai,well, you know, you can't do it
(28:28):
working hybridly. I sort ofapproach it differently. Our
challenge is to make it work,bearing in mind that the future
of work could well be hybrid. Sowe're not always going to be
able to sort of stand by thewater cooler or sit somebody on
your knee and sort of teach themfrom the master. So the question
is, how can we do that? But I doworry about that, because it's
(28:49):
such a great industry, greatwork that we do. How are we
going to make sure the nextgeneration is best prepared to
do that?
John Simboli (28:57):
Steve, thanks for speaking with me today.
Steve Uden (28:59):
Quite searching questions, John. It's quite nice
to sit back and actually reflecton how one got here in the first
place. I hope some people findit interesting. I've certainly
really enjoyed talking to you.
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