February 17, 2025 • 37 mins
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Ran Zhang was hire number one at Landmark Bio back in 2021. Today, she's CEO of the 70+ employee cell and gene therapy manufacturer. We caught up with her and Life Science Leader chief editor Ben Comer at the JP Morgan Healthcare Conference in San Francisco for a discussion on Landmark's role in addressing the ATMP patient access and cost reduction challenges. Along the way, we cover innovations in distributed manufacturing, non-viral gene delivery, and the importance of collaboration with academia to make these transformative therapies widely available.
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Transcript
Episode Transcript
Available transcripts are automatically generated. Complete accuracy is not guaranteed.
Matt Pillar (00:04):
Ran Zheng had already built a storied career
at Amgen when she took thebiotech dive with Orchard
Therapeutics, where she servedas CTO for a few years before
being tapped on the shoulder ashire number one at Landmark Bio
in 2021.
I'm Matt Pillar and I'm BenComer, and this is the Business
(00:25):
of Biotech.
Jp Morgan edition.
Ben Comer (00:29):
We're here in San Francisco with Ran for a talk on
how she's applying a diversehistory of biologic therapeutic
development experience to herrole at Landmark building and
deploying next-generation celland gene therapy manufacturing
technology.
Ran, thanks for joining us.
And it's Deploying NextGeneration Cell and Gene.
Ran Zheng (00:47):
Therapy Manufacturing Technology, ran.
Thanks for joining us and it'sgreat to see you.
Thank you very much, pleasureto be here.
Matt Pillar (00:50):
It's a pleasure to have you here.
I know it's a very busy weekfor you, so I appreciate you
coming along to spend some timewith us, and I want to get the
show off the ground here bytalking a little bit about you
specifically.
As I noted, you were Landmark'sfirst hire, which is pretty
cool.
I'm sure there's a prettyinteresting story there because
the company's grownsubstantially in subsequent
(01:12):
years.
But what were you doing priorand why did you kind of take
that leap to Landmark?
Ran Zheng (01:18):
Yeah, great question.
I have been very fortunate towork with a great group of
people at a great company.
I spent six years at Amogen,worked in different products in
different functions.
The last few years, while I waswith Amogen, I had opportunity
(01:41):
to touch on some uniquemodalities neoantigen oncolytic
virus, srna.
I was awestruck by this newclass of medicine and the
transformative potential thosemedicines can bring to patients.
(02:05):
I worked on a lot of biologicproducts.
Most of them are treatment, notcure.
Some of the cell and genetherapy products have a curative
potential and they're once anddone and allow patients to live
(02:25):
normal life.
It's just amazing and I want tosee more of those products on
the market.
And I also observed some gapsin the development and the
commercialization of cell andgene therapies in the
development and thecommercialization of cell and
(02:47):
gene therapies and I thought alot of what we have learned in
biologics, development andcommercialization can be applied
to this field and helpaccelerate the development.
Matt Pillar (03:02):
Yeah, many of those gaps, ramin.
I want to pause there for aminute and talk about some of
those gaps.
Many of those gaps remain gapsaround manufacturability for one
, but then beyondmanufacturability when we get
past that hurdle distributionadministration did you feel like
Landmark might give you anopportunity to play a role in
(03:24):
kind of addressing thosechallenges too?
Ran Zheng (03:28):
Yeah, you know, maybe I will also pause a moment and
to maybe kind of recap andregroup my thoughts here yeah,
regroup my thought here.
(03:48):
So I wouldn't call it alandmark bio.
Give me the uniqueopportunities.
Maybe what I could just anchoron what a landmark bio was set
up to do is to remove some ofthe bottlenecks in the early
days of cell and gene therapydevelopment.
In the early days of cell andgene therapy development, and
(04:12):
the opportunity we have there isnot just from the technology
perspective but also reallypartner with other companies to
help address some of thechallenges we have seen in this
space.
Matt Pillar (04:36):
So maybe what I can you know, if you can just let
me know what some of yourquestions are.
Oh, I know I pulled that oneout of left field.
Ran Zheng (04:39):
No, no, no, I have not seen the briefing because I
know Kathy decided that you havesome briefing but I didn't get
a chance to.
Oh, that's all right, that'sokay, yeah.
Matt Pillar (04:52):
Let me ask you this so you left Amgen for Landmark,
Landmark being a startup, Wasthere any trepidation or concern
around making the jump fromsuch an established company to?
I mean, I understand the intent.
Ran Zheng (05:08):
Right, right, yeah, no.
Well, lamar Bell is not myfirst startup company.
Okay, so you would yeah yeah,so it was actually the third
startup company, but the secondafter Amogen Experience.
Vulture Therapeutics was also ayoung company.
When I joined, I wouldn't callit a startup.
(05:30):
It has about 150-ish peoplemaybe when I joined so, but it's
much smaller company.
Ben Comer (05:39):
What did bring you to Landmark Bio?
Did you know Alan Garber beforejoining?
How did you land there?
Ran Zheng (05:47):
I don't know Alan Garber.
Ben Comer (05:49):
You don't.
Ran Zheng (05:50):
No, I don't, so it was probably a cold call from a
recruiter, but I have read theinitiative so I learned a little
bit about what they try to do.
I thought they have a veryunique value proposition and
it's great purpose and they'retrying to do something to close
(06:14):
the gaps and I'm willing to help.
Ben Comer (06:17):
Yeah.
Ran Zheng (06:17):
Yeah.
Ben Comer (06:19):
You also, I think, worked to improve the
manufacturing function while youwere at Amgen.
Correct me if I'm wrong.
Were there learnings while youwere at Amgen?
Correct me if I'm wrong.
Were there learnings that youbrought from Amgen to your
positions after that, includingLandmark?
Ran Zheng (06:35):
Yeah, I started at Amgen as a process development
scientist and I worked indifferent functions in PD,
manufacturing, quality andsupply chain.
There are a lot of learnings inbiologic development,
particularly in the CMC space,and many of those learnings are
(06:59):
applicable, includingunderstanding of applicable,
including understanding ofproducts and understanding the
quality attributes.
Understanding how the processesaffect those quality attributes
and ultimately potentiallyimpact the outcome of the
products is very important.
(07:20):
There are a lot of fundamentallearnings that we have gained
over the past two decades areapplicable to this new field.
So that's why, when I joinedLandmark Bio even though the
company is very much orientedtowards bio manufacturing to
(07:45):
provide services and to partnerothers, I have built a team with
people who come from thepharmaceutical industry, have
done years of work indevelopment and
commercialization of biologicsand commercialization of
biologics.
Because not just the experiencein development, but also
(08:07):
understanding how thedevelopment should be done.
Matt Pillar (08:10):
Yeah, is it the fundamentals that best translate
?
I'm curious because I hear thisfrequently.
Like you know, we can't.
As we improve the cell and genemanufacturing paradigm, we
should lean into things thatwe've learned along the way in
more traditional biologics.
Is that sort of a you know,stick to the fundamentals
(08:34):
conversation, or are therespecific, I guess, process or
manufacturing steps or lessonsthat translate from things like
antibodies and vaccines to thecell and gene manufacturing?
Ran Zheng (08:47):
Yeah, you know we're getting deep in that space,
right?
So there is a fundamental kindof principles on how to develop
a manufacturable process.
We're talking about themanufacturability of the process
, the scalability of the processand the transferability of the
process.
Those fundamentals are the same.
(09:09):
The principles are the same,it's just a very different
modality.
You have to apply theprinciples and maybe understand
your modality and go from thereyeah from there?
Matt Pillar (09:26):
Yeah, what would you say if you looking back on
the past four years at Landmark?
How would you sort ofcharacterize or quantify the
progress that Landmark hascontributed to addressing some
of these challenges?
Ran Zheng (09:39):
Yeah, so two of the unique major challenges in cell
energy and therapy space arefirst, one is the logistical
challenges, what we calllogistical challenges for
patients.
You know, eight out of tenpatients who are eligible for
(10:03):
CAR T therapies are not able toget to the CAR T therapies
because they just don't have theaccess.
The second challenge isprobably more on the company
side, on the business side, thefinancial challenges.
It takes a lot of capital todevelop, manufacture, deliver
(10:26):
the products, but with the highcost of manufacturing, cost of
goods that translates to a lowermargin and lower return on
investment.
So I think that challenge isneeded to overcome so that the
therapies can benefit morepatients.
So what Landmark Bell has donein the past few years since its
(10:52):
launch is you know, this ispublic knowledge we partner with
Galapagos, a European celltherapy companies, and work with
them to establish distributedmanufacturing Network.
We are their first biomanufacturing partner in United
(11:14):
States and the goal Fordistributed manufacturing is to
make the CAR T products close towhere patients are Many US
patients even today if they wantto get access to CAR T products
.
Close to where patients are.
Many US patients even today ifthey want to get access to CAR T
products and they have totravel to where the treatment
centers are established, usuallyin major cities like Boston,
(11:37):
san Francisco, new York City.
But if you live in some otherplaces it's difficult for a
patient to get the treatmentDistributed.
Manufacturing make the productscloser to where a patient lives
so patient can receivetreatment close to where they
(12:03):
live.
So I think that's one thingthat we have been working with
them for a couple of years alittle bit over a year now.
The second challenge we'retalking about is how you could
reduce cost of goods, cell andgene therapy.
(12:29):
Today most of them are exovagalcell therapies.
They take materials frompatients or donors, their cells
and doing gene modification andgive back to patients, and that
process is very complex.
They also deal with live cellsand the product is also very
(12:53):
complex.
There are a lot of constraintsin the supply chain that all
lead to higher cost of goods anda lower net margin, which is
challenging.
And if you can only imaginethat there's a way to turn the
complex ex vivo cell productsinto something more like
(13:17):
biologics and you can givepatients just like biologic
injectables or IV products, andhow many more patients would be
able to benefit, how much lowerthe cost of products that could
be.
So one of the technologicalinnovation area that we have
(13:41):
been focusing on is non-viralgene delivery to be able to
achieve this kind of in-vivoCAR-T, to be able to achieve
this kind of to leverage a humanbody to make the products
inside of the human, to lowerthe cost of goods this may be a
(14:02):
very naive question buttheoretically when I think about
distributed manufacturing itoccurs to me that that would
actually exacerbate in some waysthat cost of goods and cost of
distribution supply chain issues.
Matt Pillar (14:24):
It seems like it would exacerbate that problem
like make it worse, because nowwe're taking a few manufacturing
nodes and multiplying themacross the country.
How do you rationalize that?
Ran Zheng (14:37):
Yeah, that's a great question.
If you don't have thetechnologies to support that
kind of distributedmanufacturing network, that
could increase cost of goods.
That could increase cost ofgoods.
So the manufacturing technologyplatform and the supply chain
(14:57):
platform Galapagos has deployedallow manufacturing process to
be very efficient and it's veryeasy to tech transfer.
It's a closed process,seven-day win-to-win electronic
batch record so you manageinformation data flow
electronically.
(15:18):
Everything is standardized.
So I definitely see that it'snot your yesterday's distributed
manufacturing where everythingis, you know, manual and less
standardized, because it'shighly platformed and it's
(15:38):
standardized.
It will reduce the errorsthrough the transfer.
It will help reduce the humanerrors, improve the consistency.
Of course this is somethingthat's very new and we will have
to see in the next few yearshow that will work out, but
we're very optimistic for that.
Ben Comer (15:58):
Yeah, when distributed manufacturing, is
that satellite manufacturing,centers that are more spread out
?
Is it actually on site, like ata health care delivery center,
where that happens?
Ran Zheng (16:12):
Yeah, no, it's not at the bedside yet.
It's in a GMT manufacturingfacility that's close to medical
center.
Ben Comer (16:26):
And those are rapidly expanding in number at this
point, or is that the goaleventually?
Well, the goal eventually is toestablish many manufacturing
(16:47):
capabilities near the medicalcenters where you can make the
products.
And if you can standardize thatprocess and make it really
efficient to your point, thenthat's how you get around
raising the cost of goods, yeah,okay.
Matt Pillar (17:07):
When you addressed that you talked about the
process development, often a gapin early stage processes coming
out of academia needing to besort of redeveloped when they
make clinical progress, muchless commercialization progress.
A little bit about that likehow does, how has landmark
(17:31):
contributed to the, the academicexercise of, you know, moving
from academia to a commercial,commercially viable business,
and is that driven by industryor is academia driving that as
well?
Sort of what's the lay of theland there?
Ran Zheng (17:57):
Yeah, you know what we have seen in this field in
the past 20 years, particularlyin cell energy and therapies.
The innovations almostexclusively always started in
academic centers, where smallbiotech companies were the
science drive, how the productshave been developed and made,
but not a lot of considerationsIf you have to make the products
(18:22):
not only for one patient, twopatients, but hundreds,
thousands, millions of patients.
So what we have seen a lot ofearly cell and gene therapy
products are based on laboratoryprotocols that could work, you
know, for a fewer number ofpatients, but it does not drive
(18:45):
consistency and word robustnessand that will lead to some
repeated work later on.
So what we have seen is thatsome early phase clinical trials
conducted at an academicsetting academic setting, the
(19:22):
proof of concept, the clinicalresults is outstanding, but the
process is not robust enough andis not suitable for larger
clinical trials orcommercialization.
What they end up to be is thatyou repeat those clinical trials
and that is a lot of waste, Alot of money, A lot of money and
a lot of time right.
(19:42):
So what we do is that we workwith the principal investigators
from academia or the startupcompanies.
We help them to understand whatis the ultimate goal for the
development is to bring thisdrug to market and in order to
(20:04):
do that we need to make surethat the processes of
manufacturing the products isrobust and can deliver reliable,
consistent product quality.
So, with that in mind, todesign the manufacturing
processes, the materials, and tosource the materials, the
(20:26):
starting materials for themanufacturing processes,
starting materials for themanufacturing processes in the
early days, so that you get somekind of standardization to make
the process more suitable forcommercial use, less changes
that you have to make later on.
(20:47):
That will reduce some of thekind of wasted work.
Matt Pillar (20:55):
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Ben Comer (21:58):
on the business of biotech, is that something you
would characterize, I guess, askind of landmark bios um sweet
spot, being able to take aprocess in academia or a process
in a small startup and help tostandardize it and make it into
something that could be scaledcommercially.
Do you see that as your kind ofprimary aim?
Ran Zheng (22:24):
It's definitely one of the unique features for
Landmark Bio and the competitiveadvantage for us as well.
I probably mentioned a littlebit earlier we we're in this
space provide CMC services to alot of our partners.
The people that we build aremost of them are from drug
(22:47):
development companies, so thisis an organization built by drug
developers for drug developers,so we understand what it's
really going to take to developthe processes, develop the
product and get to the market.
It definitely help our clientsand our partners to minimize
(23:15):
some of the I would say thepitfalls and the unfortunate
errors that you know many othersmade in the early days.
Ben Comer (23:28):
Yeah.
Do the challenges faced by acell or gene startup vary a lot,
or are there some keychallenges that you mentioned?
You know, for example,non-viral vector delivery as
something that I think you'reworking toward and it also
represents a hurdle for thesector?
(23:49):
Are there other areas thatcontinue to be challenges that
you know that developers andLandmark Bio are working to
overcome?
Ran Zheng (24:02):
There are a lot of challenges.
First of all, cell and genetherapies are such a broad
category we tend to lump themtogether, but cell and gene
therapies, you know, includingcell therapies, including
gene-modified cell therapies,viral vectors.
So there are some uniqueaspects of the challenges that
(24:24):
different depends on thedifferent specific modalities
you know.
For example, when we talkedabout the viral vector in the
AAV space, the titer, the purity, you know, definitely is one of
the challenges from the CMCperspective, but from efficacy
perspective, the capsid and thedesign of the capsid.
(24:48):
There are a lot of uniquechallenges.
We're certainly not doingeverything to address all the
challenges over there and wewant to focus on the things that
we believe that can move theneedle.
For example, we think celltherapy is going to stay.
(25:11):
There are already blockbusterpathologist cell therapies are
there.
If we can make those therapiesbetter and if we can manufacture
them faster and cheaper, thatwill allow patients or provide
better access to patients, justat least from manufacturing
(25:33):
perspective.
That's really our approach.
We're very optimistic in thenon-myogen delivery space
because we truly believe if wecan turn the complex product
into a relatively simplerproduct, easier to manufacture,
(25:56):
easier to deliver, that willreally change the field.
Matt Pillar (26:02):
Yeah, you're in an interesting space because in
many ways you have a firsthandlook at not just innovation but
business volume right, and I'vehad a couple of conversations
today with cell and gene therapyleaders who talk about sort of
(26:22):
the ebb and flow of the economicinterest, the finance
community's interest in genetherapy.
I guess, more specifically,what's your take on that from
your perspective, given that yousee, you know, you see the
innovation firsthand, you seethe volume of of interest in
manufacturing services firsthand, do you have a good feeling,
(26:45):
heading into 25, that businesswill be robust on the innovation
and funding scale, or is thereany cause for concern?
Ran Zheng (26:56):
I am a firm believer of cell and gene therapies and
the transformative potentialsthis class of therapies can
bring to patients.
And you know it's alreadybeyond the proof of concept.
Beyond the proof of concept,the challenges we're facing is
from, from business perspective,is that, yes, we have seen the
(27:22):
benefit on patients, but we wantto see more patients being
benefited by this new class ofmedicine.
Look, the innovation has novalue if it does not reach to
patients.
Yeah, um, I think that's that'sreally the fundamental
challenges over there.
Uh, right now, we want, we wantthis class of therapies to be
(27:45):
able to reach broader patientpopulation.
Um, and in order to that, thereare some technological hurdles
and we have to overcome.
But I I think the science isproven and it's validated in
human.
We know it works and we know ithas curative, transformative
(28:06):
potential and it's it's on us tomake this work yeah, it's uh,
it's interesting to me too.
Matt Pillar (28:15):
Like you said, the cell and gene therapies is a
sort of a basket term for awhole bunch of different
approaches.
How does a company likeLandmark ensure that you have
the expertise not just thecapacity, but the expertise to
stay on top of all this stuff?
Ran Zheng (28:33):
yeah, yeah, um, we, we set up our business to have
quite a broad capabilities, sowe're not just focusing on cell
therapies or gene therapies, sowe have a capability using cell
gene and messenger RNA, for acouple of reasons.
(28:54):
One reason is we think thisfield is still early and the
winners are yet to emerge.
And we have seen the fieldmoving from ex-vivo to in-vivo,
because we think that's wherethe field is going.
But we need to start in ex-vand we want to capture the
(29:17):
current opportunities, but stillwith eye towards the future.
And that's how we set up.
And there are a lot of spaces, alot of areas we can innovate,
and we definitely not try to doeverything.
And, as I mentioned, someplaces that we try to do
everything, and as I mentionedthat you know some places that
(29:39):
we try to innovate, as a non,for example, non-viral gene
delivery.
We think that's the area thatwe should focus on because it
address the underlying issuesfor cell and the gene therapy.
You've got to be able todeliver the genetic material to
the right cells and that's whatwe need to focus on.
Ben Comer (30:07):
What sort of delivery materials I guess are leading
the charge in that area to getaway from viral vectors?
Ran Zheng (30:15):
So we are looking into nanoparticle technologies.
Lipid nanoparticle is oneaspect.
We also have other non-lipidnanoparticles.
Is that?
Matt Pillar (30:32):
does the innovation there, in terms of delivery
vehicles, tend to happen fromwithin, or is it largely
influenced by the developersthat you're working with?
Innovation coming from thesponsor community?
Ran Zheng (30:47):
Well, we have seen both, but in that space I think
we see the opportunities thatthe sponsors would rely on their
partners to bring thetechnologies.
What we have seen more and moreis that sponsors focusing on
(31:09):
what inside of the particle,what inside that encapsulation
which is the know, the design ofthe, the rna, the design of the
dna and what the capability iswe bring in, is more of how we
could take those dna or rna oroligos and package them in a way
(31:33):
that they can guide to theright cells and the right
tissues.
Matt Pillar (31:37):
Yeah, Do you have you noticed any particular, I
guess, energy being devoted todeveloping delivery technologies
that you know seek targets thatare in places that were
difficult or impossible to getto before, like the blood-brain
(32:00):
barrier, different organs?
Is there sort of a movementafoot there?
Ran Zheng (32:04):
Yeah, you know, people try to deliver the
targeted genes to muscles, todifferent cell types, because
the current technologies, if yougive the current lipid
nanoparticle technology, youknow formulations, most of them
go to the liver.
Lung is another space where Isee a lot of development.
Ben Comer (32:30):
Do you have a sense of the broad, I guess, cell and
gene sector and how much itcollaborates?
And I'm thinking of, you know,25 years ago with monoclonal
antibodies, I think there weresome companies at a kind of
pre-commercial basis that wouldshare knowledge and work
(32:53):
together to try to bring thatfunctionality forward.
Is there a similar effort incell and gene that you're aware
of?
I mean, is Landmark Bio workingas a convener of sorts between
different companies and helpingto fill those gaps?
Ran Zheng (33:11):
Yeah, we're part of the Ningbo, which is a
consortium.
They have a lot of initiativesin cell and gene therapy space.
You know a lot of work beingdone in a V space.
It's a pretty competitive spacewhere people can share
knowledge and experience.
Matt Pillar (33:32):
Okay yeah, yeah.
What are you most excited aboutin terms of the cell and gene
space?
You talked about yourexcitement for the
transformative.
You know opportunity, right,the patient opportunity in cell
and gene, leading you toLandmark.
Now you've been there for fouryears, looking ahead, you know,
(33:53):
another four years perhaps, oreven a year.
What are you most excited about?
Ran Zheng (33:58):
The opportunities ahead of us.
I'm very excited about theopportunities in front of us
where we can really make adifference.
It took about 10 years to havea blockbuster of monoclonal
antibodies early days and wealready have a few blockbusters
(34:23):
of cell and gene therapy on themarket and start benefiting
patients, and that is veryexciting for us.
And also the amount ofinnovation in this space.
What we have seen isunprecedented.
That is something.
Also, the amount of innovationin this space.
What we have seen isunprecedented.
That is something that we'revery excited about.
(34:44):
Yeah, yeah.
Ben Comer (34:46):
What are your goals for JP Morgan, if you have any
that are specific to thisconference?
Ran Zheng (34:54):
My goal for JPM week is really to connect with the
industry, peers, the colleagues,potential partners and
collaborators, exchange ideas,explore collaboration
opportunities and really discussthe trend of where we're going
as an industry, as a sector.
(35:14):
It's a very exciting week.
Matt Pillar (35:18):
Yeah, where did you come in from?
Are you right?
Are you in the San Franciscoarea?
Ran Zheng (35:23):
No, I am based in Boston, but I also have a house
in Southern California.
Matt Pillar (35:32):
Okay.
Ran Zheng (35:32):
Yeah, so I actually came from the LA area, okaya
area.
Matt Pillar (35:37):
Okay, yeah.
Well, this episode will dropmore than likely sometime in
February, so a few weeks fromnow.
But as we sit right now, thingsaren't looking that great in LA
.
I'm hoping that everything'sokay in your neighborhood.
Ran Zheng (35:54):
Yeah, everything's okay in my neighborhood.
Matt Pillar (35:56):
We're fortunate, but it's very challenging time,
I'm sure yeah yeah, well, safetravels and thank you for
spending, like I said, some ofyour very busy week with the
business of biotech.
I I appreciate you coming onthe show and it's uh, it's great
to get insight, like I great toget insight from uh, a leader
in the cell and genemanufacturing space, given all
(36:18):
the questions and challengesthat are ahead, so we appreciate
it.
Thank you very much for havingme.
So that's Landmark Bio CEO RanZhang, I'm Matt Piller and I'm
Ben Comer, and you just listenedto the Business of Biotech from
JPM 2025.
Ben Comer (36:39):
Biotech from JPM 2025 .
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Life Science Leader.
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Ran Zheng had already built a storied career
at Amgen when she took thebiotech dive with Orchard
Therapeutics, where she servedas CTO for a few years before
being tapped on the shoulder ashire number one at Landmark Bio
in 2021.
I'm Matt Pillar and I'm BenComer, and this is the Business
(00:25):
of Biotech.
Jp Morgan edition.
Ben Comer (00:29):
We're here in San Francisco with Ran for a talk on
how she's applying a diversehistory of biologic therapeutic
development experience to herrole at Landmark building and
deploying next-generation celland gene therapy manufacturing
technology.
Ran, thanks for joining us.
And it's Deploying NextGeneration Cell and Gene.
Ran Zheng (00:47):
Therapy Manufacturing Technology, ran.
Thanks for joining us and it'sgreat to see you.
Thank you very much, pleasureto be here.
Matt Pillar (00:50):
It's a pleasure to have you here.
I know it's a very busy weekfor you, so I appreciate you
coming along to spend some timewith us, and I want to get the
show off the ground here bytalking a little bit about you
specifically.
As I noted, you were Landmark'sfirst hire, which is pretty
cool.
I'm sure there's a prettyinteresting story there because
the company's grownsubstantially in subsequent
(01:12):
years.
But what were you doing priorand why did you kind of take
that leap to Landmark?
Ran Zheng (01:18):
Yeah, great question.
I have been very fortunate towork with a great group of
people at a great company.
I spent six years at Amogen,worked in different products in
different functions.
The last few years, while I waswith Amogen, I had opportunity
(01:41):
to touch on some uniquemodalities neoantigen oncolytic
virus, srna.
I was awestruck by this newclass of medicine and the
transformative potential thosemedicines can bring to patients.
(02:05):
I worked on a lot of biologicproducts.
Most of them are treatment, notcure.
Some of the cell and genetherapy products have a curative
potential and they're once anddone and allow patients to live
(02:25):
normal life.
It's just amazing and I want tosee more of those products on
the market.
And I also observed some gapsin the development and the
commercialization of cell andgene therapies in the
development and thecommercialization of cell and
(02:47):
gene therapies and I thought alot of what we have learned in
biologics, development andcommercialization can be applied
to this field and helpaccelerate the development.
Matt Pillar (03:02):
Yeah, many of those gaps, ramin.
I want to pause there for aminute and talk about some of
those gaps.
Many of those gaps remain gapsaround manufacturability for one
, but then beyondmanufacturability when we get
past that hurdle distributionadministration did you feel like
Landmark might give you anopportunity to play a role in
(03:24):
kind of addressing thosechallenges too?
Ran Zheng (03:28):
Yeah, you know, maybe I will also pause a moment and
to maybe kind of recap andregroup my thoughts here yeah,
regroup my thought here.
(03:48):
So I wouldn't call it alandmark bio.
Give me the uniqueopportunities.
Maybe what I could just anchoron what a landmark bio was set
up to do is to remove some ofthe bottlenecks in the early
days of cell and gene therapydevelopment.
In the early days of cell andgene therapy development, and
(04:12):
the opportunity we have there isnot just from the technology
perspective but also reallypartner with other companies to
help address some of thechallenges we have seen in this
space.
Matt Pillar (04:36):
So maybe what I can you know, if you can just let
me know what some of yourquestions are.
Oh, I know I pulled that oneout of left field.
Ran Zheng (04:39):
No, no, no, I have not seen the briefing because I
know Kathy decided that you havesome briefing but I didn't get
a chance to.
Oh, that's all right, that'sokay, yeah.
Matt Pillar (04:52):
Let me ask you this so you left Amgen for Landmark,
Landmark being a startup, Wasthere any trepidation or concern
around making the jump fromsuch an established company to?
I mean, I understand the intent.
Ran Zheng (05:08):
Right, right, yeah, no.
Well, lamar Bell is not myfirst startup company.
Okay, so you would yeah yeah,so it was actually the third
startup company, but the secondafter Amogen Experience.
Vulture Therapeutics was also ayoung company.
When I joined, I wouldn't callit a startup.
(05:30):
It has about 150-ish peoplemaybe when I joined so, but it's
much smaller company.
Ben Comer (05:39):
What did bring you to Landmark Bio?
Did you know Alan Garber beforejoining?
How did you land there?
Ran Zheng (05:47):
I don't know Alan Garber.
Ben Comer (05:49):
You don't.
Ran Zheng (05:50):
No, I don't, so it was probably a cold call from a
recruiter, but I have read theinitiative so I learned a little
bit about what they try to do.
I thought they have a veryunique value proposition and
it's great purpose and they'retrying to do something to close
(06:14):
the gaps and I'm willing to help.
Ben Comer (06:17):
Yeah.
Ran Zheng (06:17):
Yeah.
Ben Comer (06:19):
You also, I think, worked to improve the
manufacturing function while youwere at Amgen.
Correct me if I'm wrong.
Were there learnings while youwere at Amgen?
Correct me if I'm wrong.
Were there learnings that youbrought from Amgen to your
positions after that, includingLandmark?
Ran Zheng (06:35):
Yeah, I started at Amgen as a process development
scientist and I worked indifferent functions in PD,
manufacturing, quality andsupply chain.
There are a lot of learnings inbiologic development,
particularly in the CMC space,and many of those learnings are
(06:59):
applicable, includingunderstanding of applicable,
including understanding ofproducts and understanding the
quality attributes.
Understanding how the processesaffect those quality attributes
and ultimately potentiallyimpact the outcome of the
products is very important.
(07:20):
There are a lot of fundamentallearnings that we have gained
over the past two decades areapplicable to this new field.
So that's why, when I joinedLandmark Bio even though the
company is very much orientedtowards bio manufacturing to
(07:45):
provide services and to partnerothers, I have built a team with
people who come from thepharmaceutical industry, have
done years of work indevelopment and
commercialization of biologicsand commercialization of
biologics.
Because not just the experiencein development, but also
(08:07):
understanding how thedevelopment should be done.
Matt Pillar (08:10):
Yeah, is it the fundamentals that best translate
?
I'm curious because I hear thisfrequently.
Like you know, we can't.
As we improve the cell and genemanufacturing paradigm, we
should lean into things thatwe've learned along the way in
more traditional biologics.
Is that sort of a you know,stick to the fundamentals
(08:34):
conversation, or are therespecific, I guess, process or
manufacturing steps or lessonsthat translate from things like
antibodies and vaccines to thecell and gene manufacturing?
Ran Zheng (08:47):
Yeah, you know we're getting deep in that space,
right?
So there is a fundamental kindof principles on how to develop
a manufacturable process.
We're talking about themanufacturability of the process
, the scalability of the processand the transferability of the
process.
Those fundamentals are the same.
(09:09):
The principles are the same,it's just a very different
modality.
You have to apply theprinciples and maybe understand
your modality and go from thereyeah from there?
Matt Pillar (09:26):
Yeah, what would you say if you looking back on
the past four years at Landmark?
How would you sort ofcharacterize or quantify the
progress that Landmark hascontributed to addressing some
of these challenges?
Ran Zheng (09:39):
Yeah, so two of the unique major challenges in cell
energy and therapy space arefirst, one is the logistical
challenges, what we calllogistical challenges for
patients.
You know, eight out of tenpatients who are eligible for
(10:03):
CAR T therapies are not able toget to the CAR T therapies
because they just don't have theaccess.
The second challenge isprobably more on the company
side, on the business side, thefinancial challenges.
It takes a lot of capital todevelop, manufacture, deliver
(10:26):
the products, but with the highcost of manufacturing, cost of
goods that translates to a lowermargin and lower return on
investment.
So I think that challenge isneeded to overcome so that the
therapies can benefit morepatients.
So what Landmark Bell has donein the past few years since its
(10:52):
launch is you know, this ispublic knowledge we partner with
Galapagos, a European celltherapy companies, and work with
them to establish distributedmanufacturing Network.
We are their first biomanufacturing partner in United
(11:14):
States and the goal Fordistributed manufacturing is to
make the CAR T products close towhere patients are Many US
patients even today if they wantto get access to CAR T products
.
Close to where patients are.
Many US patients even today ifthey want to get access to CAR T
products and they have totravel to where the treatment
centers are established, usuallyin major cities like Boston,
(11:37):
san Francisco, new York City.
But if you live in some otherplaces it's difficult for a
patient to get the treatmentDistributed.
Manufacturing make the productscloser to where a patient lives
so patient can receivetreatment close to where they
(12:03):
live.
So I think that's one thingthat we have been working with
them for a couple of years alittle bit over a year now.
The second challenge we'retalking about is how you could
reduce cost of goods, cell andgene therapy.
(12:29):
Today most of them are exovagalcell therapies.
They take materials frompatients or donors, their cells
and doing gene modification andgive back to patients, and that
process is very complex.
They also deal with live cellsand the product is also very
(12:53):
complex.
There are a lot of constraintsin the supply chain that all
lead to higher cost of goods anda lower net margin, which is
challenging.
And if you can only imaginethat there's a way to turn the
complex ex vivo cell productsinto something more like
(13:17):
biologics and you can givepatients just like biologic
injectables or IV products, andhow many more patients would be
able to benefit, how much lowerthe cost of products that could
be.
So one of the technologicalinnovation area that we have
(13:41):
been focusing on is non-viralgene delivery to be able to
achieve this kind of in-vivoCAR-T, to be able to achieve
this kind of to leverage a humanbody to make the products
inside of the human, to lowerthe cost of goods this may be a
(14:02):
very naive question buttheoretically when I think about
distributed manufacturing itoccurs to me that that would
actually exacerbate in some waysthat cost of goods and cost of
distribution supply chain issues.
Matt Pillar (14:24):
It seems like it would exacerbate that problem
like make it worse, because nowwe're taking a few manufacturing
nodes and multiplying themacross the country.
How do you rationalize that?
Ran Zheng (14:37):
Yeah, that's a great question.
If you don't have thetechnologies to support that
kind of distributedmanufacturing network, that
could increase cost of goods.
That could increase cost ofgoods.
So the manufacturing technologyplatform and the supply chain
(14:57):
platform Galapagos has deployedallow manufacturing process to
be very efficient and it's veryeasy to tech transfer.
It's a closed process,seven-day win-to-win electronic
batch record so you manageinformation data flow
electronically.
(15:18):
Everything is standardized.
So I definitely see that it'snot your yesterday's distributed
manufacturing where everythingis, you know, manual and less
standardized, because it'shighly platformed and it's
(15:38):
standardized.
It will reduce the errorsthrough the transfer.
It will help reduce the humanerrors, improve the consistency.
Of course this is somethingthat's very new and we will have
to see in the next few yearshow that will work out, but
we're very optimistic for that.
Ben Comer (15:58):
Yeah, when distributed manufacturing, is
that satellite manufacturing,centers that are more spread out
?
Is it actually on site, like ata health care delivery center,
where that happens?
Ran Zheng (16:12):
Yeah, no, it's not at the bedside yet.
It's in a GMT manufacturingfacility that's close to medical
center.
Ben Comer (16:26):
And those are rapidly expanding in number at this
point, or is that the goaleventually?
Well, the goal eventually is toestablish many manufacturing
(16:47):
capabilities near the medicalcenters where you can make the
products.
And if you can standardize thatprocess and make it really
efficient to your point, thenthat's how you get around
raising the cost of goods, yeah,okay.
Matt Pillar (17:07):
When you addressed that you talked about the
process development, often a gapin early stage processes coming
out of academia needing to besort of redeveloped when they
make clinical progress, muchless commercialization progress.
A little bit about that likehow does, how has landmark
(17:31):
contributed to the, the academicexercise of, you know, moving
from academia to a commercial,commercially viable business,
and is that driven by industryor is academia driving that as
well?
Sort of what's the lay of theland there?
Ran Zheng (17:57):
Yeah, you know what we have seen in this field in
the past 20 years, particularlyin cell energy and therapies.
The innovations almostexclusively always started in
academic centers, where smallbiotech companies were the
science drive, how the productshave been developed and made,
but not a lot of considerationsIf you have to make the products
(18:22):
not only for one patient, twopatients, but hundreds,
thousands, millions of patients.
So what we have seen a lot ofearly cell and gene therapy
products are based on laboratoryprotocols that could work, you
know, for a fewer number ofpatients, but it does not drive
(18:45):
consistency and word robustnessand that will lead to some
repeated work later on.
So what we have seen is thatsome early phase clinical trials
conducted at an academicsetting academic setting, the
(19:22):
proof of concept, the clinicalresults is outstanding, but the
process is not robust enough andis not suitable for larger
clinical trials orcommercialization.
What they end up to be is thatyou repeat those clinical trials
and that is a lot of waste, Alot of money, A lot of money and
a lot of time right.
(19:42):
So what we do is that we workwith the principal investigators
from academia or the startupcompanies.
We help them to understand whatis the ultimate goal for the
development is to bring thisdrug to market and in order to
(20:04):
do that we need to make surethat the processes of
manufacturing the products isrobust and can deliver reliable,
consistent product quality.
So, with that in mind, todesign the manufacturing
processes, the materials, and tosource the materials, the
(20:26):
starting materials for themanufacturing processes,
starting materials for themanufacturing processes in the
early days, so that you get somekind of standardization to make
the process more suitable forcommercial use, less changes
that you have to make later on.
(20:47):
That will reduce some of thekind of wasted work.
Matt Pillar (20:55):
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Ben Comer (21:58):
on the business of biotech, is that something you
would characterize, I guess, askind of landmark bios um sweet
spot, being able to take aprocess in academia or a process
in a small startup and help tostandardize it and make it into
something that could be scaledcommercially.
Do you see that as your kind ofprimary aim?
Ran Zheng (22:24):
It's definitely one of the unique features for
Landmark Bio and the competitiveadvantage for us as well.
I probably mentioned a littlebit earlier we we're in this
space provide CMC services to alot of our partners.
The people that we build aremost of them are from drug
(22:47):
development companies, so thisis an organization built by drug
developers for drug developers,so we understand what it's
really going to take to developthe processes, develop the
product and get to the market.
It definitely help our clientsand our partners to minimize
(23:15):
some of the I would say thepitfalls and the unfortunate
errors that you know many othersmade in the early days.
Ben Comer (23:28):
Yeah.
Do the challenges faced by acell or gene startup vary a lot,
or are there some keychallenges that you mentioned?
You know, for example,non-viral vector delivery as
something that I think you'reworking toward and it also
represents a hurdle for thesector?
(23:49):
Are there other areas thatcontinue to be challenges that
you know that developers andLandmark Bio are working to
overcome?
Ran Zheng (24:02):
There are a lot of challenges.
First of all, cell and genetherapies are such a broad
category we tend to lump themtogether, but cell and gene
therapies, you know, includingcell therapies, including
gene-modified cell therapies,viral vectors.
So there are some uniqueaspects of the challenges that
(24:24):
different depends on thedifferent specific modalities
you know.
For example, when we talkedabout the viral vector in the
AAV space, the titer, the purity, you know, definitely is one of
the challenges from the CMCperspective, but from efficacy
perspective, the capsid and thedesign of the capsid.
(24:48):
There are a lot of uniquechallenges.
We're certainly not doingeverything to address all the
challenges over there and wewant to focus on the things that
we believe that can move theneedle.
For example, we think celltherapy is going to stay.
(25:11):
There are already blockbusterpathologist cell therapies are
there.
If we can make those therapiesbetter and if we can manufacture
them faster and cheaper, thatwill allow patients or provide
better access to patients, justat least from manufacturing
(25:33):
perspective.
That's really our approach.
We're very optimistic in thenon-myogen delivery space
because we truly believe if wecan turn the complex product
into a relatively simplerproduct, easier to manufacture,
(25:56):
easier to deliver, that willreally change the field.
Matt Pillar (26:02):
Yeah, you're in an interesting space because in
many ways you have a firsthandlook at not just innovation but
business volume right, and I'vehad a couple of conversations
today with cell and gene therapyleaders who talk about sort of
(26:22):
the ebb and flow of the economicinterest, the finance
community's interest in genetherapy.
I guess, more specifically,what's your take on that from
your perspective, given that yousee, you know, you see the
innovation firsthand, you seethe volume of of interest in
manufacturing services firsthand, do you have a good feeling,
(26:45):
heading into 25, that businesswill be robust on the innovation
and funding scale, or is thereany cause for concern?
Ran Zheng (26:56):
I am a firm believer of cell and gene therapies and
the transformative potentialsthis class of therapies can
bring to patients.
And you know it's alreadybeyond the proof of concept.
Beyond the proof of concept,the challenges we're facing is
from, from business perspective,is that, yes, we have seen the
(27:22):
benefit on patients, but we wantto see more patients being
benefited by this new class ofmedicine.
Look, the innovation has novalue if it does not reach to
patients.
Yeah, um, I think that's that'sreally the fundamental
challenges over there.
Uh, right now, we want, we wantthis class of therapies to be
(27:45):
able to reach broader patientpopulation.
Um, and in order to that, thereare some technological hurdles
and we have to overcome.
But I I think the science isproven and it's validated in
human.
We know it works and we know ithas curative, transformative
(28:06):
potential and it's it's on us tomake this work yeah, it's uh,
it's interesting to me too.
Matt Pillar (28:15):
Like you said, the cell and gene therapies is a
sort of a basket term for awhole bunch of different
approaches.
How does a company likeLandmark ensure that you have
the expertise not just thecapacity, but the expertise to
stay on top of all this stuff?
Ran Zheng (28:33):
yeah, yeah, um, we, we set up our business to have
quite a broad capabilities, sowe're not just focusing on cell
therapies or gene therapies, sowe have a capability using cell
gene and messenger RNA, for acouple of reasons.
(28:54):
One reason is we think thisfield is still early and the
winners are yet to emerge.
And we have seen the fieldmoving from ex-vivo to in-vivo,
because we think that's wherethe field is going.
But we need to start in ex-vand we want to capture the
(29:17):
current opportunities, but stillwith eye towards the future.
And that's how we set up.
And there are a lot of spaces, alot of areas we can innovate,
and we definitely not try to doeverything.
And, as I mentioned, someplaces that we try to do
everything, and as I mentionedthat you know some places that
(29:39):
we try to innovate, as a non,for example, non-viral gene
delivery.
We think that's the area thatwe should focus on because it
address the underlying issuesfor cell and the gene therapy.
You've got to be able todeliver the genetic material to
the right cells and that's whatwe need to focus on.
Ben Comer (30:07):
What sort of delivery materials I guess are leading
the charge in that area to getaway from viral vectors?
Ran Zheng (30:15):
So we are looking into nanoparticle technologies.
Lipid nanoparticle is oneaspect.
We also have other non-lipidnanoparticles.
Is that?
Matt Pillar (30:32):
does the innovation there, in terms of delivery
vehicles, tend to happen fromwithin, or is it largely
influenced by the developersthat you're working with?
Innovation coming from thesponsor community?
Ran Zheng (30:47):
Well, we have seen both, but in that space I think
we see the opportunities thatthe sponsors would rely on their
partners to bring thetechnologies.
What we have seen more and moreis that sponsors focusing on
(31:09):
what inside of the particle,what inside that encapsulation
which is the know, the design ofthe, the rna, the design of the
dna and what the capability iswe bring in, is more of how we
could take those dna or rna oroligos and package them in a way
(31:33):
that they can guide to theright cells and the right
tissues.
Matt Pillar (31:37):
Yeah, Do you have you noticed any particular, I
guess, energy being devoted todeveloping delivery technologies
that you know seek targets thatare in places that were
difficult or impossible to getto before, like the blood-brain
(32:00):
barrier, different organs?
Is there sort of a movementafoot there?
Ran Zheng (32:04):
Yeah, you know, people try to deliver the
targeted genes to muscles, todifferent cell types, because
the current technologies, if yougive the current lipid
nanoparticle technology, youknow formulations, most of them
go to the liver.
Lung is another space where Isee a lot of development.
Ben Comer (32:30):
Do you have a sense of the broad, I guess, cell and
gene sector and how much itcollaborates?
And I'm thinking of, you know,25 years ago with monoclonal
antibodies, I think there weresome companies at a kind of
pre-commercial basis that wouldshare knowledge and work
(32:53):
together to try to bring thatfunctionality forward.
Is there a similar effort incell and gene that you're aware
of?
I mean, is Landmark Bio workingas a convener of sorts between
different companies and helpingto fill those gaps?
Ran Zheng (33:11):
Yeah, we're part of the Ningbo, which is a
consortium.
They have a lot of initiativesin cell and gene therapy space.
You know a lot of work beingdone in a V space.
It's a pretty competitive spacewhere people can share
knowledge and experience.
Matt Pillar (33:32):
Okay yeah, yeah.
What are you most excited aboutin terms of the cell and gene
space?
You talked about yourexcitement for the
transformative.
You know opportunity, right,the patient opportunity in cell
and gene, leading you toLandmark.
Now you've been there for fouryears, looking ahead, you know,
(33:53):
another four years perhaps, oreven a year.
What are you most excited about?
Ran Zheng (33:58):
The opportunities ahead of us.
I'm very excited about theopportunities in front of us
where we can really make adifference.
It took about 10 years to havea blockbuster of monoclonal
antibodies early days and wealready have a few blockbusters
(34:23):
of cell and gene therapy on themarket and start benefiting
patients, and that is veryexciting for us.
And also the amount ofinnovation in this space.
What we have seen isunprecedented.
That is something.
Also, the amount of innovationin this space.
What we have seen isunprecedented.
That is something that we'revery excited about.
(34:44):
Yeah, yeah.
Ben Comer (34:46):
What are your goals for JP Morgan, if you have any
that are specific to thisconference?
Ran Zheng (34:54):
My goal for JPM week is really to connect with the
industry, peers, the colleagues,potential partners and
collaborators, exchange ideas,explore collaboration
opportunities and really discussthe trend of where we're going
as an industry, as a sector.
(35:14):
It's a very exciting week.
Matt Pillar (35:18):
Yeah, where did you come in from?
Are you right?
Are you in the San Franciscoarea?
Ran Zheng (35:23):
No, I am based in Boston, but I also have a house
in Southern California.
Matt Pillar (35:32):
Okay.
Ran Zheng (35:32):
Yeah, so I actually came from the LA area, okaya
area.
Matt Pillar (35:37):
Okay, yeah.
Well, this episode will dropmore than likely sometime in
February, so a few weeks fromnow.
But as we sit right now, thingsaren't looking that great in LA
.
I'm hoping that everything'sokay in your neighborhood.
Ran Zheng (35:54):
Yeah, everything's okay in my neighborhood.
Matt Pillar (35:56):
We're fortunate, but it's very challenging time,
I'm sure yeah yeah, well, safetravels and thank you for
spending, like I said, some ofyour very busy week with the
business of biotech.
I I appreciate you coming onthe show and it's uh, it's great
to get insight, like I great toget insight from uh, a leader
in the cell and genemanufacturing space, given all
(36:18):
the questions and challengesthat are ahead, so we appreciate
it.
Thank you very much for havingme.
So that's Landmark Bio CEO RanZhang, I'm Matt Piller and I'm
Ben Comer, and you just listenedto the Business of Biotech from
JPM 2025.
Ben Comer (36:39):
Biotech from JPM 2025 .
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