In August of this year , the first TCR cell therapy to be approved for use in the US was greenlighted by the FDA for patients with resectable or metastatic synovial sarcoma who have previously received chemotherapy . It marked the first new treatment for those patients in more than a decade .
So it was a win for those patients and a win for Adrian Rockliff , who's had a hand on the wheel at Adaptimmune , the therapy's developer and manufacturer , since he joined the company as CFO in 2015 and subsequently stepped into the CEO's office in 2019 . I'm Matt Pillar .
This is the Business of Biotech , and on today's episode , we're getting to know Adrian and why he's all in on cell therapies and how he's applying a solid track record in finance and business development to make good on the promises those cell therapies offer Adrian . Welcome to the Business of Biotech .
Delighted to be here , Matt .
Welcome to the business of biotech Delighted to be here . Matt , I'm delighted to have you and congratulations . By the way , it was just so . This we're recording here in September for the benefit of our audience .
This episode probably won't drop until sometime in October late October maybe I'm not real sure , just off the top of my head , but the approval just happened in August . So exciting news for Adaptive Munich . Congratulations on that .
Thank you . It's fantastic news for us . Yeah , fantastic news for us , fantastic news for patients , fantastic news for the cell therapy field , all of those things and we're excited and , as you might imagine , just absolutely focused on launching at the moment .
Yeah . Yeah , I want to start out by getting some background on you . I want to rewind and kind of discover what makes you tick because , as we often do , we do a little bit of snooping and stalking on our guests . On paper , you're a finance guy through and through . You're a chartered accountant . You've got a PWC pedigree .
You've served in roles including president at SR1 Capital . Sr1 has been on the show before . You were VP of Finance at GSK . What sort of prompted this move into biotech leadership and , more specifically , that of a cell therapy company ? Tell me a little bit about that .
How do you go from being a PWC accountant to someone who dives headfirst into the life sciences space ?
I mean I'd love to say that there's a nice linear path , but I tend to be quite distrustful of people who claim linear paths to their careers . I I my first . My first love was was science . I went to university to read to read chemistry . I decided quite early on I didn't really like chemistry .
I switched to read natural sciences , which is a more broad-based degree . I did a lot of molecular biology , biochemistry , biology in that , and then at the end of that there's a choice , and maybe I should have realized that I'm a generalist by nature .
I'm not sure I did realize that at the time , but the choice was between okay , specialization in a field of science .
My third year thesis was on higher plant phosphatases , which is a really boring group of plant enzymes that are incredibly commercially interesting but not particularly scientifically interesting , and I really didn't want to spend the next four years focusing on that .
And this was early 90s and there was a recession in the UK and there weren't that many people who were hiring and I didn't know what I wanted to do .
So I went and I joined PwC or Coops and Librand at that point in time and part of the reason was well , it's another opportunity to get a broad based education in something to defer the decision about what to do for a while probably , and and it seemed like an attractive route to take . I'm not . I don't think many people classify me as a classic accountant .
I don't think many people classify me as a classic accountant but interestingly in the UK it's slightly different to the US , because in the UK those firms will take people with any degree . You don't have to have decided at age 15 you wanted to be a CPA or an accountant .
You could , like me , decide that that's something to do when you're 21 and having completed a degree in something else . So I did that for a few years and I really enjoyed it and I think it's foundational that lens and slant on how to analyze the finances of a business . But then I , by strange serendipity , came across an advertisement in a paper for a job .
It turned out it was a backseat welcome and I decided this was a good fit for me and I went . And I had no experience in the pharma industry at that point in time and I think not many 26-year-olds as I was then really do , unless they've been very unfortunate and so I joined into a finance group . But it was .
It was a deal finance group and that's that's the other thing . That's sort of interesting about my career at gsk , as though some of the roles are financially oriented . Very few of them were were sort of like classic finance roles until numbers right , yeah , it wasn't really until I got to cfo of north america about a decade later .
Decade later that I actually had a sort of classical finance role .
Most of the stuff in between was transactional , it was business development , it was running SR1 , gsk's venture fund , and so those roles on the interface of science and business which I think are incredibly interesting they're sort of scattered around companies like GSK but they're fascinating roles because they sort of urge you to apply the finance business side to the
science . But they also require at least some understanding of how you drive value out of science . And that was sort of essential in most of the roles that I had to that point , which were really transactional , leading up to running Worldwide Business Development , immediately before I shifted over to be CFO of North America .
Yeah , at SR1 , did you work with Simeon George or was he like , was he after you ?
Yeah , no , no , I hired Simeon , you hired Simeon . Okay , simeon joined around the time that I did and yeah , great , great little team and that I'm really happy with the success story of SR1 in 30 years at GSK and then the sort of spin out and the subsequent success that they've enjoyed .
It's a testament to the need for the opportunity for industry-focused venture capital to be effective over the long term .
Yeah , yeah , simeon was my guest , uh , a couple episodes ago . I don't have the number off the top of my head , but you'll have to check that out .
Fantastic interview , fantastic man , um , so , so I want to , I want to pick your brain a little bit about this sort of , I guess , uh , rationalization of , of of risk tolerance and financial responsibility , uh , you know , it kind of opens up that can of worms .
Right , you've got this long history and a proven history of being able to analyze deals , deal-making , the business , business transactions for for a big company like JSK . Lots of resources , cell therapy comes along and I don't want to fast forward . We can . We can kind of go forward in reverse here as much as we want . So I don't want to fast forward .
We can kind of go forward and reverse here as much as we want . So I don't want to fast forward too quick . But you joined Adapt Immune in 2015 as CFO and you did that for a specific reason , as I understand it , because you were bullish on cell therapy .
How does Adrian Rockliffe got to that point where you know I've been responsible with a lot of people's big money for for quite some time and now I have this opportunity to move into a field that at the time maybe 2015 , like there was a high degree of risk making that , making that move , um , I don't know just what . What was going on .
Give , give us a picture of what was going on in your brain at the time and how you rationalize that . The , the , the embrace of that risk .
Yeah , I mean I think there were sort of three fairly distinct reasons why I joined Adaptamine at that point . One was , I mean , just really simplistically , I was bored . I'd been CFO of the US business for four years and it sounds strange to say it and my managers and leaders at the time were like , well , it's a really important job .
And I was like , yeah , but it's not actually that interesting and it wasn't giving me the intellectual stimulation that I needed to be successful . And I didn't . I was , I'm , I'm not a particularly good maintainer , I'm a , I'm a good builder , but I'm not a good maintainer . And so so that that was one .
And then the second second piece was , you know , a strategic decision , a couple of strategic decisions that gsk made and don't get me wrong , I think very highly of my , of my time at gsk and of the company . And for reasons that I completely understand , they made two decisions they got out of neurodegeneration research and they got out of oncology .
And the second one they did a big transaction that involved them giving their oncology to Novartis and it was a great transaction for GSK . I don't think it was a bad deal , but it did mean that they got out of those two spaces and I was sitting there going .
Well , what do we care about In the Western Hemisphere , which is the place that actually pays for most of the pharmaceutical R&D to happen in one way or another ? I think those are the two things that if you ask anybody on the street , they would say what's your biggest health fear ? They would say cancer or Alzheimer's or your brain going .
Now they probably should say cardiovascular disease and obesity and all this other stuff , but those are two big fears and so GSK getting out of them , I was just like , what are we doing ? And I got to the point in my career where I was like , okay , I want to be doing something that is very significant contribution to human health . What do I know ?
Well , I've looked at a thousand biotech companies . I've done diligence on hundreds of them over the time that I was running BD or bits of BD or SR1 . And suddenly there's this field of cell therapy that's out there and starting to get to prime time and it strikes me that this is sort of similar to what happened with protein therapeutics 20 years previously .
This is a new modality of therapy . This is a significantly different way of treating patients . That would come with a whole set of opportunities and risks and challenges risks and challenges but that if it worked and that was still a fairly big if if this worked , then you change the world .
You don't just change an individual patient's life or an individual therapy . This isn't one drug , this is something that , if this works , we transform how cancer is treated and our relationship as a species with cancer .
Um , we have the opportunity to do that and I , I think so , I still believe cell therapy has that opportunity , um , and and so , looking at that , it was clear that a lot of the interest in that space at that time but still still the case is in the hematological malignancies in blood cancers .
So the CAR-T therapies were really big and that's great , and those have completely transformed that space . But the solid tumor space , the cancers that everybody recognizes , that don't have confusing acronyms that are named after major organs , those things struggle to be addressed with the CAR-T .
And yet here was this company , here was this thing , this way of approaching these with adaptamine , that was applicable to these solid tumors and again , if it works , it's huge . So when you think about risk , it's difficult to think about risk without thinking about the opportunity .
And at that point in time and I still believe this to be the case the opportunity in solid tumors with cell therapy is so enormous and so fundamental that , yes , there is a high risk that goes with it , but that is offset by orders of magnitude by the opportunity if we can get that right .
In same way that that , um , that uh monoclonal antibodies were for , for , for uh biopharmaceuticals back in back in the day . I mean I . I was at gsk from sort of 98 through to the early 2000s period when gs , when all the companies , large pharma companies , were thinking about do I get into biopharm ?
If you told almost any company then that you know seven of the top 10 selling pharmaceuticals would be biopharmaceuticals in 20 years time , I don't think they'd have . I don't think they'd have believed you . And the number one selling product in the entire world would be a , would be a . Biopharm would be humira .
I don't think people would have recognized that at the time . And so I , and I think that the opportunity in cell therapy is , um , at least as significant , uh , as that in monoclonals .
Yeah , that opportunity and sort of that , that analogy it's . It's intriguing because you said , you know you , you don't think people would have believed it at the time that a biologic would be the biggest selling therapy in the world . And they wouldn't have believed it at the time . Well , you tell me why , like , why wouldn't they have believed it ?
Yeah , you tell me . Before I tell you what I think , you tell me why not .
Well , I'm very interested in what you think . My perception is that we get stuck in paradigms , um , and the practitioners of that paradigm have a great deal of difficulty in understanding the succeeding paradigm . And the succeeding paradigm is rarely replacing the previous paradigm , it usually just adds to it in , in , in therapy , um .
So if you think about small molecules , all the practitioners of making small molecules were focused on the benefits of small molecule and their entire organization was set up to realize those benefits . And then we've sort of convinced ourselves that those benefits trumped other things . So , for example , well , patients like pills , they don't like injections .
So you come along with an injection and patients , um , you know the less value given to , uh , you know the interval between doses . Um , a real understanding of small molecules and how they interact and the positive elements of those makes you less inclined to really believe the benefits of protein-protein interactions that you might get from biopharms .
And so you downplay in your mindset of I'm a small molecule drug developer . You downplay all the things that make biopharms important Critically . It's those things that make biopharms distinct that actually deliver the benefits and the risks of that new modality of therapy . So every time a new modality comes along , it has certain inherent features to it .
In biopharm terms , it's almost always going to be injectable . Yes , people have talked about oral biopharmaceuticals , but the vast majority are going to be injectable . They're going to have a long time in situ . Half-life is measured in usually weeks or months , not in hours or days .
They are capable of exquisitely tight binding to a target because that's how the protein has evolved in order to deliver that . And so there are a set of properties that then confer .
Then , if you leverage those in development , you can confer clinical benefit to a patient from that , and those are going to be fundamentally different to the clinical benefit that you get from a small molecule because of the intrinsic nature of that modality .
And so I think when people were turning up , you can imagine I've got a brand new biotech company full of protein engineers turning up to talk to a medicinal chemist at a large pharmaceutical company about drug development , and you know well why couldn't I just drug that with a small molecule ? And how much are you going to charge for that ?
And none of those questions are convincing for the people who live in the previous paradigm .
So I think that's that's why , yeah , no , I mean I and I would agree with all that . I guess , I guess I would add to the conversation .
I mean , one of the whys is the , the complexity , right , like we're at a point now where antibody manufacturing I'm not going to , I'm not going to discredit antibody manufacturers , I mean , and you know we're seeing such to discredit antibody manufacturers .
I mean , and you know we're seeing such such incremental improvement to antibodies by specifics , and you know what we're doing with ADCs now , like , there's they're supremely complex . At the time that was the case . That's where we are with cell therapy right now .
It's a , it's an incredibly complex paradigm and I think that there's I don't want your opinion on this I think that there are there's often the misperception that the value of the company , the value of the company , is in the final product , and that's I don't .
That's not the case in biotech , certainly not in cell and gene therapy right now , where we're developing the systems , processes , equipment , you know , to make the values there right , like at this point , I mean , obviously there's , there's great value in a , in a product like the one that you just had approved to Celera , that you know has clinical benefit that we
haven't seen in a long time and is is , uh , you know , stepping in where we haven't seen advances in in 10 years . But adaptamine was valuable before that approval . So I'm interested in your perspective on that , like as you look at the way that the cell therapy space is playing out , the development of the capabilities and processes and equipment .
How does that relate to the value , the valuation that we're putting on all these cell therapy companies that are popping up ?
Yeah , I think that's a critical point and I think the starting point for me is that if you think about how pharmaceutical companies and biopharmaceutical companies create value , think back . Think any large pharma company . Once upon a time they weren't very large .
Essentially , once upon a time they were a lot smaller and they became successful because they captured , sometimes a particular technology , but much more often than a particular technology is they .
They manage to find a way of integrating multiple technologies along a value creation chain that starts with target identification and goes through , you know , identifying the right compounds and then testing those compounds in vitro , in vivo , and then being able to make them and then being able to do the clinical trials effectively and assess the patients effectively so
there's all's also technology around that in translational technologies , et cetera and then ultimately be able to bring that to market via a regulatory file which takes a specific set of knowledge associated with that . And I would argue that actually , the individual components of those technologies have a certain value .
But what pharma managed to get right was the integration of all those technologies into capabilities to say , well , this isn't just a technology play , this is I can develop this medicine , I can discover a drug , a new drug against the target .
That's the integration of a lot of technologies and I think , as new modalities play out and you think about this for biopharmaceuticals versus small molecules , you think about it for oligonucleotides and now I think about it for cell therapy , cell and gene therapy as these new modalities play out , I think one of the interesting things is that those technologies might
differ and the integration of them differs . So the capabilities that you're building from the integration of these technologies and people and processes etc . Look very different for a cell therapy company than they do for a small molecule company .
And as the new modality is developed and we're the first solid tumor , there's a few cars out there , there's some tills coming through as well all different types of cell therapies . As those therapies get developed , those capabilities get framed up properly and built by the companies that are trying to do them . Now that doesn't necessarily mean they're all internal .
They can be outsourced as well , depending on the maturity of the market . But the integration of those technologies into capabilities is critical . And for cell therapy those capabilities look very different to the capabilities for a small molecule and I think they have intrinsic value .
But they really only have intrinsic value because they enable you to develop products that ultimately , the real value creation point in this industry is when a patient patient goes to a doctor . The doctor prescribes a medicine or a treatment and the patient receives that treatment . The patient gets value , uh benefit from that and somebody pays for it .
That's the value creation point , and so the reason I think these capabilities are valuable is because they enable you to develop those products . I don't think you can develop cell therapy products without cell therapy development , discovery , development and delivery capabilities .
Yeah , and Adaptimmune has developed those capabilities internally and is in fact manufacturing T-Cellera internally , correct ?
Yes , yes , yes , we are . So tell me here in the Navy yard .
Yeah , right above you there . Yeah , so tell me a little bit about that . So you , you joined the company in 2015 as chief financial officer as , as I said , ceo in 2019 . What , what went into this decision to internalize the development of of these capabilities that you speak of ? And I , you know , I mean we look at .
We've been referring to antibodies , like I don't know . I don't know that there's outside of like big pharma and maybe some mid and larger size players . I don't know that there's a single antibody development company out there that's going . You know , oh yeah , we completely want to put a shovel in the ground and build , you know , brick and mortar facilities .
Put a shovel in the ground and build , you know , brick and mortar facilities , Although you know who knows , with the biosecure act , that could be changing . There's some , there's some outside influences that are maybe going to mess with that Cell therapy .
I know it's different , like I know that a lot , of , a lot more of this stuff is internalized , but as CFO of the company , you know , go back to those days , the CFO of the company at that stage in the therapeutics development what went into that decision-making process around building versus buying ?
So . So starting point fundamentally , what are you trying to do ? Define a strategy , align resources around that strategy very tightly and then execute on it . Really a why why is it strategically critical to build cell therapy manufacturing in-house ?
Because , if you accept , that it is , then it's a fairly simple decision to finance it , and I think there's a number of reasons why we think that is One the market was , and still remains , pretty immature actually , in terms of an external market to go and source those capabilities for .
And that is actually similar to how it was in the late 90s , early 2000s , first decade of this century were for biopharm companies .
So if you look at that generation of biopharm companies the ones who successfully brought product to market , most of them did make the decision to invest in biopharm manufacturing and they then subsequently also made the decision to sell that biopharm manufacturing and lease it back , or to actually not build the next plant and get subcontract back from somebody in a
usually a lower cost jurisdiction as well . And so I think that's because over that time period the market matured .
The market matured , but also and this is the second reason why doing this in-house at the moment makes sense the technology became essentially commoditized , commoditized and transparent , and one of the things that is a key challenge in the cell therapy space is uh and I'm going to state as a definitive statement what is actually , you know , a graduated statement , but
we don't really know why cell therapies work in some patients and don't work in other patients . The complexity that you referred to earlier is inherent to the product and it's probably why the product is effective , or a large part of it is why the product is effective . So you think about the cells here .
We call these things CD19 CAR-T cells , we call these things CD19 CAR T cells , or for T cell row , we say that it's a MAGE A4 targeting T cell , tcr T cell . But in reality we call it that because that's the bit that we changed , that's the bit we edited and we inserted new gene in to get it to do that .
In reality that cell is doing 150,000 other things all at the same time , and those other things are quite important when it comes to what the efficacy is . And so you can change what that cell does genetically by inserting new genes in CARs or enhanced TCRs , and you can insert other genes as well to get it to do other specific things .
But you can also change how that cell performs by how you make it in a way that is orders of magnitude more important than it is for glycosylation patterns on monoclonal antibodies . And so the manufacturing of cell therapies defines it's not just that , it defines that this product is that thing ?
It actually defines the efficacy and the safety of that product , and so , as we think about that , we don't understand how that really works , and yet there's so much knowledge to be gained about what an effective cell looks like and how you can define that through the manufacturing process .
It was key to us from an early stage that we had to have control of that , because it doesn't just enable us to service patients on a patient by patient basis and everyone needs to be right .
It also gives us incredibly valuable information about what constitutes a good cell therapy product that you feed back into your research organization , into your translational organization , and you change your GMP manufacturing to produce better product iteratively , and so therefore , it goes from being something that is a means by which you produce your product to something
that actually defines what your product is and therefore is much more strategically important if you're interested in getting the best possible sale product over time .
So that's why we did it , and I dread to think what would have been the situation if we had not had manufacturing in-house when we went to do the BLA with the FDA , because not having control of that would have been , I think , very problematic .
Was financing that initiative as simple as giving your stakeholders that profoundly eloquent justification ?
that you just gave me .
Was it that easy ?
No , I don't think it was To be that , which was variable , and the starting of being able to finance the company properly that made us make that shift , and one of the sort of pivots was in 2014, . We did our first major financing as a company . We'd previously been financed in the UK by high net worth individuals in the UK .
We did our first proper financing private round and then six months later , we were in public and that private round brought in Orbimed and NEA and some new board members , many of whom had experience with BioPharm , and there was a discussion at their very first board meeting after that , which is we have to be a manufacturing tower of strength if we are gonna be
successful developing this pipeline . So that , combined with the ability to pay for it , the financing private and then public was what sort of triggered that investment in this facility .
Yeah . What are you seeing in this space now in terms of the appetite for internal manufacturing investment ? Is it changing at all ? I mean , do you see it like is it changing one way or the other , like is it becoming more acceptable to say , hey , we need more money because we need to ? You know , own this process development , this manufacturing capability ?
Or is it going the other way , because we're starting to see some maturation of the technology and some , you know , better equipped outsourcers pop up ?
Yeah , I think both things are true . I think that they're both . So the field is expanding . I think your autologous cell therapy field is expanding .
I think there are now more mature , credible third-party CDMOs , including those that will take your process from very early stages and sort of provide that sort of outsourced process , development and manufacture sort of in one flow , in a way that is suitable for cell therapies , which meets the requirements of autologous cell therapy . So I think that does now exist .
However , I do think people are very definitely now looking , though , at the fact that if you want to be commercial , then you have to think about , well , obviously , doing at least your pivotal trial out of the same manufacturing facility that you want to commercialize out of , and possibly even you want to go before that , and so there is , I think , an increasing ,
there's also an increasing understanding that continuity of that manufacturing makes sense . So if you can afford to build that out yourself , if you have a pipeline , then I think there are companies like Iovance , across the road from us here , who have gone that route .
Autoless is another one that's investing in internal manufacturing , and so I do think there is the opportunity to still support manufacturing for significant products .
The pipeline discussion is important , though , because these things only really work at some level of scale , and so if you only have one product , ever one product , and you don't have the need for that iteration that I talked about , because you're never going to have another product , and then actually outsourcing might be a very credible way of doing this , and I
think it is starting to be feasible . A very credible way of doing this , and I think it is starting to be feasible .
I think it will take another 15 years , 10 to 15 years before we're in the same position as the biopharm industry is now in , where you wouldn't even think about building in-house unless you were a very , very large company with a very , very large product .
Yeah , is there a ? This is totally question , maybe totally out of left field .
I'm just curious Is there a sort of a de facto , like a not not de facto , but like a an attitude du jour specific to the industry that you're in in terms of you know , you just , you just talked about like , if you want to go commercial , like this is this is a logical way to go , you know , in , you just talked about , if you want to go commercial ,
this is a logical way to go . In . So much of biologics and so much of the biopharmaceutical space , biotech , smaller companies , commercialization is either a pipe dream or it's way down the radar . It's like a lot of stuff is going to happen between now and phase three .
You know what I mean , and some of that stuff we'll be happy to embrace and shop and put up for sale and moving around . Is it the same in cell therapy ? We don't cover as many cell therapy companies on the business of biotech as we do . You know antibodies and ABCs and vaccines and that kind of thing . Is it the same there , or is there more sort of ?
You know , when you look around at the landscape , is there more sort of an attitude like , hey , you know we've got this very proprietary approach and we'll talk a little bit more about that transparency of technology and how that kind of juxtaposes with proprietary and differentiated processes .
But back to the question is there sort of this attitude like hey , a lot of companies want to be a company that you know sees therapeutic candidates through to commercialization , cell therapy versus you know just kind of building a business for for for saleable value ?
I think there's still exploration of what the right business model is for cell therapies . I think if there is an accepted wisdom in the space , it would be that if you want to be in cell therapy at this point in time , you've got to be all ines cell therapy and is not distracted or challenged by other needs .
Now that is possible to do in a large organization . I'd say the Kite-Gilead relationship is a good example is a good example . I'm sure that other companies have managed to work out how to organize themselves to bring that focus on cell therapy .
But it also means that there's a large number of companies who have not gone all in on cell therapy yet , in the same way that loads of companies didn't go all in on monoclonal antibodies till the mid-naughties , and therefore I think that it's difficult to sort of think about .
Well , you know , you could just take a cell therapy and put it in your normal business Whilst , for as long as that exists , as long as this requires a sort of unique focus , there is an opportunity , I think , for companies like Adaptamune , like Iovance , like Autoless , that are wholly dedicated to cell therapies to say look , actually the most important thing to be
successful here isn't actually scale , it isn't actually global reach or footprint . The most important thing is thing is is is specificity , it's focus on uh , uh , on on on being a cell therapy company , um .
And then the other complicating factor that just gets in the way when one thinks about commercializing is if you , if you want to , the large part of the commercial story or the way that we make these medicines available is in the supply chain .
You know , ultimately this needs to come out of a hospital , out of a patient , into our facility , get engineered , go through our process , go back , and that is a large piece of the logistics that cell therapy companies are investing , invest in in order to make that successful , um , and and that attaches to the product and it attaches to the BLA .
So where you manufacture this sort of is sticky . Now , that doesn't mean that you couldn't have somebody commercializing who's separate to the manufacturing , but by and large , those two things being together makes a lot of sense too . So you put it together and I think both models will work sale , sale , and then somebody else does it .
But they've got to be committed to sell therapy , and I think that's a subset of the biopharma universe that are yeah , All right , I want to jump back to that transparency of technology conversation .
You mentioned that . Did you coin the phrase ? Is that yours ?
No , old phrase going back to history of science .
Okay , all right , yeah , but we don't want to equate it directly to commoditization , do we ? They're related , but not parallel .
I think so .
I mean the transparency of technology sort of refers this sort of interesting , interesting phenomenon where the first time people are experimenting and they're on the sort of edge of knowledge , then , because they don't always understand the parameters that are important , there's a tendency to describe experiments in a way that includes a whole load of extraneous information
that over time we realize isn't important . And so the often used example is if you go back and you read Newton's stuff on light , he goes into great lengths about where he bought his prism from and how he set it up and et cetera , to split white light into the rainbow .
And then within 20 years everyone was like got prism put in light , saw rainbow , and that was the experimental method . And the same thing happens at all these technologies , and I think it does go along with commoditization .
It goes along with well , if you do really understand it , then you can optimize it , then you can reduce it to practice , then anybody can do it .
Yeah , yeah , and so that's where I want to explore your thoughts on just for a minute . And I mean , maybe the continuum is so long and stretched out in front of us that it's not like a thing that keeps Adrian Rockliff awake at night , right , like you , in in my simple mind I see , I see conflict , I guess conflict or friction .
There's tension , right , there's tension between the mastery of a quote , unquote , proprietary skill or technology or approach and the , the desire to get to a point where , for the benefit of humanity , these things that we're building are to your point . You know , buy a prism , put it in the sun , get a rainbow , you know ? Um , do you know ? Do you ever ?
Do you ever contemplate this tension ? Or does it not necessarily concern you right now ? Because , as I said , maybe you and I will be long gone by the time the transparency is so great , or maybe we won't be , because of the things that you're working on , because of the things that you're working on .
I mean , I think to an extent this is sort of a variation on the theme that the pharma industry lives with all the time . The biopharma industry lives with all the time because , essentially , what we're talking about isn't that different to what happens with a drug going off patent .
Yeah , so you know and we live with that and it's actually part of the culture . In fact , you know , there's a strong argument that says that actually the value that we are contributing to society yes , we measure that in terms of newly approved launch drugs and the value that we can create from a sales .
But in reality , from a societal perspective , you're interested in when that drug goes off pattern .
And I think you know , as an industry , we live with that and we accept that our job is to bring that forward , understand it well enough to be able to reduce it to practice , get that registered , back that up with data that shows to practice , get that registered , back that up with data that shows clinical benefit , get it registered and then be able to
monetize that for a period of time , and then it will go off patent and we should logically accept that it goes off patent because that's part of the contract we have with society .
We'll mark these words down . When T-Cellular goes off patent . We're going to revisit this with Adrian and find out how he's feeling about it .
The challenge with monoclonal antibodies , with these other technologies that have been produced , particularly where the manufacturing process is the product defines the product , I think . I think this has been shown to be more challenging . So , people , there are some people who say there will never be generic cell therapies .
Um , and I tend to think that never is a long time when it , when any , when any eminent scientist tells you that something's impossible , they're almost certainly wrong .
Incidentally , it's just a question of time , resources and if you think about the incentives , if cell therapy is , as I believe , one of the largest opportunities for value creation , then when Humira went , when was when Humira was approaching genericization , there were 20 billion reasons why , why people would like Humira to go generic .
I think , in the face of that , you know the the industry once said there'll never be generic biofarms . No , there aren't generic biofarms , there are biosimilars .
They they perform the same function , not exactly the same , but they will , over time , I think , make that democratized access to biopharmaceuticals , and the same will be true , in some way , of cell therapies .
I don't have a clear angle on how exactly we need to evolve the regulatory world in order to do that , but I do think that it lies through the same things that I was talking about before , which is a better understanding of the relationship between the product and the manufacturing process and the outcomes .
Because if you could know which were the salient features , the critical salient features , then you could define what it would take to produce a product . Maybe it's not exactly the same , because actually every patient cells are different , but it would be essentially the same product and then you could define a route through to approvability of that .
Yeah Well , thank you . Thank you for indulging some of my more naive , naive questions . I appreciate it . I want to jump back in the time that we have left . This time is going by very quickly with you , adrian , as I knew it would .
Having the benefit of a conversation with you a couple of weeks ago no-transcript , a chartered accountant and a CFO , but you've got the deal-making experience . You've got the .
You know the , the hard cold , you know a lot of , plenty of science experience , but I'm curious about how you know it occurs to me that the financial chops that you've earned over the years would be like a great skill set to have in your current role .
Perhaps also there might be times where it's , you know , sort of a drag to look at everything through the financial lens , um , so I want to jump back to that real quick and just kind of get your perspectives on where that financial and deal-making experience has been like incredibly beneficial to you in your role as CEO at Adaptimmune , and perhaps , maybe a little
bit on where , uh , that experience , um , may I don't know weighs you down or otherwise causes you , uh , you know , internal strife yeah , um , I think my starting point is that I'm not sure anything is appropriate .
Any reasonable route is appropriate preparation for being ceo , uh .
So , and you know , if you think about it , if you thought , okay , well , what , what are the , what are the areas I need to understand to be the ceo of a biotechnology company , and you thought about this from a acquisition of knowledge and skills , um , perspective , you'd say , okay , I need to spend five years in each of the component areas .
Okay , all of our CEOs would be 140 . And I'm not sure they'd have the energy to be a CEO at that point in time . So I think the question is okay , which bits of this prepared me ? Well , but where were the gaps ?
And I think most of those places I look at not actually from a skills and experience perspective , although that's clearly part of it , but from a sort of leadership perspective , because I think skills , particularly as ceo , you have the opportunity to build a team and there's almost no set of skills that you can't , um , you can't , uh , uh , find and and have in
your team . You don't need to have them all yourself by any stretch of the imagination . So then , what is it from a , from that background , that that is has been so . Then , what is it from that background that has been good and what is it from a leadership perspective and where are the gaps ?
So I think the spaces where it was good for me was I think business development and those transactional experiences , including investing at SR1 , et cetera , were exercises in integration , integrating disparate data and information to form a view and to make decisions and judgment , and you know very much not .
Okay , these are the numbers and this is what I'm going to do , pulling it all together , and they're also , interestingly , I think , the BD side was . If you think about you go and you do 45 due diligences on late stage , very late stage assets that completed phase three , you're going to do diligence on one of those .
You get to see everything that's happened in the last decade of drug development in the asset . It's an amazing privilege actually . You get to think , well , why did you make that decision and how did you think about that clinical trial and that one failed ? What did you do ? And you get to understand all of the correspondence with the FDA .
So it's like living an entire decade of drug development .
In that drug you can basically vicariously access what the people who led that drug development sort of experienced over that period of time , and so that's an amazing opportunity to get a breadth of knowledge about how different companies have made different decisions and which turned out to be important or not .
So I think all of that is sort of like okay exercises , the sort of integrative thinking chops , and also , I think , speaks to the importance of those teams . Are teams that come together , break apart , come together , break apart , so building and effectively managing high-performing teams often overused phrase but towards objectives . That piece is also there .
Objectives is sort of that . That piece is also there . I , I , I think where it ? Um , it also speaks to some things that I have that are , uh , peculiar . I , I think I was successful and good at that because I am , I have a pathological comfort with ambiguity . Um , yeah , off the spectrum I am completely okay with .
I don't know any of that and I'm okay with all of that .
And that's actually sort of , you know , a weakness actually when it comes to running much larger organisations where a load of the people who work in that organisation need a clear route forward as opposed to a whole series of options , and so so there's a bunch of stuff that that helped me in that , and then there's a number of things that didn't from a from a
leadership perspective that I had to build elsewhere . The last thing I'll say is you know , and this is , there's a lot that you can learn on the ground in biotech , and my exercise in the last nine years has been just immense amount of learning from a leadership organization or science business perspective .
But the large pharmaceutical companies I think large companies in general run pretty effective leadership development for their people , and so I did have the opportunity to take advantage of some fairly structured and fairly what I now understand .
At the time , I'm not sure I really understood the value of this always , but now , looking back , I'm like I got access to some world-class leadership thinking that evolved me and was incredibly useful when I did step into this CEO role .
Yeah , very good , very good , all right . So in the time that we have left , which is very little , very good , very good , all right . So in the time that we have left , which is very little , I want to maybe glean some insight from this . Is a giant . It's a terrible one to end on because you could go really long on it .
I'll try to be precise .
We'll do it another time We'll get into the whole . I mean the clinical . I'd love to have an hour-long conversation with you about your clinical trials experience . We'll do that another time . We'll do that another time .
But what , I guess what are some of the more , the more pithy or valuable lessons that you learned recently in this approval process that you might feel compelled to share with another biotech founder or CEO who is you know , maybe , maybe on the cusp of one has an experienced one .
I think one . It will take longer than you think . Okay , Particularly if you haven't experienced it , it is almost certain to take longer than you think and it will require substantially more resource than you anticipate .
And particularly if you've come from a large pharma , that might not be obvious because they have large departments and groups that do this stuff and those resources are available , Whereas with a small company you have to be explicit about either having them or accessing them , and it's substantial .
So I used to say that something like a quarter of the company during the BLA was pretty much dedicated to getting that BLA . So that's 100 and something people for the course of 18 months or so . That's one I think .
Secondly and this I think people will debate because I think there's always diversity of opinion on this , because I think there's always diversity of opinion on this , but there is a time and a place to have scientific debate with the agency and to try to drive for the best possible answer .
I would suggest that time and place is not while you're trying to get a product approved . When you're trying to get a product approved , the first part is okay . Let me understand really , what the agency wants and make sure that those are well thought through .
And then the last piece of that , which goes on for a decent amount of time of writing and then engagement with the agency , is delivering that . Not arguing about it , not suggesting that it should be something different , just okay .
How do I deliver what the agency has told me that they need , particularly when they've told you repeatedly and particularly where you know it might not be what you want to hear .
You might think you have a better answer , but actually the answer is consistent with the agency's role , and so I think there's a lot of biotech companies and I certainly saw a lot when I was in BD who would say hey , yes , the agency asked for this , but we're going to do this instead .
And then they're surprised when the agency sends them a letter saying we're not approving your product because we asked you to do this and you didn't . Now that's obviously subject to nuance .
I'm not suggesting the agency is omniscient , but in that process of approval they are omnipotent , and so , whilst you can discuss and make sure that you are aligned on what you want , what you want to have , at the end of the day your job is to deliver that and to get that product approved , since that , for most companies , is the most important thing you're
doing at that point in time .
Yeah , incredible . That's super thoughtful advice , great response . Do you have time to just wrap it up with one more ?
Yeah , yeah sure .
Yeah , just I'm hoping we can wrap things up with a look ahead Without saying anything forward-looking . That's going to get you in trouble . Ahead without without seeing anything forward looking , that's going to get you in trouble . Uh , what ? What's going on with the pipeline now , post post approval ? Uh , what's on the immediate horizon for adrian rockliffe ?
so post , post , post approval t-cell we are we're we're launching , we're rolling out into the atcs um . If you go on to the t-cellcom website you'll see that there are seven treatment centers accepting patients referrals at the moment . They're building that up to 30 . So we've got a network across the country that will cover the patients with synovial sarcoma .
These are the top sarcoma centers of excellence in the country . Behind that , that , behind t-cell is , is lettuce cell . Lettuce cell is very similar to t-cell and engineered tcr t-cell therapy for soft tissue sarcomas . It's about two years from approval um . It completes its pivotal trial .
So we're moving forward with that to get that registered um and then we'll be able to commercialize that through exactly the same footprint that we've developed for the launch of T-Cell . So there's a lot of operational synergies there . We feel really good about that . And then behind that is a pipeline of products targeting things that are not Sarcovers .
So UserCell is the most advanced that's in a phase two study , could potentially be registrational , depends on data and timing , et cetera for platinum resistant ovarian cancer .
So starting to get into those larger oncology markets where cell therapy I think should be able to really demonstrate the benefits of a single , of a one-off therapy with hopefully transformative benefit in those broader tumor types , but all that to be proven , long-term whole load of preclinical stuff moving into the clinic over the next 24 months as well .
So I think , yeah , integrated pipeline T-Cellular the first product . We've got to do a good job with T-Cellular because , apart from the else , as well as getting to the patients with T-Cellular who desperately need it , I think it will also reflect on the opportunity in the rest of the pipeline if we are successfully able to commercialize .
T-SAL Very exciting . Thank you so much for coming on the show , adrian . Like I said , I really appreciate the sincerity and thoughtfulness in your responses to my questions . There's a ton of value here , I think , for our audience and I really appreciate your time . Absolute pleasure . Thanks for having me . Yeah , fast hour right , very Fully passed .
Yeah , we'll have to do it again soon . I'll be in touch with your people , love to . Cheers man that's Adapt Immune . Ceo , adrian Rockliffe . I'm Matt Pillar . You just listened to the Business of Biotech . We're produced , produced by life science connect and we represent the entire community of learning , solving and sourcing resources for biotech builders .
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