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FORUM TRANSCRIPT

CRO Industry – Q2 2022 Update & Competitive Dynamics

  • Public Equity
  • Healthcare
  • North America
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Specialist

Former executive at Pharmaceutical Product Development Inc (PPD)

Agenda

  • CRO (contract research organisation) market trends and themes
  • Competitive landscape across the CRO industry – Iqvia (NYSE: IQV), PPD (NASDAQ: PPD), Covance (NYSE: LH), Charles River Laboratories (NYSE: CRL)
  • Contracting models in the CRO industry – product-based services vs outcome-based models
  • CRO focus on patient centricity and DCTs (decentralised clinical trials)
  • 12-18-month growth outlook for the CRO industry

Questions

Transcript

1.
What recent developments and shifts within the CRO [contract research organisation] industry are worth highlighting?

Specialist (SP): I think some of the recent shifts which have happened in the contract research industry particularly have been a lot of acceleration. Contract research industry has had a lot of new work in the last two years. Again, there has been some slowing of capital for biotech firms in the last quarter or so, or in 2022, until 2021. Because of high influx, there has been a very high growth rate of all the CROs and that has lifted all boats until, I think, the beginning of this year, but, primarily, some of those have been related to the acceleration of a lot of COVID-related business. Since COVID happened in the last two or three years, (1) there have been a number of CROs, I think particularly the top five CROs, I can very confidently say, have been involved in a number of therapeutics, vaccines around COVID development. That has accelerated a lot of the business and then that has also spurred, while at the same time, a number of innovative-related things, because access to patients, access to sites was difficult, and thus, everything which was more in trial mode or technology-wise became real-time. We couldn’t get patients to sites, so how do we use that? Decentralised trial methodologies became more mainstream in many ways. Not fully decentralised, but in many ways, what do you think about the hybrid type of models?

Then risk-based monitoring, which was gaining traction even before the COVID hit in 2020, but everything became, because you couldn’t really do 100% source data verification, so another technology advancement. Things like accessing direct EMR to EDC types of things, how do you transfer most of the data, do it remote, I think, became, so there have been a number of accelerations on the technology side which have pushed the industry forward and have caused a lot of growth. While, at the same time, I think one of the other or the biggest challenges that CROs have also faced is being able to keep up with supply, and that is where inflation has led to wage inflation in this industry quite a lot and there have been a lot of job shifts and people have taken up different jobs, so being able to keep a stable team, which is important, has been a big problem. There is only so much the growth can be done in a certain way, which is a very people-intensive business. CRO is still a lot of people-intensive business, so to be able to manage that growth has been quite a challenge for the CROs and the pharmaceutical industry alike.

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2.
What is the impact of the recent inflation and high labour cost pressures on the CRO industry?

SP: Again, it would be my guesstimate in terms of doing that. I now, at least for the last year, or it’s exactly a year since I left my last CRO employment, but I’m now a customer to that, so I can tell you, from my read or just an overall read, the wage inflation, the estimates would be anywhere in between 10% to 15% as, particularly in growth, they haven’t made that many adjustments, but they have done some retention bonuses or things like that for the employees who are there and then the newer employees, to attract them, to be competitive. I think at least 10-15% is what my guess would be. Just to get more and more, I don’t think they have yet passed on many of those challenges to the sponsors as of yet from a pricing perspective, at least not from what I’m seeing in the current scenario, at least the mid to small pharma. It is possible that some of the larger contracts, they may have passed on some of that, but that’s what my guess would be.

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3.
Sources estimate that the biotech and pharma companies outsourcing services market size will be more than USD 90bn by 2028. How would you assess the demand for outsourced pharma currently, and what percentage of companies are outsourcing their services vs maintaining in-house capabilities?

SP: This information, from the accuracy and the modelling perspective, I haven’t very recently looked at the numbers per se, but I think most of these numbers, you can take the Evaluate Pharma staff reports or things like that, I think they are fairly in the same ballpark around that number which you project. It could be more than that, but my opinion on this primarily would be that it would be more north of that since there is a greater inclination for even the smallest biopharmas to not have in-house staff as much. If you follow the news, even in the most recent reorganisation announced by Novartis in the last couple of weeks’ time, where they are creating major lay-offs and things like that, wherein Novartis was very well-entrenched and they have a huge outsourcing budget and is a major pharma. Everybody is right now looking to outsource more and more than they would want to do and keep it internally, so I think that that number would be probably beaten by at least 10-15% towards the north side, that it would be USD 9bn-10bn more than that because there will be an acceleration.

That acceleration, again, I would say it is going to be because of the fact that we will have more technology deployed, and thus, the oversight which pharma wants to have could be enabled much, much more easily than has been in the past, and I think that’s one of the keys here, that in 2028, it’s still six years from now, or the journey towards 2028. Right now, with the speed at which oversight mechanisms are building up, pharma will be more and more inclined to outsource more and keep less expertise in clinical development in-house because of the fact that they can provide much better oversight through a better use of technology and have a lot more transparent mechanisms to oversee that.

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4.
Small- to mid-cap biotechs are facing great losses, with 80% of them trading below their IPO price. How might this biotech funding slowdown put a dent in raising additional equity, and thus, crimp CRO demand and potentially disrupt revenue?

SP: This really is a key thing, and that will affect some of the CROs or some of the CRO markets, but it will not affect as much the big ones. The big boys, they are not that entrenched. For example, if you see Iqvia just recently, there are several analyst reports which have come about on Iqvia, so most big CROs and at least the public CROs, in my mind, would still be insulated to the big effect of the biotech bloodbath, so as to say, and this was expected. If you come to think about it, there was just so much of capital in the market in the last few years that biotechs had gotten so much and some of that capital was going to be sucked in at some point in time. The party was not going to go on forever, so this was expected, but from a CRO standpoint, I think this hit… some of this may be conjecture, but if I were to see from a public CRO perspective, this hit the CROs like Premier, Clinipace, which are not public CROs. The only public CRO I think I would count in that would be Medpace, to some extent, but I think this hit them a lot more than actually the big boys, because they have been trying to get into that market, but their revenues are not that hitched to that bandwagon, the biotech bandwagon, and also they have the big pharma and the larger programmes and they are fairly entrenched, so I’m not that worried about the CRO demand, the major CROs, to be that affected by this.

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5.
There has been much M&A across the CRO industry, with recent acquisitions such as Charles River-Explora Labs, Labcorp with Covance and Thermo Fisher with PPD. How do you expect the M&A and consolidation trend to grow within this industry, and what are the potential synergies? What are the most attractive services within the CRO industry at this point?

SP: I think in the M&As there has been rumour in the market with Syneos being swallowed by either Covance, by Labcorp… there has been a rumour in the market that Covance, or Labcorp, may take up Syneos, because Syneos was having some trouble and they were being undervalued for a little while. Similarly, Charles River, but I think the integration piece, something similar to what Thermo Fisher did, Charles River, I feel, may go for. That may add the overarching, centralised, what was a grand vision of CROs a few years back, to become more…

I think it may take it to another level of what I call as fully integrated. Charles River has a business which is similar to what Thermo Fisher’s original businesses were, the non-clinical pharma, and they can integrate into a client like Thermo Fisher. One of the stories has been how PPD was fully involved with Moderna for their bringing the piece, which is, again, public information, and then how Thermo Fisher was involved and then how, again, the entire integrated. I think there is that story to be told and I think there is that story which is gaining traction, and I do think so that there are those areas where it is going to make sense, but I also don’t know about this whole Covance-Labcorp piece, that that will make sense for Syneos to be acquired, but there will be some level of consolidation still happening in the near future, and it’s very, very fragmented, so there would be a number of tuck-ins which will happen, too. CRO is a very, very fragmented market, too, so opportunistically, like Quintiles has done or Iqvia has done over a number of years, taking so many of these smaller CROs here and there, even smaller CROs have done that. I think that will happen opportunistically over a period of time, that would be my see, but Syneos is an interesting target right now at this time for somebody to take up. They just had a new CEO and a new position, COO, who’s an ex-Labcorp executive announced yesterday.

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6.
What else besides Syneos’ leadership team could be attractive about it for anyone to acquire?

SP: I think the key pieces of Syneos for them to be acquired are, Syneos is one of the only CROs which, besides bringing in revenue and tons of customers, 25% of them is still the commercial activities, which is they have that aspect which some of the other CROs don’t have. They basically integrate into the whole value chain of a pharma customer, if you will, if you are looking to see it as a value statement, unlike some of the other CROs, so it would be an interesting target for somebody like Charles River and even, for that matter, Labcorp in that thing. Their current leadership, or the new leadership, I don’t know much about Michelle Keefe, who’s the new CEO, but their new COO, which is a new position that has been Michael Brooks, has done a really good job in his previous roles at PRA and even PPD and then he had a shorter stint at Labcorp, or Covance. He has established track record of leading strong delivery engines, so it may be in for a good time from that, and he has a very strong leadership depth as well as experience there.

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7.
What type of services are most attractive and profitable within the CRO industry at the moment? Would it be contract research division between clinical and preclinical, contract development or manufacturing?

SP: Within the CRO industry, I think almost everything that they sell is the clinical services. Clinical monitoring, clinical operations and project management are their bread and butter, so that is where they make the most money, that is where they make the most margin, and everything else they have to do because it’s like data management is low margin and the other ends of QC and the other pieces are not very high margin. Again, this is about all the CROs except for Iqvia, because Iqvia is a very different company. If you come to think about it, Iqvia, they have a very high growth, and that’s why Iqvia stands out among all of the other major CROs, because they have that entire technology and analytical solutions group, which eventually, in many ways, can actually reinvent how the CRO industry is. If you stay on, that’s why Iqvia is a very interesting company to think about, because that particular company can reinvent what the CRO and how the CRO delivers. Today they are not there, but in the future they have that right… I’m forgetting the name, what they call the… technology and analytical solutions, sorry. Yes, that group, which is about 40%-something of their revenues, and that is the engine which can probably eventually enable. Nobody else has that, nothing close to it. Nobody else has that. That came primarily from them developing their IMS data services to everything else and adding to that, and that could make everybody else a follower to that eventually, in the space. That will revolutionise the industry, in my mind, at some point in time, but they’re not there yet.

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8.
What is the competitive positioning of players such as Iqvia, PPD, Syneos, Charles River and Medpace – whose stock has taken a beating – in terms of market share, service offerings and pricing?

SP: Iqvia, again, is probably the most premium-priced service and offering, and people really buy at it, too, because they have the biggest strength when they come across in terms of the end-to-end delivery of CRO services per se. Their competitive advantage primarily lies, besides that they have the biggest footprint and deep entrenched local leadership across the biggest global footprint, but their biggest advantage is actually the technology and analytics solution which enables them in many ways, so that delivery engine, which they have continued to change its name, and their data engine. They have almost everything. They have all the technology solutions. They can be the one-place shop for it in many ways. I think that aspect, and even now, all of the smaller CROs they acquired, they’re creating an attractive Iqvia biotech model also, Novella and some of the other CROs they acquired along the way, so I think their core differentiation is that, in my mind. PPD from, I think, now being part of Thermo Fisher, its core competitive advantage where they will see the biggest growth is that they have a strong cost base. The way they have managed their costs over a period of time, they have these multiple hubs, low-cost hubs, which are very attractive to customers in many ways.

For example, unlike Iqvia, which is deeply entrenched in India or some one geography, which becomes difficult because of customer interaction and the other things, but they have spread it around in between Asia, eastern Europe, Mexico. I think their cost base helps them in terms of being able to provide that, plus the investment which PPD has done over the past five years around one of the biggest problems of clinical trial, that is sites and patients. They have site networks, they have a real-world consulting company which they acquired, they have a patient recruitment, that Accelerated Enrollment Solutions. Their site and patient access is a huge differentiator, particularly in chronic, ambulatory and many other indications, because they can run the table there in many ways. Not necessarily they have all these solutions for the most complex oncology and rare disease, but for everything else, it is very hard to beat them because they have the most complete set of solutions around finding sites, around finding patients, around being able to manage those trials in the most cost-effective way for a customer. That is very, very attractive and that’s where they, either all the vaccine trials or all the other trials which have been in public information, they have done extremely, extremely well.

With regards to Syneos, again, it’s hard to say, actually, Syneos’s advantage in my mind, because they have actually been a fits-and-starts type of a company. They have used their consulting business and their commercial business to bring in the clinical business revenue in many ways. They have used some of that. Unlike, for example, Iqvia, which never could succeed in the consulting business well and integrate and increase their share of the wallet with the customers, I think Syneos has done a good job with that. Frankly, I really can’t say much about what would be Syneos’s big differentiator, because they have struggled with that for a long time in many ways. They capture some of the market. Their customer look, they don’t have that many big accounts, large accounts, but they have few which are a significant portion of their revenue, so that is a risk with Syneos any one way. I think that’s gone down a little bit, a couple of accounts, but they don’t have that many, so they are not very well spread, in my mind. Again, it’s hard to say about what would be Syneos’s real advantage there.

Charles River I don’t know much, to be honest. Charles River I don’t know, because they are now not in the clinical space. They have done well, Charles River as a company, in their preclinical and the other space. Overall, they have done quite well and I think they may want to get back into it, because they had divested their clinical business a long time back, so I don’t know much about Charles River. Medpace, as you probably know, the stock has taken a beating and Medpace is a smaller company. It survives largely on biotechs. That, I think, is about that.

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9.
Covance focuses on preclinical and clinical, Charles River on preclinical and manufacturing and Iqvia happens to be a full-service provider. How much of a benefit is it to be a full-service provider, one-stop shop such as Iqvia vs a single-service provider such as Covance? Do you think it’s better for CROs to focus on one product or multiple products together?

SP: Again, the thought process for that is, what time span are we thinking about? If we are thinking about the next 5-10 years, then I think the world is going to move more towards a one-stop shop, and that is where, I think, the pieces of Thermo Fisher type of an acquisition, which happened with PPD last year, or Iqvia, so I think it is going to become that, but the market is not there as of yet. That also, I can fully say that, because it will take a little while before that happens. Today, the customer’s behaviour in terms of buying services, even in really big companies, you can take any segment, you can take the big pharma, you can take the mid-sized pharma, you can take the small biotech, in any of these the buying model of services is not all integrated and they are not able to do that. From my own experience and seeing that, CROs have tried very hard to sell more, cross-sell their other services, but the buying is very individualised and still the decision-making around clinical services buying is different than preclinical services buying than the other ones, so these are not rolled up at that level.

However, that is slowly changing and it may have an exponential inflection point at some point in time in the near future. My guess would be 7-10 years, so it will be more like an Iqvia type of a model, more like where Thermo Fisher, what it talks about, the model now is end to end. It’s offering the services and bundling approaches and more, and bundled pricing and product offerings, but today that is not there. Today, what has already become a reality is the place for what I would say is end-to-end clinical services, because where we are coming from is where pharma is going to choose, they will find a BPO like Accenture or Tata for data management and they will find another one for pharmacovigilance services. Then they will find clinical services, they will take a traditional CRO or they will have an FSP model, like Amgen likes having large FSP models to be working in these things. That has evolved already to where they now are looking to saying, “This creates too much of challenges for us to deliver, too much of transitions, too much of oversight, too much of listing.” They have moved towards at least having clinical, “Let’s just outsource this to one person, one thing,” so the industry is already moving towards that.

For it to move towards more pieces like a Thermo Fisher or a combination of Charles River and something, some clinical CRO fully, I think it will take still 5-10 years, in my mind. Labcorp has not really been a real big winner since they acquired Covance. They have operated very separately and, actually, that has somewhere cost them on both sides, in my mind, I would feel that way, and they haven’t really become a very serious player in some of these things, but they are turning the corner even there, if I were to think about it.

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10.
A CRO’s main focus is to reach the entire customer segment in a more holistic fashion, the trend starting with Quintiles. How would you assess players such as Iqvia and PPD, and their efforts to reach the customer? Which one has been the most successful in doing so, in your opinion?

SP: I think in this, yes, that is true, that they are trying to reach the customer, and that’s where, as I was saying, PPD, now with Thermo Fisher, they want to have more of those things. Syneos, they have always tried the commercial angle and got some clinical business along with that, and their consulting angle and then got clinical business along with that, so yes, they have always been trying to do that and fully integrate into a customer. The one which has been successful most has been Iqvia within that, because they actually have the most robust set of capabilities in that sense, and there is a big difference between them and everybody else. I think everybody else is where, I would say, they are still trying. Iqvia is there, in many ways. They actually bring in the might of their different technologies. “You want an eTMF, we have Wingspan. You want CDMS, we have this,” so they basically bring in all the stakeholders and they try that.

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11.
There are quite a few small companies which are small today but not too far behind, such as Science 37 and Lightship. How are the major CRO companies competing with these smaller companies, and how much of a threat could they be?

SP: I think they are not trying to compete with the smaller CROs. As you correctly said, it’s a very, very fragmented market, and there are more and more companies keep coming in and, sometimes, too small companies. I think there was a company right in my backyard here, Premier Research, which acquired one more company, and Clinipace acquired, so I think that is the thing. They all, all the small pharma companies, for the most part, they look for a certain type of a customer, so they look for small to medium-sized biotech pharma customers. They look for a customer which has a certain set of needs where they need a lot more hand-holding, so they provide that constant human support, and they don’t have that many systems to do that.

Within that segment, I think some sort of a consolidation will happen or, if they become too interesting for one of these big guys because they can bring in revenue, they can bring in some capability or they can bring in a set of customers, one of these guys will acquire them, and I think that’s been happening forever, but there is a place for all of these niche CROs which are there globally everywhere. They are there in the US and they are there in Europe as well, and they become attractive at a certain revenue point, at a certain customer segment type or all or any of these things. Catalyst, which is a CRO, came out from NovaQuest, the fund, which is a fund from Dennis Gillings, the CEO and Founder, and they have grown suddenly quite a lot in the last two years and things like that. I think there is a place for these CROs in the near future, and then they may become attractive to one of these bigger CROs and then that happens.

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12.
Could you speak to the traction of niche and PE-backed CROs within the industry? What niche approaches are these CROs focused on, and how quickly do you expect them to grow?

SP: I think all these PE-backed CROs are the ones which I was speaking about a little bit also, Premier Research or Clinipace or Catalyst, so these PE-backed CROs are primarily… or, actually, for that matter, even the big ones, Parexel is PE-backed by Goldman now, so even some of these CROs. I think it depends on the size, so if it is a Parexel, then it competes head and shoulders with the Iqvias and the Labcorps and all the other ones because it was taken private a couple of years back, and I think it is going to go public at some point in time, but the other smaller ones, I think, are primarily tending towards mid-sized to biotech customers and they are highly dependent on them. They’re bringing a certain segment of revenue. Their approach, there is nothing very, very differentiated other than having personalised, individual relationships to some of this network of biotech executives, the medium to small biotech executives, and providing a very custom approach to them.

They don’t have very scalable, and where it becomes a challenge even for them is because they don’t have that same global footprint like a big CRO can bring, because most of the trials that even the small biotechs are trying to do are global. Those are the challenges and that’s why they don’t get selected sometimes, but the level of personal attention and service is what is their USP. That is what they try to sell. Their relationships with the biotech executives are what they try to sell, so there are all those types of aspects which they are trying to do that.

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13.
How strong do you think the larger CROs’ pricing power is, and do you think they can pass through cost and wage increases as easily as they would have you believe? Will we finally witness the disappearance of small- and medium-sized CROs, as they cannot invest as much money into new technologies and further advancements?

SP: Again, looking at it from a price-sensitivity perspective, usually the pharma and biotech, even, for that matter, smaller biotechs are not very price-sensitive. The people are not very price-sensitive in this industry. Most of the time, they are looking for the capability that somebody who can help me deliver this particular programme by a certain time. That is there. Most times, as much as there is that procurement level piece and all, unless it is significantly different, unless it is three times or something like that, which rarely happens, I have not seen in a long time where you lose out to somebody because somebody just priced it. That used to happen a while back, but I think pricing is not necessarily something which makes the difference that much. People can buy into a Quintiles or an Iqvia. The reason why they don’t buy sometimes is because they feel that… the mid-sized or smaller biotech and pharma, they don’t buy into Iqvia because they feel that Iqvia, either they may have had some bad experience or somebody there may have had a bad experience at some point in time, or they feel Iqvia may be too big for them or PPD may be too big for them sometimes, so it is that aspect.

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14.
How are contracting models trending within the CRO industry, specifically the move towards the outcome-based model from the traditional model? How fast is this shift occurring?

SP: I still feel that it is more traditional. There are more risk and reward types of pieces which are coming in. I’ve been trying to move the industry towards output- and outcome-based, because that makes it simpler even from a CRO perspective, for the last 10 or 12 years, but it is very slow, so the contracting models are still more traditional fee-for-service-type, for the most part. There are versions of innovations of that, to put it in another way. For example, things wherein you have some more flexibility around partnering a little bit more, which is creating some risk-reward penalties and things like that, but I don’t think that we are there in terms of an outcome-based. They have been tried and they get tried every now and then, a very small percentage. If I had to take a guess, less than 10% of all the contracts being signed would be outcome- or output-based, and most of them lead eventually right back to the traditional model in many ways, at least at this time.

Again, the technology revolution which I’m talking about, which we are in the middle of or at the beginning of, I would still say we’re at the beginning of that and it will not take too much time, it will go on an accelerated clip and pace, but I think that technology revolution will move it to the outcome-based model in a very rapid pace. Things which have not happened, and we have been chipping away, over the last 10-15 years have been primarily because there is lack of transparency, there is lack of traceability, of either costs or efforts or outcomes to be needed or measured. When that changes, I think this will change, and that’s where I feel fairly confidently that, again, that’s the same five- or 10-year horizon, that that clip will suddenly happen and then almost everything will be like that in many ways.

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15.
How will the shift in contracting models change market dynamics, specifically with how services are bought and sold by different customers?

SP: I think the main changes at that point in time, which it would be, are that it will commoditise everybody else and it will actually concentrate the market, if you think about it, when that happens. That’s where providers like Iqvia or even other major CROs would be better off, or, who knows, it’s like Tesla coming in between the car industry, it could be a Science 37 growing up, suddenly grown up and coming from nowhere, so it could be a non-incumbent, too. Basically, my thinking is that at, that point in time, everything else will be super commoditised, so all the monitoring visits, all the things that are priced for today and that generate revenue will be fairly commoditised. What you would gain in terms of outputs would be how efficient your engine to produce all those outcomes and outputs is, and thus, what is your differentiation in terms of technology or what’s your secret sauce on how you get it done? To me, that would be the differentiating factor in that point in time.

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16.
You mentioned the pandemic has been a large catalyst with DCTs [decentralised control trials]. How have these been trending within the CROs? Would you be able to speak to the development of DCTs? Which companies have had the highest growth potential with DCT trials, and why?

SP: I think the major ones in terms of if you think about DCT companies, which are all start-ups, so they’re all start-ups, so none of the DCT companies per se are at scale at this point in time. Having said that, and I will give you the names, which ones I’m talking about, but there are some which are very promising ones within that, but then all the other CROs or all the major CROs are also offering some way or form of DCT market. Today, the DCT market would be somewhere totally, if you say USD 7bn or something of that, that would be an estimate of a DCT market, but the start-ups which are there, the big ones are Science 37, which is now public-listed company, Medable, Lightship, Thread, Castor. These are some of the bigger, more well-known start-ups which have gotten some funding and they have got a lot of attention, media attention and market attention, so these are the ones which are the ones in that. I find them to be not very differentiated from each other, they’re all trying to go and prove… Science 37 more recently tried to reinvent itself in a different way, trying to look at that, but my challenge with looking at these start-up entrepreneurs is that they are not yet at scale.

While that is happening or while they have some very promising hypotheses, this is a very, very traditional industry which they’re dealing with, so where DCT has really got into the mainstream in the last two years or since COVID is basically using the current models which all these major CROs had because people were doing the clinical trials. They just couldn’t reach those patients, they just couldn’t reach those sites, they just couldn’t do all of those things, so they started using what I call as the hybrid models, so they started using e-consent, they started using e-source, they started using e-COAs, they started saying, “Can we do…” there are a number of these hybrid models which are in the middle of. What Science 37s and Medables and Threads of the world are doing right now is they’re trying to generate the scale where they can do that and they can show their differentiation while they do it at this point in time. I think it is an interesting transition period. I feel that it is easier for a new company to set up a whole new model of DCT than actually an incumbent CRO, because an incumbent CRO is always very, very wary and risk-averse because they are, in some sense, cannibalising their mainstream revenue, which comes through monitoring visits and their cash cows, revenue denominators, so as to say.

It could possibly be, it would possibly be one of these or some other company which will probably make the cut there, so I think I would be keenly looking into which one of those it would be. Today, from my best assessment of all of these DCT companies, I can’t say that it will be Science 37 or Medable or Thread or Lightship. They have similar approaches, some strengths here and there, things like that, but they have the best chance. They are actually creating and building their future, which will actually become mainstream in not too far a future, Signant or any one of these, because they are not tied to the rest of the pieces of risk, which is where the main CROs are at at this point in time and the change, or the challenge to change, so as to say, their economic model, revenue model and everything else.

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17.
What is the expected growth for the CRO industry within the US and EU respectively, and how would you assess international players such as Wuxi’s competitive positioning vs large North America-based CROs we’ve discussed?

SP: I think the CRO industry is bullish for a 10-15% growth in the next 3-4 years, in my mind, so I don’t think so that even with this biotech slowdown right now, things like that won’t really impact the overall market and the industry, because there is already enough capital which has been deployed. There are enough and more pieces with the big pharma which would push further, so I would still say about something like 10% of CRO growth would still be possible in the next 4-5 years and that’s where it would go towards. In terms of any ex-US, so the Wuxi and all that, I think that’s growing and it will do, but today, in terms of going to grow the market or to be able to deliver a global trial, any pharma company, doesn’t matter where it is based, it could be in whichever country, needs a global partner. All major North American CROs are very well-entrenched now in being able to deliver a global study, so I think that would keep the major North American CROs to be in a great position.

Again, there are things which are developing in terms of the cell and gene therapy, as I think, and the other precision medicine pieces, so I think one of the main trends would be that that aspect will grow as more and more cell and gene therapy products get on top of this thing with the data and with the precision medicine and the growth of basket platform and all of these complex trials, the master protocol trials as they happen, which is what is becoming an increased pattern. I don’t think that there are many oncology trials which happen that are not basket trials or platform trials in some way or form, so I think that’s going to be a major future trend, and how does technology enable that? Because it brings in its own sets of complications and complexities to a normal trial, so I think that’s going to be a big, big piece.

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18.
How is the CRO industry advancing into the C&GT [cell and gene therapy] market, and how quickly? How do you see this playing out?

SP: Cell and gene therapy, I know from my personal knowledge that it is a major area of centre of excellence in every big CRO. All big CROs have that, so they are trying to collect and collate the expertise within them to be able to become a major player, because they are aware of the growth that market is going to experience, going forward. They want to be there, so they’re bringing in experts, they are bringing in regulatory experts, they are bringing in medical experts, they are bringing in protocol-writing experts. They are bringing in the expertise and trying to gather as much experience they can in that market, because it is going to overwhelm the market eventually and all the major CROs want to be playing out, and that’s where I think every major CRO has a cell and gene therapy centre of excellence. They are trying to sequester resources to be able to build some technology on how to manage or keep their experience and demonstrate that experience for getting. That’s what my take would be on that.

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19.
What major hurdles are CROs facing at the moment, regulatory environment being one, and how is the regulatory environment changing within the CRO industry in the US?

SP: Not sure I understand the question. If anything, regulatory environment has been more conducive in recent years in many ways, and I can say that from both CROs and also from the pharma perspective, because now there are more discussions that you have. Either it was the Operation Warp Speed drug development, there were more clearer regulatory discussions that happened to build and to help to operationalise, to recruit patients, to prevent time lags, so I think regulatory environment is now getting more and more conducive, so I don’t see it actually as much of a barrier. Of course, there are challenges which come. I’ll give you a specific example which has been an industry-wide challenge in the last 2-3 years. As you may have seen from, I suppose, the diversity and inclusion of patients, FDA has been on it for many years now, but it came to the fore when all of these news reports came about with COVID trials that most of the patients who we conduct in a clinical trial, we don’t include sufficient minority populations, and that has led to now more discussions around that we need to have…

The FDA has come up with several papers, and I think one came about most recently in the last week, a guidance on bringing in diversity and inclusion into the… making sure that the patients, the demographic of a particular disease is represented in the clinical trial, and that’s a very, very hard thing, to be honest. Recruiting for an oncology phase 3 metastatic castration-resistant prostrate cancer study is hard enough already, and on top of it, if you have to make sure that it happens in a certain way… those patients, it’s very difficult to get regardless, and if you have to make sure that it has to have a certain demographic distribution as a mandate, that will become hard. That day is not yet today, but that may happen in the future and it doesn’t seem that that future is too far, so that is a real hurdle, that kind of a hurdle. I think the industry is moving towards that to make sure that we can do that, but we don’t have… recruiting patients has become harder and harder with precision… as much as the cell and gene therapy and all of these things have helped, it has also made it harder with the precision medicine because you are actually looking for a needle in a haystack, so those kinds of things make it more and more challenging.

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20.
What is your 12-18-month outlook for the CRO industry? What are you most excited for, and what should we be looking out for?

SP: Where do I see them? Let me start with things that they will struggle with. They will struggle with their resourcing and supply issues and inflationary challenges. They will struggle with that, but while they’re struggling with that, I’m also very optimistic and very positive that that will force them to figure out more tech-savvy solutions that will help them to be able to provide transparency and technology-supported solutions. Their risk-based monitoring of clinical trials models or their planning models will become better because they would be forced to think in different ways to be able to bring in solutions, because in spite of these biotech challenges, funding challenges in this quarter, I still see that the demand is not going to slow down significantly and there will be high demand. Thus, there will be struggle from the supply side for resources, and that will spur them to bring more mainstream decentralised clinical trial solutions, to make it more mainstream and more automated, their end-to-end delivery of pieces. That’s what I would say.

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