Embark on a journey through the dynamic landscape of clinical trial outsourcing with Jason Gubb, the co-founder of ClinOps Clarity and Emergent Teams. As we navigate the historical shift from predominantly in-house operations to the intricate web of external partnerships, Jason sheds light on the critical decision-making processes that shape the pharmaceutical and biotech industries. Grapple with the challenges and opportunities presented by R&D budget constraints and learn how emerging biotech firms are steering through fluctuating funding currents. Discover a world where the right choice of vendors can make or break a clinical trial, and how companies balance the scales of internal project management and external collaboration.
With Jason's sage guidance, gleaned from his tenure at GSK and his entrepreneurial ventures, we dissect the artistry behind cultivating successful clinical trial partnerships. He shares insights on the transformative effects of smart decision-making and the vigour of challenging established practices while ensuring that every partnership is rooted in open communication and shared goals. Jason also illuminates the impact of a patient-focused ethos and addresses the nuances between co-creation and mere collaboration. So tune in to expand your understanding of the pivotal role that culture and relationships play in shaping the outcomes of clinical trials and to witness the emergence of alliances that are as resilient as they are innovative.
________
Reach out to Sam Parnell and Ivanna Rosendal
Join the conversation on our LinkedIn page
Embark on a journey through the dynamic landscape of clinical trial outsourcing with Jason Gubb, the co-founder of ClinOps Clarity and Emergent Teams. As we navigate the historical shift from predominantly in-house operations to the intricate web of external partnerships, Jason sheds light on the critical decision-making processes that shape the pharmaceutical and biotech industries. Grapple with the challenges and opportunities presented by R&D budget constraints and learn how emerging biotech firms are steering through fluctuating funding currents. Discover a world where the right choice of vendors can make or break a clinical trial, and how companies balance the scales of internal project management and external collaboration.
With Jason's sage guidance, gleaned from his tenure at GSK and his entrepreneurial ventures, we dissect the artistry behind cultivating successful clinical trial partnerships. He shares insights on the transformative effects of smart decision-making and the vigour of challenging established practices while ensuring that every partnership is rooted in open communication and shared goals. Jason also illuminates the impact of a patient-focused ethos and addresses the nuances between co-creation and mere collaboration. So tune in to expand your understanding of the pivotal role that culture and relationships play in shaping the outcomes of clinical trials and to witness the emergence of alliances that are as resilient as they are innovative.
________
Reach out to Sam Parnell and Ivanna Rosendal
Join the conversation on our LinkedIn page
You're listening to Transformation in Trials. Welcome to Transformation in Trials. This is a podcast exploring all things transformational in clinical trials. Everything is off limits on the show and we will have guests from the whole spectrum of the clinical trials community and we're your hosts, ivana and Sam. Welcome to another episode of Transformation in Trials. Today, in the studio with me I have Jason Goebb, and Jason is the co-founder of Cleanups, clarity and Immersion Teams. Welcome, jason.
Speaker 2:Hey, it's great to be here, Ivana.
Speaker 1:Well, today we're going to dive into the topic of how the clinical trial outsourcing landscape is changing and to set the stage for us. Jason, can you tell us more about what was the traditional clinical trial outsourcing landscape?
Speaker 2:Yeah, sure. So the clinical trial outsourcing landscape has changed massively over the past few decades. Back in the 80s, pharmaceutical companies tend to do most of their work, you know, in the house. But this all changed in the mid to late 90s, when there was a boom in the biotech industry, who were flush with cash but they had limited resources, and so that led to sort of a steep increase in the demand for CROs and other service providers to conduct various aspects of clinical trials, and so the growth in the outsourcing market allowed responses to access from the specialized expertise and resource and to scale output without necessarily having to build all that capability in house, which is obviously appealing and about.
Speaker 2:At that same sort of time, some of the bigger farmers started to outsource some of the non-core or time consuming activities that they would supplement their internal resources via FSPs or functional service providers' relationships in areas like data management, entry, central labs, cardiac monitoring, spirometry, et cetera. So around the turn of the century, as CROs and the service providers grew and their global reach was broad and so were their services, some of the larger farmer companies entered into full service outsourcing partnerships, and the attraction was that a single provider could deliver a whole study or program or even a portfolio. And I remember actually my first FSO study was with Smithclown Beecham back in 2000 for a large post-marketing commitment study. But I guess that does age me somewhat.
Speaker 1:That's a great overview, the way that you just kind of took us through the evolution of it. Maybe a curiosity from my standpoint, because we're in the situation where a lot of the cash that was so freely available for the biotechs is drying up. Are we also seeing that this alters the venture landscape?
Speaker 2:I think, yeah, absolutely, biotech are under a lot of pressure and their cash is not necessarily so readily available. But you have to remember that biotechs, by nature, are small infrastructures and as they go through and hopefully progress their assets through phase two, phase three or phase four, they need to have that additional capacity, access to resource expertise that they don't have internally. So I think that, whilst there's always a pendulum, there's always a great need for a myriad of service providers and CROs to support biotechs, and that won't change because of their constraints around resource.
Speaker 1:Really, I like how it separates the difference between having cash readily available and having sufficient resources, because those are two different aspects and probably two different reasons to use vendors for both a biotech and a pharmaceutical company.
Speaker 2:Yeah, absolutely.
Speaker 1:I would be curious to learn from a large pharmaceutical company perspective what are some of the reasons for outsourcing or partnering up, as you are saying.
Speaker 2:Yeah, I think for me, R&D spending pressure is just increasing.
Speaker 2:The budget available to actually deliver a portfolio is becoming more and more constrained. Any company really needs to have a strategic outsourcing model that balances both internal project expenditure or your fixed costs with external project expenditure or flexible costs, and so there's always this balance, because no company can ever resource themselves to do everything, and I think my experience is it's somewhere usually around the range of a 60-40 split. Drug development is risky. There's inherent risks, and the number of molecules and potential treatments actually get to the market is very few, and so you need to be able to pivot along the way and ensure that you are investing your resources in the best fashion, and that requires really looking at what are the capabilities and expertise you have internally and how can you best utilize that to add incremental value, and then have a real understanding about what are your capability gaps right, what are the areas that you've not strategically invested in, that you need to partner with others. So I think the pressures on R&D budgets and spending is always necessitates this need for this sort of flexible resourcing model.
Speaker 1:That makes sense. I would also be curious what kind of vendors are we talking about? Because for a clinical trial there are, of course, the actual outsourcing of the trial, but I know that there's also a whole landscape of adjacent services that you can purchase.
Speaker 2:Yeah, I mean there's the explosion. There's been an explosion in vendors, their offerings, and these continually change right as technology advances occur and needs emerge as you go down. So I try to think of it as you've got the big zeroes, the big players that can pretty much provide support across the whole study, and then you've got your technical providers that are giving you either cutting edge solutions to problems throughout the whole trial development and delivery piece, and then you've got also some niche zeroes and providers that can offer sort of deep expertise in specific areas. So there's a real blend of providers that are out there all jostling for bits of the market, and so it's quite overwhelming at times, really, when you look at the landscape, to understand who is actually going to be the right fit for you and for your study.
Speaker 1:And how would you determine who is the right fit for you and your study?
Speaker 2:Yeah, it's always a fascinating question and there's various ways you can look at it.
Speaker 2:Some companies might have a preferred relationship and preferred supplier list and then there'll be a push to actually try and utilize those suppliers Because in some instances that gives you discounts based on the volume of work that you give with them and if you invest in a particular relationship that you know each other's ways of working and how you're going to operate together and integrate together.
Speaker 2:But then there are others that will you know, especially, for example, this small, you know, biotech, or in companies where they're entering a new therapy area, where actually they need to go out and look and find different partners who perhaps may be able to give them that edge based on the services that they need. So there's different ways of looking at it and really it requires sort of an assessment of the market really to understand what is out there. But then also, looking internally around your outsourcing strategy and I think you know at the outset the most important thing for any company is to have a really robust strategy around outsourcing. And you know to take a good hard look at themselves around. You know what they want to keep in, what they want to partner with and what do they want to go and seek and explore with all the innovation that's happening?
Speaker 1:Internally in a pharmaceutical company. Who would be able to lead that strategy development effort, and how could one go about creating that strategy?
Speaker 2:Yeah, no, it's really interesting because you, you know, it depends on the size of the company, right, I think, in essence, and that'd be strategic goals for a company, and you might have, you know, governance structures that are looking at trying to see some synergies and some benefits across, you know, in the large, the large companies, in the smaller ones, and then you'll have clearly defined roles and you'll have multiple different players.
Speaker 2:You'll have procurement and contracts and business. You know the clinical operations, the therapy area leads and then all the functional experts, so you'll have a whole army of people that you happen to coroll to get a, you know, alignment on a strategy. It's very different for the biotechs because they may have, you know, a person wearing multiple hats. They are developing the protocols, they are actually also the outsourcing person, they are actually responsible for, you know, the procurement and the relationship building and everything. And so it's fascinating when I sort of observe different companies and you know you can actually see a lot more innovation in some small companies because they've got a real and clear need to have people help them in that journey and decisions can be made faster. But yeah, it depends on size, it depends on therapy area experience, it depends on multiple things.
Speaker 1:I recently spoke to a tech vendor who had a product that kind of goes across some of the traditional fault lines in the outsourcing landscape for a clinical trial, and one of the things that he mentioned was that it was very hard to explain exactly how their product fit into the suite of other options, because it was a little bit different exactly what that did. I imagine that that happens in multiple areas if you think about the clinical value chain. And how should the pharmaceutical industry kind of stay up to date with what is actually happening and what options there are in the different pieces of the clinical value chain?
Speaker 2:Yeah, I mean I think you're talking about a number of different things there. There are people who are creating solutions to problems they perceive are really important that might not jive with the needs that potential buyers want. Right, you've got providers that are playing in the same space of recruitment and retention, for example, but then you know they've got to be able to articulate the difference you know as benefits amongst quite a crowded landscape. So it is really quite tough and I think you hit on. You know the opportunities are hugely exciting and it's great that all of these tech providers are coming up with these wonderful solutions. But the challenge for sponsors is you know, how do you they abreast of all the latest developments? And as the number you know is ever increasing and their offerings evolve, that becomes really tricky.
Speaker 2:And you know you can go and deline information from you know I've just returned from you know running some panels at scope. You go to the DIA, so there's various conferences that you can go to where you'll be able to be. You know talk to lots of representatives or you can look at. You know subscribing to different newsletters. You know clinical leader or I don't know clinical research news and things like that that give you insights into different areas of need and potential. You know providers or you can find out from you know peers in your community. You know transcellerate and CTGI.
Speaker 2:You know there's lots of exchange that's happening, which is, you know it's really great and I guess, of course, this podcast is a way of also giving about different. So that's super. And you know, recently, you know I was looking at Clinico, which is you know part. It's a Cambridge Health Care Institute company and a spin off from scope and they've developed an interesting web based platform and community that connects, is aiming to connect all the different stakeholders of decentralized, hybrid and conventional trials with the hope to sort of unite sponsors, cros, service providers and sites via a clinical trial marketplace with the intent that you know, enabling people to explore, engage, exchange capabilities within the ecosystem of partners. And I think having all that information in one place is super helpful. You know, and you know probably I'd encourage listeners to sort of look out for Clinico and, you know, register the company or go and see what's on there, Because I think the more that you can have this information shared within an ecosystem that includes all parties, then it's going to be beneficial for the industry as a whole.
Speaker 1:That makes sense. I almost imagine, kind of like a puzzle that you can lay between the sponsor, the site, the patients, and what kind of offerings do we have between the three?
Speaker 2:Absolutely yeah.
Speaker 1:Well, I would be curious, Jason, about your experience. How did you get into this space? Tell us something about your journey.
Speaker 2:Yeah, so I've spent 27 years in the pharmaceutical industry in global clinical operations, strategy and leadership, and you know all within GSK well, actually within Smithclime, beachham and then, as it all you know, evolved and developed and the organizations that I've sort of led and had the privilege to lead have relied heavily on partnering with CROs and solution providers across multiple therapeutic areas and all you know ranges or phases of development.
Speaker 2:I sort of worked with all the big CROs, have sat on a number of strategic steering committees and, you know, been part of transformational outsourcing projects and in fact, actually recently I looked at the total amount of spend that throughout my career that my teams and I, you know, have been countable for in terms of external projects spend, and it was almost $1 billion. And so that is an illustration of just how much how important having a really vibrant and reliable sort of outsourcing community and partners is because it's trusting so much that whole ecosystem to deliver potentially life changing treatments for patients. So it's a huge area and an important area. So you're asking sorry I digress, I go go on.
Speaker 1:Yeah, no so they didn't.
Speaker 2:So in the latter part of my time at GSK I had a chance to work to head up a small group looking at delivery optimization and informatics, and that's where I had the chance to start really working with some of the newer companies that are emerging and really develop how we worked on a protocol design lab, partnering with multiple different vendors, which got adopted and rolled out across R&D. And then I was at Council for Developing the DCT strategy, again looking at all of the different vendors out there, and actually that led me after that of the excitement to change career. And so now I provide consulting services to biotechs farmers and vendors and trying to help them make smart, rather than safe decisions to help deliver their trials and their portfolios. And I hope that through having experienced both great successes and also significant challenges in collaborative partnerships, it enables me to help sort of clients be more efficient in what is a really complex and evolving environment. So that is sort of my experience. So what's happening now? Well, I have a lot of experience and I have got two offerings set up.
Speaker 2:One was a co-founded company called ClinOps Clarity which is really apt for this conversation today because it uses a sort of a question-based framework to support sponsors in the scope, in the selection and onboarding of outsourcing partners. And it's through like six steps that we use where we go into really deep questions and get really clarity at the outset about are you setting or is your trial setting up for success? Is it really patient-focused? What is your appetite for risk for a patchwork of vendors? I think you described it as or do you want just one vendor? What have been your previous experiences? What are the things that keep you awake at night and really get into that scoping space?
Speaker 2:And then we move into on the latest steps of going into supporting the evaluation of the marketplace, using Clinico and other mechanisms to try and match the right providers to the specific trial that they've got and navigate the RFI and RFP process, but again trying to not get seduced by marketing fluff and promises but really to use powerful questions to cut through to the things that really matter.
Speaker 2:And then the last stage is to really focus in on laying the foundations for a successful partnership, because we can talk about the number of vendors, we can talk about all the different expertise, but unless you lay the right foundations for a successful relationship that really embraces challenge, that really actually encourages folk to speak up, to be honest, to be proactive and to collectively own the outcome. If you don't focus on how you're gonna operate and focus all on the what you're gonna do, then I don't think you get the best outcome. So there's a real people element and a real culture element that really supports all of the processes and the systems and everything else like that, and if you don't invest in that, then in my experience, that's where things start to go wrong.
Speaker 1:And we'll dive into that in just a minute. But first I do want to ask what is a smart choice versus a safe choice, and how would you know the difference?
Speaker 2:Yeah, I mean. For me, it's about challenging the status quo. We see it all the time. People will do cookie cutter, protocol templates. They will look at well, this is who I used before, I'm going to use them again. They will say, oh, I'm just going to have one point of contact, that's what I want, but not understanding that actually, even within a big zero, they're subcontracting to multiple other partners.
Speaker 2:You're just one person, I think sometimes what people perceive as a safe option actually, when you tease it out, it's not. The smart decisions for me are ones where you actually have your real specific need and you're looking across the whole market to see who is best to provide it. I don't think people should be scared of having a patchwork or a jigsaw I think you used was the word as long as you put in the appropriate governance structures and oversight. I don't think you should be afraid of that because you might be missing out on something that's really going to be transformative for you. Safe and smart is really being more deliberate in what you're going to do rather than just following old ways of doing things.
Speaker 1:I think that's a really great distinction. I also like that you point out that, yes, you can find one partner that can deliver everything, but often that will mean that you actually take on the risk of that partner being able to manage their subpartners. That is, at least in my experience. Where most likely you will fail is in the management of those relationships. I think that you are the right person to ask how do you set up a collaboration like that for success?
Speaker 2:Yeah, so for me, it starts with people. Everything that we do is all about relationships Right, it is all about the connection between one to multiple relationship systems, really, and so for me it's really about spending time going back to my point around, looking at how you're going to operate versus what you're going to do. I'm a true believer in the concept of co-creation with partners versus collaboration with partners, and the distinction for me is co-creation, by definition, is you're creating something new that didn't exist before and, as we know, every trial is unique. But having a mindset of co-creation means that both parties have to accept an element of risk. They have to overcome challenges together. They have to know when to turn various interventions off if they're not working. Be honest and transparent and proactive about that. They need to weather storms, but have each other's backs when they're going through it, and I have observed so much wasted time in micromanagement, in issue discussion and resolution, in arguing about changes in scopes for contracts and lengthy discussions which distract you from actually what needs to be done. But the causes of that are because you haven't invested in the relationship and the partnership and how you're going to work together.
Speaker 2:How are you going to deal with changes in scopes. What are you going to agree? What are you going to disagree with? What ones are you going to share on? How do you engender productivity from service providers that actually might not be in their interest? If they're getting ready for doing the same thing that actually isn't giving you the value you want, then what's the incentive?
Speaker 2:But if you actually nurture that relationship and make sure that where money is allocated, it's going to be used to the best outcome for the study and that it can be switched to somewhere else if it's not working, then it's those sort of things that are hugely, hugely important. And then I think there's oversight and governance, which is obviously getting so much more attention, and rightfully so is. We need to pay a lot more attention on having the right information shared and making sure that your KPIs and your reports and everything else that you've got are actually equipping you to actually make informed decisions, rather than just giving some very high level, quite nebulous information. That again has to be discussed in that how are you going to work together around? What do you both need to actually be able to operate successfully? So there's a few examples.
Speaker 1:That makes sense. How could you have those conversations initially to set up the collaboration? Is there any tricks or is it person-dependent?
Speaker 2:Well, it's interesting because that led to. So I talked about Clidop's clarity, which is like the combined consulting and coaching, but I also co-founded a company called Emergent Teams, and that is all about trying to address that huge gap, because we all need to thrive and survive in a really complex and dynamic environment. That's fact. That's the nature of doing the business that we do. But you need to be able to have a framework and also set psychologically safe conditions for those conversations to take place, and that's where the coaching part of me really comes in. So I'm a practitioner in systemic coaching, which looks a bit weird on my website, but for me, that is the part that actually really brings it together, because you have to create those conditions for you then to be able to have the conversations.
Speaker 2:You can't throw two teams together or two parties together and expect it's going to work, and for me, vulnerability is probably one of the most powerful assets in any relationship, where someone will come to me and say, actually I can't do it all, but this is what I'm really good at and this is what I can help you out. How does that fit with your need, rather than saying I can do everything, it's all going to be perfect, which is disingenuous, does it? But similarly, sponsors need to be able to be vulnerable as well and say that if I am giving you relinquishing control, then I'm going to let you do that and trust that you'll give me the information I need to reassure stakeholders and to be confident that we're delivering to plan with the quality that's needed. And so that's what with Merchant teams. What we do is we work either with collaborations of sponsors and providers or within leadership teams, because it's still the same challenges that we have, or mergers and acquisitions, where that adds a whole new level of complexity as well. Oh, absolutely.
Speaker 1:Who would usually call you in, who can identify that the collaboration is actually dysfunctional and ask for help?
Speaker 2:And that's an inherent problem, right, because there's a lot of people out there that are offering high performance teams, sort of training or agile frameworks, and so it's really done through, hopefully, credibility and connections within the industry, where people say, actually, we're just about to embark on what can be £100 million, it could be £10 million, it could be even more. Actually, we think it's probably worth investing a bit of time out front to make sure it's a success, and I think it's usually people who have experienced the untangling of things when that's not worth. But it's tough, right, because, again, money's tight. So is it another cost? You're paying for a service, so I expect the service to be delivered, but ultimately we're humans and we need that time to actually set those conditions in a psychologically safe environment, and the rewards downstream will save many times over the investment, but it is an investment.
Speaker 1:Absolutely, jason. This leads us to the question that we always ask our guests on the show, and that is if we gave you the transformation trials magic wand that grants you one wish, that would change something in the life science industry. What would you wish to change?
Speaker 2:Yeah, I think it's the one I've talked about, which is our industry needs to focus more on co-creation. We, rather than collaboration, we don't want familiar results. We want something new and we want something that's going to be better than what we've done before. Value is created through the relationship you build. It isn't by just having a relationship right Without that clarity, goal alignment, proactive agility with vulnerability, and really paying attention to how you're going to operate together, not focusing on what's going to do. That is what is really going to move our industry forward, and it's brave if people really start looking and embracing that co-creation approach.
Speaker 1:I wish that your wish comes true, jason. This has been an absolute pleasure. If our listeners have a follow-up question to you or would like to learn more about you, where can they find you?
Speaker 2:Yeah, so you can either just look on jasongovcom, which gives the broad view of what I do, or you can search for emergenteamsworks or the coaching work, or clinopsclaritycom for the scoping, selection and onboarding. And I'd love to have just a chat with anybody, because I learn so much through talking to people across the industry.
Speaker 1:Absolutely Well. Thank you so much for coming on the show, jason.
Speaker 2:Well, thank you, it's been an absolute pleasure.
Speaker 1:You're listening to Transformation in Trials. If you have a suggestion for a guest for our show, reach out to Sam Parnell or Ivana Rosendahl on LinkedIn. You can find more episodes on Apple Podcasts, Spotify, Google Podcasts or in any other player. Remember to subscribe and get the episodes hot off the editor.