Our 50th Episode Featuring Teckro CEO Gary Hughes

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HANNAH LIPPITT: This week marks a very special episode of the Totally Clinical podcast. It seems like just yesterday we launched our first episode – with, of course, the unforgettable assistance of Dr Cox from Scrubs! That was almost a year ago and today is our 50th – yes our 50th – episode!

Over the past year the podcast has gone from strength to strength reliably supplying you with a stream of high-quality content from the best in the industry, with a range of exciting and diverse guests all eager to participate and share their knowledge on a variety of fascinating topics.

So, fittingly for Totally Clinical’s 50th episode, I’d like to welcome Gary Hughes, our CEO, back to the podcast. This week Gary is going to expand on Teckro’s vision as a company that is leading the way when it comes to the topics that make a real difference.

Welcome back, Gary, to the podcast and thank you for joining me for this landmark episode.

Let's start by talking about trees. Now, Teckro recently partnered with One Tree Planted, a non-profit organization focused on global reforestation. Could you explain more about this and why it ties in with Teckro’s core values?

GARY HUGHES: Sure, but maybe before we start talking about trees as such, I think it's important just to say, well done to you and all the team for the great work you've been doing over the past year. I think you've managed to bring in a lot of interesting voices and engage a lot of stakeholders in really topical issues that really affect the whole industry. So, it's great to be here for the 50th episode of the podcast to talk specifically about what we're doing with One Tree Planted and the initiative. From day one, our core values have been: “Be responsive, do the right thing, make an impact.”

I think if you look at what's going on in the industry generally, there's some really great initiatives. There's a real awareness building of the need to drive towards carbon zero initiatives and things like that. And I think it's important for an organization like Teckro to participate in that. There's lots of great companies doing great things and these initiatives need to be commended and we should all try to engage in similar initiatives and do what's possible.

Specifically, what we're doing with One Tree Planted, I think there's a real visceral connection between the idea of planting a tree and paper. And I think for us it was important, you know, it aligns very much, as I said, with our core values, but also with the products we're building the infrastructure, the digital infrastructure we've created, the connections that facilitates that, really, it does remove the need for paper. And I think it's a nice fit for us to be able to almost present a digital-first approach which can really benefit the industry in lots of different ways, but also that the work we're doing correlates nicely with, with the planting of trees and that drive towards net carbon zero.

HANNAH LIPPITT: You must have learnt so much about biodiversity and the ecosystem working closely with One Tree Planted.

GARY HUGHES: It's not so much just about planting trees – and there's lots of examples in Ireland and I'm sure in lots of other countries around the world where hundreds and thousands of acres of trees have been planted – but it's almost been the trees that have been planted are almost like a commercial crop. When you go into those forests, if we can call them that, they aren't teeming with life in the way you would expect in a truly natural environment, and it is really a commodity that people are farming. So,

it really comes down to that ability to nurture biodiversity and give nature a chance. And I think there's lots of parallels as well with clinical trials. I mean, you know, the industry for a long time has pursued a particular model that required a lot of, let's say, traditional sites to be involved in clinical trials. And it's probably made it difficult for other physicians, other community hospitals, other health care providers to engage in clinical research because the infrastructure required to support those trials is very different to what you might have set up in your institution today or the way you would work today in normal, everyday health care practices.

So, I think if we want to really broaden the pool and you know, if you think about it, sort of, I guess an analogy with biodiversity, we really need to enable new research sites to be established, and to come into clinical research. And that really brings new patient populations into clinical research as well, which is, I think, a goal that everybody is trying to work towards as well. So, I see a lot of parallels between what we're doing with One Tree Planted, you know, their goals around biodiversity, what we're trying to do with a digital-first approach, engaging more health care professionals in clinical research, and in turn really enabling additional patient populations to avail of and participate in clinical research as well, which I think is just a win-win for the industry.

HANNAH LIPPITT: Yes and I think what's also really fascinating is that despite the technology advances made during COVID

and the huge financial benefits for sponsors with paperless trials, the industry is still frustratingly slow to adapt. What signals have you seen that the industry is taking action to move away from paper and towards digital trials?

GARY HUGHES: I think there's probably a couple of different factors. You're right, there was a lot of advances or proliferation of new technological ideas, I guess during COVID, whether it's telehealth or the use of wearables or these type of things that kind of came to the fore. But I think what's driving a lot of change is, I think just the changes that are happening in the industry. We're seeing sites really find their voice and push back to a certain extent against the avalanche of apps and technologies that they're expected to use and engage with. And, you know, I've seen various stats and various commentary around the amount of training time sites are expected to do now on a monthly basis from the different vendors and organizations that are brought there.

Yeah, there's been lots of new ideas that have come to the fore during COVID. And I can see your point when you talk about, you know, maybe it might seem like it's frustratingly slow for people to adopt and change. But I think there are a lot of positive signs that are coming forward. And I think it's not so much just the idea of digital trials, it's just this idea of a digital-first approach. We still need service models. We still need, in some cases, aspects of paper or paper-based processes. But I think the idea

for pharma that – and for people involved in the conduct of clinical trials and the design of clinical trials – that digital first is now a real option.

HANNAH LIPPITT: How do you think Teckro is helping to support this shift, especially among sites to prioritize digital methods of communication?

GARY HUGHES: I think what's been good about Teckro is we've really built something that sites find valuable, easy to adopt, easy to use. It doesn't bring the overhead of training that so many other systems require. I think another thing that's going to drive real change is, is I guess the mass resignation, if you like, or the Great Resignation, really, that's affecting the CRAs that are in the industry; experienced CRAs are leaving the industry and there's a real shortage of CRAs to support some of those more traditional models which are probably service-heavy.

Probably those factors that are driving a lot of the change. But I do think, yeah,

it's making things that work for sites. I think sites are valuable stakeholders, they always will be in clinical research, I think just the reality of the changes that are happening in the workplace, just the availability of CRAs to do what they've always done, that's becoming increasingly difficult and it's forcing people towards a digital-first approach.

HANNAH LIPPITT: We’ve got a blog on our site discussing how we could be just a few years away from completely paperless trials. And there definitely seems to be a shift in this direction. What are your thoughts on this timeline?

GARY HUGHES: I mean, the capabilities are there today to do it. I think it's you know, what we've always kind of talked about is you've got to bring every stakeholder with you, and that's the real challenge. So, yes, we could go paperless tomorrow, but I think it's just making sure that we engage and move at a pace that which everybody can adopt. In some cases, you have to force that pace a little bit. In other cases, you've got to show people the art of the possible. But I do think it's a realistic time frame to expect sort of real change. And it's not so much the word “paperless” that's important. I think it's this idea of digital first and the new approaches, the new models,

the new types of trial design that will become possible, the ability to engage new types of research sites into clinical research, to broaden the net, to expand access to more patients. That's what will really drive the adoption of a digital-first approach. I think in doing that, I think we'll see less of a reliance on paper or a heavily service-based model to make clinical trials work.

HANNAH LIPPITT: From a social perspective, Teckro is an advocate for diversity and many of our podcast guests have represented different points around diversity, equity and inclusion. Can you talk about why this is important?

GARY HUGHES: I think it's very important for Teckro and for the industry as a whole, you know, that instead of simply forcing statistical study populations to reflect, you know, traditional demographic categories, you know, we can make trials truly inclusive and invite all people so that, you know, the resulting patient populations are reflective of all facets of our society, cultures and so on.

You know, we talk about expanding clinical trials, expanding the pool, reaching more patients. It's really important that people factor this into their planning, whether it's into trial design, whether it's into site selection, whether it's into the conduct of various visits and things like that, and also some of the patient-facing materials that we use so that we're really successful in creating a more inclusive, diverse patient population into every trial.

I came across something I think one of our colleagues had mentioned and it's “diversity is inherent. Inclusion is a choice.” And I think it's a really nice way to put it. I think we've got to think about what does inclusion really mean and what are the things we need to do as an organization or as a platform or as a technology or as a service

provider or as a pharmaceutical company sponsoring a trial to make this happen? And it was great for Teckro. I think we've led the charge in some respects – it was great that we were able to work with the Center for Information and Study on Clinical Research Participation to facilitate an advisory meeting amongst various patients and community members. It's really helping us to inform clinical study staff and industry on, you know, considerations and best practice to engage, you know, the LGBTQ+ community, but also to optimize clinical trial experiences for everybody into the future. So, it's been great to be part of that debate and that discussion, and, as I said, I think it's, Teckro’s played a really leading role in bringing some of these things to the fore, engaging these different communities to really understand the challenges, to overcome some of the barriers and to really, as you said, point out best practice in terms of how to make a more diverse, inclusive clinical trial possible.

HANNAH LIPPITT: Now, Teckro is a real champion for sites. Last year, we launched Teckro Powered, a community for research sites to help with their day-to-day burdens. And earlier this year, we teamed up with the Society of Clinical Research Sites – that’s SCRS – as a Global Impact Partner. This podcast has seen many site guests sharing their perspectives. Why do you think it's so important to highlight the role of sites and what impact do you feel Teckro’s had?

GARY HUGHES: I think we've always been very much site-centric in the design of our platform, the approach we've taken, you know, our views on where the industry needs to go. And basically it comes back to

the physician, the investigator – they're still a key stakeholder in a clinical trial, not just for the sponsor, but also for the patients. I've said this many times before: the doctor-patient relationship is very important. They're very much the trusted advisor. They're the people we look to when we're in those moments of doubt or uncertainty, when we're faced with a diagnosis or a condition. And I think that sort of connection is really important to patients. So, we've always kind of taken the view that to be patient centric, you first of all, have to be site centric. It's also about what we've talked about throughout this podcast: bringing more physicians and health care professionals into clinical research. That doesn't mean everybody – every doctor – has to be an investigator, but every doctor should be able to facilitate a patient's queries about what treatment options are available, potentially become an investigator, potentially refer a patient into a trial, or potentially participate in the clinical trial in some sort of new way as an extension of a research site where you're able to support the patient closer to where they live, so, I think it's hugely important.

HANNAH LIPPITT: Now, staying on the subject of sites, we’ve had a number of guests on the podcast talking about the overwhelming effect of too much technology. This can have the opposite effect, burdening site

staff rather than helping them. What are your thoughts on this?

GARY HUGHES: I still believe that to be patient centric, you have to be site centric, but also to be site centric, you've got to create the tools, the platforms and so on that really makes it possible for clinical trial sites to be successful. There's no point giving people 10 different technologies because in theory they should all increase the speed or reduce timelines, etc., if people use it. I mean, we've got to, first of all create technology that sites are able to and willing to use, and we've seen a lot of technologies that haven't succeeded simply because it's too difficult for the site. It takes them away from the point of care. It takes them away from their typical working model. And we've really focused from day one, pretty much, on making technology work for the site, making it fit in, in a very seamless, frictionless way that it's, it doesn't require training, it's simple UX, it's intuitive, it mirrors in many respects everyday technologies that we all use and know and rely on. And it's bringing that type of thinking – that type of design thinking – into clinical research to enable sites to be successful, to enable more sites to be created, more physicians, more health care professionals to engage in clinical research. And I think that's where the benefit will come to the industry –

and ultimately to patients.

HANNAH LIPPITT: We had Grayson from Centricity Research discussing this very issue on the podcast recently.

GARY HUGHES: Yeah, it's a great point because it's easy to make an argument for a piece of technology if it improves the lives or the efficiency or the performance of one stakeholder. It's very difficult to bring all stakeholders forward. So, you've seen over the years some very successful companies, some very successful technologies, but really they only work in one stakeholder. So, something that might work, for example, across an enterprise like a pharmaceutical company and how they perform certain tasks – there's lots of good examples of that out there where that works – but, you know, it doesn't necessarily work for research sites and vice versa. I think the real challenge is how do you make it work for all stakeholders? And how do you bring all stakeholders forward on this sort of technical journey or this digital journey that we all want to pursue and go on? Because we can see the benefits

if we can get to a digital-first or a paperless approach, you know, everyone's kind of clear on what those benefits will be, but it's, the challenge is the path that you take and the technology you adopt to help you get there. So, yeah, you can see why sites struggle with technology, why sites roll their eyes when the prospect of another technology is

being foisted upon them. And I think we've really tried to take a very different path. It's really: “How do you make it easy for sites to be successful in the conduct of clinical research?” The technology itself is almost, well, it should be secondary, it should be almost invisible in some respects. We really want to optimize that patient-doctor experience that they are successfully able to participate in, conduct the clinical trial. And that's really what it's about.

HANNAH LIPPITT: Now, looking to the future, what most excites you when it comes to Teckro and making an impact?

GARY HUGHES: What's probably most exciting is, you know – and I've talked about this in various other places over the last couple of years – is it's really the engagement and the adoption at site level. And, you know, when you know you're creating something that people truly value, that they start to rely on, then you know, you're making an impact.

And, it takes a lot of different iterations. We didn't try to go out and do a Big Bang approach that we're going to change the whole industry overnight. It was really starting from a place of pragmatic outlook on what is possible. How do you engage sites, how do we engage sponsors, how do we engage CRAs? How do we take them on this journey step by step? And that's what's probably been most exciting, is that we're starting to see that really work.

We're also starting to see the industry change and turn more towards the type of applications we've developed and the approach we've taken. And that's also really exciting.

HANNAH LIPPITT: Is there anything else you’d like to add on this topic?

GARY HUGHES: I think master protocols is a huge opportunity and I think Teckro can really unlock the potential of master protocol design simply by the approach we've taken, the communication capabilities, and the platform, the distribution, the digital engagement capabilities that are there. And that's just one of many opportunities that I think we can start to see and that our customers are starting to see as well, which is really good.

HANNAH LIPPITT: And that's your dose of Totally Clinical. You can download our podcast on Apple, Spotify and Google. Please subscribe and leave a rating and review so more people can find the show. See you on your next visit and remember to bring your friends. Thanks for listening. Goodbye!