Evinova’s CTO on Scaling Technology Adoption in Large Pharma

You’ve worked in technology across pharma and vendors; what has that taught you about bringing in and scaling technology in large organizations?

You have to start with the basics, and if something sounds too good to be true, it probably is. Everyone gets very excited about the latest technology, but you very quickly run into roadblocks when you don't think foundationally, and ask “How does the technology or a new approach change what we’re doing? What’s the outcome we’re trying to achieve?” If you jump to doing the innovative, brand-new things before thinking about the change journey and how you would support that and scale, you’re going to end up with a one-hit wonder.

A lot of my career in life sciences has focused on driving innovation with technologies that were widespread in other industries, yet faced many barriers to adoption in biopharma companies for a variety of reasons. You need to think systematically, and break down big problems into its component parts, because that allows you to deliver value iteratively as you work to achieve scale.

How did you develop the understanding of how to get value out of technology in a large-pharma setting? 

When I first came into my role at AstraZeneca, we were dealing with hundreds of disconnected systems in the clinical trial landscape. We had to get that ecosystem under control and focus on value. We were working through a digital transformation at the same time that AstraZeneca was going through a patent cliff. We knew that we needed to get control around cost and timelines by doing things differently, so that when we did have the opportunities to invest more the R&D pipeline, we could be more efficient in doing so, ultimately getting our medicines to patients faster. 

We focused on defining clear business cases for our digital investments, partnering with our finance colleagues in measuring benefits realization. We then leveraged those benefits to reinvest in the next stages of digital transformation with more advanced technologies. The discipline that AstraZeneca demonstrated in response to multiple patent expiries positioned them to be a leader in the digital race, in a lot of ways.

"You need to think systematically, and break down big problems into its component parts, because that allows you to deliver value iteratively as you work to achieve scale."

What has that experience taught you about how other large pharma organizations are thinking about innovative technology? 

When I moved into the vendor landscape, I worked with a number of top 20 pharma companies, who all had similar challenges despite being multinational, with headquarters in different countries and taking different approaches to digital technology. They all wanted to solve similar challenges such as speed of getting a trial up-and-running, improving the patient experience, improving the site experience, etc. 

The difference I found was in the level of work they had done to prepare for implementing digital technologies. The companies that did the best were the ones that did the introspection  needed with a clear vision and outcomes before jumping into a partnership with a software vendor. 

How do you balance innovation with pragmatism, to avoid unnecessary overspending? 

Focus on holistic value and outcomes, versus cost and speed. If someone asks, “How do we get the number of weeks down for study start-up, from 16 to 12, or from 12 to eight?” it’s often done by  reducing what is collected during   the trial . But when people look at complexity and say, “We need to make it simpler,” you equally need to acknowledge that bringing a medicine to market is a complex problem and when you reduce the data you collect, you may not gain as much insight.. 

Sometimes you have to embrace complexity and then focus on transforming it. If there is a solution that would make a process 16 weeks, versus the standard 10, most people would choose the seemingly faster solution. But what if that extra six weeks saved you 30 weeks in the context of the trial duration? That gets into the value equation. 

In R&D, there are many different functions, and people in those functions are trying to get their individual process time down. You have to look end-to-end and start to measure those elements together with a systems-thinking mindset. If you do that, and embrace the complexity, you will get to a better overall value proposition even if some elements take longer. 

My experience has proven that leaving individual component parts to innovate in isolation often leads to incremental improvement with considerable cost that can’t be justified. It’s really important to keep the definition of innovation front and center: creating value with something new or novel. Pilots and proof of concept efforts have their place, but they’re often overused and lead to overspending.  

"Sometimes you have to embrace complexity and then focus on transforming it."

What are the sponsor-vendor disconnects that we need to address? 

In the same way that sponsors say, “We need to meet patients where they are,” technology partners need to meet sponsors where they are. From the technology side, there may be a sponsor process that looks antiquated or inefficient, but it could be  due to a regulation that hasn’t been updated. Until recently, there wasn’t strong guidance from the FDA or EMA on decentralized trial technologies, so folks were relying on laws that were twenty years old and trying to navigate around them. The technology vendors need to have the empathy to understand that. 

The other disconnect is around how poorly defined the word “partnership” is. Sometimes, sponsors aren’t looking for a partner. Sometimes, sponsors are entering a conversation where they don’t know the answer, but they know they need something different. That requires more than just a technology solution. At Evinova, we’re trying to focus on “How does novel trial design achieve a better outcome for sponsors and patients? How do we apply first principles thinking to understand and develop strategies for a therapeutic area, a disease area, and specific patient populations? That then drives how we develop and implement our software products. 

Can you walk through the work that you're leading and how it can help the industry change their processes?

Our most game-changing product for biopharma sponsors looking to scale innovation in their clinical trials is the Unified Trial Solution. That’s where we enable novel trial designs with digital and composite endpoints, capturing data directly from patients including with connected devices, and leverage a common web portal and single sign-on to streamline the trial site experience. Our human-centered design differentiates the experience for all users: patients, sites, sponsors and CROs and really shines in critical need areas such as remote patient monitoring in oncology trials. I’m really proud of some of the ways we partner with AI companies to evaluate the quality of patient data in real time, informing site staff at the time of collection if data is acceptable. This alone helps avoid the need for patients to travel back to trial sites, providing feedback to site staff in seconds where it would often be days. 

But the story of a really innovative trial starts long before you select the trial technology at the design phase. Our study design solution streamlines the process to automate trial cost estimation and feasibility as well as optimize trials to reduce patient burden and climate impact. Costing and re-costing can take weeks or months, and the opportunity to reduce carbon impact of trials is significant. There is huge waste of sample kits at sites, and it’s also a huge burden on them to be storing all these kits. 

We’ve also focused on a solution for real-time visibility across an entire R&D pipeline, including prioritization of the portfolio and deep insights into trial execution. As opposed to waiting six months and doing a retrospective to understand where a trial began to delay, we can identify the actions that need to be taken, in the moment, to meet timelines. This transparency drives a culture shift where everyone, from CEOs to CRAs, can get real-time insight into what’s happening with a trial and where risks or issues need to be actioned.

"It’s really important to keep the definition of innovation front and center: creating value with something new or novel."

What conversations do sponsors need to have with potential vendor partners to take real advantage of technology? 

It starts with establishing big, bold ambitious goals. You don’t have to know how you’re going to reach those goals right away, but you have to set them in order to have any chance of meeting them. The mindset we encourage our customers to have is to be flexible on the details, how we get there, and how we outline measurements of success, once they establish those goals. 

Measurement is critical. In Nature, Evinova published with AstraZeneca an implementation of a digital health technology framework in clinical trials; we give specific examples of what those measures are. Everyone needs to understand how you are measuring those outcomes; and we mean outcomes, not activity. Our enemy is motion without progress – “We did X pilot.” We want to ask, for example, “Did we tangibly improve the patient experience in this indication for one of these assets, such as by decreasing in-clinic visits?” or “Did we drive down the cost per patient in this disease area?” 

Whenever we meet with customers, we encourage them to establish what those big outcomes and measures are; that helps to define the therapeutic area strategy all the way through to the technology choice. 

In This Article