The future of clinical trials innovation

Medidata is engaging with regulators to advise on the future of clinical trials, but CEO Tarek Sherif cautions against getting overhyped about new innovations. We spoke with him and general manager EMEA Christian Hebenstreit at NEXT London to find out more.

Medidata are big advocates of pharma needing to break down silos – but I’ve been hearing about the need for silos to be broken down for years now. Why do you think it hasn’t happened yet?

Tarek: In this industry, everything happens very slowly, which makes it hard to do. There are lots of reasons why that’s the case. In some instances it’s actually quite good because it’s such a regulated industry. At the end of the day, you’re dealing with patients’ lives. If a social media company rolls out an update to their software and it takes everyone down, the odds are no one’s going to die from it. There’s going to be a much bigger impact if pharma rolls a new process and it leads to poorer quality.

The argument then becomes, what’s going to be the forcing mechanism? I think there are both pressures and opportunities. The opportunity comes from the fact that there is a wave of innovation happening in drug development right now, where there are more compounds that can actually cure people than we’ve ever seen before – but the way the infrastructure is set up is too slow and not nimble enough to handle it. So there’s an imperative that if you want to get your drug to market you have to force change in your organisation in order to capitalise on that opportunity before somebody else will. Because somebody else always will.

“I don’t think regulators were this open just a couple of years ago, but it’s changing rapidly”
Christian Hebenstreit

The persuasion side, if you will, is coming from regulators and payers. The regulators are saying that the data that companies are providing isn’t comprehensive enough and isn’t always the quality they want, so they need to enhance it by bringing in real-world evidence, digital techniques etc. The payers are coming back and saying they will pay for value. If you have a novel drug that saves somebody’s life, that’s valuable. If you have a me-too drug, which is as good as standard of care or slightly better or worse, they’re not going to pay you for that anymore.

So you have economic pressures, you have more stringent safety guidelines and you have opportunities. They’re all pushing on the process, forcing a reevaluation that will eventually break down the silos.

Do you think it’s common to see enthusiasm for more agile ways of working amongst leadership? Or is it still something that they need to work on?

Tarek: It’s a mix right now. I think the momentum is building in favor of it becoming more dominant. There are some companies that were early out of the gate, and there are some smaller companies that have been very aggressive about it.

What we’re hearing more of in large pharma today is the concept of a digital transformation. They’ve started to bring people on board to help them think that through. They report typically to the CEO so it’s getting more attention from the board and the senior executives. They’re not embedded in the organisations fully yet, and it will take some time, but the momentum is certainly shifting in that direction.

Are you horizon scanning for what’s going to be the next big change in the industry in clinical trials or are you just making sure you’re adaptable for anything that comes?

Tarek: I would say we have a point of view and we try to inform that point of view based on conversations with customers, but part of the reason we are the scale we are today is that we adapt to what’s happening in the market on a real-time basis as well. Our point of view is informed by the market, but we have a distinct view about what’s going to differentiate and create value for clients and patients and shareholders in the longer term.

Patient centricity is one example of something we see as being increasingly important. In part that’s because there’s more technology that allows you to do it, such as sensor data, and there’s also a greater focus from payers and regulators. We’re also seeing a transition towards having greater analytic and data science capabilities that inform better decisions.

Looking at trends like those is taking a high-level point of view, while the tactics that get us there are being informed by customer interactions on a daily basis.

How are you using patient-centric approaches to inform your work?

Tarek: We have a sensor data business where we collect data directly from patients, whether it’s through patients’ diaries or sensor tech.

It can also come through trial design. Synthetic control arms, for example, are very patient-centric in the sense that you are having a direct impact on the patient population, such as through fewer patients having to receive placebos or standard of care. There’s a direct one-to-one correlation if more people get the potential drug that impacts their lives.

Christian: One thing that we’re discussing right now with the European Medicines Agency is the use of e-consent solutions within Europe. That might be a game changer in terms of making it much easier for patients to participate in clinical trials. Currently in Europe, patients often have to deal with 50, 60, 80 pages of consent forms.

We are seeing various activities like this in Europe, and it confirms that regulators are being more open in terms of proactively engaging with companies like us.

When you’re having these conversations with regulators, is there anything else you’re trying to bring to the table?

Christian: They are explicitly asking for new ways to bring drugs to patients faster and accelerate the entire process. They are quite open with us. I don’t think that they were this open just a couple of years ago, but it’s changing rapidly. They are now actively reaching out to us, saying that they want to listen and learn from us – for example about different approaches we’re utilising in Europe compared to the US.

Tarek: The FDA also has an office of innovation that’s looking at different techniques that can facilitate higher quality, better safety, and speed. They’re open to innovation and new perspectives from companies like us because they know it will improve outcomes.

It must be useful for them when everything in the industry is changing so fast.

Tarek: There’s a lot of hype in the industry, with people rushing to conclusions when they don’t understand how the industry operates. I’ll give you a good example – the idea that electronic medical records are going to supplant what happens in typical data capture anytime in my lifetime is ridiculous, but that was a popular concept a while ago. People are still saying that we won’t have randomised controlled clinical trials anymore, we’re just going to use real-world data.

It’s not going to happen. We’re going to supplement randomised trials with real-world data so that you get a better perspective, but those trials are not going away – it’s just going to evolve. That’s the kind of hype cycle that is easy to get into.

Yes, it’s quite hard for companies to walk that balance between not getting too hyped but not falling behind as well. How do you approach that?

Tarek: By listening to your customers, by seeing where they’re putting their energy. But there’s a bit of a trick to it. You need to think about what you see as the likely trend, but you don’t bet the company on it. You invest, and then you ratchet it up as you get more information back from the market.

About the interviewees

Tarek SherifTarek Sherif is co-founder, chairman & CEO of Medidata Solutions. Tarek has more than 30 years of leadership experience in health-tech and finance. Prior to Medidata, he co-managed and managed equity funds focused on public and private technology and life sciences companies, as well as holding various positions in finance.

ChristianChristian Hebenstreit is SVP, EMEA Region at Medidata. Christian brings more than 20 years of operational and commercial experience across multiple sectors to his role at Medidata. Christian joined Medidata from Salesforce.com, where he was the regional vice president for Central Europe.