We caught up with Medidata’s co-founder and CEO at the most recent NEXT conference to see how he expects digital R&D processes to transform the industry
Do you think smaller pharma firms and CROs are more rapidly adopting digital R&D practices than larger companies?
Because they don’t have legacy infrastructure in place and they tend to outsource frequently, smaller companies can adopt technology much faster. They may not adopt as broad a platform, but where they adopt they’re going to be much faster at it because you’re dealing at a different scale.
There’s also a different appetite for change, because typically smaller organisations may be focused on only one or two compounds rather than running hundreds of studies and taking a portfolio approach. Therefore their appetite for risk is higher because they’re trying to get to a defined endpoint, perhaps the next round of financing, the sale of a company, approval at an IPO – all of those are propositions that make them more willing to be flexible and take more risks.
On the other hand, if you’re a large pharma company and you have a portfolio of 100 drugs and you’re running 500 studies concurrently, if one of them fails it’s a big deal but it’s not going to put you out of business – you’ve already got a revenue stream, you’ve got financing in place. Smaller companies don’t have all those lifelines and so they will be behave differently, and that’s definitely something we’ve seen happen, and we’ve seen it be successful for them.
Do you come across a lot of siloing in bigger pharma companies?
Absolutely. It’s a challenge that the industry is working through right now. Siloing is indicative of how pharma companies have evolved with the regulatory environment and what the technologies at the time looked like – for example a decade ago everyone thought doctors would never get on the internet. That was wrong, but it was the perception at the time. If you came out with a platform back then, no one is going to be using it now.
Now people have got comfortable with the technologies, but when you deal with individual silos getting them to change is not easy. We find ourselves in situations where, for example, an organisation wants to adopt our entire platform but you still have a mindset lower within the organisation, within those silos, that they’d rather go with the vendor they know already, even though ultimately it’s much better for the organisation as a whole if they work on a different platform because it changes the workflow for people up and downstream.
That’s why executive sponsorship is so important, that people from that level – the head of R&D, the CIO, the CTO, the CEO etc – support this and push for the change. That’s the only way it actually happens, because otherwise people won’t want to make a change. Whether or not there’s risk in it is irrelevant, it’s just a behavioural thing, and it’s a process – everyone’s overworked, so if you have to change your process mid-stream that’s incrementally more work.
What other kinds of cultural change would you like to see from the sector?
I would say that we’re seeing a lot of good culture change happening already. What’s been interesting to me is that in an industry that has been relatively slow to adopt new technology, what seems to be one of the top conversations at the executive level is digital transformation. While typically pharma lags behind, e.g. in adopting cloud technology, it feels like that’s accelerating and they’re actually moving much faster than they have in the past. For me that’s indicative of an industry that’s going through a seismic change, and that’s really positive.
What do you envision the position of companies like Medidata being in the industry over the next five years?
I’d like to envision us as playing a central role! Right now we have 1,100 customers, we run concurrently about 6,000 clinical trials, with 18 of the top 25 pharma and a big smattering of the top 100. We hold in our data centres their entire future revenue stream and IP. That’s an interesting place to be. I’d like to think of us as the connecting tissue and infrastructure they live on.
The data that companies have looked at historically has been very narrow. They’re now looking at much broader datasets – that’s happening because of regulatory departments shifting, it’s happening because the payers are requiring it and it’s happening because patients are actually speaking up about quality of life issues. You take that together and you see that the way they utilise technology, the kind of technology they utilise, is going to shift in the next decade, where we can be the underlying infrastructure but we can also provide a lot of knowledge that helps them make better decisions faster.
If you want to be successful in a world of precision medicine you need to close that loop between development and commercial and I think we’re in a very good position to help do that.
What do you think are going to be the biggest challenges for the industry in the next few years?
The large amounts of process change with companies is one of them. The regulatory environments are an interesting challenge because on the one hand you have regulators like the FDA asking companies to move faster, but then you have the cross-current of data privacy questions coming up where you are required now to house data in different geographic areas around the world. The power from the data comes from combining it, so if you’re being kept from doing that it’s a risk. Clinical trials tend to be carved out but not always, and that’s because the regulatory framework is just starting to evolve; data privacy is a new enough concept that regulations aren’t that granular yet. So that’s a big potential challenge.
The other is that the technology is still evolving. People like to talk about things like artificial intelligence, and you can throw the words around, but the reality is that five years from now technology is going to be much more sophisticated than it is today. I think it’ll actually make the adoption easier, but you’ll also need very sophisticated techniques, more sophisticated that what we have today, to actually get useful information from that data. So that’s both an opportunity and a risk.
Tarek Sherif was speaking at the 2018 Medidata NEXT conference in New York in October