Vasant Narasimhan: Can I do trials without trial sites?

February 15, 2017 01:25 am | Updated 01:32 am IST

Vasant Narasimhan, Global Head Drug Development and Chief Medical of Swiss multinational pharmaceutical company Novartis, speaks during the annual press conference at the Novartis Campus in Basel, Switzerland.

Vasant Narasimhan, Global Head Drug Development and Chief Medical of Swiss multinational pharmaceutical company Novartis, speaks during the annual press conference at the Novartis Campus in Basel, Switzerland.

Global Head of Drug Development at Novartis Dr. Vasant Narasimhan is all for the pharma industry embracing tools of modern technology. Predictive learning analytics and digital technologies in clinical trials can help improve process efficiency, cut costs and gain time. He also sees a greater role for the company’s development centre in Hyderabad. Excerpts from an interview:

You had earlier pointed to how the pharma industry has not been as aggressive in technology adoption. In what ways can data analytics contribute to drug development?

The insight we had is other industries, whether aerospace, oil and gas, other industrial sectors and consumer packaged goods, started investing in technology in their operations to become much more efficient.

The pharmaceutical industry did not do that at the same time. We lagged the rest.

But if you now look at how sure predictive learning analytics, digital technologies are, there is an opportunity to put that to make [clinical] trials much more efficient. We would like to lead in it and be more advanced.

A lot of work is [already] being done in Hyderabad. Some specific examples would be to use predictive analytics to run global clinical trials.

We run clinical trials in 52 countries. We constantly have to make a decision on where we open a trial site and adapt a trial.

This can be done by investing in technology infrastructure and building predictive analytics tools rather than based on human decisions.

We use data, try to embed that data, which is not different from what GE, Siemens or other industrial companies have done. We want to do that in our operations.

Second is about using sensors and technologies with patients themselves measuring better how they are doing using this technology and make our clinical trials much more focused. Technology can be used to simplify the whole drug development process.

It sounds crazy, but can you do a clinical trial without any clinical trial sites – just through telemedicine and using iPhones?

Could you then bring the trial to the patient? But a lot of things seemed crazy 10 years ago.

If enough of those things could actually happen at scale, then you could actually bring down the costs.

What about the cost component of technology?

We see all these technologies [giving] pretty big returns. We have not successfully scaled them yet.

What we project is they would bring down the cost, speed us up and reduce the amount of touch points on how much the data is getting touched and thus increase the efficiency. You have to invest.

As a company of the size of Novartis, we are willing to take those risks, put our money and invest in these technologies. Next, you have to be okay with some of these failings.

Not all of this stuff will work. You have to have a tolerance of failure. If you have a setback, keep going, saying that this is the way we have to move. We have to bring down the cost of development.

How do you expect regulators to react?

We have to do a lot of work to educate regulators. The first reaction is, it is a big change and we are nervous about it.

So they need to be convinced. You need to engage with them early. Often regulators say it is very interesting but we are not sure whether it is going to work to our expectations.

During your visit, Novartis and T-Hub incubator signed an MoU for mentoring start-ups in the healthcare tech space. What role do you see for start-ups?

We build all of these things through partnerships.

We want to have expertise in-house, but the real technological capabilities can be outside. We do it through seed funding, venture capital. We would look similarly, with T-Hub, for people with ideas.

It was very interesting when we were there. Companies have developed a sensor that can measure EKG (electrocardiogram) for two weeks and wirelessly transmit [findings] to a phone; a telemedicine portal as part of which kiosks where a patient would come and get all of the lab [tests] done; and how robots can be used to help at the clinical trial site. I think these are things we want to see and support.

What is your perspective on the Indian pharma industry?

It definitely has become the engine of generics for the U.S. and partially for Europe.

I see world-class capabilities in chemistry and small molecules, growing capabilities in biologics. But for novel drug discovery, if you are going to discover a molecule and bring it through development in India there is more work to be done.

You need stronger ecosystems of academia, government-supported labs, research and industry coming together.

One of the things you have to accept if you are going to go into novel drug discovery is attrition rates. If you are in generics, you have a small molecule and probably crack it. When we take a molecule into the clinic, on an average from the first time human study, we have 10% success rate. In discovery, it is less than 1%. That you have to accept, a capital put at higher risk. You can’t do it small scale; if you want to take one out in pre-clinical you need to have 100 projects. You can’t have five projects and say I want to get one out.

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