“What does the youngest chief executive in Big Pharma want? A control room straight off the starship Enterprise.”

Clinical trials: how technology is driving digitisation

That was the headline of a recent Forbes article on the vision of the new Novartis CEO, Vasant Narsimhan, on how he would like to run clinical trials and revolutionise the lab-to-launch process of innovating new drugs. The article paints a clear picture of Vas, as he is popularly known, as one of the most forward-thinking big pharma leaders and, having spoken on the subject on more than one occasion, I could surely agree on many key areas that he highlighted!

Speaking at Innovation Day, our annual flagship event, in November 2017, I highlighted how the innovations in connectivity, cloud, data analytics and visualisation technologies could revolutionise the care pathway in oncology. Although, instead of a control room straight off the starship, I was thinking more of the global command and control centre of AT&T!

I have a very similar view of times to come regarding running clinical trials and the role of the big data. However, there were some interesting aspects that I discussed during that presentation that I'm highlighting here, and were probably missing in the article covering Vas’s vision. I believe they form an important pillar of any successful digital innovation strategy. In my opinion, oncology is the therapeutic area that will fuel the introduction of these new technologies and enable this paradigm shift in the industry with a rather high inertia to change. Shear complexity of disease, hundreds of cancer variants and millions of dollars poured into oncology research will require the industry to reset the way drug discovery is managed and care delivery is structured today.

Compared to diseases such as diabetes or asthma, cancer as a therapeutic area will require high-throughput R&D. However, this isn't necessarily associated with the availability of more resources (i.e. capital investment). Moreover, this doesn't mean that neither pharmaceutical companies nor payers (be it insurers, governments or NGOs) are willing to pick up any additional costs of development. As a result, somehow, the same level of investment needs to result in more successful drugs being launched. The improvement in R&D throughput is needed for sustainable care delivery.

The only way out of this problem is to embrace technology and capitalise on the latest innovations. And oncology makes the easy case of ROI considering the number of drugs in the pipeline and number of trials globally.

2000+ clinical trials
300+ drugs in research
10+ years survival
Creating unsustainable cost of care

While Vas was spot-on about bringing care into the home by leveraging telemedicine, one enabler that probably was left out was the use of self-administration drug delivery systems that are part of the connected eco-system interwoven with monitoring, diagnosing, testing and care support network. 

It's very important to understand these enabling technologies in the form of advanced self-help drug delivery systems that patients can use in the home setup while being closely monitored and supported by care providers and healthcare professionals. In my opinion, they're the real change agents that will make it possible to realise the vision of modernising clinical trials and bring care into the home. When a 42-step process of administering a single dose of injection is reduced to three steps and a press of a button (along with a hope for cure with a better drug), you're more likely to motivate patients to enrol in clinical trials, with patient recruitment for clinical trials highlighted by Vas as a known challenge.

As far as the role of these modern technologies in drug discovery is concerned, my thinking is that there are obvious value drivers in terms of real-world evidence and real-time data that would drive efficient R&D and better outcomes. When value drivers are obvious, the ROI case becomes that bit easier to build. It's just a matter of when and who, and not if. It seems Novartis is about setting a breakthrough example, once again!

Harshal Shah
Head of Oncology Innovations, Global Medical Technology

Harshal is part of our global medical division based out of Boston, with more than a decade of experience in medical device development, product life cycle strategy, and innovation management. He has significant expertise in oncology patient journey, economics of cancer care and innovations in oncology. He has a Bachelor of Mechanical Engineering degree from Nirma Institute of Technology in India, an MBA from Syracuse University, New York, and he recently completed a post graduate program in cancer biology and therapeutics development from Harvard Medical School.