Back in the 1990s, the idea of running computer-simulated clinical trials would have seemed far-fetched. The internet had only just emerged, personal computers were the size of suitcases, and Microsoft Windows was a novelty. The pharma industry was still, apparently, enjoying its hey-day.
In fact, R&D productivity was already in decline – and had been for decades. Clinical pharmacologist and entrepreneur Prof. Jean-Pierre Boissel, nova’s co-founder, was acutely aware of this brewing challenge. He had spent a distinguished academic and research career developing and improving clinical trial methodology, including running one of the first randomized multi-centre, with centralized randomization, controlled clinical trials in cardiology in France during the 1970s.
Boissel was also watching two other emerging trends: the rapid increase in biomedical knowledge – even then, far too great for any single human physician or investigator to absorb it on time for decision making – and a fast-maturing IT sector. The data revolution was underway. Boissel was an early adopter: during the 1980s he’d used France’s pre-internet “Minitel” data sharing system to check eligibility, randomize patients, capture, check and correct trial data onsite. The process was extended in ambulances with the first available pocket computer, during an EC-funded trial of thrombolysis in patients at risk of a heart attack. It was clear to Boissel that computer-powered simulations could one day become the third pillar of drug R&D, alongside conventional in vitro and in vivo experiments.
Fast forward to the summer of 2007. Boissel and his wife are in Tokyo, visiting their son Francois-Henri, then working at Lehman Brothers. “One morning at breakfast, my father mentioned this crazy idea: if I was willing to one day quit banking, we should start a company around clinical trial simulation,” recalls Francois-Henri, co-founder and CEO. When Lehman collapsed less than a year later, Francois-Henri began his pivot from banking to biotech.
Nova launched in 2010, with co-founder Fred Cogny, CTO, and further support from friends and family.
The entrepreneur’s road is never smooth, and this one was no exception. “I made all the rookie [entrepreneur] mistakes,” admits FH, from questionable hiring decisions to massively over-estimating how fast a product would find its market. “Compared to the cost of a failed program, modeling is cheap,” says Francois-Henri. “I thought most pharma would want to try it.”
Still, nova’s mission – to improve drug R&D productivity and help get better drugs to patients, faster – drove the team through the tough years. Among the frustrations was the pharma industry’s slow adoption of digital technologies – despite (or perhaps because of) their focus on biomedical innovation.
Today, the forces driving nova, and its mission to enable greater use of modeling and simulation in drug R&D, are undeniable.
- Drug R&D is still unproductive, yet the pressure on drug prices is rising.
- Medicines are more personalized, making it harder to find the right trial patients, and in sufficient numbers, to run a statistically meaningful study.
- Computers are cheap and powerful; the cloud has radically reduced IT infrastructure costs. Biomedical knowledge continues to accumulate exponentially and is stored digitally.
In the 2020s, running computer-based trial simulations looks both logical and urgent. Simulated trials allow researchers to test multiple hypotheses prior to recruiting actual patients, saving time and money, and reducing the burden of trials on individuals and their families.
That’s why, in 2018, the US FDA began to promote in silico trials. Nova was among the first participants in its Model Informed Drug Development pilot. This validation from regulators “was a game changer for nova,” says Francois-Henri.
Nova’s journey is far from over. Yet it may have covered the hardest part of the road – patiently yet doggedly preparing the world for a new approach. Along the way, nova has assembled a team of talented people, highly motivated scientists and data engineers, and worked with several biopharma and biotech clients. The company’s trial simulation platform jinkō was launched in 2021.
The proudest achievement so far for nova’s CEO? “Seeing how invested my team is in our mission to accelerate drug R&D.”