Reuters Events | Pharma

Thought leadership and innovation for the Pharmaceutical Industry

 

The pandemic crisis has been focusing minds in healthcare and demonstrating the possibilities to innovate faster.

 

Pharma should remember this in the aftermath, says Sanofi Pasteur’s David Loew, not least because, given the economic damage of a near global lockdown, governments can soon be expected to be on the hunt for savings from pharma. 

 

“Given the economic downturn we have to expect there will be price pressures,” says Loew in his keynote on day one of the eyeforpharma Philadelphia Virtual conference (available free to anyone who registers).

 

Pharma, healthcare providers and health ministries have a golden opportunity to come together to drive innovation that will lead to new efficiencies, says the EVP & Head of Sanofi Pasteur.

 

The company’s “groundbreaking” new approach to reengineering clinical trials by generating large sets of data in a prospective manner offers just such a way forward for the industry, he adds. “We have an urgent need to reinvent ourselves in the way we are conducting clinical trials. Pharma is a high-risk industry. We are making big bets. We have to find a way to come up with innovations at a lower cost.” 

 

Insights at scale

The way to improve the odds for pharma in trials, while also ultimately improving outcomes, is bringing digital technologies to bear via Machine Learning (ML)-based analysis of large-scale sets of health records data.

 

Sanofi is already busy trialling this approach. It is prospectively comparing two flu vaccinations with Kaiser Permanente in a trial involving 1.6 million people and with the Nordic Group in Finland it is conducting a similar prospective comparative trial with a 68,000 people.

 

What makes these studies possible is the large integrated healthcare systems of Sanofi’s two partners that offer comprehensive data from GPs, specialists, labs and hospitals, offering valuable longitudinal patient insights and reducing the risk of demographic bias.

 

The benefits are clear, he says. “The Kaiser study allows us to deep dive, using ML or pre-specified analytics, into sub groups of people, for example those with cardiovascular disease, diabetes or obesity, to see if certain groups are responding better or worse if they don’t get the right vaccine.

 

“The Nordic study allows us to explore the analysis on a quality-of-life [basis] thanks to linkages to other novel databases. It also allows us to comprehensively evaluate multiple outcomes as all the healthcare system encounters are being captured. We have a 360-degree view on what is happening to the patient,” says Loew.

 

While such studies may not offer the precision of clinical trials, their advantage is very large sample sizes, says Loew. “With 800,000 people over two flu seasons, for example, that is a huge amount of data. If we have some data points missing it will probably even out and we will find really robust results."

 

Key to this exciting future of real-world insights is the widespread adoption and interoperability of electronic health records. Some promising initiatives are in development, such as moves in the EU towards more interoperability in healthcare records. Germany and France, meanwhile, are already exploring options to make their respective EHRs more interoperable. 

 

New correlations

Much more needs to be done, however. Many healthcare systems still need to migrate to EHRs, and ensure the quality of the data because only then is it possible to compare these larger data sets that capture encounters at every point of the healthcare system, says Loew.

 

Running such analysis at scale across different healthcare systems would create the opportunity for new insights into a range of therapies. Larger data lakes would enable AI to find new correlations at a fraction of the cost of traditional RCTs.

 

This system-wide approach would do away with the need for pharma companies to programme dedicated databases, or for the study nurses in hospitals to recapture all the relevant data on a dedicated database rather than having it already on the EHRs. “We will be able to include massively larger numbers of patients at less cost,” he says.

 

Despite interest from HCPs, health ministries and regulators, hurdles remain, says Loew. Healthcare systems are often stuck with legacy IT systems that inhibit interoperability. Sometimes processes between hospitals, clinics or GP surgeries are not fully harmonised so biases can be introduced.

 

The push to drive the right changes may have to come from the top down to incentivise hospitals to join in. A good place to start is the national healthcare systems which already have EHRs, such as the UK, Israel and Finland, along with the integrated private providers in the US, says Loew.

 

There is a need, too, for industry advocacy with health ministries and the European Commission. “We also need the regulators to come to the table but they are becoming curious and open to having discussion with the industry,” adds Loew.

 

“We can get there if we can manage to get interoperable databases in place. I am optimistic. Everyone faces cost pressures, industry know it, regulators know it. Who knows, perhaps the COVID-19 crisis can help accelerate all this?”