Pharma

Sanofi CMO offers window on ways pharma is integrating tech into drug development

Sanofi Chief Medical Officer Dr. Ameet Nathwani expressed excitement about the technology developments that stand to benefit drug development in a fireside chat at StartUp Health Festival this week but noted that integration poses its own set of challenges.

The rise of companies such as Science 37 and Palantir combined with the FDA’s modified approach to regulation present new opportunities for the pharma industry to reduce the cost of drug development. But as Sanofi Chief Medical Officer Dr. Ameet Nathwani discussed in a fireside chat at StartUp Health Festival this week, figuring out how to integrate that technology poses its own set of challenges.

First, he outlined the current state of the drug industry.

“How does our industry move to a new world and become a much more tech, hybridized industry? If you think about what it takes to develop a drug today, it costs $1 billion. One in 10 of the drugs developed ever fully pays back the development costs. Yet the costs of development keep increasing and the outcomes or rewards of the drugs we’re developing are dropping — nearly 50 percent in the last 8 years. So if you look at what we do, it’s ridiculous”

Speaking to the audience, he highlighted the current shortcomings of clinical trials. 

None of you call a cab, you’d probably call Uber. You probably don’t even visit a bank, yet we expect patients to go and enroll in clinical sites, visit them every three months, do blood tests from home and yet, we use that data to make an interpretation of what that drug will do in the real world. That’s crazy.”

The hope is that the integration of technology from companies such as Science 37 and Sanofi’s collaboration with Verily will give Sanofi the ability to use remote monitoring so clinical trial participants can take part from their home, a more natural setting to assess a drug’s impact. That could also help improve the diversity of clinical trial participants.

Technology business Palantir is even taking humans out of the equation with simulated clinical trials. It uses analysis of internal drug development data with external data sources (such as PubMed, TCGA, and ChemBL) and real-world data to help users understand patient population dynamics and drug outcomes, according to its website.

Nathwani said it has a program with Palantir referred to as “Darwin AI” and has loaded 300 million lives on that platform across many diseases

“We have done simulated trials in that dataset, which allows us to decide whether to go forward [with a drug]at a fraction of the cost.”

Despite Nathwani’s enthusiasm for technology adoption, another challenge becomes how to attract entrepreneurs to work with Sanofi. It’s very hard to get entrepreneurial, techie people into big pharma, Nathwani said. Instead, it has focused on partnerships as the way forward.

Another interesting wrinkle is the development of real-world evidence clinical studies —using data from the real world as a form of control, which can help make these clinical studies cheaper and faster to carry out. These studies are an example of the kind of clinical research innovation the 21st Century Cures Act supports.

Another development that excites Nathwani is how quickly China is moving into the regulatory space and ramping it up now.

“There are 150 cloud hospitals in China and with the volume they have they can do it. If we went to China and said can we do a telehealth project with you, they have the infrastructure to do it.”

Illustration: Erhui1979, Getty Images

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