There is a lot we can be optimistic about the vaccine development for COVID-19, says Glen de Vries. We have enough interest for vaccine development, and enough patients eager to participate in clinical trials. 

Two of the important things in clinical trials are determining the endpoints and their value. The next thing is, how quickly can you find suitable patients for a clinical trial? Patient recruitment is especially tricky in rare diseases, which in general affect a small number of people. In a pandemic, however, recruitment is much easier.

Data gathering is not a problem in COVID-19 race towards a reliable vaccine. The challenge is how to evaluate it, says Glen de Vries, Co-Founder and Co-CEO of Medidata. Medidata is a US-based company providing pharmaceutical, biotech, medical device, diagnostics companies, and academic researchers with a platform for clinical development, commercial, and real-world data. End of July Medidata started working with Moderna to support clinical trials of mRNA-1273, Moderna’s COVID-19 vaccine candidate.

Glen recently wrote a book titled The Patient Equation in which he writes about the evolution of clinical trials and precision medicine. As he writes, our understanding of the human body has grown a lot more than clinical trials. Until now, we have lacked the infrastructure and connectivity to think differently about the way we do research.

. “If we look at what’s happening in the world of COVID-19, half a year ago, we had a very limited view of what really mattered in terms of predicting who would be exposed to the virus and how sick they would get. Age and immune status were seen as the two primary drivers. Today we are unfortunately seeing children coming down an inflammatory syndrome. In some cases, the virus is fatal for young, otherwise healthy people. So perhaps the inputs should be broader than just age and immune status. Wouldn’t it be useful if we could predict what are the input variables that result in bad cases of COVID-19?” says de Vries.

He has been in the clinical trial space for over 20 years. Lack of proper infrastructure for clinical trials was what triggered the idea for Medidata two decades ago. Glen was working in cancer research in the 90’s. At the time, the whole lab he worked in shared one computer and researchers would take turns using it. Part of the data was on paper, another part in a hospital system in another building or patients’ paper charts. Data was a problem then, and it still is today. While it is easier to connect data points today, data harmonization is still a huge, but a not unsolvable challenge, he says.

Glen believes that combining data from clinical trials into larger data sets and real-world data will enable us to create reliable predictive mathematical models supported by machine learning and AI.

“One of the most exciting things that are happening in the world of healthcare at large is that we are moving away from thinking about populations to thinking about individuals. What is more patient-centric than coming up with an equation for what is the best therapy for an individual? That, to me, is patient centricity. Taking things that used to be population problems to being able to say what a particular person needs in a given moment, may it be preventative care or dealing with a chronic condition.”

Tune in for the full discussion:

Some questions addressed:

• With the rising number of COVID-19 patients, we are all hoping a successful solution will reach the market fast. When COVID-19 hit the US government announced Operation Warp Speed which “aims to deliver 300 million doses of a safe, effective vaccine for COVID-19 by January 2021, as part of a broader strategy to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics (collectively known as countermeasures).” The time predicted towards the first vaccine is unprecedented — if successfully discovered by 2021, the vaccine will be the fastest developed vaccine globally. There are few questions here: to which extent can money increase the speed of vaccine development, how far are we with AI and data collection and standardization to come to meaningful results faster? What was your response when you head about Warp speed?

• How are you following, looking at the 140 vaccines in development? What has the COVID-19 crisis meant for Medidata as a company?

• For a light start: Medidata was founded 20 years ago. Companies always have a vision but then often pivot. What was your initial idea 20 years ago and how did it develop to where Medidata is today?

• You recently wrote a book titled The patient equation. What is the difference between patient centricity and the patient equation?

• What did you learn in the writing process?