Technology meets biology for gathering and analyzing data from unique five-year study.
Sanofi is embarking on a unique five-year study of asthma patients that will merge traditional lab techniques with an array of digital tools, enabling scientists to gain a far deeper understanding of the workings of one of the most widespread chronic diseases. The first study of its kind involving asthma, it will follow nearly 1,200 people who are living with various forms of asthma. Along the way, researchers will be collecting a massive range of information, including traditional clinical data as well as genomics, environmental, and sensor data from connected inhaler devices.
The study will be a collaboration involving clinical research teams from Sanofi, Sema4 – a patient-centered predictive health company, and Mount Sinai Health System. Unlike a clinical trial, which is conducted to test the safety and efficacy of a specific drug, this is a longitudinal study focused on understanding the patients themselves. The goal is to learn more about how the disease affects each of them individually, and why it affects some individuals differently than others.
“Our goal is to develop a holistic view of each patient in the study, which is why we’re excited to add digital technology to the traditional types of medical examinations conducted in this study. It’s a new way to approach this enormous problem, connecting real world clinical and scientific data, that we hope will translate into new ways to treat asthma” said Frank Nestle, Global Head of Immunology and Inflammation Research and Chief Scientific Officer, North America, Sanofi.
The collaboration will focus on integrating different types of data, from the genomic to the behavioral, and analyzing that information using “big data” techniques. The researchers involved will conduct analyses in an effort to gain insights into mechanisms of disease functions, triggers for asthma “attacks” (acute episodes of respiratory distress that can occur without warning), which patient segments are most likely to respond to certain therapies, and for which patient segments are current therapies more or less effective. Using such information, researchers would then attempt to pinpoint new targets for the development of future medicines, as well as investigate ways to translate such information that could potentially help healthcare providers make more effective treatment recommendations for patients.
“Asthma is an incredibly complex condition associated with genetics, environmental factors, activity levels, the immune system and more,” said Eric Schadt, PhD, Chief Executive Officer of Sema4. “We believe the only way to fully understand asthma is by using sophisticated modeling tools to mine the rich, multi-dimensional data set we aim to generate in this study. This approach could reveal entirely new avenues for alleviating and more effectively treating asthma.”
Asthma: A Growing Global Problem
It’s also the leading chronic disease in American children and has been on the rise in both adults and children in the US since the early 1980s.
Asthma can cause children to stay home from school and adults to stay home from work. It’s also expensive: $56 billion a year in direct health care costs and indirect costs such as lost productivity and premature disability in the US. Similarly high costs are the rule in places where asthma is most prevalent.
Asthma is not only costly and disruptive – it also can be deadly. It is estimated that 180,000 people die each year from the effects of the disease.
“Evidence shows that the prevalence of asthma is increasing, and with it healthcare costs as well as indirect costs associated with the loss of productivity and early disability,” said Linda Rogers, MD, Associate Professor and Clinical Director of the Adult Asthma Program at the Mount Sinai-National Jewish Health Respiratory Institute. “Despite advances in recent years, we see many patients struggling with asthma in our program, so there is still a tremendous need for innovation to reduce the burden of this disease.”
Five Years of Data to Analyze
The study will gather real world patient experience and physiology through innovative digital sensor technologies and machine learning / advanced analytics. That information can be linked with data involving patients’ activities just prior to the attack, as well as environmental factors such as pollen levels, to help create a “real-world” view into each episode.
As the study progresses and more data are collected, researchers will have a larger pool of information to analyze for patterns and insights. It is expected that the study will produce one of the richest data sets of this type on asthma that has ever been available.
“Our hope is that the insights from this first-of-its-kind study in asthma will help us to potentially bring novel medicines to patients faster” said Heather Bell, Global Head of Digital and Analytics at Sanofi.