As part of the most ambitious medical research program in the history of American medicine, The Scripps Research Institute (TSRI) and its partners including Sage Bionetworks have received an initial award of $20 million for their role in President Obama’s national All of Us Research Program (previously referred to as Precision Medicine Initiative or PMI), announced by the National Institutes of Health (NIH) on July 6. This landmark longitudinal research effort will engage one million or more U.S. participants to improve the ability to prevent and treat disease based on individual differences in lifestyle, environment and genetics. The program will leverage smartphones and other personal technologies to support participant enrollment and data collection.
In collaboration with Scripps Participant Technologies Center (PTC), Sage Bionetworks will be responsible for the patient consent and data governance related to the All of Us Research Cohort Program’s software products, as well as the community outreach and participant engagement efforts of the Participant Technologies Center. The Sage team will also be engaged in the scientific and engineering work to develop new methodologies for measuring symptoms of health and disease, including developing symptom measurements for phone, wearable, and other sensors. This builds on the mobility sensor work Sage Bionetworks is currently doing on a number of mobile app-based research studies, including mPower for Parkinson’s Disease patients.
“Recent developments in mobile and sensor technologies have given researchers new tools to better understand the symptoms patients experience in their daily lives. We are excited to bring these approaches into such a large scale and innovative study.” said Lara Mangravite, President of Sage Bionetworks.
Press Release issued by THE SCRIPPS RESEARCH INSTITUTE (TSRI), LA JOLLA, CA – October 5, 2016 – updated November 29, 2016
Grant to TSRI-Led Consortium Expands to $207 Million
Responsibility Broadens for Enrollment of Participants into NIH Precision Medicine Initiative Cohort Program
LA JOLLA, CA – October 5, 2016 – The National Institutes of Health (NIH), as part of its national Precision Medicine Initiative (PMI) Cohort Program, has expanded a five-year funding award to The Scripps Research Institute (TSRI) from $120 million to $207 million.
The award marks a significant increase in scope from the initial award announced in July and provides additional details about the network of partners in the TSRI-led consortium. Read Full Press Release
Press Release issued by THE SCRIPPS RESEARCH INSTITUTE (TSRI), LA JOLLA, CA – July 6, 2016 –
TSRI Awarded $20 Million for U.S. Precision Medicine Initiative Cohort Program
STSI to Spearhead Participant Technologies Center that Leverages Smart Phone Technology
LA JOLLA, CA – July 6, 2016 – As part of the most ambitious medical research program in the history of American medicine, The Scripps Research Institute (TSRI) has received an initial award of $20 million for its role in a national Precision Medicine Initiative, the National Institutes of Health (NIH) announced today.
“We are thrilled to have the opportunity to help lead this far-reaching, transformative program of one million or more U.S. participants with long-term follow up,” said the new grant’s principal investigator Eric Topol, MD, who is director of the Scripps Translational Science Institute (STSI), professor of genomics at TSRI and chief academic officer at Scripps Health. “Our focus at STSI for the decade of its existence has been to advance individualized medicine. Using genomics, mobile apps and biosensors and providing data back to each participant, this study will set the foundation for new medical knowledge and ways of engaging people in research as citizen-scientists.”
“This grant—which will total almost $120 million over five years—is one of the largest federal grants ever awarded to TSRI,” said TSRI CEO Peter Schultz, PhD, “and it represents the expanding leadership role that Eric and TSRI will play in this new era of biomedical research.”
The five-year award is part of the Cohort Program of President Obama’s Precision Medicine Initiative (PMI); the PMI Cohort Program is a landmark longitudinal research effort that aims to engage one million or more U.S. participants to improve the ability to prevent and treat disease based on individual differences in lifestyle, environment and genetics.
“STSI already has played a pivotal role in a digital medicine revolution that is radically transforming the way we think about and provide health care,” said Chris Van Gorder, president and CEO of Scripps Health, which operates STSI in partnership with TSRI. “This grant ensures the continuation of that work for years to come on a scale that will benefit the entire nation.”
The new grant will support a Participant Technologies Center through STSI that will play a key role in enrolling participants in the study, as well as providing mobile applications. In parallel, the center will develop platforms to deliver these same functions to those without smartphones and work with various technology organizations to increase smartphone accessibility.
STSI has partnered with the NIH-funded Vibrent Health of Fairfax, Virginia, which will provide the technology platform to enroll and engage participants through mobile apps, web app, interactive voice response, feature phones and wearable sensors; Vibrent Health will develop, test, maintain and upgrade the technology platform to enroll, consent, collect data from, communicate with and retain participants throughout the grant period.
In addition, Seattle-based Sage Bionetworks, an integral partner in the design, development and data hosting for many of mobile-app-based research studies on Apple’s open source ResearchKit platform, will be responsible for developing symptom measurements from phone, wearable and other sensors, as well as community outreach and participant engagement efforts with the Participant Technologies Center.
The initiative also includes an extensive network of high-profile partners including Walgreens and PatientsLikeMe. Working collaboratively with other entities, the Scripps Participant Technologies Center will be responsible for enrollment of at least 350,000 participant-volunteers.
“These partners provide unparalleled outreach and engagement, along with data privacy and security capabilities,” Topol said.
The team aims to begin initial enrollment into the study this year, with the aim of meeting its enrollment goal by 2020.
Participants will be invited to answer questions about their health history and status, share their genomic and other biological information through simple blood and urine tests and grant access to their clinical data from electronic health records. In addition, mobile health devices and apps will provide lifestyle data and environmental exposures in real time. All of this will be accomplished with essential privacy and security safeguards. As partners in the research, participants will have ongoing input into study design and implementation, as well as access to a wide range of their individual and aggregated study results.
“This range of information at the scale of 1 million people from all walks of life will be an unprecedented resource for researchers working to understand all of the factors that influence health and disease,” said NIH Director Francis S. Collins, M.D., Ph.D. “Over time, data provided by participants will help us answer important health questions, such as why some people with elevated genetic and environmental risk factors for disease still manage to maintain good health, and how people suffering from a chronic illness can maintain the highest possible quality of life. The more we understand about individual differences, the better able we will be to effectively prevent and treat illness.”
The knowledge gained from the PMI Cohort Program will extend successes of precision medicine in some cancers to many other diseases. Importantly, the program will focus not just on disease, but also on ways to increase an individual’s chances of remaining healthy throughout life.
For more information on the Precision Medicine Initiative (PMI), see https://www.whitehouse.gov/precision-medicine. For more information on the PMI Cohort Program, see https://www.nih.gov/precision-medicine-initiative-cohort-program. For more information about NIH and its programs, visit www.nih.gov.
About The Scripps Research Institute
The Scripps Research Institute (TSRI) is one of the world’s largest independent, not-for-profit organizations focusing on research in the biomedical sciences. TSRI is internationally recognized for its contributions to science and health, including its role in laying the foundation for new treatments for cancer, rheumatoid arthritis, hemophilia, and other diseases. An institution that evolved from the Scripps Metabolic Clinic founded by philanthropist Ellen Browning Scripps in 1924, the institute now employs more than 2,500 people on its campuses in La Jolla, CA, and Jupiter, FL, where its renowned scientists—including two Nobel laureates and 20 members of the National Academy of Science, Engineering or Medicine—work toward their next discoveries. The institute’s graduate program, which awards PhD degrees in biology and chemistry, ranks among the top ten of its kind in the nation. For more information, see www.scripps.edu.
About Scripps Health
Founded in 1924 by philanthropist Ellen Browning Scripps, Scripps Health is a nonprofit integrated health system based in San Diego, Calif. Scripps Health treats more than 600,000 patients annually through the dedication of 3,000 affiliated physicians and more than 15,000 employees among its five acute-care hospital campuses, hospice and home health care services, 28 outpatient centers and clinics, and hundreds of physician offices throughout the region.
Recognized as a leader in prevention, diagnosis and treatment, Scripps Health is also at the forefront of clinical research, genomic medicine and wireless health care. With three highly respected graduate medical education programs, Scripps Health is a longstanding member of the Association of American Medical Colleges. Scripps Health has been ranked four times as one of the nation’s best health care systems by Truven Health Analytics. Its hospitals are consistently ranked by U.S. News & World Report among the nation’s best and Scripps Health is regularly recognized by Fortune, Working Mother magazine and AARP as one of the best places in the nation to work. More information can be found at www.scripps.org.
About Scripps Translational Science Institute
The Scripps Translational Science Institute aims to replace traditional one-size-fits-all medicine with individualized health care by leveraging the power of genomic medicine, wireless health sensors and mobile phone applications, and other digital medicine technologies. In a unique collaboration, STSI merges the considerable biomedical science expertise of The Scripps Research Institute with Scripps Health’s exceptional patient care and clinical research capabilities. STSI is supported in part by the National Institutes of Health Clinical and Translational Science Award. For more information, visit www.stsiweb.org.