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Verily, an Alphabet company, has announced strategic alliances with Novartis, Otsuka, Pfizer Inc., and Sanofi to develop digitally innovative, patient-centered clinical research programs using Project Baseline’s evidence generation platform and tools.
Across the United States, the number of people participating in clinical research - including clinical trials and observational studies - is less than 10% of the population.1 In addition to low participation, challenges in research include data fragmentation, inefficient operations and limited value for patients.
Alongside academic research institutions, patient-advocacy groups and health systems, Verily and its industry partners aim to implement a more patient-centric, technology-enabled approach to research, and increase the number and diversity of clinical research participants. They will also explore novel approaches to generating real-world evidence using the Baseline Platform to collect, organize, and activate health information from electronic health records, sensors, and other digital sources. Over the coming years, Novartis, Otsuka, Pfizer and Sanofi each plan to launch clinical studies leveraging the platform across diverse therapeutic areas, such as cardiovascular disease, oncology, mental health, dermatology and diabetes.
“Evidence generation through research is the backbone of improving health outcomes. We need to be inclusive and encourage diversity in research to truly understand health and disease, and to provide meaningful insights about new medicines, medical devices and digital health solutions,” said Jessica Mega, M.D., chief medical and scientific officer, Verily. “Novartis, Otsuka, Pfizer and Sanofi have been early adopters of advanced technology and digital tools to improve clinical research operations, and together we’re taking another step towards making research accessible and generating evidence to inform better treatments and care.”
The evolution of project baseline
Verily launched Project Baseline in 2017 with the Project Baseline Health Study to develop the technology and tools to help researchers create a more comprehensive, precise map of human health. The company’s interdisciplinary team of engineers, clinicians, scientists and partners have since developed and continue to expand:
Verily’s Project Baseline has also built a connected ecosystem with the aim of linking patients and advocacy groups with clinicians and health systems, integrating clinical research with clinical practice and making the process engaging. It started with a community of researchers, study sponsors and study volunteers, including Duke University School of Medicine, Stanford Medicine, Google and the American Heart Association (AHA) who helped test tools and technologies in the landmark Project Baseline Health Study. Next, Verily launched the Project Baseline Advisory Board of luminaries spanning healthcare, technology, medicine and patient advocacy. Then, in early 2019, Verily and the AHA announced Research Goes Red, which will leverage the Baseline Platform to engage more women in research, and an ongoing collaboration to connect patient communities with relevant research opportunities. Finally, this month Verily launched the Baseline Health System Consortium with vanguard health systems in the United States to explore the use of new tools and technology to improve research broadly and help bridge the gap between clinical research and clinical care.
“If we are truly to achieve the realization of patient-centered care, we must advance innovative research methodologies that focus on the patient and their needs, values and lifestyles," said Reed Tuckson, M.D., chairman, Project Baseline Advisory Board. "Project Baseline, in collaboration with these innovative companies, is well positioned to achieve this vision and have a transformative impact on research.”
Verily’s initial strategic alliances with Novartis, Otsuka, Pfizer and Sanofi strengthen the innovative research ecosystem that will continue to expand and could help foster greater scientific discovery through the creation of next-generation research and development programs.
“At Novartis we are advancing treatments that stand to change the course of disease, or even offer cures, but our ability to bring new medicines to patients quickly is often hampered by inefficient or limited participation in clinical trials,” said Badhri Srinivasan, head, global development operations, Novartis. “By combining our complementary sets of expertise, we have the opportunity to develop a new trial recruitment model that gives patients and their physicians greater insight into the process of finding treatments for their disease, and how they can participate.”
“The clinical research process is antiquated in many ways. Our collaboration with Verily aims to redefine and redesign this process to make clinical trials more accessible to patients, and clinical research more precise and targeted so we can obtain results and seek approvals sooner, which would put therapies into the hands of physicians and their patients earlier,” said Debbie Profit, Ph.D., M.S., vice president, applied innovation and process improvement, Otsuka. “As an early adopter of the Baseline Platform, we have the opportunity to leverage real-world data, through sensors, EHR integrations and other tools to corroborate evidence around the treatments and interventions we are studying – while reducing the burden on clinical trial participants.”
“In clinical research, for several years now we have been pursuing game-changing possibilities to deploy digital technology and data science to re-engineer how we operate,” said Rod MacKenzie, chief development officer and executive vice president, Pfizer. “The science behind our potential new medicines is cutting edge, yet many clinical trial processes have remained relatively unchanged over decades. To bring scientific breakthroughs to patients more quickly and increase the diversity of the patient population in our clinical trials, Pfizer is committed to exploring new technologies and innovative ways to conduct clinical research, and we are proud to partner with Verily in that effort.”
“Our scientific knowledge has exploded over the past generation, but efficiently bringing these new breakthroughs from lab bench to patient requires us to greatly improve the way we conduct these complex clinical trials,” said Lionel Bascles, global head of clinical sciences and operations, Sanofi. “Project Baseline will allow us to better recruit appropriate patients and more efficiently integrate data for a greater understanding of diseases, reconnecting trials to our patients’ healthcare journeys.”
For more information, please visit www.projectbaseline.com