Leading biopharmaceutical organizations join Project Baseline initiative to engage more patients and clinicians in research and speed evidence generation
South San Francisco, CA – May 21, 2019 – Verily, an Alphabet company, today announced strategic alliances with Novartis (NYSE: NVS), Otsuka (NYSE: OTSKY), Pfizer Inc. (NYSE: PFE) and Sanofi (EURONEXT: SAN, NASDAQ: SNY) to develop digitally innovative, patient-centered clinical research programs using Project Baseline’s evidence generation platform and tools. The Baseline Platform is designed to engage more patients and clinicians in research, increase the speed and ease of conducting studies and collect more comprehensive, higher quality data, including outside the four walls of a clinic.
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. In addition to low 1 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:
1 https://www.researchamerica.org/sites/default/files/July2017ClinicalResearchSurveyPressReleaseDeck_0 .pdf
- User-friendly devices, dashboards and analytical tools that create an engaging experience for patients and provide research decision support to study coordinators and researchers;
- An interoperable platform that provides access to timely, normalized data in order to streamline enrollment and management of studies; and
- A robust infrastructure that enables collection of dynamic data, like electronic health records, biometric or self-reported information, which may provide significantly more context about the value of an intervention.
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."
About Project Baseline Verily launched Project Baseline in 2017 with the goal of bridging the gap between research and care. Its first initiative was the Project Baseline Health Study, a landmark study in partnership with Duke University School of Medicine, Stanford Medicine, Google and the American Heart Association to develop the technology and tools to map human health. Verily has since expanded Project Baseline through alliances with patients, patient-advocacy groups, academic research institutions, health systems and life sciences organizations to build a connected research ecosystem. Verily and the Project Baseline team continue to develop tools and technology like the Baseline Platform, an end-to-end evidence generation platform, to engage more patients and clinicians in research, make it faster to conduct studies and collect higher quality, more comprehensive data from the real world. For more information, please visit projectbaseline.com.
Launched in 2015, Verily is a subsidiary of Alphabet focused on life sciences and healthcare. Verily’s mission is to make the world’s health data useful so that people enjoy healthier lives. Verily develops tools and devices to collect, organize and activate health data, and creates interventions to prevent and manage disease. Verily partners with leading life sciences, medical device and government organizations, using deep hardware, software, scientific, and healthcare expertise to enable faster development, meaningful advances, and deployment at scale. For more information, please visit www.verily.com.
Novartis is reimagining medicine to improve and extend people's lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world's top companies investing in research and development. Novartis products reach more than 750 million people globally and we are finding innovative ways to expand access to our latest treatments. About 105,000 people of more than 140 nationalities work at Novartis around the world. Find out more at novartis.com.
About Otsuka Otsuka Pharmaceutical Company, a global healthcare company, established a presence in the U.S. in 1973. Today, its U.S. affiliates include Otsuka Pharmaceutical Development & Commercialization,Inc. (OPDC) and Otsuka America Pharmaceutical, Inc. These two companies’ 1,800 employees develop and commercialize medicines in the areas of mental health, nephrology and cardiology, using cutting-edge technology to address unmet healthcare needs. OPDC is an indirect subsidiary of Otsuka Pharmaceutical Company, Ltd., headquartered in Tokyo, Japan. The Otsuka group of companies employed 47,000 people worldwide and had consolidated sales of approximately USD 11.7 billion in 2018. All Otsuka stories start by taking the road less travelled. Learn more about Otsuka in the U.S. at otsuka-us.com.
About Pfizer Inc: Working together for a healthier world®
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world’s best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at pfizer.com. In addition, to learn more, please visit us on www.pfizer.com and follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Sanofi, Empowering Life.
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