The collaboration is advancing the use of rapid recruitment approaches and participant engagement technologies to drive efficiencies and expand representation in clinical studies.
Princeton, NJ and South San Francisco, CA, February 1, 2023 – Otsuka Pharmaceutical Development & Commercialization, Inc. (Otsuka) and Verily, an Alphabet precision health company, today announced their expanded work together on innovative approaches to clinical trials studying treatments for adults with Major Depressive Disorder (MDD).
The collaborators recently launched the Juniper study, which will recruit 336 participants for a phase 2 clinical trial to evaluate centanafadine extended-release capsules, as a monotherapy or in addition to a selective serotonin reuptake inhibitor for adults with MDD. The Otsuka-sponsored trial uses Verily’s Clinical Research Suite for rapid recruitment and participant engagement across 55 trial sites in the U.S. Otsuka and Verily are jointly committed to greater awareness and accessibility of clinical trials for patients with mental illness - to more effectively enroll representative study populations. This work expands on and incorporates learnings from the Mirai study, launched with Click Therapeutics and Verily in 2021, which applied remote trials technology and recruiting solutions to study new digital therapeutics to treat adults with MDD.
The Juniper study utilizes Verily's rapid recruitment solutions, while adopting a patient-centered study design that enables participants to engage with the trial using digital tools and technologies in addition to direct engagement with study sites across the country. Throughout their healthcare journey, people with mental illnesses such as MDD face a range of challenges that can serve as a barrier to trial participation. User experience (UX) research is embedded throughout the study, beginning with in-depth interviews with MDD patients and healthcare providers to identify their unique needs and inform recruitment, engagement, and retention approaches. Verily UX teams also co-developed new trial management tools with study sites, visiting the research sites to stress test and adapt study workflows.
“We’re pleased to expand our collaboration with Verily based on our shared vision for changing the landscape of clinical research,” said John Kraus, M.D., Ph.D., executive vice president and chief medical officer at Otsuka. “Together, we are continuing to apply novel solutions to increase the pace of studies and collect higher quality, more comprehensive data in a real-world setting. We want to create future trials that are more efficient, patient-centered and more representative of the people who will use the treatments.”
“Otsuka has been a true innovation partner, working with us to build tools and systems that will enable clinical research of the future,” said Amy Abernethy, MD, PhD, president of product development and chief medical officer at Verily. “These new recruitment and participant engagement capabilities offer the promise to include more participants in clinical research and to accelerate timelines to get treatments to patients faster.”
Depressive disorders, including MDD, affect roughly 280 million people worldwide. According to the World Health Organization, depression is also a leading cause of disability worldwide and a major contributor to the overall global burden of disease. New approaches to clinical research can help accelerate the development and delivery of innovative treatments to serve the millions of patients in need of safe, effective, convenient and accessible care.
Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: Otsuka–people creating new products for better health worldwide. Otsuka researches, develops, manufactures, and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health.
In pharmaceuticals, Otsuka is a leader in the challenging areas of mental, renal, and cardiovascular health and has additional research programs in oncology and on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a “big venture” company at heart, applying a youthful spirit of creativity in everything it does.
Otsuka established a presence in the U.S. in 1973 and today its U.S. affiliates include Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) and Otsuka America Pharmaceutical, Inc. (OAPI). These two companies’ 2,000 employees in the U.S. develop and commercialize medicines in the areas of mental health and nephrology, using cutting-edge technology to address unmet healthcare needs.
OPDC and OAPI are indirect subsidiaries of Otsuka Pharmaceutical Company, Ltd., which is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 47,000 people worldwide and had consolidated sales of approximately USD 13.6 billion in 2021.
All Otsuka stories start by taking the road less traveled. Learn more about Otsuka in the U.S. at www.otsuka-us.com and connect with us on LinkedIn and Twitter at @OtsukaUS. Otsuka Pharmaceutical Co., Ltd.’s global website is accessible at https://www.otsuka.co.jp/en/
Verily is a subsidiary of Alphabet that is using a data-driven, people-first approach to change the way people manage their health and the way healthcare is delivered. Launched from Google X in 2015, Verily’s purpose is to bring the promise of precision health to everyone, every day. Verily is focused on generating and activating data from a wide variety of sources, including clinical, social, behavioral and the real world, to arrive at the best solutions for a person based on a comprehensive view of the evidence. Verily uses its recognized expertise and capabilities in technology, data science and healthcare to enable the entire healthcare ecosystem to drive better health outcomes. For more information, please visit verily.com.
1. Global, regional, and national burden of 12 mental disorders in 204 countries and territories, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet Psychiatry. 2022;9(2):137-150.