Le Lézard
Classified in: Health, Science and technology
Subject: Contract/Agreement

Otsuka Pharmaceutical Development & Commercialization, Inc., and the Columbia University Mailman School of Public Health Enter Into a Global Pharmacovigilance Agreement


Otsuka Pharmaceutical Development & Commercialization, Inc., announced an agreement with research experts from the Columbia University Irving Center Vagelos College of Physicians and Surgeons and Mailman School of Public Health to help support the epidemiological needs of Otsuka Global Pharmacovigilance (GPV) for products, enhanced training, and employee education.

The three-year agreement, through October 2022, draws on the extensive expertise of faculty at Columbia Mailman and the Columbia University Irving Medical Center's Vagelos College of Physicians and Surgeons. Faculty members will work with Otsuka on activities such as post-marketing safety and effectiveness studies, the development of data registries, and investigations of rare exposures and outcomes. Columbia Mailman faculty will also provide executive education to Otsuka's pharmacovigilance and clinical research and development employees, including conducting workshops in epidemiology and biostatistics, journal clubs, seminars, and formal courses.

"The expertise and scientific depth of the Columbia University Irving Medical Center faculty will help us enhance the epidemiological support for various Otsuka Global Pharmacovigilance regulatory reports and publications," said Mirza I. Rahman, MD, MPH, senior vice president and chief global pharmacovigilance officer, Otsuka Pharmaceutical Development & Commercialization, Inc., and a Columbia University Mailman School of Public Health alumnus. "Patient safety is our highest priority and the knowledge sharing, learning, and scientific exchange resulting from this initiative is consistent with Otsuka's commitment to excellence in pharmacovigilance."

Leading Columbia Mailman School's research team is Alfred I. Neugut, MD, PhD, MPH, professor of Epidemiology and Myron M. Studner, professor of Cancer Research in Medicine at the Vagelos College of Physicians and Surgeons. Other members of the Columbia University Irving Medical Center team include Drs. Judith Jacobson, Lambert Lumey, Jason Wright, and Daniel Freedberg.

"Our work with Otsuka is a unique and innovative approach to enhancing drug surveillance and safety efforts," said Dr. Neugut of the Mailman School.

About Otsuka

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' 1,700 employees in the U.S. develop and commercialize medicines in the areas of mental health, nephrology and cardiology, using cutting-edge technology to address unmet healthcare needs. Otsuka's most recently approved product in the U.S. is the first-ever treatment for autosomal dominant polycystic kidney disease, a genetic disorder in which fluid-filled cysts develop in the kidneys over time, often leading to kidney failure.

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 billion in 2019.

All Otsuka stories start by taking the road less travelled. 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 www.otsuka.co.jp/en/.


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