INC Research, a therapeutically focused global CRO with a Trusted Process for delivering reliable results, has announced three key management appointments to enhance its growing presence and clinical R&D leadership team in Japan. Hiromi Wakita, Ph.D., has joined the company as general manager and clinical director and will lead the company’s operations in Japan. He is supported by the appointments of Hiroshi Uoji, who joins as regulatory and safety director for Japan, and Shinichi Sato, who joins as project director, CNS Clinical Development in Japan. With these appointments, INC Research is able to offer its global drug development customers a highly qualified and experienced regulatory and therapeutic team to capitalize on existing strong relationships and navigate the complexities of conducting research in this market.
“As the world’s second largest pharmaceutical market, Japan offers huge potential in terms of advancing new medicines globally,” said Garth Tierney, executive vice president, Asia/Pacific. “Having an experienced leadership team in place to better assist customers in gaining access to the world’s No. 2 ranked product market, while helping them navigate some of the cultural and regulatory differences in conducting research here, is key. With more than 90 years of collective experience in the pharma industry, Hiromi, Hiroshi and Shinichi will be instrumental in strengthening our presence in this important market."
Wakita brings nearly 30 years of clinical development expertise to his role as general manager and clinical director for INC Research Japan and will be based out of the company’s Tokyo office, which manages all of its clinical operations, study startup and regulatory activities. Having worked for both pharma and international CROs, he has broad industry experience and has held senior roles in a range of functions, including regulatory affairs, marketing, clinical development, business development and project management.
Uoji, who will lead the company’s regulatory consulting and clinical regulatory operations as well as supervise its safety reporting functions in Japan, also is based in Tokyo. He brings more than 30 years of regulatory and pharmacovigilance expertise to his role as regulatory and safety director for Japan.
As project director, CNS Clinical Development in Japan, Sato will support one of the most actively targeted therapeutic areas for R&D in Japan. Sato brings a wealth of CNS-specific experience in drug development and operational execution in such indications as depression, schizophrenia and Parkinson’s disease. He will provide consultation and oversight on the company’s ongoing CNS work in the region from the Tokyo office.
Further demonstrating its commitment to the region, INC Research also has released a new white paper that offers biopharmaceutical companies key strategies to advancing their R&D activities in Japan. The paper explores the recent regulatory changes that have sparked renewed interest in Japan as a valued destination for both regional and global clinical trials, while providing creative and differentiated business strategies to conducting research in the region.
INC Research has 20 offices in key locations across the Asia/Pacific region in addition to Japan, including a presence in China, India, Australia, Singapore, Philippines, South Korea, Taiwan, Hong Kong, Malaysia, Thailand, Indonesia and New Zealand. Having provided phase I to IV clinical development services in the Asia/Pacific region for nearly 20 years, the company has conducted more than a 1,000 studies across a broad range of therapeutic areas.