PPD completes JV to push further into Japanese clinical development services

07-Apr-2015 - Last updated on 08-Apr-2015 at 21:16 GMT

A view of Tokyo

Wilmington, North Carolina-based CRO (contract research organization) PPD (Pharmaceutical Product Development) and Tokyo-based Shin Nippon Biomedical Laboratories (SNBL) have closed an agreement to form a joint venture to provide clinical development services in Japan.

Under the terms of the agreement, the JV is majority-owned by PPD. The transaction closed on April 1.

“PPD-SNBL will build on the combined experience of having conducted more than 150 clinical trials in Japan over the past five years across all major therapeutic areas, including both global trials and studies based solely in Japan,” Paul Colvin, EVP of clinical development at PPD and chairman and CEO of the JV, told Outsourcing-Pharma.com. “While the local CRO market in Japan is sizable ($1.3 billion), global trial registrations in Japan are increasing and will expand the total market size significantly, making Japan critically important to PPD.”

First announced in January, the JV combines SNBL’s clinical research division and PPD’s clinical development operations in Japan and provides a range of services, including Phase I-IV trial monitoring, project management, biostatistics, site intelligence and activation, data management, medical writing, pharmacovigilance, regulatory and FSP services.

As the world’s second-largest single-country pharma market, Japan is key for any CRO operating at a global capacity.

“With a shrinking drug lag and a separate initiative to loosen pricing controls on drugs, Japan has become a much more attractive market for foreign and domestic pharmaceutical companies and the contract research organizations (CRO) that support them,” PPD said in a 2013 perspective paper on the country.

With combined offices in Tokyo, Osaka and Kagoshima, and approximately 400 clinical development employees, the JV brings together PPD’s global resources and clinical trial expertise with SNBL’s nearly 20-year history and in-depth local knowledge.

The JV also means that PPD and SNBL will collaborate in a number of areas outside clinical development, including via SNBL’s early stage businesses, which encompasses its translational research out-licensing business, Phase I services in the US for Japanese bridging studies, specialized neuroscience studies, vaccines studies and biologic studies, as well as Phase I services in Japan, and bioanalysis services and site management services in Japan.

Colvin added that the JV will help to solve one of the main challenges of running studies in Japan: recruiting and retaining quality trial staff. “For some multinational CROs, it can be challenging for them to recruit and retain experienced clinical trial personnel from a relatively limited talent pool of professionals who are familiar both with Japanese practices and culture and also with increasingly harmonized global standards, while speaking English fluently.

“PPD-SNBL’s talent advantage is in combining the best of both worlds – a Japanese-based CRO and a global CRO – in a joint venture that offers employees new opportunities for professional growth and career development with a dynamic and growing company,” he added.