Singapore: Pharmaceutical Product Development (PPD) and Shin Nippon Biomedical Laboratories have formed a joint venture to provide a full range of clinical development services in Japan, including Phase I-IV clinical trial monitoring, project management, site intelligence and activation, biostatistics, data management, medical writing, pharmacovigilance, regulatory and FSP services.

The joint venture, to be named PPD-SNBL, will result from the combination of SNBL's clinical research division and PPD's clinical development operations in Japan, and it will have offices in Tokyo, Osaka and Kagoshima with approximately 400 clinical development professionals.

Under the terms of the agreement, PPD-SNBL will be majority owned by PPD. Mr Ryoichi Nagata, chairman and president of SNBL, will serve as the president of the joint venture.

The parties have also entered into an agreement under which they will collaborate in a number of areas outside of the clinical development joint venture in Japan.

This collaboration will involve SNBL's early stage businesses (including translational research out-licensing business), Phase I services in the United States for Japanese bridging studies, specialized neuroscience studies, vaccines studies and biologic studies, Phase I services in Japan, Japanese bioanalysis services and site management services in Japan.

"PPD is honored to be joining forces with SNBL to provide a unique clinical development service offering in Japan for biopharmaceutical clients," said Mr David Simmons, chairman and CEO, PPD. "PPD-SNBL will be one of the largest clinical development service providers in Japan, both for clients seeking to conduct global clinical trials and also for trials based solely in Japan, and builds on the shared commitment of both organizations to the delivery of high-quality clinical development services."

Dr Nagata said, "The close partnership between SNBL and PPD offers significant opportunities to promote and strengthen global clinical trials in Japan. In addition, the formation of this joint venture would also assist in completing our plan of building a strong global value chain in the entire drug development process."

The transactions are subject to customary closing conditions and are expected to close in April 2015.