In 2012, Japan’s Pharmaceuticals and Medical Devices Agency (PDMA) revised the J-GCP standards to further harmonize with ICH-GCP in a bid to boost clinical trial activity in the country.
Whether this harmonization will ultimately have the desired effect remains to be seen. In January PDMA researcher Yuki Ando told us fewer multi-region clinical trials (MRCT) included Japanese sites last year than any year since 2008.
One firm to see a positive impact is PPD according to Paul Colvin, who is vice president of clinical development and CEO of the firm’s joint-venture with Japanese contract SNBL.
Colvin told Outsourcing-pharma.com “pharma companies are now accelerating the inclusion of Japan in global drug development programs concurrently with development in the US and Europe markets.
“The earlier inclusion of Japan in global trials has resulted in sponsors attempting to harmonize Japan development with global CRO partners in order to gain efficiencies. As a result, Japan capabilities have become a factor in the selection of CROs during global partnership decisions.”
The idea that Western drugmakers developing products for the Japanese market choose to do so in partnership with Western CROs is not particularly a surprise. The existence of CROs with global reach indicates that sponsors often favor known suppliers irrespective of the market.
But the J-GCP harmonization is also impacting traditionally inward looking Japanese drugmakers according to Colvin who suggested that, increasingly, such firms want contractors with global expertise.
“In our experience, many Japan-based biopharmaceutical companies prefer to work with global CROs such as PPD because they see significant benefits from the comprehensive services, therapeutic expertise and technology advantage we can bring to their R&D programs.
“We’ve received overwhelmingly positive feedback about forming PPD-SNBL, both from clients who tell us the service offerings are perfect for their focus on global trials and also from clients working on trials based specifically in Japan.
“This” Colvin continued “confirms our belief that this business model is the bright new paradigm for clinical research in Japan.”
Japan specific challenges
So – according to PPD - being in Japan makes sense given the increasing demand for global CROs from local and international drugmakers.
But the US contractor also believes having a local partner is important.
Colvin told us “It’s vitally important for pharma companies conducting trials in Japan to partner with a global CRO that understands the opportunities and challenges of patient recruitment in the country and that has innovative and comprehensive patient recruitment resources to drive success.
“One of the reasons we’re excited about our new joint venture, PPD-SNBL, is the huge benefits we can bring our clients by drawing on years of experience in managing sites and recruiting patients for Japanese clinical trials.”