Parexel partners in Japan for decentralized trials and regenerative medicines

Parexel has teamed with Kyoto University Hospital in Japan to promote novel trial approaches and tap demand for cell and gene therapy studies.

Under the deal – financial terms of which were not disclosed – the hospital will join Parexel’s network of clinical trial sites.

The CRO will also access Ki-CONNECT, the hospital’s early-phase trial organization that runs trials focused on treatments for cancer, intractable diseases as well as regenerative therapies.

A Parexel spokeswoman told us “Kyoto University will support clinical trials as usual, but with this alliance, Kyoto University and Parexel will collaborate to simplify processes and adopt new approaches such as decentralized clinical trials.”

She added that the partnership will support all types of trial, including those for advanced therapies, explaining “The development of cell and gene therapy products is increasing in Japan, and Kyoto University has the most experience for CAR-T clinical trials in Japan.”

Cell and gene therapies in Japan

The Japanese cell and gene therapy sector has expanded over the past few years in part due to regulatory measures introduced to support the wider regenerative medicines sector.

Examples include a dedicated approval system for regenerative medicines and the introduction of the “Sakigake” product designation, which is analogous to the “breakthrough therapy” classification used elsewhere.

This Government support for regenerative medicines helped create the environment for the partnership according to the Parexel spokeswoman.

“As the Japanese government took various measures to support the development of the regenerative medicines sector, Kyoto University established Kyoto Innovation Centre for Next-Generation Clinical Trials and iPS Cell Therapies – called Ki-Connect - in 2020.”

In a press statement Ki-Connect director Manabu Muto stressed the benefits of the approach for his organization, Parexel and other parties.

“We expect that this will be an advantage not only for Ki-Connect but also for various other developers. I sincerely hope that many innovative medical treatments will reach the clinical stage based on this alliance.”

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