Around the Globe

Parallel Tracks: DIA, ICH, and Me
ACJ Chair Reflects on DIA History and Future in Japan
Hironobu Saito
Daiichi Sankyo Co., Ltd.
I

n July 2019, Hironobu Saito became Chair of the DIA Advisory Council of Japan (ACJ). He shares below how his professional growth and the growth of DIA Japan became the same story.

Looking back to the year 2000, DIA activity had just begun in Japan. Then DIA President John Alexander, Global Head of R&D at the Japan-based pharmaceutical company (legacy) Sankyo, said to me, “You should raise issues around the ‘drug lag’ situation in Japan at our 2000 DIA Annual Meeting in San Diego.”

This was the beginning of my engagement with the DIA world. I organized a session focused on clinical trials and medicines development in Japan with Kazuo Nakamura, Chairman of the Japan-based CRO CMIC, and Teruo Omae, President of the National Cerebral and Cardiovascular Center Hospital. Discussions were lively and it was a great success. And I was very impressed by DIA.

Progress in Clinical Trials and in Asia

At that time, the hot topic throughout Japan was improving the quality of clinical trials through site management, and professionals in Japan’s R&D environment were struggling to adapt to GCP requirements that were formally established in Japan in 1998. Soon after that DIA Annual Meeting, and with John’s support, I organized a clinical trials workshop with Sigeru Kageyama at The Jikei University School of Medicine, titled Progress in Clinical Trials.

The first joint panel discussion between clinical research sponsors and health authorities in Japan took place at our fifth workshop, in 2005. Contributors to this workshop included Kazuhiko Mori, Councilor of the Ministry of Health, Labour and Welfare (MHLW), and Yoshiaki Uyama, a senior member of the Pharmaceuticals and Medical Devices Agency (PMDA) and a member of DIA’s regulatory council (and now Global Forum Regulatory Science Co-editor). Our moderator was Yasuhiro Fujiwara, who is now the Chief Executive of PMDA. Again, I was so impressed by the open environment of honest discussion and fair debate.

Although Japan is an island, it does not stand alone in the modern world of global R&D, and by 2007 our sights had expanded to Asia. Working together with Ling Su, another former President/Chair of DIA, we presented the first DIA Asia Workshop in 2007. Its success provided another cornerstone for collaborations in clinical research, drug development, and regulatory science, throughout Asia.

Hironobu Saito with Akio Uemura and Atsushi Tsukamoto
The author with DIA Japan Senior Vice President & Managing Director Akio Uemura (on left) and DIA Contents Committee Chair Atsushi Tsukamoto (on right).

ICH and DIA Similarities

Beginning in 2012, I also served on the Steering Committee of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) while simultaneously working on various DIA activities. Within ICH, I witnessed leaders in industry (Peter Honig from PhRMA) and in regulatory science from the EU (Lenita Lindström-Gommers) and the US (Theresa Mullin) collaboratively contribute their talents and serve as excellent role models for my own work. I also saw the high value that ICH placed on contributions from its Japanese senior regulators (Nobumasa Nakashima and Naoyuki Yasuda) and how Japanese regulatory junior members grew professionally through their ICH activities.

DIA Next Steps in Japan

When I became the head of oncology clinical development for Daiichi Sankyo in 2017, I realized that the most important elements of my fifteen years of experience with DIA and with ICH were also an essential aspect of my responsibilities for Daiichi Sankyo: To deliver promising drugs as quickly yet as safely as possible to patients who need them.

In order to succeed, the Advisory Council of Japan (just like ICH and DIA) needs the collaborative contributions of talented experts in clinical research, drug development, and regulatory science; a global yet streamlined strategy; and a commitment to delivering operational excellence. We are pursuing this success from several strategic directions:

Continued collaboration with ICH and Asian health authorities: Industry and regulatory experts from Japan have contributed to ICH for thirty years. We look forward to continuing the DIA-ICH relationship through a thirty-year anniversary event; through joint sessions with China, Korea, and even other non-ICH countries in Asia; and through active, collaborative ICH participation in our next DIA Asia International Conference.

Collaboration with like-minded organizations: Discussions among organizations such as the Association of Clinical Research Professionals (ACRP) and the American Society of Clinical Oncology (ASCO) are, like conversations at DIA, continuing to refine and reshape future global clinical trials from a site management perspective. We have already approached ASCO Chairman Howard Burris to discuss possible future collaborations where our interests overlap.

Oncology is one of the world’s largest, most difficult, and yet most promising therapeutic areas. PMDA Chief Executive Yasuhiro Fujiwara has already made public his strategy of “4 Firsts:” Patient First, Access First, Asia First, and Safety First. Using this strategy as our guide, we are working with colleagues across the EU and US to soon present a new workshop on global oncology development to address unmet patient needs.

All these activities will be conducted based on a model of patient centricity actively led by the Patient Engagement Community (PEC) in Japan and supported by the global DIA PEC.

In Japan, DIA has become one of the definitive collaborative platforms through which industry, academia, and government can work to improve R&D that delivers truly beneficial therapeutic products to patients. We welcome communications from members in China, the EU, the US, and elsewhere, and look forward to active engagement with you. DIA, what a wonderful platform!

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