We Are DIA

Dr. Tatsuya in a professional headshot against a blue background
BLK and Kondo
Dr. Tatsuya Kondo at the DIA Awards
Dr. Tatsuya in a professional headshot against a blue background
Dr. Tatsuya Kondo at the DIA Awards smiling and holding a DIA newsletter
Kondo with Dr. Gerald Dal Pan standing with arms wrapped around each other posing for a picture
Dr. Tatsuya Kondo with BLK and (former) Board President Sandra Milligan
Dr. Tatsuya Kondo: “A visionary leader and friend”

IA honors the life and work of Tatsuya Kondo, a long-time leader, mentor, and friend of many in our community, who died on September 26, 2021.

A Fellow of DIA and long-time active DIA supporter and contributor, Dr. Kondo served as the Chief Executive of the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan from 2008-2018. His leadership made a profound impact not just on PMDA but also its role in the world. As a compassionate neurosurgeon, he brought a fresh perspective and a determination to apply regulatory science to improving the health of all people.

Many PDMA milestones were announced and celebrated at DIA meetings over the course of Dr. Kondo’s long career, including clear progress on reducing the “drug lag” in Japan, a pragmatic commitment to regulatory science and novel therapies, sustained international engagement, and more.

As DIA Japan Annual Meeting 2019 Program Chair, Dr. Kondo explained the concept of rational medicine in his keynote address: Placing Patients at the Center of Rational Medicine: Reflections on Science, Technology, and Ethics to Build Tomorrow’s Healthcare Environment.

In his follow-on Global Forum article, Dr. Kondo wrote: Rational Medicine will only be realized when various technologies—including medicine, ethics, regulations, etc.—are applied to rationally work in harmony…

It is important to note that the younger generation is adding its power to the drug development field as well as to DIA in Japan. This generation is increasingly important because of their role in creating new ideas for utilizing these new technologies, and for new concepts/models that will reach far beyond current organizations and positions. Working across generations in Japan will increase DIA’s essential importance as “a forum for discussion to create Rational Medicine with collaboration among government, industry, academia and patients.” To realize Rational Medicine for patients, we must diligently seek “medical excellence” and implement it with stakeholders all over the world.

“Dr. Kondo was a true innovator who also, importantly, knew how to effect deep transformation, and did so effectively in Japan, across Asia, and especially with the DIA community around the globe,” said Barbara Lopez Kunz, Global Chief Executive of DIA. “We have lost a unique change agent and diplomat, but even more, a visionary leader and friend.”

The following are just a few of the tributes we have received from Dr. Kondo’s many colleagues and friends.

Dr. Kondo was a visionary giant among top regulators. He helped transform PMDA, promoting constructive communications with industry through a disciplined consultation process and an unwavering focus on regulatory science. A former neurosurgeon, he brought a fresh perspective to a governmental bureaucracy, and politely but firmly modernized it and promoted its global engagement with other economies in Asia Pacific and beyond. Under his leadership, PMDA took on the role of Rapporteur for ICH E17, the Guideline on Multiregional Clinical Trials. Recognizing the benefits of his domestic and international impact, the Japanese Government renewed his PMDA mandate repeatedly for 11 years. Dr. Kondo embodied that rare blend of inspiring, visionary, transformative, compassionate and approachable leadership that drives true sustainable change. Dr. Kondo was a strong supporter of DIA in Japan and across the globe. For many years he accompanied numerous PMDA expert presenters and staff to the Global Annual Meeting, the EuroMeeting, and of course the Japan Annual Meeting. He led by example, standing at the podium or contributing to panel discussions and delivering important lectures and insights. We in the DIA global family miss him deeply, but he lives on in our hearts.

Alberto Grignolo (PAREXEL; Fellow of DIA; Global Forum Editor-in-Chief)

Since arriving as chairman of PMDA in 2008, Dr. Kondo made significant contributions in building a strong foundation for regulatory science in Japan. Global simultaneous drug development increased sharply, and the review process of new drug applications was greatly enhanced, to a globally competitive level, under the leadership of Dr. Kondo. He also actively interacted with the pharmaceutical industry and, as a board member, I am grateful for his strong support of DIA. Dr. Kondo was always very nice and open to people. We appreciated his useful advice on various matters, and I am sure many people who knew him really miss him. I personally would like to express my deepest sympathies, and sincerely pray that he rests in peace.

Kihito Takahashi (BONAC Corporation; DIA Board Director)

I am deeply grieved to hear of Dr. Kondo’s sudden passing. As a member of PMDA, I really appreciated his leadership during his eleven years as PMDA Chief Executive. He devoted himself to formulating the philosophy that transformed “PMDA in Japan” into “PMDA in the world.” Strengthening the PMDA examination system and eliminating Japan’s drug and medical device lag are among his greatest achievements. Many people recognized Dr. Kondo’s huge contributions in regulatory science, respected him, and valued working with him. His warm and charming personality was beloved by all. I would like to add that he was a talented neurosurgeon and truly knew the suffering of patients and their families. He also greatly contributed to the development of DIA, and I genuinely pray that he rests peacefully.

Haruko Yamamoto (PMDA; Chair, DIA Advisory Council of Japan)