Mr.Shigeru Nakaji is the Strategic Operations Lead in the Office of the Chief Medical Officer at Astellas Pharma and chairs the Drug Evaluation Committee of the Japan Pharmaceutical Manufacturers Association (JPMA). With over 30 years of experience in clinical development and project management, Mr. Nakaji has built a distinguished career spanning Japan, the United States, and China. His international expertise offers a unique, multinational perspective on the global pharmaceutical industry.

 

Mr. Nakaji made history as Astellas' first clinical trials specialist assigned to China, where he established the company’s synchronized clinical trial operations. His pioneering efforts laid the groundwork for Astellas’ current achievements in Multi-Regional Clinical Trials (MRCTs), most notably illustrated by the recent global approval of the Claudin 18.2 monoclonal antibody Zolbetuximab—an accomplishment that included simultaneous clinical development and regulatory submission worldwide.

 

As Chair of the JPMA Drug Evaluation Committee, Mr. Nakaji has led strategic dialogues uniting industry leaders, regulators, and academic experts to address critical sector challenges. His active participation in global forums has helped align Japan’s pharmaceutical ecosystem with international regulatory standards and clinical trial practices.

MR. Nakaji with his colleagues in China joined the 2024 DIA China Annual Meeting in Suzhou.

 

Recently, Mr. Nakaji has focused on strengthening Sino-Japanese pharmaceutical collaboration, working to harmonize approaches and facilitate cross-border cooperation in clinical trials.

 

Early Stages of Formative Career Years

 

Mr. Nakaji’s interest in the pharmaceutical industry began during high school. Sparked by a passion for science, he built an expertise in pharmaceutics and pharmacovigilance, which led him to study at Kyoto Pharmaceutical University. Graduating during Japan’s economic boom in the 1990s, he joined Fujisawa Pharmaceutical (now part of Astellas) in 1991 as a Clinical Research Associate (CRA). At Fujisawa, a firm renowned for its antibiotics and immunosuppressants, Mr. Nakaji honed his focus on ensuring the quality of clinical trials in Japan.

 

The 2005 merger of Fujisawa and Yamanouchi Pharmaceuticals not only created Astellas Pharma Inc. but also reshaped Japan’s role in global pharmaceutical innovation. This merger propelled Astellas into the forefront of therapeutic research, with targeted R&D in oncology, urology, immunology, infectious diseases, dermatology, and CNS disorders—delivering breakthrough treatments for patients with unmet needs.

 

Mr. Nakaji’s cross-functional roles at Astellas provided valuable, end-to-end insight into the drug development process, covering protocol design, trials management, and global operations. This comprehensive experience gave him a deep understanding of the clinical development pathway and regulatory requirements.

 

The early 2000s were transformative for Japan's pharmaceutical sector, as the PMDA’s regulatory reforms and leadership in ICH standards opened new global opportunities. Japanese companies, empowered by these changes, established a worldwide presence through MRCTs.

 

From 2004 to 2008, Mr. Nakaji worked at Astellas’ Northbrook office, forging partnerships with leading US clinical researchers and deepening his expertise in FDA regulations. He successfully adapted global best practices within Astellas’ operations and represented JPMA in global academic forums, further enhancing his leadership within Japan’s pharmaceutical governance.

 

Pioneering Clinical Trials in China

 

At the height of his US and Japan tenure, Mr. Nakaji was assigned to lead Astellas’ clinical development operations in Beijing. It was a strategic move, as the company had not previously established a local clinical development presence in China.

 

Mr. Nakaji accepted the assignment in 2012, a time when China’s role in global drug development was often underestimated in Japan. His boss, Dr. Toshiro Iwamoto, recognized China’s emerging pharmaceutical landscape. The genetic similarity between Chinese and Japanese populations offered a unique opportunity to optimize global development timelines for East Asian-targeted therapies.

 

“China is more than a commercial opportunity—it’s a strategic accelerator for global R&D,”  Dr. Toshiro Iwamoto emphasized. This perspective marked the start of Mr. Nakaji’s transformative work in China.

 

Supported by strong corporate backing, Mr. Nakaji found China’s innovation environment dynamic and collaborative. The NMPA’s nationwide reforms in 2015 spurred engagement in clinical research, and Chinese investigators were highly receptive to Japanese-sponsored studies. “The professionalism and insight of Chinese PIs exceeded all expectations,” Mr. Nakaji recalled.

 

A Transformative Mentorship

 

Wang Na, Deputy General Manager and Head of Development at Astellas China, once worked alongside Mr. Nakaji for a year. She was also the first local Chinese manager in Astellas China's R&D department. It was Mr. Nakaji who recruited her into Astellas and personally shared with her the company's strategic vision and long-term goals for conducting clinical trials in China，insights that left a profound impact on her. “Mr. Nakaji extended his trust from the start and continued to support me even after his return to Japan,” Wang recalled.

 

“His deep commitment to China’s pharmaceutical development came from direct experience. He witnessed NMPA’s regulatory reforms, felt the industry’s rapid growth, and participated in critical moments like China’s ICH accession. These experiences gave him both historical perspective and enduring faith in China’s potential.”

 

Mr. Nakaji’s management style blended mentorship with transformative organizational impact. He championed the elevation of China’s clinical trials team to an independent strategic unit with full local decision-making authority, significantly enhancing its professional standing and capabilities.

 

“A leader’s true impact,” he often said, “is measured not by titles, but by the lasting influence on the team. If people look back with gratitude, you’ve succeeded.” For Mr. Nakaji, leadership was about legacy: “To leave a footprint in the world, to uplift your community, and to guide the next generation—that is the meaning of life.”

 

Scientific Collaboration for Global Partnership

 

After his assignment in China, Mr. Nakaji remained deeply involved with Astellas’ Chinese clinical development, fostering regular Japan-China research exchanges. His commitment extended beyond his formal responsibilities, reflecting a dedication to both organizational excellence and industry advancement.

 

He has observed China’s rapid rise in global drug development with admiration, but also offers advice: “When Japanese partners consider collaboration, the first question is whether your research addresses unmet patient needs—not just market size.” He emphasizes the importance of scientific rigor: “Any lapse in clinical data quality in China reverberates globally. Lasting alliances depend on therapies validated by science, not just market potential.”

 

A continuing challenge is the lack of mutual clinical data recognition across Asia. Mr. Nakaji recalls promising, but ultimately stalled, 2008 discussions between China, Japan, and South Korea. Today, he advocates for renewed multilateral efforts to create reciprocal frameworks, which would improve efficiency while maintaining rigorous standards.

 

As head of the JPMA committee, Mr. Nakaji highlights the association’s role in uniting established companies and innovative biotechs to advance science at every development stage, from protocol design to real-world evidence generation. The JPMA serves as a crucial interface, ensuring regulatory policy is informed by industry expertise and that patients have access to breakthrough therapies supported by the highest standards of evidence.

 

Mao Donglei, Editor-in-Chief of PharmaDJ with Mr. Nakaji in Tokyo.

Edited by:Justin