Dr. Kenichi Nakamura, Director of the International Development Department and Head of the Clinical Research Support Department at the National Cancer Center Hospital(NCCH) in Japan.

For over 20 years, Dr. Nakamura has been revolutionizing cancer treatment through clinical trials, bridging gaps in healthcare, and promoting global collaboration. Today, he holds dual roles as the head of the Clinical Research Support Department and the Director of the International Development Department at the NCCH. He supports multicenter collaborative trials within Japan while also spearheading the expansion of clinical trial networks across Asia through the Asian Clinical Trials Network for Cancers (ATLAS).

Connecting Asia for Better Cancer Care

The ATLAS project is a groundbreaking initiative that aims to enhance cancer treatment and care through coordinated clinical trials in countries and regions throughout Asia. The program is building a strong network of clinical trials to ensure that participating institutions have the resources they need, like skilled principal investigators, clinical research coordinators, and advanced equipment, as well as adherence to global standards like ISO 15189.

"The idea behind ATLAS project is to create a unified front in Asia for cancer clinical trials," explains Dr. Nakamura. "We want to leverage the strengths of each country and the institution to conduct impactful research that can improve patient outcomes across the region."

Under Dr. Nakamura's leadership, ATLAS project has forged collaborations with leading cancer research institutions in Japan, Singapore, Chinese Taiwan, Malaysia, Vietnam, Thailand, the Philippines, Indonesia, and South Korea. Each country and region has designated institutions and coordinators working in tandem to implement and manage clinical trials within their respective regions.

One of the flagship trials under the ATLAS project umbrella is the PATHWAY trial, an Asian Collaborative Investigator-Initiated Registration-Directed Trial (IIRDT) for advanced breast cancer. This trial evaluates the efficacy and safety of different treatment regimens for HR+ and HER2- advanced breast cancer patients. With sites in Japan, South Korea, Chinese Taiwan, and Singapore, the trial exemplifies the cross-border collaboration that ATLAS project fosters.

"The PATHWAY trial is a prime example of how we can work together across Asia to address unmet medical needs," says Dr. Nakamura. "By pooling our resources and expertise, we can conduct trials that would be difficult to achieve by any one country or region alone."

"Our goal is to improve cancer treatment outcomes through coordinated and high-quality clinical trials," he added. "By working together, we can achieve this goal more effectively."

Extensive experience in MRCTs

Over the past decade, the NCCH Japan has experienced remarkable growth in its clinical research capabilities, particularly in First-in-Human (FIH) trials, which are critical milestones in drug development.

From 2010 to 2021, the NCCH experienced a surge in clinical trials, expanding from two FIH trials in 2010 to 64 FIH trials by 2021. This growth underscores the NCCH's leadership in pioneering new treatments and commitment to advancing healthcare through cutting-edge research.

The NCCH’s clinical trials are supported by a robust infrastructure and a team of highly skilled professionals. The institution is home to several influential clinical physicians with expertise in a variety of domains. Moreover, a A team of over 50 highly skilled CRCs ensures the efficient and high-quality management of trials, while the NCCH’s extensive experience in international collaborations allows it to adhere to global standards.

The hospital conducts the more clinical trials than any other in Japan. It’s also a highly efficient operation, with a short timeline from contract signing to the enrollment of the first patient. Its clinical trial unit is ISO 9001 certified, ensuring the highest quality management systems. Additionally, the NCCH offers competitive costs for conducting trials and has the unique capability to develop strategies that incorporate Investigator-Initiated Registration-Directed Trials (IIRDTs).

Investigator-Initiated Registration-Directed Trials: Filling the Gaps

Dr. Nakamura sees IIRDTs as crucial for addressing the limitations of the pharmaceutical industry. "The pharmaceutical industry, despite its vast resources, cannot cover every medical need," he explained. "There are gaps, particularly in the area of rare cancers, which often lack sufficient prioritization due to the limited patient population and potential market size."

IIRDTs allow academic institutions to act as regulatory sponsors, bridging the gap between research and clinical practice. By focusing on neglected diseases and rare conditions, academic institutions can drive treatment development where the industry may not have the incentive to invest. Collaboration with the pharmaceutical industry is essential, as the study drug and, in many cases, funding is provided by industry partners.

"This collaboration is mutually beneficial," Dr. Nakamura emphasizes. "Positive trial results enable industries to submit New Drug Applications, leveraging the research conducted by academia. Moreover, routine costs, excluding the study drug, are often reimbursed by national health insurance, making it more feasible for academic institutions to conduct large-scale clinical trials."

The success of IIRDTs is evident in the NCCH's track record, with more than 10 new drug approvals achieved through this approach. "IIRDTs represent a valuable model for bridging the gap between academia and industry, addressing unmet medical needs, and accelerating the development of new treatments for patients," Dr. Nakamura states.

Opportunities for Collaboration with China  

Dr. Nakamura sees potential for collaboration with Chinese biotech companies. "We welcome collaborations with institutions like Mainland China," he says. "The more we can expand our network, the more impactful our research can be. By joining ATLAS, Mainland China can participate in cutting-edge clinical trials, contribute to the development of new cancer treatments, and benefit from the shared knowledge and resources within the network."

"China has a thriving biotech industry,” he added, “and we are eager to work with Chinese companies to advance cancer research and treatment. By combining our expertise and resources, we can accelerate the development of new therapies and bring them to patients more quickly."

One area of particular interest is the development of treatments for cancers that are specific to Asia, such as liver, bile duct, uterine, and stomach cancers. "These cancers are not of interest to Western big pharma, but they are a significant health burden in Asia," Dr. Nakamura notes. "By collaborating with Chinese biotech companies, we can address these unmet needs and improve patient outcomes in our region."

A Personal of Growth and Innovation

Dr. Nakamura's journey in medicine is marked by a pursuit of excellence and a commitment to innovation. After completing his surgical residency, he switched to clinical research, where he thought he could make a more meaningful impact on cancer treatment. 

A pivotal moment came when he spoke up at a meeting to determine the future direction of clinical trials for esophageal cancer in Japan. He challenged the status quo, advocating for a more globally relevant approach. This earned him the support of many of his fellow doctors, and he ultimately changed the trial's direction. "That moment gave me a sense of accomplishment and solidified my resolve to take a leading role in clinical trials," he recalls.

He eventually enrolled at the Globis University Graduate School of Management, where he graduated as a top-performing student in 2022. "The lessons I learned at Globis, particularly the importance of aligning strategy, organization, and finance with excitement, have been invaluable in my work," he says. "By fostering excitement and a shared vision among team members, we can achieve great things."

He is also never content to rest on his laurels. His latest initiative, Decentralized Clinical Trials (DCT), has become a game-changer for patients in rural areas who previously had limited access to clinical trials. "By leveraging ICT technology, we can make clinical trials more accessible and inclusive," he explains. "This is just one example of how we are continuously innovating to improve patient care."

Dr. Nakamura’s work serves as an inspiration to the next generation of cancer researchers and clinicians. His journey, marked by resilience, determination, and a relentless pursuit of excellence, is a testament to the power of a single individual to make a lasting impact on the world.

Mao Donglei, PharmaDJ’s editor-in-chief, with Dr. Nakamura.

Dr. Nakamura,with Mrs. Cao Xiaochun (CEO and co-founder of Tigermed, center) and Mr. Jin Chengzhe (Director of Tigermed's Japan Office).

Editor：Justin Fischer