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DIA Vice President Dr. Mitsuhiro Niimi: Insights into Global Healthcare, Pharmaceutical Innovation, and Collaborative Efforts

·10/21/2025

By Donglei,Mao

 

At the 22nd Annual DIA Japan Conference, a landmark event gathering Japan and Global experts in pharmaceutical innovation and regulatory affairs, we had the distinct honor of interviewing Dr. Mitsuhiro Niimi, Vice President of DIA (Drug Information Association). His insights shed light on pivotal trends shaping the future of healthcare collaboration and industry standards.

 


Vice President of DIA,Dr. Mitsuhiro Niimi

 

The theme for the 22nd DIA Japan Annual Meeting, "Strong Ties of Japan with Asia and the World for Delivering ‘Tomorrow’s Normal’ to Patients," was crafted by Dr. Fujiwara. As the Managing Director, Dr. Mitsuhiro Niimi offers a comprehensive interpretation. He emphasizes that "Delivering Tomorrow's Normal" is a recognition of the fact that healthcare innovation has transcended national boundaries. In today's global healthcare context, collaboration across Japan, Asia, and the world is not just beneficial but essential.

 

For patients, "Tomorrow's Normal" has a dual - faceted meaning. On one hand, it pertains to the restoration of the normal daily life that illness has disrupted. However, it goes beyond a mere return to the past. The concept of "tomorrow" envisions a future where, thanks to advancements in digital health, decentralized trials, and personalized therapies, a patient's normal can be significantly enhanced. It represents a step forward into an improved quality of life, where patients can experience better health outcomes and a more fulfilling existence.

 

When asked about the long - term vision underpinning the establishment of strong ties between Japan, Asia, and the world for patient - centered healthcare, Dr. Niimi points to the evolving pharmaceutical landscape. In the past, novel drugs in the development pipeline were predominantly sourced from large pharmaceutical companies. However, this is no longer the case. Nowadays, there is a heavy reliance on startups and academic institutions to identify potential drug candidates for the pipeline.

 

This shift necessitates closer collaboration, focusing on substance rather than just form. The public sector, including the government, is actively facilitating this collaboration to expedite the delivery of innovative medicines to patients. The Pharmaceuticals and Medical Devices Agency (PMDA) has also adopted a proactive approach, supporting the acceleration of drug development instead of merely taking a backseat.

 

Over the next decade, Dr. Niimi envisions this vision being actualized through increased collaboration between the academic sector, the PMDA, and industry players. Small biotech firms and large pharmaceutical companies are being encouraged to work together. This initiative will enhance global healthcare access to advanced medical treatments for patients across different regions. By streamlining the drug development process and facilitating cross - border collaboration, patients worldwide will have faster access to life - changing therapies.

 

Among the various challenges discussed at this year's meeting, such as AI, Clinical Development & Operations, Clinical Safety & Pharmacovigilance, Data & Data Standards, Medical Affairs & Scientific Communication, and Patient Engagement, Dr. Niimi identifies three key criteria as the most attention - grabbing highlights.

 

Firstly, the application of AI is a pivotal aspect. AI has the potential to revolutionize various aspects of the pharmaceutical industry, from drug discovery to clinical trial design and patient monitoring.

 

Secondly, patient engagement is crucial. The ICH E6 guidelines emphasize patient - centric innovation and the use of data to ensure the quality of clinical trials. By actively involving patients in the research and development process, healthcare providers can develop treatments that are more tailored to individual patient requirements. 

 

Thirdly, data and standards are vital for facilitating the cross - border sharing of data. Many countries and regions are experimenting with digital and AI technologies in the healthcare field, exploring how to transition from theoretical knowledge to practical implementation in daily life. Japan aims to be an active participant in this global endeavor, demonstrating its responsible and transparent utilization of data and technologies.

 

Japan's Pharmaceutical Innovation and Challenges

 

When it comes to how Japan's pharmaceutical industry is leveraging new biological insights and technologies (e.g., RNA, gene, and cell therapies) to drive innovation in this "golden era," Dr. Niimi acknowledges that there is no one - size - fits - all answer. Currently, many companies are attempting to leverage Japan's Nobel Prize - winning technologies or new modalities to treat real diseases, primarily those that are genetically inherited or rare.

 

These genetic diseases present significant treatment challenges. Establishing the safety profile of these new modalities is difficult, and the high costs make it challenging to justify the expense of such medicines. Regulators also need to introduce guidelines for these cutting - edge technologies. It is crucial for all stakeholders to work together to transition these new technologies from the lab to clinical utilization. The key focus areas include improving the safety and efficacy of these therapies, reducing costs, and ensuring regulatory compliance.

 

Japan is employing unique innovative strategies to remain competitive amid the global surge of new treatments. For example, some companies are positioning themselves as global entities with Japanese origins, working for the global market rather than just catering to the Japanese market. Innovation is adhering to global standards, which allows Japanese companies to compete on an international level.

 

Funding Challenges and Political Landscape Impact

 

The funding challenges for biotech companies and the shifting political landscape have a significant impact on Japan's pharmaceutical industry. Dr. Niimi notes that no company can claim to be exclusively Japanese, working solely for the Japanese market, as pharmaceuticals require cross - border collaboration. For instance, if a company comes up with a groundbreaking idea for a single molecule, it needs to engage scientists and clinical investigators from many countries, including China, Japan, Asian countries, the US, and Europe.

 

Nowadays, companies typically conduct multi - national, faster clinical trials, enabling a single data package to be utilized for regulatory approval in many countries. From a Japanese perspective, it is challenging to define a specific strategy for each company. However, some large companies position themselves as global entities with Japanese origins. Innovation should adhere to global standards to ensure success in the international market.

 

Regarding the fundraising situation in Japan, the Japanese government is attempting to assist startup companies in securing funds from national agencies, such as those under the academia sector. They have a special grant system in place, along with a matching investment scheme. Once the government designates a venture capital firm, they will invest as a matching fund in these smaller companies. However, this depends on the quality of their assets, the robustness of their R&D plan, and their business plan.

 

Dr. Niimi mentions that China is much more advanced in this regard, and many Japanese are trying to learn from China's success in funding innovative companies. The Chinese government also invests in discoveries at universities, such as hospital research or academic studies. This learning can help Japan improve its fundraising environment for biotech startups.

 

collaboration Opportunities and Barriers between Japan and China

 

There are significant key opportunities for collaboration n between Japan's pharmaceutical industry and China's life - science sector. Many industries aim to minimize investment in clinical development by leveraging existing clinical data. For instance, if there are ongoing Multi - Regional Clinical Trials (MRCTs) in China, the Chinese pharmaceutical industry might wonder why they can't utilize this data for Japanese regulatory submissions without conducting additional clinical trials in Japan.

 

There is a belief that there are no significant ethnic differences between Japanese and Chinese populations. However, this needs to be scientifically explained, perhaps through population pharmacokinetics. Once this is demonstrated in a data - driven manner, regulatory agencies like the National Medical Products Administration (NMPA) or PMDA should accept the cross - border use of such data.

 

The main barriers to collaboration include regulatory differences and a lack of experience in cross - border data sharing. To overcome these barriers, efforts are already underway to gain more experience on a case - by - case basis. China is the second - largest pharmaceutical market globally, and Japan may be the third. Together, they can collaborate and even surpass the United States and the EU, as they share similar disease profiles and medical needs.

 

The Chinese government, along with the Korean FDA, PMDA, and other Asia - Pacific regulatory authorities like those in Malaysia and the Philippines, are working together. Additionally, the PMDA has set up an office in Thailand, which fosters excellent discussion and dialogue between governments. Over time, the number of approved drugs may increase in both China and Japan. Hopefully, brilliant scientists will be able to analyze how to justify the mutual use of clinical data with a minimal data package, possibly by applying modeling and simulation techniques in the future. The PMDA's new policy of not requiring local Japanese data from the early phases anymore is a positive sign for collaboration.

 

About Dr. Niimi’s Personal Career Pathway and Industry Insights

 

Dr. Niimi has spent over 35 years in the pharmaceutical industry and has been involved in numerous endeavors. At this particular stage of his career, he is wondering what lies ahead. He wants to contribute to a broader ecosystem, not just within a single company, but on a more expansive scale. DIA (Drug Information Association) has become a natural choice for him as it is a neutral platform with a global presence. DIA brings together a wide range of stakeholders from academia, government, and industry, making it the perfect organization for him to contribute to.

 

One of the biggest challenges in taking on the new role as DIA Japan Manager and Vice President is bringing the new segment of startups into the DIA community. The current source of the drug pipeline is shifting from large pharmaceutical companies to startups, and DIA needs to expand from the existing segment to this new one.

 

Dr. Niimi plans to contribute to the development of DIA Japan and the Japanese pharmaceutical industry by creating opportunities for mutual learning and talent development. The importance of connecting with diverse individuals cannot be overstated, and through these connections, he aims to foster an environment where different stakeholders can learn from each other.

 

Dr. Niimi has spent 15 years working between Japan and Germany and around 20 years in Japan and the US. The majority of his life has been devoted to cross - border collaboration. Throughout his 35+ years in the industry, he has realized the importance of good collaboration. He believes that by working together, stakeholders can bring innovative medicines to patients as quickly as possible. This lesson has been invaluable in his career and has shaped his approach to collaboration in the pharmaceutical industry.

 

Future Plans for Collaboration

 

When asked about future plans to work more closely with DIA China or other organizations, such as Chinese media, Dr. Niimi envisions Northeast Asian countries—China, Japan, and Korea—working more closely together to define the role of North Asian countries in the global context. Asia is set to become the most populous region, giving these countries more power and responsibility in the global healthcare arena.

 

He recalls that around 20 years ago, Mr. Kondo, the former director of the PMDA, also promoted collaboration among the three countries. He believes that in the future, closer collaboration can bring significant benefits to patients in Asia. By working together, these countries can share resources, knowledge, and expertise to develop more effective and affordable healthcare solutions.

 

In conclusion, Dr. Mitsuhiro Niimi's insights provide a comprehensive view of the current state and future prospects of the pharmaceutical industry in Japan and its collaboration with Asia and the world.

 

 


The editor-in-chief of PhamaDJ Donglei, Mao and Dr. Mitsuhiro Niimi.

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