The Medicinal Chemistry Research Department within the Research Division focuses on creating high-quality development molecules through “technology-driven drug discovery.” In parallel, the Pharmaceutical Research Department, part of the Pharmaceutical Technology Division, accelerates the development of these complex molecules using advanced technologies. Through close collaboration, both departments aim to deliver innovative pharmaceuticals to patients as efficiently as possible. In this article, two department managers provide insight into the reality of interdepartmental collaboration.

*Reprinted from Chugai's official talentbook (https://www.talent-book.jp/chugai-pharm). The descriptions and affiliations are current as of June 2025.

Collaboration Supporting Quality-Centric Drug Discovery: Delivering Excellence Across Departments

In the synthesis of low- and medium-molecular-weight pharmaceuticals at Chugai Pharmaceutical, the Medicinal Chemistry Research Department and the Pharmaceutical Research Department play vital roles in drug creation and development.

Shiina　Our role in the Medicinal Chemistry Research Department is to design compounds using world-class drug discovery technologies, synthesize them, evaluate the compounds in animal models, and create clinical candidate products. Within our department, the synthetic chemistry group primarily synthesizes compounds for animal testing and explores new technologies useful for synthesis. As development advances toward clinical trials, we collaborate with the Pharmaceutical Technology Division to jointly develop synthesis methods.

Rather than simply handing over our findings, we share challenges and work together, sometimes spending several months on research or labor-intensive, large-scale synthesis. During this process, we proceed through ongoing discussion, sharing knowledge and addressing challenges. This collaborative approach is a distinctive feature of our interdepartmental work.

Iwamura　Our department becomes involved once potential drug seeds are discovered and optimized, often after years of work by the Research Division. Typically, about three clinical development candidate compounds are selected. As research progresses to clinical stages, we must establish synthesis methods that ensure scalability, speed, quality, cost-effectiveness, safety, and robustness.

Innovation in production technology is also essential, including supply chain optimization and reducing environmental impact. Previously, the Pharmaceutical Technology Division became involved only after a candidate was selected. Now, to accelerate delivery to patients, we engage at an earlier stage.

Both comment on the nature of this interdepartmental collaboration.

Shiina　Compared to other companies, we design and refine synthesis processes with late-stage development in mind, beginning from the non-clinical testing phase. As development timelines accelerate, we pursue early collaboration between departments to prevent downstream issues.

Many of our pharmaceuticals achieve high success rates in clinical trials. Several are designated as Breakthrough Therapies*, so we emphasize early collaboration to avoid having to redesign synthesis methods later in the development process.

*Breakthrough Therapy: A designation established by the U.S. FDA (Food and Drug Administration) to expedite the development and review of drugs for serious or life-threatening conditions. It applies to drugs showing potential for significant improvement in clinically important outcomes compared to existing treatments.

Iwamura　I was involved in process chemistry in my previous position, and I can confirm that our company has a strong development pipeline and a high clinical success rate. For process chemists, this translates into more opportunities to bring drugs to patients, which is deeply rewarding.

Moreover, the high success rate allows us to approach manufacturing technology development with a medium- to long-term perspective, rather than focusing solely on short-term supply. This fosters significant growth opportunities for researchers.

Such interdepartmental collaboration occurs naturally because of our company’s culture, which values organizational cooperation. Chugai has succeeded through a strategic alliance with Roche, and management frequently emphasizes the importance of “Chugai Pharmaceutical becoming an indispensable partner for Roche.”

I believe everyone understands the importance of each department developing its own strengths while cooperating toward a shared goal.

Shiina　Chugai Pharmaceutical prioritizes "Quality-Centric drug discovery." Committed to excellence, we aim to deliver the highest-quality pharmaceuticals through meticulous development and refinement.

This approach contributes to our high clinical success rate. As the likelihood of success increases, fewer drug discovery resources are wasted. In many cases, the benefits of streamlined development outweigh the risks of advancing joint efforts early in the process.

Challenge of "Technology-Driven Drug Discovery": Researchers Exploring New Drugs Based on Proprietary Technology Rather Than Disease Targets

Chugai Pharmaceutical adopts a distinctive approach to drug development that diverges from conventional industry practices.

Shiina　We engage in a unique form of "technology-driven drug discovery," in which we do not begin with a specific disease target. Instead, we explore what types of pharmaceuticals we can develop using our proprietary technologies.

To deliver high-quality pharmaceuticals to patients efficiently, we first design compounds based on sound conceptual frameworks and then evaluate their safety, pharmacokinetics, and efficacy. If limitations arise, we identify root causes, make improvements, redesign, and synthesize new compounds. This iterative cycle allows us to refine our candidates continuously.

Moreover, Chugai’s medicinal chemistry capabilities are world-class. In recent years, we have focused on developing compounds with highly complex structures to address difficult targets.

Iwamura　The Pharmaceutical Technology Division is dedicated to rapidly developing Chugai’s distinctive, high-quality, and technically challenging molecules using cutting-edge technologies. Due to their complexity, many of these compounds are difficult to synthesize. Existing technologies are often insufficient to manufacture them at scale, quickly, and at low cost, necessitating the development of proprietary solutions.

We also aim to provide pharmaceuticals with high pharmacological activity to enhance patient outcomes and minimize side effects. To ensure safety for researchers and manufacturing personnel, and to protect the environment, we have strengthened our production technologies. These include advanced containment systems for handling potent compounds. To maintain the stable manufacture of safe and reliable pharmaceuticals, we collaborate closely with other departments, manufacturing facilities, and partner organizations.

Shiina　I believe it’s essential to communicate both the scientific rationale and our passion as researchers, our desire to deliver the best pharmaceuticals to patients quickly, to the colleagues who will shape the future. When I speak directly about the process behind creating treatments for diseases that still lack established therapies, Iwamura and others often respond with empathy and understanding. This shared sense of purpose strengthens our mutual motivation.

However, certain insights cannot be fully conveyed through brief written or oral communication. That is why I deeply value the opportunity for the Research and Pharmaceutical Technology Divisions to conduct joint research for approximately six months.

Iwamura　Effective communication during research often leads to subsequent projects. We can also address forward-looking topics, such as “We could not implement this due to time constraints, but let us incorporate it from the beginning in the next project.” This approach contributes to the effective implementation of the PDCA [Plan-Do-Check-Act] cycle.

Beyond project-based collaboration between the Research Division and the Pharmaceutical Technology Division, Chugai has also established formal mechanisms to promote broader cross-departmental collaboration.

Iwamura　One such initiative is the “Chemistry Symposium,” which has been held annually for approximately 20 years. This event brings together members from across the organization, including drug discovery, pharmaceutical manufacturing, and production sites, who are deeply engaged in chemistry. They share challenges and strategic directions, fostering a culture of mutual learning and collaboration.

Additionally, on a quarterly basis, managers overseeing chemistry functions across both research and pharmaceutical departments meet to engage in constructive discussions on current challenges and long-term visions. These meetings are strategically designed to enhance mutual understanding and promote alignment across departments.

Medium-Molecular-Weight Pharmaceuticals Pioneered Through Meticulous Collaboration: Challenging Highly Unique Modalities Characteristic of Chugai Pharmaceutical

The Research Division and the Pharmaceutical Technology Division at Chugai Pharmaceutical have collaborated closely from an early stage to establish manufacturing technologies for medium-molecular-weight pharmaceuticals, a current strategic focus of the company.

Shiina　While typical projects involve about six months of collaboration, our work on medium-molecular-weight pharmaceuticals as a new modality required earlier and more intensive cooperation. Over three years, we conducted in-depth, face-to-face discussions involving various stakeholders.

Iwamura　Conventional peptide drugs are typically injectable, with potent physiological effects, and therefore require only small production volumes. The Merrifield method, a standard peptide synthesis technique, has been in use since the 1960s. Initially, I assumed developing a medium-molecular-weight process would be relatively straightforward.

However, our goal was to create orally administrable pharmaceuticals targeting intracellular pathways inaccessible to antibodies and small molecules. These include cyclic peptides with numerous N-alkyl amino acids. Existing peptide synthesis technologies could not produce the necessary quantities for project advancement.

Shiina　Chugai’s medium-molecular-weight drug discovery is highly distinctive and could not be realized using existing technologies alone. Due to the molecular complexity, we needed to establish a proprietary synthesis strategy. Although this presented significant challenges, it was professionally rewarding to participate in the development of a groundbreaking modality.

Reflecting on how they overcame these challenges, both managers underscore the company’s collaborative ethos.

Shiina　One of Chugai’s defining cultural strengths is its unwavering commitment to execution. Despite encountering technically complex and unprecedented challenges in medium-molecular-weight drug discovery, the collective determination to "accomplish the goal together, no matter what" contributed to our success.

Iwamura　For a company previously focused on antibodies and small molecules, entering the medium-molecular-weight field was an unprecedented challenge. We addressed a wide range of issues in pharmaceutical and production technology, including drug substance and formulation development, analytical methods, quality assurance, regulatory compliance, and supply chain design.

We succeeded because every department involved shared a unified commitment to “creating innovative medium-molecular-weight technology that will define Chugai’s future.” Our achievements were driven by interdepartmental collaboration that leveraged deep expertise across all functions.

Turning Anxiety About Results Not Going as Expected into Excitement: The Researcher Mindset Sought by the Drug Discovery Field

Having led development from early- to late-stage processes, the two reflect on Chugai’s enduring appeal.

Shiina　Our appeal lies not only in our commitment to technology-driven drug discovery but also in our strong passion for research itself. At Chugai, it is part of our culture to address significant scientific challenges, acquire cutting-edge knowledge, and evolve our proprietary technologies.

Iwamura　Another key strength is our ability to tackle challenges at a globally competitive level through our strategic alliance with Roche. Global meetings and personnel exchanges expand our perspectives and sometimes lead to breakthrough innovations. While interaction with other companies can occur at academic conferences, our relationship with Roche allows for more substantive, long-term collaboration, something not possible in typical conference settings.

Both also cite Chugai’s enriched research infrastructure as a major benefit.

Shiina　Being part of the Roche Group gives us immediate access to global research infrastructure. Moreover, our new research facility, the Life Science Park Yokohama, is equipped with the latest synthesis and analytical technologies, creating a highly advanced research environment. This allows researchers to focus on demonstrating their expertise while engaging in complex, rewarding projects. Surrounded by talented colleagues, there are ample opportunities for skill development and innovation.

Iwamura　For pharmaceutical technology, a comprehensive CMC (Chemistry, Manufacturing, and Control) research environment is available at our Ukima site in Tokyo. Meanwhile, next-generation factory construction and facility upgrades are underway at three Chugai Pharma Manufacturing production sites, including Fujieda, Ukima, and Utsunomiya. For process chemists, one of the most rewarding aspects is scaling up their methods for commercial production. By refining innovative manufacturing technologies in collaboration with factory teams, we can reliably deliver essential pharmaceuticals to patients.

What kind of talent does Chugai Pharmaceutical seek in its pursuit of the fastest, highest-quality development of drug candidates?

Shiina　In the low- and medium-molecular-weight fields, we seek individuals with deep expertise in organic synthesis who are also capable of immersing themselves in research. Ideally, candidates should not only perform the necessary technical work but also observe phenomena, verify findings chemically, and implement advanced PDCA cycles. As we anticipate the emergence of new modalities, we welcome those who are excited by the prospect of tackling novel challenges.

Iwamura　As drug discovery modalities evolve, pharmaceutical technology challenges become more complex. Within the Pharmaceutical and Production Technology Division, we have conducted "Techno" activities for over 15 years, proactively developing technologies to meet future challenges. This is a distinctive initiative focused on basic research in pharmaceutical technology. Advanced technology development does not always yield expected results, and uncertainties can create anxiety. However, I believe that those who remain passionate despite setbacks can thrive here. I look forward to working with individuals who can drive research forward while envisioning their contributions five to ten years into the future.