Asia-Pacific Biotech News

Approaching Innovation with International and Japanese Best Practices

In approaching innovation, Japanese pharmaceutical companies such as Kyowa Kirin are striking a balance between embracing international business practices and retaining some of the defining features of the Japanese style of management.

by Dr Tan Boon Heon

Misconceptions of the Japanese Management Style

Contrary to popular belief, the culture of Japanese businesses is one of consensus, where a decision is made only after consulting with stakeholders, lining up the resources, and instituting the processes to support the decision.

By extension, standard operating procedures (SOPs) for decision-making tend to be clear and well-documented, and for more complex processes, senior personnel are trained and empowered to guide people who are new to them. While this may give the impression that the Japanese style of management is hierarchical, particularly to non-Japanese, it is in fact this culture of farsighted planning and consensus-building that has been instrumental in Japanese companies’ ability to retain staff over many years.

However, as Japanese pharmaceutical companies expand and globalise, new processes must be developed for new situations, and existing processes must be modified, posing new challenges.

For Kyowa Kirin to advance as a single unit, it is essential for employees to adjust, adopt, and integrate Japanese and international best practices, not just in management but in their approach to innovation.


How Globalisation Changes Product Distribution

The sooner you are able to bring an innovative therapy to market and the more markets you bring it to, the higher the chances of improving patients’ survival rates and quality of life. Adopting international best practices can help accelerate and streamline a novel therapeutic’s journey from bench to bedside, particularly when entering new markets.

The pharmaceutical industry is a highly regulated industry, and to successfully license products, you will need to meet requirements that tend to vary from one regulatory authority to another and from country to country.

Adopting some of the more developed practices of Western multinational corporations (MNCs) with decades of experience bringing new products to markets that are new to us has helped Kyowa Kirin move faster.

However, one of the challenges this may pose to Japanese companies such as Kyowa Kirin is that while there are many committed, loyal, and long-term mid-level and senior employees, embracing international practices tends to bring new challenges, such as working with associates across multiple countries and time zones in a second language. When anticipating change, the management is advised to have support structures in place to help those affected mitigate and even overcome it.


How Management Impacts Openness to Embracing Global Standards

Management practices and their attitudes towards innovation tend to be contingent on the profile of the leadership. In addition to being a global specialty pharmaceutical company, Kyowa Kirin is an R&D-oriented company. Most of our senior leadership has been trained in research, which has fostered the company’s openness to and support of innovation and influenced how the company is managed.

Part of embracing international best practices involves increasing diversity among its leadership. Diversity in leadership improves decision-making and the organisation’s performance, as not only are leaders of different expertise and from different cultures more likely to examine problems from several angles, they are also more likely to have unique ways of approaching and tackling them.

In addition to an increasing number of members from commercial as well as research backgrounds, Kyowa Kirin’s Global Executive Committee today consists of several members originating from the United States and Europe, a far cry from the homogenous Japanese committees of previous decades. In Singapore, almost half of the Kyowa Kirin Asia Pacific leadership team are women, including the two general managers of our two larger entities, China and the ASEAN and Hong Kong Cluster.


How Kyowa Kirin Incorporates International and Japanese Best Practices to Develop Innovative Drugs and Bring Them to Market

When we work with partners to bring a drug through Phase 2 and Phase 3 clinical trials to market, we ensure a high level of engagement with them in that we treat any new product we are investing in like it is our own. At first glance, many people may associate the openness to engage and consider different viewpoints and ways of doing things with international best practices, but it is in fact aligned with the Japanese approach to decision-making, which is consensus-building through meaningful stakeholder engagement.

This practice can be supported by another defining feature of Japanese business culture: long-term sustainability. So before we go into any kind of partnership, we do our due diligence to ensure a product has the potential to be successful and that we have the means to maximise its chances of success.

Our culture of consultation and innovation also works well for R&D and is reflected in our laboratory successes. Our management style helps to bridge the gap between adhering to existing processes and encouraging diversity and innovation, which are particularly important in the development of novel therapeutics.

In recent years, we have developed novel technology platforms, such as our state-of-the-art proprietary antibody technologies, which, combined with our expertise in our core therapeutic areas of oncology, nephrology, the central nervous system, and immunology, have enabled us to create innovative new drugs.

We call this “technology-driven drug discovery” because it focuses on exploring the possibilities of key technologies like POTELLIGENT® antibody technology. Our scientists discovered that when an antibody had a reduced amount of fucose in its sugar chains, it exhibited much higher Antibody-Dependent Cellular Cytotoxicity (ADCC) activity as compared to a highly fucosylated conventional antibody.1

Soon after, it was demonstrated that the mechanism behind the enhanced ADCC of a low/no-fucose antibody was its increased affinity to FcγRIIIa (CD16), the major Fc receptor for ADCC in humans.1,2 To take advantage of the above finding, our scientists strategically knocked out a gene called FUT8 that is responsible for the fucose addition to sugar chains in order to create a new production method for fucose-free antibodies in CHO cells: the FUT8-knock-out CHO cells (POTELLIGENT® Cells).3 These cells are shown to produce fucose-free, thereby ADCC-enhanced antibodies, in effect a superior therapeutic antibody, whose basic properties such as stability, growth rate, productivity, and scalability remain unchanged compared to parental CHO cells.3

Making the most of our knowledge and experience in protein and antibody engineering technology as well as in the control of glycosylation, we are now engaged in the research and development of next-generation therapeutic antibodies, e.g., immune-activating antibodies and tissue-homing antibodies, in collaboration with external research institutes.4 Several POTELLIGENT® monoclonal antibodies (Mabs) are currently in ongoing clinical trials. We expect clinical trial results to show immense benefits in efficacy and potency. We also anticipate that these antibodies will be safe and well-tolerated in humans.3,5

Another area where Kyowa Kirin is particularly innovative is in developing new types of small-molecule drugs. Our approach to small molecule drug discovery involves what we call rational drug design, i.e., structure-based drug design (SBDD), ranging from the structural analysis of disease-associated biomolecules (therapeutic targets) to the design of small molecules.4

In pursuit of an effective process from drug target hunting and seed discovery through producing drug candidates, we utilise phenotypic assays for disease state models, chemical biology, and bio- and chemo-informatics. We believe that combining chemistry and biologics has great potential, and we are currently doing more research in that field.4

We think there are huge possibilities for future nucleic acid drugs and are working on developing the essential delivery technology required by nucleic acid drugs as well as technology for enhancing functions using nucleic acids.4 With our partners, we are also actively engaged in collaborative research related to targets and new technologies, through which we aim to create innovative new drugs, especially for drug targets that are difficult to target with therapeutic antibodies or small-molecule drugs.3,4

For Kyowa Kirin, it’s not just about the numbers but also about the science. And this science that revolves around patients, patients’ needs, and how they are going to respond will always inform our business practises and management, whether in Japan or around the world. [APBN]

About the Author

Tan Boon Heon (PhD) is the President of Kyowa Kirin Asia Pacific, a Japan-based global specialty pharmaceutical company with a heritage of more than 70 years in therapeutic areas such as nephrology, oncology, immunology, allergy and neurology. Visit www.kyowakirin.com to learn more.