1) Challenges for Diverse Modalities
The pharmaceutical industry is diversifying its modalities, from development centered on small molecule drugs to biopharmaceuticals (antibody drugs, nucleic acid drugs, gene therapy, and cell therapy). In addition, recent advances in engineering and information technology have led to the search for new medical treatments through the integration of these technologies, and major pharmaceutical companies in the U.S., Europe, and Japan have already begun to shift their focus from the business of pharmaceuticals alone to the business of medical solutions in general, and development in interdisciplinary research areas attracts attention. Therefore, in addition to the chemical and biological research that has been the main focus of our company to date, we would like to broaden our horizons to include engineering and information research in order to create a diverse and attractive portfolio of research and business. With regard to new modalities, we believe that we can contribute to the ecosystem for the development of pharmaceuticals and other products by cultivating seeds discovered at universities and other public research institutions and connecting them to major companies. In order to create innovative next-generation medicine, we will promote open innovation among industry, academia, and government, including the fusion of different fields of medicine, pharmaceutical, and engineering in the healthcare industry.
2) Accelerating Artificial Intelligence (AI) Research
In the post-coronavirus era, in addition to wet-lab (chemical and biological) research, dry-lab (information engineering) research, especially efficient research using artificial intelligence (AI), is predicted to emerge, without a doubt, in the life science field. AI should be increasingly used for patient selection, trial design, and data analysis in investigator-initiated clinical trials. In the past, our business partners were mainly pharmaceutical companies, but recently we have been focusing on research and business development collaborations with medical engineering companies、medical device campanies and IT companies. We believe that R&D and business development collaboration with companies in a variety of fields is important to create an attractive portfolio.
3) Global Development
We have been conducting basic research with many foreign universities, and will further focus on clinical research outside Japan. The key to expanding new drugs developed in Japan to overseas markets is (1) globally accepted intellectual property rights (substance patents including new drug compounds), (2) globally accepted data and materials, and (3) a system that can promote global R&D. We believe that it is important to have high quality non-clinical data packages and investigational new drugs that can be used internationally, to cooperate with regulatory authorities in each country, and to have a framework that enables development from a global perspective. To date, we have conducted three clinical trials in collaboration with overseas universities and medical institutions: Northwestern University (novel coronavirus infection) in the United States, Medeniyet University (novel coronavirus infection) in Turkey, and Maastricht University (diabetes) in the Netherlands.
In recent years, the World Health Organization (WHO) has been focusing on aging-related diseases (non-communicable diseases), and has designated cancer, cardiovascular diseases, diabetes, and chronic respiratory diseases as non-communicable diseases (responsible for 74% of all deaths worldwide). Our products under development target all four diseases, namely cancer, cardiovascular disease, diabetes, and chronic respiratory disease, and we believe that they will become important drugs not only in developed countries but also in developing countries, thus contributing widely to the international community.
4) Ecosystem formation based on network expansion
Until now, most pharmaceutical companies and drug discovery biotechs have focused on building the pipeline value chain (building up all stages of development) on their own to increase business value. However, in areas such as pharmaceuticals, where the probability of success is extremely low, the development period is long, and the investment is large, the R&D and business risks are high. Therefore, it is essential to form a portfolio that combines many pipelines and diversify the risks. Major pharmaceutical companies, backed by ample funds, can develop drugs within the existing framework by forming their own value chain of pipelines, but it is difficult for biotech companies that do not have sufficient funding
We have been practicing development to maximize development efficiency including cost by making maximum utilization of the resources of external organizations (research institutes, medical institutions, contract research organizations (CROs)/academic clinical research organizations (AROs), IT vendors, etc.). We are considering building many value chains based on alliances with external organizations, and our strategy, R&D, and human resource management are different from existing biotechs. We do not have a research center, but we are able to expand our pipeline and modalities with few human resources and expenses. If we can build a platform to create innovation efficiently by focusing on external resources and the external environment, rather than focusing only on our own resources and internal environment, we can expect significant growth.