OKUYAMA Ryo | APU RESEARCH SEEDS - Ritsumeikan Asia Pacific University

Studying medical drug discovery processes, strategies, and ecosystems from a global perspective, using the findings to support drug discovery research and contribute to policymaking

Japan’s international competitiveness in drug discovery is low. One reason for this is that almost all novel drugs are created by large, established pharmaceutical companies, and drug discovery startups are not nurtured adequately.
The drug discovery process entails significant time and money, and its management requires multi-faceted knowledge, know-how and strategy. However, it is difficult for researchers in academia and drug discovery startups with little experience to assemble all these resources, so it is essential to obtain the support of professionals well versed in the drug discovery process and its management.
Other countries, especially in Europe and North America, have established ecosystems* to support researchers in academia and drug discovery startups, and the support of professionals with drug discovery management expertise is yielding major results.
I, the principal investigator in this project, (1) study drug discovery management globally, and use my own extensive knowledge and experience to provide drug discovery startups and researchers with advice and complementary support in drug discovery strategy and research and development processes. At the same time, I aim to (2) survey and analyze the current status and challenges in drug discovery ecosystems in Japan and across the world, and provide government, specialized authorities, companies, and other stakeholders with insights and proposals for a drug discovery innovation ecosystem tailored to Japan’s characteristics.

*Ecosystem: A drug discovery startup ecosystem comprises human resources such as academic entrepreneurs, entrepreneurs from the business sector, and researchers working in startups, as well as investors providing capital for startups, existing companies collaborating with them, and national and local government authorities that establish and implement entrepreneurship support programs.

This is a comparison of the years of establishment of companies in the United States, Europe, and Japan that produced new drugs approved by the U.S. Food and Drug Administration (FDA) between 2017 and 2021. In the US, 74% of new drugs were produced by startups and new companies established since 1980. On the other hand, 100% of new drugs from Japan were produced by “veteran” companies established before 1980

One of the few professionals in Japan with expertise in drug discovery processes and their management

Doing research on drug discovery management and ecosystems demands both knowledge of the trends and developments in cutting-edge pharmaceutical technologies, and knowledge of analytical approaches and methods from the management discipline. Very few researchers possess both of these attributes, and prior research is scarce. These limitations have resulted in the following conditions in drug discovery in Japan:

• (1)

  There is a shortage of professionals well versed in both drug discovery processes and their management and capable of advising and supporting drug discovery startups and researchers from an impartial standpoint.

• (2)

  The measures taken by government and industry in response to claims of weakness in Japan’s drug discovery capabilities thus far have not included scientific attempts to shed light on the causes of the weakness from a management perspective, so they have not led to fundamental improvements.

I, the principal investigator in this project, hold doctoral degrees in both pharmaceutical sciences and technology management, as well as high-level research management experience as a research institute director and global research head of a major pharmaceutical company, and academic research experience related to drug discovery innovation systems and drug technology management. As one of the few professionals in Japan with this combination of expertise, I am currently pursuing academic research on drug discovery management and drug discovery innovation ecosystems.
I also continue to apply the findings of this research together with my many years of experience and know-how in highly unique activities for drug discovery researchers and startups, and with specialized authorities and companies.

Aiming to support drug discovery research and propose a “Japan-style drug discovery innovation system”

This research aims to strengthen Japan’s drug discovery capabilities. To do so, the research findings will be applied to (1) support drug discovery researchers and startups, and (2) contribute to drug discovery related policymaking.

• (1)

  I will provide complementary support to startups and researchers at various stages of the drug discovery process.

  Drug discovery demands multiple facets of knowledge and know-how even at the research stage, including both specialized expertise in science and technology, and the ability to formulate a drug discovery concept from market trends and patient needs, to efficiently obtain data that substantiates the concept, to develop a drug candidate compound with pharmacological efficacy and safety, and to obtain data that differentiates it from existing drugs and technologies. The clinical development stage too requires advanced development strategies in areas such as selection of target diseases and patient profiles, and establishment of study protocols to enable development to be pursued efficiently with a limited budget. Additionally, late-stage clinical development entails major capital investment, so strategies for alliance with other companies on joint research and development and licensing are needed at the research and early clinical development stages (see Figure).

  As a professional well-versed in the drug discovery process and its management, I am already working with a number of drug discovery startups and university research teams, providing advice and complementary support related to drug discovery strategy and research and development processes. This is highly practical support that extends across many stages of the drug discovery process. It corresponds to a broad range of technologies and medical conditions, and can assist with various tasks including practical issues such as providing information on specific experimental contents and subcontractors.

  
• (2)

  The research aims to propose a “Japan-style drug discovery innovation system” that will strengthen Japan’s drug discovery capabilities.

  Today, as several countries in Asia join those of Europe and North America in pursuing research and development of novel drugs, it is an urgent priority for Japan to build a drug discovery innovation ecosystem that is globally competitive.
  However, the current weakness of Japan’s international competitiveness in drug discovery is related to factors such as distinctive Japanese business practices, social customs, and public attitudes, so successful models from other countries cannot easily be applied as-is to the Japanese context.
  Japan needs to develop a “Japan-style drug discovery innovation system” that leverages existing innovation system features to raise drug discovery capabilities. The insights from this research can be applied to areas such as drug discovery related policymaking.
  I am already cooperating with the activities of the Japan Agency for Medical Research and Development (AMED). I intend to further my collaborations with policymakers, specialized authorities, and companies, and contribute to a strengthening of Japan’s drug discovery capabilities.

  Pharmaceutical Start-Up Support Ecosystem