午夜剧场

After graduating from the Juku School of Medicine in 1995 and engaging in clinical practice, I have spent approximately 20 years since 1999 conducting pharmaceutical research and development at two American pharmaceutical companies. I have followed a career path I never imagined at graduation, but I feel fortunate to have witnessed many moments where new drugs changed the world and to have contributed to them. Since pharmaceutical research and development today is likely unfamiliar to many people, I will describe it briefly.

The ideal flow starts with a discovery in basic research where a target (e.g., a receptor) associated with a disease is identified within the living body. Compounds that act on the target—preferably small molecule compounds—are synthesized. If that is difficult, the recent trend has moved toward various modalities regardless of type, such as antibodies, nucleic acids, modified cells, or modified viruses. Once a lead compound is identified as a starting point, research proceeds toward optimizing the compound for more favorable characteristics. To advance to the human research in which I specialize, numerous toxicity tests, pharmacological tests, and pharmacokinetic studies in animals are further required.

In human research, while exploratorily evaluating pharmacokinetics, safety, and efficacy, research and development proceeds with the investment of vast amounts of human and financial resources. This involves verifying hypotheses through clinical trials on how to optimize the benefit-to-risk ratio and enhance medical and business value relative to existing treatment systems, optimizing formulations, and organizing data and arguments for acceptance by regulatory authorities and medical societies.

By overcoming these difficulties, HIV infection, which was once a death sentence, has become a chronic disease that is no longer fatal with appropriate treatment. Hepatitis C virus infection, which causes liver cirrhosis and liver cancer, has reached a stage where it can be cured in nearly 100% of cases. Cancer immunotherapy is reaching a point where it surpasses existing treatments for some types of cancer.

Looking back on this work, I realize once again that once a compound is finalized as a drug candidate, the compound itself as a physical object does not change at all. It is an endeavor where science and business intersect, adding and crystallizing medical information regarding that compound by utilizing researchers from many different specialized fields, management resources, teamwork and leadership, cross-border division of labor, and decision-making amidst uncertainty.

*Affiliations and titles are those at the time of publication.