Hiromichi Shirasawa: The Intersection of Science and Business

2018/06/26

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. Although I have followed a career path I did not envision at graduation, I feel fortunate to have witnessed many moments where new drugs changed the world and to have been able to contribute to them. Since I believe pharmaceutical research and development today is unfamiliar to many people, I will describe it briefly.

The ideal flow begins with a discovery in basic research where a target associated with a disease (e.g., a receptor) is identified within the body. Compounds that act on the target—preferably small molecule compounds—are synthesized. If that is difficult, the recent trend has been to use 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 to achieve more favorable characteristics. To progress to research in humans, which is my specialty, further extensive toxicity tests, pharmacological tests, and pharmacokinetic studies in animals are 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 the drug should be positioned clinically and used to optimize benefits against risks, thereby increasing its value in terms of medical sciences and business relative to existing treatment systems. It also includes optimizing formulations and organizing data and arguments for acceptance by regulatory authorities and medical sciences societies.

By overcoming such 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, what strikes me again is 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 sciences information regarding that compound by utilizing researchers from many different specialized fields, management resources, teamwork and leadership, cross-border division of roles, and decision-making amidst uncertainty.

*Affiliations, job titles, etc., are as of the time of writing.