We must investigate safety and efficacy of new medications with human volunteers before delivering them to patients around the world.
I always keep the following two points on conducting clinical trials, in the global clinical development.
- All data from clinical studies must be made useful for the development plan, considering the participants’ sacrifices.
- To construct appropriate, efficient, and good development plan with an understanding of cultural background in the targeting countries.
It is most important for us to protect the safety and human rights of the subjects in these studies because test compounds are experimental drugs. Furthermore, we always have to remember the preciousness of the data resulting from the volunteers’ sacrifices, perhaps at the risk of their lives. Therefore, it is our obligation to handle such data carefully and avoid any mistakes during the process.
Because this industry handles a large amount of money and spends a lot of time to conduct a myriad of studies, they force out preferred results at times.
However, I believe that doing only essential studies and making sure of the necessity leads to a fast and low-cost development, and will be able to deliver the novel medications to more patients earlier. Clinical studies with a smaller number of subjects are also ethically worthy.
The development program understanding the cultural background and the true requirements of the agency in the target country is the key to an effective strategy in the global marketing. I hope to provide the optimum development programs to sponsors by utilizing our experiences from the clinical studies done in the US and Japan over the years, and our experiences from our daily lives.
I hope to deliver efficient medications to more patients worldwide, as early as possible.
■The president’s career
Toru Mimura has worked for Ajinomoto, a Co. Ltd. major food company in Japan, and researched “Umami” for three years. He then moved to the department of pharmaceuticals development and was in charge of anti-cancer medications and anti-HIV drugs. He has worked in the pharmaceutical development field for more than 30 years.
Toru came to the US in 1997, and was in charge of anti-HIV medications. Later, he moved to PRA International Co. in 2001. There, he joined the pharmaceutical development as a CRO staff member, instead of the sponsor’s staff. He has experienced clinical development in both US and Japan, and from both sponsor and CRO perspectives over the years. He established HGMI Health Inc. as a global CRO based on a lot of experience in 2018.
Born in Gunma, Japan, Toru graduated the School of Pharmaceutical Science of the University of Tokyo in 1979, and has earned Ph.D. from the University of Tokyo in 1998.
He is also a certified translator.