Providing good education is essential for Global Clinical Trial Development Project, we think, therefore following last year, we held the very first “Academia Clinical Development Seminar in 2019 FSY” on Friday 24^th 2019, at the multi-media hall, Osaka University Hospital.

We welcomed Dr. Yoshiaki YAMAGISHI from Pharmaceuticals and Medical Devices Agency (PMDA) to give a lecture entitled “Current status of Research and Development in Pediatric field”

At the beginning of the lecture, he started to talked about the current status and issues of Pediatric area.

Clinical trials on children are very strict and regulated in overseas, especially in Europe. During a process of research and development for new drug in Europe, pharmaceutical companies need to develop and submit Pediatric Investigation Plan (PIP) to EMA before starting phaseⅡtrials for adults. On the other hand, rules or regulations for pediatric medicine development have not yet been established by the law in Japan. Pediatric physicians usually try to calculate optimal doses for children based on their body weight in clinical practice setting referring the doses that are prescribed in adult. Pharmaceutical companies cannot easily take actions because of low expected profitability and overwhelming difficulties.

In order to overcome the issues of research and development in pediatric field, he emphasized the following 3 points that become to be extremely important; "keeping sufficient number of subjects", "Use of adult data"and "Scheme of study design" He further explained about these factors more in detail. To obtain sufficient number of subjects in clinical trials, we may use clinical research network, conduct international clinical trials, and collaborate with patients’ association. Besides, we may consider to refer data derived from adult. Furthermore, we may take account for study design including small clinical trial with biomarker as well as utilization of real world data. These idea may help to proceed research and development for new drugs in pediatric field.

Through the 90 minutes lecture, he explained deeply about the direction of domestic and foreign pharmaceutical regulations・outlines of incentives and the direction of development strategy in childhood illness and rare diseases. Because the pre-notification of abstract the lecture caught people’s attention and also, the seminar on research and development in the pediatric field was the first time, thankfully more than 50 people from inside and outside the university participated.

At the end of the lecture, he received a number of key questions concerning the system for conducting clinical trials in childhood illness and rare diseases, and he kindly gave some detailed answers with actual examples of the current supports from government and the role of patients association.

It was impressive that all of participants were taking notes and listened eagerly.

Following the last year, we are planning to conduct the fruitful seminars for mainly researchers and students from inside and outside university to acquire necessary knowledge in creation of academia originated medical technology and global clinical research for the purpose of practical use.　Anyone with slightest interest is always to join us!

The second academy clinical development seminar will be held at the same place at the same time by inviting Dr. Tatsuo IIYAMA from the National Center for Global Health and Medicine (NCGM) on　Friday, July 12. Don’t miss it. Don’t miss it.