This session was organized in order to contribute to the patient safety through “translational science” with linkage between basic science and therapeutic medication as the advanced science. We focus on “the central nerve system side effects”, raising the post marketing concrete example by questioning from different stand points of experts.

In order to find the effective information for the post marketing safety management, MSSF (Mechanism based safety strategy forum) has dedicated to make the opportunity for crosstalk between basic science and clinical fields, trying to find the mechanism of adverse reaction which emerged after the post marketing by tracking back to nonclinical basic science.

In this session in JSCPT annual meeting, it is very prominent opportunity to discuss the solution by raising the concreate examples and questioning from the multiple viewpoints, focusing on the adverse reactions, specially central nerve system.

Referring to the recent “Rennes incidence” in France with developing the brain death and central nerve dysfunction in Phase 1 study, EMA revised the “Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products' (EMEA/CHMP/SWP/28367/07 Rev. 1)” in July 2017. This guideline initially stipulated the new measure for the first human dose setting as the turning point of the TGN 1412 incidence. The revision is said to intend to identify the influenced factors for potential risk of new investigational drugs during the human first dose/the early clinical phase in order for strategic risk minimization and risk management.

Considering the change of domestic environment for clinical development, the first marketing in Japan and/or academic seeds etc. have been raised as the subject for the discussion and we really hope to contribute to create the new collaboration and linkage through this discussion on the consolidated management from nonclinical to clinical science based on the mechanism of adverse reaction.