Outcome Documents of the Science Board

The Fourth Term (-March, 2020) Subcommittees

• Report on Clinical Evaluation of Antimicrobial Agents for AMR

 

• Genome editing, an innovative technique, may cause alterations in genes other than the target gene (off-target effects) or unexpected mutations in the target gene (on-target mutations), and these mutations need to be evaluated.

The Science Board has prepared a report summarizing the issues to be considered in the development of gene therapy products using genome-editing technology.

 

White-paper for quality and safety for gene therapy products using gene editing technology

 

The article explaining the basis and comparison of the key concepts with information provided by foreign regulatory authorities has now been published in the paginated issue:

 

Aspects of Gene Therapy Products Using Current Genome-Editing Technology in Japan (Human Gene Therapy, Volume 31, Issue 19-20, 1043-1053, 2020)

 

The Third Term (-March, 2018) Subcommittees

• Current state of therapeutic development for rare cancers in Japan, and proposals for improvement(Cancer Sci., 109(5):1731-1737, May 2018)

 

• Issues in and Proposals for Facilitating Drug Discovery by Collaboration between Academia and Industry2017 - In the Trend of Rapidly Advancing Science -

 

• Regulatory Science on AI-based Medical Devices and Systems(Adv Biomed Eng., 7: 118-123, 2018)

 

The Second Term (-March, 2016) Subcommittees

• Report on the Use of Numerical Analysis for Strength Evaluation of Orthopedic Implants

 

• Current Status and Perspectives of Placebo-controlled Studies

 

• Report on the use of non-clinical studies in the regulatory evaluation of oncology drugs(Cancer Sci., 107(2):189-202, February 2016)

 

• Discussions on Evaluation of Medical Devices in Pediatric Use

 

• Proposal on Basic Principle to Quality Assurance of Cell Therapy (CT) Products

 

The First Term (-March, 2014) Subcommittees

• Current Perspective on Evaluation of Tumorigenicity of Cellular and Tissue-based Products Derived from induced Pluripotent Stem Cells (iPSCs) and iPSCs as Their Starting Materials


• Summary of Discussion on Non-clinical Pharmacology Studies on Anticancer Drugs


• Summary of discussion on the assessment of the current status of personalized medicine related to development and regulatory review