Abstract
Recently drug modalities have been diversified, and new modalities including oligonucleotide drugs, gene therapy, and protein degraders have emerged in addition to small molecule drugs and antibody drugs. In general, risk management for small molecule drugs involves treatment cessation, monitoring by biomarkers and imaging, ensuring a safety margin, and dose reduction. However, some new drug modalities such as gene therapy that assumes only one treatment or oligonucleotide drugs with a long half-life after tissue distribution are considered to be therapeutic modalities where it is difficult to manage risks by "treatment cessation". As an alternative, use of an antidote to control the side effects (including exaggerated pharmacology) may be an option.
In this study, we conducted a survey of public information, and a questionnaire survey of JPMA member organizations with the aim of understanding the current status the development of antidotes in new modalities such as gene therapy and oligonucleotide drugs. In this presentation, we will introduce the results and discuss them based on the results of the survey.
