Host: The Japanese Pharmacological Society
Name : The 96th Annual Meeting of the Japanese Pharmacological Society
Number : 96
Location : [in Japanese]
Date : November 30, 2022 - December 03, 2022
In recent years, drug development has expanded rapidly from small molecules and some biologics, such as insulin and monoclonal antibodies to new modalities including oligonucleotide, cell and gene therapies. These therapies may have the potential to transform patients' lives and cure diseases by addressing the root cause of the diseases rather than the symptoms. As technologies continues to evolve, regulatory authorities have drafted new guidance accordingly in each region. However, harmonization of guidelines for international regulatory authorities has been still limited. Although some of new modalities fall outside the scope of the ICH guidance entitled "M3(R2): Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals" and "S6: preclinical safety evaluation of biotechnology-derived pharmaceuticals", the guidance for small molecules and the conventional biologics may be useful in pre-clinical safety assessment of new modalities by considering new modalities-specific safety concerns. This presentation will provide points to consider in pre-clinical safety assessment of new modalities, focusing on differences from that of conventional modalities.
