Dr. Fukui (Senior Director, Safety BU) to Deliver an Oral Presentation at the 52nd Annual Workshop of the Japanese Society of Toxicology

2025.06.23

Senior Director and Senior Consultant Dr. Fukui from the Safety Business Unit will deliver an oral presentation at a workshop during the 52nd Annual Meeting of the Japanese Society of Toxicology, to be held from July 2 to 4, 2025, at the Okinawa Convention Center in Japan.
If you plan to attend the conference, we encourage you to join the session and hear the presentation.

Conference Name: the 52nd Annual Meeting of the Japanese Society of Toxicology

Date & Time: Thursday, July 3rd, 11:00am – 12:30pm (JST)

Location: Okinawa Convention Center, Japan

Title: Development of radiopharmaceuticals containing complexes of peptides and radioisotopes

Presenter: Hideo Fukui, PhD, DABT, DJSOT

Presentation Summary
In terms of new-modality drugs, ICH guidance has not been developed yet, and the IND package is determined by the regulatory authorities in each country. For therapeutic radiopharmaceuticals, guidance on non-clinical safety studies have been published by FDA, but not by PMDA. For peptide medicines, a draft guidance on non-clinical safety studies is available in Japan from AMED Peptide Group but has not been issued by FDA.
Recently, therapeutic radiopharmaceuticals containing complexes of peptides and radioisotopes as active ingredients have been developed, but there are regulatory challenges in the global development of pharmaceuticals in fields where ICH guidance has not yet been developed, which may lead to confusion for pharmaceutical companies. This presentation will focus on peptide-based radiopharmaceuticals and the differences in nonclinical safety studies required by regulatory authorities in various countries.

Axcelead DDP’s Soulution
Axcelead DDP has extensive experience in the development of new types of therapeutic radiopharmaceuticals, which are attracting attention as next-generation modalities. Please contact us if you have any questions about IND/NDA packages, or non-clinical safety study plans, etc.