[S24] Driving innovation and regulation for the future of medium-sized peptide therapeutics

Fri. Mar 29, 2024 3:30 PM - 5:30 PM [Room 315] Conference Center 315 (3F)

Organizer: Yosuke Demizu (NIHS), Yoshiro Saito (NIHS)

In recent years, next-generation medium-sized molecular peptide drugs are being developed around the world. These peptide drugs combine the unique advantages found in both small molecule and biopharmaceuticals, and thus hold great promise as a new treatment for unmet medical needs. To facilitate their practical application, well-controlled manufacturing methods and quality and safety evaluation methods based on the characteristics of these drugs should be established. However, developing such methods for novel peptide drugs is not easy with conventional technologies, and guidelines should be established to specify appropriate regulatory requirements.
This symposium will feature speakers from academia who are at the forefront of peptide drug development and experts who are actively involved in the development of regulatory guidelines in Japan. They will speak on the current status of the development of peptide drugs and efforts toward the creation of regulatory guidelines.

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趣旨説明：出水庸介（国立衛研） (3:30 PM - 3:37 PM)

3:37 PM - 4:04 PM

[S24-1] Development of chemical modification method for specific tryptophan on peptides and proteins

Hayate Shida¹, Yuma Tokita¹, Yan Cui¹, Shinpei Kasama¹, Sho Konno¹, Atsuhiko Taniguchi¹, Akihiro Taguchi¹, ○Yoshio Hayashi^1,2 (1. Sch. of Pharm., Tokyo Univ. of Pharm. and Life Sci., 2. Sch. of Life Sci., Tokyo Univ. of Pharm. and Life Sci.)

4:04 PM - 4:31 PM

[S24-2] Devising pseudo-natural peptides by engineered translation and posttranslational modification

○Yuki Goto^1,2 (1. Graduate School of Science, Kyoto University, 2. Graduate School of Science, The University of Tokyo)

4:31 PM - 4:58 PM

[S24-3] Regulatory considerations for ensuring quality of middle-sized peptide drugs

○Akiko Ishii-Watabe¹, Ken-ichi Izutsu² (1. NIHS, 2. IUHW)

4:58 PM - 5:25 PM

[S24-4] PMDA perspective on nonclinical safety assessment for mid-molecular peptide drugs

○Kazushige Maki¹ (1. PMDA)

総括：齋藤嘉朗（国立衛研） (5:25 PM - 5:30 PM)