Symposium

[S43] Current Status and Issues of Nucleic Acid Drug Development

Mon. Mar 27, 2023 1:50 PM - 3:50 PM [Room M1] The Alumni Hall "Frate": Hall (1F)

Organizer: Junji Kawakami, Takao Inoue, Satoshi Obika

Nucleic acid drugs allow versatile molecular design that does not depend on the structure or physical properties of the target protein, and their practical application has been rapidly progressing, especially since 2016. Although most of these nucleic acid drugs have been developed overseas, the first domestically produced nucleic acid drugs were approved in Japan and the U.S. in 2020, and many nucleic acid drugs are currently undergoing preclinical and clinical trials. In preparation for the accelerated development of nucleic acid drugs and their subsequent application for approval in Japan, it is an urgent issue for industry, government, and academia to reach a consensus on how the quality control of nucleic acid drugs should be. In this symposium, we will discuss the issues that need to be resolved in the near future with regard to CMC (Chemistry, Manufacturing and Control) of nucleic acid drugs, based on the past efforts in industry, government and academia. In addition, we will introduce our activity in the AMED project for the development of basic drug discovery technologies for the realization of next-generation therapies and diagnostics (development of RNA-targeted drug discovery technologies).

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シンポジウム趣旨説明：川上純司, 井上貴雄（甲南大FIRST, 国衛研） (1:50 PM - 1:55 PM)

1:55 PM - 2:10 PM

[S43-01] Points to consider in the production, purification, and analysis of oligonucleotide therapeutics

○Satoshi Obika^1,2,3 (1. Grad. Sch. Pharm., Osaka Univ., 2. OTRI, Osaka Univ., 3. NIBIOHN)

2:10 PM - 2:30 PM

[S43-02] PMDA Perspective on CMC of Oligonucleotide-based Drugs

○Kosuke Ito¹ (1. PMDA)

2:30 PM - 2:50 PM

[S43-03] Initiative activities for quality control of therapeutic oligonucleotides by JPMA Oligonucleotide Quality Task Force

○Mitsuaki Sekiguchi^1,8, Naomi Takiguchi^2,8, Natsuki Kobayashi^3,8, Yuko Kobayashi^4,8, Junichi Mizoguchi^5,8, Jun Saito^6,8, Aya Ishihara^7,8 (1. Shionogi & Co.,Ltd., 2. Sumitomo Pharma Co.,Ltd., 3. AstraZeneca K.K., 4. Sanofi K.K., 5. Eisai Co.,Ltd., 6. Kyowa Kirin Co.,Ltd., 7. Janssen Pharmaceutical K.K., 8. JPMA Oligonucleotide Quality Task Force)

2:50 PM - 3:10 PM

[S43-04] Analysis of impurities in oligonucleotide manufacturing

○Hirokazu Nankai¹ (1. Ajinomoto Bio-Pharma Services, GeneDesign)

3:10 PM - 3:40 PM

[S43-05] Approvals of siRNA therapeutics in Japan

○Minoru Kamakura¹ (1. Alnylam Japan)

3:40 PM - 3:50 PM

[S43-06] Activities in the AMED-CMC Project for Oligonucleotide Therapeutics

○Junji Kawakami^1,2 (1. FIRST, Konan Univ., 2. KOLOT)

Session information