The American College of Toxicology 2022 annual meeting will be held in Denver on November 13 to 16, and an international symposium between the US, EU and Japan will be held on Tuesday, November 15, 2022. Dr. Hideo Fukui, a Senior Director of Axcelead Drug Discovery Partners, Inc. will chair the session “Antibody-Drug Conjugates, Exosomes: Perspectives from Researchers and Regulatory Scientists on These New Modalities of Drug Delivery”. Dr. Fukui is the past president of the Japanese Society of Toxicology annual meeting in 2021. In this session, he will keep you updated about the latest information on new modalities from the US, EU and Japan.
Learn more（ACT‘s Website）: 8. Symposium – International Symposium
Antibody-Drug Conjugates, Exosomes: Perspectives from Researchers and Regulatory Scientists on These New Modalities of Drug Delivery
Hideo Fukui Ph.D. DABT, DJSOT
Senior Director / Senior Consultant
Specialty: nonclinical safety, gastrointestinal pharmacology
Career: In 1989, after graduating from the Department of Nutritional Biochemistry, School of Bio-agricultural Sciences, Graduate School of Nagoya University, he joined the Drug Safety Research Laboratories, Takeda Pharmaceutical Company Limited. In 1993, he got a Ph.D. of pharmacology from the Graduate School of Kyoto University. After studying at the School of Medicine, Colombia University in the US, he led a nonclinical safety evaluation of drugs for gastrointestinal medications at Global Takeda Pharmaceuticals, and had much experience with solving various challenges of toxicity, dealing with regulatory authorities, and engaging in due diligence on in-license candidates. Since July 2018, he has served as the director of the in vivo Toxicity Evaluation Group, Nonclinical Safety Division, Axcelead DDP, and assumed his current position in April 2020. Currently, he has been preparing the nonclinical safety evaluation guidebook for peptides in the AMED nonclinical study research group. He is also the past president of the 48th Annual Meeting of the Japanese Society of Toxicology (in Kobe) in 2021.
[Oligonucleotide Drug Discovery]
Axcelead Solutions to address challenges in safety
Axcelead is collecting the latest information on new modalities from the US, EU and Japan, and supports your non-clinical development with the best strategies. As an example, we introduce our services for oligonucleotide safety issues.
Two types of toxicity are observed in oligonucleotide drugs: A) hybridization-dependent toxicity and B) hybridization-independent toxicity. Among cases of hybridization-dependent toxicity, hybridization to the non-target sequences is specific to oligonucleotide drugs and selecting oligonucleotide drug candidates that have a low risk of toxicity to humans is important.
On the other hand, hybridization-independent toxicity can usually be detected by conventional toxicity tests, but special attention should be given to toxicity to the immune system, blood system, liver, and kidneys, which are often problematic areas with oligonucleotide drugs.
— Axcelead Solutions —
1.Assessment of off-target toxicity (hybridization-dependent) using transcriptome analysis
2.Assessment of off-target toxicity (hybridization- independent) using various toxicity assay systems (immune system, blood system, liver, and kidney toxicity)
3.LNP formation and analysis of immunostimulatory activity