For strategic planning and problem solving in nonclinical development, consult with us at Axcelead.
Our experts are rich in experience
and will offer you the best solution!
- Select and design nonclinical safety and DMPK studies according to the indication, pharmacological target, and physicochemical and biological properties of the candidate.
- Analyze obtained toxicology data to determine whether they are adverse and clinically relevant or not.
- Propose the selection of target metabolites and the handling strategies for reactive metabolites in consideration of NDA.
- Support interactions with regulatory authorities to file IND and to succeed in further clinical development.
- Propose the mechanistic studies to clarify the MOA and to find biomarkers of the dose-limiting toxicity.
Meet the Team
Hirofumi Nagai DVM, PhD, DJSTP
Specialty: toxicology pathology, nonclinical safety
Career: In 1987, after getting the master’s degree in veterinary science from the Graduate School of Agricultural Science, Yamaguchi University, he joined the Drug Safety Research Laboratories, Takeda Pharmaceutical Company Limited. He served as the manager of toxicological and pharmacological pathology, and the head of Drug Safety Research Laboratories. He concurrently served as the global head of Drug Safety Research & Evaluation, a member of the Safety Board, First in Human Committee, and the Occupational Exposure Limit Panel at Takeda Pharmaceuticals International, Inc.
. Since July 2017, he served as the head of the Nonclinical Safety Research at Axcelead DDP, and assumed his current position in April 2020. Outside of work, he has participated as a representative of the Japanese Society of Toxicologic Pathology in the publication of International Harmonization of Nomenclature and Diagnostic Criteria (INHAND) Cardiovascular System and Characterizing “Adversity” of Pathology Findings in Nonclinical Toxicity Studies: Results from the 4th European Society of Toxicologic Pathology (ESTP) International Expert Workshop.
Ryo Fukuda DVM, MS, DJSTP
Specialty: toxicological pathology, nonclinical safety
Career: In 1988, after getting the master’s degree in veterinary science, Graduate School of Agricultural Science, Tokyo University of Agriculture and Technology, he joined the Drug Safety Research Laboratories, Takeda Pharmaceutical Company Limited. He also studied abroad at the National Cancer Institute (NCI) in the US while employed after joining Takeda, and served as the global pathology head of Drug Safety Research & Evaluation at Takeda Pharmaceuticals International, Inc. Since July 2017, he served as the director, leading the Pathology Group, Nonclinical Safety Research at Axcelead DDP, and assumed his current position in April 2020. Outside of work, he was a panel member of Registry of Industrial Toxicology Animal-data, and acts as an expert at ICH S1 Expert Working Group.
Hideo Fukui PhD, DABT, DJSOT
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. 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 will also act as the president of the 48th Annual Meeting of the Japanese Society of Toxicology (in Kobe) scheduled to be held in 2021.
Our achievements (partial)
✓ Discovery of biomarkers for on-target toxicity using KO rats
✓ Elucidation of the mechanism of off-target toxicity, and proposal of clinical biomarkers
✓ Support for a bio-venture company to realize IND of candidate chemical compounds
✓ Support for resolution of clinical holds associated with toxicity, and restarting clinical development
✓ Denial of extrapolation of off-target toxicity to humans by utilizing omics analysis
We offer support catered to your individual goals!
Modeling & simulation ×biomarker exploration – Model Based Drug Development –
Package service for preclinical safety evaluation