Seminars
Accelerate and achieve an optimal IND for your project～Smart-IND®～
A webinar co-hosted by Axcelead Drug Discovery Partners (ADDP), SEKISUI MEDICAL, and KRCC. The webinar is for Korean scientists. After the speech, the breakout meeting rooms are available, where our experts will answer your further and detailed questions.
Webinar Overview:
Are you interested in one-stop service that can support your IND-enabling studies from planning to implementation? There are many obstacles and individual issues to overcome when applying for an IND. To solve these problems, the integrated IND-enabling service, Smart-IND® is launched. The entire preclinical study process will be managed by Axcelead as a hub to significantly reduce your burden for IND. Programs for IND are considered and proposed based on the Target Product Profile by our well-experienced scientists. Also, the whole process of your individual studies from planning to report finalization, preparation of an investigative brochure, response about inquiries from regulatory authorities, will be supported promptly and fully. In this seminar, an overview of Smart-IND® and detailed examples of solutions will be introduced. After that, the breakout meeting rooms are also available, where our experts will answer your further and detailed questions.
Presentation:
Speaker
Fumihiro Jinno
Axcelead Drug Discovery Partners Inc,Applied Regulatory Science Director
1993, School of Pharmaceutical Science of University of Shizuoka, JAPAN(Bachelor of Pharmaceutical Science)
1995, School of Pharmaceutical Science of University of Shizuoka, JAPAN(Master of Pharmaceutical Science)
2012, Graduate School of University of Shizuoka, JAPAN (Ph.D. in Pharmaceutical Science)
1995-, Takeda Pharmaceutical Company Limited, Animal Drug Research Office
1999-, Takeda Pharmaceutical Company Limited, Drug Metabolism and Pharmacokinetics Research Laboratories
(2007-2008) Takeda Global Research & Development Center Inc.
2012-, Associate Director, Takeda Pharmaceutical Company Limited, Drug Metabolism and Pharmacokinetics Research Laboratories
2017-Current, Director, Axcelead Drug Discovery Partners, Inc.
Experts in Breakout Room
Hideo Fukui, PhD, DABT, DJSOT
Axcelead Drug Discovery Partners Inc, Applied Regulatory Science Senior Director/Senior Consultant
1989 M.S. in Agriculture (Major: Nutritional Biochemistry), Nagoya University, Nagoya, Japan
1989 Research Scientist, Toxicologist, Drug Safety Research
Laboratories (DSRL), Takeda Chemical Industries, Ltd., Osaka, Japan
1994 Ph.D. in Pharmacological Science, Kyoto University, Kyoto, Japan
2000 Visiting Scientist, Edward S. Harkness Eye Institute, Department
of Ophthalmology, Columbia University Medical Center, NY, USA
2002 Diplomate, Japanese Society of Toxicology (DJSOT), certified
2004 Diplomate, American Board of Toxicology (DABT), certified
2014 Drug Safety Therapeutic Area Lead for GI (Gastro-Intestine) in
Global Drug Safety Research and Evaluation, Takeda
Pharmaceutical Company Limited, Japan
2017 Director, Nonclinical Safety Research, Partnership Research
Center, Research, Takeda Pharmaceutical Company Limited, Japan
2018 Director, Nonclinical Safety Research, Axcelead Drug Discovery
Partners, Inc., Japan
2020 Senior director/Senior consultant, Nonclinical Development
Strategy, Applied Regulatory Science, Axcelead Drug Discovery
Partners, Inc., Japan
2021 President of the 48th Japanese Society of Toxicology(JSOT) annual meeting in 2021 (Kobe, Japan)
Executive board member of the JSOT (2016-2020),
Observer of executive board of the JSOT (2020-2022)
Shotaro Miura
Axcelead Drug Discovery Partners Inc,Chemistry, Discovery Science Director
1998, M.S. in Pharmaceutical Sciences, Graduate School of Pharmaceutical Sciences, Tokyo University of Pharmacy and Life Sciences, Tokyo, Japan.
1998, Research Scientist, Pharmaceutical Manufacturing Laboratory, Chemistry, Manufacturing and Control Research Center, Takeda Chemical Industries, Ltd., Osaka, Japan.
2000, Research Scientist, Medicinal Chemistry Laboratories, Pharmaceutical Research Division, Takeda Chemical Industries, Ltd., Japan.
2003, Principal Scientist, Medicinal Chemistry Laboratories, Pharmaceutical Research Division, Takeda Pharmaceutical Company Ltd., Japan.
2010, Visiting Scientist, Department of Clinical Neuroscience, Karolinska Institute, Stockholm, Sweden.
2011, Principal Scientist, Medicinal Chemistry Laboratories, Pharmaceutical Research Division, Takeda Pharmaceutical Company Ltd., Fujisawa, Japan.
2017, Principal Scientist, Synthetic Chemistry, Discovery Science, Axcelead Drug Discovery Partners, Inc., Japan.
2020-current, Director, Synthetic Chemistry, Discovery Science, Axcelead Drug Discovery Partners, Inc., Japan.
Axcelead Drug Discovery Partners Inc.
Japan‘s first drug discovery solutions provider established as a spin-off from Japan’s largest pharmaceutical company, Takeda Pharmaceutical.
SEKISUI MEDICAL CO., Ltd.
With over 50 years of experience, we are the leading company in the field of RI-ADME studies.
KRCC Co., Ltd.
Agent of domestic and overseas CROs such as preclinical intro test, in vivo test, metabolites biotransformation, RI compound synthesis, toxicity, and comprehensive for new drug development.