[Webinar] Cell & Gene Therapy (Regenerative Medicine) Development in Japan: Challenges and Key Success Factors for Rapid Approval
The global regenerative medicine market was valued at USD 23.8 Billion in 2018 and is projected to reach USD 152 billion by 2026. The market anticipates to expand remarkably due to advancement in technology in this field and growing applications in the treatment of chronic and incurable diseases. Asia-Pacific generated USD 6 Billion in 2018 and is predicted to be the fastest growing region for regenerative medicine.
In Japan, two laws regulating regenerative medicine became effective in 2014: The Act on the Safety of Regenerative Medicine (Safety Act) and The Act on Pharmaceuticals and Medical Devices (PMD Act). The PMD Act established an expedited conditional approval system for regenerative medicine that led Japan to be the world’s fastest approval.
As the first and largest CRO in Japan, CMIC Group’s three experts from regulatory consulting, non-clinical, and clinical research, will share current challenges and provide you with key factors for success.
- Regulatory framework in Japan and its challenges
- CMIC’s approach in the non-clinical area (regulation, guidance/guideline for non-clinical studies, case studies)
- Clinical trial: tips for success (current status and key points for regenerative medecine clinical trials in Japan)
Senior Consultant, Head of Regenerative Medicine Group, Consulting Division
CMIC Co., Ltd.
Dr. Kazuhiro Fukuta is a Senior Consultant and the Head of Regenerative Medicine Group, Strategy & Regulatory Affairs Consulting Department, Consulting Division in CMIC. He received his Ph.D. in agricultural chemistry from Kyoto University. He is specialized in science, regulation and clinical development of regenerative medicine based on his experiences as a researcher of biochemistry, molecular biology and molecular regenerative medicine at university and his 10 years’ career at a biotech company.
Director, Science Business Development Division
CMIC Pharma Science Co., Ltd.
Dr. Hiroyuki Komatsu is the Director of Science Business Development Division in CMIC Pharma Science. CMIC Pharma Science is a non-clinical CRO of CMIC Group that focus on CMC (Chemistry, Manufacturing and Control), bioanalysis and non-clinical study services. Dr. Komatsu obtained his PhD in Agriculture from the Gifu University. He has been a study director for non-clinical studies (toxicity, bio-distribution studies, etc.) for over 13 years and is in charge of studies related regenerative medicine since 2016.
Director, Clinical Research Division
CMIC Co., Ltd.
Ms. Sayaka Fukura joined CMIC in 2004. Over 15 years at CMIC, she experienced more than 30 clinical trials in multiple therapeutic areas. In October 2016, CMIC formed “Regenerative Medicine of Clinical Research Department” to allocate dedicated resource to support the clinical trial and research. Ms. Fukura has been responsible for the regenerative medicine team since 2017. Currently, she is also in charge of managing hematology and respiratory studies. With her therapeutic expertise and experience in regenerative medicine, she leads the customers to conduct their clinical trials smoothly in Japan.