Challenges and Potential Solutions for Taking Your Cell and Gene Therapy Clinical Program to Japan
Sponsored by Hitachi Chemical Advanced Therapeutics Solutions, LLC
Organized by the ISCT Business Models and Investment Subcommittee
Wednesday, December 6, 2017
13:00 PST, 15:00 CST, 16:00 EST, 06:00 JST (Dec. 7)
Chair: David Smith, MEng, PhD, Biomedical Engineer, Hitachi Chemical Advanced Therapeutics Solutions, LLC, United States
- Colin Novick, Managing Director, CJ Partners Inc., Japan
- Kazuchika Furuishi, PhD, Deputy General Manager, Hitachi Chemical Regenerative Medicine Business Sector, Japan
- Robert Preti, PhD, General Manager, Hitachi Chemical Regenerative Medicine Business Sector, CEO and President, Hitachi Chemical Advanced Therapeutics Solutions, Chairman, Alliance for Regenerative Medicine, United States
About the Webinar:
Regulatory changes within PMDA supporting Conditional Approval of promising cell and gene therapy (CGT) products in Japan, have led to greater interest in taking CGT clinical programs to Japan for development, partnering and earlier commercialization. In response to these changes, the October 10, 2017 Memorandum of Understanding between ISCT and FIRM (Forum for Innovative Regenerative Medicine) creates a timely partnership for facilitating entry of innovative CGT product programs from outside Japan to PMDA filings, development and commercial access to patients in Japan.
As a result of this recent partnership, the ISCT Business Model & Investment Subcommittee has planned a two-part series on CGT development and business opportunities in Japan.
This first session will focus on the PPD and regulatory considerations for taking your CGT clinical program to Japan. Participants will learn about the attractive regulatory changes at PMDA which have resulted in increased offshore filing activity in Japan, the challenges to consider, and examples of solutions for successfully bringing CGT programs to Japan.
The second session in 2018 will be more focused on partnering and the value of adding Japan to your CGT program. These are must-attend webinars if you are considering Japan as part of your business model!
- To get an update on PMDA CGT regulations, especially in relation to Conditional Approval
- CGT under the PMD Act. = Regenerative Medical Products
- CGT under the ASRM = Specified Cell Products
- To better understand the benefits and opportunity for CGT candidate developers to pursue clinical trials in Japan and eventual market approval
- To gain insight on some of the challenges you will need to overcome when submitting a CGT CTN (the equivalent of a US IND) in Japan
- To gain insights on CMC Quality levels that need to be adhered to when commencing a CGT clinical trial in Japan
- Pertinent guidelines
- Adherence to the Japanese Standards for Biological Raw Materials
- In-Process Controls & Specifications
- Final Product Stability
- To understand how Japanese CGT manufacturing requirements may differ from US CGT manufacturing requirements