ISCT Webinar



Partnering in Japan: The Athersys • Healios Story

(Second Session of the ISCT Japan Series Webinar Program)



Sponsored by Nikon Cell Innovation Co.



Organized by the ISCT Business Models and Investment Subcommittee

of the ISCT Commercialization Committee



Event Date

Wednesday, December 12 /Thursday, December 13 (Japan)

14:30 PST, 17:30 EST, 07:30 JST (Dec 13)





Chair

Bill Milligan

Senior Vice President

Steminent Biotherapeutics Inc.

Co-Chair, ISCT Business Models and Investment Subcommittee Speakers Thoughts on Partnering and Development in Japan

Gil Van Bokkelen, PhD

Chairman and CEO

Athersys

United States Healios Business Strategy

<3 pipelines +3 years>

Hardy Kagimoto, MD

Chairman and CEO

Healios

Japan Tech Transfer to Japan: Lessons Learned

Kim Raineri, MBA

Vice President of Operations

Nikon Cell Innovation Co

Japan



About the Webinar:



Favorable regulatory changes came into effect at PMDA in November 2014 which introduced potential for conditional market approval of CGT / RM therapeutic candidates after Phase II clinical development and led to increased interest for partnering in Japan. As a result, ISCT and FIRM formed a strategic partnership in October 2017 to facilitate creating a better understanding of the opportunities these changes present for the respective ISCT and FIRM communities of organizations.

The first session for the ISCT Japan Webinar Series in December 2017 focused on clarifying the new, PMDA regulatory changes to support CGT clinical development in Japan. PCT/Hitachi sponsored and provided perspective in this webinar which can be accessed on the ISCT website.

This second session in the ISCT Japan Series is focused on the actual partnering experience, how to partner, the value of partnering, and key learnings from the active Athersys : Healios Japan partnership. This webinar will provide insights and learning from Athersys (US) and Healios (Japan) leadership as well as provide the manufacturing perspective for Japan partnerships from Nikon (Japan). Athersys, Healios and Nikon demonstrate that biotechs, chemical companies, CMOs, and other organizations beyond Big Japanese Pharma are active in seeking and developing Japanese CGT / RM partnerships.



Learning Objectives:

To gain valuable insights and learning from the Athersys • Healios partnership experience: How the partnership started and working collaboratively How the partnership has advanced their clinical development programs Managing the regulatory and manufacturing challenges together

To see how partnering in Japan with opportunity for Conditional Approval can add substantial value to your technology platform and clinical development assets.

To better understand the benefits for CGT / RM developers to pursue partnerships for clinical development and commercialization in Japan and eventual market approval

To learn about the challenges in creating a partnership in Japan from both the Western perspective and from the Japanese perspective



Registration for this Webinar has been sponsored by Nikon Cell Innovation Co.