1. Director, Asia Pacific Japan and U.S. Clinical Operations
Building Synergy Between US and Japan: DES Clinical Trial Designs – Industry View
Gary Thompson
Director, Asia Pacific Japan and U.S. Clinical Operations
Abbott Vascular

2. What is synergy?
A synergy is where different entities cooperate advantageously for a final outcome. Simply defined, it means that the effect of the whole is greater than the sum of the effects of the individual parts.
en.wikipedia.org/wiki/Synergy

3. Building Synergy
Global Harmonization Task Force
Working Towards Harmonization in Medical Device Regulation
The Global Harmonization Task Force was conceived in 1992 in an effort to achieve greater uniformity between national medical device regulatory systems. This is being done with two aims in mind: enhancing patient safety and increasing access to safe, effective and clinically beneficial medical technologies around the world.
- Welcome to the GHTF Website

4. Building Synergy cont. Harmonization By Doing
The HBD initiative is a pilot project launched in December 2003 that seeks regulatory convergence between FDA and MHLW-PMDA premarket review of device cardiovascular technology. Instead of taking a theoretical approach to harmonization, HBD will utilize parallel development, application submissions and review of actual medical device projects by FDA and MHLW-PMDA in conjunction with the above-named constituencies. The objective is to eliminate redundancies, added costs, and time delays inherent in sequential trials. The intent of HBD is not simply to create guidance and discuss policy but to develop common protocols for investigational clinical studies that would allow safe and effective "breakthrough" cardiovascular technologies to benefit patients worldwide.

5. Building Synergies cont.
Pre-IDE Process
Informal Guidance Meetings
Formal Guidance Meetings
Pre-IDE Submissions
Clinical Trial Consultations
Pre-consultations
Formal Consultations

6. Building Synergies cont.
ANNOUNCEMENT (June 23, 2009): U.S. – Japan Pilot Program Regarding Medical Device Collaborative Consultation and Review of Premarketing Applications
The goal of the pilot program is to improve both the speed and quality of the consultation and review stages, allowing for potential earlier market access and an increased benefit to public health.

7. Structure of SPIRIT III
Data on file at Abbott Vascular
© 2010 Abbott Laboratories.

8. Structure of SPIRIT III
Data on file at Abbott Vascular
© 2010 Abbott Laboratories.

9. Trial Design Ideas Global Trial - Single Protocol
Multiple countries (including Japan & U.S.)
Meeting country specific requirements
Two Country Trial (Japan & U.S.) – Single Protocol
Country Specific Trials – Two Protocols
Possibility of pooling data

10. Panel Question
Are we seeing a synergy between the U.S. and Japan that will provide earlier market access to breakthrough technologies resulting in an increased benefit to public health? If so, what is the evidence?

11. Thank you