While at DIA Japan, I had the opportunity to visit with Barbara Kunz, DIA Global Chief Executive, and reflect on the long history between DIA and CDISC. Did you know DIA has supported CDISC since the very first meeting, before we incorporated as a non-profit in 2000? They sure did. DIA provided us meeting room space for our initial meeting, as the idea of CDISC was blossoming between Becky Kush, myself and a handful of committed volunteers. It was at this meeting where the name CDISC was coined by one of our early volunteers. Even in the early ‘90s they were already encouraging and nurturing Innovation. Look how far CDISC has come since. CDISC and DIA have had a Memorandum of Understanding in place for a number of years and CDISC was at DIA China last May. We look forward to expanding this collaboration around Asia and “Transcending Boundaries” together.


CDISC also has a rich history in Japan, with the J3C being formed in 2002, soon followed by the inaugural CDISC Japan Interchange. The early years of CDISC were very much about Development…developing early foundational standards, developing a non-profit business and developing a global presence. This development has led to significant Innovations over the years such as: development of Therapeutic Area standards for priority disease areas, leading to discovery of new biomarkers and clinical endpoints; launch of the CFAST initiative; participation in data sharing and open science initiatives through public- private partnerships, consortia and patient foundations; development of IHE integration profiles, connecting healthcare and clinical research workflows; and most recently the development of the CDISC SHARE Metadata Repository.


DIA Japan provided an opportunity for me to reflect on how far we have all come together. 2014 was a year of Advancing for CDISC Japan with many significant milestones.


1. Record attendance at the CDISC Symposium (16 May) and the CDISC Japan / Asia Pacific Interchange (31 July – 1 August) with nearly 250 attendees at each event


2. PMDA Notification (20 June) of intent to require CDISC standards by 2016 3. PMDA joined CDISC as a Platinum member 4. CDISC welcomed our 350th member – Hitachi Inspharma Ltd (Japan) 5. CDISC participation in DIA Japan for the first time


I finished my week in Tokyo meeting with the Japan CRO Association (JCROA) and Japan Pharmaceutical Manufacturers Association (JPMA). JCROA representatives kindly took me to a nearby shrine to ensure good fortune and future success for CDISC.


Strength through Collaboration


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