Additional activities that took place at the Harborside during the week of 1-5 November included a meeting with FDA representatives to discuss ‘derived variables’ and how best to incorporate these into a submission, SDTM, ADaM. Many know this has been one of the “favorite” team topics over the years and we are hoping that the solution is becoming nearer with the recent support and renewed interest from FDA CDER and CBER in providing feedback on submissions using CDISC standards. The CDISC Board Technical Advisory Committee (TAC) held a meeting to review CDISC projects. The CDISC Advisory Board also held their annual NA Face-to-Face meeting at the Interchange and there was a meeting with the Translational Research Institute (TRI) of Japan.
CDISC Advisory Board Meeting
The CDISC Advisory Board (CAB) met face-to-face on 2 November from 10 a.m. until 2 p.m. The meeting was chaired by Trisha Simpson (Schwartz Biosciences/UCB) and chair-elect Dave Evans (Octagon). Lauren Shinaberry (PRA International) was announced as the new Chair-elect.
After approving the minutes from the last teleconference, the CAB held their election for the Director on the CDISC Board. Dr. Kiyoteru Takenouchi of CMIC was elected by the CAB for a term of 2011 through 2013. He was present at the meeting to speak to his nomination (prior to the vote). Dr. Takenouchi has been working closely with CDISC for over 10 years now through the J3C, which he led for the past two years. He stated his interest in CDISC, his activities related to CDISC for the prior decade (including active support of the Healthcare Link initiative and RFD in Japan) and the commitment that his company has agreed to provide in ensuring that he will be able to attend the face-to-face Board meeting should he be elected. Indeed, he was actively involved in working with the TRI on behalf of CDISC (see article and photo below). No other candidates were present at the meeting. However, CDISC Board members in attendance at the CAB meeting included Wayne Kubick (Oracle); Sue Dubman (Genzyme), who was recently re-elected for a second term; and, newly elected Bob DiLaura (Cleveland Clinic).
Representatives of the CAB to Board Committees for 2011 will be Gary Walker (CDISC Board Technical Advisory Board); Dave Evans (CDISC Board Financial Oversight Committee) and David Handelsman (CDISC Board Strategy Committee). Beginning in 2011, Dave Evans and Lauren Shinaberry will be ex-officio members to the CDISC Board and are invited to attend all Board Meetings and Teleconferences. The Board Committee representatives gave updates to the CAB on the Committee activities over the past month after which the CAB participated in a CDISC CAB-FDA “Town Hall” format with four FDA representatives responding to questions from the CAB. Notes from this meeting and the Town Hall with FDA will be available on the CDISC CAB Portal.
The CDISC Advisory Board is comprised of one representative of each of the CDISC Sponsor-level organizations, which include CROs, academic institutions, service and technology providers, biopharmaceutical companies, the National Cancer Institute, the Critical Path Institute, and new member Clinical Trials Transformation Initiative (CTTI). The CAB has teleconferences every other month and the theme in 2010 has been to hear presentations from different CDISC member companies about their CDISC implementation experiences. The CAB also has a team working with FDA to evaluate tools for testing compliance to SDTM. Trisha Simpson and Marcelina Hungria presented on this work at the Interchange on Wednesday afternoon. There is discussion of potentially holding a CAB face-to-face in Europe around the CDISC Interchange in Brussels; feedback on this idea is most welcome.
We would all like to express our sincere gratitude to Trisha Simpson for chairing the CAB in 2010 and for her leadership in this regard.
CDISC Meeting with TRI
Also during the week of the Interchange in Baltimore, CDISC representatives from Japan and the U.S. met with Ms. Masako Yamada, Seeds Assessment and Cultivation, of the Department of Research and Development, Translational Research Informatics Center (TRI) a non-profit organization in Japan. TRI has already translated the CDISC Glossary and is interested in translating the CDISC standards to make them more broadly available for Japanese researchers. CDISC and TRI have been developing an MOU so that the work can continue and will be executing an Agreement in the near future. In the photo below from left to right, the participants of this meeting were CDISC President and CEO, Dr. Rebecca Kush; J3C Leader, Dr. Yoshio Tsukada, TRI representative Ms. Masako Yamada; CDISC Manager of Global Relations, Ms. Sheila Leaman; newly elected CDISC Board Member, J3C Past-Chair and CAB member, Dr. Kiyoteru Takenouchi.
Dr. Rebecca Kush
CDISC President & CEO
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