INVESTOR NEWSLETTER ISSUE N°3 CDISC EUROPE INTERCHANGE
7-11 APRIL 2014, PARIS, FRANCE The 2014 CDISC Europe Interchange was an incredible success, thanks to the incredible support of our distinguished speakers, generous contributions from our sponsors and exhibitors, and efforts from our CDISC staff around the globe.
Below are articles written by CDISC staff and colleagues that attended this event, detailing major topics, successes, and thoughts on this Interchange. CDISC regularly posts such articles on the CDISC Blog, which can be found here.
The Glass Half Full with CFAST Alana St. Clair, CDISC Project Planner The Coalition for Accelerating Standards and Therapies (CFAST) was a popular topic at the CDISC Europe Interchange. CFAST combines the efforts of CDISC and C- Path; its partners include TransCelerate BioPharma, the U.S. Food and Drug Administration (FDA) and the National Cancer Institute – Enterprise Vocabulary Service (NCI- EVS). There is also participation and input from other organizations, including Europe’s Innovative Medicines Initiative and the Association of CROs.
Rhonda Facile, Senior Director of Standards Development for CDISC, kicked off the presentation with an overview of CFAST, discussing its objectives and the differences between CFAST and other CDISC projects. As CDISC standards are mapped to clinical concepts, there is a shift from developing standards independently, as with foundational standards, to a more interrelated approach with therapeutic area (TA) standards.
John Owen, a CFAST project manager from Johnson and Johnson, continued the session with his perspective and the lessons he has learned from leading two therapeutic area standards development projects – QT Studies and Hepatitis C. Project managers conduct lessons learned meetings throughout the development process and share the findings with other teams and project managers. The goal is continuous process improvement.
Dr. Ron Fitzmartin, Senior Advisor of the Data Standards Program in the Office of Strategic Programs at the Center for Drug Evaluation and Research (CDER) in FDA, concluded the session by discussing the FDA collaboration on TA standards. Dr. Fitzmartin also illustrated the impressive headway made by CFAST and contributing organizations. Early discussions of TA standards resulted in
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the proposed development of 58 TA standards. Dr. Fitzmartin revealed that at least half of these therapeutic areas standards proposed “have been touched in some way.” His ‘glass half full’ attitude (represented on his closing slide with red indicating a half-way mark) was contagious and encouraging. He remarked about CFAST: “The process is working.”
To complete the session, three panelists, Dr. Kieran Breen, Angelo Tinazzi and Marc-Antoine Prodhomme, discussed the intersection of TA standards, patients, public health and effective treatments, sharing their experiences with TA standards implementation.
Visit the CDISC website to read more about the development and status of the CFAST TA standards. If you would like to volunteer for a CFAST team, please visit the homepage of the CDISC website or follow this link.
CDISC Education at the Europe
Interchange Saad Yousef, CDISC Manager of Education and Membership Services The CDISC Europe Interchange, which took place in lovely Paris, concluded on 11 April and the phrase best describing this event would be…a smashing success. Not only did the parallel track conference sessions garner many new attendees, attendance at the CDISC Education courses hit an all-time high. In fact, the registration numbers for 2014 doubled those of 2013! Why is this happening? Many reasons. One is because industry organizations have realized the importance and usefulness of standardized clinical data. Regulatory authorities around the world are also better understanding the importance of CDISC standards and have begun playing a much bigger role in the use of CDISC standards in their communities. The addition of the Define-
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