CDISC Announces New Board Members and Chief Technology Officer

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CDISC ushers in the New Year with changes to its leadership. The addition of three highly qualified individuals to its board of directors will bring invaluable expertise to the CDISC organization for the term 2012 - 2015. Returning to the Board are Dr. C. David Hardison, and Dr. Pierre-Yves Lastic, joined by new board member Mr. Robert Goodwin. Each brings a unique skillset to the BoD to help guide CDISC as it moves forward with its goals and initiatives in 2012. Sincere appreciation goes to Dr. Charles Mead and Mr. Shawn Wang, who have now completed their terms on the CDISC Board of Directors.

CDISC ushers in the New Year with changes to its leadership. The addition of three highly qualified individuals to its board of directors will bring invaluable expertise to the CDISC organization for the term 2012 - 2015. Returning to the Board are Dr. C. David Hardison, and Dr. Pierre-Yves Lastic, joined by new board member Mr. Robert Goodwin. Each brings a unique skillset to the BoD to help guide CDISC as it moves forward with its goals and initiatives in 2012. Sincere appreciation goes to Dr. Charles Mead and Mr. Shawn Wang, who have now completed their terms on the CDISC Board of Directors.

Following the charter of the Board of Directors, we will also appoint new members of the Executive Committee of the Board. Dr. Frank Rockhold will become Past-Chair while Paula Brown Stafford takes the helm as Chair of the CDISC Board of Directors. “I look forward to utilizing my clinical research experience to assist the CDISC team achieve its vision of Informing patient care and safety through higher quality medical research and to meet the strategic goals of the CDISC Board for 2012-2015,” stated Ms. Brown Stafford. The new Chair-Elect will be Dr. Pierre-Yves Lastic. Dr. Edward Helton will complete his term as Past-Chair and his service on the Executive Committee; CDISC is extremely grateful for his many years of Board service to CDISC.

The CDISC Advisory Board (CAB) will also have new leadership in 2012 as Lauren Shinaberry assumes the role of Chair of the CAB and David Handelsman comes in as CAB Chair-elect. We sincerely thank Mr. Dave Evans who is stepping down as CAB Chair. In addition, CDISC is extremely pleased to welcome Mr. Wayne R. Kubick, who will assume the position of CDISC Chief Technical Officer in January 2012. “I am absolutely thrilled to finally have this opportunity to contribute full-time to CDISC, which has been a passionate area of interest for me over the past 12 plus years,” Mr. Kubick articulated. “I am eager to begin as we face continued challenges to further establish our foundational standards while also moving toward a new semantic infrastructure to advance research and improve interoperability with healthcare systems.”

“I am excited to welcome these new team members to the board,” stated Frank Rockhold. “They will undoubtedly add invaluable expertise to the ongoing efforts of the CDISC team, and I am optimistic about the future of CDISC under the direction of Ms. Brown Stafford and Dr. Kush.”

Biosketches:

C. David Hardison, Ph.D. is Managing Director of Health Sciences for Recombinant Data Corporation, responsible for their global biopharmaceutical business. In this general manager role, he is currently focused on establishing Recombinant’s European operations and facilitating the adoption of tranSMART, Recombinant’s Translational Research platform, throughout the biopharmaceutical, academic research, and patient-led disease communities. Dr. Hardison is a seasoned executive with over 30 years experience working as a team builder and change agent at the intersection of biopharmaceuticals, health care delivery, performance improvement, and information technology in both executive and board-level roles. In addition to his current role with Recombinant, Dr. Hardison has a long history of experience with such organizations as SAIC, First Consulting Group, Inc., Carolina Medicorp, Inc. (now Novant Health), Hospital Corporation of America, and Lilly. Previously, he served as CDISC Chairman from 2005-2007.

Robert R. Goodwin, MS, MBA is Vice President and WW Head, Safety, Evaluation and Reporting in the World Wide Safety and Regulatory Operations at Pfizer Pharmaceuticals. Mr. Goodwin brings over 19 years of experience in all facets of clinical operations including statistics, data acquisition, reporting and pharmacovigilance. He has established a track record of achieving cost reductions while increasing productivity through restructuring, process transformation and system reengineering, utilizing methods such as Lean and Six Sigma. Mr. Goodwin has held numerous positions within Pfizer Pharmaceuticals, Bayer Corporation, and the VA Medical Center in diverse roles, beginning as a biostatistician to current management roles in Pharmacovigilance.

Pierre-Yves Lastic, Ph.D. is currently Senior Director of Data Privacy and Healthcare Interoperability Standards at Sanofi. Dr. Lastic has over 20 years of experience in diverse management positions in the field of clinical research, leading clinical data management, biostatistics, clinical operations and clinical information management teams with Ciba-Geigy (Switzerland), Synthelabo, Sanofi-Synthelabo, and lastly with Sanofi-Aventis (France). He is specialized in the development and implementation of standards for the exchange of information in the healthcare area and is a member of the Personal Data Protection Committee of Sanofi-Aventis. Dr. Lastic has also previously served on the CDISC Board during an earlier term and currently chairs the European CDISC Coordinating Committee. Dr. Lastic is also a member of the BoD of the International Pharmaceutical Privacy Consortium (IPPC). He is furthermore a member of the Advisory Council Europe of the Drug Information Association (DIA), as well as a member of the Knowledge Management Group of the European Innovative Medicine Initiative (IMI). He is one of the experts on the European Medicine Agency’s (EMA) EudraVigilance Expert Working Group and EudraCT Joint Operations Group.

Wayne Kubick, MBA has over 25 years of experience in clinical research and drug safety, including executive management and strategy development. He has most recently worked for Oracle Health Sciences as Sr. Director of Product Strategy, and previously as Sr. Vice President for Lincoln Technologies/Phase Forward. Mr. Kubick has held several leadership positions with CDISC since 1999, as an original and current Board member, CDISC Technical Director and team leader; he led the development of the CDISC Study Data Tabulation Model (SDTM) for regulatory submissions and other standards efforts.

ABOUT CDISC
CDISC is a global, open, multidisciplinary, neutral non-profit organization that has established standards to support the acquisition, exchange, submission and archive of clinical/medical research data and metadata through a consensus-based process. The CDISC mission is to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare. The CDISC Vision: Informing patient care and safety through higher quality medical research. CDISC standards are open and freely available via the CDISC website. Additional information on CDISC can be accessed at http://www.cdisc.org.

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Diana Harakeh
CDISC
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