This is the News

As Dr. Frank Rockhold assumes the position of Chair, CDISC Board of Directors, this month, CDISC would like to formally congratulate Paula Brown-Stafford on being voted as the new Chair Elect of the CDISC Board.  Paula has more than 20 years experience of working in the Pharmaceutical and CRO industry. She has worked closely with the CDISC standards and has ensured that Quintiles has devoted time and energy to their implementation within the organization.  She has also served as head of the Board Financial Oversight Committee for the Board for the past two years and will continue in this role.  Dr. Edward Helton, who served as Chair for the past two years, is now Past-Chair and head of the Board Governance Committee.

In addition, following a rigorous process of selection, CDISC is pleased to announce that two highly qualified individuals will be added to its Board of Directors for a three year term (2010-2012).  Dr. Steven Hirschfeld and Wayne R. Kubick will have now been welcomed to the CDISC Board.  Sincere appreciation goes to Dr. Christopher Chute, who served his three year term on the CDISC Board but did not run again since he assumed the role of Chair, ISO TC 215 (Healthcare Standards) as of January 2010.  We look forward to continuing to work with Dr. Chute within ISO.   Dr. Pierre-Yves Lastic completed two 3 year terms on the CDISC Board, but will remain on the Board in an ex-officio capacity through his role as Chair of the European CDISC Coordinating Committee (E3C), which officially begins in April 2010.  William Rosen will be staying for one more year to complete a second term on the Board.

Dr. Steven Hirschfeld has recently become the Acting Director for the National Children’s Study at the National Institutes for Health, in Bethesda, MD and he also holds the position of Associate Director for Clinical Research at the National Institute of Child Health and Human Development. Dr. Hirschfeld brings a thorough knowledge of and first-hand experience with CDISC standards and their implementation.  He has been FDA Liaison to CDISC for Data Analysis, Adverse Event Analysis and Protocol Representation, with additional work on the CDISC Glossary.  In addition, he is a co-lead for the CDISC Integrated Safety Data Pilot work with the FDA. After gaining his MD at Columbia University, he began a distinguished career as a pediatrician at the University of California. Dr. Hirschfeld joined the FDA Center for Drug Evaluation and Research as a Medical Officer working in the Division of Oncologic Drugs and the Pediatric Program.  He also worked for the FDA Center of Biologics Evaluation and Research as a medical officer in the Office of Cellular, Tissue and Gene Therapy. 

Wayne Kubick has over 25 years experience, primarily involving clinical research, drug development and product safety, including executive management, strategy development, consulting and software development. He is currently Sr. Vice President and Chief Quality Officer at Phase Forward Lincoln Technologies. Mr. Kubick has vast consulting experience in clinical data architectures, product safety, data mining and analysis technologies, electronic regulatory submissions, information technology strategies, and business processes for clinical research. In addition, he has made major contributions to CDISC over the last 10 years bringing his expert knowledge to CDISC.  Wayne generated the initial strawman SDTM model (with Dave Christiansen) before CDISC was incorporated and served as a team leader for the SDS team and also on the first CDISC Board.  Wayne has also worked with the HL7 standards, regulatory processes and quality systems, EDC, CDMS, electronic publishing, database and analysis software applications.  We are glad to have him back ‘on Board’.

The skillsets and experience that these two new Board members will bring is complementary to and augments that already within the CDISC Board of Directors and will no doubt prove invaluable during their coming terms.