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CDISC Implementation on a Rheumatoid Arthritis Project Partnership |
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TITLE: CDISC Implementation on a Rheumatoid Arthritis Project Partnership
ABSTRACT:
In late 2007 Genentech of South San Francisco US and Roche of Welwyn UK decided to take a risk and begin a new collaborative rheumatoid arthritis (RA) project using CDISC structures. With little experience among us at the start, the effort has been both fun and challenging. This presentation will address our intelligence-gathering approaches, documentation standards, SDTM modeling conventions and conversion processes, ADaM specifications and structures, and plans for electronic submission to the US Food and Drug Administration (FDA).
AUTHORS: Patricia L. Gerend, Genentech, Inc.; Olivier LeConte, Roche Products Limited; Chris Price, Roche Products Limited; Michelle Zhang, Genentech, Inc.
PRIMARY AUTHOR BIOGRAPHY AND CONTACTS:
Patty Gerend has utilized SAS and other software for analysis and submission of clinical trial data for over 20 years on immunology, oncology, respiratory, GI, and analgesic projects. In addition she has led a SAS biostatistics technical support group as well as numerous technical and process efficiency initiatives. Patty has a master’s degree in Biochemistry and the equivalent of a minor in Computer Science.
Patricia L. Gerend
Senior Manager, Statistical Programming & Analysis
Genentech, Inc.
South San Francisco, California, USA
gerend@gene.com
650-225-6005
CO-AUTHOR BIOGRAPHIES AND CONTACTS:
1) After a Master’s degree in Mathematics and Computer Engineering, Olivier LeConte has been working in the pharmaceutical statistical programming arena for 11 years heading both Support & Clinical Project groups. He is also involved in the Pharmaceutical Users Software Exchange society (http://www.phuse.eu ) and chaired the 2008 PhUSE conference in Manchester UK. He joined Roche Products Limited in UK 3 years ago as Programming Team Leader where he is looking after auto-immune projects.
Olivier LeConte
Programming Team Leader
Roche Products Limited
Welwyn Garden City, UK
olivier.leconte@roche.com
+44 (0) 1707 36 5710
2) After completing a Masters degree in Statistics with Applications in Medicine, Chris Price has been working in the pharmaceutical statistical programming area for five years across ophthalmic, cardiovascular, and immunology therapeutic areas. He is also involved with organizing programming related training courses for PSI (Statistics in the Pharmaceutical Industry, www.psiweb.org) within the UK.
Chris Price
Senior Programmer
Roche Products Limited
Welwyn Garden City, UK
chris.price.cp1@roche.com
+ 44 (0)1707 365801
3) Michelle Zhang has been working on oncology and immunology projects for over a decade, including being one of the technical leads on the first production CDISC project for Genentech and Roche. Prior to this, she worked at other pharmaceutical companies and in agricultural economics. Michelle holds Masters degrees from Purdue University in both Applied Statistics and Applied Mathematics.
Michelle Zhang
Senior Statistical Programmer Analyst
Genentech, Inc.
South San Francisco, CA, USA
zhang@gene.com
650-225-7414
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