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Welcome to PharmaSUG 2009 .....................................................................................................1 PharmaSUG 2009 Conference Committee.................................................................................2 PharmaSUG 2009 Section Chairs ................................................................................................3 PharmaSUG 2009 Special Volunteers ........................................................................................4 Consolidated Conference Schedule ...........................................................................................5 Conference Highlights..................................................................................................................9 Area Attractions............................................................................................................................12 SAS at PharmaSUG 2009 ............................................................................................................14 SAS® Keynote Speaker................................................................................................................15 Conference Keynote Speaker ....................................................................................................16 Abstracts ........................................................................................................................................17 Pre-Post Conference Seminars ..................................................................................................88 Sponsors.........................................................................................................................................96 Exhibitions and Demonstrations ..............................................................................................98 Welcome to PharmaSUG 2009! The PharmaSUG 2009 Conference Committee welcomes you to the annual meeting of the Pharmaceutical Industry SAS® Users Group. We are pleased to be located at the Hilton Portland & Executive Tower in Portland, Oregon. The conference formally begins with the Opening Session. This year the conference committee will be in- troduced and we’ll have two outstanding speakers addressing our conference. Kathy Council, vice presi- dent of Publications from SAS® Institute will talk about “Celebrating the SAS User - A history of the part- nership between SAS and its user community” and Representative Dr. Mitch Greenlick, elected to Oregon House of Representatives in 2002 House District 33, will address our conference and he will talk about “Towards Universal Access to Health Care”. An excellent dinner will immediately follow. We are pleased to again supplement the conference with pre- and post- conference training seminars. These seminars, ranging from beginning to advanced levels and taught by renowned experts, will be of- fered Saturday (May 30), Sunday (May 31), Wednesday afternoon (June 3) and Thursday (June 4). In addi- tion to seminars, this year Toastmasters International and Toastmasters District 7 will be providing free speaker training on Sunday (May 31). Two and a half days packed with paper presentations and invited Hands-on Workshops will begin on Monday morning and continue through Wednesday morning. SAS personnel will present selected papers. A record number of Poster presentations will be available for your viewing in the SAS Exhibit and Demo room. The Exhibit and Demo room will be open all day on Monday and Tuesday, plus Wednesday morning. This year, we will have over 12,500 sq. ft. of space for exhibits and demonstrations! This is also the location of the snack breaks and the SAS User Appreciation Mixer on Monday evening. Monday evening is the 5th annual Game Night. This year, again we’re holding a ‘no money exchange’ Texas Hold ‘Em poker tournament and a Ping-Pong tournament. Both tournaments are additional fee events for participants, but spectators may attend for free. In addition to tournaments, this year we are of- fering Yoga classes Monday and Tuesday evening, 8:00 – 9:30 p.m., $20 per section payable at the door. Portland offers many cultural and fun activities for all ages. We hope you can spend a few days prior to or after the conference to do some sightseeing in this versatile city. More information about things to do in Portland is contained later in this book. Thank you for attending PharmaSUG 2009. We wish you a terrific conference that is both educational and fun. Welcome to Portland! Syamala Ponnapalli Ellen Brookstein Academic Chair Operations Chair 1 PharmaSUG 2009 Conference Committee Academic Chair Registration Desk Coordinator Sponsor & Exhibitor Coordinators Syamala Ponnapalli Jacques Lanoue Iza Peszek ICON Clinical Research MannKind Corporation Comprehensive Neuro Sciences Matt Becker Freddie Paino Operations Chair PharmaNet Quintiles Ellen Brookstein Octagon Research Scholarship and Speaker Sharing Co- Media & Materials Coordinators ordinator Dan Downing Publications Coordinator Richard Allen CVS Caremark James Wu Peak Statistical Services Joshua Horstman Sanofi-Aventis First Phase Consulting, Inc Seminar Coordinators Treasurer Margaret Hung Newsletter Editors Cindy Song Stat-Tech Services, LLC Mal Foley Sanofi-Aventis Cecilia Mauldin Contractor/Trainer Comprehensive Neuro Sciences Cindy Song Registrar Sanofi-Aventis Elaine Dempsey Meal Coordinator Omnicare Clinical Research Ellen Brookstein Events Coordinator Octagon Research Kim Truett Assistant Registrar Brian Shilling KCT Data, Inc. Matt Becker Octagon Research PharmaNet Volunteer Coordinators Matthews Carol United Biosource Mullins Lynn Statking Consulting 2 PharmaSUG 2009 Section Chairs Applications Development Management Statistics & Pharmacokinetics Mary Anne Hope Jackie Lane Guowei Wu BCBS of Arizona ICON Clinical Research Merck & Co Inc Gopal Rajagopal Pete Yribar Xingshu zhu Merck & Co Inc Genentech, Inc Merck & Co Inc Coders Corner Posters Technical Techniques Sandy Paternotte Jeanina Worden Jim Johnson PPD ClinOps, LLC RPS Meera Kumar Helen Wang Eric Larson Sanofi-Aventis Merck & Co Inc Tutorials Data Management & Quality Public Health Research Nancy Brucken Laura DiTullio Richard Allen i3 Statprobe GE Healthcare Peak Statistical Services Xiaohui Wang Dave Izard Paul Slagle Novartis Octagon Research United Biosources Hands-On Workshops Regulatory Submissions & Stan- Susan Fehrer dards BioClin Inc Eunice Ndungu Alissa Ruelle Merck & Co Inc PharmaNet Cindy Lee Hsiu-yung Eli Lilly 3 PharmaSUG 2009 Special Volunteers Copyright Coordinator FDA & Industry Recruiter SAS Liason Lin Yan Sandra Minjoe Michael Smith Merck & Co Inc Genentech, Inc SAS Institute, Inc. Sandy Paternotte PPD, Inc Photographers Scholarship & Speaker Sharing Diane Carow Assistant Game Night Coordinators Quintiles Pamela Butler Truett Kim (ping pong) Sanofi-Aventis KCT Data, Inc. Speaker Training Yribar Pete (poker) Paul McDonald Webmaster Genentech, Inc PRA International Michelle Langston Graphic Artists Code Clinic Kim Riddell Kirk Paul Lafler KCRiddell, LLC Software Intelligence Corp Ramona Martin Rographix Art & Design Studio 4 Consolidated Conference Schedule SATURDAY, May 30 7:30 AM - 8:00 AM Seminar Registration – Seminar Attendees Only ..................................Plaza Foyer 8:00 AM - Noon Morning Seminar Sessions * 1. CDISC De-mystified: An Introduction to CDISC .................Broadway I/II 2. Testing and Validating SAS® Programs in an FDA Regulated Environment .......................................Broadway III 3. Building the General-Purpose Program: Exploring the Developer’s Mindset and Toolbox .................Broadway IV Noon - 1:00 PM Lunch – On Your Own 12:30 PM - 1:00 PM Seminar Registration – Seminar Attendees Only ..................................Plaza Foyer 1:00 PM - 5:00 PM Afternoon Seminar Sessions * 4. Practical CDISC: Implementing CDISC with SAS® .............Broadway I/II 5. Advanced ODS .........................................................................Broadway III 6. SAS® & XML .............................................................................Broadway IV SUNDAY, May 31 7:30 AM - 8:00 AM Seminar Registration – Seminar Attendees Only ..................................Plaza Foyer 8:00 AM - Noon Morning Seminar Sessions * 7. Advanced Reporting and Analysis Techniques for the SAS® Power User: It’s Not Just About the PROCs! .............Broadway I/II 8. Best Practices in Base SAS® Coding .......................................Broadway III Noon - 1:00 PM Lunch – On Your Own Noon - 4:00 PM Presentation rehearsal...............................................................................Galleria North 12:30 PM - 1:00 PM Seminar Registration – Seminar Attendees Only ..................................Plaza Foyer 1:00 PM - 6:00 PM Conference Registration Desk Open ....................................................Plaza Foyer 1:00 PM - 5:00 PM Afternoon Seminar Sessions * 9. Leadership 101: What Everyone Should Know About Managing SAS® Programmers ...................................Broadway I/II 10. Quick Results With SAS/GRAPH® Software ......................Broadway III 2:00 PM – 4:00 PM Toastmasters Training on Public Speaking............................................Galleria South 5:00 PM - 6:00 PM Presenter, Section Chair, and Volunteer Meeting .................................Galleria North 6:00 PM - 7:30 PM Opening Session.......................................................................................Pavilion Ballroom 7:30 PM – 9:00 PM Welcome Dinner.......................................................................................Pavilion