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Welcome/Opening Remarks

Welcome/Opening Remarks. Jeff. A. Sloan Mayo Clinic Comprehensive Cancer Center Rochester, MN. FDA Guidance on Patient Reported Outcomes: Discussion, Dissemination, and Operationalization Chantilly, VA, February 23 – 25, 2006. I was a lot younger when we started planning this meeting….

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Welcome/Opening Remarks

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  1. Welcome/Opening Remarks Jeff. A. Sloan Mayo Clinic Comprehensive Cancer Center Rochester, MN FDA Guidance on Patient Reported Outcomes: Discussion, Dissemination, and Operationalization Chantilly, VA, February 23 – 25, 2006

  2. I was a lot younger when we started planning this meeting…

  3. In fact we were all a lot younger… kristy martha michele marlene laurie jane

  4. …at times it was challenging…

  5. …but the guidance is out and we are all here

  6. Thanks • FDA & Mayo partnership • Laurie Burke, Jane Scott • Writers and Reviewers • Funding from Corporate Sponsors • North Central Cancer Treatment Group • Mayo QOL Team • Marlene Frost, Michele Halyard • Kristy Vierling, Kara Curry • Martha Hoag and Mayo CME

  7. Corporate Sponsors LEADER: Amgen Eli Lilly Takeda PATRON: GlaxoSmithKline Genetic, Inc. Roche Laboratories, Inc. Wyeth CONTRIBUTOR: Merck Research Laboratories NeoPharm, Inc.

  8. Syllabus • Schedule, Faculty bios, financial disclosures • FDA draft guidance • Draft manuscripts, produced before the guidance was released • Slide presentations

  9. Housekeeping: Facilities • Breaks / Meals • Phones, copier, fax, messaging, wireless • Emergency phone number: 703-818-0300

  10. Work Hard: Play Hard • Reception tonight 6:00 – 9:00 • Dinner hosted by George and Martha Washington • Can still sign up at registration desk

  11. Work Hard: Play Hard Reception tomorrow 7:00 – 9:30 • Hockey/Movie Night in Canada • Heavy hors d’oeuvres • Trivia • “Strange Brew”

  12. Meeting Survival Facilitation • Massage therapists • Free chair massage • Signup at registration desk

  13. Primary Meeting Goals • Provide a focused process to facilitate discussion among all stakeholders • INPUT and FEEDBACK • Present conclusions of each paper • Delineate ways to best operationalize the guidance into clinical trials

  14. Meeting Format • 90 minutes per paper • 20-30 minute presentation of findings • 0-5 minute FDA commentary • 40-60 minute moderated Q&A / discussion • Audience may submit written questions • Team members / FDA panelists respond

  15. Ground Rules • Brevity is the soul of wit: 1-minute wisdom • Disagreements are not personal • Keep to time schedule • We have a path already chosen, the time for going back to square one has past • People can be nominated for massages

  16. Mayo/FDA Meeting on PRO: Faculty Paper I: Conceptual Issues Margaret Rothman, Ph.D. Johnson & Johnson Philippe Beltram, Pharm.D. Sanofi-Aventis Joe Cappelleri, Ph.D. Pfizer Joe Lipscomb, Ph.D. Emory University Bonnie Teschendorf, Ph.D. American Cancer Society Paper II: PRO Instrument Selection Michele Halyard, M.D. Mayo Clinic Dave Cella, Ph.D. Northwestern Joseph Jackson, Ph.D. Bristol-Myers Squibb Claire Snyder, Ph.D. Johns Hopkins Maria Watson, Ph.D. GlaxoSmithKline Paper III: PRO Instrument Development Issues Ralph Turner, Ph.D. Phase V Technologies Charles Cleeland, Ph.D. MD Anderson Joel Kallich, Ph. D. Amgen Bhash Parasuraman, Ph.D. Astra Zeneca Alexandra Quittner, Ph.D. University of Miami

  17. Mayo/FDA Meeting on PRO: Faculty Paper IV: PRO Validation Marlene Frost, Ph.D. Mayo Clinic Ron Hays, Ph.D. UCLA Astra Liepa, PharmD Eli Lilly & Company Bryce Reeve, Ph.D. National Cancer Institute Joseph Stauffer, Ph.D. Alpharma Paper V: Interpretation of Results Based on PRO’s Jeff Sloan, Ph.D. Mayo Clinic Amylou Dueck, Ph.D. Mayo Clinic Pennifer Erickson, Ph. D. Pennsylvania State Univ. Harry Guess, Ph.D. Univ. of North Carolina Dennis Revicki, Ph.D. MEDTAP International Nancy Santanello, M.D. Merck

  18. Mayo/FDA Meeting on PRO: Faculty FDA Response: Laurie Burke, Jane Scott, Donald Patrick et al Canadian Perspective (NCIC): David Osoba, M.D. et al European Perspective (EORTC): Neil Aaronson, Ph.D. et al European Perspective (ERICA): Catherine Acquadro, Ph.D. et al

  19. In Memorium Harry A. Guess, M.D.,Ph.D.

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