ISPE 2010 Mid-Year Meeting Agenda

April 12, 2010
Marriott Raleigh City Center, Raleigh, NC

Distributed Networks: Opportunities and Challenges

Planning Committee:
Co-chairs: Elizabeth Andrews, FISPE, RTI and Til Stürmer, FISPE, UNC
Members: Alice White, GSK; Scott Smith, AHRQ; Judy Racoosin, FDA; Nancy Santanello, Merck; Stephen Evans, LSHTM; Mick Murray, UNC
Mark Epstein, ISPE; Andrew Jerdonek, ISPE

Purpose: The one-day symposium will provide a forum for sharing information and viewpoints on the policy, practical, and methodological aspects of conducting active medical product safety surveillance and pharmacoepidemiology research using data from multiple electronic data sources using the distributed network model. While the symposium aims to capture the most current thinking from various US initiatives, including the Sentinel Network, the Observational Medical Outcomes Partnership (OMOP), and the DEcIDE network, the topics have been chosen to address issues that apply more broadly.

  • 7:30-8:30am Registration
  • 8:15-8:30am Welcome From the Program Chairs
    —Til Stürmer, FISPE, UNC
    —Elizabeth Andrews, FISPE, RTI Health Solutions
  • 8:45-9:45am Opening Session — Programs and Potential Policy Implications
    This session will feature four 15-minute presentations, with time for Q&A, and finish with a panel discussion.

    Moderated by: Til Stürmer, FISPE, UNC & Elizabeth Andrews, FISPE, RTI Health Solutions
    • FDA Sentinel
      —Judy Racoosin, FDA
    • OMOP
      —Thomas Scarnecchia, OMOP
    • EU ADR
      —Miriam Sturkenboom, FISPE, Erasmus University
    • Strategic Issues
      —Stephen Evans, London School of Hygiene and Topical Medicine
    • Open Panel Discussion

  • 9:45-10:15am Break
  • 10:15-10:45am Keynote Address: Mark McClellan, Brookings Institute
    A medical doctor and economist, Mark McClellan works on promoting high-quality, innovative and affordable health care. Once commissioner of the Food and Drug Administration and administrator of the Centers for Medicare & Medicaid Services, Dr. McClellan now directs the Engelberg Center for Health Care Reform, at the Brookings Institute.
  • 10:45am-12:00pm Strategic Issues
    This session will feature three 20-minute sessions and a 15-minute panel discussion, which will identify and discuss terminology, roles for signal detection, strengthening, and evaluation. The session will prominently feature the discussion of: what is in place for evaluating all of these events vs. health outcomes of interest? How should we work though potentially false positive signals? How are we interpreting and communicating results from data mining and non-experimental studies?

    Moderated by: Stephen Evans, London School of Hygiene and Topical Medicine
    • —Bob Chen, FISPE, CDC
      —Nancy Santanello, Merck
      —Judy Kramer, Duke University

    • Open Panel Discussion

  • 12:00-1:30pm Lunch
  • 1:30-3:00pm: Alternative Data Models and Maintaining the Integrity of the Source Data
    This session will feature four 15-minute presentations, with time for Q&A, and finish with a panel discussion.

    Moderator: Frank Destefano, CDC
    • Applying the OMOP common data model across administrative claims and electronic health records
      —Patrick Ryan, GSK
    • Federated model at Regenstrief
      —Shaun Grannis, Regenstrief Institute
    • D:A:D cohort in HIV
      —Susan Sacks, FISPE, Roche
    • Mini-Sentinel experience from Harvard Pilgrim
      —Jeff Brown, Harvard
    • Open Panel Discussion

  • 3:00-3:30pm Break
  • 3:30 – 5:00pm Methods for analyzing data across multiple data sources
    This session will feature four 15-minute presentations, with time for Q&A, and finish with a panel discussion.

    Moderator: Scott Smith, AHRQ
    • Aggregate-level meta-analysis vs. individual-level ‘pooling’: Are we drowning in jargon?
      —Jesse Berlin, Johnson & Johnson
    • Pooling of Reduced Files (e.g., HDPS)
      —Sebastian Schneeweiss, FISPE, Harvard Medical School
    • Use of standardized terminologies across an active surveillance network
      —Christian Reich, OMOP
    • OMOP Methods Library and Results of OMOP Cup
      —David Madigan, Columbia University
    • Open Panel Discussion

  • 5:00-5:15pm Last Word and Transition to 2010 Annual Meeting
    —Corinne de Vries, University of Bath