Leveraging EHR Data within Drug Development
Agenda
| Day One – Monday, August 13, 2012 | |
| 8:00 AM | Registration and Continental Breakfast for Workshop Participants |
| 9:00 AM | Pre-Conference Workshop: Workshop Leader: Jack Cappitelli, M.D., President and Managing Partner, NEW JERSEY ASSOCIATES IN MEDICINE |
| 12:00 PM | Lunch for Workshop Attendees / Registration Opens for Main Conference |
| MAIN CONFERENCE BEGINS | |
| 1:00 PM | Chairperson’s Welcome and Opening Remarks Stan W. Kachnowski, Professor, IIT DELHI, New Delhi India, Chair, HEALTHCARE INNOVATION TECHNOLOGY LAB, NEW YORK, NY USA, Fellow, ROYAL SOCIETY OF MEDICINE, ENGLAND |
| 1:15 PM | The Challenges of Establishing EHR Criteria from Biomarker Data Terry Katz, VP, Biometrics (Global Statistics and Data Management), |
| 2:00 PM | Incorporating EHR Data as a New Tool for Adaptive Clinical Trial Design R. Stephen Porter, Pharm. D., CEO and Chairman, |
| 3:15 PM | CASE STUDY: Exchanging EHR Data from Clinical Trials to Hospitals Joris Van Dam, Translational Sciences Strategic Project Leader, |
| 3:30 PM | Networking and Refreshment Break |
| 4:00 PM | Managing Regulatory and Legal Risks while Using EHR Data for your Study John Showalter M.D. MSIS, Chief Medical Information Officer, |
| 4:45 PM | PANEL DISCUSSION: Using EHR Data for Site Selection Moderator: Panelist: |
| 5:30 PM | Conclusion of Day One |
| Day Two – Tuesday, August 14, 2012 | |
| 7:00 AM | Continental Breakfast |
| 7:30 AM | Chairperson’s Recap of Day One |
| 7:45 AM |
Enabling the Exchange of Patient-Care Data in the Research Environment: The Art of the Possible - An HL7 Perspective
Charles Jaffe, MD, Ph.D., CEO, HL7 |
| 8:15 AM | Repurposing eClinical Data for Research Mark Weiner, MD, FACP, FACMI, Director of Information Systems Integration for Research, Associate Professor of Medicine, Perelman School of Medicine, UNIVERSITY OF PENNSYLVANIA |
| 9:00 AM | Networking and Refreshment Break |
| 9:15 AM | Creating Strategies for EHR Adoption and Configuring to your System J. Wesley Tank-Day, Senior Clinical Analyst, |
| 10:00 AM | Current Trends & Vision of Innovation in Leveraging Social Media with Applications to Health IT Robert Boland, Directing Senior Manager, External Innovation R&D IT, |
| 10:30 AM | Networking and Refreshment Break |
| 11:00 AM | The Current and Future Use of EHRs in Patient Recruitment Jennifer Wulff, Director, Clinical Innovation, |
| 11:45 AM | Using EHR Data to Enhance Protocol Feasibility Part 1: Utilizing EHR to Support Clinical Protocol Design & Feasibility Assessment Part 2: Barriers in Leveraging EHR in Protocol Feasibility |
| 12:30 PM | Luncheon |
| 1:30 PM | Utilizing EHR for Patient Recruitment to Determine the Most Qualified Participants to Create the Best Patients for your Clinical Trial Stan W. Kachnowski, Professor, IIT DELHI, New Delhi India, Chair, HEALTHCARE INNOVATION TECHNOLOGY LAB, NEW YORK, NY USA, Fellow, ROYAL SOCIETY OF MEDICINE, ENGLAND |
| 2:15 PM | Utilizing Claims Data for efficient Post-Approval Drug Safety Surveillance Andres Gomez, PhD, MPH, GPV&E-Medical Safety Assessment, Executive Director – Head of Epidemiology, BRISTOL-MYERS SQUIBB |
| 3:00 PM | Chairperson’s Closing Remarks |
| 3:15 PM | Conference Concludes |
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Clinical Trials Inspection Readiness
Leveraging EHR within Drug Development
Featured Presentations
THE CHALLENGES OF ESTABLISHING EHR CRITERIA FROM BIOMARKER DATA
- Identifying biomarkers that are integral to the design of the trial
- Evaluate the type of data for biomarkers generated by chemical, molecular, and micro-imaging testing
- Discussing standards in CDISC and HL7 messaging as the precursor to establishing a comprehensive EHR
Terry Katz, VP, Biometrics (Global Statistics and Data Management), ImClone Systems Incorporated
CASE STUDY: EXCHANGING EHR DATA FROM CLINICAL TRIALS TO HOSPITALS
In case study session, you will hear examples of exchanging data from clinical trials to hospitals; which would be able to create hospital to enhance their capabilities of flagging health records.
You will hear:
- Strategies to encourage patients and physicians to consider possible participation in a clinical trial as part of their treatment
- Communication techniques to better information patients and physicians about existing opportunities that can act as part of their care
- Adhering to rules and regulations of state government
Joris Van Dam, Translational Sciences Strategic Project Leader, Novartis Institutes for Biomedical Research
THE CURRENT AND FUTURE USE OF EHRS IN PATIENT RECRUITMENT
- Analyzing the current uses of EHR data and how it is revolutionizing itself to adapt to future developments
- How the use of EHRs are creating advancements in patient recruitment techniques
- Discuss the current use of EHRs in patient recruitment and how to enhance your existing techniques
Jennifer Wulff, Director, Clinical Innovation, Pfizer Worldwide Research & Development