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YPrime Expert Community Event - Final agenda

April 4, 2019

Event venue: The Science History Institute

7:30 – 8:30       Breakfast & Registration

8:30 – 8:45       Opening Remarks – Mark Maietta, President, YPrime

8:45 – 9:15       YPrime Product Updates – Mike Hughes, Vice President, Operations and Development, YPrime

9:15 – 9:50       User Acceptance Testing: Best Practices – Dawn Sorenson, Associate Director Clinical Systems and Devices,  Theravance Biopharma and Aubrey Llanes, Associate Portfolio Director, YPrime

10:00 – 12:15 eCOA/IRT Sessions

eCOA Session

10:00 – 10:45 A Framework for BYOD Success – Willie Muehlhausen, Chief Innovation Officer, Muehlhausen  Ltd.    and Donna Mongiello, RN, BSN. Vice President, Strategic Solutions, YPrime

10:45 – 11:00 Break

11:00 – 11: 45 The Challenges of Capturing Patient Voices in Cancer Clinical Trials, Ari Gnanasakthy, Principal Scientist, Patient-Centered Outcomes Assessment, RTI Health Solutions and Colin Cleary, Vice President of Strategic Solutions, YPrime

11:45 – 12:15 Computerized Adaptive Tests in Clinical Studies – R.J. Wirth, PhD. CEO, Vector Psychometric Group

IRT Session

10:00 – 10:45  BREXIT Update –  Impact on Clinical Trial Supplies, Eric Valentine, MBA. Vice President,                          Clinical Supplies Services, Catalent Pharma Solutions 

10:45 – 11:00 Break

11:00 – 11:30 IRT Inspection readiness – Craig Mooney,  Director, Interactive Response Technology, Bristol-Myers Squibb

11:30 – 12:15  Clinical Supply Best Practices – How to Leverage a Highly Configurable IRT System to Lower              Packaging and Distribution Costs - Bryan Clayton, Vice President, Strategic Solutions and Korinne D'Orsi, Associate Director, Clinical Supply Consulting, YPrime

ALL

12:15 – 1:15 Lunch

1:15 – 1:45   Governance Best Practices + Lessons Learned, Dan Hilby, Principal Technical Services Manager,         PRA Health Sciences and Justin Jaeschke, Vice President, Technology Solutions, YPrime

1:45 – 2:30   Digital Patients: Best Practices for the Introduction of Wearables and Sensors into Clinical Studies, Marie McCarthy, Senior Director of Product Innovation; Information Technology, ICON Plc

eCOA/IRT Breakout Sessions

eCOA Breakout

2:45 – 3:30  eCOA Device Strategies, Mike Hughes

3:30 – 4:30   Panel Discussion: Effective eCOA Implementation – a Lifecycle Approach, moderated by Donna Mongiello                                                                                                                                                                                                                       

IRT Breakout

2:45 – 3:30 Panel Discussion: IRT Configurability vs. Customization, moderated by Bryan Clayton

3:30 -4:30 Group Discussion: The State of IRT, moderated by Sarosh Anjum, MPH. Senior Manager – ISS, Astellas Pharma

ALL

4:30 Closing Remarks