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
ALL4:30 Closing Remarks