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Wednesday, June 30 • 4:00pm - 5:00pm
#352 SL: Breaking the Document Paradigm to Digitize Study Start Up: The Digital Data Flow Initiative

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-627-L04-P; CME 1.00; IACET 1.00; RN 1.00

TransCelerate’s Digital Data Flow Initiative is facilitating a pathway to clinical study startup automation. Project work has advanced from proposed conceptual design and prototypes to planning for an open source, reference implementation model.

Learning Objectives

Engage in a discussion on pharmaceutical industry transformation to a modernized, digital workflow focused on study start-up processes; Discuss what is needed to advance a vision for an open source reference implementation solution that all interested stakeholders, including technology vendors and pharmaceutical companies, can utilize.

Chair

William Illis, MPH

Speaker

Digital Data Flow: Technology and Standards
Robert Hayden, MS

Digital Data Flow: Ecosystem Readiness
Elinor Lobner-Olesen

Digital Data Flow: Long Term Governance
Todd Georgieff, MBA, RPh



Speakers
avatar for William Illis

William Illis

Global Head, Collaboration/Technology Strategy, Clinical Development & Analysis, Novartis Pharmaceuticals Corporation, United States
Bill is Global Head of Technology Strategy and Collaboration in Clinical Development and Analytics responsible for developing and implementing the analytics technology strategy and managing collaborations with internal and external partners. He has been responsible for leading large-scale... Read More →
avatar for Todd Georgieff

Todd Georgieff

Content Standards Lead, Hoffmann-La Roche Limited, Canada
Todd has worked in drug development and clinical operations for 30 years, in roles ranging from global study management to CRO oversight and process development and improvement. He is currently working in Roche's Content Reuse and Automation Office and until recently was Roche's Program... Read More →
avatar for Robert Hayden

Robert Hayden

Architecture Director, R&D Informatics, Amgen, United States
Robert (Bob) Hayden leads Enterprise Architecture for Research and Development Informatics at Amgen. Bob has contributed to multiple Transcelerate initiatives and leads the Technology team for the Digital Data Flow initiative. Prior to joining Amgen, Bob held various architecture... Read More →
avatar for Elinor Lobner-Olesen

Elinor Lobner-Olesen

Vice President of Change Management, Data Management and Standards, Novo Nordisk A/S, Denmark
Elinor is Vice President of Change Management in the Data Management and Standards area at Novo Nordisk, and is currently heading a large transformation project across the global DM unit. She has been head of data management and standards departments as well as Chair for the Standards... Read More →


Wednesday June 30, 2021 4:00pm - 5:00pm EDT
TBD Virtual Event Horsham, PA 19044
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