DIA DIRECT: How to Build a Data-Sharing Strategy for Pharma Innovation

Presenters

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  Niamh Catherine McGuinness

  • Clinical Trial Transparency Anonymization Expert
  • Privacy Analytics, Canada

  Niamh McGuinness is a technical lead with Privacy Analytics’ Clinical Trial Transparency (CTT) business unit, having joined the company in 2016. Her team specializes in statistical anonymization of clinical trial assets - both structured individual patient data and clinical trial documents. Drawing on her academic research background, Niamh has helped develop Privacy Analytics’ CTT methodology and proprietary toolsets, contributing to the ultimate goal of protecting patient privacy while also preserving the utility in clinical data.

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  Laura Dodd, MSc

  • Senior Manager, Global Clinical Data Sharing
  • ICON Plc, United States

  Laura has worked in Voluntary Data Sharing since 2015. She has experience sharing data with Clinical Study Data Request, Vivli, and C-PATH. Voluntary Data Sharing requires her to interact with many functional areas to obtain approval to share and fully protect both the intellectual property rights and personal patient data found in the documents. Laura heads the DIA subgroup on EMA’s Policy 0043/FOIAs, and is the subject matter expert at PRA for Public Release of Clinical Information and Policy 0070 redactions. Prior positions include writing CSRs and submission summary documents for 20 years and coordinating research studies for industry, NIH, and NCI.

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  Jingyi Liu, PhD

  • Senior Director, Statistics, Data & Analytics
  • Eli Lilly and Company, United States

  Jingyi is the one of the main drivers behind the data sharing and transparency initiatives at Lilly. He led the effort of data sharing through TransCelerate and worked closely with Vivli and ProjectDataSphere. In addition, he championed several projects to utilize the historical clinical trial data from TransCelerate to improve the efficiency of drug development. Jingyi has over 10 years of experience in the pharmaceutical industry across all stages of global clinical development of medical products, with extensive regulatory and submission related experience in different disease areas including oncology and autoimmune disease.