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Is My Data Fit For Purpose: View From a Data Vendor

The growing importance of real-world data for uses across the medical product lifecycle, from clinical trial design to disease epidemiology to outcomes research to regulatory decision-making, highlight the need to better understand how to know if a specific data source is appropriate for a specific question. Data vendors and others can help address the question by optimising transparency in data ingestion and curation activities and enabling feasibility assessments with minimal administrative friction. Researchers and data vendors should work together to match the question to the data to the methods to the intended use. Dr. Brown will summarise his experience working across multiple data sources and uses cases in support of research for FDA and medical product manufacturers. 

This forum will take place over zoom on 18 April 14:00–15:00 (BST) 09:00–10:00 (EDT) 


Presenter

Bio

Jeffrey Brown, TriNetX

Jeffrey Brown, PhD, Chief Scientific Officer at TriNetX and part-time lecturer part-time at Harvard Medical School (HMS), is an internationally recognised expert in using real-world data to support the evidentiary needs of regulatory agencies and medical product sponsors. He is also an expert in assessing data quality of real-world data resources. Dr Brown focuses on the value of collaborative research with an emphasis on federated networks. He has expertise in assessing the fitness-for-use of real-world data and matching questions to methods to data to generate robust evidence. He has nearly 20 years of experience facilitating large-scale, multi-institutional observational research through using distributed health data networks to support a learning health system and using electronic health data to support decision-making.

In his previous role as Associate Professor at Harvard Medical School, Dr Brown served as the Lead Data Scientist for the FDA Sentinel Operations Center and as a member of the Sentinel Operations Center Executive Committee. He has also been Principal Investigator of the analytic coordinating centre for the Innovation in Medical Evidence Development and Surveillance (IMEDS) programme and the Biologics and Biosimilars Collective Intelligence Consortium (BBCIC). While at Harvard he also served as PI of several industry-sponsored multi-site pharmacoepidemiologic studies to support FDA and EMA regulatory requirements. Dr Brown holds a master’s degree in economics from Tufts University and a PhD in Social Policy from Brandeis University.

Michèle Arnoe, IQVIA

During her career Michèle Arnoe has followed all the stages of the drug development life cycle, from preclinical research to clinical development and commercialisation. She initially worked for the French company Cegedim (technology and services in digital healthcare ecosystems) to launch their international expansion. In 1999, Michèle joined Parexel, where she became Vice President for Business Management and Strategy for the European Peri Approval division and was responsible for both the sales and project management teams. The organisation she built ensured a strong alignment between sales, project design, project management and client objectives.

 Michèle has also worked for Cerep, leader in preclinical pharmacology, and ADME-Tox, where she was Global Head of Business Development for six years. She then joined ScreenCell (a company designing medical devices in support of oncology diagnostics) in 2011 as VP Marketing & Business Development. She went back to Cegedim in 2013 as General Manager for France Cegedim Strategic Data and VP Medical Research, then joined the CRM (Customer Relationship Management) BU to manage the global account managers team focusing on large pharma.

 Following Cegedim’s acquisition by IMS Health, then the IMS-Quintiles merger, Michèle became Head of Innovation in France. She was then appointed Head of Global Real World Data Assets, with responsibilities focusing on RWD visibility across geographies and functions, including access, transformation and compliant usage, with the aim of leveraging secondary data when appropriate throughout the drug life cycle.

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