Meet the Real-World Data Provider |
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In this community forum, we focus on the role of the data provider in our increasing use of Real-World Data. The content will cover a range of topics related to data provision, including the challenges associated with delivering data to the end user and the various ways in which the data provider can assist. These may involve optimising transparency in data ingestion and curation processes, as well as facilitating feasibility assessments with minimal administrative obstacles. We will also consider these issues and solutions in the specific context of registries and the process for setting these up in a smart and actionable way. This forum took place on 18 April via zoom. |
Presenter | Bio |
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| Michèle Arnoe, IQVIADuring 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. |
| Jeffrey Brown, TriNetXJeffrey 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. |
| Benjamin Forred, Sanford ResearchBenjamin Forred has worked in the field of biomedical and clinical research for over 10 years. He has spent much of that time in the research laboratory and has a background in cellular and molecular biology. For the past several years, Benjamin has served as director of clinical research at Sanford research, overseen research project management group, genetic and genomic studies and Sanford rare disease registry, CoRDS. He also oversees the administration of the experimental therapeutics screening facility as the director of translational research at Sanford research. Forred holds, a B.S in biology A, MBA from the University of South Dakota, and the certificate in clinical trial conduct and management from the university of California at Berkely. |
