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For European pharmaceutical and medical device organizations developing treatments for international markets, real-world data can inform many decisions throughout the product life cycle. However, developing a compelling real-world evidence (RWE) strategy can be challenging. From identifying data assets, to conducting complex studies and navigating regulatory landscapes, life sciences organizations face many considerations when generating RWE to address go-to-market goals in the United States.

Join us for a presentation on how European pharmaceutical and medical device organizations can leverage RWE to strengthen their research and commercialization agendas in the United States. Experts will present common use cases across the product life cycle, review case studies using a variety of methodologies, and share insights and predictions on the use of RWE.

  • How to maximize your product’s reach in the United States by leveraging RWE throughout the product life cycle
  • Key stakeholders and decision-makers involved with evidence generation and communication
  • Trends in the use of real-world data and evidence and how your organization can stay ahead of the competition


Speakers:

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Liisa Palmer, PhD

Outcomes Research Portfolio Leader

IBM Watson Health


Liisa Palmer, PhD has more than 20 years of experience using real world data to generate insights and evidence in the area of health economics and outcomes research, epidemiology and value communication for Life Sciences companies, non-profit organizations and government agencies. During this tenure she has created and managed large analytic databases for survey implementation and analyses on both prospective and retrospective research initiatives. Dr. Palmer’s activities have spanned various therapeutic areas including mental health, autoimmune, diabetes, infectious diseases, respiratory diseases, osteoarthritis, and cancer, and has been published in several leading journals. In addition to being an expert in retrospective data, she has managed several multiyear, multi-site prospective studies that involved the collection, database construction, and analysis of patient, physician, and organization-level data. Liisa holds a PhD in health policy and administration from The Pennsylvania State University.

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Robert Reynolds

Vice President, Epidemiology and Patient-Centered Outcomes

GlaxoSmithKline (GSK)


Dr. Reynolds is Vice President, Epidemiology and Patient-Centered Outcomes in Value Evidence and Outcomes, part of Research and Development at GSK. His group is responsible for leading the epidemiologic and patient-reported components of integrated evidence plans. He is also an Adjunct Associate Professor of Epidemiology at the Tulane School of Public Health and Tropical Medicine. Prior to joining GSK, he worked at Pfizer for twenty years, most recently leading Epidemiology in the R&D organization. He is a Fellow and former Board member of the International Society for Pharmacoepidemiology. He holds an AB in Biology from Bard College and a MSc in Epidemiology and ScD in Population and International Health from the Harvard T.H. Chan School of Public Health.

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Amy P. Abernethy, MD PhD

Former Principal Deputy Commissioner and Acting Chief Information Officer

US Food & Drug Administration (FDA)


Amy P. Abernethy, MD PhD is an internationally-known oncologist, health data expert and digital health leader. Her >500 publications span real-world data & evidence, clinical trials, patient reported outcomes, clinical informatics, health policy and patient-centered care. Most recently, Dr. Abernethy was Principal Deputy Commissioner and Acting Chief Information Officer of the US Food & Drug Administration, serving from February 2019 to April 2021. Dr. Abernethy initiated multiple critical efforts during her tenure including FDA’s technology and data modernization action plans and FDA’s efforts to leverage real-world data & evidence to address critical questions during the COVID-19 pandemic.

Dr. Abernethy was Chief Medical Officer and Chief Scientific Officer at Flatiron Health from July 2014 to January 2019. Before joining Flatiron, Dr. Abernethy was Professor of Medicine at Duke University School of Medicine, and directed the Center for Learning Health Care in the Duke Clinical Research Institute and Duke Cancer Care Research Program in the Duke Cancer Institute. She has served as an appointee to multiple National Academy of Medicine committees, as Chair of the Health Data Research UK International Advisory Board, on the Board of the Personalized Medicine Coalition, and President of the American Academy of Hospice & Palliative Medicine.

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Dilhan Weeraratne, PhD

Senior Biomedical and Genomics Scientist

IBM Watson Health


Dr. Dilhan Weeraratne serves as a precision medicine, genomics and life sciences expert within the Center for AI, Research, and Evaluation (CARE), at IBM Watson Health. Dilhan is invested in leveraging the explosion of genomics and other real-world data to transform disease treatment and improve patient outcomes. He has over 15 years of post-PhD experience in clinical genomics and life sciences both in academia and in biopharma. He currently leads the life sciences and RWE research portfolio at Watson Health. Dilhan did his postdoctoral fellowship at Harvard Medical School and Broad Institute, MIT in medulloblastoma genomics where his work was pivotal in the development of the WHO accepted molecular subgrouping of this pediatric tumor type. He then transitioned to Thermo Fisher where he was in the core team that developed a comprehensive next generation sequencing gene panel which is currently in use for the NCI MATCH basket clinical trial. Dilhan graduated with a PhD in Neuroscience/ Molecular Biology from University of Vermont.

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Ellen Thiel, MPH

Researcher

IBM Watson Health


Ellen Thiel, MPH, has more than 5 years of health economics and outcomes research experience supporting life sciences clients. She specializes in the design and management of administrative claims and EMR database studies. Ellen gained experience in the technical details of the EMR and claims databases as a research analyst and has conducted HEOR studies in numerous disease areas focusing on healthcare resource utilization, treatment patterns, mortality and clinical outcomes. She was awarded the best general poster presentation at ISPOR 2018, and finalist recognition at 2019 ISPOR meetings. Ellen received her MPH in epidemiology from the University of Michigan School of Public Health.

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Adrian Cassidy

VP and Global Head of RWE and Data Science

Novartis


Adrian Cassidy is an epidemiologist by training with international experience and expertise in leading data/analytics/informatics programs across the public and private sector. Adrian has an exceptional track record developing high value data/digital transformation strategies at GSK Vaccines, Hoffmann La-Roche, and Novartis to accelerate innovative real world approaches for product development, payer and medical evidence generation. Adrian currently serves as Vice President and Global Head of RWE and Data Science to advance Real World Data/Science/Evidence applications and solutions across the product lifecycle to help reimagine medicine and improve the lives of patients.


Moderated by

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M. Nielsen Hobbs

Executive Editor

Informa Pharma Intelligence

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