Content Comparison

This introductory webinar aims to orient attendees on the intersection of the estimands and target trial emulation (TTE) frameworks, along with a suggested causal roadmap overview. After two presentations from publication authors, there will be a panel discussion comprised of a regulatory agency representative and the two authors/presenters. Attendees should have a basic knowledge of estimands from the ICH E9(R1) Addendum.

• A causal roadmap for generating high-quality real-world evidence (22Sep2023)

• Real-World Evidence to Support Causal Inference: Methodological Considerations for Non-Interventional Studies (18Jun2024)

Speakers

Bios

Matt Baldwin, Amgen (Moderator)

Dr Rachele Hendricks-Sturrup, Duke-Margolis Institute for Health Policy

Dr Rachele Hendricks-Sturrup is the Research Director of Real-World Evidence (RWE) at the Duke-Margolis Institute for Health Policy in Washington, DC, strategically leading and managing the Institute’s RWE Collaborative and RWE policy research portfolio and education. As an engagement expert, biomedical researcher, bioethicist and policy practitioner with over 18 years of experience, her work centres on addressing implementation, regulatory, and ethical, legal and social implications (ELSI) at the intersection of health policy and innovation. She partners with Duke University faculty, scholars, students and external practising experts to advance the Institute’s biomedical innovation work. She received a Duke-Margolis Mentor Award in 2023. To date, she has published commentaries and articles in high-quality, peer-reviewed journals and has presented at and served on programme committees for conferences.

Dr Hendricks-Sturrup has served as adjunct faculty at rural Ohio University, teaching graduate courses in the Department of Interdisciplinary Health Studies’s Health Policy Certificate programme, and has taught graduate courses within the Master of Health Care Innovation programme at the University of Pennsylvania’s Perelman School of Medicine. She also served as executive leadership for the National Alliance against Disparities in Patient Health (NADPH) between 2020 and 2024. She presently serves on the Board of Directors for Public Responsibility in Medicine and Research (PRIM&R) and on the Professional Society for Health Economics and Outcomes Research (ISPOR) Steering Committee. She served on the 2023 and 2024 Program Committee for the Drug Information Association’s annual RWE Conference, and is a 2024 AcademyHealth Trust Scholar. 

Prior to joining Duke-Margolis, Dr Hendricks-Sturrup was Health Policy Counsel and Lead at the Future of Privacy Forum (FPF), leading the organisation’s health and genetic data initiatives and working group. Prior to FPF, she served in administrative and scientific roles at industry, healthcare and academic institutions. She is an accomplished health science journalist, having completed a comparative effectiveness research fellowship with the Association of Health Care Journalists in 2017.

Dr Hendricks-Sturrup received her bachelor of science in biology from Chicago State University, her master’s in pharmacology and toxicology from Michigan State University, her master’s in legal studies from the University of Illinois, and her doctor of health science from Nova Southeastern University. She completed a predoctoral internship with the National Health Service in London, UK, and postdoctoral research training with the Department of Population Medicine at the Harvard Pilgrim Health Care Institute and Harvard Medical School.

Dr Lauren Eyler Dang, NIAID Biostatistics Research Branch

Dr Lauren Eyler Dang joined the NIAID Biostatistics Research Branch as a mathematical statistician in 2023. She obtained an MD from University of California, San Francisco, and an MPH and PhD in Biostatistics from University of California, Berkeley. Her research at NIAID focuses on applied and methodological causal inference problems and global infectious disease research.

Dr Juanjo Abellán, European Medicines Agency

Dr Juanjo Abellán is a mathematician and statistician. He has worked as a statistician in public offices, academia, and the pharmaceutical industry and has wide experience in epidemiology and clinical drug development. He works for the European Medicines Agency (EMA) in the Netherlands as part of the Data Analytics and Methods Task Force. His main interests focus on methodology for the generation of sound evidence in clinical trials and non-interventional studies to support regulatory decision-making around the efficacy, effectiveness and safety of medicines. He has been working on estimands for more than 10 years. He has coordinated the development of the EMA reflection paper on Use of RWD in Non-Interventional Studies To Generate RWE for Regulatory Purposes and has contributed to the development from the EMA side of the Data Analysis and Real World Interrogation Network (DARWIN EU), a platform for the generation of real-world evidence for regulatory purposes.