Real World Evidence Webinar Series 2025

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)

Matt Baldwin is a Biomedical Data Stewardship Senior Manager at Amgen, where he leads data standards efforts for ADaM datasets. After 10 years as a biostatistician, he made the switch to data standards three years ago and couldn’t be happier. He has a passion for improving clinical data analysis processes with statisticians and programmers. His current interests include the implementation of estimands and many aspects around real-world data.

Matt started volunteering with DIA in 2015, but now exclusively participates in volunteer teams with CDISC and PHUSE. His PHUSE Working Group involvement mainly falls under Optimizing the Use of Data Standards and Real World Evidence.

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.

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.