2024 DIA Real-World Evidence Conference: Editor’s picks of the sessions to attend
As the DIA’s 2024 Real-World Conference, taking place October 24–25, 2024, in Philadelphia, PA, USA, approaches, we present our selection of key sessions you won’t want to miss.
Session 1: A Year in Review (Thursday October 24, 8:45 AM–9:45 AM)
This regular part of the program sees Sarah K Martin (Senior Director – Global Regulatory Policy [Oncology], Eli Lilly & Co, USA) recap the major advances in real-world evidence (RWE) over the past year. Martin will be joined by speakers from the FDA, who will update the audience on the developments in the draft and final guidance on RWE released by the agency as well as progress with the SENTINEL initiative and the FDA’s real-world data (RWD) and RWE-focused demonstration projects.
Session 4: Real-World Data Standards for Regulatory Submissions: Exploring the Challenges, Solutions, and Potential Alternatives (Thursday October 24, 2:10 PM–3:25 PM)
Diane Gubernot (Epidemiologist, US FDA, USA) will be joined by an expert panel as they discuss new developments in RWD standards for regulatory submissions. Speakers from each stakeholder group, including James Browning (Amgen, USA) providing the sponsor perspective, and Dan Riskin (Verantos, USA) offering the data provider viewpoint, will describe the challenges faced when developing and utilizing standards for RWD and how these can be overcome.
Session 5: Health Equity in Drug Development: Leveraging RWD to Inform and Improve Diversity (Thursday October 24, 4:00 PM–5:15 PM)
RWD can address the lack of diversity in clinical trials by capturing key factors that define representativeness and inclusion. In this session, led by Brittany Avin McKelvey (Director, Regulatory Affairs at Friends of Cancer Research, USA), attendees will learn how to leverage RWD to generate unbiased insights for drug development, and see examples of how RWD can build diverse study populations across different research strategies, with a focus on social determinants of health and health equity.
Session 6: Sand in Your Shoes? The Nitty-Gritty in Generating Regulatory-Grade RWE Using Emerging Data Sources and New Platforms: Global Perspectives (Friday October 25,8:00 AM–9:15AM)
Rachele Hendricks-Sturrup, Research Director, Real-World Evidence at the Duke-Robert J Margolis, MD, Center for Health Policy, will chair this session addressing the growing availability of RWD and the challenges of applying guidance to assess its suitability for generating RWE. Panelists, drawn from sponsors and data providers/aggregators, will share their experiences in evaluating new data sources for specific research objectives, emphasizing the importance of practical approaches, collaboration, and aligning stakeholder expectations to ensure timely, credible, and valid outcomes.
Session 9: Is the Future Here, Near, or Neither? Exploring the Intersection of AI and RWD in Pharmacoepidemiology (Friday October 25, 1:30 PM–3:00 PM)
This session will explore the benefits and challenges of using natural language processing (NLP) to extract data from clinical notes to generate RWD, the role of generative AI in optimizing clinical study designs, and the potential of machine learning (ML) to optimize patient selection for clinical trials through personalized medicine. Attendees will also consider the policy implications of generative AI in the context of RWD. The session will be moderated by Keri Monda (Amgen, USA) and include presentations by Jenna Wong (Harvard Medical School and Harvard Pilgrim Health Care Institute, USA), Susant Mallick (Cloudhub BV, The Netherlands), Flavio Dormont (Sanofi, USA) and Emilie Scherrer (Tempus AI, USA).
Meet us at DIA’s 2024 Real-World Evidence Conference
Our Editors, Jo Walker and Laura Dormer, will be attending the DIA’s 2024 Real-World Evidence Conference in Philadelphia, providing full coverage of the event. If you’re attending and would like to connect, reach out to Jo to discuss The Evidence Base, or to Laura about contributing to the .
