DIA’s Real-World Evidence Conference: Editor’s picks of the sessions to attend
DIA’s Real-World Conference is taking place October 16–17, 2023 in Baltimore, MD, USA with the theme ‘Translating Insights into Real-World Value’. Here, Laura Dormer, Editor of The Evidence Base, provides her top picks from the program to help you make the most of the event.
Session 1: A Year in Review (Monday October 16 2023, 8:45 AM–10:00 AM)
Simon Dagenais (Senior Director, RWE Center of Excellence, Pfizer Inc, USA) will chair this session exploring the key events related to real-world evidence (RWE) from the past year (2022-2023). The session will set the stage for various sessions that will be discussed in greater detail later on in the conference. Dagenais will be joined in this session by several speakers, including Shahid Hanif who will discuss the GetReal Institute and how the organization is developing a multistakeholder approach to advance the use of RWE for better healthcare decision-making.
Session 4: Healthcare Data Tokenization: Integration of Clinical Trials and Real-World Evidence (Current & Future Perspectives) (Monday October 16, 2:25–3:40 PM)
Tokenization is being increasingly utilized in RWE to link de-identified patient data across multiple datasets, offering a number of potential benefits for several stakeholder groups, including patients, healthcare providers, industry sponsors, and regulators. In this session, representatives from Amgen, Moderna, HealthVerity, Inc and Verily will discuss principles and applications of tokenization in healthcare, including its value, challenges, and benefits for these different groups.
Session 5: Case Studies from Recent Approvals of RWD/RWE Submissions (Monday October 16, 4:15–5:30 PM)
The FDA has made significant progress towards the use of RWE to support regulatory decision making. In this session, chaired by Yun Lu of the FDA, attendees will learn about the use of RWD and RWE to in regulatory submissions, with examples from recent use cases, as well as be able to understand the differing perspectives from industry and the FDA.
You may also be interested in:
- How the FDA are using RWE in our interview with Jie Li, Gerald Dal Pan and John Concato from the FDA
- Discover our Infographic charting the milestones in the FDA’s Real-World Evidence activities
Session 6: Objectivity and Transparency: Roundtable Discussions on Real-World Studies to Support Regulatory Decision-making (Tuesday October 17 8:00–9:15 AM)
The subject of RWE in regulatory decision making continues in Session 6 of DIA’s Real-World Evidence Conference, which is chaired by Sarah Martin (Senior Director – Global Regulatory Policy (Oncology), Eli Lilly & Co., USA). Martin is joined by Rohini Hernandez (Director, Center for Observational Research, Amgen, USA), who will discuss the ‘what and how’ of RWE to support regulatory decision-making and Brian Conroy (Principal Scientist II, Aetion, USA) who will explore trial emulation in helping to maintain objectivity in RWE studies.
Session 9: Special Populations’ Perspectives on RWD and RWE (Tuesday October 17 1:30–2:45 PM)
One of the key benefits of RWE is the ability to observe and monitor treatment outcomes among clinically and socio-demographically diverse patients in the real world. In this session, Rachele Hendricks-Sturrup (Research Director, Real-World Evidence, Duke-Robert J. Margolis Center for Health Policy, USA) and co-speakers will discuss how regulators are using RWD to inform clinical trials and post-marketing strategies, generate knowledge into social determinants of health, and monitor outcomes in rare disease patients and populations underrepresented in clinical trials.
Meet our Editor
Laura Dormer will be attending the DIA’s Real-World Evidence Conference in person. If you would like to meet with Laura in Baltimore to discuss working with The Evidence Base or submitting to our partner publication, the Journal of Comparative Effectiveness Research, please get in touch.