WASHINGTON — September 13, 2024 — DIA, a global non-profit organization of life sciences professionals, will facilitate in-depth discussions on recent advancements in real-world evidence (RWE) and highlight use cases from early development to post-market settings during the DIA Real-World Evidence Conference, to be held Oct. 24-25 in Philadelphia.

The conference will unite industry representatives, government officials, regulators, academics, and patients to explore new methodologies and technological innovations in RWE and real-world data (RWD). Discussions will cover international regulatory perspectives and updates, improvements to health equity and diversity, and the challenges of using novel data sources for RWE generation.

"Real-world evidence is no longer just a tool being deployed in post-market safety monitoring," said Tamei Elliott, Associate Director, Scientific Programs at DIA. "It's now influencing outcomes at every stage of product development. This conference will provide participants with increased knowledge of how RWD and RWE are being utilized to enhance our understanding of diseases, refine treatment approaches, and substantiate coverage decisions."

Attendees will gain insights into new methodologies and technological innovations that demonstrate RWE's impact on global healthcare, including AI-enabled data abstraction and linkage, causal methods such as propensity scores and machine learning (ML)-based approaches, and negative-control outcome studies designed to assess the comparability of potential treatment groups. They'll also receive updates from the Food and Drug Administration (FDA) on its guidance on drugs and biologics, its Sentinel demonstration projects, and its commitments under the seventh reauthorization of the Prescription Drug User Fee Act (PDUFA VII).

Use cases will demonstrate the effective application of RWD and RWE, such as external controls in early-phase single-arm metastatic pancreatic cancer studies, endpoint optimization for clinical trials in myotonic dystrophy type 1 (DM1), registry-based randomized controlled trials to improve drug development efficiency, and post-approval studies on the safety of medications during pregnancy.

Speakers will include representatives from Aetion, Amgen, AstraZeneca, the Duke-Margolis Institute for Health Policy, Eli Lilly, Friends of Cancer Research, Medidata, Sanofi, and Target RWE who are actively involved in the implementation of RWD/RWE.

Advance registration rates are available until Sept. 27, with discounted rates for students and patient advocates. To register or view the event program, click here. Media members can request credentials by emailing diaglobal@gregoryfca.com.

Media Contact

Denise DiMeglio
Gregory FCA
denise@gregoryfca.com
+1.610.228.2102