Industry Outlook for 2025—Real-World Data

The use of real-world data (RWD) and real-world evidence (RWE) has become a focus of pharmaceutical regulators in recent years. In December 2024, FDA’s Center for Drug Evaluation and Research announced a new Center for Real-World Evidence Innovation that will coordinate and promote the use of these data in regulatory decision making (1). The agency also published a number of guidance documents on data in 2023 and 2024 (2,3). The European Medicines Agency is also working to promote the use of RWD and RWE (4).

To gain more perspective on these data and other trends impacting the industry, BioPharm International® spoke with Sujay Jadhav, CEO of Verana Health. “We're seeing exponential changes in both of those particular components,” says Jadhav. “[F]rom an approach perspective, particularly in clinical research, we're seeing sort of external control arms becoming more mainstream. Part of [this is because] of [FDA] and their guidance of late, which [is about] helping facilitate the leveraging of real-world data and external control arms in the overall drug discovery process. But a key component is that this is an incredible source to help improve sort of efficiency and the quality of our research overall.”

“One of the other trends that we are also seeing is predictive analytics and AI [artificial intelligence], and how this can help predict disease progression and assist with early detection to support patient recruitment and retention … AI and these technologies, they can identify trends for data, [and lead to] informed decisions across the drug life cycle.”

Click the above video to watch the interview.

References

1. Haigney, S. FDA Creates CDER Center for Real-World Evidence Innovation. PharmTech.com. Dec. 13, 2024.
2. FDA. Guidance for Industry, Data Standards for Drug and Biological Product Submissions Containing Real-World Data (CDER, CBER, December 2023).
3. FDA. Guidance for Industry, Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products (CDER, CBER, July 2024).
4. Barton, C. Using RWD in Non-Interventional Studies. Pharmaceutical Technology Europe 2024, 36 (6).