Andy Moye, PhD: In today’s challenging economic climate, how are biotech leaders navigating the funding landscape, and what is the general sentiment?

Nick Glover, PhD: I agree, we are all feeling more optimistic, but the key question is which companies are attracting capital and why. There has been a real shift toward well-established targets, leaving those of us on the leading edge with novel mechanisms in a difficult position. It has become a “show-me situation.” You have to put compelling data on the table that gives investors a reason to believe. For a novel target, you have to convince people with evidence that you have achieved something and show them where you are taking it.

Brad Hirsch, MD: The improving sentiment is the first sign, but it will take time for the reality to catch up in the market. New investors are the last to arrive. I have to be cautiously optimistic, like everyone else, that this is the natural order of things. The concern about regulatory uncertainty is very real, but so far, there are ways to navigate it. We have to bring the regulators along on the journey so they can understand new approaches and gain confidence in them.

Andy Moye, PhD: How does RWD specifically help companies de-risk development and build the confidence that investors and partners are looking for?

Matthew Price: RWD is also essential for navigating major regulatory changes, like the FDA’s Project Optimus, requiring dose optimization and the increasing demand for overall survival (OS) data. For a smaller company that cannot afford a large, randomized controlled Phase 2 trial, the question is how to benchmark the expected OS in your target patient population. The published literature is often outdated. RWD provides a solution by allowing us to find real-world patients to benchmark outcomes and build a credible, de-risked story for our registrational trial design.

Andy Moye, PhD: Can you share specific examples of how you have used Tempus’ RWD to make critical decisions?

Nick Glover, PhD: Our use case was different. We are drugging MYC, which is a complex transcriptional regulator. It is not a single target; it is a systems biology question. We utilized Tempus’ multi-omics data to enhance our understanding of MYC transcriptional biology and hierarchically rank indications. The analysis was illuminating. It showed us sensitive cohorts in almost every cancer and allowed us to strategically prioritize where to go first, building a sophisticated development plan that is grounded in real-world biology from the start.

Andy Moye, PhD: From an investor and regulatory perspective, what is the key to successfully using RWD and ensuring it is high quality?

Andy Moye, PhD: Finally, what advice would you give to other biotech leaders who are considering an investment in RWD and AI-enabled tools?

Matthew Price: While AI is hot, the hard reality of clinical development is inescapable. We use these tools to get more out of the development process itself. The watchword of the last few years has been focus. These AI-enabled data curation tools allow you to focus in a productive way. We have been impressed with the speed at which you can generate insights, which can lead to faster timelines, more efficient use of capital, and potentially better outcomes.

Brad Hirsch, MD: My advice is to ask if the AI or tech component fundamentally changes the business. Does it give you a proprietary data advantage? Does it change the economics of development by shortening timelines or improving patient selection? If it does, it is a true differentiator. If not, it may still be a fantastic company with a compelling mechanism, but we try to separate the hype from the real, tangible impact on business.