Articles

The Value of Early Real-World Data in Clinical and Commercial Strategy

PurpleLab
September 23, 2025
Life Sciences, RWD

Although randomized controlled trials remain a cornerstone of evidence generation, pharmaceutical and biotech companies are increasingly recognizing the necessity of leveraging real-world data (RWD) and real-world evidence (RWE) earlier in the product lifecycle to inform decision-making.

PurpleLab sponsored a recent BioPharma Dive webinar titled, “The Value of Early Real-World Data in Clinical and Commercial Strategy,” that brought together a panel of experts to explore the role of RWD and RWE as a strategic asset that can shape pipeline priorities, clinical design and commercialization plans.

The discussion featured insights from Mathew Weinreb, Vice President of Life Science Sales at PurpleLab and GSK leaders: Chris Bell, Senior Director, US Specialty, Value Evidence and Outcomes; Jamie Drenocky, Director, US Specialty, New Product Strategy; and Sheila Natarajan, Director, Real World Analytics. The conversation highlighted key principles for leveraging RWD to shape pipeline priorities, clinical design, and commercialization plans.

Transforming Raw Data into Actionable Insights

The conversation kicked off with an important distinction between RWD and RWE. Chris explained that RWD is the raw material, RWE is the insight. RWD gathered from claims, electronic health records and registry data offer rich but messy inputs. It’s only through thoughtful analysis and interpretation that those inputs become RWE that supports strategic choices.

Early-stage teams don’t need exhaustive studies; they need the right level of evidence to move confidently in uncertain terrain. Sometimes this means asking straightforward, directional questions rather than launching complex analyses. The key is fit-for-purpose evidence that matches both the stage of development and the probability of success.

The panelists stressed that integrating RWD earlier in the pipeline enables pharma companies to refine product planning strategies, challenge assumptions and inform more strategic decision-making. Jamie added that this early utilization can also lead to smarter commercialization and position assets for maximum value at launch.

Tapping into Curiosity

The need for curiosity was a recurring theme of the webinar. Curiosity has the power to drive better insights. For example, claims data might show a 53/47 gender split between men and women that, at first glance, seems unremarkable but adding additional filters can change the distribution and raise crucial questions.

Is disease biology at play?
Do comorbidities influence diagnosis patterns?
Are primary care physicians or specialists recognizing symptoms differently?

Jamie acknowledged, “No one is going to get it 100 percent right…so what we’re really trying to do is understand the current space, what needs to potentially evolve [and] what it needs to look like in the future to be…able to deliver value to the patient group.”

Breaking Down Silos

The panelists acknowledged the challenges of operating in silos and admitted that silos often prevent organizations from realizing the full value of RWD. In addition to stressing the importance of shared definitions and collaborative interpretation, Chris highlighted four essential components for maximizing its impact.

Agreeing on the question that is being answered
Sharing insights across the board
Aligning on the interpretation of data
Accepting that there are not always defined protocols or statistical methodologies to get to an answer

“Sometimes we have to be a little looser with our definitions to get the most out of what we’re seeing,” he added.

Cross-functional dialogue ensures the right questions are asked and blind spots are caught before planning is derailed. The solution is not to eliminate differences but to recognize them, align where possible, leverage complementary expertise and use data to drive accomplishments, according to Sheila.

Balancing Breadth, Depth and Timing

The panelists also discussed the strategic need to balance the breadth and depth of data based on the stage of development. Early in the pipeline, a wide breadth of data can be more valuable than deep, complex studies. As development progresses, however, longitudinal data and rigorous RWE studies become more important.

“Understanding the tradeoff between breadth versus depth and what decisions need to be made and when is pretty critical in order to make sure that I’m providing the right support to our teams,” Sheila says.

The panelists also highlighted the need to recognize that data sufficiency is situational and that over-investing too early can waste precious resources.

“Resource constraint is a real thing for all of us,” Jamie says. “I would like to have unlimited patient-level data for every therapeutic area across all of these specialty assets that [are] approaching a phase II commitment…but I recognize that it’s not a good use of resources.”

Selecting the right partner for data and analytics is essential. When it comes to choosing a vendor, the panelists recommended four key criteria:

Population fit: Ensure datasets represent the target patient populations. “Having…one database that has representation across the board is not always the easiest thing to find,” Chris says. “Making sure that you got the right database that you want to work in and that you get really truly actionable insights.”
Agility: Partner with vendors who can pivot quickly to answer new questions, providing a crucial “decision advantage”
Expertise: Seek partners with embedded clinical subject matter experts who accelerate data interpretation and ease the burden on internal teams.
Additional capabilities: Look for vendors who offer expertise beyond a simple data platform, as this becomes a critical need when internal resources are limited. At GSK, Sheila wants, “the ability to work with data vendors who…have expertise beyond just providing data in a platform where we can access. It is not only a nice to have but a critical need to have especially when you’re resource constrained.”

Conclusion:

Throughout the webinar, the panelists underscored that RWD is a strategic asset that must be accessed earlier in the pipeline to shape clinical development, market access and commercialization strategies.

For organizations to be successful, there must be a willingness to ask simple, curious questions, break down functional silos, balance the breadth and depth of data based on timing and treat vendors as expert partners, not just data providers.

“There are always blind spots, not just in the data but also the kind of analysis that we do,” Sheila says. “It’s important to be cognizant of the value that claims data brings to this particular function which is asset strategy.”

Ready to unlock the full potential of real-world data for your clinical and commercial strategies? Partner with PurpleLab to access actionable insights, expert support, and tailored solutions that drive success. Contact us today or schedule a demo to see how we can help transform your data into strategic advantage!