Getting real with investors: How Real-World Evidence Can Accelerate Investment For Biotech Companies Fundraising

Fundraising in biotech, particularly when the runway is dwindling and operational pressures are, shall we say, acute, is an utterly bruising affair. Biotech leaders must juggle justifying their strategy, dissecting nuanced datasets, and selling a grand vision all while convincing investors their lead programme or platform stands out in a market that’s complex, crowded, and frankly, unforgiving. What further compounds this gauntlet is the ticking clock. With runway shortening by the day, every pitch becomes a high-stakes gamble, where sceptics (many who have never been on the wrong side of protocol in their lives) demand not just promise but proof.

Enter real-world evidence (RWE), a tool that if used appropriately can transform a pitch into a data driven narrative that clearly differentiates a program or company clinically, commercially and strategically. By weaving in data from patient registries, electronic health records, or claims data, RWE doesn’t just supplement your clinical data, it paints a vivid picture of real-world impact that makes investors sit up and listen.

“RWE often starts and ends in the market forecast sections of traditional pitches”

While highlighting the potential market size of a given therapeutic area is a critical element to any fundraising narrative, highlighting a multibillion-dollar market opportunity isn’t going to be the determining factor on whether a fundraise is successful.

Yet, for most biotechs, this is where real-world evidence begins and ends a fleeting nod in the market sizing section comprising of generic incidence and prevalence stats, barely scratching the surface of what’s possible and leaving significant value on the table. 

This is emblematic of a wider problem in biotech pitches, leaders are often focused on their innovative therapeutic or platform and negate how they can differentiate their company by also innovating the way drugs are developed. What follows are three concrete ways that RWE can be used to differentiate a biotech fundraise. 

“From Market Forecast to Recruitment Optimisation” 

Most biotechs treat recruitment like a necessary evil: Throw cash at a CRO cross fingers, and hope patients trickle in before the runway runs dry. This is despite recruitment delays being a biotech’s (and pharma’s) Achilles heel, often inflating costs or derailing programs entirely. Investors are painfully aware of this; many have seen promising programmes stall or collapse because patients couldn’t be found fast enough.

The frustrating part of this reality is that the work already undertaken to produce the incidence and prevalence forecasts in most market sizing sections of biotech pitches provides a clear path to completely mitigating any recruitment challenge and unchaining biotechs from the outdated analogue approach to trial recruitment perpetuated by CROs. Instead of just stating "X million patients exist," you can use RWE to pinpoint where these patients are being seen. Which clinics? Which healthcare systems? You can analyse patient journeys to understand referral patterns and identify sites with genuinely accessible patient pools that match your protocol. This isn't about vague heatmaps; it’s about actionable intelligence. Presenting a data-backed recruitment strategy, showing investors, you've identified high-performing sites or patient clusters before site initiation, demonstrates operational foresight. It tells them you’re actively managing a major risk, not just outsourcing and hoping for the best. This transforms recruitment from a budget line item into a strategic advantage.

“Define, Differentiate, De-risk”

Investors are increasingly scrutinising not just if a drug is likely to work, but how it will fit into complex treatment paradigms and deliver value. RWE can shape this narrative long before a product has entered late phase development.

For example, understanding the real-world burden of illness in the specific patient subgroup of interest coupled with the actual costs, the quality-of-life impact and the limitations of current standard of care; allows precise positioning of a potential therapeutic beyond generic unmet need claims that litter most biotech presentations. 

Critically, RWE can de-risk programmes earlier by facilitating the use of external control arms (ECA/SCAs). For early phase trials, say a Phase 1b signal-finding study, constructing an ECA from robust RWE sources allows you to contextualise your single-arm trial data against a relevant comparator group. This provides an earlier read on potential efficacy or differentiation, offering crucial insights that can guide development decisions and, importantly, build investor confidence long before results from larger trials are available. While the regulatory pathway for ECAs in pivotal studies is still evolving, their power in early de-risking and demonstrating initial promise is undeniable for shaping an investment thesis.

Additionally, RWE can inform the design of your development programme to capture data that resonates beyond just regulatory approval. What are the outcomes that truly matter to patients and physicians in the real world? Perhaps it's a reduction in hospitalisations, less need for concomitant medications, or an improved ability to perform daily activities. RWE can help identify these relevant endpoints. You can also use RWE to characterise the performance of current treatments in comparable real-world populations, providing a benchmark that, even if not a direct comparator in a trial, gives investors context for your drug’s potential real-world advantage. This shows you're thinking about the entire evidence package required for access and adoption, not just an approval a few years down the line.

“Laying the Groundwork for Payer Acceptance, Early”

The spectre of market access and reimbursement hangs over every biotech investment. A drug can be a scientific marvel, but if payers won't cover it, it’s a commercial failure. Investors know this. Many biotech pitches defer the health economics argument, but RWE allows you to address it proactively, even at early stages. By analysing claims data or electronic health records, you can start to quantify the current economic burden of the disease your drug targets. What are the direct and indirect costs associated with existing treatments? Where are the inefficiencies? This data helps you build a foundational value story. You can show investors that you understand the payer landscape and are already thinking about how your drug will provide not just clinical benefit, but also economic value. Will it reduce hospital stays? Decrease the need for expensive supportive care? RWE can help identify these potential cost offsets. Signalling this early awareness and data-backed approach to value demonstration gives investors confidence that you’re not just developing a molecule, but a product with a viable path to market.

Ultimately, in the brutal biotech fundraising arena, demonstrating early points of differentiation beyond therapeutic modality is critical. Highlighting a data-rich narrative; one fuelled by real-world evidence to emphasise your strategic clinical and commercial development edge isn't just an advantage; it's fundamental to building investor confidence and significantly accelerating your fundraising timelines.