SOARING HEALTH

SOARING HEALTH We help drug companies demonstrate real-world evidence through outcomes research.

There's a quiet revolution happening in how we validate therapies, and most pharma teams aren't paying enough attention ...
05/29/2026

There's a quiet revolution happening in how we validate therapies, and most pharma teams aren't paying enough attention to it. The Therapeutics Initiative at UBC has been doing something remarkable for years. They're generating independent, evidence-based guidance on healthcare interventions without the noise of commercial incentives. No marketing spin. Just rigorous pharmacoepidemiology work that informs clinical practice.

Here's what struck me: while we spend millions on RWE studies and health economic models to demonstrate value to payers, there's this parallel stream of clinical evidence being generated by academic institutions that shapes how physicians actually prescribe. And frankly, it's not always aligned with how we're positioning our therapies.

If you're in market access or medical affairs, this matters. The evidence that moves prescribers isn't always the evidence that moves formulary committees. One is rooted in clinical effectiveness and safety signals from real populations. The other is rooted in economic value and budget impact.

Neither is wrong. But they're not the same thing.

The question I'm sitting with: how do we better integrate independent clinical evidence streams into our value communication strategy? Because ignoring what organizations like TI are publishing means we're potentially missing critical insights about how our therapies actually perform outside controlled settings.

PharmacoEpidemiology Group (PEG) conducts research in the areas prescription drug utilization, epidemiological research methods, evaluation of drug policy and educational interventions, and drug safety and effectiveness. Selected journal articles and reports co-authored by PEG members are listed bel...

The regulatory landscape for real-world evidence is evolving rapidly. A major milestone occurred with the finalization o...
05/28/2026

The regulatory landscape for real-world evidence is evolving rapidly. A major milestone occurred with the finalization of ICH E6(R3) in January 2025, which formally acknowledges pragmatic trials, registry-based studies, and RWD in clinical research. This represents a fundamental shift in how regulators view evidence generation.

For pharmaceutical and biotech organizations, the implications are significant. Payers increasingly demand RWE to justify reimbursement and negotiate outcomes-based contracts. The competitive advantage will belong to companies who can convincingly demonstrate real-world value beyond traditional clinical trials.

What does this mean for your evidence strategy? Organizations that invest in robust RWE infrastructure now will be positioned to accelerate approvals and strengthen market access discussions. The path forward requires integrated evidence planning that connects regulatory, health economics, and payer perspectives from day one.

How is your organization preparing for this shift? What challenges are you navigating in building credible real-world evidence? Let's discuss in the comments.

Explore the state of Real-World Evidence (RWE) analysis in 2025-2026. This guide covers RWD sources, analytical methods, FDA/EMA regulatory frameworks, ICH E6(R3), synthetic control arms, AI-driven RWE platforms, and compares RWE with RCTs

The real-world evidence solutions market is projected to reach 5.6 billion by 2030. But growth alone doesn't guarantee s...
05/27/2026

The real-world evidence solutions market is projected to reach 5.6 billion by 2030. But growth alone doesn't guarantee success. What matters is how you're deploying RWE across the product lifecycle.

Think about it: AI-powered analytics, expanded RWE platforms, predictive modeling tools, and enhanced collaboration between payers and pharma are reshaping how value gets communicated and reimbursement decisions get made.

Yet many organizations are still operating in silos. Clinical development teams design trials without input from market access. Market access teams craft value stories without input from the data scientists generating the evidence. The result is a disconnect between what you're measuring and what payers actually care about.

The organizations that win are the ones integrating these functions early. Building RWE strategies that align regulatory, clinical, and commercial objectives from day one.

Are your teams working in isolation or in integration? The answer determines your competitive position.

The Business Research Company is a global market research and consulting firm that offers in-depth industry analysis, valuable insights and actionable recommendations. We provide our clients with the information they need to make better business decisions.

Real-world evidence has evolved from a supplementary approach to central to pharmaceutical development and market access...
05/26/2026

Real-world evidence has evolved from a supplementary approach to central to pharmaceutical development and market access strategy. Yet many organizations still struggle with the critical gap: translating vast healthcare datasets into actionable decisions.

The constraint isn't data volume. It's organizational capability. The teams asking the right questions, generating defensible analyses, and ensuring findings drive clinical adoption are the ones winning in market access.

The strategic advantage comes from tighter integration between evidence generation and real-world ex*****on. Organizations that reach institutional maturity in RWE generation will design more efficient trials, support regulatory submissions with greater confidence, and accelerate therapy uptake.

What's your organization's RWE maturity level? Are you still acquiring data assets, or have you moved into advanced analytics and organizational integration?

Learn how companies that treat RWE as an operational capability will be better positioned to design more efficient trials, accelerate therapy adoption, strengthen payer negotiations, and demonstrate value across the healthcare ecosystem.

I've been thinking about the data quality challenge in real-world evidence generation. We have access to massive amounts...
05/25/2026

I've been thinking about the data quality challenge in real-world evidence generation. We have access to massive amounts of RWD from EHRs, claims data, and registries, but handling diverse, complex, and unstructured data at scale remains genuinely difficult. From clinician notes to imaging data, extracting meaningful insights requires more than storage capacity. It requires advanced partnerships and tools that can process and interpret that complexity responsibly. The FDA's framework for evaluating RWE in regulatory decisions has created an accountability standard. Regulators are now expecting pharmaceutical companies to demonstrate that their real-world evidence is fit-for-purpose, methodologically sound, and defensible. This shifts the conversation from quantity of data to quality of evidence. Organizations investing in AI-enabled infrastructure combined with epidemiological expertise are seeing the payoff in faster regulatory pathways and stronger payer negotiations. But this only works if the underlying data is clean, validated, and analyzed with scientific rigor. For HEOR professionals and evidence teams, this is an opportunity to position real-world evidence as a strategic asset rather than a compliance requirement. What does that look like in your organization?

Pfizer partnered with Premier Applied Sciences to raise the bar for real-world evidence (RWE) as an engine for quality, credibility and impact in regulatory and scientific decision-making.

The RWE market is experiencing unprecedented expansion. The pharmaceutical and life sciences real-world evidence market ...
05/22/2026

The RWE market is experiencing unprecedented expansion. The pharmaceutical and life sciences real-world evidence market is projected to grow from $3.57 billion in 2026 to $5.6 billion by 2030, driven by AI-powered analytics, expanded RWE platforms, and predictive modeling tools.

What's accelerating this growth? Organizations are moving beyond asking whether to leverage real-world evidence and focusing on how to responsibly harness it. The shift reflects a fundamental maturation in the field.

Key drivers reshaping the landscape include:

Integration of AI-enabled technology in data interpretation

Expanded collaboration between payers and pharmaceutical companies

Growing adoption of personalized medicine approaches

Standardized frameworks like FRAME and CanREValue for RWE evaluation

For HEOR and market access professionals, this moment represents an inflection point. The organizations capturing value aren't just generating evidence anymore. They're building the infrastructure to turn data into regulatory-grade insights that inform faster approvals, stronger reimbursement cases, and ultimately, better patient outcomes.

The question for your organization: Are you positioned to leverage RWE as a competitive advantage in 2026?

The pharmaceutical and life sciences sector is increasingly relying on real world evidence RWE to enhance drug development and patient care This evolving market reflects a growing trend toward data driven decision making based on real life clinical outcomes Let ...

Here's what keeps me up at night in healthcare: we're drowning in data but starving for insight. Think about it. Pharmac...
05/21/2026

Here's what keeps me up at night in healthcare: we're drowning in data but starving for insight. Think about it. Pharmaceutical companies now spend nearly $20 million annually on real-world evidence generation. Regulators are setting up dedicated RWE centers. Payers are demanding outcomes-based contracts. And yet, many organizations still struggle to translate real-world data sets into actual decisions that move the needle.

The constraint isn't the volume of data anymore. It's organizational capability.

I keep coming back to this distinction: having more health records, claims data, and registries doesn't automatically give you an advantage. What matters is whether you can frame the right decision-relevant questions, generate defensible analyses, and actually influence how your therapy gets adopted in real-world settings.

This is where implementation science enters the conversation. It's not enough that a drug works in trials. The hard work is understanding adoption barriers, workflow integration, and sustained use. That's what separates companies that merely generate evidence from those that translate evidence into market access wins.

The competitive edge in 2026 belongs to organizations that don't just collect more data, but build the infrastructure to turn it into decision-ready evidence that payers and providers actually trust.

What's your biggest challenge in moving from data collection to actionable insight?

Learn how companies that treat RWE as an operational capability will be better positioned to design more efficient trials, accelerate therapy adoption, strengthen payer negotiations, and demonstrate value across the healthcare ecosystem.

The payer perspective in RWE generation is still underutilized. Most real-world evidence projects I see are built from t...
05/14/2026

The payer perspective in RWE generation is still underutilized. Most real-world evidence projects I see are built from the clinical or manufacturer angle. You generate the data, run the analysis, and hope it speaks to payers. But that's backwards.

When payers are actually embedded in how you design your evidence strategy from day one, the translational value changes completely. You're not retrofitting insights to fit a reimbursement narrative. You're building evidence that answers the questions decision-makers are already asking.

Integrated data sources matter, sure. Claims, EHR, lab results, mortality data. But the real multiplier is knowing upfront what a payer needs to see to actually move on coverage or pricing decisions. That context shapes everything about how you structure your analysis.

The firms that get this right aren't just better at RWE. They're better at getting evidence into decisions.

With decades of experience working with our data, we are skilled at translating evidence into actionable information for stakeholders.

Columbia's pharmacoepidemiology center just reminded me why the talent pipeline matters so much in our field. They're ex...
05/13/2026

Columbia's pharmacoepidemiology center just reminded me why the talent pipeline matters so much in our field. They're explicitly training the next generation of RWE professionals through internships and real-world consulting work. Not theoretical exercises. Actual projects with pharma companies where students learn to translate population-level drug effects into actionable insights.

This is how you build institutional knowledge. It's also how you solve one of our biggest challenges: finding people who actually understand both the epidemiology AND the business side of evidence generation.

Too many organizations treat RWE as a technical box to check. The ones winning at market access and payer strategy? They're investing in people who think like clinicians, analysts, and strategists at the same time. That doesn't happen by accident.

We collaborate with leading pharmaceutical companies to perform high-quality consulting & research in pharmacoepidemiology & health outcomes research.

The gut-brain axis keeps showing up in clinical trials and real-world evidence studies, and I think we're still underest...
05/11/2026

The gut-brain axis keeps showing up in clinical trials and real-world evidence studies, and I think we're still underestimating what it means for outcomes research. Most of our HEOR models treat mental health and GI outcomes as separate buckets. But the research is pretty clear: dysbiosis doesn't just cause digestive symptoms. It's linked to depression, anxiety, cognitive function, sleep quality. The downstream effects are real.

What's interesting from a market access perspective is that we're not yet translating this into value propositions effectively. If a therapy can demonstrate impact on gut microbiota composition and show downstream improvements in mood, cognition, or fatigue, that's a compelling real-world evidence story. But it requires cross-functional thinking that most pharma organizations haven't built yet.

The challenge: most claims data and EHR analyses don't capture microbiome status. So how do we actually measure this in RWD? Patient-reported outcomes help, but there's a gap between what the science shows and what payers can actually verify in their populations.

I'm curious whether anyone's built outcomes research strategies around the gut-brain axis for a therapy launch. The clinical mechanism is solid. The evidence generation piece is still catching up.

How Can Gut Health Affect Mental Health? Have you ever had a “gut feeling” about a situation? How about feeling “butterflies” in your stomach?

Regulatory agencies worldwide have made significant strides in recent years by developing coordinated playbooks for util...
05/09/2026

Regulatory agencies worldwide have made significant strides in recent years by developing coordinated playbooks for utilizing real-world evidence (RWE) in regulatory decisions—something many in the pharmaceutical industry once deemed unlikely.

Agencies such as the FDA, EMA, PMDA, NMPA, TGA, and others have transitioned from position papers to comprehensive guidance on RWD quality, study methodology, and submission procedures. This is not just an incremental change; it represents a foundational shift in infrastructure.

A notable aspect is the focus on Europe. Initiatives like the EHDS proposal, the Data Act, and DARWIN EU are establishing a centralized network for RWD across member states. This indicates a move beyond mere acceptance of RWE; they are creating the necessary systems to implement it effectively across diverse health systems.

For those currently developing evidence strategies, this evolution is crucial. The regulatory landscape that seemed uncertain just 18 months ago has transformed. The discussion has shifted from "will they accept this?" to "how do we generate it to their specifications?" This marks a significant change in the conversation.

Leveraging the value of real-world evidence (RWE) to make informed regulatory decisions in the field of health care continues to gain momentum. Improving cli...

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