Advancing Real-World Evidence in HEOR: A Q&A With Experts

Real‑world evidence (RWE) is recognized as a decision-critical input that can help secure regulatory approval, shape product development and access strategy and pricing, and help biopharma manufacturers demonstrate the effectiveness and thus value of their medicines in routine medical practice. It is no longer a post-approval “add-on” but a critical element of R&D and product commercialization.

At Precision AQ, real‑world evidence is treated as a strategic investment. By combining deep expertise in real‑world data access and evidence generation with policy‑aware, decision‑focused HEOR strategy, our teams help ensure evidence is credible, timely, and actionable.

Ahead of ISPOR North America 2026, we spoke with Mitch DeKoven, MHSA, Vice President in Evidence Generation, and Shelby Corman, PharmD, MS, BCPS, Vice President in RWE. These leaders at Precision AQ specialize in real‑world evidence strategy, execution, and application. They share how RWE has evolved, where misconceptions persist, and how life sciences teams can better prepare for the demands ahead.

Precision AQ: Tell us about yourself and your professional focus.

Shelby Corman: My team and I specialize in the identification and analysis of real-world data (RWD) from diverse sources such as claims, electronic health records (EHRs), registries, surveys, and patient charts. We love helping our clients develop and refine their research questions and find the best source of RWD to answer them. I have 13 years of experience in conducting outcomes research in a consulting environment, providing RWE strategy and services to life science organizations of all sizes.

Being a pharmacist allows me to quickly develop and lead projects in new therapeutic areas, review medication and diagnosis lists with a keen eye for relevance and completeness, and translate our findings in ways that resonate with other clinicians whose practice can be influenced by them.

Mitch DeKoven: I lead research teams in a variety of HEOR projects, particularly integrated evidence plans, targeted literature reviews, and both retrospective and prospective studies. I’m also instrumental in both thought leadership and new business development efforts.

I bring over two decades of HEOR leadership and research experience, along with a listening ear to help our clients determine, demonstrate, and communicate the value of their therapies to various stakeholders.

AQ: What is the biggest change you have seen in RWD and RWE during your career?

SC: When I started my career in RWE, our data options were limited: we used claims for what we could, and chart review and prospective studies for the rest. Using EHR data to generate RWE was just starting to gain traction, but slowly. Since then, we have seen an explosion in EHR data sources, from those containing structured data on a broad patient base, to those that use therapeutic area-specific EHRs, to those that use natural language processing of unstructured notes extracted into structured fields. Our options have grown exponentially, and as a result, it’s more important than ever to keep abreast of new sources of data.

AQ: What’s one persistent misconception about RWE that you wish more biopharma leaders understood?

SC: The biggest misconception is that the data needed to answer their critical questions doesn’t exist or isn’t accessible. Through our relationships with RWD vendors, integrated delivery networks, academic partners, and others, we have successfully identified and used data to address some very specific and challenging research questions. Finding data that was believed to be nonexistent is very satisfying!

MD: One persistent misconception about RWE is that it is merely “supportive” or retrospective validation - something you bring in after pricing and access decisions have already been made. The utility and potential that RWE offers are most valuable when considered a strategic lever, helping shape how value is (and can be) defined before launch and aligning that data to support payer decision criteria from day one. Too often, RWE is viewed as a way to “fill gaps” left by clinical trials, rather than as a core input into access strategy.

AQ: What forward-looking trend do you believe will most influence RWE over the next 3–5 years, and how should life sciences teams prepare for it?

MD: Historically, the success of RWE has been measured by the number of peer-reviewed publications. Publications still matter, but the applications have expanded significantly. RWE is now expected to inform formulary tiering, support value‑based contracts, drive strategic and lifecycle-management decisions, guide pathway placement, and influence post‑launch evidence commitments. Along these lines, if the output of an RWE study does not clearly map to a decision made by a payer or provider, the research may be ignored. As pricing and access models continue to evolve (e.g., outcomes‑based agreements, indication‑based pricing, and reassessment mechanisms), they require ongoing evidence, not static dossiers.

Given these trends, life science teams should prepare by embedding and considering RWE earlier (and deeper) into strategy. The strongest RWE teams influence what gets studied, not just how it is analyzed.

AQ: How is your team helping to ensure RWE remains at the forefront of policy and access conversations as the healthcare landscape evolves?

MD: At Precision AQ, our RWE team is often augmented by our colleagues with expertise in policy and access, namely our Access Experience Team, our on-staff team of access decision makers and influencers, as well as our Access Consulting team with deep connections to sitting payers. As such, our multidisciplinary team often mirrors our clients’ teams, ensuring that strategic discussions and associated RWE analyses capture all key stakeholder perspectives, paving the way for a successful launch.

Elevating Real-World Evidence at ISPOR 2026

As expectations for evidence continue to rise, real‑world evidence will play an even more central role in shaping access, reimbursement, and policy decisions. The work led by Mitch and Shelby reflects Precision AQ’s belief that RWE must be intentional, decision‑focused, and deeply integrated into HEOR strategy.

At ISPOR 2026, discussions around evidence credibility, relevance, and impact will be front and center. If you’re looking to strengthen your RWE strategy or explore how real‑world data can better support access decisions, we invite you to connect with Mitch and Shelby.

Schedule time to meet with our team at ISPOR 2026 to learn how Precision AQ’s experts help translate real-world data into decision-ready evidence.