Enhancing REMS Programs: A Real-World, Risk-Informed Approach from Venebio

A Smarter Approach to REMS

As the pharmaceutical landscape evolves, Risk Evaluation and Mitigation Strategy (REMS) programs have taken on increased importance in ensuring safe medication use while balancing access and innovation. Yet too often, REMS programs are treated as regulatory hurdles rather than strategic tools for improving public health. At Venebio, we take a different approach. We believe that REMS should be dynamic, data-informed systems that evolve over time and truly deliver on their promise to mitigate risk without unintended burden.

That philosophy begins with the REMS Logic Model. Endorsed by the FDA, this model serves as more than a planning tool, it functions as a guiding framework for every stage of the REMS program’s lifecycle. From initial goal setting through implementation and evaluation, the logic model ensures each component is aligned with the program’s public health objectives, with clear feedback loops to support ongoing refinement. At Venebio, we embed this structure into our work from day one, helping sponsors build REMS that are not only compliant but also adaptive and outcome-oriented.

Venebio’s REMS work draws on a depth of expertise across scientific, regulatory, and operational domains. Our team includes consultants with backgrounds in REMS strategy, post-market surveillance, real-world evidence, data science, regulatory writing, implementation science, logic model development, and program evaluation, enabling us to tailor REMS strategies to each product’s unique safety profile, regulatory history, and target population.

Turning Evidence Into Action

One of the most powerful tools for evaluating and improving REMS performance is real world evidence (RWE). By using sophisticated analytics, predictive modeling, and post-market data integration, we help sponsors understand how REMS requirements are playing out in practice.

Are patients and providers adhering to safety protocols? Are there barriers to access that disproportionately affect certain groups? Are safety outcomes improving over time?

Venebio uses RWE not only to answer these questions, but also to provide regulators with the evidence needed to support modifications to the REMS requirements, or, in some cases, to remove the REMS entirely. Importantly, we map these analyses back to logic model goals, ensuring that the data not only describe the performance of the REMS, but drive it.

We also recognize that REMS programs exist within complex systems of care. Their effects ripple across provider workflows, pharmacy practices, health equity, and patient trust. That is why we take a systems-based approach to evaluation, assessing how REMS programs influence access, equity, and behavior across the healthcare ecosystem. For example, a REMS program that delays treatment access may reduce theoretical risk but increase harm in other ways. Our public health team works to surface these tradeoffs and offer solutions that reflect real-world complexity, not just regulatory intent.

Building Tools that Work for Everyone

Digital health technologies offer promising new avenues for risk mitigation, but their value depends on thoughtful integration. We help clients assess when and how digital tools, like patient portals, mobile apps, or telehealth can enhance adherence, education, and evaluation, without introducing new inequities. Drawing on behavioral science and health communication principles, we ensure these tools reinforce, rather than distract from, the REMS goals outlined in the logic model.

Tailoring REMS programs to the needs of specific populations is another critical piece of the puzzle. Certain groups, such as women, older adults, children, and underserved communities, may face unique risks or burdens that standard REMS programs overlook. Our epidemiologists and women’s health experts work closely with clients to evaluate how REMS requirements affect these populations and to adjust elements like education materials, Elements to Assure Safe Use (ETASUs), and outreach strategies accordingly.

Making REMS Measurable – and Defensible

We also recognize that robust REMS assessment often requires working with imperfect data. Whether due to fragmented electronic health record (EHR) systems or inconsistent data capture, sponsors often struggle to evaluate program impact. Venebio bridges this gap by combining quantitative analysis with qualitative methods, drawing from diverse sources such as provider/patient surveys, abuse-related data, and EHRs. By aligning these data collection efforts with the logic model from the outset, we ensure programs are evaluable, and defensible, throughout the product lifecycle.

That defensibility can be critical. Increasingly, REMS design and implementation are surfacing in product liability litigation and compliance investigations. Venebio supports sponsors with litigation-aware REMS strategies that emphasize clear documentation, scientific rationale, and rigorous evaluation. We help ensure that REMS programs can withstand legal scrutiny and demonstrate that the sponsor took meaningful steps to protect patients.

Risk Communication that Changes Behavior

Of course, no REMS program succeeds without effective communication. Simply disseminating information is not enough. To change behavior, REMS materials must be accessible, relevant, and delivered at the right time and place. We apply behavioral science, health literacy, and program evaluation methods to assess communication strategies and adapt them based on what works. Whether for prescribers, pharmacists, or patients, we make sure REMS messaging supports informed, risk-aware decision making.

Why Venebio?

At Venebio, we bring together regulatory fluency, scientific rigor, and a practical understanding of real-world implementation. We do not believe in one-size-fits-all templates; we deliver REMS strategies that are right-sized, evidence-based, and designed for impact. Most importantly, we treat REMS as living, learning, systems built to evolve through continuous feedback and improvement. That is why every REMS engagement at Venebio begins and ends with the logic model.

If you are ready to build a smarter, more strategic REMS program, we are ready to help.

Contact: rems@venebio.com | www.venebio.com | 877.344.4347