Sharmeen Roy, PharmD, BCPS 

The pharmaceutical industry’s digital shift now influences not just R&D, but delivery, pricing, and utilization. Precision dosing, powered by model-informed tools such as Bayesian analytics and real-time pharmacokinetic modeling, is no longer a clinical “nice-to-have.” It’s a boardroom lever. 

While the clinical benefits of model-informed precision dosing (MIPD) have been increasingly recognized, its commercial potential is only beginning to be fully realized. This isn’t just about patient outcomes; it’s how companies win in markets driven by cost discipline, speed to scale, and demonstrable value.

From optimizing inventory management to reducing drug waste, precision dosing technologies are helping pharmaceutical companies reimagine how they develop, manufacture, and distribute high-value therapeutics. As commercial leaders seek to extract more value from increasingly specialized therapies, model-informed precision dosing offers new levers for differentiation, efficiency, and market success.

Smarter forecasting and commercial supply chain efficiency

Precision dosing enables more accurate demand forecasting across different patient populations. Traditional dosing models often result in broad-based assumptions that fail to reflect the nuanced variability in drug response. This mismatch can lead to overproduction, underutilization, and costly inventory write-offs.

Model-informed dosing tools map out the real distribution of dosing needs, replacing blunt averages with precise, patient-level forecast that informs smarter manufacturing, vial sizes, and dosage formulations. For commercial and supply chain leaders, this data can inform everything from manufacturing run sizes to vial configurations and packaging strategies. For instance, with better visibility into typical dose ranges, companies can rationalize the production of certain vial sizes, minimize waste and simplify inventory management.

This level of forecasting precision is particularly valuable for biologics and cell and gene therapies, where the cost of goods is high and shelf life is limited. It also empowers just-in-time manufacturing strategies, which reduce inventory carrying costs while ensuring availability of appropriately dosed product when and where it’s needed.

Reducing drug waste in high-stakes therapeutic areas

In therapeutic areas like oncology and transplantation, drug dosing is not just a science, it’s a strategic imperative. These domains frequently involve narrow therapeutic windows, high cost per dose, and significant risk of toxicity or treatment failure.

In high cost, high-stakes areas such as oncology and transplantation—even minor dosing mismatch—can cost tens of thousands of dollars and expose patients to avoidable risk. Model-informed precision dosing addresses both financial waste and clinical risk directly. For example, transplant centers often discard partial vials due to dose mismatches, contributing to substantial waste. Similarly, oncology regimens based on body surface area may fail to account for real-time pharmacokinetic variables, leading to drug loss and avoidable adverse events.

By individualizing therapy through model-informed tools, pharmaceutical manufacturers and hospital systems can significantly reduce waste, an outcome that resonates with both payers and sustainability-minded stakeholders. The commercial benefit is twofold: increased drug utilization efficiency and improved customer satisfaction.

Enhancing market access and payer value propositions

Payers are increasingly scrutinizing the value delivered per dose, particularly for high-cost therapies. Precision dosing tools offer a compelling value proposition: they demonstrate that a manufacturer is not only delivering an innovative therapy but also ensuring its optimal use.

When precision dosing strategies are baked into the label, it doesn’t just help with clinical adoption—it arms market access teams with justification for reimbursement and pricing negotiations. Pharmacoeconomic models that incorporate reduced waste, fewer adverse events, and improved clinical outcomes can support pricing and access discussions in competitive therapeutic categories.

Furthermore, health technology assessment (HTA) bodies and pharmacy benefit managers (PBMs) are showing growing interest in dosing optimization as part of their cost-effectiveness evaluations. Model-informed precision dosing offers quantifiable proof that a therapy is being deployed with maximum value.

 Now a commercial tool, not just a clinical one.

 Cuts drug waste and optimizes supply chains.

 Strengthens payer negotiations with value data.

 Simplifies dosing for faster clinician uptake.

 Speeds label expansion into new populations.

Accelerating adoption of complex therapies

Advanced therapeutics, including immunotherapies, antibody-drug conjugates, and precision biologics, often require complex administration protocols and careful dose titration. Adoption can be hindered by prescriber uncertainty or logistical constraints in delivering individualized therapy.

Precision dosing platforms can streamline the onboarding process for clinicians by simplifying dosing decisions, providing clinical decision support, and reducing the burden of therapeutic drug monitoring. These tools reduce prescriber friction, shorten time to adoption, and improve clinician confidence in new therapies.

For commercial teams, this is a critical advantage. In a competitive launch window, trimming just a week off the adoption curve can mean millions in early revenue, driven by clinical confidence and reduced onboarding friction. Moreover, demonstrating that a therapy comes with precision dosing support helps differentiate the brand in crowded indications.

Supporting lifecycle management and label expansion

Model-informed precision dosing also plays a pivotal role in lifecycle management. As companies explore label expansions to pediatric populations, renal-impaired patients, or other special populations, model-informed tools can de-risk development by simulating outcomes and optimizing study design.

This not only accelerates timelines but can reduce the cost and complexity of post-marketing studies. Regulatory agencies are increasingly accepting model-informed evidence as part of dosing justifications, particularly when supported by robust pharmacokinetic/pharmacodynamic (PK/PD) modeling.

The commercial implications are significant: faster time to new market segments, broader patient access, and extended exclusivity windows for therapies proven safe and effective across populations.

Conclusion: From innovation to commercial strategy

Precision dosing is no longer a niche clinical tool, it is a strategic asset with wide-reaching implications for commercial success. Companies that embed model-informed precision dosing into their product strategies are not only improving patient care but also enhancing their competitiveness across the pharmaceutical value chain.

As the industry moves toward value-based care, pricing pressures, and more sophisticated market access requirements, precision dosing offers manufacturers a way to demonstrate stewardship, efficiency, and innovation. When clinical outcomes and commercial results align, dosing stops being an afterthought and start being a growth driver. That’s where model-informed tools earn their place, not just in the clinic, but at the center of a company’s market strategy. For the forward-leaning pharmaceutical leader, precision dosing is more than a capability, it’s a competitive advantage.

Sharmeen Roy, PharmD, BCPS, is the chief strategy and science officer, DoseMe, a Bayesian dosing platform.

Articles

The pharmaceutical industry's digital transformation is reshaping R&D, delivery, pricing, and utilization, with model-informed precision dosing (MIPD) emerging as a key strategic tool. MIPD enhances demand forecasting, reduces drug waste, and optimizes supply chain efficiency, particularly for high-cost therapies like biologics and oncology treatments. It supports market access by demonstrating value per dose, aiding reimbursement and pricing negotiations. Additionally, MIPD accelerates the adoption of complex therapies and facilitates lifecycle management, offering significant commercial advantages and aligning clinical outcomes with business success.

By reducing waste, improving forecasting, and strengthening payer negotiations, these  technologies are helping pharmaceutical companies unlock efficiency, accelerate adoption, and differentiate in competitive markets.