Advancing pharmacoequity through model-informed drug development: Insights from ASCPT 2026

Pharmacoequity is no longer an aspirational concept. It is becoming a scientific and regulatory imperative.

Across sessions, experts emphasized that equitable access must be embedded upstream at the level of study design, modeling strategy, regulatory engagement, and global evidence generation. Persistent disparities in pediatric access, maternal-fetal therapeutics, global vaccine distribution, and advanced modalities such as cell and gene therapies require intentional, quantitative solutions.

Equity must be integrated by design, not addressed retroactively.

Model-informed drug development provides the framework to enable this shift. Approaches such as physiologically based pharmacokinetic modeling, quantitative systems pharmacology, model-based meta-analysis, and real-world data integration allow sponsors to extrapolate evidence to underrepresented populations, reduce unnecessary trial burden, and inform global regulatory decisions.

Learn how Certara supports integrated model-informed drug development strategies:
Model-Informed Drug Development​ Solutions

For broader program-level alignment from discovery through registration, Certara’s drug development strategy services integrate quantitative science with regulatory and commercial insight:
https://www.certara.com/services/drug-development-services/

With ICH M15 finalized, model-informed drug development is increasingly foundational to regulatory submissions.

The focus has shifted from whether modeling should be used to how model-based evidence is strategically planned, generated, and communicated. Regulators increasingly expect:

• A clearly defined context of use
• Transparent assumptions and methodologies
• Decision-oriented quality of inference
• Harmonized global submission strategies

Regulatory agencies are engaging earlier and more collaboratively, strengthening totality-of-evidence frameworks that integrate mechanistic modeling, clinical data, and real-world insights.

Clinical pharmacology and translational medicine teams play a critical role in ensuring that modeling strategies are scientifically rigorous and aligned with evolving regulatory standards. Explore Certara’s clinical pharmacology and translational medicine expertise:
https://www.certara.com/services/clinical-pharmacology/

Organizations that embed model-informed drug development early in program strategy will be better positioned to accelerate timelines while maintaining regulatory confidence.

Artificial intelligence was one of the most discussed topics at ASCPT 2026. The consensus was clear: AI will augment, not replace clinical pharmacology expertise.

As AI-enabled tools become embedded within simulation and modeling workflows, enthusiasm is balanced by essential guardrails:

• Predictive accuracy must be paired with biological plausibility
• Transparency and interpretability are essential for regulatory trust
• Human oversight remains non-negotiable
• Biased or incomplete data risk reinforcing disparities

Responsible AI must remain mechanistically grounded and ethically accountable.

Over the next several years, competitive advantage will come not from adopting AI fastest, but from integrating it responsibly within model-informed drug development frameworks supported by strong clinical pharmacology foundations.

A recurring theme at ASCPT was the movement toward integrated, mechanistic evidence frameworks.

Development and regulatory decisions increasingly rely on the totality of evidence, combining:

• 定量系统药理学
• PBPK modeling
• 基于模型的荟萃分析
• Real-world data
• Epidemiologic and health economic modeling

High-quality, integrated data are becoming strategic assets.

Mechanistic approaches such as quantitative systems pharmacology enable robust extrapolation, informed dose and schedule selection, and predictive insights where traditional clinical data are limited.

Explore Certara’s quantitative systems pharmacology capabilities:
https://www.certara.com/services/quantitative-systems-pharmacology/

This integrated approach is especially critical for special populations, emerging modalities such as CAR-T and gene therapies, and preventive and global health programs.

ASCPT 2026 highlighted an important evolution in industry thinking. Regulatory approval is no longer the sole milestone of success.

The focus is expanding toward:

• Trial efficiency and reduced development burden
• Cost-effectiveness and value-based frameworks
• Sustainable pricing strategies
• Global regulatory convergence
• Real-world implementation

As innovation accelerates, aligning scientific advancement with affordability and global access remains one of the defining challenges of the decade.

Model-informed drug development provides the quantitative backbone to support this transition from innovation to implementation.

ASCPT 2026 delivered a clear message: the future of drug development will be model-informed, AI-enabled, and equity-driven.

Pharmacoequity must be embedded in development strategy. ICH M15 has elevated model-informed drug development to regulatory standard. AI adoption requires discipline and transparency. Totality-of-evidence frameworks are reshaping decision-making. And success must extend beyond approval to sustainable patient access.

Over the next three to five years, organizations that integrate quantitative science, clinical pharmacology excellence, and strategic development planning will lead the industry forward.