Certainty US 2026 recap: advancing model-informed drug development right from the start

Certainty US 2026 brought together biopharmaceutical leaders across clinical pharmacology, regulatory science, and data science to explore how model-informed drug development (MIDD) continues to evolve, gain adaptation, and accelerate bringing treatments to patients. This year’s event emphasized a forward-looking theme, “Right from the Start”, and highlighted how AI-enabled approaches are reshaping decision-making across the drug development lifecycle. We’ve compiled the key insights for you below.

How AI is transforming MIDD

This MIDD Strategy session featured expert panelists from AstraZeneca, Takeda, Pfizer, Genentech, and Novartis. Together they explored how AI integrates with QSP, PBPK, MBMA, and real-world evidence to reduce uncertainty.

The question posed: If we know that MIDD delivers a clear and measurable ROI, why isn’t it being used in every drug development program?

The answer: Drug development is outpacing our capacity to model it. Thus, the bottleneck is the ability to execute an MIDD strategy, not science.

Key Takeaway: The integration of AI in MIDD workflows will be critical to our ability to scale it to every program.

Additional insights from this session were:

• AI is most impactful when paired with scientific expertise (“scientist-in-the-loop” models) that retains human judgement and accountability.
• Integrated AI software platforms are breaking down silos between data, models, and workflows
• Faster insights enable earlier, higher-quality decisions across development phases

In short, AI is not replacing existing methods but amplifying their value and scalability.

Where Certara AI is scaling MIDD today

Certara proof points across discovery, development, and regulatory workflows

Case studies and further discussions also demonstrated how organizations are using MIDD and AI to:

• Optimize first-in-human dosing
• Improve productivity by streamlining workflows
• Reduce risk and uncertainty earlier in development

From model-informed drug development to model-informed evidence

One of the most important shifts highlighted at Certainty 2026 was the evolution from traditional MIDD to model-informed evidence (MIE). Sessions explored how quantitative frameworks—such as PBPK and Quantitative Systems Pharmacology (QSP)—are no longer just supportive tools, but central to generating regulatory-grade evidence and improving patient-centric outcomes.

Certara’s own Amin Rostami, Britta Wagenhuber, and Mirjam Trame emphasized how these approaches are helping biopharmaceutical organizations:

• Anticipate regulatory expectations earlier
• Incorporate virtual trial insights into more patient-centric development strategies
• Strengthen submissions with more robust, integrated evidence packages
• Integrate AI into MIDD workflows

This progression reflects a broader industry trend: modeling is moving upstream and becoming foundational, rather than supplemental.

Chasing the cure for rare diseases

The first day of Certainty ended with an incredible Keynote presentation from David Fajgenbaum, MD, MBA, MSc. Dr. Fajgenbaum shared his journey of being diagnosed and seeking treatment for Castleman disease, an incredibly rare disease that impacts roughly 1,500 patients annually.

In his book, Chasing My Cure, he shared how he sought out new ways to repurpose existing medicines to treat himself, and eventually share that treatment with other patients. His non-profit, Every Cure, is continuing this work by researching potential new uses of existing drugs for rare disease patients. We were honored to have had such an inspiring and motivating speaker remind us WHY we do what we do: to help patients gain access to medicines faster through scientific research and technology.

Looking ahead: achieving certainty from molecule to market

The overarching message from Certainty US 2026 was clear: achieving greater certainty in drug development requires integrating modeling, data, and AI from the earliest stages. By embedding these capabilities “right from the start,” organizations can make faster, more informed decisions and ultimately deliver therapies to patients more efficiently.

As the industry continues to evolve, Certainty remains a key platform for sharing innovations, aligning on best practices, and shaping the future of model-informed drug development.

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