From Models to Impact: What QSPC 2026 Revealed About the Future of Drug Development

Beyond the main sessions, the poster presentations at QSPC 2026 offered a closer look at cutting-edge applications of QSP and PBPK modeling. Certara’s contributions, in particular, showcased how mechanistic modeling is being applied across modalities, from biologics to cell therapies.

Minimal PBPK model with detailed ocular physiology to compare target occupancy for anti-VEGF antibodies
Presenter: Suruchi Bakshi (with Merck)

This work introduced a streamlined PBPK model incorporating detailed ocular physiology to evaluate target engagement across anti-VEGF therapies.

Why it stands out:

• Enables comparison of antibody performance in the eye
• Supports optimization of dosing and delivery strategies
• Addresses a critical need in ophthalmology drug development

QSP modeling of T-cell exhaustion as a driver of relapse in long-term treatment with T-cell engagers
Presenter: Jonas Denk

This QSP model explores how T-cell exhaustion contributes to relapse, a major challenge in immuno-oncology.

Key contributions:

• Mechanistic insight into long-term treatment dynamics
• Identification of relapse drivers
• Potential strategies to improve durability of response

IO Simulator: A QSP platform for immuno-oncology (IO)
Presenter: Sirin Yonucu

This platform represents a move toward scalable, reusable QSP frameworks for IO.

What it enables:

• Simulation of complex tumor–immune interactions
• Evaluation of combination therapies
• Faster hypothesis testing across drug candidates

Minimal PBPK model for pH-dependent FcRn binders with optional albumin binding domain
Presenter: James Wade

This model addresses the complexity of pH-dependent binding on FcRn-mediated recycling and IgG levels.

Highlights:

• Cross-species translation (mouse → monkey → human)
• Flexible modeling that can include albumin-binding domains
• Improved prediction of PK/PD behavior

Model-informed first-in-human dose selection for BCMA CAR-T therapy in multiple myeloma
Presenter: Chris Morris

This work demonstrates how modeling can support safer and more efficient clinical entry for cell therapies.

Impact:

• Reduces uncertainty in dose selection
• Supports regulatory strategy
• Enhances early-stage decision-making

Mechanistic modeling of CAR-T therapy in multiple myeloma
Presenter: Vicky Kostiou

This model integrates public and real-world data to better understand patient response.

Key insights:

• Identification of patient-specific response drivers
• Evaluation of multi-antigen targeting strategies
• Support for personalized treatment approaches

A QSP Platform Model of Hematopoiesis for Evaluating Therapeutic Interventions in MDS and AML
Presenter: Viji Chelliah

This poster introduces a QSP platform model of hematopoiesis designed to support drug development in myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML), two areas with complex disease biology and significant unmet need.

Key highlights:

• Captured the dynamics of blood cell formation and disruption in disease
• Enabled evaluation of therapeutic interventions across multiple mechanisms
• Supported translation from biology to clinical outcomes in hematologic disorders

Authors: Jaehee Shim1, Douglas Chung1, Alison Smith2, Shivani Malik2, Binaifer Balsara2, Francis Burrows2, Piet H. van der Graaf1,3,4, Amitava Mitra2*
1. Certara Applied BioSimulation, Sheffield, UK, 2. Kura Oncology, Inc., San Diego, CA, USA, 3. Leiden Academic Centre for Drug Research, Leiden University, The Netherlands, 4. Cincinnati Children’s Hospital Medical Center, US. *Presenting Author

This poster presents a mechanistic QSP model of PI3K and HRAS signaling to guide patient selection and dosing for combination therapy in head and neck cancer, integrating preclinical, clinical, and molecular data into a unified framework.

Highlights:

• Predicts tumor response across genetically defined patient subgroups, identifying those most likely to benefit
• Uses virtual patient simulations to optimize dosing and improve therapeutic outcomes
• Shows that treatment response varies significantly by mutation type, reinforcing precision medicine strategies

Authors: E. Roesch (1), R. Sheehan (2), G. Boka (1), V. Chelliah (2), M. Jansen (2), M. Kumar (1), M. Peakman (1), E. Sundermann (1), P. van der Graaf (2), B. Wagenhuber (1)
1. Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany, 2. Certara, Radnor, US.

This poster presents a quantitative systems pharmacology (QSP) model of Type 1 Diabetes (T1D) progression that integrates autoimmune mechanisms with metabolic outcomes across defined disease stages. The model provides a mechanistic framework to support immunomodulatory drug development by linking immune-mediated β‑cell destruction to clinically relevant glycemic endpoints, both in the presence and absence of exogenous insulin therapy.

Key highlights:

• Mechanistically captured the islet–immune cycle driving autoimmune β‑cell loss and natural disease progression
• Linked immune activity and β‑cell preservation to clinical and metabolic outcomes such as HbA1c, C‑peptide, and time‑in‑range
• Forms a mechanistic framework for quantitatively evaluating immunomodulatory treatments and disease‑modifying effects

Authors: Katharina Koep1, James Wade2, Athena Grant2, Allison Christiaansen3, Achim Doerner1, Anis Krache1, Enrico Guarnera1, Tom Snowden2, Piet van der Graaf2
1. Merck KGaA, Darmstadt, Germany, 2. Certara UK Limited, London, England, 3. EMD Serono

This work shows how a minimal PBPK model can be used at the concept stage to evaluate design hypotheses, specifically whether adding an albumin-binding domain could improve FcRn inhibitors, before any molecule is physically created.

Highlights:

• Albumin binding extends half-life and improves PK, but not enough to enable practical subcutaneous dosing
• Modeling enables early go/no-go decisions, reducing reliance on costly experimental iteration
• Highlights limitations of animal models due to species differences in FcRn and albumin binding

While scientific talks and posters showcased the evolution of QSP, Certara IQ™ demos, led by Andrew Matteson, emerged as a standout highlight. Attendees weren’t just seeing what’s possible; they were able to see how it actually works in practice.

From Models to Usable Workflows

The demos focused on how Certara IQ enables teams to:

• Integrate diverse datasets into a unified modeling environment
• Streamline QSP and PBPK workflows
• Improve collaboration across multidisciplinary teams
• Accelerate decision-making with more accessible, scalable tools

Across sessions, several consistent themes emerged:

1. Convergence of QSP and PBPK: PBPK had a stronger presence than expected, signaling increasing integration between disciplines.
2. Virtual Populations Everywhere: Virtual patients are now central to trial simulation, variability analysis, decision-making, though questions remain around how they are generated and validated.
3. Regulatory Engagement Is Increasing: There is growing alignment on the role of QSP in submissions, the need for credibility frameworks, and best practices for model reporting.
4. AI/ML Is Emerging, But Still Maturing: AI is being explored for model building, automation workflows, and data integration. But compelling, large-scale success stories are still developing.
5. Expansion into New Modalities: From mRNA therapeutics, gene therapies, oncolytic viruses, QSP is being pushed into areas where traditional approaches struggle.
6. Speed and Scalability Are Becoming Critical: There is increasing demand for faster decision-making, reusable platform models, and more scalable modeling workflows.

Because QSPC happens only every four years, it offers a unique opportunity to reflect on progress.

By the next meeting, we may see:

• Routine use of QSP in regulatory submissions
• Standardized approaches to model validation and credibility
• Broader adoption of virtual trials in development programs
• Deeper integration of AI with mechanistic models
• Increased use of QSP in clinical decision-making

Most importantly, the field is aligning around a shared goal: Turning models into measurable impact for patients. No longer a niche capability, QSP is becoming central to how we understand, develop, and deliver therapies.