Originally aired: Tuesday, March 17, 2026
In antibody–drug conjugate (ADC) development, identifying an initial dose is only the beginning. Long-term success depends on optimizing dose regimens that balance efficacy, safety, and regulatory expectations as programs advance from early clinical development into registrational planning. Achieving this requires integrating multiple quantitative approaches to ensure dose and regimen decisions are robust, defensible, and aligned with strategic development objectives.
In this on-demand webinar from the CHI ADC series, Certara’s experts share how to integrate population pharmacokinetics (PopPK), exposure–response (E-R), toxicology, and mechanistic modeling approaches including PBPK and QSP to optimize dose regimens across development phases.
The session explores how to define informative early regimens, design expansion and backfill strategies, and build Phase 3 and BLA/MAA dose justifications that clearly demonstrate an optimal risk–benefit profile. You will also gain practical insight into common challenges and real-world solutions for designing regulator-ready dose optimization strategies.
Key learning objectives:
- Define dose regimens that are both informative and safe, supporting early efficacy assessment while managing risk
- Integrate PopPK, exposure–response, PBPK, and QSP to strengthen dose and regimen decisions across development stages
- Design expansion, backfill, and Phase 3 regimens that enable robust risk–benefit justification for BLA and MAA submissions
Who should watch?
- Clinical pharmacology and pharmacometrics leaders responsible for PopPK, E-R, PBPK, and QSP-driven dose and regimen decisions
- Clinical development and translational medicine scientists designing Phase 1/2 studies, expansion cohorts, and Phase 3 dosing strategies
- Regulatory and clinical pharmacology professionals supporting regulator-ready dose justification for BLA and MAA submissions
Speakers
- Felix Stader – Senior Research Scientist, Simcyp Division
- Khaled Benkali, PhD, MBA – Senior Director, Team Lead, Clinical Pharmacology
- Armin Sepp – Senior Principal Scientist, Certara Simcyp
- Eline van Maanen – Director Consulting
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