Sponsored by Certara
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 second webinar of the CHI ADC series, Certara’s thought leaders, Khaled Benkali, Eline van Maanen, Armin Sepp, and Felix Stader will discuss 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 will focus on defining informative early regimens, selecting expansion and backfill strategies that balance signal detection with risk, and building Phase 3 and BLA and MAA dose justifications that clearly demonstrate an optimal risk–benefit profile. Attendees will also gain practical insight into common challenges and real-world solutions for designing regulator-ready dose optimization strategies.
Key Takeaways
• 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/MAA submissions
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Prior to joining the industry, he was initially trained as a pharmacist at the University of Algiers, Algeria, and completed his training with a PhD in pharmacology and pharmacometrics at the University of Limoges, France, working with immunosuppressant drugs, and a post-doc focusing on the individualization of tacrolimus therapy using Nonmem. Dr Benkali masters gap analyses, due diligences and regulatory interactions.
Functional Expertise
• Clinical pharmacology
• DMPK
• Drug development strategy
• Due diligence
• Non-compartmental analysis
• Regulatory strategy
• Specialty Areas
• Dermatology
• Immunology
• Monoclonal antibodies
• Orphan diseases
• Pediatrics
Eline received a PhD in Pharmacology from Leiden University in 2017, where she studied systems pharmacology of the amyloid cascade under the supervision of Prof. Meindert Danhof. Eline has a background in engineering, holding a MSc degree in Life Science and Technology from Delft University of Technology. Outside of work, Eline enjoys pilot-gig rowing.
