CHI ADC Webinar Series: From First-in-Human Dose Selection to Label Optimization, Commercial Expansion, and Market Access

• Gain an end-to-end view of ADC decision-making, from FIH dose range selection through Phase 3, approval, and post-approval expansion
• Learn how and when to apply PopPK, E-R, PBPK, and QSP to inform dosing, regimen design, labeling, and lifecycle strategy
• Understand regulatory expectations across the ADC lifecycle and how model-informed evidence strengthens submissions and labeling
• See how quantitative approaches support commercial expansion, global access, and reimbursement discussions, not just clinical development

Tuesday, February 17, 2026 | 11am – 12pm ET

Antibody drug conjugates (ADCs) present distinct challenges in first-in-human (FIH) dose selection due to their structural complexity, narrow therapeutic windows, and evolving regulatory expectations. As the ADC landscape continues to mature, sponsors must integrate translational science, mechanistic modeling, and regulatory strategy to confidently define safe and informative starting dose ranges and set development teams up for successful entry into the clinic.

In the first webinar of our 3-part CHI ADC series, Certara leaders Fran Brown, Piet van der Graaf, and Helen-Marie Dunmore will guide attendees through the current ADC landscape, key lessons from recent successes and failures, and best practice approaches to FIH dose range selection. The session will demonstrate how mechanistic modeling approaches, including physiologically based pharmacokinetic (PBPK) and quantitative systems pharmacology (QSP), can be applied alongside translational PK and PD to support regulatory-ready FIH packages.

Attendees will gain practical insight into aligning scientific rigor with nonclinical regulatory expectations to reduce early development risk, enable confident first-in-human transitions, and support more informed dose selection decisions for ADC programs.

• Understand why ADCs differ from other modalities, including the nuances that impact first-in-human development
• Learn from recent ADC successes and failures, and how drug–antibody ratio (DAR) and narrow therapeutic windows influence FIH dose decisions
• Recognize ADC-specific dose selection challenges that extend beyond traditional small-molecule and biologic approaches
• Set teams up for a successful first-in-human transition through the right nonclinical strategy and informed dose selection
• See how PBPK, QSP, and translational PK/PD can be applied to define safe starting doses and efficacious dose ranges
• Align FIH dose strategies with nonclinical regulatory expectations to build stronger, submission-ready packages

• Clinical Pharmacology, Pharmacometrics, and Modeling & Simulation professionals involved in FIH dose selection
• Translational science, nonclinical, and early development teams supporting ADC programs
  QSP, PBPK, toxicology, and DDI experts contributing to mechanistic and translational modeling strategies
• Clinical Development and Regulatory Affairs leaders responsible for FIH strategy and submission readiness
• Portfolio, program, and early asset strategy leaders overseeing oncology and ADC pipelines

Tuesday, March 17, 2026 | 11am – 12pm ET

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.

• 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

• 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

Thursday, April 2, 2026 | 11am – 12pm ET

As antibody–drug conjugates (ADCs) transition from late-stage development to approval and commercialization, modeling and simulation play an increasingly strategic role—shaping labeling decisions, enabling global regulatory alignment, supporting commercial expansion, and strengthening market access narratives.

In the final webinar of the CHI ADC series, Certara leaders Amy Cheung, Isabelle Desprez, Roman Casciano, and Ananth Kadambi will demonstrate how model-informed approaches can be leveraged beyond approval to optimize product labels, support special populations, guide drug–drug interaction (DDI) strategies, and unlock new commercial opportunities.

The session will explore how quantitative evidence including PBPK, extrapolation strategies, and integrated evidence generation can inform pediatric and global regulatory strategies, enable post-approval expansion into new indications or dosing regimens, and support value demonstration for reimbursement and access discussions. Attendees will gain practical insight into using modeling as a long-term asset across the full ADC lifecycle.

• Use modeling to optimize labels for special populations, DDIs, and global regulatory alignment
• Enable pediatric and post-approval strategies through extrapolation and model-informed evidence
• Support commercial expansion and market access with quantitative evidence that strengthens value and reimbursement discussions

• Clinical Pharmacology, Pharmacometrics, Quantitative Science, and Modeling & Simulation professionals
• Regulatory Affairs, Regulatory Science, and Clinical Development leaders supporting ADC labeling and global strategy
• Market Access, HEOR, Evidence Generation, and Value & Reimbursement teams
• Commercial, lifecycle, and portfolio strategy leaders driving post-approval expansion
• Senior cross-functional stakeholders (Director–VP level) involved in late-stage and commercial ADC programs