From First-in-Human Dose Selection to Label Optimization, Commercial Expansion, and Market Access

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A Three-Part Webinar Series on Model-Informed ADC Development



Antibody–drug conjugates (ADCs) present a distinct set of scientific, clinical, and regulatory challenges that span the entire development lifecycle. From defining safe and informative first-in-human (FIH) dose ranges, to optimizing dose regimens for registrational success, and ultimately extending value through labeling, expansion, and market access, ADC programs demand an integrated, model-informed strategy.

This three-part webinar series provides a practical, decision-focused walkthrough of the ADC development journey. Each session highlights how quantitative approaches, including population pharmacokinetics (PopPK), exposure–response (E-R), physiologically based pharmacokinetic (PBPK) modeling, and quantitative systems pharmacology (QSP), can be strategically applied at critical inflection points to reduce risk, improve confidence, and support both regulatory and commercial success.

Across the series, Certara experts share lessons learned from real-world ADC programs, outline best practices for embedding modeling and simulation into development plans, and demonstrate how quantitative evidence can be aligned with evolving regulatory expectations and market realities. Attendees will gain a clear understanding of how modeling and simulation can move beyond analysis to serve as a strategic asset, from first-in-human entry through approval, lifecycle management, and value demonstration.


Why Attend

  • 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

 

Webinar 1: Start Right, Finish Strong: Antibody-Drug Conjugate (ADC) Studies for Success

Tuesday, February 17, 2026 · 11:00 a.m. Eastern Time (US & Canada) (GMT -5:00)   

Fran Brown Senior Vice President, Certara Drug Development Solutions - Certara

Piet van der Graaf Senior Vice President, Quantitative Systems Pharmacology - Certara

Helen-Marie Dunmore, MSc Senior Director, Toxicology, Certara Drug Development Solutions


 

Webinar 2: Right Dose, Right Regimen: Model-Informed Strategies for Antibody–Drug Conjugates (ADCs)

Tuesday, March 17, 2026 · 11:00 a.m. Eastern Time (US & Canada) (GMT -4:00)   

Felix Stader Senior Research Scientist, Simcyp Division

Khaled Benkali, PhD, MBA Senior Director, Team Lead, Clinical Pharmacology

Armin Sepp Senior Principal Scientist, Certara Simcyp


 

Webinar 3: Extending the Value of Antibody–Drug Conjugates (ADCs): Model-Informed Labeling, Expansion, and Market Access

Thursday, April 2, 2026 · 11:00 a.m. Eastern Time (US & Canada) (GMT -4:00) 

Ananth Kadambi, PhD VP, Real World Evidence & Modeling Solutions

Amy Cheung, PhD  VP, Europe/APAC Regional Lead of Quantitative Science, Global Lead of Certara’s Pediatric and Maternal Innovation Engine

Roman Casciano, PhD, MEng SVP, Evidence & Access

Isabelle Deprez Director, Consulting