Building regulatory-ready, defensible FIH packages for ADC programs
Originally aired: Tuesday, February 17, 2026
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 guided attendees through the current ADC landscape, key lessons from recent successes and failures, and best practice approaches to FIH dose range selection. The session demonstrated 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.
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.
Key learning objectives:
- 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
Who should watch?
- 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
Presenters
- Fran Brown, PhD, Senior Vice President, Global Head, Drug Development Science
- Helen-Marie Dunmore, MSc, Senior Director, Toxicology, Certara Drug Development Solutions
- Piet van der Graaf, PharmD, PhD Senior Vice President and Head of Quantitative Systems Pharmacology
