Sponsored by Certara
Building regulatory-ready, defensible FIH packages for ADC programs
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 the 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.
Key Takeaways
• 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
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Her past appointments include leadership roles within large Pharma as well as in small biotech organizations including head of clinical pharmacology, clinical leader, project development leader, head of clinical operations and due diligence asset assessment. She has over 10 years of experience in providing consulting advice to the pharmaceutical industry and non-profit Global Health Organizations ranging from individual project support to strategic TA strategy and development planning, portfolio management and corporate transformation. She joined Certara in 2017 and is currently the SVP of Drug Development Science within Integrated Drug Development.
Here is how Helen-Marie can help you:
• Extensive expertise in managing complex non-clinical R&D projects across diverse therapeutic areas, including oncology, gene therapy, and rare diseases, leading to successful marketing authorization applications.
• Strong leadership in providing strategic non-clinical advice for first-in-human clinical trials and regulatory submissions, including guidance for FDA and EMA processes.
• Proven experience at MHRA in reviewing clinical trial applications and optimizing study designs, ensuring effective transition of therapies from research to clinical development.
