Date: Tuesday, September 29, 2026
Time: 10:00 - 11:00am ET
Summary
Drug development keeps outpacing the guidance written to govern it. Modalities have multiplied, multispecifics, ADCs, cell therapies, radiotherapeutics, oligos and the dose-setting conventions built for simpler molecules don’t always hold. Meanwhile, most teams are making the first-in-human call under real constraints: an incomplete nonclinical package, a fixed IND date, and a budget that won’t stretch to every analysis on the wish list.
The result is a decision that gets made by default rather than by design. A starting dose that’s too conservative adds cohorts, months, and cost to escalation. One built on assumptions the molecule violates carries risk in the other direction.
This 60-minute session is about the decision itself. Four Certara translational scientists will walk through the full spectrum of FIH dose prediction approaches: MABEL, PK/PD and target-engagement, mPAD, PBPK, and QSP, with a common framework for each: what it actually estimates, what data it demands, and the specific situations where it earns its complexity. Illustrative case studies show each approach in practice, including where two or more were combined.
You’ll leave with a clearer way to pressure-test your own program’s approach, including how to recognize when your current plan is the right one.
Key learning objectives:
- Match the method to the molecule: test modality, target biology, and available data against what each approach assumes, and find where those assumptions break.
- Weigh complexity against constraints: decide how much modeling the question actually warrants given your data, timeline, and budget.
- Plan past the first dose: combine approaches instead of choosing between them, and account for how today’s choice shapes later escalation.
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Elliot Offman, BSc Pharm, MSc, PhD
Vice President, Clinical Pharmacology & Translational Medicine, Certara Drug Development SolutionDr. Offman has over 20 years of drug development experience and joined Certara in 2017 where he leads translational pharmacokinetic and pharmacodynamic efforts in Certara’s Clinical Pharmacology & Translational Medicine group.
Martin Beliveau
Vice President Consulting, CertaraDr. Martin Beliveau has over 10 years of modeling experience in clinical pharmacology. He joined Certara Strategic Consulting in 2007. Before that, he was a pharmacokinetic scientist and Study Director at Charles River Laboratories. His entire career has been in the area of pharmacokinetic analysis, modeling and simulation for regulatory submissions and decision making. His work covers areas a wide range of indications with a particular focus on translational medicine, first-in-human predictions and biodefence.
Dr. Martin Beliveau received a PhD in Public Health from the Université de Montreal under Dr. Kannan Krishnan in physiologically-based pharmacokinetic modeling in 2004. Aside from his modeling/simulation activities, Martin enjoys reading a good Spider-Man story.
Dr. Britta Wagenhuber
VP, Head of QSP Consultancy, CertaraBritta oversees QSP projects and quantitative pharmacology strategy. She advances virtual patient engines and in-silico clinical trials to impact drug research and development, improve portfolio decisions, increase probability of success, and accelerate development of innovative medication for patients. With more than 14 years of experience in the pharmaceutical industry, she brings remarkable expertise and proven track record of delivering high value modeling & simulation solutions for diverse modalities across therapeutic areas. Britta holds a PhD in Computational Life Science from Luebeck University.
Alex MacDonald, PhD
SVP, PBPK ConsultancyDr. Alex MacDonald is a quantitative clinical pharmacologist with experience across the Pharma/Biotech, consulting and government sectors. Alex brings more than 25 years of experience in clinical pharmacology, pharmacokinetics, and modeling and simulation across the full drug development spectrum, from early discovery and translational science through late-stage regulatory submissions and post-marketing activities.
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