Drug development moves faster than the guidance written to govern it. New kinds of molecules keep arriving, and the dose-setting conventions built for simpler drugs don’t always hold. Most teams still have to make the first-in-human call with an incomplete data package, a fixed IND date, and a budget that won’t cover every analysis on the wish list.
The result is a decision made by default rather than by design. A starting dose that’s too conservative adds cohorts, months, and cost to escalation. An approach that’s too simplistic can invite regulatory pushback and raise safety concerns.
This 60-minute session is about the decision itself. Four Certara translational scientists will walk through how to find the fit-for-purpose approach for a given program, one that accounts for the molecule’s pharmacology, the biology behind its response, and the data actually in hand. Case studies show what that looks like in practice, including programs that combined more than one approach.
You’ll leave with a clearer way to pressure-test your own program’s approach, including how to recognize when your current plan is already 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.
This webinar is ideal for:
Translational scientists, clinical pharmacologists, preclinical and early development leads, pharmacometricians, regulatory strategists, and program leaders responsible for IND-enabling decisions and FIH dose justification.
Speakers:
Elliot Offman, BSc Pharm, MSc, PhD
Vice President, Clinical Pharmacology & Translational Medicine, Certara Drug Development Solution
Martin Beliveau
Vice President Consulting, Certara
Dr. Britta Wagenhuber
VP, Head of QSP Consultancy, Certara
Alex MacDonald, PhD
SVP, PBPK Consultancy
