From dose escalation to dose optimization: Making model-informed early clinical development work in practice
Friday, October 30 at 15:00 GMT | 16:00 CET | 11:00 EDT | 08:00 PDT
Early clinical development is moving beyond traditional toxicity-driven dose escalation towards a more integrated approach to dose optimization. This evolution is also reflected in the regulatory landscape, with the recently finalized ICH M15 guideline providing an international framework for the planning, assessment and use of Model-Informed Drug Development evidence to support decision-making.
This webinar will explore how safety, PK/PD, biomarker and early efficacy information can collectively support timely, evidence-based clinical decisions. From Clinical Operations and Clinical Biometry perspectives, including PK/PD and pharmacometrics, the speakers will discuss what needs to be planned upfront, how data from different sources can be made available and decision-ready during study conduct, and how effective governance connects emerging evidence with dose and cohort decisions. The session will also consider how a Model-Informed approach can reduce uncertainty and inform the broader development strategy, including target population selection and later-stage study design.
Certificate of attendance
If you attend the live webinar, you will automatically receive a certificate of attendance, including a learning outcomes summary, for continuing education purposes.
If you view the on-demand webinar, you can request a certificate of attendance by emailing editor@selectscience.net.
Webinar details
Cost: Free to attend
Location: Online
Duration: 60 minutes
Registration is required to secure your place. If you register but can’t attend live, you will receive a link to the on‑demand recording once it becomes available.
Speakers
Who should attend?
Clinical development decision-makers involved in planning, executing or outsourcing early clinical programmes, including:
- Chief medical officers
- Chief development officers
- Heads of clinical pharmacology
- Quantitative pharmacology and translational medicine
- VPs/Directors of clinical development; program and outsourcing leads
- Clinical pharmacology/quantitative sciences teams evaluating external development partners
This webinar is also particularly relevant to small and mid-sized biotech companies that need to externalize multiple capabilities while maintaining an integrated development strategy.
What will this webinar cover?
- Why early clinical development is moving from dose escalation towards evidence-based dose optimization.
- How a Model-Informed approach can support clinical decision-making through the combined use of clinical, PK/PD, biomarker and efficacy information around key decision points.
- The operational, data-flow and governance elements that need to be planned upfront to enable timely dose and cohort decisions.
- How integrated early clinical evidence can inform the broader development strategy, including target population selection and later-stage study design.