Navigating the regulatory pathway in early oncology development can be a challenging journey, especially in the context of designing first in human trials within the Project Optimus framework. Although, this guidance originates from the FDA, similar approaches are in place within the UK and EU, that encourage building dose optimization strategies into clinical development plans that aim to maximize not only the efficacy of a drug but the safety and tolerability for the patient as well.

This talk aims to shed some light on the impact of this guidance on early oncology trial design in practical terms, discuss how and when to talk to the regulatory agencies in the US, UK and EU and highlight the latest guidance and useful tools in all 3 regions to help you with the development of your early-stage assets.

Speakers:

• Stephen Rees, PhD

• Shamim Kazmi-Stokes, PhD

To register your attendance, please email shamim.kazmi-stokes@catalystcr.com