Cytel is partnering with LIDE Biotech to conduct a series of webinars, in exploring the use of co-clinical trials in expediting drug development for cancer patients. Co-clinical trials uses functional diagnostic testing and clinical trials, conducted simultaneously, to enable real-time data integration to accurately stratify and customize treatment for patients individually. 

During the third webinar in this series, Michael Fossler and James Matcham will provide why a key aim in early oncology drug development is to estimate the Recommended Phase 2 Dose (RP2D) and to investigate which patient populations are optimal for further treatment. The FDA’s Project Optimus initiative also sets expectation to evaluate a wider range of doses in development rather than focusing on using maximum tolerated dose approach for pivotal trials.  During the third webinar in this series, our speakers will outline the types of dose escalation designs that are available and highlight the evolving Basket designs that investigate biomarker defined patient populations. The role of PK/PD modelling in determining the RP2D and schedule will also be emphasized.

In this webinar the speaker will discuss:

• Dose Escalation Design Options
• Basket Study Design Options
• PK/PD Modelling for identifying the RP2D

Meet the Speakers: 

• James Matcham, Vice President, SC QS&DS
• Michael Fossler, Vice President, Strategic Consulting