Conducting a successful oncology development program under Project Optimus requires increased emphasis on determining the optimal dose for the compound under study. Rather than a singular focus on the maximum tolerated dose (MTD), oncology drug development under Project Optimus requires one to develop an approach based on all available data. This includes safety (including all AE’s – not just dose-limiting toxicities), response rate, biomarker responses and pharmacokinetics.

The increased emphasis on determining the optimal dose has led to a number of changes in how clinical trials for oncology drugs are conducted. In this webinar, we will describe several case studies which will demonstrate the following:

Key topics

• The advantages of using novel adaptive trial designs over the standard 3+3 design in monotherapy and combination dose escalation
• Assessment of early efficacy by the use of Bayesian methods for decision-making, and the use of early phase basket studies
• The need to characterize the long-term safety of the drug under study
• The importance of developing exposure-response models as early as possible for your asset, and how these models can assist you in determining the optimal dose for your compound

Speakers

• James Matcham, Vice-President, Strategic Consulting, Statistics
• Michael J. Fossler, Vice-President, Strategic Consulting, Clinical Pharmacology and Pharmacometrics