Exploring Pharmacodynamic Safety Profiles for Successful Clinical Translation

Time: 3:50 pm
day: Day One


• Dissecting various dosing strategies and dosing versus efficacy

• Addressing translational challenges of extrapolating animal dosage predictions and demonstrating optimal doses

• How can we demonstrate a clear mechanistic route between dose, mechanisms of action and endpoints?

• How can we increase the probability of dosing high enough to reach efficacious concentrations and ensure target engagement?

• What are the best end points for your mechanism of action and what are the biomarkers that align with your primary endpoints?

• How do we ensure safety and efficacy going into the clinic?

• How do we implement biomarkers from the safety point of view ?