Rosa Webinar Series

Webinar Program

VPs... You got to know when to hold them, know when to remove them, know when to resample, know when to run.

• Christina Friedrich, PhD, Chief Engineer, Rosa & Co, San Carlos, CA

• Stephen Duffull, PhD, Professor, (1) Senior Scientific Advisor, Certara, (2) Otago Pharmacometrics Group, School of Pharmacy, University of Otago, Dunedin, New Zealand

• Theodore Rieger, PhD, Associate Research Fellow, Pfizer Inc, Cambridge, MA

• Kapil Gadkar, PhD, Staff Scientist, Denali Therapeutics, South San Francisco, CA

Typically, the workflow of a QSP model includes the creation, simulation, and analysis of Virtual Patients (VPs). VPs are parametric variations of a QSP model, and are used to explore the systemic implications of the uncertainty and variability of the model’s parameters. Simulation of VPs provides an understanding of the mechanistic drivers of clinical variability and predict the range of responses to a novel therapy. Special ensembles of VPs, termed Virtual Populations (VPops), predict the distribution of responses to novel protocols or therapies. Over the past decade, sophisticated techniques have emerged to automate the creation of VPs and VPops.

However, how confident are we that Vpops generate plausible clinical responses to therapeutics? Like the mechanistic physiology they represent, QSP models are complex and non-linear. Might these features lead to either unexpected or non-physiological solutions? What risk does this pose for use of QSP in decision-making? Is emergent behavior, that might not match our intuition, a strength or a weakness of QSP models?

In this webinar, we will explore these questions with a panel of QSP experts. Drs. Stephen Duffull, Ted Rieger, and Christina Friedrich will share their perspectives and participate in a panel discussion moderated by Dr. Kapil Gadkar.