"At Genentech, I found a lot of enthusiasm for cross functional collaborations around the implementation of novel modeling and simulation approaches to better understand the disease and the treatment effect to optimize drug development decisions and treatment options for patients. This comes with an extraordinary pipeline of innovative drugs as well as a group of passionate scientists and makes this a great place to be."
I have been providing scientific leadership in the development and application of Modeling and Simulation (M&S) in drug development during the past 35 years. I initiated and led M&S groups in Rhone-Poulenc Rorer (1987-2000) and Genentech in a previous tenure (2000-2003, Sr. Scientist, Head of Pharmacometrics). I spent 13 years with Pharsight/Certara Consulting Services (2003-2016, Managing Director) where I consulted and led M&S projects for many different companies from small biothechs to major pharmas. I joined Genentech back in 2016 as Staff Scientist.
My specific research interest has been in oncology (and immuno-oncology) tumor growth inhibition modeling, including linking tumor dynamics to outcomes data such as Overall Survival, and application of these models to trial design and development decisions in early and late stage projects. I have published 76 peer-reviewed research articles, 19 invited book chapters, reviews, and commentaries, and delivered 60+ invited lectures at global scientific conferences and universities.
I am one of the founding members of the Population Approach Group in Europe (PAGE) and hosted the 1st meeting in 1993 in Paris. I have been a member of the International Society of Pharmacometrics (ISoP) Board of Directors (2012-2017) and served as ISoP president (2016-2017).
As M&S Lead for a late-stage immunotherapy , I could deploy tumor growth inhibition-overall survival model simulations to address a variety of key Clinical Pharmacological questions as part of regular filing activities and to support ongoing discussions with regulatory agencies. My focus is now to implement these approaches to speed-up early decisions for immunotherapy combinations.