9. Modelling and simulation for the early development of a modified administration route

Team:Prof Mauro Gasparini (Polito-IT), Dr Tina Mϋller (Bayer-DE)
Clinical Advisor: Dr Edda Battaglia, doctor at the Gastroenterology and Endoscopy Unit at the Cardinal Massaja Hospital in Asti, Italy.
Location: Politecnico di Torino (Turin, Italy)

During the development of novel treatments, the route of administration is sometimes changed, e.g. from subcutaneous to intravenous injection. In such situations, PK/PD models can be modified to account for these changes by altering an existing pharmacological model. In practice, this will mean reformulating the model to account for the changes, make relevant simulations to assess their impact, and finally collect new data that allow the sponsor to start the clinical development of the new formulation.

In this project a Bayesian framework will be developed that allows formal inclusion of previously collected information in the models. The framework will allow the previous data to be merged and tuned with accumulating data from the new administration route. Personalized predictions and optimal strategies will therefore be made possible by individualizing the model via patient-specific characteristics.

Meet our Early Stage Researcher: Elvira Erhardt, Politecnico di Torino

I obtained my Master degree in Biostatistics at the University of Ulm (Germany) in 2015, where I had previously earned a Bachelor degree in the same specialization. For my thesis I investigated the topic “Evaluation of the impact of a clinical hold in survival studies under different assumptions regarding the true effect” at the Biostatistics department of Merck Serono in Darmstadt (Germany).

Due to a double-degree-program I also hold an American Master degree in Operations Research from the Florida Institute of Technology.

I am currently enrolled as a PhD student in Pure and Applied Mathematics at the Politecnico di Torino (Italy). My research focus as Marie Curie ESR is models and simulations for the early development of a modified administration route.

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