Malte Bøgh Senniksen

ESR 12: Application of an end–to-end, animal-free modelling approach to the development of enabling drug products: focus on amorphous solid dispersions (ASD)

Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Germany (Fraunhofer)

Supervisor: Prof. Jennifer Dressman (Fraunhofer)

Planned secondments: Roche (Purpose: Comparison of end-to-end approach versus current industrial workflow)             Certara (Purpose: PBPK modelling using the SimCYP Simulator®)

Project Description

The scientific objectives of the ESR 12 project are to 1) Apply the rDCS to assess suitability of various drugs for formulation as an ASD. 2) Develop a computational pharmaceutics approach for ASD formulation design, and 3) Couple Biorelevant in vitro testing with PBPK modelling to simulate bioavailability advantages of the prototype ASDs. The end-to-end modelling approach will be compared to current screening practices at Roche, with the interest of increasing the ability to predict the optimal formulation composition for a given drug. This innovation is expected to improve market viability for new drugs, improve efficacy for existing drugs and lead to a new “best practices” workflow for ASD formulations.

Background

Malte Bøgh Senniksen holds a bachelor’s degree in pharmacy and a master’s degree in pharmaceutical sciences from the University of Copenhagen.

Throughout his education Malte has had a special interest in the design and development of drug delivery systems and dosage forms for oral administration. An interest that has been the driving force for multiple academic placements during his studies. Malte spent one year from 2018-2019 as an undergraduate research assistant to develop a microgram scale video-microscopic method to investigate dissolution behaviour of poorly water-soluble drugs at the physiological pharmaceutics groups, University of Copenhagen, Denmark, supervised by Professor Anette Müllertz and Professor Thomas Rades. In 2020 Malte spent half a year of research to characterize 3D-printed solid SMEDDS formulations at Monash institute for pharmaceutical sciences, Monash University in Melbourne, Australia, supervised by Professor Benjamin Boyd. Most recently Malte spent half a year from 2020-2021 at the formulation R&D department at Roche in Basel, Switzerland, where he carried out his master’s thesis work concerning the formulation design of tablets for supersaturated drug delivery, supervised by Professor Thomas Rades from the University of Copenhagen and Dr. Felix Ditzinger from Roche.

As an ESR in the InPharma consortium, Malte will now focus on optimizing the development and performance of amorphous solid dispersions (ASDs) intended to enhance systemic absorption of poorly soluble drugs and predicting the in vivo performance of ASDs after oral administration with an animal-free modelling approach.