. What has your research project focused on and what are your key results and innovations coming from your research project?
My project focused on the development of patient-centric biopharmaceutics testing, specifically, new in vivo and in silico tools and methodologies were proposed to evaluate paediatric formulations. Currently, bioavailability and bioequivalence studies for paediatric formulations are mainly performed in healthy adults following protocols applied for adult drug products. An exploratory bioavailability study in healthy adults was designed and performed to understand the impact of age-specific foods on oral drug absorption for the first time; next, a physiologically based pharmacokinetic (PBPK) modeling approach to translate the data acquired in adults to the target paediatric population was proposed. Additionally, bioavailability data acquired from a preclinical animal model (Beagle dogs) applying different dosing conditions were evaluated regarding their usefulness to inform paediatric drug product development in combination with PBPK modeling and to predict formulation performance in paediatrics.
2. What impact does your research project and your outcomes have?
Development and availability of biopharmaceutics tools is of paramount importance in populations where clinical testing in the target population is limited by ethical concerns. The proposed study design and PBPK modeling workflows can contribute to the biopharmaceutics risk assessment for paediatric medicines, which would further facilitate the development of safe and effective paediatric medicines. The proposed workflow could accelerate paediatric product development timelines, resulting in faster access to medicines specifically tailored for the different age groups of paediatric patients.
3. What were your personal highlights over the course of your research project?
The training and networking opportunities from the PEARRL consortium were a highlight for me, as they helped me grow professionally and gain new skills and knowledge. The PEARRL Wisdom Weeks provided a unique platform to share recent scientific advances from each project, receive constructive feedback from the experts in the pharmaceutical field, and above all encouraged networking and collaborations within and outside the PEARRL consortium. During my industrial and regulatory secondments, I gained valuable insights into different fields of pharmaceutical sciences within a dynamic environment with scientists from different backgrounds, which has been beneficial for improving team-working abilities and cross-functional collaborations.
4. Are there any elements of the training you received that you find should be integrated in local doctoral programmes?
The training received on PBPK modeling and regulatory sciences are highly relevant for a successful and efficient pharmaceutical development. PBPK platforms have immense potential to inform drug product development not only for adults, but also for special populations and different patient groups. Furthermore, knowledge in regulatory sciences can be integrated throughout the development process, which would facilitate regulatory evaluation, increase chances for approval and ensure the needed medication reaches the patients.
My project focused on the development of patient-centric biopharmaceutics testing, specifically, new in vivo and in silico tools and methodologies were proposed to evaluate paediatric formulations. Currently, bioavailability and bioequivalence studies for paediatric formulations are mainly performed in healthy adults following protocols applied for adult drug products. An exploratory bioavailability study in healthy adults was designed and performed to understand the impact of age-specific foods on oral drug absorption for the first time; next, a physiologically based pharmacokinetic (PBPK) modeling approach to translate the data acquired in adults to the target paediatric population was proposed. Additionally, bioavailability data acquired from a preclinical animal model (Beagle dogs) applying different dosing conditions were evaluated regarding their usefulness to inform paediatric drug product development in combination with PBPK modeling and to predict formulation performance in paediatrics.
2. What impact does your research project and your outcomes have?
Development and availability of biopharmaceutics tools is of paramount importance in populations where clinical testing in the target population is limited by ethical concerns. The proposed study design and PBPK modeling workflows can contribute to the biopharmaceutics risk assessment for paediatric medicines, which would further facilitate the development of safe and effective paediatric medicines. The proposed workflow could accelerate paediatric product development timelines, resulting in faster access to medicines specifically tailored for the different age groups of paediatric patients.
3. What were your personal highlights over the course of your research project?
The training and networking opportunities from the PEARRL consortium were a highlight for me, as they helped me grow professionally and gain new skills and knowledge. The PEARRL Wisdom Weeks provided a unique platform to share recent scientific advances from each project, receive constructive feedback from the experts in the pharmaceutical field, and above all encouraged networking and collaborations within and outside the PEARRL consortium. During my industrial and regulatory secondments, I gained valuable insights into different fields of pharmaceutical sciences within a dynamic environment with scientists from different backgrounds, which has been beneficial for improving team-working abilities and cross-functional collaborations.
4. Are there any elements of the training you received that you find should be integrated in local doctoral programmes?
The training received on PBPK modeling and regulatory sciences are highly relevant for a successful and efficient pharmaceutical development. PBPK platforms have immense potential to inform drug product development not only for adults, but also for special populations and different patient groups. Furthermore, knowledge in regulatory sciences can be integrated throughout the development process, which would facilitate regulatory evaluation, increase chances for approval and ensure the needed medication reaches the patients.
5. How did the PEARRL network impact your doctoral experience? The PEARRL network had a huge impact on my doctoral experience, as the PEARRL team atmosphere was present from the very beginning. From professional point of view, it provided an opportunity to discuss the course of the scientific work with experts from the biopharmaceutic and pharmaceutical field who offered invaluable constructive feedback. The PEARRL trainings and the presentations from fellow scientists broadened my knowledge on different aspects of drug formulation and biopharmaceutics evaluation, which will be undoubtedly helpful for my future career path. Last but not least, PEARRL introduced me to like-minded and motivated scientists from different countries, whose ultimate goal was to improve patient’s lives through innovation. |
6. What are your plans for the future?
I recently joined Novartis AG as a Senior Expert Data Scientist within the Biopharmaceutics Team. In this role, I will be not only contributing to medicines development with the knowledge and skills gained during my PhD studies, but will be able to further develop my expertise in the field.
I recently joined Novartis AG as a Senior Expert Data Scientist within the Biopharmaceutics Team. In this role, I will be not only contributing to medicines development with the knowledge and skills gained during my PhD studies, but will be able to further develop my expertise in the field.