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  • PEARRL Project
    • Beneficiaries
    • Partner Organisation
    • People >
      • Supervisors >
        • Prof. B. Griffin
        • Prof. M. Kuentz
        • Dr. C. Saal
        • Dr. L. Kalantzi
        • Dr. E. Kostewicz
        • Prof. C. Reppas
        • Prof. J. Dressman
        • Dr. N. Fotaki
        • Dr. R. Holm
        • Dr. M. Vertzoni
        • Dr. K. Box
        • Prof. C. O'Driscoll
      • Researchers >
        • Niklas Köhl (ESR1)
        • Felix Ditzinger (ESR 2)
        • Daniel Price (ESR 3)
        • Georgia Tsakiridou (ESR 4)
        • Sandra Jankovic (ESR 5)
        • Chara Litou (ESR 6)
        • Christina Pentafragka (ESR 7)
        • Rafael Leal Monteiro Paraiso (ESR 8)
        • Laura Henze (ESR 9)
        • Patrick O'Dwyer (ESR 10)
        • Marina Statelova (ESR 11)
        • Mariana Guimarães (ESR 12)
        • Ioannis Loisios-Konstantinidis (ESR 13)
        • Alexandra-Roxana Ilie (ESR 14)
        • Angela Effinger (ESR 15)
      • Scientific Advisory Board >
        • Prof. Carla Caramella
        • Dr. Paul Dickinson
        • Dr. Andrea Edginton
        • Dr. Susanne Keitel
        • Dr. Mehul Mehta
    • PEARRL Wiki >
      • FAQ
      • Glossary
  • Research
    • Workplan
    • WP1: Bio-enabling formulations
    • WP2: Biopharmaceutical tools
    • WP3: In silico methods
    • Results >
      • Scientific Publications
      • Conference Contributions
      • InfoPEARRLs
      • Media
  • Training
    • Local
    • Network-wide
    • PEARRL Online Learning Portal
    • Member Area
  • News
  • Events & Meetings
    • Webinar: Regulatory Science Apprentice
    • Annual Meeting 2019
    • Model Informed Drug Development Symposium 2019
    • Annual Meeting 2018
    • Regulatory Science Symposium 2018
    • Annual Meeting 2017
    • Regulatory Science Symposium 2017
    • PEARRL Calendar
    • International Conferences

Georgia Tsakiridou (ESR4) successfully defends her PhD and gives an interview!

5/29/2020

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Congratulations to Georgia Tsakiridou (ESR4) which after successfully defending her thesis via online meeting, has received her PhD. Find below a short interview with Georgia Tsakiridou about PEARRL and her future goals.
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1. What has your research project focused on and what are your key results and innovations coming from your research project?
Nowadays, more and more active pharmaceutical ingredients (APIs) present solubility problems. A common formulation choice for these APIs is the formulation of ASDs, where the API in the amorphous state is dispersed in a polymeric carrier. However, the development of these formulations is often hindered by the possible instability of the amorphous API, that tends to revert to its crystalline state during manufacturing and storage, and  by our difficulty in predicting adequately their in vivo behavior. With this work we introduced a workflow that enables the acceleration of the development of ASDs in a step by step manner, using Tacrolimus as a model API. First we introduced a novel rheology based method to the field of ASDs which enables the selection of appropriate polymers for the preparation of stable and successful ASDs, by connecting the viscosity of the API-polymer solutions to the miscibility of API and polymer, as it has been reported that API-polymer miscibility is crucial for ASD stability. The polymers deemed most appropriate were used in order to prepare tacrolimus ASDs via the Spray drying method in a design of experiment approach. Stability experiments showed that amorphous tacrolimus remained stable even 6 months after preparation, further verifying the importance of the rheology-based method. On the second front of predicting the in vivo behavior of ASDs we investigated the usefulness of the apparatus IV, using biorelevant media that mimic the conditions in the gastrointestinal lumen, in predicting the in vivo performance of 2 commercial tacrolimus formulations and one test formulation prepared based on the output of the rheology based method. It was revealed that the dissolution data from the apparatus IV showed a good predictive ability for the initial exposure of these formulations in vivo, which underlines the need to move towards more biorelevant set-ups and apparatuses that better mimic the physiological conditions in order to better capture the in vivo performance of ASDs.

2. What impact does your research project and your outcomes have (in your field of research, in drug development, any benefits for the general public etc.)?
ASDs are a very important part of drug development, as a formulation choice, because they provide many advantages. However, their commercial use is not as pronounced as it could be due to the bottlenecks in their development. In my opinion, this work provided a systemic way of dealing with these bottlenecks from early formulation choices to the in vivo performance of ASDs. Undoubtedly, this work shows many limitations but it could provide a framework for the potential acceleration of ASDs development, especially for APIs with similar characteristics to tacrolimus.

3. What were your personal highlights over the course of your research project (training, results, awards, networking etc.)?
It is definitely a combination of all those but I also distinguish the effect of the “PEARRL people” in this experience. It was a great opportunity to be able to converse with leaders in the field of pharmaceutics, who approached each of us with a truly inspiring love for teaching and science. It was also a wonderful experience to meet and collaborate with the other ESRs of the PEARRL network which was a great learning environment.

4. Are there any elements of the training you received that you find should be integrated in local doctoral programmes?
The importance of Physiologically based pharmacokinetic (PBPK) modelling is constantly being proven in the field of Pharmaceutics. Consequently, the fact that the PEARRL network gave me the opportunity to attend related workshops and familiarize with the topic was a great training experience that I believe would benefit other PhD candidates. Moreover, another great learning experience was the three months I spend in the Greek regulatory agency for medicines, as it provided an inside view of the work being done in the regulatory agencies, which is another aspect of the drug development process.

5. How did the PEARRL network impact your doctoral experience?
The fact that I was a member of the PEARRL network greatly affected my doctoral experience, as the sense of a team was very prominent from the beginning, not only due to the collaboration opportunities and monthly virtual meetings and annual conferences, but also due to the sense of moving towards the common goal of providing better medicine in a safer manner to the public. Moreover, another thing that greatly impacted my experience was the mobility that was introduced in the PEARRL program that allowed me to experience different working environments in academia, industry and the regulatory sector.

6. What are your plans for the future?
My future plans include working in the pharmaceutical sector at Pharmathen S/A in the department of Clinical Operations, where I can apply many skills acquired during my PhD, potentially including PBPK modelling. Moreover, my future plans, also, include raising a family.
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An interview with Felix Ditzinger (ESR2)

5/5/2020

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Felix Ditzinger (ESR2) has recently received his PhD. We would like to congratulate Felix on successfully defending his PhD and have held a short interview to hear about his experience in PEARRL.

1. What has your research project focused on and what are your key results and innovations coming from your research project?
The key aspect of my research was to explore new excipient combinations for hot melt extrusion (HME). We focussed on interacting small molecular additives in combination with established polymers to change the physico-chemical properties for a more feasible processing in HME. Such an approach should lead to new modified polymeric matrices, which broadens the selection of carriers for the development of an amorphous solid dispersion.
As a result of this project, we were able to develop various modified polymeric matrices and have demonstrated  the beneficial properties with regards to stability of the amorphous form, amount and duration of supersaturation in biorelevant media as well as downstream processing capabilities. Moreover, we could show in an in vivo rat study that the matrices are capable of improving the oral absorption of a poorly water-soluble drugs.
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2. What impact does your research project and your outcomes have (in your field of research, in drug development, any benefits for the general public etc.)?
The concept of my research, which includes the combination of small molecular additives with polymeric compounds, can be applied in the development of new drug products, especially if a feasible carrier cannot be found. In brief, this concept has the potential to enable more drugs to be formulated as an amorphous solid dispersion and consequently can lead to improved drug products on the market.

3. What were your personal highlights over the course of your research project (training, results, awards, networking etc.)?
In my opinion, the personal highlights of this project are not awards or only the results. The personal benefit of my research project lies also in the collaboration with my fellow ESRs and other partners. Through such a network, personal growth and the capability to work in a team-orientated environment are encouraged, which should be the focus in such a network.


4. Are there any elements of the training you received that you find should be integrated in local doctoral programmes?
The scientific writing training and the presentation training, I received during the Wisdom Weeks should be integrated in more doctoral programs, since those two things are a key aspect to success of every PhD.

5. How did the PEARRL network impact your doctoral experience?
Through my participation in the PEARRL network, I got the opportunity to collaborate with many fellow scientist and other people, which provided significant scientific results. Moreover, on the personal side I learned to organize projects with fellow ESRs, who were not located at my university. In line with the growth in social skills throughout the project, I was encouraged to become a more team-oriented researcher.

6. What are your plans for the future?
In the future, I am going to be working in the pharmaceutical industry at Roche, which gives me the opportunity to apply the capabilities I learned during my years in the PEARRL network. My working field will be the formulation development, which fits perfectly to the field I did my PhD in.
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This project has received funding from the European Union’s Horizon 2020 Research and Innovation Programme under grant agreement No 674909.
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