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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

Interview with Alexandra-Roxana Ilie (ESR14)

9/17/2020

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We would like to congratulate Roxana who has recently successfully defended her PhD. Within the PEARRL project, Roxana's individual project focused on establishing a biopharmaceutics tool to investigate the in vivo performance of supersaturated SNEDDS, useing the in vitro understanding to develop an in silico model to predict the in vivo performance and comparing the in vitro and in silico predictions to observations in vivo. In a short interview Roxana explains more about her project and the impact of PEARRL on her research and training.

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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?
My research project was focused on the design and development of supersaturated lipid-based drug delivery systems (sLBDDS) for applications in pharmaceutical industry. Given that many novel drug candidates in pipelines are poorly water-soluble drugs, development of bio-enabling strategies such as sLBDDS are needed. Supersaturated lipid systems have the advantage of low-tech manufacturing methodology, ability to load high drug concentrations and improved drug absorption via excipient-mediated effects relative to conventional formulations. The work in my research project showed that sLBDDS can be designed for a range of poorly water-soluble drugs, that should have good lipid solubility and a high glass forming ability. Furthermore, it was concluded that simple one or two component lipid systems have the advantage of streamlining drug development processes and the better performance in comparison to more complex three component systems was shown. Furthermore, the use of two in vitro dispersion/digestion-permeation models has been successfully investigated with sLBDDS. Optimizations such as inclusion of precipitation inhibitors in sLBDDS improved drug absorption of cinnarizine, a drug which presented poor stability in lipid systems. To sum up, the work tackled three research pillars of design, development and optimization of supersaturated lipid-based drug delivery systems.    
 
2. What impact does your research project and your outcomes have? 
The different insights into design, development and optimization of supersaturated lipid-based drug delivery systems in a pharmaceutical industry setting sparked the interest of formulation scientists for such technology. The guidance maps and flow charts presented in my PhD thesis will be shared with the different groups in R&D and will serve as starting point for further development of these lipid systems. These will potentially determine inclusion of sLBDDS as formulation options in preclinical and clinical testing and will advance the development in the field. 

3. What were your personal highlights over the course of your research project?
To me, the whole PERAAL experience was like a “dream come true” since I always wanted to do a PhD project in pharmaceutical industry. Even though in some aspects I missed the academic student life, the leanings I got from my colleagues in Janssen Pharmaceutica were of immense importance for my development. I feel that I was shaped as a rigorous scientist, who can handle different scientific or practical challenges, pays great attention to details and is always ready to “advertise” the research in order to set-up novel experimental designs. Several workshops and courses were also very relevant and covered very important topics such as development of scientific writing competencies, presentation and communication skills.
 
4. Are there any elements of the training you received that you find should be integrated in local doctoral programmes?
From PEARRL, I enjoyed the most the possibility to go on secondments. I think inclusion of these are a fantastic idea. For me both the regulatory secondment at the Medicines and Healthcare products Regulatory Agency and at the University of Southern Denmark were exceptional experiences where I learned so many novel skills, interacted with very interesting people and also expanded my experimental results and publications portfolio.

5. How did the PEARRL network impact your doctoral experience? 
The PEARRL network greatly benefited my doctoral experience from both professional and personal perspectives. From a professional point of view, I enjoyed a lot sharing my research at international conferences or during symposia, discussing my results and identifying opportunities for improvement. Getting to know so many highly educated people enriched my ability to communicate, to network and create strong interpersonal connections.   

6. What are your plans for the future? 
After my PhD, I returned to my home country, to bring some of the knowledge accumulated internationally “back home” and to add value to social and professional aspects in Romania. I will soon start a position at a Romanian pharmaceutical company as Formulation and Analytical Scientist. This will allow me to continue my career in R&D, while advancing my knowledge in late stage drug development processes and manufacturing technological transfers for Parenterals.

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Interview with Laura Henze

9/4/2020

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Laura Henze has recently successfully defended her PhD online on exploring the utility of the porcine model for predicting bio-enabling oral drug products performance in humans. We have taken this opportunity to ask her some questions in an interview on her research, her experience in PEARRL and her plans for the future.
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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?
My research project focused on the suitability of the pig as a preclinical model in oral drug product development. We established in vitro- in silico models for the pig that improve interpretation of preclinical results which can streamline the drug development process.
 
2. What impact does your research project and your outcomes have?

The pig biorelevant medium developed as part of this work will be hugely beneficial to industry during the drug development process, streamlining early phases in preclinical development phases. Obtaining relevant information at an early stage of development facilitates a more efficient development process, which can save time and money for industry, as well as enabling earlier access of patients to new medicines. By incorporating species specific in vitro – in silico tools, a better understanding of the factors affecting the performance of the drug can be achieved. This should help to reduce the number of animals required in the future, highly beneficial from both a resource and ethical point of view.

3. What were your personal highlights over the course of your research project?
The training provided within the PEARRL project helped me to continue to develop and progress professionally by gaining new skills and knowledge. It was a great experience to work in an international network with experts in the field, with an added benefit of getting very constructive feedback to improve your research, and discuss the latest results of your research. In addition, it was a great opportunity to build collaborations between all the projects, work packages and partners involved in PEARRL. Several conferences and workshops gave us an opportunity to present and talk about our research.

4. Are there any elements of the training you received that you find should be integrated in local doctoral programmes?
I think the regulatory secondments were a great part of the PEARRL project. I really enjoyed my secondment at the HPRA in Dublin, it was great to experience the regulatory environment. Further training provided at the PEARRLs of wisdom weeks were hugely enjoyable.

5. How did the PEARRL network impact your doctoral experience?
Being part of the PEARRL network hugely benefited my doctoral experience, a key part was European wide network that combines academia, industry and regulatory authorities. Especially the chance of being in contact and getting feedback from experts around the globe improved my work enormously.
 
6. What are your plans for the future?
I have recently started a position as a Postdoc at Janssen Pharmaceutica in Beerse Belgium, as part of the Dissolution Sciences team.
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Interview with Sandra Jankovic

9/3/2020

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Sandra (ESR5) has been studing computational methods and novel in vitro tools according to their suitability to support the development of solid dispersions. She recently successfully defended her PhD and we held a short interview with her to find out more about her experience within PEARRL.

1. What has your research project focused on and what are your key results and innovations coming from your research project?
My research project was about new analytical approaches for solid dispersion characterizations. Solid dispersions are one of the technologies employed to improve the apparent solubility of poorly soluble drugs. In my dissertation thesis I worked on Fluorescence Spectroscopy and Diffusing Wave Spectroscopy and show their potential as a novel approaches to gain a deeper understanding of both manufacturing but also dissolution behavior of amorphous solid dispersions.

2. What impact does your research project and your outcomes have?
There is still a lack of understanding of the dissolution behaviour of ASDs so there is a high need for novel analytical approaches mainly for the drug development.

3. What were your personal highlights over the course of your research project? 
I improved my presentation and writing skills and at the same time living abroad gave me the opportunity to learn a new culture and new research approaches.  What I liked most about the Marie Curie Fellowship is the opportunity to live and learn about another country and its research environment. I am grateful to the people I meet who enriched my journey.

4. Are there any elements of the training you received that you find should be integrated in local doctoral programmes?
I would integrate more presentations and scientific discussions at my local University. One of mine wishes is that a Marie Curie Fellowship implement free courses of the local language. It helps to integrate in the new environment and the research would benefit as well.

5. How did the PEARRL network impact your doctoral experience?
I enjoyed collaborating within PEARRL on different topics and broader my knowledge in other fields of pharmaceutical sciences.
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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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