My research project has focused on understanding the gastrointestinal (GI) drug transfer and GI contents’ composition under fed state conditions, and exploring areas for improving the simulation of relevant processes and characteristics in vitro.
Towards this end, a clinical study was performed to collect samples from the stomach and the upper small intestine of healthy adults after administration of two model drugs and the standard meal suggested by regulatory authorities (FDA, EMA) to induce fed state conditions in bioequivalence/bioavailability studies. Drug levels were measured to inform on the GI drug transfer process. In the same time, physicochemical characteristics of luminal contents that are relevant to oral drug absorption were quantified. In addition, experiments with TIM-1, a multi-compartmental dynamic model mimicking the upper and middle GI tract, were performed to evaluate reproducibility of the clinical study data.
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.)?
Only few publications are available in literature to date on the GI drug transfer process in the fed state.
Characteristics of luminal contents such as the buffer capacity, osmolality, viscosity, lipid species’ and bile acids’ content were measured for the first time after administration of the standard meal.
Suggestions on how to address the GI drug transfer process and luminal characteristics after the standard meal in in vitro methodologies were made, based for the first time on actual luminal data. Specific comments for improving the in vivo relevance of TIM-1 data under fed state simulating conditions were also made.
3. What were your personal highlights over the course of your research project (training, results, awards, networking etc.)?
Being part of a European-wide training network bridging academia, industry and regulatory authorities was the highlight of my PhD. Insight into all three sectors allowed for developing a multidimensional skillset that helped me launch my project and is also invaluable to my professional career. Collaboration with prominent scientists and highly motivated fellow ESRs within the network was priceless. The opportunity to attend international workshops and conferences was another incontestable asset of the programme.
4. Are there any elements of the training you received that you find should be integrated in local doctoral programmes?
Both the regulatory and industrial secondments were among the greatest of opportunities offered within PEARRL. Much as industrial collaborations are regularly part of doctoral projects, the regulatory part is rarely given similar attention. My personal short experience in BfArM definitely provided me with very instructive training, allowing me a clear and more spherical view on medicines’ regulatory matters that should be proven useful to my future career.
5. How did the PEARRL network impact your doctoral experience?
The PEARRL network markedly benefited my doctoral experience through all the above mentioned opportunities offered. In the end of this PhD adventure, I would like to extend my sincere and heartfelt gratitude towards all the members of the consortium for the constructive advice, cooperation, fruitful scientific discussions, knowledge exchange, and friendship during the project.
6. What are your plans for the future?
I have recently started a position in the Clinical Research Department of ELPEN Pharmaceutical Co. Inc. in Greece, where I can apply many of the skills acquired during my PhD.