15/10/2018 3DNeonet

Seeing the Regulatory World Through Spanish Lenses!

By Marina Zaki (UCD-Ireland to Ocupharm-Spain)

My name is Marina and I’m here to tell you about my journey with 3D-NEONET! I am a biomedical scientist turned social scientist – but that didn’t stop 3D-NEONET from including me in their very inspiring and diverse consortium! As a pharmacology graduate who swaped my lab coat for a voice recorder, I never thought I would be so fortunate to call myself a Marie Curie fellow! I have Prof. Breandán Kennedy and Dr. Yolanda Alvarez to thank for what was truly a wonderful experience – introducing me to a new world of medical device regulations, ocular therapeutics and of course, delicious Spanish food!n more welcoming.

My secondment, part of Work Package 3, was encouraged by my PhD in clinical trials. 5 months of collaboration later, I packed my bags for Spain, to spend 6 weeks in OcuPharm, a CRO based in the Faculty of Optics and Optometry in the Universidad Complutense de Madrid. Breandán, Yolanda and my new work family at OcuPharm could not have been more welcoming.

My secondment allowed me to gain experience of being involved in a clinical trial, understanding it from the patients perspective – which was quite important since my PhD is very much behind the scenes looking at trial methodology. I got to understand the challenges of trials gaining ethical approval, which, despite the language barrier and having to translate some documents, proved to be rather rewarding and definitely improved mi español!

I was introduced to their state of the art Optometry clinics and shown around the cutting edge labs and facilities available for for both pre-clinical and clinical research. My secondment in OcuPharm gave me the chance to collaborate with different disciplines, showing me the true meaning of inter-disciplinary research. I worked with optometrists, biochemists, pharmacologists and a pharmacoeconomist to achieve my objectives and gain different insights. Of course, the scientific side was priority, but I had entered tourist mode from day 1! No doubt, I made the most of the Spanish sun exploring the capital city, in awe of the architecture and wonderful sights. And I was also lucky to spend my birthday sight-seeing the beautiful Spain!

Under the supervision of the very knowledgeable Dr. Gonzalo Carracedo, I took the lead in writing my first soon-to-be-published paper! We looked at international medical device regulations in the context of contact lenses and lens care solutions.

We compared and contrasted FDA and EU regulations, noted some key challenges in the medical device regulatory field, physio-chemical tests and the emerging field for lenses to be used as ocular therapeutics. The accurately named work package 3 task 1, truly allowed me to gain an “appreciation of requirements to bring therapeutics and medical devices through to clinical trials”!

Through our inter-disciplinary collaboration, we were able to put patient safety at the core of our paper and through these lenses (pun intended!), appreciate the necessity of regulations and testing. An exchange of knowledge was definitely at the centre of my secondment, where I learnt from the very experienced Dr. Basilio Colligris, Executive Director of OcuPharm Diagnostics SL. My first experience of an industry-academia collaboration – this secondment allowed me to understand the workings of a CRO and the elements required for OcuPharm to reach its current successful status.

No doubt, my secondment has given me a newfound set of transferable skills and accomplishments for my C.V.! I was honoured to receive runner-up poster prize at the Ocular Therapeutics workshop in UCD in June 2018, from the work I did in OcuPharm. Thank you 3D NEO-NET and the Marie Skłodowska-Curie Actions’ RISE fellowship for an amazing experience!

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