El esfuerzo adicional
Sue Lee habla sobre su puesto en World Courier, los esfuerzos a los que se enfrentará su equipo para obtener lo mejor para cada paciente, y los desafíos y las ventajas de la región de Medio Oriente y África del Norte (MENA).
Published in Clinical Trials Insight
EPC: What was your entry point into the pharmaceutical
Sue Lee: I trained as a microbiologist, but it became clear that working in a lab all day was not the job for me—I wanted to spend my time with people rather than Petri dishes. When World Courier started moving patient samples and pharmaceutical shipments, I was lucky enough to be able to apply my existing knowledge and stay up-to-date with what was happening in healthcare.
Which part of your current role do you most enjoy?
Definitely being part of a community which is working to provide patients with medicines which will improve their quality of life, particularly in the developing world. Every day I work with people who are making this happen, and if I can assist with that process then I feel it has been a worthwhile day.
Which part is the most challenging?
Keeping current with everything that is going on, taking into account all the different countries, new regulations, new technologies, and so on. Fortunately, I have colleagues all over the world that I can call on anytime I need to know what is happening locally.
What has been your proudest moment?
I worked on a seasonal study delivering hundreds of vaccine shipments into 22 countries over the course of a month. The planning took forever, and when it came to the deliveries there was terrible weather and many flight delays into Eastern Europe. I remember logging onto the computer in the middle of the night to see how things were going, and finding that the Polish deliveries had been made in the early hours of a Friday morning. I couldn’t work out how, as all the doctors’ surgeries were closed.
I fired off emails, and in the morning found out that the drivers had been to collect not only the shipments but the willing doctors from their homes, then taken them to their offices to access the supplies, even though it was the middle of the night. We ended up with an overall excursion rate of less that 0.1 per cent in a harsh winter, thanks to the hard work of everyone.
Another high point which I cannot leave out was being asked to take part in discussions at the United Nations and share my expertise with a working group on vaccine supply and storage in the developing world. I hope that my input will help to save some children because they are now being vaccinated with functioning supplies.
How does the clinical research operating environment in the Middle East and North Africa (MENA) contrast to the worldwide pharma industry scene?
The biopharma industry has been forced to move out of its safe and comfortable markets in North America and Europe, and the MENA region is set to take their place, offering naïve patient populations and cost reductions per patient.
There are additional challenges, partially due to the extremes of climate, with temperatures regularly hitting over 50oC, but they are predictable and when these are offset against phenomenal recruitment rates, the balance has to fall in the region’s favour. It is reported that Egypt, Jordan, Lebanon and Syria produced a patient recruitment-related site productivity of 475 per cent above US levels.
The region has significant numbers of patients suffering from genetic and orphan diseases, such as Alkaptonuria (known as Black Bone Disease), which is 170 times above the global average in Qatar. Across the MENA region there are high incidences of asthma, cancer, cardiovascular disease and obesity, as well as a wealth of impressive facilities and existing patients.
What does the pharma sector in the MENA region need to focus on in 2014?
The infrastructure required to import clinical supplies needs to be put in place successfully, and the pharma industry needs to apply pressure for this to happen. Currently, for example, there are not enough temperature control facilities in airports, so that shipments can be successfully stored while they await customs and regulatory clearance.
Countries need to align their regulatory requirements to be closer to that of the European Union and North America to make it simpler for companies to comply.