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Pharmaceutical Manufacturing and Packing Sourcer

No Such Place As Far Away


PMPS
: What drew you to biopharma transportation?


Sue Lee: Before I joined World Courier, the company was mostly known for moving sensitive documents, computer discs and other time-critical technologies. We were only starting to transport clinical materials around the time I joined in the 1980s, and it was a great opportunity to use my knowledge of microbiology and applied biotechnology. Of course, things have moved on a lot in the last 25 years. Every day we move shipments that may save a life or improve quality of life, and I have worked on hundreds of studies. I cannot think of a better reason to come to work in the morning.

Which part of your job do you most enjoy?

I feel very privileged to talk to people all over the world – both colleagues and clients – and do my part to arrange shipments and research information on the countries that we serve. There are so many interesting projects going on in different places, as well as specific needs that are continually evolving. There are new places, shipping temperatures and regulatory requirements; every day brings fresh obstacles to overcome. It is great to be a part of the clinical world getting new drugs to market.

And which aspect is the most challenging?

Everywhere in the world is so very different, and making certain that we keep up-to-date is vital. It can be difficult to get the necessary information in a timely fashion from the relevant authorities and airlines, although the industry has begun embracing Good Distribution Practice (GDP) guidelines and continues to work with pharma to improve the supply chain.

What is the most difficult location or situation you have coordinated delivery to?


It is surprising how difficult it can be sometimes to make shipments into the developed world. Getting clearance into the US through the FDA and the Department of Agriculture can be trickier than getting into sub-Saharan Africa. Personally, my most challenging shipment was 60 kilograms of penguin faeces from South Georgia (east of the southern tip of South America), which was being tested to see whether salmonella had been introduced into the native population. There are very limited services into the South Atlantic and a distinct lack of dry ice!

What would you like this year to bring?

2015 brings us much closer to the implementation dates for both the Falsified Medicines Directive and the Drug Quality and Security Act, which cover the EU and US, respectively. This is the year when great strides are intended in the planning of electronic systems that will be used to track materials, strengthening controls and checks on the standards to be applied to medicines as they move through the legitimate supply chain. Ensuring adequate tracking has to be balanced against having patient packs that still fulfil patient needs. It will be very interesting to watch that process unfold during the year.

Are there any developments in the industry's pipeline that readers may not be aware of?

The airline industry has been changed by the implementation of the International Air Transport Association (IATA) Temperature Control Regulations, which are specifically written for the needs of pharmaceutical shipping, and address the requirements of healthcare logistics. IATA have created a certification programme for airlines and airports – similar to their efforts on security certification – which should help the pharma industry plan routes using airports either with the certification, or that are independently trained and certified in GDP. This should really improve standards across the whole sector, enhancing airports and providing the necessary facilities to look after shipments and maintain the required conditions during transport and clearance.


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Sue Lee, Technical Portfolio Manager, has worked for World Courier for 25 years. During this time she has experienced a variety of customer service and operational functions, including setting up numerous multinational clinical sites for the transportation of biological samples. Sue has orchestrated the delivery of thousands of shipments with very specific temperature requirements to a host of challenging locations.
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