Online Exclusive: Tony Wright, MD, Exelsius
Tony Wright, founder and managing director of cold chain management consultancy Exelsius, explains why good control of your temperature-controlled chain has never been more important.
Why is cold chain management so vital?
For pharmaceutical, biotech and other temperature-sensitive commodities, effective Cold Chain Management is vital. As the globalisation of production sites expands, so does the distance to consumer markets. And since over the next two-three years over 50% of all newly-approved medicines will be highly temperature-sensitive biopharmaceuticals, the pressure to create an effective, secure temperature-controlled supply chain has never been more acute.
Grappling with the regulatory, procedural and overall supply-chain partnership needs of the pharmaceutical sector is a challenge that needs a cross-discipline and indeed cross-cultural understanding if the risk of temperature excursions is to be reduced. Cold Chain Management is a vital practice to these sectors, particularly as manufacturers grapple with the development of new products which do not fit their existing distribution capabilities.
What can Exelsius offer companies in the Middle East?
Exelsius has continued to develop its unique knowledge of logistics, healthcare and other temperature-sensitive products into a business that brings a range of consultancy, research and training services to manufacturers and service providers. The key objective is to close the ‘knowledge & risk’ gap that can occur through inadequate understanding within the cold chain and improve overall temperature management.
In the logistics sector Exelsius has helped airlines, forwarders and other companies understand and implement the requirements of Good Distribution Practice (GDP) for pharmaceutical & biotech products. From an initial capability assessment through to business analysis & workshops, Exelsius has enabled them to carefully introduce differentiated & branded cool chain ‘products’ that can add real bottom-line value to their existing business. This market-entry preparation has helped to create sustained success for those companies.
Surely the last thing companies need right now is added expense?
The issue of good management has never been more relevant than in the current environment where the air cargo sector is seeing a considerable slowdown in general freight commodities, whereas the temperature-sensitive pharmaceutical business continues to grow and provide an opportunity to address declining yields. However, it is a complex and regulated sector that needs to be carefully understood and managed in order to succeed. It requires a long-term vision and commitment but has it rewards.
For manufacturers, Exelsius uses it independent knowledge of the distribution and air cargo sector in order to improve Standard Operating Procedures and reduce the risk of temperature excursions. This is particularly important as supply chains get longer, more complex and with the potential for many individual SOPs to be developed. Exelsius has used a Logistics Assurance Plan to harmonise these separate procedures into a single purpose. Additionally, it provides unbiased assessment of new cold chain technologies and the logistics services available for a specific product within a chosen supply chain process.
Is there anything that local governments can do to facilitate the strength of the cold chain in this part of the world?
As governments increase healthcare delivery systems to match the growing population in the Middle East, there will inevitably be a significant demand for not only medicines but also medical equipment. The Middle Eastern market therefore offers a variety of opportunities for pharmaceutical companies seeking to expand international operations.
The Gulf Cooperation Council (GCC) countries constituting Saudi Arabia, Kuwait, Jordan, UAE and Oman among others offer another fresh perspective for demand, particularly as they have low domestic pharmaceutical production. The Middle East has a significant opportunity not only to address this but also to have a substantial share of the research and contract manufacturing side of the industry and this can be aided by the continued development of governmental ‘free zones’ that may offer tax and other trading benefits.
Local and regional governments can therefore play a role in ensuring that the vision of developing high-quality facilities is achieved through supporting businesses in a variety of ways. It can support the promotion of those facilities and the maintenance of standards that meet the needs of regional and local participants. It can create the infrastructure that facilitates the continued placement of the region as a major distribution hub for commodities that require temperature management.
What are the greatest challenges that airlines, shipping companies and forwarders face when trying to maintain the security of the cold chain?
Just like any other logistics activity, the success of an efficient temperature controlled supply chain depends upon the coordinated management of many individual participants, though ultimately the manufacturer has responsibility for patient safety and therefore has to play a significant role.
The key objective is clearly to get a product to market in a condition that meets the needs of both manufacturers and users. Pharma companies want a return on the high levels of R&D investment and patients want a safe product. Easy words and undoubtedly major forwarders and 3PLs have developed advanced systems that have narrowed the gap between providing this degree of security and being cost-effective.
But most temperature excursions occur not because of poor packaging or storage facilities, but through a lack of understanding of the product and its needs. The real challenge is for all participants in the cold chain to be adequately trained and I further recommend that they are independently certificated in cold chain awareness. This will raise the standards of handling, reduce risk and improve overall coordination within the supply chain.
How do you think the Middle East is performing with regard to cold chain security in comparison to other regions? What is your opinion of the facilities here?
The Middle East has emerged not only as a region with high levels of local demand but also as a leading hub for many logistics providers in the temperature-controlled sector. It is an obvious geographic gateway position between, for example, the pharmaceutical manufacturing sites of the Indian sub-continent and the consumer regions of Europe and Africa, make it a natural transit point.
Not surprisingly, major airlines and forwarders have established high-quality handling facilities in the Middle East that are amongst the best in the world. The airport facilities in Dubai, for example have recognised the market for value-added distribution and I think there is sufficient opportunity for other regions to look closely and urgently into the development of similar sites.
What new cold chain products/technologies will be available to the industry this year?
There have already been significant advances in the use of technology in order to improve temperature management during transportation. New air cargo containers that can retain the desired stability even under the most challenging ambient environment by using a compressor-driven cooling and heating system are now more widely available. Envirotainer in Europe and CSafe in the US both have this user-friendly technology available for lease.
Data management and evidence of temperature history in the supply chain is an increasingly important of overall end-to-end temperature assurance and something that regulators demand before product release to the market. There are new simple devices that even in remote last-mile circumstances can produce a pdf. File of temperature history. In addition, the development of RFID technology that combines temperature monitoring with visibility through a web portal is advancing rapidly, though perhaps with a little concern from some sectors of the pharma industry about potential effects of UHF RFID on the actual product.
What guidelines are available for air carriers?
However, since a high proportion of the world’s temperature-sensitive healthcare products are transported by air, it has been important to focus on the guidelines available for air carriers. I have chaired one of the working groups within the IATA Time and Temperature Task Force which has addressed the challenge of improving handling for healthcare products. Through a unique collaboration of airlines, forwarders, manufacturers, regulators and service providers, a new set of binding rules has been developed and ratified for use by all IATA carriers as from 1 July. IATA is currently developing a brand-new training programme that will be available not only to those carriers, but to all the participants in the healthcare supply chain.
Is there anything else you would like to add?
Good Cold Chain Management is an integration of several processes; some regulated and technology-assisted and some more reliant upon written procedures, monitored activity and above all, good quality training. Working in harmony they can provide a high quality pharmaceutical logistics process that can cope with the more stringent demands of newly developed products. But working in isolation and without sufficient ownership of the total supply process, they can put at risk the very issue we are all working towards – patient safety.
Tony Wright has over 35 years experience of the air cargo and temperature-controlled logistics sectors, having worked with British Airways World Cargo and Envirotainer. He is a member of the Parenteral Drug Association (PDA) and serves on its European Cold Chain Interest Group. Tony went on to establish Exelsius – an independent consultancy supporting the development of logistics for the international distribution of pharmaceuticals and other temperature-sensitive products. Email: email@example.com; www.exelsius.co.uk