Pharmaceuticals hit warp speed

posted on 9th December 2021
Pharmaceuticals hit warp speed

Pharma shippers want to see a continuation of the increased openness and collaborative spirit that Covid has brought about in the pharma logistics supply chain, reports Megan Ramsay from this year’s Airfreight Pharma digital conference

Covid-19 has further underlined air freight’s importance in ensuring the timely delivery of often urgent and life-saving healthcare products around the world. And this year’s Airfreight Pharma digital conference, ‘Essential Transport for an Essential Industry’, opened with a discussion on the main challenges pharmaceutical companies face when shipping their temperature-sensitive products – in general and during the pandemic.
Julian Wann, associate director procurement, global freight and logistics, at pharmaceutical company AstraZeneca, said that although the last 18 months or so have been “tumultuous”, the pandemic has brought shippers and their logistics partners closer together.
“Throughout Covid, we have maintained supply and service and continued to distribute to and access all the markets we needed to,” Wann said. “The pandemic has highlighted the relevance of working with people for a longer period of time, and enabled us to work more closely together and to be particularly open and honest about challenges.”
Airlines have been among those pulling out all the stops to satisfy the requirements of pharma shippers during this difficult time.
Julian Sutch, pharma global sales at Emirates SkyCargo, says following the initial grounding of aircraft, the carrier was very quick to reintroduce capacity to serve key sectors that desperately needed it – predominantly, pharma, PPE and fresh produce. This was by no means easy. It required new routes, landing rights, constant communication with customers and the management of crews who were subject to travel restrictions and quarantine rules.
“It was something we’ve never faced before, but people came to the table very quickly, got together and made it happen,” Sutch said.

Good communication enables flexibility
Effective communication throughout the supply chain, and a deep understanding of it from end to end, enables flexibility in the face of unforeseeable challenges, Wann noted. He said that the degree of visibility and communication both between AstraZeneca and its supply chain partners and within the company itself – particularly in terms of making sure each individual understands not only their own role, but that of the rest of the supply chain too – is something that has come to the fore during Covid and will continue to be a focus for AstraZeneca.
Wann stressed that AstraZeneca has high expectations of its transport suppliers “whichever mode we ship, because the expectation on us to maintain our products is exceedingly high.”
Procurement decisions in terms of logistics are based on those expectations. With the integrity of pharma shipments potentially at risk at every handover between manufacturer and consignee – particularly at airports – SOPs and an awareness of the value of each item to the patient it will treat are essential.
More consistency needed
Wann called for handovers on the ground to be simplified so as to reduce the risk of temperature excursions, and stressed the need for airport pharma facilities to enable greater standardisation of processes.
Certainly, pharma air freight capabilities vary around the world. Airports like Miami, Brussels and Singapore have created pharma communities where the airport, airlines, forwarders and handlers come together – while in Africa only two airports “really know how to handle pharma”, Sutch said.

Reliability over speed
Wann pointed out that while speed is important, reliability is even more so, particularly in light of this pandemic. “Things take longer now as the availability of capacity doesn’t necessarily match demand,” he explained. “It’s not great having to extend the supply chain, but as long as it’s consistent and we know we can rely upon it… we can build that into our planning processes.”
Another significant threat to the pharma business and the patients it serves is the production of counterfeit products based on stolen genuine items. Supply chain security is a top priority for pharma shippers.
“From a transportation and procurement perspective, we have to be extremely diligent when selecting suppliers and locations,” Wann went on. “Ordinarily you’d go and visit a location… [The challenge now is that] a lot of this is being done virtually, which means a reliance on partners and on people in the markets to assess risk on our behalf.”

Adapting during the pandemic
Another pharmaceutical company represented at Airfreight Pharma was Sanofi. Walter Heider, head of distribution platform Frankfurt, told a session on Adapting during the pandemic that the key to maintaining high quality during Covid was the ability to be agile and flexible.
“With the breakdown of so many supply chains we normally used, we had to adapt to scenarios we are not used to. Pharma is not typically quick in adapting to situations, so this was one of our main learnings,” he said. Plus: “We had to meet patients’ needs, so we had to join forces a lot more.”
Sanofi uses a mix of ocean and air freight, with the split being 90/10. During Covid, the company’s use of airfreight went up 20%. “There was no other way”, Heider said.

Stable sea freight
“The quality and stability of the supply chain is better in sea than air. It takes longer, but it’s much more stable. There tends to be less damage, and the quality of the product is better at the point of delivery. You also have the ‘ecoprint’: sea freight’s CO2 emissions are much better versus air freight.
“Plus, air freight is expensive. The cost is much higher per pallet. Of course, sometimes you need to be quick and there is no other way than air freight – but if there’s a risk that the product won’t be useable on arrival, it’s very tricky.
“Whatever we ship is on qualified routes with qualified partners, with standard shipping instructions and quality agreements,” Heider went on, “and yet we have identified partners (or partners of partners) who are not working up to these levels.”
There is a need for a higher level of dedication and enthusiasm throughout the pharma supply chain, he said, in order to fill these gaps.
Heider also called for more capacity as well as greater flexibility from carriers to enable shippers to meet unplanned peak demands for their products. “It’s a chicken-and-egg situation,” he said, acknowledging that carriers need accurate forecasts of demand from shippers in order to put the necessary capacity in place for them.

Stepping up
Alongside the immediate practical challenges of the pandemic and the evolution of the air freight industry in response, regulatory requirements are becoming stricter. Airlines are stepping up, as Abdullah Bahadır Büyükkaymaz, special cargo product manager for Turkish Cargo and Tom Sohorab, manager for cargo solutions strategy and business development at Air Canada Cargo explained.
Air Canada and Turkish faced the same challenges other as other airlines when Covid struck: staff reductions, flight reductions, downgraded and grounded aircraft, plus customers struggling to book cargo into much narrower lanes. Airlines had to figure out how to prioritise and handle cargo under these constraints without allowing service quality to suffer.
Büyükkaymaz recalled: “Everyone was asking how they were supposed to move vaccines, medicines and medical supplies with such limited capacity. We converted some passenger aircraft to ‘preighters’ and added a couple of lanes to our routes as well.”
Noting that Turkish Cargo is IATA CEIV Pharma certified, Büyükkaymaz said: “We work by IATA guidelines so during the pandemic crisis we have been working closely with the World Health Organization as well. There were some additional temperature requirements and changes to dry ice limits.
Clarity on regulations needed
“In the coming months or years, medical devices and equipment may have temperature requirements as well (15-25°C), which is good – as long as we’re ready for the requirements. We’re not afraid of any regulations. As long as we understand each other and build something collaboratively, it’s good.”
That collaboration extends to working with the authorities, too. Sohorab said Air Canada’s senior director for cargo transformation, Janet Wallace, had discussions with the Canadian government regarding the airline’s role in supporting the influx of vaccines into Canada.
“This was part of understanding the new regulations that are going to come in regarding the transportation of vaccines and pharmaceuticals,” he said. “If they are changing, we don’t want to be the last to know from the shipper telling the freight forwarder who then tells us. We want to know direct from the government, and we want to let the government know that they can have confidence that we are CEIV certified and have guidance from IATA as well.”
Transparency is honesty
Sohorab continued: “Pharma companies are bringing transparency to the forefront because they need custody records. Transparency is honesty and that’s what we want to build.
“There are privacy issues and other components we need to get over to put this in place. IATA’s ONE Record [which aims to cover the entire transportation chain, from shipper to consignee, with a single record view of each shipment] is heading in the right direction.”

Teamwork across cold chain
Transporting pharmaceutical products by air demands a rigorous logistical approach on the ground, too, of course. Handling facilities and equipment are important – but so are harmonised handling procedures and above all, strong cooperation among cold chain partners.
A case in point is Sotrovimab, a breakthrough monoclonal antibody (MAB) treatment for Covid-19, which – thanks to the collaboration of the entire supply chain – reached the first-ever patient within hours of plane wheels touching ground at Abu Dhabi International Airport.
Jeff Kemprecos, director for communications, government affairs and market access at GSK Gulf, said: “When the pandemic broke out, we committed to a range of activities, primarily focusing on vaccine capabilities in partnership with other players in the industry. In March, [we developed] Sotrovimab – a therapeutic drug, separate from and parallel to vaccines.
“Vaccines were coming on stream from December to March but in limited quantities. They had not reached a lot of the population, so the idea that we might have a therapeutic was exciting.”
Sotrovimab is administered via a drip. The infusion takes 30-40 minutes and symptoms begin to ease as early as the day following treatment.
US Food and Drug Administration (FDA) approval of the drug took a few months; within hours of that, the UAE issued emergency use authorisation and “everything went to warp speed to distribute it”, Kemprecos said. “We thought we had a six-to-eight-week window for delivery, but the authorities in Dubai wanted six to eight days.
“Ahead of the first shipments, as we thought about how to compress timelines, early in June we held daily calls with Etihad, the Department of Health and GSK people from all over, to share vital information,” he went on. “As the supply situation matured and stabilised, we moved to weekly calls. They’re an essential touch point because if the government expects a spike, GSK can work with Etihad to adjust supply accordingly.”
Hassan F Hassan, head of customer service, logistics, warehouse and distribution at GSK Gulf, added: “The teamwork behind making this possible is something I’ve seen for the first time in my career. There were people from production, quality, freight forwarder, airline, scientific office, commercial, agent, importer, government officials and sub-bodies, all working together for the same cause. It was phenomenal.
“Before Covid, a new product launch [from initial registration to distribution] would take about six months, minimum. We are talking about weeks here – and we did it.”

Customs pre-clearance
Customs facilitated pre-clearance of the shipments so that the cut-off time could be halved, and unloading was done in minutes rather than hours.
Regarding the question of whether cool chain storage facilities are as necessary now as they once were, given both the speed of the pharma supply chain and advances in the packaging that protects shipments from the elements, Fabrice Panza, manager for global cool chain solutions at Etihad Cargo, said: “In the case of Sotrovimab, we really wanted to shorten the cut-off time, and an active container was the best solution to avoid the need for storage – but we would have needed a pharma facility in case of any delay as part of our contingency plan.
“We managed to operate cross docking so effectively the product didn’t go through a warehouse – it went direct from the aircraft parking lot to the truck. This would not have been possible if we had not anticipated and cleared the documentation in advance. Certain other products would require long hours or even days before being Customs cleared (this can depend on the country, too).”
Cost is another consideration. An active container is a premium product, and if a pharma item has a lower value or urgency and can withstand a few hours in an airport, then a ‘normal’ supply chain may be the better option. “In those cases you need advanced infrastructure, advanced monitoring and trained personnel. This still applies to… 70-80% of the pharma flow,” Panza said.
At the time of the conference, Sotrovimab had treated around 23,000 patients in the UAE, Bahrain, Kuwait, Oman and Qatar, with Abu Dhabi serving as a hub for distribution up and down the Gulf. There had not been a single quality incident in transit.

Lessons learnt
Conference speakers agree that lessons have been learnt through the pandemic that will stand the air freight industry in good stead in the future. Most notably, there is an increased willingness to share information in order to benefit the entire supply chain and ultimately, in the case of pharma, patients.
Forwarders know that shippers are talking directly with carriers and they appreciate the value of such discussions, Wann said. “We might find something out that can lead us to put something in place that helps everybody,” he notes. “After all, we’re looking at the sustainability of airlines to be able to move product.”

Collaborative spirit
Wann called for a continuation of the increased openness and collaborative spirit that Covid appears to have brought about in the pharma supply chain, for the benefit of patients.
“We want to get it right every time so that the expectations of the people relying on our products are fulfilled every time,” he said.
Kemrecos agreed. “As a pharma company, we overcame a lot of rigidities in terms of information sharing and got a lot more flexible in terms of sharing data,” he said. “There’s a big learning in there – not only for pandemics, but for accelerating the delivery of cutting-edge vaccines and medicines to patients that need it anywhere in the world, any time.”

 

Case study: Collaboration, transparency and information sharing ‘critical for success’

Another session at Airfreight Pharma comprised a case study of the transport from Milan to Chicago of a drug requiring deep-frozen temperature maintenance.
Chiara Venuti, business development director and strategic account manager at SkyCell, outlined: “The customer was a pharma company headquartered in Italy, which produces a compassionate drug for a rare disease. For rare diseases, you’re not talking about mass production; if something goes wrong, the drug has to be produced again, so there’s no room for mistakes in the supply chain.”
Miguel Rodríguez, senior manager for climate control products at Qatar Airways, noted that collaboration, transparency and information sharing were put in place from the very beginning and are “critical for success” in this type of project.
“What happens before and after is as important as what happens while a shipment is under our care,” he said. “You need to keep working with the forwarder, container supplier, consignee and authorities to make sure the product is delivered as expected.”
Venuti confirmed that there were “lots of tripartite calls” to ensure all parties understood the product, as well as risk analysis to understand and mitigate potential problems. Elements to consider included ground handling capabilities and facilities, weather conditions, duration of flight, and temperature settings in the aircraft.
According to Fabrizio Iacobacci, head of pharma business development at Italian handler BCUBE air cargo, risk is opportunity.

Extra gap analysis
“You have to make an extra gap analysis,” he explained. “Every time you do that, every negative occurrence you experience in your operational life improves the level of your backup capacity. The more you do this, the more you can be confident of solving risk. We made an extra gap analysis for this project, such as a backup of extra dry ice, and the logistics of that.”
The Italian-made drug has a critical point of –20°C, so the decision was taken to deploy SkyCell’s 1500 DF deep frozen container, which uses dry ice (the drug can withstand extreme negative temperatures).
The container was placed in BCUBE’s –20°C facility and re-iced prior to the flight. Iacobacci said that the deep-frozen container’s requirement for dry ice
is quite low – only 100kg.
“That’s not a massive amount, and it’s compatible with other shipments we carry as well,” he said. “Thanks to Covid-19 vaccines, dry ice limits have substantially increased, so today we can carry a lot more of it in our bellies and freighters than before the pandemic. This is one of the positive outcomes of the crisis.”
As the drug is for a rare disease, the US FDA automatically put a hold on it in order to do some checks on arrival in Chicago, Venuti said. The shipment was placed in the consignee’s facility, however, which kept it below –20°C until the FDA released it.