The 3rd CCA Pharma & BioSciences Conference took place in Basel in early October and was opened by Cool Chain Association chairman Sebastiaan Scholte and Daniel Setz, SVP for global cargo operations at key sponsor Swissport.

 

The first presentation was delivered by Camelot, a consulting firm specialized in the pharmaceutical market. Its latest ‘Pharma Radar’ survey shows that Temperature Control, Traceability, Security and Regulatory Developments were among is the key topics in the pharma industry at the moment. Finding the right balance between ‘Low Cost’ and ‘Low Risk’ also appeard to be a constant challenge.

 

Camelot  noted that limited IT solutions are a major obstacle and limit visibility for end-to-end traceability. Real-life examples of temperature excursions show that new systems require a more regional or even global solution design with a risk-based approach, contingency plans, and integrated transport management, processes and systems.

 

According to the survey, market trends that will impact logistics in the coming five years include Customized Treatments, Homecare, and Direct to Pharmacy / Patient Deliveries. These will result in more patient-centric solutions offering new services “beyond the pill” as well as stronger patient focus and alternative distribution channels.

 

Integrated strategies within manufacturing, supply chain, distribution, and sales will also enable new value creation across the value chain, the survey indicated. This will result in multi-channel management, visibility, new replenishment concepts, collaborative logistics and flexible, small batch packaging. Meanwhile, the Internet of Things is slowly but surely gaining relevance in enabling these developments.

 

Christian Hay of GS1 delivered the next presentation, which provided an in-depth view of the different types of codes and technology available for serialization and traceability. There are global standards available and they are ready to be used, but there are still deviations that need to be taken into consideration, he observed. The EPC (Electronic Product Code) and EPCIS (EPC Information Service) are two likely candidates for pharmaceutical information dissemination and are already regularly used in combination with RFID technology.

 

Next, Manu Jacobs of Air France KLM Cargo told delegates how the pharma business is growing by 5% annually, year over year. Although pharma shippers are using more sea freight, they still rely heavily on the airline industry for its speed and efficiency. However, air freight's market share is down from 17% in 2000 to 11% today, he observed, with the majority of shipments still going by truck.

 

He said AF-KLM had developed a new website with track and trace information, proactive communications, and complete shipment status for their customers, improving visibility across the pharma network. The airline group also uses advanced technologies like RFID, GPS, and GPRS for connectivity and automated identification.

 

Next on stage was Nicola Caristo of Alha Group, a cargo handler at Malpensa Airport in Milan. Italy is the second largest Pharma producer in Europe, ranking among the ‘top 10’ importing and exporting countries worldwide. Alha’s solution model is geared around critical areas such as: facilities and temperature monitoring; trained staff and accountability; control points and compliance; service, security, and transparency.

 

Swissport’s Daniel Setz outlined how activities at the terminal and at the ramp can easily break the cool chain if they are done by two separate companies. That is why Swissport integrates those activities, based on a formula of global standards, quality, and efficiency, he explained. In order to catch up with other means of transport, he said the air cargo industry needed to modernize and improve speed through a focus on quality management (via C2K), end-to-end transparency, as well as interface and partnership management. And digitalization is a must, with a strong focus on e-Freight initiatives, developments and messaging performance, he added.

 

He said innovation will help to improve speed and quality, noting that Swissport had introduced its new Cargo Customer Portal with a mobile ‘Event Management Tool’ that ensured an efficient operation and compliance with applicable SLAs, real time information for stakeholders, and pro-active management of operations and performance by capturing quality milestones.

 

Edwin Kalischnig, secretary general of the CCA, moderated a lively panel discussion on the topic: ‘Temperature controlled supply chain management - an end-to-end approach’, with a lot of interaction from the audience. In the evening of the first day, all delegates and speakers enjoyed a networking dinner at a restaurant in Basel.

 

Day two of the event was opened by Bernhard Bärtschi of SkyCell, who presented one of the latest developments in passive container technology. The container “recharges” when it is put inside a freezer or cooler and the special insulation suppresses effectively all three ways of heat transfer: radiation, convection, and conduction.

 

The SkyCell container is used to establish a door-to-door solution by air - similar to a reefer container in sea freight. The key process steps include: ‘Preparation of shipment’; ‘Delivery to loading site’; ‘Transport inclusive pre-carriage’; and ‘Delivery to offloading site’. Return logistics is part of the service provided and the company also provides a risk assessment tool. The longest shipment to date is an impressive 31 days from Basel, Switzerland to Sao Paulo in Brazil.

 

Andrea Gruber (IATA) and Brice Bellin (SDV) delivered a joint presentation on CEIV Pharma certification, what it entails, and what SDV’s experiences were as one of the first certified forwarders. The Centre of Excellence for Independent Validators (CEIV) is a globally consistent IATA standard, developed for the industry, by the industry. It is a recognized and standardized certification for pharma shipments in air freight, with the key objective to maintain product integrity.

 

SDV implemented CEIV across its global healthcare network of 16 stations in the US, Europe and Asia. Key reasons to do it are to address customers’ needs, to implement a global standardized certification and to align knowledge and training throughout the network. The initiative was a follow on from SDV’s participation to the initial BRU CEIV Community project and will help build a recognized brand in the industry, SDV believes.

 

Fabrizio Iacobacci presented another CEIV-certified company, BCUBE. Key advantages for BCUBE are the common standards, compliance, harmonization, and definitions across the company. During the implementation, the key challenges were resistance (including from airport authorities, airlines and freight forwarders) and contradictions (commercial vs quality; tradition vs standardization; bad practices vs awareness).

 

Finnair is the first CEIV-certified airline, and Pasi Nopanen delivered a presentation on the airline’s advanced capabilities, including a state-of-the-art automated ULD-handling system. Finnair said the recognized modal shift from air cargo to sea freight requires collaboration among the air cargo players in order to regain the confidence of the pharma industry. CEIV certification is a good tool, system, standard, and framework to further build the required true partnerships, Finnair believes.

 

Last but not least, Ruud van der Geer of MSD/Merck took the microphone to talk about his view as a shipper. His presentation covered the whole product-handling pyramid including compliance, product stability, protection, monitoring and KPI tracking, discussing robustness and expectations.

 

In terms of compliance, he referred to the EU GDP 9.2 and “defining control limits”, control measures, and how to ensure process visibility. In terms of risk evaluation, the main purpose is to identify what is Critical to Quality (CTQ) and what is Critical to Business (CTB), he observed.

 

He stressed that storage and shipping are two different things in pharmaceutical logistics, and shipping ranges are set wider than storage ranges. The combination of product stability and thermal protection systems allow for relatively broad variations in temperature (especially for Controlled Room Temperature - CRT products). At MSD, on average 1,000 shipments would trigger 100 (temperature-deviation) alerts, of which only one shipment would need to be discarded.

 

The general expectation of the shipper is that when they buy a ‘15-25oC service’, they will actually receive a ‘15-25oC service’, but this is not always the case, he observed. As a result, performance monitoring and a shipment temperature dashboard are important. Although CEIV certification may be “too much” of a requirement for a number of shipments, the pharma industry endorses IATA’s pharma standard for both strategic reasons (building a sustainable, value-driven health care system) as well as operational reasons (measurability, risk reduction and ROI on services), he said.