CoolChainAssociation

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3rd CCA Pharma & BioSciences - Event Summary

3rd CCA Pharma & BioSciences - Event Summary

The 3rd CCA Pharma & BioSciences Event was opened by Chairman Sebastiaan Scholte and Daniel Setz of key sponsor Swissport. The first presentation was delivered by Camelot, a consulting firm specialized in the pharmaceutical market.

Their latest “Pharma Radar” survey shows that “Temperature Control” is a key topic in the pharma industry at the moment, along with “Traceability”, “Security” and “Regulatory Developments”. Finding the right balance between “Low Cost” and “Low Risk” seems to be a constant challenge.

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.

Market trends that will impact logistics in the coming 5 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 amongst manufacturing, supply chain, distribution and sales will enable new value creation across the value chain. This will result in multi-channel management, visibility, new replenishment concepts, collaborative logistics and flexible, small batch packaging. “Internet of Things” (IoT) is slowly but surely gaining relevance in enabling these developments.

Christian Hay of GS1 delivered the next presentation, which provided an in-depth view 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. The EPC (Electronic Product Code) and EPCIS (EPC Information Service) are 2 likely candidates for pharmaceutical information dissemination and are already regularly used in combination with RFID technology.

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

AF/KLM have developed a new website with track & trace information, proactive communications and complete shipment status for their customers, improving visibility about the pharma network. They also use advanced technologies like RFID, GPS and GPRS for connectivity and automated identification.

Next on stage is Nicola Caristo of Alha Group, operating at Malpensa Airport in Milan. Italy is the second largest Pharma producer in Europe, ranking amongst the top 10 importing and exporting countries worldwide. Alha’s solution model is geared around critical areas like facilities and temperature monitoring, trained staff and accountability, control points and compliance, service, security and transparency.

Ground handler Swissport was presented by Daniel Setz, who showed that activities at the terminal and at the ramp can easily break the cool chain if they’re done by two separate companies. That is why Swissport integrates those activities based on a formula of global standards, quality and efficiency. In order to chatch up versus other means of transportation, the air cargo industry needs modernize and improve speed through focus on Quality Management (C2K), End-2-end Transparency as well as Interface and Partnership management. Digitalization is a must, with a strong focus on eFreight initiatives, developments and messaging performance.

Innovation will help to improve speed and quality and Swissport introduced their new Cargo Customer Portal with a mobile “Event Management Tool” that ensures 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.

Secretary General of the CCA, Edwin Kalischnig, 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 nice networking dinner at a cosy restaurant in Basel.

 

Day 2 of the event was opened by Bernhard Bärtschi of SkyCell, who presented 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 3 ways of heat transfer: radiation, convection and conduction.

The SkyCell container is used to establish a door-2-door solution by air (similar as 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 certification, what it entails and what SDV’s experiences were as one of the first certified forwarders. As “Center 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 their global healthcare network of 16 stations in the US, Europe and Asia. Key reasons to do it are to address customer’s needs, to implement a global standardized certification (v.s. national independent) and to align knowledge and training throughout the network. The initiative was a follow up from the SDV participation to the initial BRU CEIV Community project and will help build a recognized brand in the industry.

Fabrizio Iacobacci was proud to present 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 their advanced capabilities, including a state of the art automized ULD handling system. The recognized modal shift from air cargo to sea freight requires collaboration amongst 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.

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).

Storage and shipping are 2 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 1000 shipments create 100 alarms of which 1 shipment is discarded.

The overall perception of the shipper is that when they buy a “15-25 oC service”, they actually get a “15-25 oC service” and this is not always the case. Hence the fact that 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 operation ones (measurability, risk reduction and ROI on services).

 

Before the conference started, all delegates went on a Site Visit to Swissport.

 

For copies of the presentations and more pictures, please visit the events page here.