百靈佳殷格翰談供應鏈如何應對未來的製藥挑戰　Orchestrating a global pharmaceutical supply chain

為了能成功生產並分銷全球患者所需藥劑，必須盡可能地準確預測未來需求。百靈佳殷格翰人類製藥業務的需求預測基於服務涵蓋內所有地區和國家的數據。供應鏈團隊與來自營運、行銷、銷售、財務和其他相關部門專家合作，規劃未來的供應計畫。

「我們正在統籌並策劃全球化的製造和分銷網絡。我們確認要生產和分銷的產品，了解患者需求，以及我們的供應網絡能如何滿足這些醫療需求。」百靈佳殷格翰人類製藥供應鏈管理與策略規劃部門全球總監 Jens Schader 表示。「我們會預測可能出現的狀況，因為未來總是模糊、充滿未知，供應鏈必須更具調整性。」

「因為世界變得更加動盪和未知，供應鏈必須更有彈性。」

人類製藥全球供應策略部門主管 Jiong Qu 補充：「當供應預測因為需求變化出現波動時，製藥商無法僅啟動幾台新機器、碰觸幾個開關，就能生產出充足並且符合需求的產品。」

對供應鏈的需求改進永無止盡。為了滿足不斷增長的需求，百靈佳殷格翰正在採取行動，目標是在 2028 年時將 Jardiance^® 的生產及分銷量增加一倍以上。相關的措施有：雇用和培訓新員工，要求外部合作製藥夥伴參與其他藥品製作以釋放內部製造的量產壓力，讓監管機構了解局勢，持續與區域和在地合作夥伴重新規劃和擴大分銷渠道。

Jardiance^® 是 CRM 疾病治療藥物，也是百靈佳殷格翰最暢銷的產品。隨著 Jardiance^® 從最初的第二型糖尿病適應症，拓展到可治療腎臟和心臟衰竭等適應症，藥品需求在 2022 年底激增。在百靈佳殷格翰工作 24 年的資深營運人員 Qu 回憶道：「短短三個月之後，我們發現供應量必須增加 40% 。超出我們當初預測的最高值。」

從原料到交貨

確認特定產品需求之後，供應鏈必須通過四個關鍵階段：

1原物料採購

第一階段，百靈佳殷格翰從精心挑選的供應商採購原料和賦形劑。公司與合作夥伴須確保供應安全、具有調整性和可持續，並符合相關法規要求。整個供應鏈的製造品質、商業道德和實踐、工作場所人權和健康，以及環安衛標準都得謹慎審核。

2製造與包裝

第二階段：製造與包裝。在此階段，原料被製為活性藥物成分及成品。百靈佳殷格翰的藥物原料分為兩大類：化學或生物製劑（chemical or biological entities）。其中有許多產品在歐洲生產，那裡具備成熟的專業知識、高度訓練的工作人員、迅速反應時間、可靠的品質控制能力，以及運輸到主要市場的短距離優勢，因此能達成高標準的監管和供應安全性。在產品製造方面，百靈佳殷格翰依賴自有的製藥生產基地，以及外部合約製造合作夥伴，共同組成了強大的全球生產網絡。公司因此能靈活管理全球的供應產能，以因應市場需求變化或滿足在地患者需求。我們為即將上市銷售的產品提供客製化的內包裝和外包裝，例如泡殼包裝或瓶裝及盒裝；其他產品，例如透過自動注射器投藥的藥物，可能需要更高級別的醫療設備配合使用。

3 跨國運輸

第三階段是運輸。藥品被裝入配有溫度記錄器的容器中，確保全程維持最佳的運輸條件。百靈佳殷格翰優先選擇海運作為跨國運輸方式，相比之下，我們極少採用空運。原因是海運更能確保運輸過程中的溫控條件，同時產生更少的二氧化碳。

Schader 補充道：「永續性變得愈來愈重要。我們只要必要或者臨時的狀況下使用空運。滿足患者的需求是首要目標。」

4 最後一哩路配送

在第四階段，百靈佳殷格翰與在地的配送分銷夥伴合作，將產品送達給批發商、醫院或藥局，再由他們將產品提供給患者。每個步驟都可追蹤，不僅確保藥物品質，也能保證及時供應必要藥物。若需求方或供應方出現波動， Schader 和他的團隊會利用當地的安全庫存作為緩衝。

2023 年，全球供應鏈受到區域衝突、產能短缺、能源緊張的壓力，甚至一度中斷，影響供應可靠性。百靈佳殷格翰在供應鏈各階段設置緩衝措施，確保產品依然能如期交付。

設計以未來為取向的供應鏈

為了令客戶和分銷商感到安心，並且避免其他產業中常見的倉鼠心態，整個供應鏈中的溝通必須清晰流暢。倉鼠心態會導致過度囤貨，影響供應鏈的運作；供應方必須密切注意客戶行為，並監控是否有重複訂購的情形出現，以確保產品在患者實際需要時能夠提供和交付。

供應鏈管理是一種持續的平衡行為，安撫分銷系統中不同的利益相關人，向他們保證我們可以滿足現在和未來的需求。Qu 說：「我們有很多方式可以用來確保供應。」

這個重點強調再多次都不為過。通過高效運作的供應鏈，百靈佳殷格翰的供應鏈團隊能確實並且如期提供患者所需要的產品。

Schader 表示：「未來，全球供應鏈的脆弱性是各產業都必須面對的關鍵挑戰。」當規劃未來的策略時，Schader 和他的團隊清楚知道，在公司產品線持續擴張的狀態下，他們必須持續調整和優化百靈佳殷格翰管理全球供應鏈的方式。

Shader 補充道：「我們正處在一個關鍵時刻，為了帶給我們的客戶具備發展性的未來，我們需要合適的網絡、流程和最先進的系統。我們必須在永續發展跟充足的供應鏈產能之間取得完美的平衡，才能繼續滿足患者的藥物需求。」

Orchestrating a global pharmaceutical supply chain

It takes a lot to ensure that the right patients receive the right products at the right time, in an efficient and sustainable way – especially when the product is a life-saving medicine. Each step of Boehringer Ingelheim's supply chain, from the production of active pharmaceutical ingredients to finished products, is carefully coordinated to serve patients' needs.

To successfully produce and distribute the pharmaceutical products that patients need around the world, one must predict the future demand as accurately as possible. Demand forecasting at Boehringer Ingelheim's Human Pharma business is based on data drawn from all regions and countries it serves. The supply chain team then works with experts from operations, marketing, sales, finance and other functions, to plan for future supply.

“We're orchestrating a global manufacturing and distribution network. We define what we're going to produce and distribute, what patients' needs are, and how our flexible supply network can meet them,” says Jens Schader, Global Head of Supply Chain Management & Strategy for Human Pharma at Boehringer. “We anticipate various scenarios because, as you can imagine, the future is not all crystal clear. Supply chains must be more resilient because the world is getting more volatile and uncertain.”

“Supply chains must be more resilient because the world is getting more volatile and uncertain.”

“When supply forecasts fluctuate due to changing demands, pharma manufacturers don't have the luxury of just spinning up a few new machines, flipping a few switches and producing more and more,” says Jiong Qu, Head of Global Supply Strategy for human pharma operations.

The need to refine supply chains never stops. To cater for ever growing demand, Boehringer is for example implementing measures to more than double the number of Jardiance^® tablets it will manufacture and distribute by 2028. These efforts include: Reengineering factories to handle new processes; hiring and training new employees; freeing manufacturing inhouse capacity by asking external contract manufacturing partners to pitch in to handle other products; keeping regulators in the loop; and constantly, remapping and expanding our distribution network with regional and local partners.

Jardiance^®, a cardio-renal-metabolic treatment and Boehringer's best-selling product, saw demand shoot through the roof in late 2022 as the product expanded from its initial Type 2 diabetes indication to include indications for kidney disease and heart failure. “Within three months, we found ourselves needing to boost our supply by 40%,” recalls Qu, a 24-year Boehringer Ingelheim operations veteran. “It exceeded our most optimistic expectations.”

From raw materials to final delivery

Once the company has assessed the demand for a given product, the supply chain must work to meet that demand through four key stages of activity:

1 Raw Material Procurement

In stage one, Boehringer procures raw materials and excipients from its carefully chosen suppliers. The company and its partners must ensure that the supply is safe, resilient and sustainable and meets compliance requirements. Manufacturing quality, ethical business practices, human rights in the workplace and health and safety standards are actively audited across the supply chain.

2 Manufacturing & Packaging

Stage two covers manufacturing and packaging. Here, the raw materials are formulated into active pharmaceutical ingredients and finished product. Boehringer Ingelheim's drug substances fall within two main categories – chemical or biological entities. Many of which are produced in Europe, where established know-how, a highly trained workforce, rapid reaction times, reliable quality control and short transport distances to major markets enable high levels of oversight and supply security. For the manufacture of products, Boehringer Ingelheim relies on a strong global network consisting of both its own production sites and external contract manufacturing partners. This makes it possible to manage global supply in a flexible way responding to changes of market demand and local patient needs. To prepare products for distribution to the market, they are packed in their custom designed primary and secondary packaging, such as blister packs or vials and boxes; while other products may require further medical devices, such as medications delivered via autoinjectors.

3 Inter-country Shipment

Stage three is shipment. Medications are packed in containers equipped with temperature loggers to help verify they are transported under optimal conditions. For worldwide shipping of its products, Boehringer gives preference to sea freight and uses less air freight than any other company in the industry. That is because ocean shipping offers better temperature control while generating less CO2.

“Sustainability is becoming more and more important,” says Schader. “We only use air freight for exceptional cases when we have to be adaptive or reactive. When flexibility is needed, the primary goal is to meet urgent patient needs,” he adds.

4 Last-mile Distribution

In stage four, Boehringer uses local distributing partners to deliver its products to wholesalers, hospitals, or pharmacies, that provide them to the patients. Every step of the journey up to this point has been tracked to guarantee the quality of the medications and to ensure their timely availability. If demand or supply fluctuates, Schader and his team make use of local safety stocks as a buffer.

In 2023, when global supply chains were stressed or even disrupted by regional conflicts, capacity shortages, and energy constraints, this created pressure on supply reliability. Buffers in all stages of the supply chain ensured that Boehringer Ingelheim could carry out scheduled product deliveries.

Designing a future-proof supply chain

Clear communication all along the supply chain is needed to reassure customers and distributors and avert the pack-rat psychology which afflicts other industries with less predictable supply chains. The supply team keeps a close eye on customer behaviour, monitoring for signs of double-ordering, to ensure that products are available and delivered when patients actually need them.

That's why supply chain management remains a constant balancing act, reassuring different stakeholders in the distribution system that the company will manage to meet existing and forthcoming needs. “We have lots of levers at our disposal to assure supply,” Qu says.

This point can't be overemphasized. In operating an efficient supply chain, Boehringer Ingelheim's supply chain organization delivers the reassurance that Boehringer Ingelheim manages to provide product needed by our patients on time.

“Going forward, the vulnerability of global supply chains is one of the key challenges industries must face,” says Schader. In preparing for the future, Schader and his team know they must continue to adjust and optimize the ways Boehringer manages its global supply chain – particularly as the company's product pipeline keeps evolving.

“We are at a pivotal point,” he adds. “To be able to bring this promising pipeline to our customers, we need the right network, processes and state-of-the-art systems in place. We need to strike the perfect balance between acting sustainably and making our supply chain resilient enough so that we can continue to meet the needs of all the patients who rely on our medicines.”