Digital Evolution in Life Sciences Supply Chain and Strategic Procurement Processes

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1 SAP Ariba Solutions for Direct Spend Digital Evolution in Life Sciences Supply Chain and Strategic Procurement Processes Driving Innovation by Digitalizing and Virtualizing Supply Chain Collaboration 1 / 11

2 Table of Contents 4 The Changing Face of the Life Sciences Industry 6 Vision: Full Digitalization of Direct Procurement and the Supply Chain 7 How SAP Ariba Solutions Can Help 9 The Benefits of Digitalizing Supply Chains for Direct Procurement 10 Proving the Value: Customer Successes 11 The Future of Supply Chain Collaboration in Life Sciences 2 / 11

3 The information contained herein may be changed without prior notice. Some software products marketed by SAP SE and its distributors contain proprietary software components of other software vendors. National product specifications may vary. These materials are provided by SAP SE or an SAP affiliate company for informational purposes only, without representation or warranty of any kind, and SAP or its affiliated companies shall not be liable for errors or omissions with respect to the materials. The only warranty for SAP or SAP affiliate company products and services are those that are set forth in the express warranty statements accompanying such products and services, if any. Nothing herein shall be construed as constituting an additional warranty. In particular, SAP SE or its affiliated companies have no obligation to pursue any course of business outlined in this document or any related presentation, or to develop or release any functionality mentioned therein. This document, or any other related presentation, and SAP SE s or its affiliated companies strategy and possible future developments, products, and platforms, directions, and functionality are all subject to change and may be changed by SAP or its affiliated companies at any time for any reason without notice. The information in this document is not a commitment, promise, or legal obligation to deliver any material, code, or functionality. All forward-looking statements are subject to various risks and uncertainties that could cause actual results to differ materially from expectations. Readers are cautioned not to place undue reliance on these forwardlooking statements, and they should not be relied upon in making purchasing decisions. 3 / 11

4 The Changing Face of the Life Sciences Industry Life sciences is an industry on the move. Driven by regulatory changes, manufacturing capacity, and margin pressures, the industry s supply chain and procurement leaders are relying heavily on contract manufacturing organizations (CMOs). These relationships require new ways of managing product quality and costs across the supply network. Learn how a true digital strategy can optimize internal and external processes and extend them beyond the enterprise so you can excel in today s complex market. Innovators in the life sciences industry are investing heavily in digitalization and virtual supply chain collaboration. But what s driving this trend? And how are these organizations benefiting? After a decades-long period of relative industry stability when years-long investments in R&D could yield patent-protected blockbuster drugs, pharmaceutical companies now face challenges such as downward pressure on margins, ever-evolving regulatory requirements, and new competitive threats. Innovators are responding by transforming their operational model by engaging in new kinds of manu facturing models and partnerships. This level of transformation requires unprecedented leadership from supply chain, sourcing, and procurement to: Digitalize source-to-contract processes and integrate them with execution processes Develop seamless, arms-distance partnerships with CMOs, active pharmaceutical ingredient (API) providers, and other trading partners Predict and manage regulatory requirements across the extended supply network Let s explore the industry trends spurring this supply chain and procurement innovation. DOWNWARD PRESSURE ON MARGINS Increased margin pressures are emerging from new competitive threats, continued patent expiries, and a lengthy cash conversion cycle averaging 116 days for the industry (nearly twice the global average of 65 days). 1 At the same time, healthcare reforms occurring in several key regions drive uncertainty and the possibility of further margin impacts. These pressures are heightening management s focus on containing costs and finding ways to reduce spending. But risks such as unstable commodity prices, intricate costing and pricing structures, and the sheer complexity of life sciences spend categories could make it difficult to achieve the cost reductions and cash flow improvements needed to reach profitability targets. Innovators in the life sciences industry are transforming their operational model by engaging in new kinds of partnerships with CMOs and API providers. 1. Source data for analysis from S&P Capital IQ. 4 / 11

5 NEW MANUFACTURING MODELS In response to margin pressures, many life sciences firms have moved to more flexible contract manufacturing models. Contract manufacturing partnerships have grown and matured in recent years to such a degree that, among biopharmaceutical companies that outsource, 67% of manufacturing is conducted by third parties. 2 The prevalence of contract manufacturing, in conjunction with globalization and increased off- and near-shoring activities, is creating complex global supply chains that must be transparent, orchestrated, and harmonized. This is critical to achieving economies of scale and enabling the many disparate divisions of multinational marketing authorization holders (MAHs) the drug or device manufacturers and brand owners who hold the rights to market a product in a specific market to manage their respective CMO relationships in a consistent way. Because of the substantial responsibility MAHs now share with CMOs, it s critical that they collaborate and share full transparency into inventory, manufacturing quality, and timing. But the technological skills and infrastructures of CMOs can vary widely and this technical immaturity can make it difficult for MAHs to gain the transparency and seamless collaboration with CMOs they need. GREATER RISK AND REGULATORY CHANGES Life sciences companies face increased regulatory pressure to ensure patient safety and reduce the risk of noncompliant products, which is a key issue for quality assurance. Achieving and maintaining compliance is complicated by the fact that regulatory requirements are country specific and typically include new, increasing, and evolving disclosure requirements. In addition, regulatory agencies require extensive reporting to governments on product quality and certifications. This information is often held in the systems of contract manufacturers and other suppliers, making it difficult for brand owners to provide it. What s more, governments across the globe are aggressively pursuing policies to reduce and eliminate the growth of counterfeit products, including requiring pharmaceutical and biopharmaceutical manufacturers to serialize products at the smallest saleable unit. To meet this requirement, brand owners must ensure supplier qualification, tight alignment with manufacturing and packaging operations, and precise tracking and submissions of serialized shipments to global markets. Among biopharmaceutical companies that outsource, only one-third of manufacturing is conducted in-house Contract Development and Manufacturing Outsourcing Models, ISR Reports, November 2016, Industry Standard Research. 5 / 11

6 Vision: Full Digitalization of Direct Procurement and the Supply Chain To meet these challenges, innovative life sciences leaders are digitally connecting their people, processes, CMOs, API providers, and other suppliers end to end. Let s explore how. DIGITALIZED SOURCE-TO-CONTRACT AND EXECUTION PROCESSES Life sciences leaders are finding better ways to qualify and manage supplier information, as well as to screen, select, and manage their global CMOs, API providers, and raw-materials supply bases. This is vital, given that MAHs can outsource the operation or process, but ultimately they are responsible for the final product and thus the output of their CMOs, API providers, and other suppliers. They are also driving out process and information inefficiencies by tying supplier selection and sourcing agreements to manufacturing execution. SEAMLESS, ARMS-DISTANCE PARTNERSHIPS WITH CMOS Leaders in the life sciences industry seek efficient, effective, and consistent processes with CMOs, API providers, and other partners such as standar d- ized, harmonized supply chain planning and execution processes across divisions. However, many CMOs experience inconsistency in their interactions with MAH divisions. Collaborative, digitalized processes enabled by a global technology platform can solve these issues. For example, they can drive process harmonization across multinationals, eliminate manual transactions and rekeying efforts, and standardize supplier-facing processes to provide a single, consistent face to CMOs. Because CMOs can vary in size and technical sophistication, the platform must be able to work with any CMO IT system. SEAMLESS EXCHANGE OF QUALITY INFORMATION By digitally collaborating on critical operational processes (such as quality processes), life sciences firms can eliminate manual work (such as rekeying data) while significantly improving product quality. For example, they can streamline quality checks at each step of manufacturing and delivery through the automated exchange of quality information, inspection results, work-in-process data, and certifications. Full visibility into batch and finished products similarly protects against product counterfeits. Life sciences leaders are digitally connecting their people, processes, CMOs, API providers, and other suppliers end to end. 6 / 11

7 How SAP Ariba Solutions Can Help As summarized in the following table, SAP Ariba solutions for direct spend can accelerate the digital transformation of procurement. That s because they provide a single face to your CMOs and API providers for collaboration on key supply chain planning, quality, and execution processes regardless of their technological sophistication. SAP Ariba Functionality Forecast collaboration with contract manufacturing organizations (CMOs), active pharmaceutical ingredient (API) providers, and other suppliers Contract manufacturing collaboration Single platform Comprehensive CMO, API provider, and supplier onboarding services Quality collaboration Associated Benefits Extend supply chain planning, ERP, and other related systems to CMOs, API providers, and other suppliers to give them visibility into demand and obtain their commitments over planning horizons. Provide connectivity options that meet the needs of suppliers of all sizes and technical abilities. Collaborate with CMOs on purchase orders and subcontract service orders, including consigned inventory, components shipped, and components to be used; receive component consumption data from CMOs; and provide manufacturing visibility to them. Use a networked-based, single system that harmonizes processes and provides a single face to CMOs, APIs, and others across multiple tiers of trading partners. Use turnkey supplier onboarding services and on-demand technology including supplier enablement and help-desk services that are built in with every deployment. Quickly onboard thousands of global CMOs, API providers, and other suppliers, and flexibly connect their systems and processes to yours. Share quality information including inspection results and deviations on components, work in process, and end products with CMOs, contract packaging organizations, contract research organizations, direct suppliers, and other trading partners. This helps ensure alignment before, during, or after manufacturing, shipment, or invoicing. Create a joint record and resolution process for quality issues initiated by your or your trading partners quality assurance teams across multiple quality notification types (deviations), and request and obtain inspection results from your trading partners. Obtain certificates of analysis, confirm or make usage decisions and stock postings based on inspection results, and collaborate with partners to exchange and review quality documents, including unstructured communications such as batch record reviews or change control requests. Equip quality managers with better visibility into the quality of supply from suppliers and CMOs. 7 / 11

8 Serialization Supplier-managed inventory (SMI) collaboration Supplier risk information Supplier qualification matrix Supplier categorization and segmentation End-to-end process management Integration with ERP and advanced supply chain optimization tools Complex services and service master Total landed cost calculation Generate high volumes of unique serial numbers and disseminate them through the value chain on a single network. Note: These are future capabilities on the road map. Gain instant visibility into inventory managed by your direct spend trading partners. Collaborate with them on schedule agreements, inventory and minimum/maximum information, replenishment signals, advance ship notices, and goods receipt notices to help optimize inventory levels across the supply network. Obtain targeted risk intelligence and enable compliance across source-to-settle processes to help ensure a focused approach to risk due diligence during the selection, onboarding, and contracting of CMOs, APIs, and other suppliers. Proactively monitor and address risks throughout your entire supply base. Qualify suppliers down to the plant level using a flexible matrix for supplier qualification and segmentation. Use comprehensive tools to onboard, qualify, segment, and manage supplier performance, as well as control whom to invite to bid so you can drive spend to preferred suppliers. Use a unified vendor data model in the cloud, which suppliers can keep up to date in a self-service model to help ensure accurate supplier records. Integrate sourcing and contracting processes with manufacturing execution through your ERP system so that terms negotiated are fully executed. Enjoy streamlined integration with back-end systems so that sourcing agreements flow to your ERP software from SAP Ariba solutions. Execution documents such as purchase orders, work orders, and quality notifications also flow smoothly between internal and supplier systems. Choose from a portfolio of integration options and get support for over 100 preconfigured processes to accelerate digital supply chain transformation. Simplify and improve strategic sourcing with seamless data sharing through integration with services, materials management, and vendor management systems. Note: These are future capabilities on the road map. Use advanced lookup tables and customized data to include values not specified in sourcing activities but germane to total landed cost calculations in cost formulas. You can include, for example, shipping and logistics costs to compare different Incoterms and Incoterm locations offered by the supplier; taxes and import duties; key internal costs; exchange rate scenarios; and other reference data to obtain a comprehensive view of total landed costs. 8 / 11

9 The Benefits of Digitalizing Supply Chains for Direct Procurement When you adopt SAP Ariba solutions for direct spend, you unlock a whole new world of benefits for your business. For example, you can: Reduce services and materials costs for higher margins Reduce days inventory outstanding (DIO) and improve working capital Gain better visibility and predictability of total costs Decrease IT costs for example, by simplifying supplier integrations and eliminating the need to manage multiple systems Have fewer production delays and greater availability of supply Shorten the lead times of supply Reduce the need for buffer stock and inventory carrying costs for CMOs Increase productivity using automation that reduces manual processes for all parties Enable easier information access and planning process consistency for all parties Achieve greater regulatory compliance with higher-quality products and reduce revenue losses or delays associated with stock-outs by equipping quality managers with better visibility from suppliers and CMOs Lower brand and financial risk Attain greater manufacturing consistency Automate quality management with CMOs to reduce manual processes and tasks, along with the cost of improving quality Improve customer satisfaction by responding faster to quality issues Enterprises can achieve a 12% reduction in days inventory outstanding with dynamic, frequently updated forecasts. 3 Accelerate your digital transformation of procurement and provide a single face to your CMOs and API providers to collaborate on supply chain planning, quality, and execution with SAP Ariba solutions for direct spend. 3. SAP Performance Benchmarking. 9 / 11

10 Proving the Value: Customer Successes Companies in the life sciences industry are already adopting SAP Ariba solutions for direct spend and realizing impressive results. Consider the following real-world customer examples. A GLOBAL MARKETING AUTHORIZATION HOLDER A US$40 billion MAH in the life sciences industry has joined forces with the SAP Ariba team as a co-innovation partner. This company, like so many others, is heavily dependent on its contract manufacturing organizations and seeks to partner very closely with them. In fact, the company partners with more than 100 CMOs. By so doing, it can flex manufacturing capacity rather than work within the constraints of internal manufacturing capability alone which can be underutilized in periods of soft demand or overutilized when demand peaks. CMO partnerships offer greater manufacturing flexibility with controlled, predictable internal operating costs. However, they also can create challenges around data integrity and alignment on end-product quality. Quality is a top priority in an industry that impacts human lives. Today, this MAH is working with the SAP Ariba team as a co-innovator in some groundbreaking work to collaborate with CMOs on quality initiatives (for example, around inspection results and deviations on components, work in process, and end products). It is also working with CMOs to easily request and obtain inspection results and certificates of analysis from its CMOs and other trading partners. This collaboration is helping to ensure alignment before, during, and after manufacturing, shipment, or invoicing. It s also making it easier to confirm or make usage decisions and stock postings based on the inspection results. As a result, the MAH can utilize the manufacturing abilities of its CMOs without sacrificing visibility into manufacturing and end-product quality. A LEADING MEDICAL DEVICES OEM A medical devices OEM with a product portfolio that includes implants, surgical equipment, endoscopic and communications systems, and emergency medical equipment faced similar challenges in working with its contract manufacturing partners as the company discussed above. In addition, this OEM sends its manufacturing requirements to suppliers and uses a supplier-managed inventory (SMI) process for its internal and external manufacturing operations. Management adopted SAP Ariba solutions to: Align and integrate supply chain and manufacturing Optimize its SMI processes based on forecasts, projected stock calculations, and contracted minimum and maximum inventory levels (to be provided in the inventory hubs) Improve productivity, processing times, and visibility through transaction automation and validation Our virtual supply chain program creates a new standard way for suppliers and CMOs to work with us, leveraging SAP Ariba solutions. Leader, External Manufacturing Supply Chain, Process and Systems 10 / 11

11 The Future of Supply Chain Collaboration in Life Sciences Emerging technologies, including the Internet of Things (IoT), artificial intelligence, and blockchain, can drive further efficiencies and greater compliance in the life sciences industry. EFFICIENCIES ACROSS THE SUPPLY NETWORK Not all participants in the supply chain are as technologically savvy as multinational MAHs. CMOs, API providers, and other trading partners often operate at a local level, focusing on their biopharmaceutical expertise and research rather than technology. Many of these suppliers are already connected to industry networks and platforms. But, imagine making these connections possible without the mapping and testing associated with integrated connectivity and even without the training and manual processes that portal-based connectivity requires (such as retyping information from a back-end system to a portal operated for the MAH). Intelligent bot technology, an opportunity in the not-so-distant future, will enable substantial efficiencies in partner onboarding. Bots that can learn which back-end systems to scour for data, which specific data elements to scrape, and how to respond intelligently to a collaboration request from trading partners could enable business connectivity at a massive scale. COMPLIANCE DRIVEN BY INTELLIGENCE INSTEAD OF INVESTMENT In another example, new regulatory requirements to serialize products at the smallest saleable unit have driven life sciences MAHs and manufacturers globally to make massive investments in infrastructure, packaging equipment, and supply chain and logistics process changes. Envision an application that generates tens of millions of serial numbers and integrates with a network that connects millions of trading partners to distribute that information into work orders and other key documents. Such an application would transform the ability of MAHs and their partners to comply. It would represent compliance without the massive investment in infrastructure and process changes. And, it is already being developed. IOT-ENABLED COLD CHAIN LOGISTICS In a final example, today s supply chain and operations professionals are using IoT technology as a bridge to connect information across internal and external systems globally. This helps them gain visibility into real-time data and issues, such as delayed delivery trucks. Bringing IoT data together with enterprise data unleashes the power to make critical decisions immediately based on real-time insight from the field and intelligent business rules from your enterprise applications. Imaging bringing this power to the life sciences industry, where cold chain logistics, for example, is so critical to quality and regulatory compliance. Real-time monitoring of temperature, humidity, and other factors bounced against storing and shipping condition information held in back-end systems has tremendous potential to preserve quality and compliance while minimizing waste due to off-spec shipments. These technologies are already in development and being tested among early adopters. They present substantial opportunity to drive further compliance, efficiency, and quality in the life sciences industry. NEXT STEPS To learn more about SAP Ariba solutions for direct spend, please visit /solutions-overview/supply-chain. 11 / 11

12 Studio SAP 53047enUS (17/10) No part of this publication may be reproduced or transmitted in any form or for any purpose without the express permission of SAP SE or an SAP affiliate company. The information contained herein may be changed without prior notice. Some software products marketed by SAP SE and its distributors contain proprietary software components of other software vendors. National product specifications may vary. These materials are provided by SAP SE or an SAP affiliate company for informational purposes only, without representation or warranty of any kind, and SAP or its affiliated companies shall not be liable for errors or omissions with respect to the materials. The only warranties for SAP or SAP affiliate company products and services are those that are set forth in the express warranty statements accompanying such products and services, if any. Nothing herein should be construed as constituting an additional warranty. In particular, SAP SE or its affiliated companies have no obligation to pursue any course of business outlined in this document or any related presentation, or to develop or release any functionality mentioned therein. This document, or any related presentation, and SAP SE s or its affiliated companies strategy and possible future developments, products, and/or platform directions and functionality are all subject to change and may be changed by SAP SE or its affiliated companies at any time for any reason without notice. The information in this document is not a commitment, promise, or legal obligation to deliver any material, code, or functionality. All forward-looking statements are subject to various risks and uncertainties that could cause actual results to differ materially from expectations. Readers are cautioned not to place undue reliance on these forward-looking statements, and they should not be relied upon in making purchasing decisions. SAP and other SAP products and services mentioned herein as well as their respective logos are trademarks or registered trademarks of SAP SE (or an SAP affiliate company) in Germany and other countries. All other product and service names mentioned are the trademarks of their respective companies. See for additional trademark information and notices.

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