Supply Chain Effeciency Across the Global Network

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Currently at BMS, Natalie Gerdt Lotier is driving the Life Cycle Management process effort that works in unison with the supply chain planning system to provide significant efficiencies across the chain. From concept through design, manufacturing processes and delivery to the patient, in this session, Natalie will discuss this effort and how the product lifecycle management system at BMS has increased coordination and communication with suppliers resulting in a more responsive supply chain.

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Shire has transformed its supply chain for the synthetically derived drug products in its portfolio to a completely outsourced model with the underlying principle that excellent safety, quality, and availability will achieve improved patient outcomes. In order to execute on this, the company has focused on creating unified partnerships with its suppliers to ensure that it remains one of the gold-standard supply and manufacturing organizations. In this session, Mani Sundararajan, the VP & Head of Global Pharmaceutical Technology, will discuss the following:

• How Shire is utilizing their Process Management Informatics platform for oversight of their processes
• The Product Quality & Technical Teams role for reviewing performance and proactively driving continuous improvement
• Ways that Shire and its partners have created a collaborative and transparent relationship to drive process robustness and supply resiliency
• Attained 100% OTIF performance and a Lot Acceptance Rate of greater than 99.7%.

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With continued rise in the use of contract manufacturers, supply chain networks have become more complex then ever before. Traditionally, the supply chains built for vertical integration must be transitioned to a network environment. This panel will uncover how companies are managing that change. Historically, there has been hesitation to treating suppliers as strategic partners, but keeping them at arms length is a path to disaster. The panel will examine the following:

• What are the fundamental success factors for a network environment?
• What communication best practices within a network design?
• What should the expectations be for suppliers within this new model?

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Learn how Kenco collaborated with JDA to overcome a challenging transition in an FDA validated environment. Kenco's client experienced the following during the system implementation: An organization-wide ERP transition, five acquisitions including one that doubled the size of the organization, and major SKU proliferation and growth. Come hear how the award winning implementation resulted in a 50% productivity improvement in replenishment, 16-hour reduction in dock to stock time, and a 30% improvement in picking efficiency. All this while allowing planning serialization and delivering e-pedigree compliance.

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The ability for an organization to rapidly transform itself and integrate other businesses has needed to become a core competency as more and more acquisitions occur throughout the pharma space. Allergan is no stranger to this, with a history of integrating other organizations and products into its portfolio and core business. In this session, Jen Wang, the Vice President of Global Planning at Allergan will examine specifically the supply chain challenges and considerations when managing integrations including:

• Technology transfer
• Methodology
• Change management
• Cultural integration

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By now, everybody who is seriously involved in pharma serialization and Track & Trace programs should have heard about SAP’s new serialization/Track & Trace solution SAP Adv. T&T (SAP Advanced Track & Trace for Pharmaceuticals). With the official release date of SAP Adv. T&T so close to this conference, Movilitas is proud to be the first SAP partner with permission from SAP to share exciting news on SAP Adv. T&T. Get an update on what will be new in SAP Adv. T&T compared to the existing SAP solutions in that space and learn how the new solution offering further enhances SAP as the best of breed solution provider in the serialization/Track & Trace space.

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• How does a company quickly and properly align technical capabilities?
• How can the right expertise from both sides of the organization be aligned to create a cross-functional team that best manages the transition?
• What type of cultural integration needs to occur to avoid instability and hidden surprises?

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Cell therapies are one of the most promising new classes of biopharmaceutical treatments available today but require a very specific set of conditions for transportation and distribution. In this session, Michael Trocchia, Supply Chain Lead for Cell & Gene Therapy Unit, will discuss the differences in cold chain logistics, including Small Molecule (Ambient transport), Biologics Large Molecule (Cold Chain 2-8C) and his area of focus, Cell and Gene Therapy very cold chains LN2(-190C). Specific to Cell Therapy Logistics, the talk will cover the factors related to the transportation of Cell and Gene Therapies:

• Temperature Ambient/Dry Ice/LN2
• Transport White Glove/Overnight Carriers
• Tracking Active vs passive
• Cost

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Traditionally, the pharmaceutical supply chain has delivered scalable and conventional biopharmaceuticals. However, as more and more personalized products enter the market and immunology continues to deliver promising clinical therapies, smaller scale, alternative manufacturing and distribution approaches, methods of preservation, and fit with the endto- end supply chain will become the norm. With this continuum spanning from traditional large batch manufacturing of small molecule products to specialty treatments, there is significant differences in how supply chains should be managed and segmented. This panel will discuss:

• Approaches needed to manage the variance of supply chains
• What to expect from the integration of specialty pharmaceuticals, temperature controlled logistics, smaller volume production and more flexible manufacturing
• Lessons learned and examples of how customized supply chains were managed

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Life Science companies evolves and experiences a shift in maturity, there is a massive gap between demand and supply of global talent. With most organizations experienced with a push model, there is also a need to ensure current workforces manage the transition to network models. This talk will examine what industry needs to do to catch-up their internal resources to new environments and supply chain models.

• Sourcing talent from other industries with a similar knowledge-base
• Meeting the core requirements within a market such as salary expectations and demand of critical skills
• Baking-in skill and capability requirements into overall strategy

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Emerging markets have been identified as an immediate source of growth as well as potential sources of supply. The cost, capacity and market-access benefits of these markets emerging market supply networks will be critically important to most large pharmacos over the next decade. The performance of those global networks tomorrow is rooted in the decisions companies make at home today

• How should manufacturers be thinking about selecting supply partners when data on capabilities may not be available?
• How to ensure a transparent relationship so that quality goals are met
• Developing a hands-on approach to monitor supplier performance and manage the relationship

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Active systems provide a strong defense against temperature excursions and protect products through very proactive handling. The draw-backs can be limitations on direct distribution to hard-toaccess destinations. Alternatively, passive systems offer the ability to reach diverse destinations, but might require a much more developed receiving capability at the specific location. This panel will discuss when each system is appropriate and considerations when evaluating market viability:

• What characteristics of the destination or market necessitate an active system?
• How can internal expertise within a country impact your supply chain approach?
• When is controlling door-to-door transportation needed to make sure a product reaches the customer in the right conditions?

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