Clinical Supply Chain Management Driving Operational Performance

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1 Clinical Supply Chain Management Driving Operational Performance July 2010 PwC Your presenters EER1 Ellen Reilly Managing Director Pharma & Life Sciences Advisory Services 400 Campus Drive Florham Park, NJ Tel: Mobile: Sivakumar Rajagapalan Director Pharma & Life Sciences Advisory Services 400 Campus Drive Florham Park, NJ Tel: Mobile: PricewaterhouseCoopers 2 1

2 Slide 2 EER1 kumar need your picture and bio info Ellen E Reilly, 7/12/2010

3 Discussion items for this session Managing clinical trial supply chains is already growing increasingly difficult because of geographic expansion (primarily into emerging markets) and the complexity of pharmaceutical and life science products, including combination therapies, diagnostics, biomarkers and specialist drugs, such as biologics. Following strategies are emerging to be critical for managing the local/ regional partnerships and global logistics that will be necessary to operate clinical supply chains successfully over the next decade as healthcare become more outcomesfocused. Successful partnerships, alliances and contracts Risk mitigation tactics Tax effective supply chain management Labeling and packaging g for emerging g markets Self service and collaborative supply chain model PricewaterhouseCoopers 3 The current supply chain Significant opportunity to reduce complexity, release cost and be more responsive to the patient Raw Materials/ Intermediates Secondary/ Packaging Service Patient Pharma Co 1 site Pharma Co 2 site Pharma Co 3 site site site site site 2 o site/ packaging 2 o site/ packaging 2 o site/ packaging 2 o site/ 2 o site/ packaging packaging 2 o site/ packaging 2 o site/ packaging 2 o site/ packaging Customer 1 Customer 2 Customer 3 Customer 1 Customer 2 Customer 3 Customer 1 Customer 2 Customer 3 Customer 4 Customer 5 Customer 4 Customer 5 Customer 4 Customer 5 Safety Stock is Built in at various stages of the process PricewaterhouseCoopers 4 2

4 2020 The Future of the Pharmaceutical Supply Chain Supply chain models will polarize depending on product type Development manufacture Secondary/ Packaging Packaging ib ti Patient t NPI/ Specialist products Speed/efficiency to market most important driver Development of virtual product and virtual process in-silico factory and equipment design Link with marketing becomes important factor Link to R&D paper (virtual man, live licensing) Smaller, specialist manufacturing facilities, high degree of flexibility, automation, PAT Mass Market products Cost most important driver Efficiencies driven by economies of scale Simpler formulation types (liquid on tablet etc)? Manufacturing landscape will have to change to meet payer demands network consolidation essential, growth of manufacturing power-houses, working for all major players in one network Pharma & Life Sciences University PricewaterhouseCoopers Slide Packaging and distribution services will change to support changing primary healthcare model Development manufacture Secondary/ Packaging Packaging ib ti Patient t Needs to respond to changing primary care model virtual consultation with direct delivery of required prescription. Growth of regional packaging hubs to respond to e-orders. to patient by Fedex? Specialist courier? Companies like UPS/Wincanton etc. moving into this space? Late product customization, multiple medications in same packaging, patient specific Overall management by 4PL. Will need to be true partnership between Pharma company and service provider Pharma & Life Sciences University PricewaterhouseCoopers Slide 6 3

5 What are the key issues facing the clinical supply chain? Planning managing the overall risk what partnerships you need in place effective planning Sourcing Making Challenges Globalization of Trials Reduced budget Increased lead times Demand Supply window of response getting smaller Regulatory Challenges in emerging markets Country specific labeling requirements Infrastructure challenges in emerging markets Global Trade compliance delayed labelling strategies /regional hubs Shipping moving goods into emerging markets tax /customs impacts, alternative valuations cold chain issues Opportunities Outsourcing/Contract Manufacturing Enterprise integration Postponement Strategies, Ondemand/JIT labeling Integrated (Trial and Operations Planning) including Tax SME Supply Chain Risk management Global Trade Management PricewaterhouseCoopers 7 Managing Partnerships 4

6 To support this Virtual Model what do you need to focus on for the future? Supplier management and integration with fewer suppliers but deeper relationships maximizing: Quality and Reliability Collaborative Planning, Replenishment Systems Integration Demand Fulfillment Risk Management of an Agile manufacturing operations to support pull based system that include: Higher productive time and plant efficiency Quicker changeovers and higher utilization High Quality and reduced waste Suppliers Manufacturing Information Systems Integrated demand management to ensure high Demand visibility Demand Fulfillment Lower Demand Creation Marketing Sales Information Systems Customer Information Systems Dynamic warehousing and logistics networks Optimization Pooled Supplies Just in time labeling /e-labeling PricewaterhouseCoopers 9 Establish an Enhanced Supplier Relationship Function Supplier Network Governance Categorize (segment) supply base to determine importance to product strategy and supply. Define objectives and apply required resources for each segment of the supply base. Supplier Performance Management Close gap between company expectations/requirements and supplier performance to drive continuous improvement. Critical Elements of Supplier Relationship Management Supplier Integration Integrate & align with suppliers, leveraging their capabilities across the value chain and establishing structured strategic & operational review meetings. Capitalize on supplier capabilities for new product development. Risk Management Systemically assess, track and mitigate potential supply risks, IP risks and service disruptions in order to achieve supply chain agility & resiliency. PricewaterhouseCoopers 10 5

7 Vendor managed inventory - VMI BUYER Data Analysis Mgmt Strategy Clinical Supplies VENDOR Remote Data Collection Data Aggregation and Analysis Information Data Analysis PO/ Service Level Agreement Performance Resupply Logistics Ensure high forecast accuracy Establish Supplier trust and integration Create demand profiles Joint monitoring of inventory levels Develop a robust replenishment program Implement performance measurement and analytics PricewaterhouseCoopers 11 Risk Management 6

8 Understanding Supply Chain Risk Requires Greater Visibility Knowledge of Risks Known Knowns Context Issues Realized risks Mature RM Programs Issue management process typically, but not always, mature Known Unknowns Unknown Knowns Unknown Unknowns Potential Issues you are aware of (unrealized risks) Risks someone knows but you don t Unknown, yet to be discovered risks Risk management process varies, mature in many Pharma companies Risk management process is evolving. Heavy emphasis s/b on communication w/employees/suppliers Risk management process is typically ad hoc. Need strong process for Risk ID. PricewaterhouseCoopers Slide 13 Getting To The Unknowns/Knowns & Unknowns/Unknowns Effectively And Realistically Integrate Existing Supplier Intelligence Shipment Risk Radar Must be Enhanced PwC Point of View Mature RM Models have blind spots Supply chain risks are program risks Documen Unknowns Suppliers need help with certain risks tation Unknowns Regulatory Need to tap into supplier intelligence to Knowledge develop a better Risk Radar (further reaching/expanded view, early warning of changing risk profile) Cold An objectives-based approach will Chain Unknown result in better alignment of objectives Shipment Knowns with suppliers, discovery/communication of more Unknown unknowns, and will assist in Knowns discriminating risks (reduce clutter) Employees and suppliers s/b involved Bottom s Up Risk Identification Approac ch Program Identified Risks IPT Identified Risks Working Team Identified Risks Challenges Change mindset of PM s, SCM s & SC Engaging suppliers of varying sophistication and cooperation Leverage current processes & enablers PricewaterhouseCoopers Slide 14 7

9 Tax Global Tax regulation Impact on Global Clinical Trial and Supplies Integration of key Clinical Supply Chain functions can be leveraged to improve Operational Savings Risk Management and Data Visibility Reducing landed cost by better managing indirect taxes Reducing income taxes with proactive transfer pricing Cash Flow Improvement Risk Management Lower landed costs Optimal lead times Enhanced Compliance Locating management and control of key Supply Chain functions makes a big difference. Lead time consistency PricewaterhouseCoopers 16 8

10 Case Study VAT Savings Key factor in Clinical Trial Design Site and Depot selection can influence the savings in taxes during clinical trials Savings can be realized by actively involving Tax SME in the early stages of trial design PricewaterhouseCoopers 17 Labelling 9

11 Labeling Challenges Impact on Clinical Trial (Lead times and compliance) Labeling approval during the early stages of Clinical Trial is a tedious and time consuming process Changes to contents in the label impact the critical path in the clinical trial Global Clinical Trials with country specific needs further impact the label development and approval times Postponement strategies involving on-demand /JIT labeling dictate agility and automation in the clinical supplies labeling process PricewaterhouseCoopers 19 Major Benefits - Delayed / Postponement of Labeling Eliminate Packaging Constrictions Language Requirements Package Design Speed to Market for new products and updates to labels Real time updates of adverse events or additional benefits gathered from post market surveillance of the device Improved agility and reduced cycle time for labeling creation, updating, approval and publishing Improved visibility into the labeling management process Minimize risk of labeling non-compliance (higher conformance based on harmonized processes, information and technology) Increase supply chain flexibility with support for generically labeled product made to stock, with market specific labeling made to order PricewaterhouseCoopers 10

12 Postponement - Labeling Solutions that support Label Management Processes from Content Creation to Publishing Source Systems Product Development Labeling Application Publishing Web Content Mgmt. Manufacturing Labeling Graphics Product and Process Design Specifications Management PLM Foundation Engineering Change Control Labeling Information Product Registrations elabeling/ Submission Assembly Marketing Training Product Data Comprehensive Product Information Model All product information, including labeling, managed as part of a comprehensive production information model Capitalize on PLM Foundation to manage product data, integrate with source systems, and support engineering change control Employ Technical Publications technology integrated to PLM to render label information in various forms Employ Web Content Management and Engineering Change Control to ensure appropriate labeling content published PricewaterhouseCoopers Slide 21 Collaborative Supply Chain model 11

13 Define a Collaborative supply chain Return/ Source Supply Make Ship Reconcile Patient Destroy Collaborative Demand and Supply Planning Collaborative Demand Processes Collaborative Supply Processes Collaboration Arrangement is the process of setting the business goals for the relationship, defining the scope of collaboration The Joint Business Plan then identifies the significant events that affect supply and demand in the planning period,. Clinical Demand ing projects clinical supplies demand at the site. Order Planning/ing determines future clinical supplies ordering and delivery requirements Order Generation transitions forecasts to firm demand. Order Fulfillment is the process of producing, shipping, delivering, and stocking products for site consumption. Exception Management is the active monitoring of planning and operations for out-of-bounds conditions. Performance Assessment calculates key metrics to evaluate the achievement of trial goals Continuous Performance and Risk Management PricewaterhouseCoopers 23 Clinical Supplies Process Flow Study Manager Setup Study Structure Parameters Build Analyze Study (rollup) Plan Manufacturing Supply Planning Packaging WOD Plan Transfer Order WOD Central Supply Order Return Order IVRS (randomization engine) Enrollment Initiated Any Site Actual Enrollment Disbursement Return Subject OPM WMS Siebel CTMS Business Intelligence PricewaterhouseCoopers 12

14 Clinical Supplies Demand Management Study Manager Setup Study Structure Parameters Build Monte Carlo Simulation Analyze Study (rollup) CRO TPL Plan Manufacturing Supply Planning Packaging WOD Plan Transfer Order WOD Central Supply Order Return Order IVRS (randomization engine) Enrollment Initiated Any Site Actual Enrollment Disbursement Return Subject OPM WMS Siebel CTMS Business Intelligence PricewaterhouseCoopers Clinical Supplies Supply Management Study Manager Setup Study Structure Parameters Build Analyze Study (rollup) Plan Manufacturing Supply Planning Packaging WOD Plan Transfer Order WOD Central Supply Order Return Order IVRS (randomization engine) Enrollment Initiated Any Site Actual Enrollment Disbursement Data visibility using Portals Return Subject TPL OPM WMS Siebel CTMS Sitemonitors Collaboration Hubs Business Intelligence PricewaterhouseCoopers 13

15 2010 PricewaterhouseCoopers LLP. All rights reserved. PricewaterhouseCoopers refers to PricewaterhouseCoopers LLP, a Delaware limited liability partnership, or, as the context requires, the PricewaterhouseCoopers global network or other member firms of the network, each of which is a separate and independent legal entity. PwC 14

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