PHARMACEUTICAL and BIOTECH INDUSTRIES IMPROVING YOUR RESULTS TODAY, SECURING YOUR RESULTS TOMORROW Credentials and track record 1 “ Vision without action is merely a dream. Action without vision just passes the time. Vision with action can change the world. ” Joel A. BarkerThe evolution of the global pharmaceutical and biotech market has posed major challenges for the industry’s supply chain: Demand has been growing in emerging markets, where it’s much more volatile than in mature markets – thus challenging industry supply chain’ agility; Loss of exclusivity as patent protection expired for a large number of drugs has fuelled competition from generic players - thus increasing pressure to cut costs; Most new drugs target narrow indications, thanks to progress in genomics and proteomics, and amid healthcare budget constraints worldwide – thus requiring much smaller production volumes (typically two to five tons per year instead of several hundreds) and increasing complexity; Most new drugs are either more complex chemical molecules (requiring more synthesis steps), or biologics (requiring specialized processing) – also adding to supply chain complexity; Outsourcing and globalization have increased and resulted in more and more parties being involved in the manufacturing of a single drug, spread across the globe – again, increasing supply chain complexity; Scrutiny from regulatory agencies keeps growing, imposing the highest levels of quality, safety and compliance. Businesses are being forced to challenge and rethink their global value chains. The needs for resilience, speed and agility is now calling for greater ‘synchronisation’ not only internally, but also outside with Suppliers, Customers and the wider eco-system, to bringing greater transparency and visibility throughout the entire network. Synchronised value chains will dynamically adapt and respond faster to the “new normality”. and the competitive gap between companies that lead the way in synchronisation, and those yet to get started is widening. Our perspective on the Pharmaceutical and Biotech industry How EFESO How EFESO can support youcan support you Pharmaceutical and biotech operations were designed to deliver the highest service levels in relation to large and relatively stable production volumes, preventing potential issues by investing in inventory and production capacity. No surprise if they now underperform in the new, deeply changed scenario: drug shortages persist around the world, representing an ethical issue vs. patients and generating major losses of revenue for the pharmaceutical and biotech industry. We believe that your consulting partner must have a deep understanding of what these challenges practically mean in the biopharmaceutical industry environment, and clear ideas and experience of how to approach them. On the following pages we have summarized some selected, practical cases of how we have helped our clients to tackle these challenges and how we have worked together. If these cases remind you of the challenges you are facing, we would be very happy to discuss your transformation journey and how we can work together in a partnership spirit. KEY QUESTIONS TO BE ANSWERED In this context, Operations can regain its excellence and become a competitive advantage for those biopharmaceutical companies which act on it and find the right answers to some key questions: How to improve cost efficiency, agility and reliability of the Supply Chain, while meeting in full quality, safety and compliance stricter requirements? How to do it within each plant’s four walls? How to do it by optimizing the company’s global manufacturing network, in a world that seems to be rediscovering trade barriers? What lessons can be learned from FMCG supply chains, and how to apply them in a highly regulated environment? How to manage growing complexity? How to segment drugs and markets from a supply chain perspective? How to move from a one-size-fits-all supply chain to one tuned to each drug/market cluster’s features? How to assure that quality and compliance watchdogs – QA and QC - also act with the highest cost efficiency and agility? How to seize “digital” to transform the operations? How to successfully tackle human dynamics, and move from having experts in individual areas to having integration leaders? 3Pharma and Biotech Solutions We help management teams to translate business strategy into concrete plans that impact operational performance and result in clear cost savings and lines of growth. This involves defining, assessing and planning the required operational changes at a Group, a BU or a subsidiary level. Operational Strategy Alignment - operational strategy challenging and benchmarking - how “ready to go?”, leadership alignment and mobilization sessions Operational Strategy Deployment - cascade strategy into progression roadmap, strategic initiatives management Operation Footprint Design / Redesign - strategic make-or-buy, footprint rationalization Applying Human Dynamics to everyday organisational change is all about finding the more efficient and effective way to change people’s current mind-set and behaviour towards a desired mind-set and behaviour. Working from topfloor to shopfloor, we help you to engage the organisation on the change journey. Cultural Change - the progression path to Human Dynamic Excellence, fundamentally change the way you do things Mobilising for Progression - boost adoption and anchoring following the change roadmap Leading Progression - strengthen your leadership to boost business results Performance Behavior - drive the desired performance through the right behavior Engagement Monitoring and Measuring - engage your people and manage the process to engage We help organisations to significantly improve their Lab & Quality function processes and performance, focusing on developing a ‘System of Operations’ with processes that effectively level short interval workloads, reduce throughput times and support an appropriate level of standardization of tasks. QC – Quality Control - Chemistry, Microbiology, Raw Materials, Virology, Biochemistry, Packaging materials, Stability Lean in R&D - Discovery, Toxicology, Pharmacokinetics, Biomarkers, Method Development QA – Quality Assurance - Batch Record Deposition, Change Control, Validation, Deviations & CAPA RA – Regulatory Affairs - Submissions, Publishing, M.A. Changes, Market Surveillance & Reporting Real Lean Transformation Real Lean Transformation in QC, R&D, QA, RAin QC, R&D, QA, RA Human DynamicsHuman Dynamics Turn Strategy into ExecutionTurn Strategy into Execution 4We analyze your potentials, derive the use cases, define your target architecture for a full vertical and horizontal integrated connected I40 platform, including your internal production and logistic processes as well as your customer and supplier integration, as basis for your individual roadmap: Productivity – each process step becomes as effective and efficient as possible, within your fully connected self-optimizing smart factory Transparency - visualise the progress of all initiatives, real-time with our digital Progression Management System SOLVACE Insight - unleash the value locked in your performance improvement data, with IBP and OEE monitoring, based in digital twins of the entire supply chain Compliance - avoid production failures through digital operator guidance and process control, get a quick root cause analysis of deviations, and accelerate product releases Efficiency - better synchronize production steps by using leading-edge AI /self-learning technologies for advanced planning and controlling We help organisations to get the most value out of local and global operations by focusing on physical assets and industrial footprints to optimize the full lifecycle and set the framework for higher productivity and safety – taking the most important asset along: the people. Operational Excellence - TPM, maintenance & operations excellence, WCOM™, Advanced process excellence/ Lean Six Sigma & yield management, Continuous Improvement Program Management Office & Knowledge Management - portfolio & resource management, intelligent knowledge databases Structured Progression processes and Transformation projects - (Power Leaps), based on Lean and WCOM™ best practices Our focus is to help Pharma businesses gain alignment between external pressures and internal actions and to ‘think’ and ‘behave’ End-to-End across the entire Value Chain to create competitive advantage. We work on all the value creation levers to deliver true value for our customers, including revenue increase, cost reduction, assets/cash efficiency, service improvement and risk mitigation. Our proprietary Concurrent Digitalised Value Chain (CDVC) model provides a framework for identifying gaps and establishing ‘concurrent progression’ in the areas that have the greatest impact on the ‘value’ generated. Development & portfolio strategy - Pipeline Optimisation, Portfolio Strategy and Rationalisation, Commercialisation Integrated Business Planning - S&OP Progression, Supply Chain Performance Management, Demand/Supply Planning, Digital IBP cockpit Sourcing & Procurement Excellence - Strategic Sourcing (API, Packaging), Supplier/CMO Relationship and Contract Management Early management - Design Thinking, Vertical Start-Up, Manufacturing Oversight, Industry 4.0 Supply Chain Strategy - Network Optimisation, Route to Market Working Capital Optimisation - Inventory Balance, Order-to-Cash Improvement E2E Value Chain Improvement - Customer/Supplier Synchronisation, Value Chain Segmentation Manufacturing: World Class Operations Manufacturing: World Class Operations Management (WCOM™)Management (WCOM™) Digital Transformation Digital Transformation Supply Chain: Value Chain SynchronisationSupply Chain: Value Chain Synchronisation 5CLIENT SITUATION & APPROACH The Benelux affiliate of an international pharma company was looking for expertise and methodology to structur- ally and culturally prepare their Belgian organisation for the coming year strategy, including the expansion of their product portfolio and a target of 40% in sales increase. We supported in: Implementing a three-dimensional approach: ‘Organisational Re-design’ combined with ‘Expected Team’s Behaviors Identification’ ‘Leadership Practices Adjustment’ with the scope to concretise real change toward increased sales results RESULTS Definition, through a participative approach, of a new way to organise the teams, of some roles’ purpose and of a new organisational chart Identification of the expected team behaviors Start of the thinking process around the leadership practices to underline the expected cultural change Delivering tangible business value CLIENT SITUATION & APPROACH The Client produces, for the world market, inhalation products. The sites’ productivity increase targets are > 10% per year. Industry 4.0 activities are the main lever to achieve this target. The client wanted to have an implementation roadmap for the complete plant network. The approach we proposed followed three streams: Collation of a short list of Industry 4.0 opportunities, starting with 3-day site assessments to determine the as-is situation Identification and evaluation of Smart Factory projects, along with a recommendation on which projects should be prioritised and launched Implementation plan on the road to the Smart Factory RESULTS Identified more than 50 Smart Factory projects with a positive business case Implementation roadmap for these projects Identified savings have a payback time of 1.4 years for the first wave Human Dynamics Human Dynamics Leading Progression and Mobilising for Progression Digital Transformation Digital Transformation Industry 4.0 CLIENT SITUATION & APPROACH A leading pharma company engaged us to increase project workload capacity at their R&D facility whilst improving the schedule adherence of current project workloads. Advanced bioreactor labs utilization was optimized at a site respon- sible for the development of the next gener ation of biological derived drugs, including one $6 billion/year blockbuster Robust capacity planning process for all projects that maximized equipment utilization and let scientists focus on scientific innovation (NVA tasks minimized) Rhythm wheel levelling strategy for preculture processes Established standard work practices for the sampling and analysis of results Electronic visual management system to monitor projects progress and report instructive KPIs RESULTS Optimized utilization of advanced bioreactor labs by 29% with significant downtime reduction thanks to new planning and re-engineered changeover processes CLIENT SITUATION & APPROACH The Operations Top Management of a leading French pharma group with 10 units in France, aimed at building a more efficient model to face growth. We supported in: Defining the long-term vision and goals Mapping and diagnosing the current situation and defining the core competencies Defining the levers for the current organization: cost reduction, complexity management, new target operating model Defining and evaluating several scenarios RESULTS Alignment with production, Supply Chain, marketing and sales Production footprint optimization: location, capacities, production plant technology (Factory 4.0), resources and capabilities New Industrial Master Plan Modelling Definition of a 10 M€ cost reduction plan included masterplan and impact study on the organization Operations StrategyOperations Strategy Turn Strategy into Execution QA/QC/RA/R&D: Real Lean Transformation QA/QC/RA/R&D: Real Lean Transformation Biopharmaceutical R&D 6CLIENT SITUATION & APPROACH A leading international pharma company, operating profi- ciently yet in a traditional manner (S&OP with limited multifunctional involvement, Supply Chain disconnected from rest of Value Chain) seeked for vertical and horizontal integration. EFESO partnership on Digital with FibonacciLab boosted proficiency in process re-design, data management, technology understanding and change management imple- mentation. We supported in: Designing and integrating data with all ERPs Identifying and implementing technology solutions with existing systems and work processes RESULTS Service improvement from 97 to >99%, inventory reduction: 13%, remnants reduction: 3%, workforce rightsizing: -75% Integrated Business Planning cockpit based on ONE number and ONE source of truth Machine learning based autonomous Demand forecasting and narrow artificial intelligence generated Prescriptive Supply Planning CLIENT SITUATION & APPROACH A global, patient-dedicated biotechnology company discov- ering, developing and delivering drug products for rare metabolic diseases. In its journey to becoming a scalable operation the company wanted to understand its current level of Value Chain maturity and to develop a plan to become ‘fit for growth’. We supported this by: Helping them to align the overall vision, strategy and risk profile and perform a Value Chain Assessment Developing a Progression Roadmap for Tech Ops Supporting delivery of the Progression Plan in all key areas of the Value Chain with specific interventions to maximise business ‘value’ RESULTS VC Progression Roadmap containing functional, leadership and digital themes – bringing it to Level 2 (In Control) on EFESO’s Value Chain maturity model Tech Ops RACI and governance process agreed KPI definition and Performance Control System in place Value generation targets cascaded in key areas of Cost, Service, Quality, People and Risk Value Chain SynchronisationValue Chain Synchronisation Concurrent Digitalised Value Chain CLIENT SITUATION & APPROACH A leading company in pharma industry had the challenge to manage performance in an efficient way, reducing bureaucracy and improving its knowledge capitalization efforts. To digitalize its performance improvement meetings and problem solving process we implemented Solvace, the EFESO Digital Progression Management Suite: White boards replaced by touch screens, allowing teams to run performance meetings without changing habits Root cause analyses moved from paper to digital Adoption was fast among the users, typically able to use Solvace after a couple of meetings RESULTS Digitalized log book for authorities on deviations and daily operations 1500 meetings run digitally every month Up to 20% higher adherence to action plans 100% of Problem Solving and Performance Improvement data capitalized Digital TransformationDigital Transformation Progression Management System Value Chain Synchronisation Value Chain Synchronisation Mobilising for Progression CLIENT SITUATION & APPROACH The Client has 87 manufacturing sites in 38 countries, employing ±100,000 people. To respond to health needs worldwide, the client needed to strengthen production capacity, promote inter-site collaboration and increase its presence in emerging markets. EFESO designed the Maturity Assessment System to increase collaboration and efficiency in order to sustain this industrial network strategy by: Customisation and system design Initial training of future internal leaders and system calibration based on EFESO’s professional assessors’ support Global system roll-out to converge towards Manufacturing System and system maintenance RESULTS More than 150 people actively using the system with 30 certified internal assessors After the first year, the assessment has been rolled out to all the regions Manufacturing: WCOM™Manufacturing: WCOM™ Maturity Assessment 7Copyright © 2020 EFESO Consulting CALL US AT +33 1 53 53 57 00 OR LET US KNOW ABOUT YOUR CHALLENGE VIA INFO.MARKETING@EFESO.COM “Improving results today, securing results for tomorrow” means achieving tangible business results and simul- taneously developing the capabilities, leadership and culture to continue progressing faster than competition. EFESO Consulting brings more than 40 years’ experience and thought leadership, supporting many of the leading global brands in both mature and emerging markets. We are a group of over 500 experienced consultants representing 45 nationalities, operating from 35 offices around the world with a strong presence in Europe, USA, South America, Middle East, Africa and Asia. Our people bring together hands-on experience and expertise spanning sectors and functional capabilities and, in an engaging and sustainable way, we partner with our Clients on their progression Journey. EMEA ASIA SOUTH AMERICA AMERICA NORTHNext >