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EFESO Pharma and Biotech industry

PHARMA & BIOTECH


Biopharma Operations evolved to deliver the highest service level in respect of large and relatively stable production volumes by investing in inventory and production capacity – fulfilment whatever the cost!

Today, because there are new drugs targeting narrow indications, smaller volumes are produced. The result of this expanding portfolio of products, combined with outsourcing and globalization, is major complexity in pharmaceutical supply chains.

No surprise, therefore, that Operations now underperforms as a result of this new scenario

More and more supply chain agility is challenged by demand growth in emerging markets. The pressure to cut costs is high, as new generic players are entering the market after the patent protection has expired for a large number of drugs.

By managing these issues effectively, Operations can regain its excellence and become a competitive advantage for those biopharmaceutical companies which recognise the need to act now!

We believe that the right consulting partner must have a deep understanding of what the above challenges mean in the biopharmaceutical environment and have clear methodologies and experience on how to overcome them, and EFESO has these capabilities.

Schedule a call with a consultant

NEWS ABOUT THE PHARMA & BIOTECH INDUSTRY


  • The Pharma world of contract manufacturing needs massive and fundamental…

    When is a CMO not a CMO?

    by Hugh Williams

    Contract Manufacturing Organisations (CMOs), particularly in Asia, are facing some interesting times and challenges. In their own countries, they are looking at how to respond to growth, different buying practices in China, and an ageing and maturing market. In the West, they have to satisfy growing complexity and an increasingly complicated demand model that is looking for much faster delivery, smaller batch sizes, and customer centricity.

     

  • Breaking Barriers In Pharma

    Operational Excellence in Laboratories

    The pharmaceutical sector is very different from the short cycle manufacturing environment that Lean was originally developed for (i.e. mostly batch processes with relatively long cycle times).

     

FOCUS AREAS FOR THE PHARMA & BIOTECH INDUSTRY


EFESO’s Pharma offer covers the entire value chain, seamlessly incorporating Human Dynamics and Digital transformation. We help our clients to tackle today’s challenges by co-creating a tailored approach which will achieve the best results.


  • 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.


    Progression Strategy Solutions Overview

    01

    Operational Strategy Alignment - operational strategy challenging and benchmarking - how “ready to go?”, leadership alignment and mobilization sessions​

    02

    Operational Strategy Deployment - cascade strategy into progression roadmap, strategic initiatives management​

    03

    Operation Footprint Design / Redesign - strategic make-or-buy, footprint rationalization​

    04

    Complexity optimisation - increase companies’ efficiency and responsiveness through an optimal balance between product variety and process optimisation, helping them to reach value out of complexity

     

  • We help clients to achieve alignment between external pressures and internal actions and to ‘think’ and ‘behave’ End-to-End across the entire Value Chain as a means of creating competitive advantage

    Our Value Proposition

    01

    We understand the challenge for the Pharma industry – the pace of change, pricing pressures, erosion of guaranteed primacy offered by patents, product development to commercialisation, competition, sourcing risks, and changing patient needs.​

    02

    Our focus is to help Pharma businesses achieve alignment between external pressures and internal actions and to ‘think’ and ‘behave’ End-to-End across the entire Value Chain as a means of creating competitive advantage.​

    03

    We understand that there is no ‘one size fits all’ approach to the Pharma sector and/or sub-sectors and our approach is to help clients tackle current and future challenges by co-creating a tailored approach.​

    04

    Our proprietary Concurrent Digitalised Value Chain (CDVC) model provides a framework for identifying current levels of maturity, highlighting gaps and establishing ‘concurrent progression’ in the areas that have the greatest impact on the ‘value’ generated or ‘risk’ mitigation.​

    05

    We do this through the development of people’s understanding and leadership capabilities, support and enablement of the right digital environment and the management of process change across the business (Process-Human Dynamics-Digital)​

     

  • We help organisations to significantly improve their Lab & Quality function processes and performance.

    EFESO Pharma & Labs practice, trading as BSM focusses 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.


    Our approach to Real Lean Transformation

    • We provide a deep knowledge and practical application of Real Lean and Operational Excellence concepts in Laboratory and QA environments that provide significant business value in a short period of time.

      Our focus is on developing a ‘system of operations’ and processes that result in Leveling of short interval workloads, reduction of throughput times (i.e. creation of  Flow) and support an appropriate level of standardization of tasks (i.e. Standard Work) . These new processes are supported by visual management based Short Interval Control and Performance Management processes  


      The benefits of our approach

      01

      Defined, structured and controlled processes delivering more consistent and predicable performance​

      02

      Significantly Increased productivity ​

      03

      Improved RFT (Right First Time) ​of 15 % to 30% after the first 2-3 months

      04

      Reduced throughput-times​

      05

      Reduced Unit Costs​ via H/C reduction, H/C avoidance, or increased throughput

      06

      Reduced levels of WIP and associated Management effort ​

      07

      ​Greater empowerment of Operating Personnel​

      08

      ​A culture of engagement and pro-active performance management and continuous improvement​

      09

      Internalisation of Skills and Knowledge


      The EFESO Pharma & Labs practice, trading as BSM, experts in applying ‘Real Lean’ in Labs and QA functions, have developed innovative methodologies and solutions specific to the Pharma and Biotech Quality function environment. ​

      Many weaker Lean initiatives are based almost totally on waste elimination and the application of easy to understand tools like 5S, Value Stream Mapping and Kaizen. While these methods will certainly yield some results we know that more significant and sustainable gains will be realized by also applying the deeper Real Lean concepts of leveling, flow, pull and standard work.​


      Labs and QA functions are not the same as manufacturing:​

      • Workload and Mix Volatility - There is typically more workload and mix volatility (i..e the mix and volume of samples varies significantly day to day and week to week.​
      • Complex mix of Routine and Non Routine Testing - There is often a complex mix of routine and non routine testing, other tasks and project work.​

       

    • EFESO Pharma & Labs practice, trading as BSM, has shown that ‘Real Lean’ practices can help RA Organisations to provide a better Quality service and also deliver exceptional improvements in Productivity and Leadtime. This applies to the full spectrum of regulatory activities from strategy / content contribution, the associated manage and build activities, through to publishing and archiving.​

      Historically the focus within Regulatory Affairs (RA) processes has very much been on compliance and “getting the job done whatever the cost”, with little or no focus on Lean best practices and the improvements in speed, productivity and reliability that Lean can deliver.

      The opportunity to apply Real Lean in Regulatory Affairs (RA) is not intuitively obvious, because RA activities are project-based with workloads which are both variable and unpredictable.


      What we often find in RA Processes

      01

      Workload volatility​ and over resourcing to cope with peak workloads​

      02

      Insufficient visibility of open projects and future workload constraints​

      03

      Overly complex and inefficient planning & scheduling processes ​

      04

      Poor process harmonization across sites​

      05

      Poor process definition and role responsibility​

      06

      Reliance on expensive outsourcing​

      07

      Significant undocumented “Tribal” knowledge​

      08

      Product specific personnel dedication​

      09

      Long delays between work elements – “forget and re-learn”


      Our solutions are built on the Real Lean principles of Levelling​, Flow, Standard Work and Visual Management (with or without software tools)​​.

      The results are typically as follows​:

      • Significantly Improved Productivity -  typically  by up to 100 % and sometimes more
      • Improved Quality – typically a 40-50% reduction in quality issues​
      • Improved Compliance – reduced audit observations and reportable events​
      • Improved Speed - Improved Project Speed and reduced task cycle times.​
      • Improved visibility - Significantly improved visibility of workloads and the ability to make accurate ‘commit dates’ to the business ​

       

    • The reality is that the work profile in each lab will consist of a combination of (somewhat) routine activity & analysis and more creative & interpretative type tasks. Applying Real Lean principles will improve the productivity, speed and consistency of the more routine elements thereby providing more time and resources for the more creative and interpretative tasks.

      One might wonder if Lean and Operational excellence principles have any relevance in R&D labs, after all, R&D labs are significantly different from other types of laboratories. In fact R&D labs are significantly different from each other. There’s such a broad range of categories, from labs that support an R&D function with test results, to labs that develop new test methods for new products, to labs that are trying to synthesize new molecules, and on and on.​

      With such a broad range of laboratory types do the principles of Real Lean, namely Levelling, Flow, Standard Work, Short Interval Control and Performance Management, still apply? ​

      The reality is that the work profile in each lab will consist of a combination of (somewhat) routine activity & analysis and more creative & interpretative type tasks. Applying Real Lean principles will improve the productivity, speed and consistency of the more routine elements thereby providing more time and resources for the more creative and interpretative tasks.

      Work within R&D labs is usually project based. As projects move through the various stages and cycles of their lifespan they generate vastly different amounts of work for the lab. These peaks and dips in workload make it extremely difficult to be predictable, consistent, productive or fast. The extreme nature of these peaks and dips also exacerbate some of the Common practices we find in R&D labs.​


      What we often find in R&D labs

      01

      Project based work leading to intense peaks and dips in workload depending on the project stage or cycle​

      02

      Resources dedicated by project – meaning volatile project workloads are imported directly onto scientists​

      03

      Constant changes in priorities leading to stop-start-stop projects, frustration for scientists and extremely long lead times

      04

      No Flow, No metrics or performance goals

      05

      No visibility on overall workload

      06

      No visibility on individual resource workload​

      07

      No understanding of what the true capacity of the lab is

      08

      ​Poor or no resource management – meaning when one project peaks a scientist can be overwhelmed while another colleague is almost unoccupied

      09

      Delays around report writing and no common format for data reporting​

      These issues limit the time available for true innovation because most time is spent tracking, finding, communicating, prioritizing, planning and testing common samples.​


      Successfully applying Real Lean principles in an R&D setting can be massively beneficial. In fact some of the largest Lab performance improvements EFESO Pharma and Labs practice have overseen have been in R&D labs, for example:

      • 400% increase in capacity​
      • 74% reduction in cycle time​
      • Freeing more than 25% of the resources from routine work allowing them to focus exclusively on novel discovery work.​

       

     

  • We help organisations to get the most value out of local and global operations

    We do this 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.


    Our approach to turn strategy into execution

    01

    Operational Excellence – WCOM™: Advanced process excellence based on Lean Six Sigma & yield management, Continuous Improvement and TPM Maintenance Excellence​

    02

    OPEX Maturity Assessment – A broad and deep portfolio of questions and benchmarks tailored to pharma environment​

    03

    Program Management Office & Knowledge Management - Portfolio & Resource Management, intelligent knowledge databases​

    04

    Structured Progression processes and Transformation projects - High Impact Projects based on Lean and WCOM™ best practices​

     

  • Working from top floor to shop floor, we help to engage the organisation on the change journey.

    Working from topfloor to shopfloor we help to engage the organisations on the change journey, dealing with performance behavior which is one of the most important enablers for performance improvement, providing your teams with tools, methodologies, training, coaching and facilitation.​ Applying Human Dynamics to everyday organizational change is all about finding the more efficient and effective way to change people’s current mind-set and behaviours towards the desired ones. ​


    Our approach to Human Dynamics

    01

    Cultural Change – the progression path to Human Dynamic Excellence, fundamentally change the way you do things​

    02

    Mobilising for Progression – boost adoption and anchoring following the change roadmap​

    03

    Leading Progression - strengthen your leadership to boost business results​

    04

    Performance Behavior - drive the desired performance through the right behavior​

    05

    Engagement Monitoring and Measuring - engage your people and manage the process to engage​

     

  • Innovative digital solutions improves both your efficiency and your compliance

    With ROI EFESO proven track records in Pharma and Biotech and our leading-edge digitization knowledge and solutions we help you gain major efficiency progressions going with full compliance of regulations.

    Our services range from the streamlining of individual process steps with the help of digital technologies to the transparent mapping of supply chain networks as digital twins and the introduction of comprehensive, preventive quality management. in addition, we support our customers in realigning their R&D organization, for example with regard to portfolio strategy, agile development processes or the use of advanced analytics.


    Our approach to Digital Transformation

    01

    Productivity - each improvement effort becomes as lean and efficient as possible​

    02

    Transparency - know what to improve, where, and track the progress of all initiatives​

    03

    Insight - unleash the value locked in your performance improvement data​

    04

    Supply - detect events in real-time, stabilize your planning, add responsiveness throughout your value chain (sites, suppliers, customers)​

    05

    Compliance - avoid product failures, accelerate of root cause analysis, enable product release​

    06

    Efficiency - align and synchronize lab and batch production​

     

Want to know more about our tooling?

Watch the Touch Screen Visual Management Tool video

YOUR SPECIALISTS FOR PHARMA & BIOTECH


  • Tom Reynolds

    Tom Reynolds

    BSM EFESO Tom is Vice President at EFESO Consulting. He has more than twenty years industrial experience in operations and quality management Read More
  • Carlo Baroncelli

    Carlo Baroncelli

    EFESO Group Carlo is one of the founders of EFESO Consulting and has more than 30 years experience in Operations Strategy and Read More
  • Andrew Harte

    Andrew Harte

    BSM EFESO Andrew Harte, Principal Consultant and Real Lean Operations Manager, is an expert in designing and implementing operating systems using the Read More
  • Rajinder Singh

    Rajinder Singh

    EFESO India Rajinder Singh is the Chief Mentor & Country Head of EFESO Consulting in India. Over the past 32 years, he Read More
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Our leading people that partner with our clients to help them navigate business issues and achieve high value improvements.


DELIVERING TANGIBLE RESULTS

Recent proof of how we partner with our clients to help them navigate business issues and achieve high value improvements.

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