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WCI Consulting Ltd Presentation DIA Euromeeting March 2007
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WCI Consulting Ltd Presentation DIA Euromeeting March 2007

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  • 1. Effectively manage your late phase trials How can CTM deliver the right drugs in a timely and cost effective manner?
    • Mike Giffin
    • DIA Euromeeting, Vienna
    • March 2007
  • 2. Since the 80’s industries have radically stripped out costs and speeded up time to market by streamlining their internal business processes
    • Since the 80’s other industries have radically changed the way they do business
    • They have streamlined their supply chain, manufacturing and internal business processes
    • Modern supply chain management and manufacturing optimisation techniques were adopted:
      • Lean Manufacturing, SMED, 5S
      • Blitz Kaizen, Problem Solving
      • Sales and Operations Planning
      • Just in Time, Kanban, Direct Line Feed
      • Visual Workplace, Cellular Manufacturing
      • Total Asset Care, TPM
    • Applying these techniques has stripped out unnecessary costs and capital employed and has speeded up total time to market
  • 3. Clinical trial supplies have not picked up on this development, but are now feeling the pressure
    • Increased regulations are forcing Clinical Development to design Trials that are more complex, have longer duration and involve more subjects in more locations
      • Increased emphasis on ensuring patient safety
      • Over the last 20 years, the development time in clinical phase has increased by 50%
    • As a result Clinical Trial Supplies is confronted with increased complexity, higher volumes and shorter lead times.
      • Increased export/import regulations requires more knowledge, experience and manpower
      • Complex package design increases number of packaging materials, resource requirement and waste levels
      • The time that is allocated to CTS has not increased, is even becoming less
    • Due to cost pressures, the regulatory developments cannot be countered by pro rata increase in resources
      • Alternatives like outsourcing are an expensive source of additional capacity and knowledge
  • 4. The lack of proper Clinical Trial Supply Chain Management jeopardises recruitment and more than doubles overall clinical trial supply costs
    • Overall cost of drug supplies is determined by the clinical trial supply chain design
    • Traditional forms of packaging are wasteful; 50-75% of drug wastage is not uncommon in the industry
      • Trial centre kits often contain CTM for a number of subjects, causing extensive waste when under-recruiting
      • Subject packs cover a drug administration period of several months, causing waste when a subject drops out
    • Inflexible manufacturing processes and inaccurate forecasts lead to pre-production, high stock levels and further drug wastage
    • Preproduction of trials causes spikes in workload and an imbalance in utilisation of resources
    • Inaccurate forecasts lead to wrongful allocation of CTM to trial sites and non-availability of active drug substance
    • Inadequate clinical trial material consumption tracking is leading to out of stock situations at the trial centres
  • 5.
    • How can CTS deliver the right CTM in a timely and cost effective manner?
  • 6. It is imperative for CTS to supply CTM based on a ‘demand pull’ system
    • Flexibility of supplies will have enormous impact on how well supply inventories and scrap levels can be managed
    • A supply chain needs to be established that will provide rapid Just in Time turnaround of CTM to trial centres
    • By applying lean manufacturing concepts, CTS can move from a reactive, make to stock ‘push’ system to a ‘demand pull’ replenishment system
      • Actual consumption drives packaging schedule, labelling operation and replenishment orders
      • Just in Time customisation matches recruitment
      • Re-supply of single administration packs based on Kanban replenishment principles
    Time Maturity Profile Trial centre kits Subject kits Packaging “pull” Demand “pull” CTM supply chain maturity profile
  • 7. A number of enablers need to be in place before demand pulling can be implemented successfully dispense Central clinical trial supplies unit Regional distribution centre Local trial centres Kanban Kanban IVRS ‘pull’ signal 4. IVR system to manage trial centre stocks and trigger (re-)supply 5. Availability of regional distribution centres to ensure high quality, short lead-time supply of materials 2. Clinical trial supply operations set-up to provide required flexibility 3. Packaging designed for product pulling, allowing shipment and storage of the smallest possible unit 1. Periodic forum established for collaboration between trial supply management and trial supply operations bulk stock primary packaging secondary packaging 1 re stock late custo- mization 2 re stock
  • 8. 1. Periodic forum established for collaboration between trial supply management and trial supply operations
    • By applying Sales and Operations Planning concepts, a periodic form for collaboration between trial supply management and trial supply operations in established
      • Periodically review forecasts for subject recruitments, projected start and finish dates and packaging orders
      • Tracks actual recruitment rate, orders and workload and adjusts plan if required
      • Directly links strategic planning and forecasting with production planning
    • Forum provides early visibility of trial impact on resources to take informed asset and manpower decisions
      • Are critical path tasks sufficiently resourced?
      • What options do we have for resources?
      • Credible justification for recruitment, training needs and outsourcing decisions
  • 9. 2. Clinical trial supply operations set-up to provide required flexibility
    • Implementing Lean Processes will provide flexibility without compromising productivity
    • Cellular manufacturing and smooth production flows
      • Packaging instructions created to support most efficient production flow
      • Visual Workplace Management
      • Intermediate stocks with pull replenishment through Kanbans
      • Quick set-up of packaging rooms and equipment
      • Clear accountabilities aligned with a balanced set of performance measures
    • Use a ‘light’ but integrated system that supports small batch production:
      • Electronic creation and tracking of (master) batch records
      • Inventory management
      • Batch allocation and materials reconciliation
      • Creation of shipping documentation with country knowledge base
      • Order/shipment tracking
  • 10. 3. Packaging designed for product pulling, allowing shipment and storage of smallest possible unit
    • Trigger shipment to the trial site through the actual recruitment or clinical trial material consumption rate (Kanban pull signal)
    • To enable this, design the packaging for product pooling
      • Dispense small units to the subject, rather then a complete subject kit for the duration of the trial
      • Each kit is uniquely numbered, but not linked to a specific randomization block
      • This way It is possible to dispense any unit within the same randomization category to the patient, reducing total waste
    • Design the supply chain to minimize lead-times for (re-)supply
      • Small batch sizes
      • Kanban controlled Work In Process stocks
    • Multilingual labels/booklets allow supplies to be distributed to all or most clinical sites involved in the study
  • 11. 4. IVR system to manage trial centre stocks and trigger (re)-supply
    • Main benefit of an IVR system is in overall clinical trial management
      • Improves data accuracy and availability
      • Improves subject diary compliance
      • Reduces effort in data management
    • However an IVR System also balances the inventory at the trial sites, minimising wastage of drugs due to excessive stocks, without jeopardising the availability of CTM
      • IVRS Improves clinical supplies forecasting and povides clinical trial material consumption tracking
      • IVRS provides the Kanban trigger for (re-)supply
      • Automatically selects correct subject kit and manages randomisation, allowing smaller trial centre kits
      • Improves inventory and expiry date management at the trial sites
  • 12. 5. Availability of regional distribution centres to ensure high quality, short lead-time supply of materials
    • The use of regional distribution centres plays an important roll in reduction of (re-)supply lead-times to the trial centres
    • Decision on quantity and location of regional distribution centres depends on:
      • Clinical trial intelligence to determine the regions where clinical trials will be conducted
      • Required lead-time
      • What is the potential savings due to less scrap at the trial centre
      • Expected operational costs (resources, building, equipment, information system, transport)
      • Regulatory issues, import licences, local legislation
      • How long it takes to receive customs clearance
      • Outsourcing or in-house
  • 13. Implementing lean concepts will ensure you can effectively manage your late phase trials, reducing total cost of supply by more than 40%
    • Flexibility in the supply chain will be established by implementing Kanban and JIT principles, moving from a ‘CRF push’ to a ‘demand pull’ system
    • Increased flexibility will guarantee on time availability of CTM to meet the recruitment at the trial centres
    • Overall drug wastage will be more than halved, freeing up drug substance and budget for clinical development
    • Demand management and capacity planning will smooth workload and provide early visibility of trial impact on resources to take informed asset, manpower and outsourcing decisions
    Achieved Benefits