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BIOTECH SUPPLYBIOTECH SUPPLYBIOTECH SUPPLYBIOTECH SUPPLYOctober 8-9, 2012
Crowne Plaza, Foster City, CA
Solving the Missing Link Between Forecasting and ERP in
Clinical Supply OptimizationMichelle Foust, PharmD
Director of New Product DevelopmentAlmac Clinical Services
Supply Chain Management
• Focused on the patient – “Right drug, to right site,
to right patient, at the right time, in the right dose”
• Aim is to minimize waste and maximize
efficiency of the supply chain
04/19/23 2
Shared Industry Challenges
• Developing strategies with a Patient Focus– Patient compliance and safety
• Shorter lead times– Pressure on clinical supply teams to shorten protocol approval to first
patient in timelines
• Forecasting drug requirements– What tools and resources are available?
• Implementing the forecast into the overall planning process– Determining what to do and when based on material lead times,
capacity, inventory and dating, etc.– Is there visibility to key information when making decisions?
04/19/23 3
Shared Industry Challenges
• Accessing data in support of Supply Chain Management– Multiple sources– Manual processes
• Supplier’s perspective– Visibility of ‘true’ demand– Responding to urgent Client requests due to unexpected events (more rapid
enrollment or extended enrollment impacting drug dating)
• Pressure on clients to do ‘more with less’– Common for delivery on more aggressive timelines to be delivered with the
same (or reduced) headcount– In response, clients expecting greater input from partners to achieve results– Partners need to respond by developing techniques/systems to support
planning that was once in the client’s domain
04/19/23 4
Case Study – Protocol Design
• 10,700 patients– Anticipated high drop-out rate
• Double-blind study (1:1 randomization of active:placebo)
• 340 NA sites• 5 year study duration• Client criteria
– Pivotal study– Patient Compliance critical– Efficient, reliable and cost-effective end to end supply chain
• Packaging, Distribution and Drug accountability strategies
– Initial request – How much drug do we need?
04/19/23 5
Case Study – Forecasting
• Considerations– Projected patient demand and site activation– Protocol variables, study design, etc.– Drop-out rates– Product information (batch size, expiry dating)– Distribution strategy (enrollment and treatment phases)– Patient and site compliance (Bottles or patient kits?)
04/19/23 6
Time
Ma
teri
al
Re
qu
ire
me
nts
Initial Depot Seeding
Patient Demand
Safety Stock
Time
Ma
teri
al
Re
qu
ire
me
nts
Initial Depot Seeding
Patient Demand
Safety Stock
Case Study -Supply Chain Management
• Different scenarios developed with associated costs– Included distribution and drug accountability approaches– Innovative ideas to provide flexibility in supply chain
• Decision driven by patient compliance– Not based solely on costs
• Baseline forecast created based on agreed design
• Ongoing monitoring of actual events vs. projected– Patient enrollment 3x faster than expected
• Identified early, so proactively modified production plans with no disruption to site or patient supply
– Forecast updated based on actual events
04/19/23 7
Case Study -Supply Chain Management
• Distribution strategy– Monitor # and frequency of shipments
• Adjustments to IVRS parameters as needed
– Once enrollment completed, larger and fewer shipments
• Continuous improvement in technology to support the process– Objective to provide readily available data for Supply Chain Manager– Implement the clinical forecast into the overall supply plan– Automatically update the forecast based on actual patient events
04/19/23 8
Terminology
• ERP – Enterprise Resource and Planning System– A business management system that integrates all facets of the
business, including production, sales, finance and planning
• MRP – Material Resource Planning– Generic term to describe a system designed to recommend and
prioritize ordering and scheduling of dependent-demand inventories– Powerful computational tool– What, how much and when material is needed
04/19/23 9
MRP
• Commercial supply chain– Repeatable manufacturing environment
• Clinical supply chain– Blinding and randomization– May not have a high number of repeat manufacturing events– Availability of drug product– Expiry dating of drug product– More variability in demand due to unexpected events
• Clinical Forecast is used as source of demand– Requires clinical expertise to develop based on complex parameters– Must map the forecast into an acceptable format for MRP
• Item number, quantity, date needed
04/19/23 10
MRP
• System considers the following when developing MRP plan– Bill of Materials– Lead time for components– Capacity– Time to complete an operation– Inventory on hand at manufacturing facility and at depots– Pending production orders– Lead time for transfer from manufacturing facility to depot
• Outputs– Planned production orders to satisfy demand– Reschedule or expedite notifications– Planning reports
04/19/23 11
Technology Solution
12
Initial forecast •Projected patient demand•Visit schedule•Protocol variables•Scenario comparisons
Manufacturing Plan
Detailed component
planning
MRPCreates planned production orders based on:•Forecast•Safety Stock•Pending production orders•Existing inventory•Item Bill of Materials
MRP Considerations
.
04/19/23 13
Russia
Ukraine
Italy
UK
Germany
Singapore
Hong Kong
Thailand
US
Russia
Ukraine
UK
Singapore
US
50, 50, 50, 50, 50, 50,100, 100, 100, 100, 100, 100,
Country Patients Per Month 1 to 12Each depot will have a Forecast
Med Type CountryFG
T000001
T000001
T000001
T000001
T000001
T000001
T000001
T000001
T000001
FG00001
FG00001
FG00001
FG00001
FG00001
FG00001
FG00001
FG00001
FG00002
EU
Manufacturing Facility
50, 50, 50, 50, 50, 50,100, 100, 100, 100, 100, 100,
50, 50, 50, 50, 50, 50,100, 100, 100, 100, 100, 100,
50, 50, 50, 50, 50, 50,100, 100, 100, 100, 100, 100,
50, 50, 50, 50, 50, 50,100, 100, 100, 100, 100, 100,
50, 50, 50, 50, 50, 50,100, 100, 100, 100, 100, 100,
50, 50, 50, 50, 50, 50,100, 100, 100, 100, 100, 100,
50, 50, 50, 50, 50, 50,100, 100, 100, 100, 100, 100,
50, 50, 50, 50, 50, 50,100, 100, 100, 100, 100, 100,
Sourcing Rules assigned for each item Eg. Patient Kit for Russia
will be made in EU
Technology Solution
14
Initial forecast•Projected patient demand•Visit schedule•Protocol variables•Scenario comparisons
Net Forecast Inputs•Site inventory•Patients dispensing events•Expiry date
Manufacturing Plan
Detailed component
planning
Data Integration with IRT (IVRS/IWRS)
MRPCreates planned production orders based on:•Forecast•Safety Stock•Pending production orders•Existing inventory•Item Bill of Materials
Distribution Depots &
Sites
Actual patient event data considered in Net forecast
Drug Orders Patient Event DataInventory Release File
Almac & Depot inventory considered by MRP
Inventory at or in transit to sites considered in Net Forecast
Dispensing to Patients
Solutions to Challenges
• Developing strategies with a Patient Focus
– Consider patient compliance
– Deliver a reliable, efficient supply chain to ensure continuity of care for the patients
04/19/23 15
Solutions to Challenges
• Shorter lead times
– Forecasting tool allows you to make informed decisions on how much we need to produce for trial initiation
– Ensures you don’t produce too much, which eliminates potential waste if short dated material or increased study start timeline
04/19/23 16
Solutions to Challenges
• Forecasting drug requirements and implementing the forecast into the overall planning process
– Integrated the forecast with MRP, which feeds into the overall planning process
– Supply Chain Managers analyze the MRP output to develop a steady manufacturing plan, based on demand and supply (produce product at the right time)
– Integrated with IRT data to provide updated forecast based on actual patient events
04/19/23 17
Solutions to Challenges
• Accessing data in support of Supply Chain Management
– Integrated technology provides an end to end view of the supply chain
– Goal is to keep clinical supplies off the critical path
– Timely data and reports
04/19/23 18
Solutions to Challenges
• Supplier’s perspective – responding to urgent Client requests due to unexpected events
– Recognize and understand the nature of the emergency
– If we have demand on our system, we can monitor events and help the client see the issue before it happens or becomes urgent
04/19/23 19
Solutions to Challenges
• Pressure on clients to do ‘more with less’
– Developed techniques and systems to support planning that was once in the client’s domain
– Able to capture data and share more easily
– Recognize the importance of combining technology and knowledgeable Supply Chain Managers to bridge the gaps and provide peace of mind
04/19/23 20
Thank you.
Questions?