Transcript Document

BIOTECH SUPPLY
CHAIN ACADEMY
October 8-9, 2012
Crowne Plaza, Foster City, CA
Solving the Missing Link Between
Forecasting and ERP in
Clinical Supply Optimization
Michelle Foust, PharmD
Director of New Product Development
Almac 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
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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?
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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
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Case Study – Protocol Design
• 10,700 patients
– Anticipated high drop-out rate
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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?
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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 Initial
andDepot
site compliance (Bottles or patient kits?)
Material Requirements
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Seeding
Patient
Demand
Safety Stock
Time
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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
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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
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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
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MRP
• Commercial supply chain
– Repeatable manufacturing environment
• Clinical supply chain
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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
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MRP
• System considers the following when developing MRP plan
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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
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Technology Solution
Initial forecast
•Projected patient demand
•Visit schedule
•Protocol variables
•Scenario comparisons
MRP
Creates planned
production orders
based on:
•Forecast
•Safety Stock
•Pending production
orders
•Existing inventory
•Item Bill of Materials
Manufacturing
Plan
Detailed
component
planning
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MRP Considerations
Manufacturing
Facility
.
Each depot will have
a Forecast
Country
Patients Per Month 1 to 12
Russia
Russia
50, 50, 50, 50, 50, 50,100, 100, 100, 100, 100, 100,
Med Type
Country
FG
T000001
FG00001
Ukraine
EU
UK
Ukraine
50, 50, 50, 50, 50, 50,100, 100, 100, 100, 100, 100,
Italy
50, 50, 50, 50, 50, 50,100, 100, 100, 100, 100, 100,
UK
50, 50, 50, 50, 50, 50,100, 100, 100, 100, 100, 100,
Germany
50, 50, 50, 50, 50, 50,100, 100, 100, 100, 100, 100,
T000001
FG00001
T000001
FG00001
T000001
FG00001
T000001
FG00001
Singapore
US
Sourcing Rules assigned for each item
Eg. Patient Kit for Russia
7/21/2015will be made in EU
Singapore
50, 50, 50, 50, 50, 50,100, 100, 100, 100, 100, 100,
Hong Kong
50, 50, 50, 50, 50, 50,100, 100, 100, 100, 100, 100,
Thailand
50, 50, 50, 50, 50, 50,100, 100, 100, 100, 100, 100,
US
50, 50, 50, 50, 50, 50,100, 100, 100, 100, 100, 100,
T000001
FG00001
T000001
FG00001
T000001
FG00001
T000001
FG00002
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Technology Solution
Actual patient event data
considered in Net forecast
Data Integration with IRT (IVRS/IWRS)
Inventory Release File
Initial forecast
•Projected patient demand
•Visit schedule
•Protocol variables
•Scenario comparisons
Net Forecast Inputs
•Site inventory
•Patients dispensing events
•Expiry date
MRP
Creates planned
production orders
based on:
•Forecast
•Safety Stock
•Pending production
orders
•Existing inventory
•Item Bill of Materials
Manufacturing
Plan
Detailed
component
planning
Drug Orders
Distribution
Depots &
Sites
Patient Event Data
Dispensing
to Patients
Almac & Depot inventory
considered by MRP
Inventory at or in transit to sites considered in Net Forecast
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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
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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
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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
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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
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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
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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
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Thank you.
Questions?