Solving the Supply Chain Puzzle
Best Practice for Managing
Clinical Supplies in
an Evolving Marketplace
Rome 2014
Confidential © Almac Group 2014
KEY TOPICS
• Forecasting- Integrating your demand forecast and real time IRT data
into the overall planning process
• Case Study illustrating the benefits of monitoring forecast drivers,
adjusting the forecast and strategy to optimise the supply chain
• Combining IRT functionality and supply chain expertise to optimise your
supply chain .
CLINICAL SUPPLY CHAIN CHALLENGES
Number of Countries
Trials
Subjects
Costs
Complexity
Duration
INCREASED
DECREASED
Set Up Time
Resources
Expiry Date
Budgets
Drug available at trial commencement
DEMAND FORECASTING
Number of Countries
Trials
Subjects
Costs
Complexity
Duration
• A prediction of clinical events and patient activity
creating demand in the Clinical Trial Supply
Chain over time
• Develop a Supply Strategy and Packaging Plan
• Scenario Evaluation
• Budget Management
• To identify and mitigate for risk
• Stock outs , Patient harm
• To reduce costs & Minimise Waste
• Achieve the right balance of supplies
Recruitment prediction is inherently difficult so your initial forecast will change !
CRITICAL FORECAST DRIVERS
Study Design and Enrolment
Product Design / Characteristics
Randomization Parameters
Visit / Dosing Schedule
Participating Countries
Site Activation Schedule
Local Depots
Enrolment Rate
Fixed or Variable Dosing
(Titration; weight based)
Drop-out Rate
Study Completion Criteria
Therapeutic Setting
Bulk Drug Availability
Pack Types
(Primary Packaging & Kit Design)
Label Strategy
Shelf Life and Stability Program
Storage Conditions
Shipment Conditions
Inventory Management Strategy
FORECASTING MECHANISMS
> Clinical supply chain complexity has resulted in major
investments in information technology.
> Forecast Management Tools:
– Excel
– Forecasting/Simulation software
– MRP/ERP systems
– Interactive Response Technology (IRT; i.e. IXRS®, IVRS) .
INTEGRATING TECHNOLOGY
• Forecast serves as basis for demand for MRP details material needs in time
phases based on
Enrolment rates, site and country ramp up, drop out rates
Protocol design – visit schedule and titration choices
Overage, site seeding and/or safety stock`
Label Groupings
• Agreed forecast must be mapped to MRP to allow full utilization of the Supply
Chain Planning Functionality
• Forecast receive patient and drug usage events directly from the IRT via
automatic data transfer
– Automatically adjusts forecast based on actual trial activity
INTEGRATING TECHNOLOGY
• MRP uses the Forecast to produce planned production orders to satisfy
demand taking into account
– On hand inventory & Expiry Dates
– Production Capacity and operation duration
– Pending production orders
– Bill of materials/component availability and lead time for re-order
– Lead time to supply local depots
– Supply Chain Managers analyze the MRP output to develop a steady
manufacturing plan, based on demand and supply.
SupplyWise
INITIAL FORECAST
• Projected patient demand
• Visit schedule
• Protocol variables
• Scenario comparisons
NET FORECAST INPUTS
• Site inventory
• Patients dispensing events
• Expiry date
TECHNOLOGY SOLUTION
MANUFACTURING
PLAN
Detailed component
planning
MRP
Creates planned
production orders
based on:
• Forecast
• Safety Stock
• Pending production
orders
• Existing inventory
• Item Bill of
Materials
DISPENSING
to Patients
Almac & Depot Inventory
considered by MRP
Inventory at or in transit to sites considered in Net
Forecast
Actual patient event data
considered in Net forecast
Patient Event Data
DISTRIBUTION
Depots & Sites
Drug Orders
Data Integration with (IVRS / IWRS)
Inventory Release File
FORECAST MAINTENANCE
• Monitoring Forecast Drivers
– Site activation Schedule
– Enrollment:
– Drop Out Rate
– Rate of drug supply utilization
– Titration Patterns
• Frequency of forecast updates has to be decided upon
• When do we have enough data to merit a
baseline change?
Case study- monitoring forecast drivers,
adjusting the forecast and strategy
•Phase III study, >5000 patients, 15 depots, 40 countries, duration >7yrs
•Treatment Arm X, 5 dose strengths, patients can dose escalate, reduce or
maintain throughout the trial
• Dosing predictions not available, “worst case” manufacturing 100% of each
dose strength per manufacturing campaign
E
40%
D
13%
C
15%
A
14%
B
18%
• Trends to date in titration patterns and extrapolated
to future visits of existing patients and for projected patients
SUPPLY CHAIN ASSESSMENT
Breakdown of Dosage Trends on Treatment Arm X
SUPPLY CHAIN ASSESSMENT
40,000
35,000
30,000
25,000
20,000
15,000
10,000
5,000
Kits produced
historically for Arm X
Kits planned using
trends, site seeing,
safety stock of 30%
Savings
a
8,000
2,656
b
8,000
3,072
c
8,000
2,760
d
8,000
2,552
e
8,000
5,360
Total Kits
40,000
23,600
16,400
SUPPLY CHAIN ASSESSMENT
Cost £ (includes cost of kit & average shipping cost)
£500,000
£1,000,000
£1,500,000
£2,000,000
£2,500,000
£3,000,000
£0 Cost of
Kits produced
historically
for Arm X
£3,000,000
Cost of
Kits planned
using trends, site
seeding, safety
stock of 30%
£1,230,000
Savings £
£1,770,000
Combining IRT functionality and supply chain expertise
• Supply Chain Manager should have input into URS Design from a
Drug Management Perspective
• Propose Drug supply Parameters
• Review standard reports and request Ad Hoc reports if required
• Ensure receipt of “KEY” system Alerts & Notifications eg
• Insufficient product
• Temperature Excursion
• Expiry Date Alerts
• Adjust IRT settings as required during the course of the study to
optimise supply chain
Combining IRT functionality and supply chain expertise to optimise your supply chain
Ensure Maintenance
Responsibilites are Defined
Reassess Settings
Regularly
Plan for the Different
Study Phases
Define Resupply
Strategies to meet protocol
specific needs
Define IRT Inventory
Management Design
Recognise Challenges Define Goals
CONSIDER PHASE IN STUDY
ENROLMENT
• Keep higher buffer supply to account for new enrolment
• Routinely placing
drug orders
MAINTENANCE
• Keep less buffer stock as subject schedule is know
• Buffer only needed for
replacements
• May be able to decrease
schedule for placing of
drug orders
CLOSE OUT
• Plan for last patient drug assignments
• Schedule last day
of drug ordering
REPORTS AND ALERTS
Who is looking at these?
UTILISING THE IRT TO MONITOR THE SUPPLY CHAIN
V
What does the data mean?
Who is responsible for action?
TECHNOLOGY HUMAN OVERSIGHT
Who is looking at these?
What does the data mean?
Who is responsible for action?