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?