Equipping your Forecasting Toolkit to Account for Ongoing Changes

Transcription

1 Equipping your Forecasting Toolkit to Account for Ongoing Changes Presented by: Roger Parlett Supply Chain Manager January 23, 2014

2 Overview Forecast Set-up Objectives of Creating a Forecast Identify Critical Forecast Drivers Forecasting Technology Forecast Management Integrated Technology Forecast Maintenance Benefits of Monitoring

3 Forecasting Objectives Why generate a forecast? To Develop a Supply Strategy and Packaging Plan Scenario Evaluation and Contingency Planning Budget Management To Reduce Risk Depot and Site Stock-outs Patient Harm / Study Integrity Budgeting Forecasting Strategic Planning To Reduce Costs Achieve the right balance of supplies Avoid costly challenges: expiry date, stock outs

4 Critical Forecast Drivers Study Design and Enrollment Randomization Parameters Visit / Dosing Schedule Participating Countries Site Activation Schedule Local Depots Enrollment Rate Fixed or Variable Dosing (Titration; weight based) Drop-out Rate Study Completion Criteria Therapeutic Setting Product Design/Characteristics Bulk Drugs Pack Types (Primary Packaging & Kit Design) Label Strategy Shelf Life and Stability Program Storage Conditions Shipment Conditions Inventory Management Strategy

5 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)

6 Demand Forecasting Forecasting Technology > Ideally, allows the Supply Chain Manager to create clinical forecast that details material needs in time phases based on: Enrollment 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 > Allows for multiple scenarios to be programmed and compared

7 Integrating Technology Technology Relationship Forecast Tool IVR/IWR ERP / MRP

8 Integrating Technology Forecasting Technology > Forecast serves as basis for demand > Agreed forecast mapped to MRP to allow full utilization of the Supply Chain Planning Functionality > MRP and Forecast receive patient and drug usage events directly from the IRT via automatic data transfer Automatically adjusts forecast based on drug usage data Calculates a net forecast based on available inventory and expiry dates Comparison reports for forecasted vs. actual usage

9 Integrating Technology MRP Material Resource Planning Modify for the Clinical Supply Chain Clinical Forecast as Source of Demand Powerful Computational Tool for determining what, how much, and when material is needed Blinding and Randomization Smaller number of manufacturing events Limited Drug Product Requires clinical expertise to develop based on complex parameters Must be formatted to allow for mapping to MRP

10 Integrating Technology > MRP uses the Forecast to produce planned production orders to satisfy demand taking into account: Inventory on hand at Sites, Depots, and vendor facilities Expiry Dates Production capacity and operation duration Bill of materials/component availability and lead time for re-order Pending production orders Lead time for transfer from Vendor Sites to Depots

11 Technology Solution Actual patient event data considered in Net forecast Data Integration with (IVRS / IWRS) Forecast Tool Inventory Release File Drug Orders Patient Event Data 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 DISTRIBUTION Depots & Sites DISPENSING to Patients Almac & Depot Inventory considered by MRP Inventory at or in transit to sites considered in Net Forecast

12 Supply Chain Planning Manufacturing Facility Each depot will have a Forecast Country Patients Per Month 1 to 12 Med Type Country FG Russia Ukraine Russia Ukraine 50, 50, 50, 50, 50, 50,100, 100, 100, 100, 100, 100, 50, 50, 50, 50, 50, 50,100, 100, 100, 100, 100, 100, T T FG00001 FG00001 Italy 50, 50, 50, 50, 50, 50,100, 100, 100, 100, 100, 100, T FG00001 EU UK UK 50, 50, 50, 50, 50, 50,100, 100, 100, 100, 100, 100, T FG00001 Germany Singapore 50, 50, 50, 50, 50, 50,100, 100, 100, 100, 100, 100, 50, 50, 50, 50, 50, 50,100, 100, 100, 100, 100, 100, T T FG00001 FG00001 Singapore Hong Kong 50, 50, 50, 50, 50, 50,100, 100, 100, 100, 100, 100, T FG00001 Thailand 50, 50, 50, 50, 50, 50,100, 100, 100, 100, 100, 100, T FG00001 US US 50, 50, 50, 50, 50, 50,100, 100, 100, 100, 100, 100, T FG00002 Sourcing Rules assigned for each item Eg. Patient Kit for Russia will be made in EU

13 Forecast Maintenance > Monitoring Forecast Drivers Monthly, Country Level Data Collection Site activation data Enrollment: Actual monthly enrollment is captured and forecast updated Estimated enrollment rate can be re-calculated for future projection Drop-out Rate confirm agreement with projection or add to forecast Rate of drug supply utilization Is it in agreement with forecast? Should assumptions be modified? Source of Data How will data be collected? Frequency of forecast updates has to be decided upon When do we have enough data to merit a baseline change?

14 Forecast Maintenance Benefits of Monitoring Adjusting assumptions allows for optimization of clinical supply chain Supply Utilization / Inventory Balance Comparator Purchasing Assessment of retest/expiry date impact Adjustment to IRT Drug Management Settings Supply Utilization and Inventory Balance Adjust Production Schedule based on demand Adapt to changing lead times and demand Comparator Purchasing Strategic Sourcing

15 Forecast Maintenance - Benefits > Demand Monitoring Monthly Supply Need Calculations By Kit Type and Scenario Month Bulk Delivery (Qty.) Supply Release Schedule Released Supply Cumulative FS1 Projection Material Demand FS1 Projection Material Demand Cumulative Projected Balance Actual Balance Actual Demand Actual Demand Cumulative Apr May Jun Jul-12 9,500 4,997 4, ,997 4,997 0 Aug-12 4,997 2,857 2,857 2,140 2,802 2,195 2,195 Sep-12 9,497 14,494 2,594 5,451 9,043 9,442 3,054 5,249 Oct-12 9,000 14,494 4,133 9,584 4,910 5,448 3,994 9,243 Nov-12 8,997 23,491 3,426 13,010 10,481 10,991 3,454 12,697 Dec-12 1,600 23,491 3,924 16,934 6,557 7,879 3,112 15,809 Jan-13 23,491 3,410 20,344 3,147 5,746 2,133 17,942 Feb-13 23,491 2,518 22, ,533 2,213 20,155 Mar-13 23,491 1,488 24, ,001 1,532 21,687 Apr-13 23, ,033-1,542 1, ,334 May-13 23, ,052-1,561 1, ,552 Jun-13 23, ,052-1,561 1, ,552 Total ,491 25,052

16 Quantity Forecast Maintenance - Benefits > Demand Monitoring Supply vs Demand Projection 30,000 25,000 20,000 15,000 10,000 5,000 0 Apr-12 May-12 Jun-12 Jul-12 Aug-12 Sep-12 Oct-12 Nov-12 Dec-12 Jan-13 Feb-13 Mar-13 Apr-13 May-13 Jun-13 Time Released Supply Cumulative FS1 Projection Material Demand Cumulative Actual Demand Cumulative

17 Forecast Maintenance > Benefits of Monitoring Assessment of Retest/Expiry date impact Calculate site loss and replacement demand Manage multiple expiry date events Adjustment to IRT Drug Management Settings Monitoring of Shipment Quantities and Frequencies Updating Strategies applied at the site level

18 Forecast Maintenance - Benefits > Shipment Monitoring Month May Jun Jul Aug Sep Oct Nov Dec Active Sites (Cumulative) Shipments Shipments / Site Pts Randomized Shipments/Site/Month 0.73 Shipments/Site/Month 0.55 since Aug

19 Summary Create a Forecast to develop a strategy, identify and reduce risks, and manage costs Identify Forecast Drivers determine those that will be critical to the success of your trial Select an appropriate forecasting technology fit for purpose Integrate Technology this can provide an end to end view of the supply chain Monitor forecast drivers and adjust forecast and strategy as necessary Measure performance: Projected vs Actual to optimize results

20 QUESTIONS? Contact: