BIOTECH SUPPLY 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 9/21/2015 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? 9/21/2015 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 9/21/2015 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? 9/21/2015 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?) 9/21/2015 6

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 9/21/2015 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 9/21/2015 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 9/21/2015 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 9/21/

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 9/21/

Technology Solution 12 Initial forecast Projected patient demand Visit schedule Protocol variables Scenario comparisons Manufacturing Plan Detailed component planning MRP Creates planned production orders based on: Forecast Safety Stock Pending production orders Existing inventory Item Bill of Materials

MRP Considerations. 9/21/

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) MRP Creates 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 OrdersPatient Event Data Inventory 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 9/21/

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 9/21/

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 9/21/

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 9/21/

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 9/21/

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 9/21/

Thank you. Questions?