BIOTECH SUPPLY October 8-9, 2012 Crowne Plaza, Foster City, CA There is more project at the end of the money! Matt Blume, GM Catalent Pharma Solutions

Global Phase III Clinical Trial –36 Countries –3000 Patients –200 Sites –30 Languages – Regional Booklets –Multiple Arms –Limited Drug Availability –Possible Compassionate Extension –Dose Adjustments –Country list may change –Internal Pressure for accelerated FPI Date 9/5/2015 2

STRESS! –Main focus on supply and clinic start date –Total returned goods budget through 2016? 9/5/2015 3

Objectives Presentation Goals: –Increase awareness of changing trial contract environment –Examples where early communication would have changed outcomes –Take-away list of items to consider –Save everyone at least one headache on a future trial 9/5/2015 4

Contract Environment Traditional Model: 9/5/ Sponsor Company Estimated Contract Packaging and Distribution Vendor

Contract Environment New Model: 9/5/ Sponsor Company All –Inclusive Contract Clinical Research Organization Packaging and Distribution Vendor Exact PO

Real Example Clinical Trial Shipping To Global Depots Total contract courier estimate of ~$500k for life of 3 year contract Multiple shipments to Ukraine Duties and Taxes were approximately $50k per shipment Duties and Taxes not included in original budget, drove total courier cost for study over $1M Headache for sponsor, CRO, and Distributor 9/5/2015 7

Real Example Mid-Sized phase 2 trial with 40 sites and 400pts 24 month trial duration – Storage and Distribution Only Original estimate averaged 5 pallets/month of storage for study Kit size much larger than assumption, received 45 pallets several months into study Number of shipments was also higher than estimated Drove increased storage, distribution (Controlled Ambient), freight and returns costs Total budget increased from ~$76k to ~$450k 9/5/2015 8

Items to Consider What is the purpose of the budget internally? Rough estimate based on current assumptions Precise forward calculation of total spend for the trial Let the above answer drive the amount of rigor put into the original contract Multiple versions are good! Good idea to have team meetings to build, and three- way meetings if there are multiple contract holders 9/5/2015 9

Take-Away List of Specifics Storage and Receipt: Ensure the number of items / size of those items are accurate –How many items will fit on a pallet? –If cold-chain, what is the exact size of the location the items will be stored in and how many will fit? Will there be one large shipment of supplies to vendor, or could it possibly be split into multiple shipments If finished, shippable kits are sent, are they be split up by treatment group or blended together Do a “reality-check” shortly after initial receipt. 9/5/

Take-Away List of Specifics Packaging and Labeling: Usually the most visible and defined portion of contracts. Variations to scope are easily identified Booklet Labels –Small Changes in design or ordering approach can greatly alter cost –Best approach is an actual quote from booklet vendor for best-guess design rather than a placeholder estimate Unit Dose Cards –Best to receive actual quote rather than placeholder 9/5/

Take-Away List of Specifics Distribution: What is the planned shipping strategy? Ensure that the plan matches IxR system. –Number of items sent per shipment –Size of the shipper and estimated freight –Number of planned shipments per site –Initial order size vs resupply size –Especially important with controlled temperature studies Example: –Small CRT study with large kits. One kit fit in a large (~50lb) shipper. Shipping plan was 2-3 kits per shipment, but IVR was set for 14 kit seed orders. –Changed to specialty courier to unload / take away boxes – Increased cost by ~$20k for study. 9/5/

Take-Away List of Specifics Distribution (Cont): International Studies –Bulk Shipments to Depot – Same size, or varying quantities? –Pallets vs. Large shippers –Freight estimates –Estimated taxes and duties –Specialty courier quotes better than estimates – current fuel surcharges and assumptions –Approximate duration of shipment – appropriate shippers (48hr vs 72hr) 9/5/

Questions Q & A 9/5/