Determining Methods of Collaborative, Realistic, and Cost Effective Fatima Zaidi Clinical Trial Supply New England - 2013
Drug Development and Clinical Supply Annual supply chain spending for drugs under clinical trials can be substantial e.g., accounting for 20% or more of company s R&D spending Fleischhacker, A., Y. Zhao (2007). Planning for Demand Failure: A Dynamic Lot Size Model for Clinical Trial Supply Chains 2
Clinical Supply Planning Management of complex program with multinational regulations, functions, activities, and interactions 3
Challenges in Clinical Supply Planning Complex distribution network Variable enrollment rate Patient Drop-outs Expiration dating Randomization Stratification Bulk availability constraints Weight based dosage Multiple dose levels 4
Clinical Supply Optimization Minimize Risk Insufficient Stock Minimize Cost Manfg./Pckg/ Distribution Late Resupply Waste/Rush orders Insufficient overage Workload 5
Project Management Approach for Clinical Supply Planning: Getting right inventory, to right place, at right time 6
Factors Ensuring Optimization in Clinical Supply Planning Team Structure Processes Tools Systems Communication Determining Methods of Collaborative, Realistic, and Cost Effective 7
Team Structure Industry trends in clinical supply team structure(s) 8
Industry trends in clinical supply team structure(s) For productive positioning of clinical supply teams Larger CTS groups tend to be more specialized by activities: - Demand planning - Clinical trial supply set-up (packaging design, label approval, etc.) - Inventory management - IVR set-up - Outsourcing - Logistics Increasing trend in CTS is to take a project management approach: - Dedicated CTS Project Manager (PM) assigned to clinical study - CTS PM handles all activities from start to finish (demand planning, packaging/labeling, vendor management) - CTS Program Manager assigned to coordinate/plan with multiple CTS PMs 9
Efficient Processes and Systems Lean processes and integrated systems Optimizing Processes Develop processes and tools appropriate for department and company size. Create process maps, assess gaps, and identify bottle necks. Remove bottle necks Integrating disparate systems used by vendors and sponsors Identify system/technology to integrate the systems: - Cost of system implementation - Time to build and validate the integrated system Single messaging standard across vendor and sponsor system (Extensible Markup Language XML) Determining Methods of Collaborative, Realistic and Cost Effective 10
Clinical Supply Systems Used across Biopharmaceutical Industry Software system Vendor Forecasting COMPASS Almac Optimizer/Tc Visualize Smart Supplies Bio Clinica CLINapps Labeling/Inventory Management Clinicopia Aptuit SAP CTSM add on POMS CMS CTSS, ERP system Freezerworks Lodestone, Inc. Honeywell Rockwell Automation Freezerworks IVR/IWR Management Almac, Cenduit, Perceptive/ClinPhone, PPD Prelude Vision United BioSource Corp. 11
Activity Planning Tool Standard lead times for clinical supply activities Activities Lead times* Demand planning (drug substance) 9-12 months Study supply agreement (b/w clinical and CTS) Demand planning bulk drug Forecasting distribution scenario analysis, initial supply, resupply quantities Vendor selection (RFP, Contracts, Timelines) 9 months 6-9 months 6 months 6 months - Packaging distribution vendor 6 months - IVR/IWR vendor (design build, UAT, launch 6 months Label approval Label translations Booklet label printing Packaging/Labeling, Import permits Distribution ( to depots) IVR UAT/ launch 6-7 months 6 months 6 months 3-4 months 3 months 1 month Distribution to sites 1-2 weeks * - Lead times are from First Patient in (FPI) 20 March 12 2013
Cost - Develop supply budget during design phase Start the race with finish line in sight Drug product cost - API - Manufacturing Study Parameters - Number of subjects, sites, countries - Global site distribution - Dosing, blinding, enrollment forecast Packaging & Labeling - blister/bottle - number of packaging campaigns, product expiry date - booklet label/number of languages - storage and distribution Other - IVR - expiry date management PLEASE INSERT Presentation title 13
Cost - Developing Initial Study Budget Example (hypothetical) Study Parameters/Specifications Cost Total Number of subjects; sites; and countries 500; 100; 8 Study duration, expiry date 3 years, 24 months Number of subject, visits, dosing Primary packaging (100 count bottles) with booklet label $ 10.00 Number of packaging campaigns 3 12, 20 mg 100 mg flexible dose Packaging cost (total number of bottles, 3 packaging campaigns) $80000.00 240,000.00 Storage cost (3 depots) per year $10,000.00 30,000.00 Distribution cost (per shipment, and return) $100.00, $125.00 10,000.00 Other, export permits, label translation $3000.00 10,000.00 Expiry date management, relabeling Variable 10,000.00 IVR/IWR (with returns module) $350,000 350000.00 Total 740,000.00 14
Communication, Collaboration, and Transparency Between Supply and Clinical Development Encourage involvement of supply personnel at the stage of protocol development to ensure feasibility of projected timelines. Early involvement of supply personnel during protocol development phase Robust activity and timeline planning Good communication, and frequent meetings with involved parties during study design and trial phase. (Clinical supply, Clinical development, Manufacturing, Analytical, Vendors) Cross functional coordination Determining Methods of Collaborative, Realistic, and Cost Effective 15
Other Programs/Tools To achieve clinical supply optimization Technical training programs in CTS E.g., 3 month apprenticeship with rotation(s) in manufacturing, analytical, packaging & labeling, distribution, shadowing program(s). Cross-functional trainings Within R&D organization to enhance alignment on processes and lead times Establishing KPIs/metrics to measure and improve performance: - On time delivery, Waste reduction People development Career ladder within CTS Ongoing training, Incentives PLEASE INSERT Presentation title 16
Questions/Comments 17