Understanding Cell Therapy Cost of Goods

Transcription

1 Understanding Cell Therapy Cost of Goods Linking Detailed Analysis to Industry Challenges Dr Mark McCall

2 Prof David Williams Dr Rob Thomas CHI Acknowledgements

3 Outline Problem Background Development History Underlying Models Costing Process 1 st Generation Models 2 nd Generation Models Trade-offs and Final Thoughts Problem Definition Data Collection Model Formulation and Solution Validation Implementation and Monitoring

4 Problem Background - Challenging Reimbursement Headwinds Affordable Care Act of 2012 (Treatment Bundling ) Risk sharing reimbursement deals Lack of reimbursement for approved therapies - Scale challenges (Up to 5x10 9 hmsc s per dose) - Lack of common manufacturing platform - Excessive costs of validation and process development Traditional Perfused - Rigid Perfused Non Rigid Suspension Tissue Flask Roller Bottles Hollow Fibre Plug-Flow Bioreactor Wave Bag (Microcarriers) Stirred Tank (Microcarriers) Hyper flask Perfused Multilayer Perfused Macroporous Packed Bed Fluidised Bed Stirred Tank Suspension Low Degree of Process Change High

5 Our approach to understanding COGS - Multiple level of analysis approach - Used as the basis for collaborative case study work - Majority can be derived from activity based costing and precedents

6 1.00E+09" Bespoke Costing Models Biopharmaceu9cal(Facility(Cost(Vs(Size(( 1.00E+08" Facility(Cost( ( y"="888.06x" R²"=" " 1.00E+07" 1.00E+06" 1,000.00" 10,000.00" 100,000.00" 1,000,000.00" Facility(Size((sq1)((

7 Data Collection Modelling Process Process Scope General Process Map Process Platform(s) Performance History Dose range Supply Chain structure QA/QC Burden Banking strategy Processing Environment Assumptions and Constraints Model Construction and Validation Activity Based Costing Resource allocation Current Process Cost Grounding Historical Precedents Assumption Checking Performance modelling Analysis and Decision Support Cost Breakdown Cost Sensitivities Comparative Analysis Validation Costing ROI Profiling Life Cycle Costing Historic Information Process Costing Models Traditional Business Assessment Tools

8 First Generation Costing Models $200.00$ $180.00$ $160.00$ Manufacturing+Costs+for+Different+Produc3on+Systems+++ Quantum$$ Automated$HyperFLASK$ SArredBTank$MicroBCarrier$Suspension$$ Sensi%vity'Analysis)' 20$ 15$ Manufacturing+Cost++ $140.00$ $120.00$ $100.00$ $80.00$ $60.00$ $40.00$ $20.00$ $0.00$ 1.00E+03$ 1.00E+04$ 1.00E+05$ 1.00E+06$ 1.00E+07$ Annual+Produc3on+Capacity+of+a+Single+Faciity+(Millions+of+Cells)+++ + Rela%ve'Change'in'Manufactured'Cost' 10$ 5$ 0$!100$!80$!60$!40$!20$ 0$ 20$ 40$ 60$ 80$ 100$!5$!10$!15$!20$ Rela%ve'Change'in'Variable' Expansion$ Consumables$Cost$$ Labour$Cost$$ Characterisa=on$Cost$$

9 Second Generation Costing Models Example Application Allogeneic Chondrocytes Derived from hmsc s - Defined reagents - Relatively low cell dose (5x10 7 ) - Single point of manufacture Current Process (Grounding) - Low scale - Manual manipulation of HYPERStack vessels - Variable Process Outputs Future Process (Target Setting) - Closed bioreactor system - Larger batch sizes - Reduced unit processes - Improved process repeatability

10 Scenario A Manual HYPERSTACK COGS Model / 10 6 $ " 10" Process'Cost'Pareto''+'Manual'HYPERStack'Manipula8on'' Breakdown Reagents Consumables Facility Personnel 120" 100" Batch Size 6x10 8 Batch Cost $33,138 Yearly Output 2.4x10 11 Date of Update 28 April 2014 COGS Target / 10 6 $30 Rela%ve'Change'in'COGS' Unit'Process'Cost'Sensi%vity' 100$ 80$ 60$ 40$ 20$ 0$!100$!80$!60$!40$!20$ 0$ 20$ 40$ 60$ 80$ 100$!20$ 8" 6" 4" 2" 0" Suface"Coa0ng"" Suppliment"A"(Expansion)" Suppliment"B"(Diff)" Cyroprotectant"" Detachment"Enzyme"" Base"Media"" Wash"Buffer"" QC" Expansion"PlaJorm"Disposable"" Downstream"PlaJorm"Disposable"" Freezing"Bags"" Gowning"" Inter"process"vessel"" Cost Variability Utlili0es"" Cleaning"" Valida0on"" HVAC"" Watse"Disposal"" Equipment"Deprecia0on"" QMS"Staff"" Downstream"" Manufacturing"" Line"Management"" QA/QC"Personnel"" QA/QC"Samples"" 80" 60" 40" 20" 0"!40$!60$!80$!100$ Rela%ve'Change'In'Process'Performance' Expansion$ Differen5a5on$ Cell$Sourcing$ Delivery$

11 Scenario B Closed Bioreactor COGS Model / 10 6 $31.25 Batch Size 6x10 9 Batch Cost $187,480 Yearly Output 4.8x10 11 Date of Update 28 April 2014 COGS Target / 10 6 $30 Frequency) 80$ 70$ 60$ 50$ 40$ 30$ 20$ 10$ 12" 10" 8" 6" 4" 2" 0" Process'Cost'Pareto''+'Closed'Bioreactor'System'' Cost Breakdown Reagents Consumables Personnel Facility Suppliment"B"(Diff)" Suppliment"A"(Expansion)" Suface"CoaCng"" Cyroprotectant"" Detachment"Enzyme"" Base"Media"" Wash"Buffer"" Expansion"PlaMorm"Disposable"" QC" Downstream"PlaMorm"Disposable"" Freezing"Bags"" Gowning"" Inter"process"vessel"" Cost Variability QMS"Staff"" Downstream"" Manufacturing"" Line"Management"" QA/QC"Personnel"" UtliliCes"" Cleaning"" ValidaCon"" HVAC"" Watse"Disposal"" Equipment"DepreciaCon"" QA/QC"Samples"" Losses"" 100" 90" 80" 70" 60" 50" 40" 30" 20" 10" 0" %$ %$ 80.00%$ 60.00%$ 40.00%$ 20.00%$ 0$ 10$ 20$ 30$ 40$ 50$ 60$ 70$ 80$ Bin) 0.00%$

12 Further Points Trade offs (Robustness or Efficiency) Scale out vs. Scale up Setting correct batch sizes Multiple dosing requirements Integration of processes in non clean room environments Revalidation of MCB / WCB Life Cycle Costing

13 Thanks celltherapywonk.com