Cost impact analysis to inform the process development plan, clinical trial program and business planning

Transcription

1 Cost impact analysis to inform the process development plan, clinical trial program and business planning Compare a future-state model to the current as is process

2 Intro to exmoor Biomanufacturing technical & strategic consultancy Capital projects Manufacturing processes GMP compliance/ QP certification Cell Therapy and Biopharma industry focus Team of bioprocess consultants supported by process development, strategy and regulatory specialists 180+ contracts for 60+ clients since March 2004 in UK, Holland, Switzerland, Malaysia, France, Spain, Sweden, Denmark, USA

3 Show the potential of your product EUR 80,000 EUR 70,000 EUR 60,000 EUR 50,000 EUR 40,000 EUR 30,000 EUR 20,000 EUR 10,000 EUR 75,000 We know where we re starting from We know where we re going We know how to get there. EUR 35,000 EUR 7,500 EUR 0 Phase I Phase III Commercial

4 Numbers will speak for themselves Supply????? Research QC Finance MFG????? Clinical QA Cost Impact Analysis pulls all the factors together Model your business, not just the technology

5 Cost impact analysis - Definitions As is state: Represents current costs related to clinical trial supply To be state: Represents future costs related to market supply

6 Cost model: How? Level 1 1. Create cost overview of current as is state 2. Identify the target market (what, where, when, price, risks) and create to be state 3. Model alternative scenarios to meet target market 4. Identify critical areas Level of detail dependent on business model & question

7 Cost model: How? Level 2

8 Determine Required Capacity Visualize design capacity & market supply Expected batch output with: Upcoming clinical trials Supply demand Develop manufacturing strategy In conjunction with clinical trial- & market supply demand determine the type and number of facilities needed Commercialization objective company Determine potential for scaling -up or -out Develop scaling scenarios - Future state manufacturing design Include operational planning with required resources Decide on strategy to forecast failure rate Ensure you know the failure rate in as is state Determine % range for failures in in-process, release, distribution & administration

9 Cost impact analysis - overview Set-up cost model Run several TO BE scenarios Select TO BE scenario with best fit to business Perform sensitivity analysis Identify Critical Success Factors Define process development and manufacturing strategies

10 Cost impact analysis example scenarios Model Process Failure Product Volume Market As is Open process R&D Labour intense High rate (20%) Fresh Short shelf life Very small EU only Local MFG To Be Scenario 1 Closed process GMP Improved MFG design Medium rate (5%) Fresh Short shelf life Largeup to 5000 EU only Local MFG To Be Scenario 2 Closed process GMP Debottlenecked design Bespoke equipment Reduced consumables Low rate (1%) Fresh Short shelf life Largeup to 5000 EU only Local MFG To Be Scenario 3 Closed process GMP Automated Reduced QC Low rate (1%) Frozen Long shelf life Very large- 25,000 EU, US Remote MFG

11 Cost impact analysis example analysis Model CoGs / Therapy Variable costs Comments As is 40,000 4,000 Inefficient use facility, equipment & staff To Be Scenario 1 To Be Scenario 2 To Be Scenario 3 4,000 2,550 Minimal Process Development, Short shelf life product demands multiple, local, geographic facilities 2,400 1,550 Process Development effort drives down CoGs & variable costs 1,700 1,600 Frozen product facilitates automation process & single large volume facility

12 Cost impact analysis example sensitivity (1) Scenario PD late PD 5x costs Description Sales volume runs late by 2 years Total Process Development costs are 5x higher 50% sales volume Reduced sales volume by 50% 50% variable costs Reduced costs for materials, logistics & cryo 50% staff costs Reduced total staff costs by 50% 5x failure rate Test higher failure rate

13 Cost impact analysis example sensitivity (2) EUR 2,000 EUR 1,800 EUR 1,600 EUR 1,400 EUR 1,200 EUR 1,000 Facility + PD cost per therapy Raw material cost per therapy Staff cost per therapy EUR 800 EUR 600 EUR 400 EUR 200 EUR 0 Scenario 3 base case Process Dev (PD) late PD 5 times cost 50% sales volume 50% material costs 50% staff costs 5 times failure rate

14 Critical Success Factors - example Critical Success Factor Description Automation Significantly increases throughput from a given facility and reduces staff costs. Achieving automation goals more important than meeting project budget or schedule. Cold chain Changing to frozen product and associated cold chain is vital to exploit the benefits of high volume production from few facilities. Minimize variable costs per therapy With the automated, high volume facility - reducing the variable costs has the biggest impact on the CoGs Licensing strategy The business model requires significant volumes and therefore requires licenses in both the US and EU

15 Manufacturing strategy example The business model assumes rapid sales growth once in-market and to invest when proven that clinical trials are successful. Frozen product & automation needs to be proven Focus on reduction of material costs Use a smaller in-house transition facility to manufacture early phase volumes and to design, build, and test the automated solution. (This also helps to protect any IP.) The licenses need to be obtained

16 We all now agree WHAT to do & WHEN

17 Contact Evelien Stalmeijer