Dr. Liam Tully, Director, Pfizer Global Development Process Centre
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Competitiveness through Innovation in Pharma Manufacturing
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Dr. Liam Tully, Director, Pfizer Global Development Process Centre
- 1. Competiveness through Innovation in Pharma Manufacturing Liam Tully October 31st 2012
- 2. Competiveness Engineering / Rates Depreciation Water Electricity & Gas Waste Wages Manufacturing Process 2
- 3. Competiveness through Innovation The Manufacturing Process Proposition: In Ireland the biggest impact on competiveness is the Manufacturing Process Water Consumption (per kg) Electricity & Waste Gas Usage (per kg) (per kg) Engineering / Building Depreciation Requirement / Requirements Rates (per kg) (per kg) Wages (per kg) 3
- 4. Competiveness through Innovation More than just cost More than just cost Added New Value? Products? New Business Opportunities New Business Opportunities Sustain- More New way to Differentiate New way to Differentiate ability? Products? Engineering / Rates Depreciation Electricity Water & Gas Waste Wages Manufacturing Process 4
- 5. Competiveness through Innovation The Manufacturing Process The Manufacturing Process has the Many Irish Pharma do biggest impact on not have the Competiveness – Manufacturing Cost & New Process at the Opportunities centre of their Competiveness Less process burden Strategy More competitive Competitiveness Scales 5
- 6. Manufacturing Process & Competiveness Strategy Strategy is incremental year on year saving Perception that Change would only be a re-filings with distraction EU, FDA, ROW is too difficult Why would the Mfg Process not be at the centre of Competiveness Strategy? Its risky & we This isn’t our core skill don’t have a mandate Our Our regulatory competiveness group wont let strategy is focused us change on cost only 6
- 7. Competitiveness through Innovation in Pharma Focus on Manufacturing Process – the “How” A good formal A good formal innovation program innovation program can be very effective can be very effective <20% of any organisation are <20% of any organisation are natural innovators natural innovators Given the right system and tools Given the right system and tools this could rise by an this could rise by an additional 60% additional 60% When 80% of the organisation is When 80% of the organisation is innovative, tackling the innovative, tackling the Manufacturing Process is Manufacturing Process is less daunting less daunting 7
- 8. Case Study Global Process Development Centre (PDC) – Pfizer 2001 2002 2006 2009 <30% of site <30% of site New global New global Delivered new Delivered new New Kilo New Kilo chemists time chemists time resource to explore resource to explore commercial route commercial route Technology lab Technology lab spent on spent on bigger bigger to manufacture an to manufacture an opened opened optimisation optimisation improvements improvements existing existing 5% Improvements 5% Improvements Cork won the Cork won the blockbuster blockbuster in annual cost in annual cost tender and PDC tender and PDC Headcount and Headcount and Incremental Incremental assembled assembled budget increased budget increased improvement inside improvement inside Regulatory Filing Regulatory Filing 8
- 9. Case Study Global Process Development Centre (PDC)– Pfizer 2012 Snapshot Today 66Worldwide refilling’s complete on priority Worldwide refilling’s complete on priority blockbuster products blockbuster products Accumulated value >$2B to 2016 Accumulated value >$2B to 2016 Average cost reduction >50% Average cost reduction >50% Transformational impact on Pfizer Transformational impact on Pfizer manufacturing manufacturing Average footprint reduction 40% Average footprint reduction 40% Process redesign is at the core of Pfizer Process redesign is at the core of Pfizer New technology New technology manufacturing competiveness strategy manufacturing competiveness strategy biocatalysis biocatalysis continuous processing continuous processing advanced process output control advanced process output control modeling modeling new chemistry new chemistry 55Processes currently under Processes currently under full redesign full redesign 9
- 10. PDC Example 2001 - -2004 Rapid increase in demand 2001 2004 Rapid increase in demand Product A Options Evaluated Invest in new capacity (estimated $100M–$200M) Invest in new capacity (estimated $100M–$200M) Change the processes: Change the processes: Focus on capacity efficiency ––aa“Must” Focus on capacity efficiency “Must” Lower API cost would also be good Lower API cost would also be good What Happened Investigated biocatalysis technology and new downstream chemistry Investigated biocatalysis technology and new downstream chemistry Enzyme was readily available ––for washing machines! Enzyme was readily available for washing machines! Cancelled capital investment plans on the basis of lab results Cancelled capital investment plans on the basis of lab results Completed process development and had plant scale batches running in 66months from project start Completed process development and had plant scale batches running in months from project start Regulatory filing complete, approvals obtained and commercialisation 22 months from project start Regulatory filing complete, approvals obtained and commercialisation 22 months from project start No product stockout No product stockout 10
- 11. PDC Example - continued Output more thanCapacity insame equipment Output more thandoubled in same equipment doubled Capital investment negligible Capital investment negligible Spare capacity generated currently used for 33other processes Spare capacity generated currently used for other processes Costs Dramatically Lowered Material cost ––80% reduction Material cost 80% reduction Labor and overhead ––over 60% reduction Labor and overhead over 60% reduction Full cost reduced by 74% Full cost reduced by 74% Greener process Greener process Biocatalysis step run continuously in CSTR’s (Continuous Stirred Tank Reactors) Biocatalysis step run continuously in CSTR’s (Continuous Stirred Tank Reactors) Today Best quality & performance at optimal cost Best quality & performance at optimal cost 11
- 12. Learning’s from the PDC Target setting is key - 30 – 80% cost reduction - Generic Cost Seek additional ideas and skills internally and externally Key Innovation is key Learning’s - implemented formal programme Systematic interrogation of processes is essential - formal programme - BRITEST Leadership support is vital - a business imperative 12
- 13. Learning’s from the PDC Team Assembly - Challenging - ACE Model - Career Ladder Skills Shortage - Ph.D Chemists - MSc/Ph.D Analyst’s - Msc/Ph.D Engineer’s Key Government Support Vital Learning’s - Research Centres (SFI) - PMTC (EI / IDA) - HEA - R&D Tax credit Academia – Industry - Agencies - Cluster model - SSPC - Unique design – a treasure - Collaboration delivering cutting edge science - Delivers spinout companies - Delivers Ph.D’s with the targeted skills 13 - It works : Can it grow?
- 14. Conclusion Manufacturing Processes are the engines in our plants and key to competitiveness A competitive strategy that fixes or replaces these engines will deliver cost savings and new opportunity value Manufacturing process redesign requires innovation in abundance – same skillset for R&D work Innovation can be taught and optimal conditions for Innovation can be put in place Leadership is needed to set ambitious targets and state the business imperative Make the Manufacturing Process competitive early in the lifecycle to maximise the benefits Cutting edge science and technology can be an every day activity in the manufacturing environment with good external support Ongoing support form Academia and Government critically important 14
- 15. Conclusion The Proposition The Manufacturing Process has the biggest impact on competitiveness in Pharma Manufacturing The Challenge What would it take for each of our companies to be the premier facilities for Manufacturing Process Innovation as we target to maximise competitiveness 15
Editor's Notes
- Many angles to competiveness but Manufacturing Process seldom the priority number 1. Why?
- The Manufacturing Process has the biggest impact on competiveness in Pharma Manufacturing:- it is the engine that drives all other costs it is the engine that can deliver a new value proposition for Manufacturing in Ireland
- If competiveness was more than just cost If it was about sustainability......about added value....a totally new value proposition – new products and more products coming on site because we had the innovation skills to maximise the value to the company for any given product- what would your No.1 be?
- The majority of Irish Pharma do not have the Manufacturing Process at the centre of their Competiveness Strategy... Why? Our quality/regulatory group wont let us change.... perception that re-filings with EU, FDA, ROW is too difficult - Doesn't stack up. If generics can do it why can’t big Pharma do same? We don't have a mandate from HQ - Difficult one, but potentially resolvable if you assemble the full package outlining Academia support, Government support, skill set in the region etc. - Other’s have done it – through PCI could we build a stronger business case – and market more? Too difficult - Granted its not easy but if successful the competiveness improvement is truly transformational There isn't much latent value there - we have a good process from our R&D – indeed some award winning processes It highly unlikely that 10, 15, 20 year old technology – even 5 year old technology could compete with today's technology, think >50% reduction in cost /kg and 50% of existing footprint. is that worth going after? Our Quality, Safety & Supply Assurance is our priority and all we need to focus on – Manufacturing Process change would only be a distraction Quality, Safety, Supply Assurance are key and non-negotiable but are also “A Given”. These are also on offer worldwide as standards increase Its scary, its risky – we are a manufacturing organisation not an R&D one – this isn't our core skill. We are risk adverse Maybe correct but can we afford not to develop and apply that skill and bring the process to a more competitive place and present a unique offering to corporate Central to our competiveness strategy – not likely – we focus on real tangible money that can be saved, measured – defined budget to budget Understandable since manufacturing process change is unclear at the start. However year on year budgets do little for a sustainable strategy Competiveness through new value proposition – our competiveness strategy is focused on cost only A cost only strategy is a race to the bottom – “you cannot shrink (save) yourself to greatness” Focus on the manufacturing process and developing in house skills to do transformational process redesign will open up many new opportunities.
- If you accept at least some of the arguments for focus on the Manufacturing Process then “how” becomes important. Innovation is critically important when focusing on the Manufacturing Process – yet it is a woolly and unclear concept (at first) Innovation requires a system that could look like this. Personal view – <20% of any organisation are natural innovators An additional 60% can be good at innovation given the right system, permission and tools With 80% of the organisation good at innovation then tackling the Manufacturing Process is less daunting
- 2001 Site chemists supported manufacturing with <30% of their time on optimisation Annual cost improvement of circa 5% - good for year to year budget process Typically incremental improvement inside regulatory filing Was there more latent value in the portfolio? 2002 Decision made to put in place a new global, ring fenced, resource to explore bigger improvements – transformational change Cork won the tender and PDC assembled – located in UCC initially while labs being prepared 2006 delivered total new commercial route to manufacture an existing blockbuster – international IChemE award Headcount and budget increased 2009 New Kilo Technology lab opened facilitating new technology evaluation, continuous as well as batch processing and rapid scale up
- 2012- lookback sees:- 6 worldwide refilling’s complete on priority blockbuster products – processes now commercial Average cost reduction >50%. Average footprint reduction 40% New (to Pharma) technology like biocatalysis, continuous processing, advanced feedback feed forward automation, modelling and novel chemistry – all introduced, all routine 5 other processes currently under full redesign Snapshot today:- Accumulated value >$2B to 2016 Impact on Pfizer manufacturing – transformational Process redesign is at the core of Pfizer manufacturing competiveness strategy
- Product A had a dramatic increase in growth between 2002 & 2004 that pointed to supply problems in 2006 – nice problem to have! Options evaluated Invest in new capacity (estimated $100 - $200M) Change the processes:- focus on capacity efficiency – a “must” lower API cost would also be good – a “want” What happened We investigated biocatalysis technology and new downstream chemistry Enzyme was readily available since used worldwide in washing medicines Cancelled capital investment plans on the basis of lab results! Completed process development and had plant scale batches running in 6 months from project start Regulatory filing complete, approvals obtained and commercialisation 22 months from project start No product stockout
- Capacity Output more than doubled in same equipment – potential supply problem eliminated Capital investment negligible Spare capacity generated currently used for 3 other processes Costs dramatically lowered Material cost – 80% reduction Labour & Overhead – over 60% reduction Full cost reduced by 74% Greener process – primarily water based Today Biocatalysis step run continuously in CSTR’s (Continuous Stirred Tank Reactors) - standard reactors combined in an equipment train Steady state processing ensures best quality & performance at optimal cost
- Target setting is key. Post lost of patent exclusively (LOE) generic costs (if available) is a good target 50% reduction in cost is a good target start point but 80% has been achieved as have 30% - depends on initial process and molecule complexity Additional ideas and skills can be obtained across the company and outside the company in Ireland an beyond e.g., open innovation to deliver results required in the timeframe set Innovation is key. PDC developed their own bespoke programme over 2 years that morphed into a company wide innovation initiative. Systematic interrogation of processes is essential. The BRITEST methodology is a favourite in the PDC. Leadership support is vital. Early success will bring confidence. Agreeing target products is essential so stakeholder buyin at proof of concept (POC) is always there Support from Academia, globally, is important but local support through SSPC and other institutions in invaluable. Support from Government is important – 25% R&D tax credit, establishment of Pharma Manufacturing Technolog
- Target setting is key. Post lost of patent exclusively (LOE) generic costs (if available) is a good target 50% reduction in cost is a good target start point but 80% has been achieved as have 30% - depends on initial process and molecule complexity Additional ideas and skills can be obtained across the company and outside the company in Ireland an beyond e.g., open innovation to deliver results required in the timeframe set Innovation is key. PDC developed their own bespoke programme over 2 years that morphed into a company wide innovation initiative. Systematic interrogation of processes is essential. The BRITEST methodology is a favourite in the PDC. Leadership support is vital. Early success will bring confidence. Agreeing target products is essential so stakeholder buyin at proof of concept (POC) is always there Support from Academia, globally, is important but local support through SSPC and other institutions in invaluable. Support from Government is important – 25% R&D tax credit, establishment of Pharma Manufacturing Technolog
- Manufacturing Processes are the engines in our plants and the key to competitiveness for small molecule API, Bio Pharma & Drug Product A competitive strategy that fixes or replaces these engines will deliver cost savings and new opportunity value like more products, well into the future Manufacturing process redesign requires Innovation in abundance and is the same skill set as R&D process design - if opportunities arise Innovation can be taught and optimal conditions for Innovation can be put in place Leadership setting ambitious, well researched targets, greatly facilitates the Innovation process. Leadership spell out that it is a business imperative Cutting edge science and technology can be an every day activity in our manufacturing environment particularly when we reach out across our companies and out to external facilitate like those that SFI, EI and IDA have put in place Make Manufacturing Process competitive early in the lifecycle to maximise the benefits pre LOE as well as post LOE