John O'Halloran, Solid State Pharmaceutical Cluster

Solid State Pharmaceutical Cluster (SSPC)- Enabling Innovation in Pharma

Jon O’HalloranOctober 30th 2012

Where does Pharma lie – manufacturing or otherwise - in

innovation stakes?

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Investment Data• Pharma Investment V Output

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Investment Data• Pharma Investment is Substantial

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Innovation Data

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* The Innovation Premium is a measure of how much investors have bid up the stock price of a company above the value of its existing business based on expectations of future innovative results (new products, services and markets). Members of the list must have $10 billion in market capitalization, spend at least 1% of their asset base on R&D and have seven years of public data

In fact….• None of ‘Large Pharma’ Represented in ‘Top 100’• Only Celgene of mid-size Pharma represented - #12• Novartis have acquired Alcon # 21 in mid 2011• List comprised of software, and commodity companies• Should we be surprised?

– Regulated environment– Same finished product over years

• Should we be alarmed?• What can be done?

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What can be done?

Collaboration as an enabler of innovation

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Solid State Pharmaceutical Cluster• SFI Strategic Research Cluster – designed to link scientists and

engineers in partnerships across academia and industry

• Solid State Pharmaceutical Cluster- Established in 2007 led by UL

• Funding - €8 million investment by Irish Government over 5 years

ACADEMIA

INDUSTRY

Aim

• To deliver relevant solutions to address the global needs of our industry partners– No longer is just competing good enough– To demonstrate added value for doing business in Ireland– To engage the HQ with Irish affiliates more

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SSPC & Innovation• Innovative culture

– Competitive industrial partners– Equity of Resources– Inclusivity– Capability based strategy

• Introduction of new skillsets

– Mandatory student placements in industry– Embracing Marketing concepts

• Service dominant logic – BPX, ATTLAS

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“What we do here in Ireland amazes our international

colleagues. They are shocked when they hear we are

collaborating with other big Pharma. It would never happen

anywhere else even in our neighbours in the UK.” – Gordon

Hutton, GSK

Manufacturing Innovation• Case study 1Working in collaboration with our

– Calibration free method for tracking supersaturation – Prof. B. Glennon– Before

• Problems sent to corporate

– After• Irish site seen as leader in space

– Result• Investment in site capabilities• Site more strategic to HQ• SSPC Continuous Crystallisation Project

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“Working in collaboration with our SSPC partners a key crystallisation operation in the process was successfully developed and implemented in our manufacturing plant. This project delivered a significant benefit to the local Eli Lilly organisation but equally importantly, demonstrated the capability of the Irish organisation working in collaboration with the capabilities of the SSPC, to successfully complete a very complex development challenge” – Ed Canary, General Manager, Eli Lilly

Manufacturing Innovation• Case study 2

– Fundamental understanding of solution mediated polymorphic transformations – Profs. Hodnett & Rasmuson

– Before• 20% failure rate in a seeded cooling crystallisation process due to polymorph issues (8 out of 35

batches in previous campaign)

– After• Zero failures in latest 40 batch campaign due to student designed seeding regime and process

changes

– Result• “Significant commercial upside “ - Tech services director• Student begins full time employment with company in November

• “

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Tangible Benefits• A recent example (June 2012) of the benefits of adopting this

strategy could be seen where Roche Corporate made a decision to retain its plant in Ireland.

• Roche have been a partner in SSPC since its inception and indeed, the Irish site management attributes the decision to its operational excellence, its highly skilled workforce and its on-going ability to demonstrate innovative R&D capacity as a result of engagement with SSPC.

• The direct economic impact of this has been the retention of 400 high value jobs in Ireland.

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Lessons to Date• Experience of SSPC to date is that a virtual centre is not solely about the researchers

within the centre, but also represents a much broader community of practice encompassing participant companies and researchers, SMEs, service and equipment suppliers

• The centre model gives industry a single point of access to a broad suite of expertise, from fundamental skills to more applied problem-solving techniques; from the molecule to the finished drug product

• The model also allows for further growth and potential for convergence with other sectors including medical device, connected health and software

• Ultimately, SSPC and the Process R&D units of the companies will significantly strengthen the broader sectorial system of innovation

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The Future - SSPC2

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• SFI Research Centre Application – Building on Success• 3 Additional HEIs, 5 Additional Companies• Significant International Collaboration• Additional Expertise from existing HEIs

SSPC2 Objective & Impact

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The overarching objective of the research is to better understand mechanisms, control processes and predict outcomes for the efficient and environmentally friendly production of safe medicines.

The overarching economic impact of SSPC2 will be the retention, creation and transformation of direct jobs in the pharmaceutical industry in Ireland

Recent history of collaboration• 1970’s 1980’s

– Informal ‘fad’ observation based collaboration – Quality Circles, Total Quality Management, CI

• 1990’s– More Formal arrangements – Joint Ventures, Alliances

• 2000’s– Formal collaboration – Industry academic alliances, Clusters, Open innovation

• 2010’s– Convergence?

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Questions

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