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

            Jon O’Halloran
           October 30th 2012
Where does Pharma lie –
manufacturing or otherwise - in
     innovation stakes?

             www.ul.ie/sspc       2
Investment Data
• Pharma Investment V Output




                   www.ul.ie/sspc   3
Investment Data
• Pharma Investment is Substantial




                    www.ul.ie/sspc   4
Innovation Data

                      * 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
     www.ul.ie/sspc   seven years of public5
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?
                               www.ul.ie/sspc             6
What can be done?



Collaboration as an enabler of
         innovation
  The Industry Academic Alliance
              www.ul.ie/sspc       8
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



               ACADEM                     INDUSTRY
                 IA
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


                         www.ul.ie/sspc                    10
SSPC & Innovation
• Innovative culture                                “What we do here in Ireland
                                                     amazes our international
   –   Competitive industrial partners             colleagues. They are shocked
                                                      when they hear we are
   –   Equity of Resources                          collaborating with other big
                                                  Pharma. It would never happen
   –   Inclusivity                                   anywhere else even in our
                                                  neighbours in the UK.” – Gordon
   –   Capability based strategy                            Hutton, GSK
        • Introduction of new skillsets
   – Mandatory student placements in industry
   – Embracing Marketing concepts
        • Service dominant logic – BPX, ATTLAS
                                 www.ul.ie/sspc                             11
Manufacturing Innovation
• Case study 1Working in collaboration with our
  – Calibration free method for tracking supersaturation – Prof. B.
    Glennon                               “Working in collaboration with our SSPC
                                          partners a key crystallisation operation in
  – Before                                the process was successfully developed and
                                                  implemented in our manufacturing plant.
      • Problems sent to corporate
                                                  This project delivered a significant benefit to
  – After                                         the local Eli Lilly organisation but equally
                                                  importantly, demonstrated the capability of
      • Irish site seen as leader in space        the Irish organisation working in
                                                  collaboration with the capabilities of the
  – Result                                        SSPC, to successfully complete a very
                                                  complex development challenge” – Ed
      • Investment in site capabilities
                                                  Canary, General Manager, Eli Lilly
      • Site more strategic to HQ
                      www.ul.ie/sspc                                                        12
      • SSPC Continuous Crystallisation Project
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
                                www.ul.ie/sspc                          13
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.
                              www.ul.ie/sspc                       14
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
                                  www.ul.ie/sspc                                  16
•   Ultimately, SSPC and the Process R&D units of the companies will
The Future - SSPC2
•   SFI Research Centre Application – Building on Success
•   3 Additional HEIs, 5 Additional Companies
•   Significant International Collaboration
•   Additional Expertise from existing HEIs




                                                            17
SSPC2 Objective & Impact
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
                                                                       18
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                      www.ul.ie/sspc                     19
Questions




  www.ul.ie/sspc   20

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John O'Halloran, Solid State Pharmaceutical Cluster

  • 1. Solid State Pharmaceutical Cluster (SSPC) - Enabling Innovation in Pharma Jon O’Halloran October 30th 2012
  • 2. Where does Pharma lie – manufacturing or otherwise - in innovation stakes? www.ul.ie/sspc 2
  • 3. Investment Data • Pharma Investment V Output www.ul.ie/sspc 3
  • 4. Investment Data • Pharma Investment is Substantial www.ul.ie/sspc 4
  • 5. Innovation Data * 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 www.ul.ie/sspc seven years of public5
  • 6. 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? www.ul.ie/sspc 6
  • 7. What can be done? Collaboration as an enabler of innovation The Industry Academic Alliance www.ul.ie/sspc 8
  • 8. 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 ACADEM INDUSTRY IA
  • 9. 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 www.ul.ie/sspc 10
  • 10. SSPC & Innovation • Innovative culture “What we do here in Ireland amazes our international – Competitive industrial partners colleagues. They are shocked when they hear we are – Equity of Resources collaborating with other big Pharma. It would never happen – Inclusivity anywhere else even in our neighbours in the UK.” – Gordon – Capability based strategy Hutton, GSK • Introduction of new skillsets – Mandatory student placements in industry – Embracing Marketing concepts • Service dominant logic – BPX, ATTLAS www.ul.ie/sspc 11
  • 11. Manufacturing Innovation • Case study 1Working in collaboration with our – Calibration free method for tracking supersaturation – Prof. B. Glennon “Working in collaboration with our SSPC partners a key crystallisation operation in – Before the process was successfully developed and implemented in our manufacturing plant. • Problems sent to corporate This project delivered a significant benefit to – After the local Eli Lilly organisation but equally importantly, demonstrated the capability of • Irish site seen as leader in space the Irish organisation working in collaboration with the capabilities of the – Result SSPC, to successfully complete a very complex development challenge” – Ed • Investment in site capabilities Canary, General Manager, Eli Lilly • Site more strategic to HQ www.ul.ie/sspc 12 • SSPC Continuous Crystallisation Project
  • 12. 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 www.ul.ie/sspc 13
  • 13. 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. www.ul.ie/sspc 14
  • 14. 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 www.ul.ie/sspc 16 • Ultimately, SSPC and the Process R&D units of the companies will
  • 15. The Future - SSPC2 • SFI Research Centre Application – Building on Success • 3 Additional HEIs, 5 Additional Companies • Significant International Collaboration • Additional Expertise from existing HEIs 17
  • 16. SSPC2 Objective & Impact 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 18
  • 17. 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 www.ul.ie/sspc 19

Hinweis der Redaktion

  1. This chart shows the level of investment by Pharma in R&D versus outcome The investment is very significant but the level of output since 1999 has actually decreased It should be noted that there is a lag time in the investment Vs the output but even adjusting for this the output is poor Vs investment
  2. When you compare Pharma R&D investment to investment by other sectors you see that Pharma are well represented with 5 Pharma in the top 10
  3. However when you look at the top 10 innovative companies then Pharma is absent Given the level of investment the Pharma industry is relatively unproductive in R&D terms Many reasons could be used to explain this regulatory requirements which almost have an inverse relationship with innovation high gross margins means companies are in a comfort zone and under less pressure to innovate product complexity & patient safety requirements makes it more challenging to innovate
  4. With more pressure now on from lots of places including payer pressure and reductions in government reimbursements there is more pressure on innovation and particularly looking at the complete innovation cycle Cost of drug development one quarter of the costs are is spent before the clinic, another half are spent in the clinic and open quarter is spent once clinical is complete so there are many areas for cost savings & industry are exploring all of these One of the ways industry is responding is through externalisation and this includes an increase on the focus of academic-industry collaborations