Solid State Pharmaceutical Cluster (SSPC) - Enabling Innovation in Pharma. Presentation Video http://www.youtube.com/watch?v=S8BlZ8eqA94&list=UUrqilkHGkk9VlP1V1J8o-Og&index=6&feature=plcp
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
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
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
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
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