Synthesis & Solid State Pharmaceutical Centre: an interview with Dr Mary Shire, University of Limerick

Mary Shire ARTICLE IMAGE

Can you please give an introduction to the Synthesis & Solid State Pharmaceutical Centre (SSPC)?

This is a new research centre led by the University of Limerick that supports the pharmaceutical sector in Ireland.

The centre will carry out research on the key aspects of what it takes to synthesise the pharmaceutically active molecule to isolate a pure material and to formulate this into a medicine.

It is an extension and expansion of an existing multi-partner research collaboration that has a proven track record of successfully bringing together academia and industry to address fundamental challenges in pharmaceutical manufacturing.

What are the aims of the SSPC?

The aim of the SSPC is to work in partnership with the industry to support a transformation in Ireland from being a centre of excellence in pharmaceutical manufacturing to being a global hub for advanced manufacturing and process innovation.

The reason to do this it to ensure Ireland is the most attractive country to manufacture pharmaceutical material for the market but also for clinical trials.

It is critical for Ireland to get more involved in the value-add parts of the supply chain which include inputs at the clinical trial stage and also for lifecycle extensions which will give additional patent protection and thus market advantage.

The Pharmaceutical Sector is a critical sector for the Irish economy and accounts for over 56% of exports and is responsible for over 60,000 Irish jobs both direct and indirect. Ireland is playing on the global stage in this sector and an interesting statistic is that 52% of global medicines originate from Ireland.

At a technical level the aims of SSPC are to further the understanding, the prediction and control of the fundamental science and engineering involved in advanced pharmaceutical manufacturing.

How was the SSPC formed?

The SSPC builds on an existing research collaboration led by the University of Limerick that involves 5 universities and 9 multinational pharmaceutical companies.

This collaboration was established in 2007 and funded for 5 years through Science Foundation Ireland.

The focus of the original SSPC was exclusively on the crystallisation stage of the manufacturing process which in the industry is the most challenge aspects of manufacturing as there is a significant lack of fundamental understanding of the science and engineering challenges of this stage of the process.

The level of industry academic engagement has been exceptional and is seen as a model internationally of how to get industry and academia to work in real partnership.

The result of the success of the model has earned SSPC global brand recognition both in academia and industry. This is evidenced by the fact that the new centre has extended its membership to include 8 additional companies and 12 international academic institutions from North America, Europe and Asia.

The new centre has an expanded scope which now covers the full range of the process from the synthesis of the molecule to the crystallisation (isolation) of the material and formulation of this active material into the medicines we all take.

The scale of the centre has also increased to over three fold its original size and this brings it to the level of comparable centres of excellence internationally.

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How important do you think collaborations are in pharmaceutical process innovation?

Collaboration is critical for innovation in general but is particularly important for pharmaceutical process innovation as the challenges require a mixture of skills and expertise.

For many years pharmaceutical development has been dominated by a certain skill set and dominated in many cases by organic and analytical skills.

To tackle the fundamental challenges of the pharmaceutical process this research centre brings together a much wider set of skill sets. It also brings groups from different organisations and cultures including academia, multinational companies, and small to medium enterprises.

The companies are drawn from active pharmaceutical ingredient manufacture, drug product manufacture and various service providers.

It has recently been announced that the SSPC will benefit from investment from Science Foundation Ireland. How do you plan to use this funding?

The funding will be used to support an ambitious research programme. The outputs form this programme will include 60 PhDs and 28 post-doctoral research fellows and we will also have a management team.

There is a very detailed research program of what we are going to do with the funding. The first stage involves synthesising the molecule and understanding key dynamics there. For example, what we are looking at here is using novel catalysts including bio-catalysts which would be more efficient and also more environmentally friendly.

We are then going to focus on the isolation of the active pharmaceutical material and the physical properties of it, so that it is in a good condition to be formulated. We will then explore critical formulation parameters and novel formulations.

What has happened in the past is that all of these groups have worked in isolation and a product moves from one stage to another without any engagement or cross-over.

What is nice about our project is that we have brought all three of the aspects together in one. We have also linker and demonstrator projects to go from the very beginning to the very end of the pharmaceutical process.

This is a unique feature of our centre internationally. There are international centres that do pieces of it but there isn’t really a centre that is doing the holistic approach that we are taking.

How will you keep people informed of SSPC’s activities?

We are putting in place an operations team at the University of Limerick to manage the enlarged centre. This will include a number of people whose responsibility will be to keep all stakeholders update on activities of SSPC.

This includes an industrial liaise to work directly with the companies, an outreach office to work particularly with schools and students to encourage career choices in the industry and a communications officer who will be responsible for PR, marketing and communications to the wider public.

What impact will this funding have on the future of the SSPC?

The overarching economic impact objective of SSPC2 is the retention, creation and transformation of direct jobs in the pharmaceutical industry in Ireland.

We envisage that our primary impact will be on job retention and increasing the competitiveness of the existing business base in Ireland by supporting its diversification into R&D.

SSPC2 will also partner with agencies such as the IDA in promoting Ireland as a venue for FDI and new jobs particularly in R&D and advanced manufacturing.

SSPC2 will also work with Enterprise Ireland in supporting the further development of the SME sector in the pharmaceutical area.

The overarching societal impact objectives of the Centre are:

  1. enhanced education and training offerings to support a knowledge society
  2. a ‘greener’ pharmaceutical industry
  3. greater availability and choice of medicines for patients at lower cost

Are there plans for similar collaborations elsewhere in the world?

The centre involves collaborations across the globe. This involves international collaborations with 12 academic institutions including North America, Europe and Asia.

What is unique about the SSPC centre?

In the past Ireland was known internationally for its manufacturing. Corporate head R&D people are now visiting Irish sites for the first time to discuss research and development. This is very positive change for Ireland.

They are doing this because of the success and reputation of the original research cluster we put in place.

One of the quotes from one of the companies in relation to the level of collaboration is “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.”

This doesn’t normally happen as in the pharmaceutical sector intellectual property is very sensitive and the companies don’t share information.

So we have a unique situation in Ireland where the companies are actually working together.

Why are they doing this? Well they describe it as the intellectual property being in the molecule itself; whereas what we are working on is process innovation. Process innovation can help each of them, so they are willing to share. In sharing in a much more open innovation approach, they’re much more likely to see changes.

For the companies here, their competitors are in some cases sister plants, but in a lot of cases it is the generic manufacturers. So these companies are trying to position themselves to be economically competitive with generic companies that span the world.

I think this unique collaboration is the reason we have got a lot of coverage because there isn’t any other centre that has this many companies working together. There are other centres out there with smaller numbers of companies, but we actually have all of the multinationals in Ireland working on shared projects.

Where can readers find more information?

www.ul.ie/sspc

About Dr Mary Shire

Mary Shire BIG IMAGEDr Mary Shire current holds the position of Vice President for Research at the University of Limerick (UL) and is responsible for the leadership, development and delivery of the University’s research policy, strategy and support services.

Prior to this she held the role of Director of Research Support Services at UL. Prior to joining UL in 2005 Dr Shire spent 11 years in the Pharmaceutical Industry where she held management roles in a number of multinational pharmaceutical companies.

While working with leading US-based pharmaceutical company, Celgene Corporation, Dr Shire developed inventions covered by 20 US patents for drug discovery. A number of these compounds are on the market in the US and Europe. Dr Shire holds a PhD in Chemistry and an MBA.

April Cashin-Garbutt

Written by

April Cashin-Garbutt

April graduated with a first-class honours degree in Natural Sciences from Pembroke College, University of Cambridge. During her time as Editor-in-Chief, News-Medical (2012-2017), she kickstarted the content production process and helped to grow the website readership to over 60 million visitors per year. Through interviewing global thought leaders in medicine and life sciences, including Nobel laureates, April developed a passion for neuroscience and now works at the Sainsbury Wellcome Centre for Neural Circuits and Behaviour, located within UCL.

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