The SSPC: strengthening pharmaceutical innovation in Ireland

Pharmaceutical innovation in Ireland

The power of collaboration: SSPC, the Science Foundation Ireland (SFI) Pharmaceutical Research Centre.

Ireland is home to over 24 of the world’s top biotech and pharmaceutical companies. Being one of the biggest industries in Ireland, the Irish pharmaceutical industry directly employs over 28,000 people. Its highly skilled workforce supports Ireland’s position as a leader in innovation. Ireland is also the largest net exporter of pharmaceuticals in the EU, and medicines count for over 60% of all exports from the country, to the value of €65bn in 2015. The sector contributes more than €1bn in corporation tax to the Irish Exchequer annually.

The pharmaceuticals sector has also become very advantageous for the EU. Exports of pharmacy products have more than tripled over the past fifteen years, with most of these gains obtained from extra-EU transactions. A central feature of the pharmaceutical industry is its high intensity in research and development in the EU and presently Ireland ranks amongst the world’s most innovative economies.

The Irish Research Landscape

Established in 2000, Science Foundation Ireland (SFI) is the primary Irish State Agency with a research funding remit. In 2013 SFI established Research Centres with the objective of establishing Ireland as a global leader in scientific and engineering research, discovery and innovation. Key to its remit is supporting research that delivers economic development for international and indigenous companies within Ireland. The SFI Research Centres represent around 50% of SFI’s annual budget and they have created a rising tide of research activity including many new university-industry partnerships.

Currently, Ireland has 16 world-leading SFI Research Centres, all of which are part government and industry funded. SFI Research Centres bring companies from identical sectors together to work in a pre-competitive research environment. All must address working towards competitive European funding, to prepare for the changing nature of their global sector, and competition from other global Research Centres.

The sustainability of these Research Centres relies on the support offered through the Higher Education Institutes where specialist researchers are at hand and become part of the centre through their expertise.

SSPC, the SFI’s Pharmaceutical Research Centre

SSPC is a hub of Irish pharmaceutically-relevant research expertise, comprising of in excess of 40 academic researchers and over 20 industrial partners. The aim of the Centre is to address industry challenges through the execution of excellent science and research, expand our understanding of fundamental concepts associated with pharmaceutical manufacturing, to train the next generation of highly skilled pharmaceutical scientists and engineers, and engage with the public to increase awareness and challenge perceptions of science and engineering in the general and the school-going populations.

The creation of this multifaceted collaboration first came to life as the Solid State Pharmaceutical Cluster in December 2007, funded for five years through Science Foundation Ireland’s Strategic Research Cluster (SRC) programme. The founding director, Professor Kieran Hodnett, contacted ten pharmaceutical companies in Ireland to enquire about whether they were interested in joining forces to create a critical mass of research activity in the sector in Ireland. Nine responses were immediate, and the Cluster was born. Now, SSPC comprises over 20 industry partners, 150 active researchers with an initial investment of €40m in funding for six years from mid-2013 to 2019. SSPC has a substantial effect on the yield of Research and Development (R&D) and economic outputs in Ireland and are the support mechanism that will help build Ireland as a global leader in innovation.

The range of expertise – spanning synthesis, crystallisation and formulation – is truly unique. It enables a symbiotic and interdisciplinary approach to the complex research challenges proposed in order to achieve the objectives of the centre, with a mission to position Ireland as a global hub for process innovation and advanced manufacturing in the pharmaceutical industry.

Research Programme M3 – molecule to material to medicine

The research carried out by the SSPC crosses the entire pharmaceutical production chain from molecule to medicine, with the objective of gaining a better understanding of mechanisms, controlling processes, and predicting outcomes for the efficient and environmentally sustainable production of safe medicines.

Currently, the research programme consists of three research strands, New Frontiers in Pharma Synthesis, Crystal Growth & Design and Drug Product Formulation & Manufacturing. With significant expertise in crystallisation, the focus of the SSPC has expanded upstream into wet chemistry, including synthetic organic chemistry and biocatalysis, and downstream, into advanced formulation of the active pharmaceutical ingredient (API) into a drug product. Fundamental research by the SSPC significantly increased the sector’s capability to produce pharmaceutical solids with predefined characteristics including crystalline or amorphous composition, particle size, habit and morphology, tensile strength, powder flow and release properties.

SSPC leading tangential initiatives

SSPC’s unique collaborations and strong relationships ensures industry partners have access to leading researchers and, in addition, is ensuring that Ireland is becoming a more attractive base for international research leaders. SSPC has a strong governance model in place that operates under the direction and supervision of several advisory bodies to ensure all research activities contribute to the vision and strategic goals set forth in its governing agreements and its underlying ethos. As the spotlight continues to be on economic growth and innovation in Ireland and Europe, the Research Centre is a central commodity to achieving many research goals.

With innovation central to the industry lifespan and success, facilitating knowledge sharing is critical in measuring the modern collaboration and its successes, as knowledge generates innovation. Knowledge sharing is a crucial component and the central basis for expanding innovation within a project. As such, Centre stakeholders benefit from the links and connectivity established throughout many partnerships that enhance the creation of innovative ideas.

A unique and noteworthy achievement of the Centre is the agreement of over 20 pharmaceutical companies to work together in the pre-competitive research environment. This is unprecedented within the pharmaceutical industry globally, an achievement that developed through the collaborative culture developed within the Centre. SSPC is making real impacts for advanced pharmaceutical manufacturing in addition to emerging research areas in biopharmaceutical processing. The influential work of the individual Principal Investigators has given increasing weight to the collective outputs of the Centre, which includes 293 peer-reviewed journal articles in the years 2013-2017.

A key activity for the centre in the past two years has been its championing of (bio) Pharma Europe, with its collaborative partners, BioPharma Chemical Ireland (BPCI), Science Foundation Ireland, Enterprise Ireland, IDA, National Institute for Bioprocessing Research, Training (NIBRT), Pharmaceutical Manufacturing, and Technology Centre (PMTC).

Through collaborative efforts, this group seeks to raise the profile of the Irish (bio)pharmaceutical sector in Europe, to increase opportunities for research collaborations within the EU funding space, and in doing so, to maximise EU Research funding opportunities that represent the needs of the Irish (bio)pharmaceutical stakeholders.
The relationships between industry and Research Centres are an important part of innovation. SSPC prides itself on how our partners come together collectively and share mutual interests and objectives. SSPC continues to meet industry needs, for example in January 2018 in association with the University of Limerick, a specialist diploma in Regulatory Affairs was launched; this is now running for a second semester.

In June 2018, the Centre launched a new Centre initiative called WomenInSSPC (WiSSPC); set up to combat gender inequalities in the research team. The mission is to foster a culture of equality across the Centre, identify existing barriers to female progression, and put measures in place to address these barriers, as there is less female participation at post-doctoral level and issues remain concerning women leaving academia.

In addition, the exemplar Education and Public Engagement programme that the Centre presents promotes STEM subjects to school children and the wider public. The Centre is committed to efforts to increase awareness of research and scientific issues across economic and social groups in Ireland to increase those who pursue STEM careers.

SSPC PhD experience

The training of an industry-ready, highly skilled workforce is one of the hallmarks of SSPC. All PhD candidates can avail of a 3-6 months industry placement in the course of their PhD to allow them to gain experience in the industrial environment and appreciation for what is important in industrial research.

This placement provides students with relevant insight into the pharmaceutical industry by matching individual research expertise to company projects, resulting in a mutually beneficial experience for both the student and company. In fact, the professional links established between SSPC PhD students and various industry partners during the placement period often continue post-placement. SSPC also retains ties to its graduates by tracking their transition from academia to industry as a first and/or second destination.

To extend this opportunity, all students are offered an international secondment for three months to facilitate networking, learning and the broadening of the SSPC community.

Building stronger industry links

SSPC industry members benefit not only from their involvement in Centre research and research outputs, but also from access to world-leading academic expertise across the Centre, participation in focused training events and workshops, involvement in education and outreach activities and by influencing the training and development of the next generation of graduates, and ultimately employees. SSPC targets an 80% transition rate of graduates into industrial careers, a target surpassed in the outputs of the first cluster structure.

SSPC general manager Dr Denise Croker elaborates on industry involvement within the Centre: “SSPC industry partners are the backbone of the Research Centre and provide direction and guidance into the research programme and the Centre student experience. Excellence science and industrial-relevant research are not mutually exclusive; in our experience, the highest research impact is achieved when fundamental science is applied to solve an industrial-relevant real world challenge. We are very proud of the relationships we have built with industry in the last decade and this strongly knit community ensures our success as we move forward into our next phase.”

The future, 2019 – 2025: SSPC-PharM5

SFI Centres are funded specifically for a six-year period to create desired outputs within that time and can receive further funding for another six years based on performance and high-level proposals for the next phase. After a rigorous
six-year review and proposal submission in 2017, SSPC has secured a renewal of funding which will forge new partnerships and research outputs.

Conclusion

The research programme of SSPC-PharM5 will broaden the Centre’s activities so that it will cover the full scope of pharmaceutical R&D with the exception of the discovery of new chemical entities. Highlighted below are some of the key aspects of the new research programme:

  • There are now five research themes: Molecules, Materials, Medicines, Manufacturing and Modelling (hence PharM5). Projects between research themes with multiple investigators are strongly encouraged and well represented
  • Two new co-directors (Walker and Zaworotko, see below) bring complementary expertise in manufacturing and chemistry, respectively, and will jointly provide intellectual leadership to the Centre
  • Platform (multi-industry guided, pre-proprietary) and targeted (single industry directed, perhaps proprietary) research projects will be directed towards solving current challenges that face the pharmaceutical industry as identified by SSPC’s industry partners: reducing time to market; addressing new, more complex active ingredients; improving the efficacy of drug products; advanced manufacturing methods
  • Over 50% of the funded investigators (32/56) are new to SSPC. These new investigators will enable research in advanced screening, predictive modelling and drug hybrid conjugates. Predictive modelling lies at the heart of the research programme as it is seen as being key to address the challenges listed above
  • There will be greater emphasis upon IP development, technology transfer, new global partnerships and 100% industry funded proprietary projects. Ireland’s culture of teamwork and its flexible policies on IP development make fertile ground for proprietary projects
  • That fact that the research programme will be aligned to industry needs will enable a more predictive design-led approach in developing drug substances, drug products and the processes to manufacture them. There will be a disruptive change in how we manufacture drug substance (DS) and drug products (DP) and end-to-end levels, ultimately leading to an Industry 4.0 approach. This requires SSPC expertise in continuous manufacturing, flow chemistry, end-to-end flow from API to DP.

Manufacturing (DS, DP and coupled DS-DP) in the future will be ‘skid mounted’ and transferable. This requires SSPC-PharM5 research to be truly multi-disciplinary leading to innovation in chemistry, process engineering, data analytics and mathematical modelling. Industry requires manufacturing systems that have full feedback control and which are self-correcting. This requires SSPC-PharM5 to advance process modelling, PAT, and statistical modelling for model predictive control of pharmaceutical manufacturing. Industry will move to increased localisation, the requirement to perform manufacturing in countries to achieve approval and drive different manufacturing models to achieve efficiency in small volume manufacture in developing countries.

This requires SSPC-PharM5 to focus on continuous manufacturing, modular equipment and process control systems.Under the new Directorship of Professor Michael Zaworotko and Professor Gavin Walker and building on its reputation as an exemplar of academia-industry collaboration, this new iteration (2019-2025) will see the centre grow further and expand the research programme. The growth will see a broader pool of expertise exist in the centre, with much more focus on increased globalisation in the EU, USA and China.
Moving forwards, the centre will offer not only an improved flexibility in the research programme but also expanded membership options and a new business plan. A major part of this business plan is ‘going global’ by working with partners elsewhere in Europe and around the world.

In advance of the launch of SSPC-PharM5 in June 2019, SSPC has already met with prospective new company partners from Switzerland, United Kingdom, Czech Republic, China, Korea and the USA. Collaborations with international academic researchers will also be developed.

SSPC places an importance on building relationships to generate links between academia and industry recognising priority research areas and outcomes. An understanding exists that such partnerships will improve creativity, skills and forges new ideas. Now as the Centre readies itself up to move into a new era and in the words of Centre Co-Director, Professor. Michael Zaworotko, “SSPC is open for business and going global – SSPC’s scope and scale will bring to fruition its mission to become the leading centre of excellence for shaping the future of the global pharmaceutical industry”.

To find out more visit www.sspc.ie.

Louise O’Neill
Synthesis & Solid State Pharmaceutical Centre (SSPC)
Hosted at University of Limerick
+353 61 234675
Louise.oneill@sspc.ie
Tweet@ @SSPCentre
https://www.sspc.ie/

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