Time To Ask: Why Not?

Ireland's life sciences sector must embrace change and understand how innovation can be used to extend product life, benefiting both patients and profits, says Dr Ivan Coulter

AT HIS INAUGURATION in 1961, in a rallying cry to those he was to represent, US president John F Kennedy asked the American people to “ask not what your country can do for you, but what you can do for your country”.

Kennedy’s call to patriotism came three years after the First Programme for Economic Expansion was published in Ireland. Its author, TK Whitaker, believed increased competition and the end of protectionism would require a radical overhaul of the Irish economy, with a shift from an agrarian society to an economy driven by industry and services.

Through implementation of Whitaker’s vision, the Lemass and subsequent governments created an economic framework that permitted the inflow of unprecedented foreign investment into the Irish economy.

The life sciences sector grew within that framework and, with the possible exception of the ICT (information and communications technologies) sector, it has benefited the Irish exchequer more than any other in recent decades: according to a Forfás report, the life sciences sector employs over 50,000 people in more than 350 enterprises and collectively turned over €44 billion in 2008, accounting for 30 per cent of all exports.

So the global life sciences sector has done much for this country – what can we do to keep it anchored here?

The answer is simple: collaborate to build up an innovative, homegrown RD base that fulfils its needs while expanding our national portfolio and, crucially, keeping jobs. A sizeable majority of the current turnover in the life sciences sector in Ireland is based on the activities of large multinationals, all of which focus primarily on manufacturing the core active drug or finished drug product.

But Ireland is now a high-cost economy, so stakeholders must work together to develop this country as a research and development (RD) powerhouse for the global life sciences industry. The indigenous SME sector has much to contribute to the development of such a powerhouse, particularly in the area of innovation, where niches are there to be filled.

Multinational innovation tends to be less “R” than “D”, focusing more on processing efficiency and less on truly new product development. Research innovation involves risk and the culture in many multinational companies is becoming increasingly risk averse. Of the $44 billion the sector contributed to the Irish economy in 2008, little was derived from research activities – such as drug discovery or early-stage product development – performed in Ireland.

Creativity can often fly less fettered in academic labs than in multinational companies but research does not end at the gates of the universities and start again at the door of big pharmaceutical companies. With significant exchequer investment in basic research, winning ideas will be generated. To capture the true value of this investment, a conduit from basic to applied research must exist.

SMEs with the right focus can make the most of that gap and an international review of drugs on the market and in development suggests the primary source of drug discovery and development is innovation-focused SMEs.

SMEs also have the agility to turn the two current major threats to global pharma into growing opportunities: one is patent expiration, the other is the lack of compounds in the drug development pipeline. Addressing these crises for the $1-trillion pharmaceutical industry can be considered an exercise in product life-cycle management. Solutions must focus on how to expedite drug discovery and development to overcome the pipeline dearth, while also improving existing products so that patent death may be delayed.

The looming patent expiration “cliff” will see big-name products with current annual sales of $100 billion lose protection over coming years. To satisfy investor expectation of 5 to 10 per cent annual growth, big pharma companies are increasingly turning to innovative SMEs to fill the narrowing product development pipelines. Focusing such innovation at both ends of the product life cycle (drug discovery and product improvement) can pay dividends in the current environment.

Irish-born economist Charles Handy, musing in The Empty Raincoat, used the sigmoidal curve to exemplify product life cycles and suggested the secret of constant growth is to start a new sigmoid curve before the first peters out. Handy's teaching applies in the pharmaceutical sector to both drug discovery and product improvement, where innovation in both can extend product life, leading to benefits for both patients and bottom-line profit.

That style of thinking has been at the core of my company, Sigmoid Pharma. Over the last seven years we have been developing innovative ways to deliver drugs in the body – an approach that harnesses academic research and validation, converges technologies and translates them in clinical trial. Our LEDDS and SmPill formulations are now re-invigorating pharmaceutical drugs that were previously under-utilised, or applying them to new disease states, all the while ensuring they are safe, clinically useful and patient-friendly.

Success leads to success. Sigmoid has set up productive collaborations with researchers working on gut inflammatory disease and oral vaccine delivery, and has been approached by academics and clinicians who want research concepts developed into clinical products in areas ranging from diarrhoea and C difficile to hypertension and neurodegenerative diseases.

Based on our ability to innovate alone or through academic, clinical and industrial collaborations, Sigmoid has the capacity to not only act as a conduit between academic collaborators and industrial partners, but also to support big pharma life-cycle management.

The Sigmoid example is not unique in Ireland but it represents the potential of the indigenous life-science SME sector, a sector that includes drug delivery, specialty pharma, innovative generics, biomarkers, drug discovery, medical devices, analytical development – all of which, with the right model and approach, have the potential capacity to collaborate with academics and clinicians as well as partner multinationals.

The opportunities for Ireland to become a pharmaceutical research and development powerhouse exist but will require that all stakeholders buy into the opportunity in a spirit of collaboration, including competitive collaboration. No stakeholder can look inwards only – everyone must be prepared for, adopt and adapt to change. If change is not embraced, initiatives will come to a standstill – and in this business to stand still is to fall behind.

It is important not to bask in past successes but to embrace change and understand how innovation can be used to create and exploit future opportunities. To paraphrase George Bernard Shaw, it is important that we are trained not to see things and ask why, but to dream of future innovative opportunities and ask: why not?

Dr Ivan Coulter is chief executive of Sigmoid Pharma, the overall winner of The Irish Times Innovation of the year award. It also took the prize for Application of RD.