OPSONA IS a drug development company that focuses on regulation of the human immune system. It was established in 2004 by Dr Mark Heffernan and three Trinity College professors as a spin-out biotechnology company from Trinity College Dublin.

The company is identifying and developing new drugs to treat and prevent autoimmune / inflammatory diseases as well as immunotherapeutics for cancer and adjuvant formulations for infectious disease vaccines.

Heffernan explains that the business model is to identify and license highly novel pharmaceutical products at an early stage in their life cycle, and validate these through pre-clinical and clinical testing before partnering with major pharmaceutical and biotechnology companies.

The company is backed by leading global venture capitalists, including Inventages (Switzerland), Seroba (Ireland), Enterprise Ireland and the world's largest biotechnology company Genentech (US).

He believes that validation of their technology and capabilities was the signature of their major licensing and collaborative agreement with US multinational pharmaceutical company Wyeth, in addition to attracting Genentech as an investor. These events, he says, have affirmed their position as a leader in their technology area, while also being a first for Ireland.

The company's headquarters and laboratories are located at St James's Hospital in Dublin. The company directly employs 17 staff, and indirectly five staff within Irish and European universities through funded grant mechanisms.

Since 2005, the company has spent in excess of €6 million in direct research and development costs within Ireland.

Product/Service:

The company is engaged in the discovery and development of highly novel and innovative therapeutic products for the treatment of human inflammatory diseases (such as rheumatoid arthritis, lupus, diabetes and acute coronary and renal diseases), oncology and infectious diseases.

Its most advanced products are being prepared for human clinical trials to begin in 2009.

Customers:

The customers of their products will ultimately be major pharmaceutical and biotechnology companies at a point where significant value has been generated.

Opsona has a number of significant collaborative and licensing agreements with major US and European multinational companies, including Wyeth Pharmaceuticals in the US and Swiss group Nestlé.

Is there any interesting or unusual circumstance surrounding the inception of the company or its evolution?

The concept of an Aussie "walking in off the street" to Trinity College and offering services to help take a bundle of promising intellectual property/compounds and mould this into a company from scratch.

Few companies have spawned in Ireland in the biotechnology sector, primarily due to the lack of entrepreneurs with the appropriate background to catalyse the process.

What is the best piece of business advice you ever got?

Don't rely on anything happening when you think it will.

There are always a number of moving parts to any transaction, most of which are totally out of your control. Identify the risks early and plan. Also to invest and train your team - they are the intellectual capital of any biotechnology company.

What's the biggest challenge you see your industry facing?

A necessary challenge is regulation. Whilst regulation often means more red tape, it is necessary providing that it aids in the approval of safer medicines and reduces the risk of severe side-effects or toxicity. The other major challenge is the explosion of scientific information made available and keeping on top of the latest developments from around the world.