Cellestis, stepping up to the plate

From BioTech news,

http://www.biotechnologynews.net/StoryView.asp?StoryID=1539010


OPINION: How we’ve tackled TB

Amanda Ellis
Thursday, 30 September 2010

AUSTRALIAN biotechnology companies navigating commercial success need to remember that no matter how good the technology is, it won’t sell itself, Cellestis managing director Tony Radford has learned.

Dr Tony Radford

When Cellestis first launched its product QuantiFERON-TB Gold, a blood test which can detect tuberculosis (TB) infection, one could be forgiven for believing we had a product that could sell itself.

Our test was proven scientifically to be more accurate than the 100-year-old tuberculin skin test (TST) it was replacing and we could demonstrate that the new test offered economic advantages.

As the test was far more specific and sensitive than TST, it eliminated the huge amounts of time and treatment previously wasted on people who had been falsely diagnosed with TB bacteria, as a result of the old tests.

But although we knew our technology was good, we weren’t naive enough to believe the fax in our Melbourne office would instantly run hot with customers from around the world as soon as QuantiFERON was launched.

We knew from the beginning that the sales process wasn’t as simple as presenting a new test for TB to the customer and getting them to sign on the dotted line.

To gain the most significant market possible we had to be present where the customers and opinion leaders were located.

Therefore, we took the logical step of establishing a sales and distribution network to service our major markets which are the US, Europe, Japan and other parts of Asia.

We found there were several barriers to overcome.

For example, although TB is a highly infectious disease that claims one life every 17 seconds worldwide, the move to modernise TB control has been very slow.

The process is highly regulated and largely controlled by the need for changes to policy guidelines as well as the standard regulatory approvals.

Just this year, the United States Centre for Disease Control (CDC) released its new guidelines recommending the use of IGRAs, simple blood tests known as interferon-gamma release assays (such as QuantiFERON) as the preferred method to test for TB in many circumstances.

The US now joins Japan, Germany, South Korea, the UK, Switzerland and many other countries recognising the benefits of Interferon testing and QFT.

However, obtaining these guidelines was a slow process, with the most recent CDC decisions taking nearly two years to publish.

Rather ironically, Australia has little to no guideline on interferon testing for TB infection, and the federal government facilitates and subsidises the import and use of the TST reagents from overseas to compete with this Australian invention and company.

While TB infection rates are still very high on a global scale, TB tends to be one of those diseases that can be out of sight, out of mind, creating another marketing barrier.

If there is not an immediate threat, there is little need perceived for an organisation to change its testing method.

Becoming cause-related marketers

You simply cannot be involved in TB medicine without realising the burning need to make a difference to what is being done worldwide.

At Cellestis we needed to overcome long-ingrained user habits and navigate through complex public health organisations to get an audience for QuantiFERON.

But we also needed to wage a campaign at a higher level, and help to convince stakeholders from the government down that there is a need to modernise TB control and test for latent infection.

To overcome these challenges Cellestis needed to focus not only on sales but also needed to get behind TB control.

TB is a highly infectious disease and remains a threat to public health.

Although the public perception in developed nations is that TB infection is under control, in fact actual numbers are rising in some countries, and of course in developing nations infection remains endemic and rates of disease high.

Our mission was to raise awareness of the benefit of testing and treating latent TB in developed markets.

Thus we made a commitment to campaign globally with a goal to make latent TB infection diagnosis and treatment the paradigm in all countries – not just the wealthy countries who are trying to keep TB infection rates down, but also in poorer countries where rates of TB infection are high and active TB is a problem.

While this may appear self-serving, given we sell a diagnostic for latent TB, and heretical to some who believe the priority is active TB first, latent TB later, it makes solid health and economic sense.

Current, world TB-control strategies have had only limited success, and it’s clear that killing latent infection before it becomes a serious disease stops further spread – and very economically if a test with high predictive capacity for future TB such as QFT is used.

The outcome of treating latent infection, while good for Cellestis in the process, will also be good for the world and the many millions of people this strategy can save from disease and death.

To support this strategy we have launched campaigns targeting public health organisations, physicians, healthcare workers and administrators, and we have made this goal – treatment of latent infection – our company’s focus.

Given our focus on TB, and our worldwide presence, Cellestis is in a good position to aggregate and disseminate the huge amount of information from scientific journals and conferences and various public health authorities.

As part of this strategy we launched a website TackleTB.com as the centrepiece of our campaign, designed to give clear and simple facts about TB infection and remind our audience why change is needed.

We used triggers such as the release of new CDC guidelines and the publication of a detailed analysis of TB testing in the highly regarded scientific publication CHEST to engage with media, and used an array of channels including video, digital tools and fact sheets to take the message to our audiences.

Has the investment paid off?

The investment in marketing for Cellestis has paid off and will continue to be a vital component of our business.

This year we again achieved strong year-on-year sales growth, with revenues up by 17% in financial year 2010 and expected to continue to grow.

Achieving this growth has required Cellestis to transform from being a research and development company, to a company that has a global sales capability and places great emphasis on marketing.

This has required us to invest in new people and skills, and bring our staff, partners and investors with us on the journey.

For an Australian biotechnology company to tackle a global market and issue of such great proportion, is a solid achievement, particularly when at the time (and arguably still) this was an unusual model for an Australian biotechnology company – given many companies opt to license their technology to a global partner to take it to market.

Shifting the mindset

The need to make these investments and evolve the business is an important lesson to learn as the Australian biotechnology sector matures.

Only a handful of Australian biotechnology companies have so far successfully made the transition from development to manufacturing and independent sales distribution.

Although investing in marketing and acquiring these skills might sound obvious, it requires a significant shift in mindset for a company to transition from focusing on technology development to become a successful sales and marketing company.

Few precedents have been set in the local biotech industry, and it’s my belief there will need to be a period of re-education or realigning investors in the industry to understand that it’s possible to directly chase commercial rather than development success from an Australian base.

We Australians have one inherent advantage in globalisation – we all know our domestic market is insignificant, so we have to look outward and operate globally from day one.

About Tony Radford

Cellestis managing director and chief executive Tony Radford has had a 28-year career in biotechnology, initially as a successful research scientist and as a senior member of the CSIRO team that invented QuantiFERON.

He has held executive roles in the management of commercial research and development in the medical field for the past 15 years and is a founding director of Cellestis.

Radford was head of drug development at AMRAD and has a PhD and undergraduate science degree in microbiology and molecular biology from La Trobe University. B