Pre-clinical stage needs work, conference hears

A greater focus was needed on advancing Australia's pre-clinical development capabilities, a biotechnology conference was told today.

The Melbourne conference, Maximising Australia's Pre-clinical Capabilities, brought together leaders in the industry to discuss strategies to improve the research development phase of projects.

Managing director of Kendle Australia, Dr George Mihaly, said Australia's biotech industry typically rested on the oft-voiced opinion that the nation was globally recognised as a centre for excellence for the conduct of research and development.

Mihaly said the "devil was in the detail", pointing out that Australia was very good at the research side in terms of new discoveries and applied research, but not so good at development of that work.

He said Australian biotech fell behind in non-clinical areas such as manufacture and controls, quality assurance systems as well as pre-clinical testing.

"There is a need for greater discipline and systematisation, as well as the defining of processes governed by quality procedures," Mihaly said.

He said that when most Australian biotechnology companies talked about commercialising their products, they usually meant securing licensing deals or alliances at Phase II or earlier, as opposed to taking a project through to market.

"This is because there is no way many of these companies can crystallise the billion dollar process of attaining the commercial benefits and gains," Mihaly said.

"There's a transitional phase Australian industry has to go through before it can conceive of biotech companies taking something right through."

Rationalisation

Also speaking at the conference, Starpharma CEO Dr John Raff said biotech companies needed to consider rationalisation in order to attract private and public investment.

Raff said companies needed to be capitalised at $200 million plus in order to attract the appropriate investment.

And he said governments also had a role to play in supporting pre-clinical development in Australia, with governments in Japan and the United States already providing large subsidies to encourage the industry in those countries.

"There is nothing wrong with subsidies," Raff said. "We have this weird concept in Australia that once you get to the development stage, governments need to step out when in fact that is when they should be stepping in."

Mihaly agreed with the need for government support, saying that if they were not involved it made it difficult for them to devise appropriate industry strategies and policies.

He said also that if Australia failed to recognise and address the vital difference between its ability in research as opposed to its lack of ability in development, the losses would be huge.

"If we're not part of the intrinsic chain of funding, the vacuum will continue to be suffocating," he said.

"The disciplines of development are missing and if we don't understand the gap and our capability to fill these gaps, I don't think we can understand the implications of not having done so."

Also put forward at the conference's morning session was the need for an entirely new paradigm in drug development that looked for support outside the major pharmaceutical companies, and the importance of applying new technologies to save money during trials through pre-clinical lead optimisation.

The conference was to break out into workshop groups this afternoon that would report on possible strategic directions later today.