AusBiotech to wave the flag for pre-clinical industry

Industry organisation AusBiotech is to set up a working group to deliver the recommendations of a pre-clinical development meeting held in Melbourne this week.

Maximising Australia's Pre-clinical Capabilities generated a range of views on the nation's existing and potential skills in the area.

But most delegates agreed that it was vital to at least recognise the gap between Australia's research skills and its development capabilities, and understand the implications of that gap.

Summing up the meeting, Dr Tom Spurling of CSIRO Molecular Science pointed to the divergence of views among delegates as to Australia's capacity to build a pre-clinical industry.

"One view is that we should probably continue to do what we're good at, that is discovery, and source pre-clinical from overseas," Spurling said. "Another view is that we need to develop a fully integrated, research-based industry."

The divergence formed an interesting contrast to the stated visions of government.

Opening the meeting, Innovation Minister John Brumby said the State government was keen to see Australia's share of pre-clinical investment increase 10-fold over the next five years. He said Australia was already in a good position because the cost of doing such work here was estimated to be 50 to 60 per cent that of the United States.

Brumby said an objective of the forum, which was partly sponsored by the Victorian government, was to look at new ways of collaboration to increase local participation in the drug development value chain. "We will be listening very closely to the outcomes of this meeting and doing our part to put initiatives in place," he said.

In addition, the recently released Federal government Pharmaceuticals Industry Action Agenda proposes to double Australia's share of the global pharmaceuticals industry by 2012.

Action Agenda chairman Dr Graeme Blackman said the first step would be to conduct a study that would assess the opportunity, costs, benefits, incentives needed and skills requirements in the areas of pre-clinical infrastructure.

The Action Agenda discussion paper was intended to go before Federal Cabinet within the next few months, with rollout of the program scheduled for the coming year.

In the meeting's afternoon session, delegates formed groups to thrash out the issues surrounding these bold visions, and suggest possible action priorities. Some of these included:

• Developing a local register of pre-clinical expertise.
• Harmonising regulatory requirements across nations.
• Setting up an association of pharmaceutical quality controllers.
• Encouraging industry-based training programs.
• Fostering cultural changes over the importance of an integrated development industry.
• Conducting a review of Australia's capacity for scale-up and toxicology tests.
• Quantifying the benefits of having scale-up and manufacturing facilities.
• Facilitating access to standard animal models.
• Reviewing tax incentives to entice skilled people to Australia.
• Understanding Australia's capacity to support a pharmaceutical development industry.
• Facilitating a regulatory "flying circus" to help those in the industry better understand requirements.

The meeting asked that industry body AusBiotech continue the momentum by convening a working group to make submissions to the Victorian government and the Federal government Action Agenda Implementation Committee.

AusBiotech executive director Dr Tony Coulepis said he accepted the challenge, which was to be put to a board meeting today.