From today's
Sydney Morning Herald:
The boss of cancer-fighting outfit Imugene says now is the time for Australia to double down on investment in clinical trials infrastructure to become a magnet for global pharmaceuticals firms.
“If we can prove that you can develop medication here, success breeds on success,” said Leslie Chong. “If you build it, they will come.”
Imugene’s shares have been on a tear the past 12 months, gaining 1033 per cent to 34c as the company has updated the market on its key research projects. The biotech has no product on the market yet, but its sharemarket value has swollen beyond $2 billion over the past few months.
Investors have been taking notice of the company after it posted a number of key clinical updates on its immunotherapy products, including phase 1 trial data for its HER-Vaxx cancer vaccine, designed to treat cancers that over-express a protein called HER-2, like gastric and breast cancers.
“The problem we are simply trying to solve is cancer — not easy to solve, but we’re very focused on righting the wrong of your immune system, ultimately,” Ms Chong said.
There is a long research road ahead, however. Ms Chong, who was previously the clinical program lead at US biotech Genentech, says the quality of the data is the most important thing for the company’s long-term value.
“If you don’t follow the science and you don’t deliver on the science, value may never come,” she said.
As the coronavirus pandemic prompts state and federal governments to make promises about
onshore medtech manufacturing, Ms Chong says there is value in streamlining the nation’s clinical trial system and creating a plan to boost the number of research-specific hospitals and research centres.
Australia is only just starting to develop an approach similar to the US, where trial hubs are often focused on particular areas such as oncology and provide easy and straightforward ways to start research, and “it would be great to have something like that,” she said.
A focus on streamlining trials would also help boost local research while stopping inventions moving offshore, she said.
Over the past six months, some of the world’s largest pharma firms have clocked the opportunity that clinical trials research presents in Australia and have been pushing the government to make it easier for trials to start here.
Companies including coronavirus vaccine makers Pfizer and AstraZeneca have told a Senate committee reviewing the approval processes for new drugs in Australia that the country should reduce clinical trial red tape.
Pfizer Australia’s Anne Harris told a House of Representatives committee earlier this year that Australia was ”at an inflection point” when it came to approving and researching new drugs.
The pharma giant told the government that if Australia was to continue to remain competitive as a clinical trials destination, it was critical the country “reduce red tape around how clinical trials are structured and administered”.
This included a push for “clinical trials harmonisation”, where each state and territory has a set of requirements for setting up research instead of the current system, which involves several different frameworks.
COVID-19 vaccine maker AstraZeneca has also been backing the research push in Australia, calling for a national health register to connect patients who volunteer with trials across the country.
“A national register would allow a seamless connection between doctors/researchers and patients who may benefit from clinical trials.
"Currently many patients are not aware of available clinical trials for their condition, unless they are being conducted at their treating hospital/clinic,” an AstraZeneca spokeswoman said.
