Transforming the scientific inspiration for a treatment into a recognised therapy can take many years and Phase 1 clinical trial providers have a ‘make or break’ role to play in the process.
Established by the Baker IDI Heart and Diabetes Institute in 2003 and recently acquired by Blackstone (NYSE:BX), Nucleus Network has carried out more than 1000 trials on behalf of bio-technology firms, pharmaceutical companies and start-up ventures.
It’s Australia’s largest trial provider, with a workforce of 600 and clinics approved by the European Medicines Agency and the US Food and Drug Administration, in Melbourne, Minnesota and Brisbane.
The latter facility is playing a small but vital role in the race to counter the Covid virus. In mid-2020, it became Australia’s first Phase 1 trial site for the Novavax Covid-19 vaccine and it’s now involved in ongoing Phase 2 and Phase 3 trials.
Such assignments are all in a day’s work for Nucleus Network, according to Chief Operating Officer Charlotte Hall. Around half the organisation’s trials to date have been first-in-human.
Some have led to the development of treatments for conditions such as psoriasis, dermatitis, migraine and multiple sclerosis; others have failed to move forward, for a variety of reasons.
“Whether it’s Panadol, an antibiotic or a treatment for cancer, someone, somewhere in the world, has to be the first person to take a drug,” Hall explains. “Every bit of research contributes to a bigger picture.
“Our role is to manage that initial trial process and our highly trained principal investigators have enormous expertise in designing protocols and quality frameworks that ensure patient safety.”
Their reputation proceeds them: the majority of Nucleus Network’s projects come via referrals and word of mouth.
“The speed and quality of Australian outputs make us attractive to international players,” Hall says.
Late 2021 saw Nucleus Network establish a satellite clinic in regional Victoria and a similar facility is planned for south east Queensland in early 2022. Once open, it will enable more Queenslanders to do their bit for science.
Many are keen for the opportunity: around 10,000 volunteers register their details with Nucleus Network every month.
“In the past, people were cautious about clinical trials but Covid has put them front and centre,” Hall says. “Australians have become much more aware of the need to advance medicines.
“Having an outpatient clinic on the Gold or Sunshine Coast will mean trial participants from that area will be able to have their screening and follow-up visits locally and need only travel to our Brisbane site for their confinement.”
Nucleus Network is a member of Life Sciences Queensland, the peak body that provides pathways for stakeholders to collaborate, build their businesses and develop an internationally competitive life sciences industry in Australia.
LSQ Chief Executive Clare Blain says Nucleus Network has made a stellar contribution to Queensland’s bio-medical sector and generated a wealth of career opportunities for local bio-scientists and clinicians.
“Their close collaboration with the Royal Women’s Hospital, the Queensland Medical Research Institute and Q-Gen Cell Therapeutics, has helped to create a deep pool of expertise in this state,” Blain says.