Clinical trials innovator Michelle Gallaher is returning to her eye health roots as the founding CEO of CERA’s new clinical trial centre.

Gallaher, a former orthoptist, digital health entrepreneur and advocate for women in STEM, was appointed as CEO of Cerulea Clinical Trials in late 2023.

She will lead the transformation of CERA’s flourishing clinical research activities – which in 2023 included more than 80 clinical research projects involving over 3800 participants – into a global hub for innovation in ophthalmic clinical trials.

Cerulea Clinical Trials, a fully owned, not-for-profit subsidiary of CERA, is supported by a $10 million investment from Breakthrough Victoria, the Victorian Government’s innovation investment fund.

The new centre will be based on Level 7 of the Royal Victorian Eye and Ear Hospital in East Melbourne.

It will increase community access to sight-saving clinical trials for conditions such as age-related macular degeneration, glaucoma, diabetic eye disease, inherited retinal disease and other rare genetic eye conditions.

Cerulea aims to bring more international clinical trials to Victoria for the benefit of local patients.

It also has a remit to provide Australian scientists with opportunities to trial their discoveries locally rather than taking them off-shore, and to forge global partnerships that will establish it as a world-leading centre for medical research and fighting blindness.

There will also be a strong focus on increasing access to trials for rural and regional people living with eye disease through an expansion of telehealth services and new digital recruitment systems.

As a not-for-profit centre, income from Cerulea will be funneled back into vision research – to improve the clinical trial experience of participants, research infrastructure and to support CERA’s lab-based, discovery research.

Exciting opportunity

Gallaher says she is honored by “the exciting opportunity to build a centre that is recognised as world-leading and delivers excellence in ophthalmic clinical trials”.

“Cerulea will continue to deliver clinical trials for research undertaken at CERA,
as well as deliver ophthalmic trials for local and international biopharmaceutical and medtech companies,’’ she says.

“We have a very experienced team with clinical trial management and implementation capabilities in advanced technologies like gene and cell therapies, biologics, and surgical medical devices.

“I’m excited to be able to amplify CERA’s research impact and create a dedicated new clinical trials facility that will attract more major international ophthalmology trials to Melbourne, giving patients and clinicians access to the latest therapies as they emerge.”

CERA Managing Director and Cerulea Chair Professor Keith Martin says Gallaher brings a wealth of experience in life sciences innovation to her new role.

“Michelle Gallaher’s deep understanding of clinical trials, her leadership in the use of AI and digital technology to support trial recruitment and design, and her experience as a health tech entrepreneur will be enormous assets,’’ he says.

“Her unique mix of skills and experience are a great alignment with the culture of innovation and translating research into real outcomes for patients that we have at CERA – and our vision for Cerulea Clinical Trials.’’

Professor Martin says the continued support of CERA donors had been instrumental in CERA’s vision for a new clinical trial centre.

“Without donor support of both our discovery and clinical research programs, CERA would not have been able to attract the important investment in a new clinical trial centre.’’

Full circle

The new role at Cerulea sees Gallaher return full circle to her first day as an orthoptist 35 years ago.

Since then, her career has taken many turns, from leadership roles in the pharmaceutical industry and not-for-profits such as the Australian Stem Cell Centre and BioMelbourne Network, to board roles at Cancer Trials Australia and PRAXIS Australia, to founding four start-up companies.

Throughout her career, Gallaher has been known for her advocacy for women in STEM, and in 2017 she was Telstra Victorian Businesswoman of the Year.

“I always said that one day I was going to find an opportunity to return to ophthalmology and vision science and now that time has arrived,’’ she says.

“I am very proud of my clinical roots.

“Together, we now have an opportunity to build an ophthalmic trials centre that is world-class, provides a great experience for users, and plays a pivotal role in trialling discoveries that will hopefully become therapies on world markets.

“I want all of Cerulea’s trial participants to have the best experience possible so that they will recommend participating in a clinical trial to everyone they know.’’

This story was originally published in People in focus: Annual Review 2023.