Cerulea Clinical Trials

Michelle Gallaher – CEO

Michelle Gallaher is an award-winning health technology entrepreneur, speaker, and advocate.She has founded four startups, including Trialkey, which uses AI to improve and predict clinical trialoutcomes, and Opyl Ltd, an AI health tech company listed on the ASX. With a career spanning clinical,executive, and commercial roles in health, biotech, and pharmaceuticals, Michelle is also a championfor the ethical application of AI in healthcare.She is a non-executive director on several boards, co-founder of Women in STEMM Australia, and hasreceived numerous accolades, including being inducted into the Victorian Honour Roll for Women.Michelle holds an undergraduate degree in applied science, a postgraduate qualification in business,and a Global Executive MBA.

Please tell us about Cerulea
Cerulea Clinical Trials delivers ophthalmic clinical trials for Australian and international biopharmaceutical and medtech companies –
and is the home of investigator-initiated studies for the Centre for Eye Research Australia (CERA).
Cerulea is a fully owned, not-for-profit subsidiary of CERA and share its vision of a world free from vision loss and blindness. Our ambition is for Cerulea to be a world-recognised and trusted partner in clinical trials, playing a pivotal role in translating research discoveries expertly and efficiently from bench to bedside.

Tell us about Cerulea’s new state of the art facilities
Our purpose-built ophthalmic trials unit, located in the Royal Victorian Eye and Ear Hospital, was built with the support of a $10million investment from Breakthrough Victoria, an independent organisation that manages an innovation investment fund established by the Victorian Government. Officially opened in May 2024, the unique design of the new unit, our experienced teams, access to participants,
and the latest in diagnostic and treatment equipment provide us with highly specialist capabilities in trialling advanced therapeutics such as gene therapies, medical devices and biopharmaceuticals.
Our unit, offering 25 treatment rooms, PC2 bioprocessing lab and secure medication room, is now the largest dedicated ophthalmic clinical trial facility in the world.

Tell us about the type of local and international Sponsors that you work with
Cerulea currently has 30 trials either being initiated or conducted with 10 new trials so far planned to commence early in 2025.
Approximately 80% of our clients are US-based biopharmaceutical companies or small to medium sized enterprises (SMEs) biotech or medtech companies. In working with many sponsors, we also engage with local and international CRO’s on a daily basis.
Many of our clients choose Cerulea based on its relationship to CERA and depth of our experience. Our principal investigators are key in attracting sponsors and trials to Cerulea and many of our investigators have long-standing collaborative relationships with sponsors.

Please tell us about the partnership that Cerulea has made with Australian biotech company Opthea
Opthea is an ASX and NASDAQ listed company (ASX: OPT), a member of AusBiotech and has just been a wonderful company to partner with. Opthea’s Sozinibercept (OPT-302) is a first-in-class VEGF-C/D ‘trap’ currently in clinical development to treat wet Age-related Macular Degeneration (wet AMD), has the potential to become the first therapy in more than 15 years to improve visual outcomes in patients with this disease and has received fast track designation from U.S. Food and Drug Administration.
Cerulea is proud to have partnered with Opthea on its global Phase II and pivotal Phase 3 trials — the COAST and SHORe studies — both evaluating sozinibercept in combination with standard-of-care VEGF-A inhibitor, the results of which are scheduled to be published in Q2 2025. It’s very satisfying to partner with an Australian biotech, helping them to achieve their goal and providing access to emerging therapies for Australian patients.
The Opthea clinical team are an absolute delight to work with and having such a strong working relationship has ensured the smooth delivery of the trials and many shared learnings between the organisations.

What is Cerulea’s involvement with ACTA
While CERA has been a member of ACTA for many years, Cerulea became a member of ACTA in 2024 and looks forward to collaborating with ACTA more in the future to transform and expand the clinical trial sector, grow skills, build capacity, and ultimately improve the lives of people and alleviate suffering.

What advice would you give to other CTNs and ACTA members who are looking to partner with Australian and international biotech companies?
The global clinical trials landscape is a highly competitive one and we need to be clear in understanding and amplifying our competitive advantage, as well as address the elements in which we are less competitive.
Aim to build a long-term relationship, make communication and engagement with them a priority, recognise and support the value drivers for sponsors, acknowledging and mitigating their pain-points and anxieties, creating an experience for them that means they will recommend Australian CTN’s and select our sites again.
My advice in preparing to sponsor is to build a quality site capabilities deck and be proficient and polished at delivering the pitch, equip investigators to support the pitch as they are often the first contact, get testimonials, ask for feedback.
Clinical trial is a service industry and we can learn a lot from other service sectors (and each other) in building performance feedback systems, continuous improvement, business development and service promises.