On this episode of Molecular Moments, Dr. Jim McNally chats with DMPK Senior Director Dr. David Johnson, Ph.D., from BioAgilytix
The advanced laboratory facilities in Melbourne serve as our Australian headquarters, where we specialise in and are passionate about using cutting-edge thinking and technology to support the development of novel therapeutics, vaccines and diagnostics
We are Australia’s most comprehensive specialty laboratory for therapeutic, vaccine and diagnostics development. We develop and conduct pharmacokinetic (PK) and pharmacodynamic (PD) assays across a wide variety of therapeutic areas providing a one stop shop for all of your clinical trial requirements.
Australia is the jurisdiction of choice for conducting early phase clinical trials with three major advantages: Speed, Cost and Quality.
Speed: With the country’s fast and pragmatic regulatory environment for Phase 1 clinical studies, there is an average 4-6 weeks for review and approval for healthy volunteer studies due to IND not being required to conduct clinical trials in Australia.
Cost: The Australian government offers attractive R&D tax incentives including cash rebates to eligible companies. According to a cost comparison study, Australia is ~30% cheaper than the US before tax incentives; and 60% cheaper after tax incentives for conducting your clinical trials.
Quality: Australia is an OECD member resulting in mutual acceptance of data by global regulatory bodies. Data from studies conducted in Australia can be used to support international regulatory applications, including the US FDA and European Medicines Evaluation Agency (EMEA).
The advantages of Australia as an early phase location for clinical trials provides multiple options for our customers. Whether it’s starting your Phase 1 trial in Australia and transitioning to our global BioAgilytix team for Phase 2+ or choosing to conduct your clinical studies in the USA or Europe, BioAgilytix can provide a solution for all of your clinical requirements.
BioAgilytix has two locations in Australia to best serve the needs of our partners and customers.
Our Melbourne location is at the leading Burnet Institute, situated in one of Australia’s key biomedical and clinical research hubs and is co-located with Australia’s largest Phase 1 unit, which makes us well-positioned to support your clinical requirements. Our Melbourne location operates both BSL 2 and 3 laboratories.
Our Brisbane location is at the Translational Research Institute (TRI) within the Princess Alexandra Hospital. With its focus on effective translation of innovative medical research, the close physical and intellectual collaboration between academia, industry and clinicians facilitates BioAgilytix’s mission of enabling the breakthroughs of tomorrow today.
Our industry-experienced chemistry and biology teams enjoy the challenges of developing, validating and conducting sensitive quantitative determinations, metabolite identification and other complex analytical requests. Our immunology experts offer comprehensive analytical support for complex biologics, extensive immune monitoring capabilities, and the flexibility and knowledge to develop assays for new technologies. Our classically trained virology team, have a wealth of industry experience, have worked with most virus families known to science and add to the breadth and depth of BioAgilytix’s capabilities. We have the capacity to support bioanalysis for new and established small molecules, peptides, proteins and large molecules by offering services such as:
BioAgilytix has a team of exceptional biologists and chemists with global pharma and biotech industry experience and a proven track record of advancing therapeutic drugs, biomolecules and vaccines through clinical development.
We have the technical knowledge and experience to deliver accurate, reproducible and robust assay data which will progress your therapeutic through regulatory review. We are dedicated to providing a quality service that efficiently delivers results, and are proud of our reputation as a highly-skilled team with an agile and responsive approach to study management and communication.
Global BioAgilytix operates as One Team with One Mission, enabling the breakthroughs of tomorrow today.
BioAgilytix’s Brisbane laboratory is located in the Translational Research Institute (TRI). Co-located with the TRI Clinical Research Facility (CRF) at the Princess Alexandra Hospital (PAH) the facility provides state-of-the-art specialist facilities, resources and expertise for investigator led and commercially sponsored clinical trials. TRI is focused ‘bench to bedside’ on the effective translation of research and innovation into improved healthcare, consistent with our mission of enabling future medicines.
BioAgilytix’s Melbourne laboratory is located within the world-renowned Burnet Institute at the Alfred Hospital biomedical and clinical research precinct, also home to Australia’s largest Phase 1 unit. The Melbourne laboratory facilities are perfectly situated to benefit from the unique advantages of conducting studies in Australia.