Agilex Biolabs, Australia’s largest specialist bioanalytical laboratory for clinical trials, and Endpoints News launched a new webinar “How Easy is it to Move Your Trials to Australia” at BIO Taiwan 2020.
Watch here: https://tinyurl.com/y2ktufhv.
Register here: https://tinyurl.com/y2ktufhv.
The webinar details step-by-step guidance for moving new or delayed trials to Australia, and Agilex Biolabs’ clients discuss how they made the decision and the benefits, and any challenges.
Agilex Biolabs, the only FDA-inspected lab of its type in the region, is located in Adelaide, South Australia in a science and biotech specialist hub.
Australia’s relatively moderate COVID-19 impact due to rapid localised lockdowns for case clusters, combined with the world’s most attractive 43.5% rebate on clinical trials costs, makes it the ideal destination for re-booting clinical trials, according to Agilex Biolabs.
Agilex Biolabs and all the early phase units have been open throughout the global COVID-19 pandemic.
CEO Jason Valentine said the key to success was engaging with Agilex Biolabs early.
“By contacting Agilex Biolabs first, for any new trial or trial transition process from another region, we can facilitate the scoping exercise for sponsors by assessing compatible service providers to ensure a good streamlined fit.
Our 20 years of experience working with all the service providers means we understand the nuances of the Australian trial landscape and can recommend the right partners to accelerate start up and save on costs. Getting the right fit for size and experience is vital for success.
This includes everything from CROs, Phase 1 units, sites, Ethics Committees, Government authorities, setting up an Australian affiliate and legal support. Considerations also include later phase plans and continuity.
Australia is well known as an early phase trials destination and at Agilex Biolabs we have a powerful network of early phase units, sites and other providers with whom we work regularly.
In addition, our R&D team need at least 1-2 months to properly develop the assays, and conduct feasibility studies if required.”
Biotechs are particularly attracted by Agilex Biolabs’ FDA-inspected status, and the 43.5% rebate on clinical trial spend that applies in Australia.
Agilex Biolabs’ world-class bioanalytical facilities have OECD GLP Recognition with NATA (Australian Government OECD GLP Compliance monitoring authority) and ISO 17025 Accreditation for global recognition.
The company has just expanded its labs by more than 30% to accommodate biotech demand from APAC and the USA.
Watch the New Labs Walkthrough Video
Agilex Biolabs specialises in bioanalysis of small molecules and biologics for PK, immunogenicity, biomarkers and immunological pharmacodynamics assessments utilising LC-MS/MS, immunoassay (Mesoscale, Gurolab, Luminex) and flow cytometry (BD FACSymphony A3, 20 colour cell analyser).
Agilex also offers pharmacodynamics services that include immunobiology services using the latest state-of-the-art technology to support immunology, cell biology and mode of action assays, including:
– Receptor occupancy
– Cytokine release assays (whole blood or PBMC stimulation assays) and cytokine/biomarker profiling
– PBMC assays and cellular mechanism of action assays (eg: ADCC)
The biolabs has more than 90 staff including 65 dedicated laboratory staff, and annually support more than 80 clinical trials. This year they will analyse more than 60,000 samples for pharma/biotechs from US, Europe and APAC.
Australia: +61 8 8302 8777 | China: +86 21 8036 9483 | South Korea: +82 80 812 1255 | USA: +1 800 247 1909
About Agilex Biolabs https://www.agilexbiolabs.com/
Agilex Biolabs, Australia’s leading bioanalytical laboratory, has more than 20 years’ experience in performing regulated bioanalysis, including quality method development, method validation and sample analysis services. We have successfully supported hundreds of preclinical and clinical trials around the world where customers choose Australia for the streamlined regulatory process and access to the world’s most attractive R&D rebate of more than 40% on clinical trial work conducted in Australia.
We offer services for both small molecules and biologics for PK, immunogenicity (PD) and biomarker bioanalysis utilising the two platforms of LC-MS/MS and Immunoassay.
Agilex Biolabs operates a fully quality-assured laboratory ensuring that, within the principles of GLP, assays are validated to the latest FDA/EMA guidance and study samples are assayed and reported to the sponsor’s desired format using WATSON LIMS. Laboratory certifications include OECD GLP and ISO/IEC17025.
Our highly experienced team consists of over 65 dedicated laboratory staff with over 15 years average industry experience across senior scientists. Expertise includes development of robust compliant PK and PD assays de novo or by method transfer.
Our laboratory is fitted with 7 SCIEX tandem mass spectrometers, 6 API 4000 and 1 QTRAP 5500 as our standard platform for LC-MS/MS analysis. For immunoassay, we employ the state-of-the-art systems of Meso Scale Discovery (MSD) and Gyrolab xPlore.
Agilex Biolabs owns a suite of validated biosimilar assays that have already supported biosimilar studies executed in the region. These assays include Avastin/Bevacizumab, Lucentis/Ranibizumab, Actemra/Tocilizumab, Xolair/Omalizumab, Herceptin/Trastuzumab and Solaris/Eculizumab. We would like to discuss how we can support companies with biosimilar pipelines looking to conduct trials in the region. Our validated biosimilar assays require less setup saving time and money.
Agilex Biolabs also have a suite of biomarker assays that have been developed to support studies in the areas of endocrinology (estrone, estradiol, progesterone, testosterone and others).
Recently, Agilex Biolabs has added a comprehensive cannabinoid assay to its suite of validated assays to support clinical trials. The fully validated assay includes the five cannabinoids THC, CBD, CBN and the two THC-metabolites OHTHC and COOHTHC.
Our LC-MS/MS experience includes NCEs, sugars, nucleotides, enantiomers, steroids, prodrugs, peptides, immunosuppressants, nanoparticles, neurotransmitters, oligonucleotides and polymeric mixtures.
Our biologics experience entails PK analysis using colorimetric, fluorescence or chemiluminescence detection for recombinant or fusion proteins, monoclonal antibodies, ADCs, immunogenicity testing, biomarker analysis and PBMC blood stimulation assays.