Demystify the bioanalytical requirements for clinical studies
Clinical trials are multifaceted activities comprising Clinical Research Organisations, Phase 1 Units/Hospitals/outpatient settings, Patients, Clinical Laboratories and Specialist laboratories all working in tandem to move new drug entities through the drug development and approvals process.
Agilex Biolabs is the largest regulated bioanalytical laboratory in Australia with over 24 years’ experience in early phase clinical trials with a track record of enabling the movement of new drug entities to market. Agilex Biolabs specialises in pharmacokinetics, pharmacodynamics, and biomarker evaluation, which is key to understanding the drug absorption, distribution, metabolism, and excretion as well as target engagement and efficacy of the drug during clinical development.
Choosing the right bioanalytical platform for your immunology or vaccines clinical trial is critical to data collection. But navigating the intricate bioanalytical process and selection of assay platforms can be difficult. What do these platforms look like in use, and how should you go about selecting the right one?
This webinar will demystify the bioanalytical requirements for clinical studies and will discuss the most common bioanalytical platforms used during clinical trials to measure vaccine responses and levels of inflammatory mediators in biological fluids.
Presented by
Dr Kurt Sales,
Director, Immunoassay
Dr Kurt Sales has over 20 years of experience in a career spanning research and development, research management, and business development in the UK and South Africa. At Agilex Biolabs, Kurt is responsible for management and oversight of the Agilex Biolabs Immunoassay division.
Kurt has extensive expertise in pre-clinical and clinical assay development, cellular and molecular biology, molecular signaling, flow cytometry, cell-based models, and biomarkers, notably in the areas of inflammation and immunology. He also has extensive experience ensuring strict GLP compliance for bioanalytical assays and preclinical safety testing through PK/PD/Biomarker assays.
Widely published with 45 peer-reviewed scientific papers in high impact journals, a book chapter and presentations at over 30 conferences, Kurt also received the prestigious Society for Reproduction and Fertility New Investigator Award.
Kurt has a Ph.D. in Medical Biochemistry, a Masters in Biochemistry, and a Bachelors of Science in Medicine with Honours in Pharmacology, and a Bachelor of Science in Biochemistry and Physiology. He has a Diploma in Business Organisation and Management and a Post Graduate Certificate in Management.