The Australian Early Phase Biosimilars Clinical Trial Landscape - How Agilex Biolabs and Nucleus Network Work Together

In this webinar you will hear from Agilex Biolabs and Phase 1 contract research organisation Nucleus Network about how they work together to deliver clinical research outcomes in biosimilars.

Agilex Biolabs is the leading bioanalytical laboratory in biosimilars in Asia Pacific with several platforms for sensitive technology, including Gyrolab, to develop state-of-the art assays. Agilex Biolabs has supported numerous biosimilar studies conducted across Australia, Asia Pacific and Europe for phase 1 and phase 3 generic antibody/peptide therapeutics; including Teriparatide, Bevacizumab, Trastuzumab, Omalizumab and Eculizumab. Our scientists have a breadth of knowledge and experience in ligand binding assays, antidrug-antibody assays and neutralising antibody assays with in-depth expertise in troubleshooting immunogenicity assays, which can be challenging to develop, to meet the high drug and target tolerance required for later phase studies.

Nucleus Network is a leading Phase 1 clinical research organisation with three specialised clinical units: two in Australia and one in the US. Nucleus Network works closely with Agilex Biolabs and its clients, and this this long-standing relationship delivers significant advantages to biotechs wanting a streamlined and collaborative approach to their early phase biosimilars studies.

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Kurt Sales

Kurt J. Sales (B.Sc; B.Sc (MED) Hons; M.Sc, Ph.D, PGCM)

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 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.

Dr. Paul Griffin

Dr. Paul Griffin

Principal Investigator Nucleus Network

Dr. Paul Griffin is a Principal Investigator and the Medical Director at Nucleus Network’s Brisbane site; where he has overseen more than 100 clinical trials, predominantly in Infectious Diseases. He is the Director of Infectious Diseases at Mater Health Services in Brisbane and Conjoint Associate Professor at the University of Queensland School of Medicine and Affiliate Associate Professor Mater Research Institute.

He has fellowships in Infectious Diseases from the Royal Australasian College of Physicians, in Clinical Microbiology from the Royal College of Pathologists of Australasia and from the Australasian College of Tropical Medicine.

Arsalan Arif

arsalan arif

Founder & CEO, Endpoints News

Arsalan Arif is a news media entrepreneur who set out in 2015 to build his vision of an independent biotech news company at Endpoints News.