Case Studies

Conducting biosimilar clinical trials

Nucleus Network: The contact from Nucleus

Nucleus Network is a dedicated Phase I clinical trials organisation located in Melbourne, Australia.

It undertakes approximately 50 clinical trials a year, including up to 15 first-in-human studies, at its dedicated Phase I unit located within the Alfred Medical Research Education Precinct at Melbourne’s Alfred Hospital. The unit contains 50 beds and incorporates state-of-the-art subject monitoring to ensure volunteer safety and comfort. Nucleus Network is experienced in delivering adaptive clinical trial protocol designs, and has good access to patient populations through co-location with one of the state’s major tertiary teaching hospitals.

Nucleus Network’s international client base is attracted to Australia’s streamlined regulatory framework, and fast approval timelines for clinical trials. Typical timeframes for a Phase I clinical trial, from submission of Protocol and Investigators Brochure, to clinical trial approval, is 4 to 5 weeks. This pathway has proven to be an attractive and successful model for clients, who have been able to enter Phase I clinical trials sooner than originally forecast, and with quality data that is acceptable to the US Food and Drug Administration (FDA) and European Medicines Evaluation Agency (EMEA). Nucleus Network has a number of preferred provider relationships with both pharmaceutical and biotechnology companies.

Nucleus Network offers a full suite of early phase clinical studies, including first-in-human; proof of concept; pharmacokinetic and pharmacodynamic; thorough QTC; bioequivalence; drug/ food interaction studies, as well as specialty studies incorporating a range of pharmacodynamic markers such as Elispot, Flow Cytometry, Cytokine analysis and allergen challenges.

In 2014 Nucleus conducted a biosimilar clinical trial for a large biotechnology company. Incorporating an ethnopharmacology component, Nucleus conducted the trial with a cohort of 30 healthy Japanese subjects. After successful completion of the trial, the same sponsor has now awarded a second biosimilar study to Nucleus.

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