Clinical Trial Support
The volume of clinical trials for cell therapies, gene therapies, regenerative medicines, and immunotherapies is increasing globally at breakneck pace. Cell Therapies is uniquely placed to facilitate clinical trials supply in Australia. Our facility is located within the Peter MacCallum Cancer Centre, part of the Parkville biomedical precinct that also includes the Royal Melbourne, Royal Women’s and Royal Children’s Hospitals. This location enables access to a multitude of clinicians who specialise in various therapeutic areas, from cancer to infectious diseases to metabolic diseases, and clinical settings already familiar with cellular product handling and transplantation.
Most clinical trials, including those that have already been established in the US (under an IND) or in Europe (under a CTA) can rapidly be extended to Australia through the Clinical Trial Notification (CTN) scheme that requires only clinical site Ethics Committee review prior to notification to the Australian Therapeutic Goods Administration (TGA) prior to study commencement. For the small number of proposed studies that do not qualify for the CTN process, the TGA will review a detailed dossier application, in addition to Ethics Committee review, prior to study commencement (the Clinical Trial Exemption (CTX) pathway).
Our alliance with Pharmabio Corporation in Japan simplifies the extension of clinical trials into the burgeoning Japanese market, with potential to access the attractive Japanese conditional approval pathway for regenerative medicine products.
CTPL specialises in enabling global clinical trial establishment in Australia and Japan (through Pharmabio) by assisting with clinical design, protocol development, and regulatory submission. We can also act as the regional logistics hub for storage and distribution to Asia-Pacific clinical sites. Finally, in combination with our contract manufacturing services, we can be a single site solution for your clinical needs.