A Guide to Preclinical and CMC Requirements for Conducting Clinical Trials in Australia

Sponsors are increasingly interested in conducting early phase clinical trials in Australia. This is because of Australia’s strong value proposition, particularly with faster timelines due to a favorable regulatory pathway.

Navigating an unfamiliar regulatory framework can be daunting. That is why many sponsors rely on an experienced partner to guide them through the process.

This webinar will provide clarity on the regulatory requirements in Australia and the differences between the more widely known US process. This webinar will also detail the preclinical data package and chemistry, manufacturing and control (CMC) requirements for the conduct of clinical trials in Australia.

Speaker Dr. Jason Lickliter will outline the approach from preclinical to first patient first dose, which aligns with the International Conference on Harmonization (ICH) package and US Food and Drug Administration (FDA) guidelines. Dr. Jason Lickliter will also discuss the preclinical data package, including toxicology and safety pharmacology study requirements. Dr. Lickliter will be joined by Dr. Jon Fairweather to discuss the CMC requirements for investigational product use in Phase I clinical trials.

This webinar is a must-attend for biotechnology and pharmaceutical companies looking to progress from the preclinical stage. Gain invaluable advice and come away with a solid understanding of:

• How Australia’s regulatory framework compares with the US FDA approval process
• Preclinical data package and CMC requirements for investigational product use in Phase I clinical trials
• General Human Research Ethics Committee (HREC) expectations in study design for first-in-human clinical trials
• Why distance is no longer an obstacle to offshoring clinical trials

Register for this webinar to gain the knowledge needed to conduct clinical trials in Australia now.

Speakers

Dr. Jason Lickliter, Chief Medical Officer, Nucleus Network

Dr. Jason Lickliter has headed Nucleus Network’s Medical Department including an international, multi-site team of Principal Investigators and Medical Officers. For over a decade, Jason has overseen trials across all three sites, for international sponsors and CROs of biotechnology and pharmaceutical companies from all over the world.

Jason has extensive experience across all aspects of early phase clinical trials from protocol design and implementation to the integration of biomarker studies and advanced imaging into clinical research. With a Medical Oncology and Clinical Hematology background, his achievements include the establishment of a Phase I Cancer Trials Program at Monash Medical Centre.

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Dr. Jon Fairweather, Business Development Executive, PCI Pharma Services for Australia and New Zealand

Jon is responsible for facilitating cGMP Investigational Medicinal Product supply for use in early phase clinical trials through manufacturing, packaging and storage and distribution. He has worked within PCI as Director of Projects, and prior to this has held former roles including company director, COO, BDM, CMC Manager and research scientist at various life science companies. Jon thrives on accelerating products through clinical development locally and growing these opportunities globally.

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