PARTNERSHIP SERIES SEMINAR 3
Translating your therapeutic to a clinical trial, Seminar III: Engaging a Contract Research Organisation
Date: Tuesday 2 August 2022
Time: 1:00pm - 2:00pm
Location: TRI Auditorium or via Zoom (https://us02web.zoom.us/j/85174168762) - Zoom passcode: RTS2022
This is third instalment of the Research Translation Committee’s look at translating a therapeutic, from discovery to clinical trials. You will hear from two Australian contract research organisations, Q-Gen and 360biolabs, on how they work with researchers to help them achieve some of the many requirements of pre-clinical studies. There’s also a Q&A session at the end.
Brisbane-based, Q-Gen Cell Therapeutics, is an integrated cell therapy manufacturing facility within QIMR Berghofer Medical Research Institute. For more than 20 years, the company has been dedicated to translating clinical research to the bedside. It is licensed by the Therapeutic Goods Administration (TGA) for the manufacture of cell therapies for clinical trials, as well as quality control (QC) testing, including microbiological and immunobiological testing.
360biolabs provides a comprehensive speciality laboratory services organisation for therapeutic, vaccine and diagnostics development. They develop and conduct pharmacokinetic (PK) and pharmacodynamic (PD) assays across a wide variety of therapeutic areas and provide extensive support services to ensure the success of preclinical studies and clinical trials. 360biolabs has the capacity to support bioanalysis for new and established small molecules, peptides, proteins and biologics. Its industry-experienced chemistry and biology teams can develop, validate and conducte sensitive quantitative determinations as well as metabolite identification and other complex analytical requests.
About the speakers:
Angela Luttick
Executive Vice President, Business Development, Commercial
360biolabs
Angela is a virologist with more than 20 years’ experience in the discovery, development and commercialisation of novel drugs. Well accustomed to leading multidisciplinary teams and experienced in the generation and integrity of key discovery-stage biological data required for the preparation of IND packages used in filing numerous FDA submissions. Angela is a co-founder and Executive Vice President, Commercial at 360biolabs and leads business development and commercialisation strategies for the company.
Dr Andrew Masel
General Manager, Q-Gen Cell Therapeutics
Andrew is the acting General Manager of our Q-Gen Cell Therapeutics facility as well as the QIMR Berghofer in 2015. Currently Histology facility manager. Prior to these appointments, he worked for Queensland Health as a senior scientist, and before that Andrew spent 13 years with Applied Biosystems. When he left the company after 13 years, he was a Business Development Manager in the Forensics division. Andrew received his PhD in molecular biology from The University of Queensland (UQ) in 1992, and completed two post-docs at UQ, one in Plant Pathology and the second at the Equine Research Facility.
Q-Gen client: Dr Andrew Prowse
Research Fellow, AIBN, UQ
Andrew Prowse is a Research Fellow at the AIBN, UQ and StemCore Facility Manager. Andrew has over 15 years’ experience in pluripotent stem cell (PSC) biology, bioprocess, project management and commercialisation. Andrew received his PhD in 2008 from the University of New South Wales looking at improvements to pluripotent cell expansion through low oxygen culture and proteomic assessment of feeder layer secretomes. As a PostDoc from 2008 to 2013 at AIBN, Andrew continued his interest in process development and improvements to culture methods for the scale up of PSCs utilising multidisciplinary approaches. In mid-2013, Andrew took a position as a Project Manager/Lead Scientist at the Centre for Commercialisation of Regenerative Medicine (Toronto, Canada) to develop scalable PSC expansion and differentiation to cardiomyocytes with bioreactor technology. Returning to Australia, and the AIBN, Andrew continued his work on bioreactor-based expansion of PSCs and differentiation to cardiomyocytes, now focused on their use in Phase I clinical trials for treatment of cardiovascular disease.
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