INSTITUTIONAL BIOSAFETY COMMITTEE

Chair

Scientist

Simone is the Proprietor of BioPharma Regulatory Consulting (BPR) and Chair of the BioPharma Regulatory Consulting IBC. She has delivered over 15 years of successful strategic consulting in regulatory affairs specialising in the regulation of complex biological therapeutics in Australia and New Zealand. Simone was the Chair of both CNS and Novotech IBCs. All three IBCs focus(ed) on the review of OGTR licence applications for medicinal therapeutics that are GMOs. In addition, Simone has a wealth of experience consulting for programs that study GMO therapies at the pre-clinical and clinical trial stages of development. As a specialist in regulatory affairs, with a strong background in regulation at the manufacturing level, Simone has successfully managed a number of IND and other applications to regulatory authorities. Prior to her roles within CNS and Novotech, Simone worked within a pharmaceutical company (LEO Pharma), as a senior associate in regulatory affairs, quality assurance and post-marketing pharmacovigilance.

Simone has first class honours in biochemistry, a PhD in biochemistry and molecular biology and is Regulatory Affairs Certified (RAC; global scope).

Clinical Specialist

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Barbara is an employee of Graythan Regulatory Services in the position of Head of Clinical Operations and Regulatory Affairs. In her previous positions at CNS and Novotech, Barbara was a voting member on the CNS and Novotech IBCs and has held the position of IBC Chair.  Barbara is a highly experienced clinical Program Manager with over 20 years of international expertise. She has extensive experience in conducting global clinical trials in a wide variety of therapeutic areas across phases I – IV. Barbara has worked at the Sponsor, CRO, hospital and lab level and has a comprehensive understanding of the required processes. Barbara has experience across a wide range of therapeutic areas including those which are OGTR licenced and licence-exempt GMO studies. She was the program manager for an autologous GMO study which is the signature study in the field. Barbara has coordinated and supported many audits including those performed by the OGTR and has taken part in the OGTR’s Gene Technology Regulation consultation process.  Barbara holds multiple degrees from international institutions including a Bachelors in chemical engineering and a post graduate diploma in Project Management. Barbara has worked in five countries, holds three nationalities and is fluent in three languages (English, German and French).

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Biosafety and Biocontainment Specialist

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Sam is currently the Biosafety and Biosecurity Officer in the Research Integrity and Ethics Unit at the University of Tasmania (UTAS). Sam completed his PhD at the University of Tasmania in 2011, specialising in analytical chemistry hardware optimisation, and applications for separating and identifying compounds in complex substances. He branched out after finishing his degree, and worked for the Australian Antarctic Division, the Antarctic Climate and Ecosystems Cooperative Research Centre and Curtin University analysing ice cores from Antarctica and Greenland for chemical and isotopic markers of volcanism and past climate events.  After a stint at the University of Melbourne managing a soil analysis lab and working on implementation of a collaborative research infrastructure program, he returned to the University of Tasmania as the Biosafety and Biosecurity Officer and manager of their Institutional Biosafety Committee. Sam enjoys networking with the local and national research community to learn about exciting innovations and sharing information about best practices in biosafety to enable key research programs. He now provides project leadership to the University of Tasmania based on his subject matter expertise in hazardous chemical management, biocontainment, biosafety and biosecurity. 

Medical Specialist

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Dr Wraight is currently an independent consultant. He has over 40 years’ experience in health care, pharmaceutical medicine, clinical research and drug development. He has broad experience over all phases of clinical research and therapeutic areas with specialist interest in infectious diseases and early phase clinical trials.  He has held a number of senior positions in healthcare, the pharmaceutical industry and clinical research organisations including regional medical director for Gilead Sciences and most recently medical monitoring team lead for Novotech managing a team of 15 medical monitors. He was previously a member of the CNS and Novotech IBCs.  He has reviewed a number of OGTR GMO licence applications.

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INDEPENDENT MEDICAL MONITOR

Secretary

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Sonja is currently completing a Bachelor of Science at the Monash University. Her subjects include Biology, Evolution, Experimental Science, and Quantitative Methods of Science. Sonja has a passion for microbiology which is reflected in her university curriculum. Sonja also works for Life Blood Australia, manufacturing blood products.

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