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CNS Menu

Location Settings

Asia-Pacific

AU -  Sydney
AU -  Melbourne
AU -  Brisbane
CN -  Hong Kong
CN -  Shanghai
IN -  Bangalore
MY -  Kuala Lumpur
PH -  Metro Manila
KR -  Seoul
CN -  Taipei City
TH -  Bangkok
NZ -  New Zealand

North America

US -  San Francisco
US -  Boston

GLOBAL

English

GMO Solutions

CNS initiated the first national, privately owned, commercial Institutional Biosafety Committee (IBC) in Australia, successfully accredited by the Australian Office of the Gene Technology Regulatory (OGTR).

Having access to an IBC is a prerequisite for an organisation to obtain and maintain accreditation for the conduct of studies using investigational products that are genetically modified organisms (GMOs) in Australia. All necessary license and notification applications require review from an IBC before successful applications can be submitted to the OGTR.   CNS & Novotech, through our BioDesk team, has extensive expertise in providing Cell therapies services and GMO services for biotechnology companies.

We are an accredited organisation with the OGTR

CNS' IBC provides GMO classification advice and performs the review and submission of GMO licence applications and notifications to the Office of the Gene Technology Regulatory. The GMO classification types in Australia include ‘Exempt Dealings’ (GMO products or ‘dealings’ not requiring a GMO licence), Dealings Not Involving Intentional Release (DNIR), Dealings Involving Intentional Release (DIR) licensable GMOs, or Notifiable Low-Risk Dealings (NRLDs).

As a full-service CRO, CNS can act as both the Applicant for the GMO licence and the Sponsor of the clinical trial. This dual capability allows for the streamlining of Australian sponsorship for clinical trials using GMOs as CNS can be responsible for all monitoring aspects of the study. However, if a company has a legal Australian entity, they can choose to be the applicant and hold the DNIR or DIR license ensuring the conditions of the license are upheld throughout the trial.

CNS will provide ongoing support throughout the evaluation phase of the DNIR or DIR with the Office of the Gene Technology Regulatory and will respond to questions raised by the Office of the Gene Technology Regulatory in writing following consultation with our client.

Institutional Biosafety Committee Members

Dr Simone Flight. B.Sc. (Hons), Ph.D., RAC.

Dr Simone Flight

B.Sc. Hons, Ph.D., RAC.
Chairman
Dr Simone Flight. B.Sc. (Hons), Ph.D., RAC.

Dr Simone Flight

B.Sc. Hons, Ph.D., RAC.
Chairman

Simone has over 10 years’ experience in Regulatory Affairs and drug development in the US, Europe, Australia and New Zealand. Simone has worked across a broad range of therapeutic areas involving biologicals and new chemical entities and is experienced in the preparation of clinical trial and marketing…

Dr Hiram Chipperfield. Ph.D.

Dr Hiram Chipperfield

Ph.D.
Secretary
Dr Hiram Chipperfield. Ph.D.

Dr Hiram Chipperfield

Ph.D.
Secretary

Hiram has over 10 years of experience in regulatory affairs and prior to joining CNS, he held roles in a regulatory affairs consulting firm and a global diagnostics company. With experience in products from diagnostics to cell therapies, he has managed projects ranging from preclinical development, first…

Dr Caroline Dobbin. BSc. Hons PhD.

Dr Caroline Dobbin

BSc. Hons PhD.
Microbiologist
Dr Caroline Dobbin. BSc. Hons PhD.

Dr Caroline Dobbin

BSc. Hons PhD.
Microbiologist

With extensive experience in drug development, gaining over 15 years' in the Australian and US biopharmaceutical sectors, Caroline has managed preclinical programs and provided project management, medical writing, and scientific support for multiple early phase clinical studies across a broad range of…

Barbara Kienast. Ing., MIEAust, PMP

Barbara Kienast

Ing., MIEAust, PMP
Clinical Operations Manager
Barbara Kienast. Ing., MIEAust, PMP

Barbara Kienast

Ing., MIEAust, PMP
Clinical Operations Manager

Barbara has over 20 years’ experience in Clinical Research in Europe, Asia, Australia and New Zealand including pharmaceutical research as well as active implantable devices and gene therapy for sponsors, Clinical Research Organizations and in hospital settings. Barbara has a Chemical Engineer degree…

Dr Susanna Mantovani. PhD, MSci, BSci (Hons)

Dr Susanna Mantovani

PhD, MSci, BSci (Hons)
Molecular Biologist
Dr Susanna Mantovani. PhD, MSci, BSci (Hons)

Dr Susanna Mantovani

PhD, MSci, BSci (Hons)
Molecular Biologist

Susanna holds a PhD in Physiology, and a Master degree in the field of Biomedical Research from the University of Milan, She is currently completing a Graduate Certificate in Clinical Trial Research at the University of Sydney. She also has a Certificate IV in Health and Safety, an in depth understanding…

Dr Howard Wraight. MB BS

Dr Howard Wraight

MB BS
Medical Doctor
Dr Howard Wraight. MB BS

Dr Howard Wraight

MB BS
Medical Doctor

Howard has over 35 years of experience in clinical medicine, medical research, drug development and pharmaceutical medicine. Howard has experience in many aspects of drug development including clinical research, marketing authorisation/regulatory submissions, and commercialisation including reimbursement…

Dr Layne Wright. B.Sc. (Hons I), Ph.D.

Dr Layne Wright

B.Sc. (Hons I), Ph.D.
Quality Assurance
Dr Layne Wright. B.Sc. (Hons I), Ph.D.

Dr Layne Wright

B.Sc. (Hons I), Ph.D.
Quality Assurance

Layne has over 15 years of experience in preclinical research and joined CNS in 2014. Layne has provided QA services including establishment and maintenance of Quality Management Systems, Vendor, GCP and GMO audits in Australia and Asia, and Quality reviews of marketing authorisation applications,…

Dr Suzanne Elliott . BAppSc., PhD, Grad Dip (Drug Dev), ACRP-CCRC

Dr Suzanne Elliott

BAppSc., PhD, Grad Dip (Drug Dev), ACRP-CCRC
Microbiologist & Independent Member
Dr Suzanne Elliott . BAppSc., PhD, Grad Dip (Drug Dev), ACRP-CCRC

Dr Suzanne Elliott

BAppSc., PhD, Grad Dip (Drug Dev), ACRP-CCRC
Microbiologist & Independent Member

Suzanne has over 25 years experience in drug development and clinical trials in Australian hospitals, Medical Research Institutes and early Phase clinical trial companies. Suzanne has over 9 years working as a Medical Laboratory Scientist in private and public pathology providers in the areas of…

Dr Paul Griffin

Dr Paul Griffin

Medical Doctor/Virologist
Independent Member
Dr Paul Griffin

Dr Paul Griffin

Medical Doctor/Virologist
Independent Member

Paul is a Senior Lecturer in Medicine and Director of Infectious Diseases at the University of Queensland and Mater Hospitals, South Brisbane, Australia. He is the Principal Investigator and Manager of Medical Services at QPharm Pty Ltd; a specialized contract research organisation within the Queensland…