Clare Allocca is Senior Advisor for Standardization in the Standards Coordination Office at the US National Institute of Standards & Technology (NIST). The Standards Coordination Office is the NIST standardization focal point for federal government and a key information source for US industry on standards-related market access issues. Clare leads and supports extensive standards development activity as well as associated standards and conformity assessment policy. She has over 30 years of experience in program and strategic management and R&D for biotechnology standards, advanced materials, manufacturing, quantum computing, surface engineering, and measurement technology.

Clare is an officer of ISO/TC276 Biotechnology, as secretary and manager of the Working Group (WG) 3 Analytical methods, ISO/TC212-TC276/JWG6 Quality Practice for detection of SARS CoV-2 and the entire US mirror committee. As an expert of ISO/TC276/WG2 Biobanking & bioresources, she co-authored ISO 20387:2018 Biotechnology - Biobanking – General requirements for biobanking, and ISO/TR 22758:2020 Biotechnology - Biobanking - Implementation guide for ISO 20387, and contributed to multiple other standards and related documents. 

Dr. Lara Mouttham obtained a PhD in Zoology and Wildlife Conservation from Cornell University in 2016 in collaboration with the Smithsonian Conservation Biology Institute (SCBI) as part of the Cornell-Smithsonian Joint Training Program for her work on primordial follicle activation and ovarian tissue cryopreservation in cattle and domestic cats. In addition to her graduate research and subsequent postdoctoral fellowship, she maintained the SCBI Genome Resource Bank which stores gametes and genetic materials from wildlife species.

She joined the Cornell Veterinary Biobank (CVB) at the Cornell University College of Veterinary Medicine in 2018, where she is now a research associate and the Assistant Director of Biobank Laboratory Services. She is part of the quality management team that prepared the CVB to be the first biobank in the world to achieve accreditation to ISO 20387 in 2019 and has been actively involved in maintaining its accreditation status since. She is also an assessor for the American Association for Laboratory Accreditation (A2LA), performing assessments of other biobanks for accreditation to ISO 20387. Her areas of interest include biospecimen science, quality management systems, cryobiology, and translational biobanking in support of medical advancements for both humans and animals. She is passionate about educating fellow scientists on the importance of quality assurance in research and introducing the public to the field of biobanking.

Distinguished Professor Melissa C. Southey, BSc (Hons, Pathology) PhD (Medicine), GradDip (Law), is a Molecular Geneticist (FHGSA) and a Founding Fellow of the Faculty of Science, Royal College of Pathologists of Australasia (FFSc, RCPA). She is Chair of Precision Medicine, School of Clinical Sciences at Monash Health, Director of Monash University’s new Biobanking Victoria initiative and Research Director of the Monash Partners Comprehensive Cancer Consortium.

Melissa is best known for her work with multiple-case cancer families and heritable risk factors that has provided the evidence base for best practice guidelines for the clinical management of individuals at high risk of the disease.

Melissa has led multidisciplinary teams in diagnostic and research settings in Australia and internationally, supported by programmatic awards from the European Commission, the National Institutes of Health (USA), NHMRC and The National Breast Cancer Foundation. She has co-authored more than 550 peer reviewed publications and was named by Clarivate in 2018 as a Highly Cited Researcher.  She actively participates on a number of national and international scientific advisory, governance and editorial bodies.

Vivien has over 30 years’ experience in health, medical research and university sectors. She established Micromon’s DNA sequencing facility at Monash University before moving to the Monash Health Translation Precinct (MHTP) to manage the MHTP Medical Genomics facility. With the launch of the MHTP Translational Research Facility in 2015, she was appointed to a newly created position to deliver the strategic development and manage the MHTP’s research technology portfolio. Throughout her five-year tenure, she accomplished major advances in technology capabilities to support medical research.

In 2018 she was integral in laying the foundations for Biobanking Victoria. Subsequently, drawing upon her long-standing knowledge of medical testing accreditation, she established the quality management system using the newly released Australian Standard ISO 20387:2020. Then in 2021, together with the Biobanking Victoria team, she led the NATA accreditation process resulting in the facility becoming Australia’s first accredited Biobank.

Vivien has been a volunteer National Association of Testing Authorities (NATA) technical assessor for almost 20 years, is member of ABNA and International Society for Biological and Environmental Repositories (ISBER) and is the founder of QSci consulting.

Helen Tsimiklis, BSc (Hons, Microbiology) GradDip (Epidemiology & Biostatistics), is Biorepository Manager of Biobanking Victoria (Monash University) and Precision Medicine, School of Clinical Sciences at Monash Health, with over 20 years of biobanking experience.  Helen is a committee member of the Australasian Biospecimen Network Association (ABNA) and a member of the International Society for Biological and Environmental Repositories (ISBER). She has recently been invited to become a NATA Technical Assessor.

Biobanking Victoria is the first biorepository in Australia to achieve NATA accreditation to the ISO 20387 standard in Biobanking. Biobanking Victoria together with the Precision Medicine biorepository provide researchers, industry and pharma a comprehensive sample management solution, making available high quality and well annotated biospecimens.  Biobanking Victoria and Precision Medicine supports over 30 multidisciplinary cohorts/clinical trials, houses 4,000,000+ biospecimens and associated data. The biorepository actively supports national and international research endeavours and contributes to more than 15 international consortia. 

Professor Jennifer Byrne is Director of Biobanking with NSW Health Pathology, and conjoint Professor of Molecular Oncology at the University of Sydney. Jennifer trained in laboratory research at the University of Queensland and was a postdoctoral fellow in Strasbourg, France, before returning to Sydney.

Jennifer has authored over 100 papers across the fields of cancer genetics, cancer biology, research integrity and biobanking that have been collectively cited over 3,400 times. She leads the PRIMeR group (Publication and Research Integrity in Medical Research) and is based at the NSW Health Statewide Biobank in Camperdown, Sydney.

Gillian is the Deputy Sector Manager for Legal and Clinical services at NATA. The role involves liaising with stakeholders including government regulators an accredited facilities on issues related to compliance and Quality Management Systems. Prior to joining NATA Gillian had over 30 years’ experience in research and pathology and experienced significant changes in the regulatory and accreditation environments.

Gillian has been part of the introduction of automation in testing and the development of Laboratory Information Systems. ISO 20387 Biotechnology – Biobanking – General requirements for biobanking was published in 2018. This document recognises the importance of biobanks around the world for research and the exchange of knowledge. NATA is seeking to offer accreditation for biobanks with the objective of promoting confidence and cooperation between researchers and other parties.