Genomics translational pipeline resource navigation tool

Resources

The navigation tool includes a comprehensive list of resources and assets that researchers can access to progress their genomics-based therapy, diagnostic, or device through the translational pipeline.

Filter these resources by the type of genomic technology you are working on and the different stages of the Technology readiness level (TRL) development pathway to find the most useful resources.

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Resource	Description	Technology type	Technology readiness levels	Research stage	Resource type	Capabilities
ACMG Standards and guidelines	Standards and guidelines for the interpretation of sequence variants. These guidelines are refined and quantitative approaches to variant interpretation is being undertaken by the Sequence Variant Interpretation Working Group.	Diagnostics	TRL 3, TRL 4, TRL 5, TRL 6, TRL 7, TRL 8	Preclinical testing and feasibility, Clinical studies, Product development	Guidelines	Laboratory guidelines Genetic testing Classification of sequence variants In silico predictive algorithms
Angel Investors (Multiple)	Angel Investors provide private capital for early stage companies. As well as individual angel investors, across Australia there are a number of Angel Investor groups. Some of these groups that will fund companies based in NSW include: Sydney Angels Melbourne Angels (prefer Victorian based companies, but will invest across Australia) Southern Angels (based in South Australia, but will invest across Australia) Scale Investors (invest in female founded businesses across Australia)	Therapeutics, Diagnostics	TRL 2, TRL 3, TRL 4, TRL 5, TRL 5, TRL 6	Early stage research, Preclinical testing and feasibility, Clinical studies	Funding	Funding Private capital
ARCS Australia	ARCS is a professional organisation that offers career long professional development services for its members in the therapeutic goods sector. Education and training programs, competency building, and information sharing can be accessed through ARCS.	Therapeutics	TRL 3, TRL 4, TRL 5, TRL 6, TRL 7, TRL 8, TRL 9	Preclinical testing and feasibility, Clinical studies, Clinical implementation	Network, Education and training	Professional organisation and industry network Education and professional development Industry news and events
Association of Clinical Genomic Science (ACGS) Best Practice Guidelines for Variant Classification in Rare Disease 2020	Guidelines developed by the UK ACGS intended for general use in classifying highly-penetrant variants in patients with rare, monogenic diseases.	Diagnostics	TRL 3, TRL 4, TRL 5, TRL 6, TRL 7, TRL 8	Preclinical testing and feasibility, Clinical studies	Guidelines	Best practice guidelines Variant classification Rare, monogenic diseases
Australian BioCommons	Provides a range of services, including access to various community-scaled bioinformatics services, including computational and analytical tools.	Therapeutics, Diagnostics	TRL 1, TRL 2, TRL 3, TRL 4, TRL 5	Early stage research, Preclinical testing and feasibility	Education and training, Infrastructure	Community-scale bioinformatics services Bioinformatics training ‘Omic focussed communities
Australian Cardiovascular disease Data Commons	Provides harmonised multi-omic data relating to cardiovascular disease in one platform that may be accessed to explore studies, data, and variables.	Therapeutics, Diagnostics	TRL 1, TRL 2	Early stage research	Infrastructure	Data sharing platform Cardiovascular disease data
Australian Clinical Trials Alliance (ACTA)	The ACTA is the national peak body representing and supporting networks of clinician-researchers conducting investigator-initiated clinical trials, maintaining clinical quality registries, and operating clinical trial coordinating centres within the Australian healthcare system.	Therapeutics	TRL 5, TRL 6, TRL 7, TRL 8	Clinical studies	Education and training, Forms and templates, Guidelines	Network Clinical trial education and training Clinical trial guides, tools, and templates
Australian Commission on Safety and Quality in Health Care National Clinical Trials Governance Framework and User Guide	The National Clinical Trials Governance Framework provides information about each component and action within the National Safety and Quality Health Service (NSQHS) Standards. It aims to ensure clinical trials are conducted in a safe, and high-quality manner. It provides suggested strategies to support health service organisations meet the actions within the Standards. This framework can support researchers to understand responsible conduct. It includes the key components of clinical trials governance, and the roles and functions of various stakeholders involved in clinical trials.	Therapeutics	TRL 6, TRL 7, TRL 8	Clinical studies	Governance, Guidelines	Clinical trial governance User guide for clinical trial governance
Australian Functional Genomics Network (AFGN)	The AFGN is a collaboration between clinical geneticists and research scientists. Their aim is to enhance understanding of the genetic basis of rare diseases and to improve the quality of life of patients and their families through the coordination of functional genomics and clinical management in Australia. The AFGN was funded through the MRFF, and will distribute $5mllion in funding to functional genomic studies from 2021 to 2026. The Network is a part of an international network if initiative across Canada, Europe, and Japan.	Diagnostics	TRL 1, TRL 2, TRL 3, TRL 4, TRL 5, TRL 6, TRL 7, TRL 8, TRL 9	Early stage research, Preclinical testing and feasibility, Clinical studies, Clinical implementation	Network, Funding	Investigation of variants of uncertain significance Clinician – researcher partnerships Functional genomics funding
Australian Genome Research Facility (AGRF)	A not-for-profit that provides access to leading technology, enabling genomics, including single gene analysis, whole genome sequencing, microbiome profiling, and whole genome methylation sequencing along with bioinformatic services.	Therapeutics, Diagnostics	TRL 1, TRL 2, TRL 3, TRL 4, TRL 5	Early stage research, Preclinical testing and feasibility	Infrastructure	Sequencing Bioinformatic services
Australian Genomics	Australian Genomics is a national collaboration that supports the translation of genomic research into clinical practice. They undertake a number of initiatives relating to this area, and share research tools and expertise to support genomic research.	Therapeutics, Diagnostics	TRL 1, TRL 2, TRL 3, TRL 4, TRL 5, TRL 6, TRL 7, TRL 8	Early stage research, Preclinical testing and feasibility, Clinical Studies	Network, Education and training, Governance, Forms and templates	Guidance and support on: Research ethics and governance Consent and patient support materials Genomic data capture and management Evaluation, policy, translation into practice
Australian National University (ANU) Centre for Indigenous Genomics	Provides a mechanism to ensure that Indigenous decision-making is incorporated into biomedical research, and that the benefits of genomic medicine will be brought to Indigenous Australians.	Therapeutics, Diagnostics	TRL 2, TRL 3, TRL 4,	Early stage research, Preclinical testing and feasibility	Network, Infrastructure	Indigenous genomic data resources Indigenous Australian reference genome
Australian National University (ANU) Centre for Therapeutic Discovery	Aids in high-throughput screening for biomarker and therapeutic discovery, to develop potential product hypotheses. The facility can be accessed by researchers to utilise two main workstations; a high throughput screening workstation and high content/imaging workstation, equipped with various screening equipment.	Therapeutics	TRL 1, TRL 2	Early stage research	Infrastructure	High-throughput screening Compound libraries for screening RNAi/CRISPR/drug libraries Consultation services for screening
Australian Pathogen Genomics Program	A program funded through MRFF, which aims to implement large-scale integration of pathogen genomics, using a nationally integrated genomics platform, which has a central, secure, and private online locations to store, store, analyse and view national genomics data.	Therapeutics, Diagnostics	TRL 1, TRL 2, TRL 3, TRL 4, TRL 5, TRL 6, TRL 7, TRL 8	Early stage research, Preclinical testing and feasibility, Clinical studies	Education and training, Infrastructure	Pathogen genomics education and training Training events Pathogen whole genome sequencing Bioinformatic analysis of pathogens
Australian Proteome Analysis Facility (APAF)	Aims to assist the scientific community with protein analysis. APAF provides service work and research support, providing access to equipment and laboratories. A variety of services are available and service requests can be made via the website.	Therapeutics, Diagnostics	TRL 1, TRL 2, TRL 3, TRL 4, TRL 5	Early stage research, Preclinical testing and feasibility	Infrastructure	Mass spectrometry Bioinformatics Protein analysis Protein interaction analysis NATA accredited services
Australian Research Data Commons	Provides various resources associated with data management, including best-practice guides and skill building materials for digital research. Utilise this resource to find and access datasets and collections, digital research tools, software, platforms and skill-building materials.	Therapeutics, Diagnostics	TRL 1, TRL 2, TRL 3, TRL 4, TRL 5, TRL 6, TRL 7, TRL 8, TRL 9	Early stage research, Preclinical testing and feasibility, Clinical studies, Clinical implementation	Infrastructure	Accessible data Advisory services Data guidelines Data education and training Data tools Data research platforms
Biobanks (various)	Biobanks are physical repositories providing access to various clinical samples relating to particular cohorts or disease areas which may assist in investigating -omic related biomarkers. Researchers can utilise biobanks to access biospecimens and clinical data collected from patients, for research projects.	Therapeutics, Diagnostics	TRL 2, TRL 3, TRL 4, TRL 5	Early stage research, Preclinical testing and feasibility	Infrastructure	Biobanks Biospecimens and clinical samples State registries National/ANZ registries
Biologics Innovation Facility (BIF)	The University of Technology (UTS) Sydney BIF is a GMP bioprocessing teaching and training facility, designed to drive opportunities to up-skill and scale up biopharmaceutical projects using state of the art single-use equipment and industry's best practice processing techniques. BIF provides training in upstream, downstream, and clean room operations as well as contract services including process development, manufacturing, and analytics services for biologics productions. BIF is a global teaching partner with National Institute for Bioprocessing Research (NIBRT) and is supported by NSW and National Collaborative Research Infrastructure Strategy (NCRIS).	Therapeutics, Diagnostics	TRL 5, TRL 6, TRL 7, TRL 8	Clinical studies, Product development	Education and training, Infrastructure	Education and training GMP bioprocessing training Biologics process development Biologics manufacturing Biologics analytics services Upstream, downstream and clean room operations
Cancer Australia Cancer Cooperative Trials Groups (CTGs)	Cancer Australia supports Australia’s capacity to develop industry-independent cancer clinical trials, which includes 14 Cancer CTGs. These CTGs conduct world-class multi-disciplinary research for cancer control, to help inform clinical practice and improve outcomes for cancer patients. Consumer representatives may also be involved in contributing to CTGs through concept development of clinical trials, providing input into research protocols, lay summaries, and reviewing patient information sheets and consent forms. The specific aims and objectives of each CTG differs slightly.	Therapeutics, Diagnostics	TRL 6, TRL 7, TRL 8	Clinical studies, Product Development	Network	Industry independent cancer clinical trials Multidisciplinary research for cancer Consumer representative contribution
Cancer Institute NSW Clinical trials program	Resources to build the capability of the cancer control workforce and improve the cancer clinical trial landscape for patients and the clinical trial workforce.	Therapeutics, Diagnostics	TRL 6, TRL 7, TRL 8	Clinical studies	Education and training	Education and training
Cancer Institute NSW Enduring Cancer Data Linkage (CanDLe)	CanDLe is a model of collaboration aimed to improve the quality and speed of cancer research through the sharing of knowledge, experience, and peer review by a Community of Practice	Therapeutics, Diagnostics	TRL 1, TRL 2, TRL 3, TRL 4, TRL 5, TRL 6, TRL 7, TRL 8, TRL 9	Early stage research, Preclinical testing and feasibility, Clinical studies	Infrastructure	Accessible data Record linkage service
Cancer Institute NSW Patient recruitment service	The patient recruitment service offers researchers across Australia access to Cancer Institute NSW’s rich data holdings to support patient recruitment to projects aimed at better patient care and improving outcomes for people diagnosed with cancer.	Therapeutics, Diagnostics	TRL 6, TRL 7, TRL 8	Clinical studies	Network	Participant recruitment and accessing samples
Centre for Health Record Linkage (CHeReL)	CHeReL contains linked health data across NSW and ACT. The CHeReL provides advice on the design, cost, feasibility and process of linkage studies. Data/information from different sources that relates to the same individual, family, place or event can be securely linked by the CHeReL and made available to researchers.	Therapeutics, Diagnostics	TRL 1, TRL 2, TRL 3, TRL 4, TRL 5, TRL 6, TRL 7, TRL 8, TRL 9	Early stage research, Preclinical testing and feasibility, Clinical studies	Infrastructure	Accessible linked health data Record linkage service Biolink for clients of the NSW Health Statewide Biobank
Children’s Medical Research Institute (CMRI) Biomedical Proteomics	The Biomedical Proteomics Facility offers access to equipment and advice on feasibility, methodology and data analysis for proteomic analyses using Liquid Chromatography–Tandem Mass Spectrometry.	Therapeutics, Diagnostics	TRL 1, TRL 2, TRL 3, TRL 4, TRL 5	Early stage research, Preclinical testing and feasibility	Infrastructure	Untargeted proteomics and phosphoproteomics Protein analyses Custom metabolite analyses
Children’s Medical Research Institute (CMRI) Peptide Synthesis Facility	The Peptide Synthesis Facility provides high-quality peptide-based materials for researchers, partner facilities, and commercial partners with a primary goal to support cancer research projects across NSW. It provides a complete workflow for the synthesis of peptides, modification of peptides, and purification of peptides to give researchers the best possible material for their investigations.	Therapeutics	TRL 1, TRL 2, TRL 3, TRL 4, TRL 5	Early stage research, Preclinical testing and feasibility	Infrastructure	Small scale peptide synthesis Peptide purification Peptide product design
Children’s Medical Research Institute (CMRI) Single Cell Analytics	The Single Cell Analytics Facility at CMRI offers a variety of molecular analysis services at the single cell level across a range of cell types and preparations.	Therapeutics, Diagnostics	TRL 1, TRL 2, TRL 3, TRL 4, TRL 5	Early stage research, Preclinical testing and feasibility	Infrastructure	Gene expression Immune profiling Multiome analysis of transposase accessible chromatin (ATAC) Spatial transcriptomics
Children’s Medical Research Institute (CMRI) Stem Cell & Organoid Facility	The Stem Cell & Organoid Facility at CMRI offers custom iPSC services, including various cell lines and tissues, 3D organoid models, and functional analysis.	Therapeutics	TRL 2, TRL 3, TRL 4, TRL 5	Early stage research, Preclinical testing and feasibility	Infrastructure	iPSCs Differentiated cells 3D organoids
Children’s Medical Research Institute (CMRI) Vector and Genome Engineering Facility	The Vector and Genome Engineering Facility is a scientific core facility at CMRI which supports basic and translational research in vector-based and gene editing therapies for genetic diseases. The facility offers a range of services relating to vectors and genome engineering to support fundamental and preclinical research.	Therapeutics	TRL 2, TRL 3, TRL 4, TRL 5	Early stage research, Preclinical testing and feasibility	Infrastructure	Recombinant viral vectors Genome, RNA, and epigenome editing services
Cicada Innovations	Cicada Innovations is a deep tech incubator, that offers low-cost, flexible workspace, facilities, and support for deep tech businesses, including for those in the health industry.	Therapeutics, Diagnostics	TRL 2, TRL 3, TRL 4, TRL 5, TRL 6, TRL 7, TRL 8, TRL 9	Early stage research, Preclinical testing and feasibility, Clinical studies, Product development, Clinical implementation	Infrastructure	Incubator Co-working space Laboratories, clean rooms, facilities Start-up ecosystem and support
clinicaltrialsNSW	Contains a number of resources which support the translation of technologies through clinical trials, including to help in understanding the regulatory and ethics process involved, to connect to sponsors, service providers, investigators, and sites, and other resources. It provides a toolkit containing many resources, including standard operating procedure templates, protocol templates and writing guidelines, investigator brochure information, and financial, and contractual tools.	Therapeutics	TRL 5, TRL 6, TRL 7, TRL 8	Preclinical testing and feasibility, Clinical studies	Network, Education and training, Forms and template, Guidelines	Clinical Trial Connection service Clinical Trial Toolkit Clinical trial budget costing tool Clinical trial SOP templates GCP, safety and compliance guidance Clinical trial protocol tools Clinical trial insurance and indemnity information Investigators brochure Early-stage clinical trial ethics and governance support
Commonwealth Scientific Industrial Research Organisation (CSIRO) Biologics Facility	The CSIRO Biologics Facility is a cGMP facility that can produce a variety of biologics, including recombinant proteins, peptides, and viral products for therapeutic applications. The facility can enable biologics for phase I and phase II clinical trials.	Therapeutics	TRL 6, TRL 7	Preclinical studies, Clinical studies	Infrastructure	Biologics manufacturing GMP grade
Commonwealth Scientific Industrial Research Organisation (CSIRO) Protein Production Facility	The CSIRO Protein Production Facility provides the infrastructure to support therapeutic discovery, screening of antibody libraries, production of recombinant proteins, engineered biologics in quantities large enough to support animal studies, Pre-clinical studies, and phase I clinical trials.	Therapeutics	TRL 3, TRL 4, TRL 5, TRL 6	Preclinical studies, Clinical studies	Infrastructure	Recombinant protein manufacturing
CT:IQ	CT:IQ is a collaborative of stakeholders involved in clinical trials. They form project teams to develop or adapt consensus recommendations and partner with other Australian organisations.	Therapeutics	TRL 6, TRL 7, TRL 8	Clinical studies	Guidelines, Forms and templates	Clinical trials Consumer involvement Checklists, toolkits, recruitment guides
Department of Cell and Molecular Therapies	The Department of Cell and Molecular Therapies located at Royal Prince Alfred Hospital and provides services to academic an industry partners for development, manufacture, clinical evaluation, and implementation of cell and gene therapies. They work to take discovery research into clinical practice with robust cell manufacturing protocols to meet TGA requirements for biologicals. The facility provides compliant manufacturing services to academic and industry partners, as well as providing support for development, manufacture, clinical evaluation, and implementation of novel cell and gene therapies.	Therapeutics	TRL 6, TRL 7, TRL 8, TRL 9	Clinical studies, Clinical implementation	Infrastructure	Conduct of clinical trials GMP compliant OGTR compliant Clinical manufacturing of genetically modified cells
FDA Guidance Document on Use of Public Human Genetic Variant Databases to Support Clinical Validity for Genetic and Genomic-Based In Vitro Diagnostics	The FDA has published a guidance document on the Use of Public Human Genetic Variant Databases to Support Clinical Validity for Genetic and Genomic-Based In Vitro Diagnostics. The guidance aims to support a flexible approach to the regulatory oversight of next-generation sequencing (NGS)- based tests, for which publicly accessible genetic databases may be useful to support the clinical validity of NGS tests as well as single gene or panel tests that use the technology.	Diagnostics	TRL 4, TRL 5, TRL 6, TRL 7	Clinical studies	Guidelines	Variant databases Clinical validity of genetic and genomic-based IVDs
FDA National Center for Toxicological Research (NCTR) Bioinformatic Tools	The NCTR conducts research in bioinformatics and cheminformatics, as well as coordinating capabilities. The NCTR have created a set of bioinformatic tools with the goal of developing methods for the analysis and integration of complex omics (genomics, transcriptomics, proteomics, metabolomics) datasets.	Therapeutics, Diagnostics	TRL 1, TRL 2, TRL 3, TRL 4, TRL 5, TRL 6, TRL 7, TRL 8	Early stage research, Preclinical testing and feasibility, Clinical studies	Infrastructure	Bioinformatics tools Multi-omic datasets Database of Pharmacogenomic Information in Ethnic Minority Populations Pattern recognition from microarray experiments, and proteomics research
Garvan Institute of Medical Research Research Services	The Garvan Institute of Medical Research has a range of established research capabilities that use state-of-the-art equipment and technologies to enable biomedical research. Some of these can be utilised by external researchers	Therapeutics, Diagnostics	TRL 1, TRL 2, TRL 3	Early stage research, Preclinical testing and feasibility	Infrastructure	Animal imaging Genetically modified mice Data science Flow cytometry Functional genomics NATA accredited sequencing Histopathology Microscopy Nanopore sequencing
Genomics Cancer Clinical Trials Initiative (GCCTI)	The GCCTI supports the national cancer Cooperative Trials Groups (CTGs to develop cancer clinical trial protocols for studies of molecularly-targeted treatments across multiple cancer types. These trials require a shift from disease-focussed models of clinical care to molecularly focussed alliances of scientists and clinicians, which will require different networks. The GCCTI is designed to provide specialist technical support to facilitate these interactions, generate concepts and support grant applications. The GCCTI can provide input and support in a number of ways, such as testing concepts, assessment of trial feasibility, identification and approach of potential partners, grant development, and others.	Therapeutics	TRL 6, TRL 7, TRL 8	Clinical Studies	Network	Molecular-targeted cancer therapies Clinical trial ideation and feasibility Cancer cooperative trials groups partnering Grant development Biostatistical support
Genomics Health Futures Mission (GHFM)	The GHFM will provide A$500 million over 10 years under the MRFF. It provides funding for research to support the integration of genomics knowledge and technology into clinical practice. The GHFM implementation strategy guides research investment and provides transparency on purpose and direction of investment.	Therapeutics, Diagnostics	TRL 1, TRL 2, TRL 3, TRL 4, TRL 5, TRL 6, TRL 7, TRL 8, TRL 9	Early stage research, Preclinical testing and feasibility, Clinical studies, Clinical implementation	Funding	Research funding Grant opportunities Strategic information on funding priorities
Global Alliance for Genomics & Health Catalogue of Genomic Data Initiatives	Provides a catalogue of genomic data initiatives that can be filtered by disease area, data type, initiative time and geographic region. The purpose of the catalogue is to identify and aggregate global resources for sharing clinical and genomic data.	Therapeutics, Diagnostics	TRL 1, TRL 2, TRL 3, TRL 4, TRL 5, TRL 6, TRL 7, TRL 8	Early stage research, Preclinical testing and feasibility, Clinical studies	Infrastructure	Catalogue of genomic data initiatives Data sharing Aggregate of global data resources
Global Alliance for Genomics & Health Regulatory & Ethics Toolkit	Provides a range of resources surrounding the regulatory and ethics guidance for genomics and health-related data sharing, which are ready to use, or adopt for individual purposes.	Therapeutics, Diagnostics	TRL 1, TRL 2, TRL 3, TRL 4, TRL 5, TRL 6, TRL 7, TRL 8, TRL 9	Early stage research, Preclinical testing and feasibility, Clinical studies, Clinical implementation	Guidelines, Forms and templates	Guidance on genomic data sharing Templates for data sharing
Independent Health and Aged Care Pricing Authority (IHACPA) Development of a table of standard costs for conducting clinical trials in Australia	IHACPA have developed a robust set of standard costs associated with conducting clinical trials in Australia, which may help with costing/budgeting a clinical trial.	Therapeutics	TRL 5, TRL 6, TRL 7, TRL 8	Preclinical testing and feasibility, Clinical studies	Guidelines, Forms and templates	Guidelines Clinical trial costing Standard costs associated with clinical trials
Industry Genomics Network Association (InGeNA)	InGeNA is the Industry Genomics Network Association in Australia. They act as a united voice for industry partners in Australia in the field of genomics and precision medicine. They partner with other organisations across Australia, such as research institutions, as well as undertaking work relevant to the industry perspective of genomics, such as workforce, and data. InGeNA can offer support to projects in the form of letters of support and connections to their members and broader network.	Therapeutics, Diagnostics	TRL 4, TRL 5, TRL 6, TRL 7, TRL 8, TRL 9	Early stage research, Preclinical testing and feasibility, Clinical studies, Clinical implementation	Network	Letters of support for projects Connection to members and partners (including industry) Links to useful references and resources Diagnostics/pathology, technology, pharmaceuticals
IP Australia	IP Australia is the Australian Government agency that administers intellectual property rights and legislation in Australia. As well as administering IP, they have a number of resources available, including educational information relating to identifying whether your idea is protectable by IP, and how to apply for patents, how to conduct a patent search, review a competitive landscape, and use of non-disclosure agreements.	Therapeutics, Diagnostics	TRL 1, TRL 2, TRL 3, TRL 4, TRL 5, TRL 6	Discovery research, Idea generation, Preclinical testing and feasibility, Clinical studies	Education and training, Guidelines and templates	IP education Information on patent applications IP searching IP search databases Information on patent searching Non-disclosure agreement template
Knowledge Commercialisation Australia IP and Commercialisation Training	Knowledge Commercialisation Australia is the peak body for research organisations involved in knowledge commercialisations and technology transfer. They offer free training resources associated with IP and commercialisation, for university researchers, staff and students.	Therapeutics, Diagnostics	TRL 3, TRL 4, TRL 5, TRL 6, TRL 7	Preclinical testing and feasibility, Clinical studies, Clinical implementation	Education and training	Free IP and commercialisation education and training Online training modules
Macquarie University Centre for the Health Economy (MUCHE) training courses	Conducts various short courses around health economics, such as health technology assessment and incorporating health economics into clinical trials. MUCHE works closely with government agencies, not-for-profit groups and commercial organisations. It can be engaged or partnered with to conduct services such as economic evaluation, program evaluation, policy assessment and econometrics.	Therapeutics, Diagnostics	TRL 6, TRL 7, TRL 8, TRL 9	Clinical studies, Clinical implementation	Education and training	Health economics training Health technology assessment training Health economics for clinical trials Scholarship opportunities
Medical Services Advisory Committee (MSAC) Documents for Applicants and Assessment Groups	Provides guidelines and templates for applying for a technology to be considered for public funding by the MSAC. This resource provides guidelines for preparing assessments for MSAC, and MSAC and MBS application forms.	Diagnostics	TRL 9	Clinical implementation	Guidelines, Forms and templates	Public funding requests MSAC Application Form
Medical Technology Association of Australia Clinical Investigation Research Agreements	The Medical Technology Association of Australia along with the Southern and Eastern Border States (which includes NSW) Committee, have developed a suite of clinical investigation research agreements for commercially sponsored studies of medical technology.	Therapeutics, Diagnostics	TRL 6, TRL 7, TRL 8	Clinical studies	Forms and templates, Guidelines	Clinical Investigations Research Agreements Agreements, forms of indemnity and compensation guidelines Medical technology
Medicines Australia Clinical Trial Research Agreements Templates	Medicines Australia along with the Southern and Eastern Border States (which includes NSW) Committee, have developed a set of five clinical trial research agreements, which can be used by any sponsor and/or institution for specific clinical trial scenarios.	Therapeutics	TRL 6, TRL 7, TRL 8	Clinical Studies	Forms and templates, Guidelines	Clinical Trial Research Agreements Legally enforceable clinical trial agreement templates
MTPConnect	Aiming to accelerate the rate of growth of the medical technology, biotechnology and pharmaceutical sector in Australia. MTPConnect aims to build connections between research and industry to support the development of scientific and technological breakthroughs from the proof-of-concept stage through to translation and commercialisation. Through the Growth Centre Project Fund Program MTPConnect commits funding for projects and also operates multiple MRFF programs that commit funding to support projects.	Therapeutics, Diagnostics	TRL 3, TRL 4, TRL 5, TRL 6, TRL 7, TRL 8, TRL 9	Preclinical testing and feasibility, Clinical studies, Clinical Implementation	Network, Funding	Sector connection and collaboration Project funding through grant programs Policy and regulatory advocacy
MTPConnect Bridge and BridgeTech Programs	The Bridge and BridgeTech Programs provide commercialisation training focused on the development of new pharmaceuticals and medical devices respectively. The programs are collaborations between universities and industry partners, and are available to researchers and entrepreneurs across Australia.	Therapeutics, Diagnostics	TRL 2, TRL 3, TRL 4, TRL 5	Early stage research, Preclinical testing and feasibility	Education and training	Commercialisation training Pharmaceutical development Medical device development
MTPConnect Researcher Exchange and Development within Industry (REDI) Training and Development Programs	MTPConnect’s REDI initiative provides industry experiences and skills development for researchers, clinicians and sector professionals. REDI partners with research, training and industry organisations to support skills development and deliver workforce training.	Therapeutics, Diagnostics	TRL 3, TRL 4, TRL 5, TRL 6, TRL 7, TRL 8, TRL 9	Preclinical testing and feasibility, Clinical studies, Clinical Implementation	Education and training, Network	Advanced manufacturing and supply chain Business operations Clinical trials Health data and cyber security Product development and commercialisation Internships and industry fellowships Mentoring
Murdoch Children’s Research Institute (MCRI) Project Data Management Plan Template	A template document provided by MCRI for a research data management plan, which includes sections covering ownership of data and intellectual property, data generation, collection, and use, data storage, post-project data, and others. This document can be tailored for research projects.	Therapeutics, Diagnostics	TRL 1, TRL 2, TRL 3, TRL 4, TRL 5, TRL 6, TRL 7, TRL 8	Early stage research, Preclinical testing and feasibility, Clinical studies	Forms and templates	Data management plan template Online resource
NATA Criteria Accreditation Packages	Contains various sets of documents associated with NATA accreditation to various standards. This resource is useful as regulatory applications are filed to implement diagnostic tests into NATA accredited laboratories to be performed in clinical practice.	Diagnostics	TRL 3, TRL , 4, TRL 5, TRL 6, TRL 7, TRL 8	Preclinical testing and feasibility, Clinical studies, Clinical implementation	Guidelines, Governance	NATA accreditation General accreditation criteria ISO 17025 (testing and calibration) accreditation GLP accreditation
NATA Education	Various courses associated with understanding and practices relating to NATA accreditation. This resource is useful as regulatory applications are filed to implement diagnostic tests into NATA accredited laboratories to be performed in clinical practice.	Diagnostics	TRL 3, TRL , 4, TRL 5, TRL 6, TRL 7, TRL 8	Preclinical testing and feasibility, Clinical studies, Clinical implementation	Education and training, Governance	NATA accreditation Understanding ISO 17025 Quality management in the laboratory
NATA Procedures for Accreditation (within NATA Criteria Accreditation Packages)	This document contains information regarding the NATA accreditation process, including relevant standards for various programs, including human pathology, and the procedures for acquiring NATA accreditation. This resource is useful as regulatory applications are filed to implement diagnostic tests into NATA accredited laboratories to be performed in clinical practice.	Diagnostics	TRL 3, TRL , 4, TRL 5, TRL 6, TRL 7, TRL 8	Preclinical testing and feasibility, Clinical studies, Clinical implementation	Forms and templates, Governance	NATA accreditation
National Computation Infrastructure (NCI) Australia	NCI is a high-performance data, storage and computing facility. It provides expert services to the Australian research sector to enhance the computational methods and capabilities available.	Therapeutics, Diagnostics	TRL 1, TRL 2, TRL 3, TRL 4, TRL 5, TRL 6, TRL 7, TRL 8	Early stage research, Preclinical testing and feasibility, Clinical studies	Infrastructure	Data services Supercomputing expertise Data collections management Data storage Visualisation
National Model of Consent for Clinical Genomic Testing	This national model aims to facilitate a consistent and standardised approach to optimise the consent process for genomic testing. The resource contains a template for consent for clinical genomic testing, guidance for health professionals obtaining consent for clinical genomic testing, and patient information materials. This resource would be helpful in planning for the service delivery associated with new genomic tests, however could also be useful during clinical evidence generation.	Diagnostics	TRL 7, TRL 8, TRL 9	Clinical studies, Clinical implementation	Forms and templates, Guidelines	Clinical genomic testing Consent template Patient information Guidance for healthcare professionals
National Pathology Accreditation Advisory Council (NPAAC) Accreditation Standards	NPAAC is responsible for developing and maintaining the accreditation standards for pathology laboratories in Australia. They publish various accreditation standards which may be applicable to the development of diagnostics in genomics. In particular: Requirements for human medical genome testing utilising massively parallel sequencing technologies Requirements for medical testing for human genetic variation	Diagnostics	TRL 3, TRL 4, TRL 5, TRL 6, TRL 7, TRL 8, TRL 9	Preclinical testing and feasibility, Clinical studies, Clinical implementation	Guidelines, Governance	Pathology accreditation standards Genetic pathology Massively parallel sequencing Development of IVDs
National Pathology Accreditation Advisory Council (NPAAC) Requirements for the Development and Use of In-House In Vitro Diagnostic Medical Devices (IVDs)	The Requirement for the Development and Use of In-house In Vitro Diagnostics Medical Devices (IVDs) outlines the principles and assessment criteria by which in-house IVDs must be designed, developed, produced, validated and monitored for use by medical laboratories in Australia.	Diagnostics	TRL 3, TRL 4, TRL 5, TRL 6, TRL 7, TRL 8, TRL 9	Preclinical testing and feasibility, Clinical studies, Clinical implementation	Guidelines	Pathology accreditation standards Requirements for development of IVDs Principles and investment criteria
NHMRC Clinical Trials Centre (CTC) at the University of Sydney	The NHMRC CTC is a centre of excellence in clinical trials research at the University of Sydney. They design and deliver trials related research, including coordination, monitoring, data acquisition, and management, and statistical analyses. The CTC conducts research across a range of areas including oncology, cardiovascular, health economics, translational research, biostatistics, kidney health and others.	Therapeutics, Diagnostics	TRL 6, TRL 7, TRL 8	Clinical studies	Infrastructure	Clinical trials research centre Clinical trial design and delivery Analysis of trial data Health economics, biostatistics, biomarker expertise
NHMRC Indemnity and insurance arrangements for clinical trials	NHMRC has conducted a review that outlines the indemnity and insurance arrangements concerning clinical trials across the public and private sectors.	Therapeutics, Diagnostics	TRL 6, TRL 7, TRL 8	Clinical studies	Guidelines	Clinical trial indemnity and insurance Guidelines
NHMRC Management of Data and Information in Research	A guidance document that supports the implementation of the ‘Australian Code for the Responsible Conduct of Research’, which includes the appropriate generation, collection, access, use, analysis, disclosure, storage, retention, disposal, sharing, and re-use of data and information. This resource is useful at all stages of the translation pathway, as data is often accessed, collected, analysed, stored, shared, and re-used at various stages.	Therapeutics, Diagnostics	TRL 1, TRL 2, TRL 3, TRL 4, TRL 5, TRL 6, TRL 7, TRL 8, TRL 9	Early stage research, Preclinical testing and feasibility, Clinical studies, Clinical implementation	Guidelines, Governance	Data management Responsible conduct of research Responsibilities of researchers
NHMRC Risk-based Management and Monitoring of Clinical Trials Involving Therapeutic Goods	A guidance document that supports the NHMRC ‘Guidance on Safety Monitoring and Reporting in Clinical Trials Involving Therapeutic Goods’, that combined advice regarding the application of risk-based trial processes, primarily written for sponsors of non-commercial products.	Therapeutics	TRL 6, TRL 7, TRL 8	Clinical studies	Guidelines, Governance	Non-commercial products Risk management
NSW Agency for Clinical Innovation Clinical Genomics Model of Care and Toolkit	Provides information around the service delivery of clinical genomics services, and associated toolkit resources associated with this, such as the referral criteria and information templates. This resource is useful at late-stage clinical studies to design them with the ultimate model of care in mind, and during implementation of genomic technologies.	Diagnostics	TRL 8, TRL 9	Clinical studies, Clinical implementation	Guidelines, Forms and templates	Model of care Clinical genomics Implementation toolkit Referral criteria and form
NSW Agency for Clinical Innovation Patient-reported measures resources	A set of resources associated with patient-reported measures, including information on how to use them, various questionnaire’s available, and online trainings. Use this resource during clinical studies to ensure that patient-reported measures are captured.	Therapeutics, Diagnostics	TRL 6, TRL 7, TRL 8	Clinical studies	Education and training, Forms and templates	Patient-reported outcome measures surveys Patient-reported experience surveys Clinician and patient resources
NSW Government Intellectual Property arising from Health Research Policy Document	This policy directive states the obligations of Public Health Organisations and employees regarding intellectual property arising from health research.	Therapeutics, Diagnostics	TRL 1, TRL 2, TRL 3, TRL 4, TRL 5, TRL 6	Early stage research, Preclinical testing and feasibility, Clinical studies	Guidelines	Intellectual property obligations and guidelines Intellectual property protection
NSW Health Centre for Genetics Education Clinical Genomics Research Resource	The clinical genomics research resource provides clinicians and clinician-researchers with important concepts associated with conducting clinical genomics research. This includes information and considerations associated with study design, ethics, participant consent, data management, and returning research results. Use this resource as you prepare to conduct clinical studies for genomic technologies.	Therapeutics, Diagnostics	TRL 6, TRL 7, TRL 8	Clinical studies	Education and training	Clinical genomics research Ethical considerations Gathering expertise Project design and preparation Participant recruitment and accessing samples Generating and analysing genomic data
NSW Health Commercialisation Training Program	Provides short training courses (on various topics including intellectual property, clinical trials, regulatory affairs and navigating the healthcare system) that provide knowledge and skill on how to commercialise innovations successfully. There are a variety of courses, suitable for those undertaking commercial research and development. If in the early stages, there is an online course and seminars on building foundational commercial knowledge and skills. The program also offers targeted training in specific sectors including therapeutics, medical devices, software as a medical device and diagnostics for those who are more progressed and have validated their idea.	Therapeutics, Diagnostics	TRL 1, TRL 2, TRL 3, TRL 4, TRL 5, TRL 6, TRL 7, TRL 8	Discovery research, Idea generation, Preclinical testing and feasibility, Clinical studies	Education and training	Commercialisation Introduction to IP Regulatory affairs Clinical trials Navigating the healthcare system Business fundamentals Customer discovery Medtech foundations Specialised training in medical devices, diagnostics, therapeutics and software as a medical device
NSW Health Early Phase Clinical Trials (HREC) Scheme	The Early Phase Clinical Trials HREC Scheme (a service of clinicaltrialsNSW) provides support for consistent, high quality, scientific ethics review and approval process for all clinical trial phases up to but not including phase II.	Therapeutics	TRL 5, TRL 6	Preclinical testing and feasibility, Clinical studies	Governance, Guidelines, Forms and templates	Early-phase clinical trials Ethics application Ethics review and approval
NSW Health Education and Training Effective Business Case Design	A short course which helps NSW Health staff with the principles and skills required to develop a successful business case within NSW Health organisations.	Therapeutics, Diagnostics	TRL 6, TRL 7, TRL 8, TRL 9	Clinical studies, Clinical implementation	Education and training	Business case development Training on business case requirements and development
NSW Health Increasing the Scale of Population Health Interventions: A Guide	A guide for the scaling up of health interventions, which covers a scalability assessment, developing a scaling plan, preparing for scaling up, and then scaling the intervention. It can also be useful when considering designing research studies for interventions that are potentially suitable for scaling. Therefore, this resource may be useful during late clinical studies and clinical implementation.	Therapeutics, Diagnostics	TRL 8, TRL 9	Clinical studies, Clinical implementation	Guidelines	Scaling health interventions Scalability assessment Developing a scaling plan Preparing for scaling up
NSW Health Intellectual Property & Commercialisation Framework	The NSW Health Office for Health and Medical Research has updated the policy directive on intellectual property arising from health research, and provided a guidance document that aims to provide accessible information to NSW Health employees engaged in the commercialisation of intellectual property. The policy directive only applies to employees within NSW Health Public Health Organisations.	Therapeutics, Diagnostics	TRL 1, TRL 2, TRL 3, TRL 4, TRL 5, TRL 6	Early stage research, Preclinical testing and feasibility, Clinical studies	Guidelines	Intellectual property protection Commercialisation of intellectual property Guidelines and framework
NSW Health Medical Devices Fund	The NSW Health Medical Devices Fund is a competitive technology development and commercialisation program. The fund provides funding support to individuals, companies, public and private hospitals, medical research institutes, and universities based in NSW across the medical devices industry to take local innovation to market. The Fund increases the uptake of NSW medical devices by the health system, where they are cost effective and contribute to improved patient outcomes.	Diagnostics, Devices	TRL 3, TRL 4, TRL 5, TRL 6, TRL 7, TRL 8	Preclinical testing and feasibility, Clinical studies, Product development	Funding, Commercialisation	Medical device grant funding Technology development and commercialisation
NSW Health New Health Technologies and Specialised Services Guideline	The NSW New Health Technologies and Specialised Services Guideline outlines the process for the assessment and implementation of new health technologies from the local to statewide level.	Therapeutics, Diagnostics	TRL 9	Clinical implementation	Funding, Guidelines, Forms and templates	Specialty health services Purchasing decisions Statewide implementation
NSW Health Pathology Research Services	NSW Health Pathology offer a range of research services, such as access to biospecimens and data, as well as being able to perform a range of genomic sequencing services, which can support research projects in various ways.	Therapeutics, Diagnostics	TRL 1, TRL 2, TRL 3, TRL 4, TRL 5, TRL 6,	Early stage research, Preclinical testing and feasibility, Clinical studies	Infrastructure, Guidelines	Clinical research services Biomarker discovery NSW Health Statewide Biobank research services Analytical and/or clinical validation of new tests
NSW RNA Production and Research Network	Provides the research community with the required materials, services, and support to translate newly developed RNA therapeutics into advanced pre-clinical studies, and includes three pillars; Production, Pilot Research, and Services & Support.	Therapeutics	TRL 3, TRL 4, TRL 5	Preclinical testing and feasibility	Network, Infrastructure	mRNA. RNA. LNP production Sequencing Animal testing Proteomics High-throughput tests GLP and GMP training
NSW Treasury Business Case Resources	Guidelines and templates associated with developing a business case for investments by the government.	Therapeutics, Diagnostics	TRL 6, TRL 7, TRL 8, TRL 9	Clinical studies, Clinical implementation	Guidelines, Forms and templates	Business case development Business case templates
Ocular Gene and Cell Therapies Australia	A joint initiative between Sydney Children’s Hospital Network, Children’s Medical Research Institute, Save Sight Institute, and the University of Sydney, which aim to accelerate the genomic diagnosis and development of novel genetic therapies for ocular diseases in Australia. The program is made up of research experts. The work includes the translation of multi-omics for additional diagnostic and mechanistic insights in ocular diseases, development of further novel genetic and cellular therapies, and clinical trial and clinical delivery of genetic therapies.	Therapeutics, Diagnostics	TRL 2, TRL 3, TRL 4, TRL 5, TRL 6, TRL 7, TRL 8, TRL 9	Early stage research, Preclinical testing and feasibility, Clinical studies, Clinical implementation	Network	Advanced therapies Multi-omic research Paediatric and adult ocular diseases
Office of the Gene Technology Regulator Resources	Resources, such as guidelines, forms, and protocols, which are associated with the regulation of the use of genetically modified organisms in human health – including developing diagnostic tests, treating genetic diseases with gene therapies, and developing targeted medicines. Use this resource during clinical studies and clinical delivery to ensure that the proper regulations around gene technologies are followed.	Therapeutics, Diagnostics	TRL 6, TRL 7, TRL 8, TRL 9	Clinical studies, Clinical implementation	Guidelines, Forms and templates, Governance	Research on gene technology Physical containment facilities
Omico	Omico is an initiative which bring together partners from leading cancer centres, research institutes, the government, industry and patients, to help facilitate the use of genomics in cancer clinical trials	Therapeutics, Diagnostics	TRL 6, TRL 7, TRL 8	Clinical studies	Network	Cancer molecular screening
Pathology Technology Australia	Pathology Technology Australia is the peak body of Australian sponsors, manufacturers, and distributors of in vitro diagnostics and innovative pathology technology.	Diagnostics	TRL 3, TRL 4, TRL 5, TRL 6, TRL 7, TRL 8, TRL 9	Preclinical testing and feasibility, Clinical Studies, Clinical implementation	Network, Governance	Pathology Peak industry body Representation of manufacturers and importers of tests and technologies
Patient Organisations (multiple)	Many individual patient organisations exist across Australia and globally for a wide range of diseases. Patient organisations may help in multiple ways, however support provided will vary by specific research project, and individual organisation. Some areas in which patient organisations may help, include: Many individual patient organisations exist across Australia and globally for a wide range of diseases. Patient organisations may help in multiple ways, however support provided will vary by specific research project, and individual organisation. Some areas in which patient organisations may help, include: Providing grants and funding for promising research projects that have the potential to improve patient outcomes in that specific disease area May be able to help with further understanding of patient perspective, management, and outcome of interest in the specific disease area, which can be utilised in product development and clinical trial design May help with patient recruitment for studies across Australia Can be involved in providing consumer/ patient voice for funding applications	Therapeutics, Diagnostics	TRL 1, TRL 2, TRL 3, TRL 4, TRL 5, TRL 6, TRL 7, TRL 8, TRL 9	Early stage research, Preclinical testing and feasibility, Clinical studies, Clinical implementation	Network, Funding	Funding opportunities Patient recruitment Patient voice
Phenomics Australia	Phenomics Australia is supported the Australian Government’s National Collaborative Research Infrastructure Strategy (NCRIS) and provides a range of services to enable precision medicines, and better health through discovery of gene function.	Therapeutics, Diagnostics	TRL 1, TRL 2, TRL 3, TRL 4, TRL 5	Early stage research, Preclinical testing and feasibility	Infrastructure	Mouse sperm and embryo biobank Bespoke in vivo genome engineering and disease modelling In vitro genome engineering and disease modelling (includes cell, organoid, tissue models and 3D bioprinting) Next-generation sequencing Phenotyping Bioinformatic capabilities Functional genomics High-throughput screening Histopathology Missense mutation library International Mouse Phenotyping Consortium searchable database of genomic and phenotypic information for in vivo disease models
Postgraduate Courses (various)	There are numerous postgraduate courses offered across a variety of topics which may be useful in learning and developing knowledge and skills across a range of topics. Individual courses from various postgraduate courses may also be taken as opposed to undertaking an entire course. Some of the relevant courses in NSW include: University of Sydney Genomics and Precision Medicine University of New South Wales Medicine and Health Short Courses	Therapeutics, Diagnostics	TRL 1, TRL 2, TRL 3, TRL 4, TRL 5, TRL 6, TRL 7, TRL 8, TRL 9	Early stage research, Preclinical testing and feasibility, Clinical studies, Clinical implementation	Education and training	Short postgraduate courses Genomics and precision medicine upskilling and training
Ramaciotti Centre for Genomics	Includes multiple pieces of technology/ infrastructure associated with sequencing, expression analysis, and high throughput microarray systems, which are useful during the early research, preclinical testing, and feasibility stages of development.	Therapeutics, Diagnostics	TRL 2, TRL 3, TRL 4, TRL 5	Early stage research, Preclinical testing and feasibility	Infrastructure	Sequencing Microarrays Bioinformatics ISO 17025 accredited
Sydney Cell & Gene Therapy	Provides access to leading experts, state-of-the-art GMP certified clean room facilities, and robust quality systems intended to promote advances in cell and gene therapies. The facilities and expertise offered can be useful during clinical studies to enable product development utilising appropriate grade material.	Therapeutics	TRL 6, TRL 7, TRL 8	Clinical studies, Product development	Network, Infrastructure	GMP clean rooms Aseptic and biocontained manufacturing suites NATA accredited pathology Technical expertise
Sydney Health Partners Clinical Trial Resources	Contains various resources for those who want to learn more about running clinicals trials. It includes resources for investigator-initiated trials, such as ethics and governance information, electronic mater file resources, lists of standard operating procedures, and more.	Therapeutics, Diagnostics	TRL 6, TRL 7, TRL 8	Clinical studies	Education and training	Investigator-initiated trials Electronic trial master file Clinical trial recruitment
Sydney Health Partners Ethics and Governance Resources	Provides some resources associated with understanding and applying for ethics and governance approvals for clinical and health services research.	Therapeutics, Diagnostics	TRL 6, TRL 7, TRL 8	Clinical studies	Education and training, Governance	Ethics and governance Governance checklist HREC fundamentals HREC submission deadline calendar
Sydney Health Partners Genomics and Precision Medicine Partnerships	Genomics and Precision Medicine Partnerships is a Clinical Academic Group of Sydney Health Partners, with an implementation science research approach for upskilling and integration of genomic diagnostics and advanced/precision therapies across all subspecialty groups.	Therapeutics, Diagnostics		Clinical studies, Clinical implementation	Education and training, Forms and templates	Genomics and precision medicine upskilling and training Implementation science Network of experts (ophthalmology, paediatrics, women's health and family medicine, nephrology, metabolic medicine and neurogenetics, implementation science, diagnostic genomics) Research on genomics translation and model of care
Sydney Health Partners Implementation Science Resource Hub	A library of resources (including articles, videos, textbooks, and templates) to help develop skills in implementation science, which may be useful in late-stage clinical studies and implementation.	Therapeutics, Diagnostics		Clinical studies, Clinical implementation	Education and training, Forms and templates	Implementation science Implementation in research grants
Sydney Partnership for Health, Education, Research and Enterprise (SPHERE) GenomeConnect Clinical Academic Group	A core team with clinical geneticists, genetic counsellors, genetic pathologists, biomedical scientists, health economists, and education experts, whose goal is to provide further education in genomics, create genomics transition clinicians, and better manage patient’s genomic information.	Therapeutics, Diagnostics	TRL 2, TRL 3, TRL 4, TRL 5, TRL 6, TRL 7, TRL 8, TRL 9	Early stage research, Preclinical testing and feasibility, Clinical studies, Clinical implementation	Network, Education and training	Clinical genomics education and workshops Network of experts (clinical geneticists, genetic pathologists, health economists) Research on genomics translation and model of care
Terra Bio	Terra is a scalable platform for accessing data, running analysis tools and collaborating in biomedical research, including an online data library, interactive analyses, workflows and workspaces as part of an open data ecosystem.	Therapeutics, Diagnostics	TRL 1, TRL 2, TRL 3, TRL 4, TRL 5	Early stage research, Preclinical testing and feasibility	Infrastructure	Data management Data discovery Cloud-based tools and workspaces
Therapeutic Goods Administration Clinical Trials Information	Provides information, guidance and forms associated with the regulatory considerations of initiating clinical trials in Australia.	Therapeutics, Diagnostics	TRL 6, TRL 7, TRL 8	Clinical studies	Education and training, Guidelines, Governance	Good clinical practice inspection program Clinical trials notification scheme Clinical trials approval scheme
Therapeutic Goods Administration ICH Guideline for Good Clinical Practice	The International Council for Harmonisation (ICH) Guideline of Good Clinical Practice (GCP) is an international accepted standard for designing, conducting, and reporting of clinical trials. The Therapeutic Goods Administration have provided some additional comments on this Guideline.	Therapeutics, Diagnostics		Clinical studies	Education and training, Guidelines	Principles of ICH GCP Investigator brochure Clinical trial protocol and protocol amendments
Therapeutic Innovation Australia iQDOCs – Quality Documents	Contains a set of over 450 open access generic quality system documents that relate to development, manufacturing, and testing to satisfy the requirements of a relevant regulatory or accrediting body (including NPAAC, TGA, FDA). The variety of quality documents are useful during preclinical and feasibility testing through to late clinical studies.	Therapeutics, Diagnostics	TRL 3, TRL 4, TRL 5, TRL 6, TRL 7, TRL 8	Preclinical testing and feasibility, Clinical studies	Forms and templates	Quality documents ISO 17025 ISO 9001 ISO 13485 ISO 15189 NPAAC ICH-GCP PICS GMP Medicines TGA cGMP Human Blood and Tissues FACT
University of New South Wales (UNSW) Founders 10X Accelerators	UNSW Founders 10x Accelerators are suited for high potential tech-enabled startups. Two of the streams that are relevant to potential genomic technologies and are open to anyone are the Health (H10x) accelerator, designed for teams developing affordably and scalable solutions for global unmet medical needs, and the SynBio (S10x), which accelerate the growth of synthetic biology start-ups through providing access to PC2 labs and shared scientific infrastructure.	Therapeutics, Diagnostics	TRL 1, TRL 2, TRL 3, TRL 4	Discovery research, Idea generation, Preclinical testing and feasibility	Network, Funding, Infrastructure	Accelerator Funding Infrastructure Synthetic biology Global health needs Commercialisation expertise
University of New South Wales (UNSW) Recombinant Products Facility (RPF)	The RPF is an ISO 9001 accredited research facility located at UNSW that offers protein production and purification services. The RPF also offers training.	Therapeutics	TRL 3, TRL 4, TRL 5, TRL 6	Preclinical testing and feasibility, Clinical studies	Infrastructure, Education and training	ISO 9001 accredited Protein expression Protein production Protein purification Protein characterisation Training
University of Sydney Digital Research Infrastructure	Provides access to many high-performance computing and cloud facilities, digital platforms and tools, including research data management platforms. These tools may be useful from early research, Preclinical testing and feasibility, and clinical studies for the various data and computing needs associated with the use, analysis, and generation of data in genomics-related research.	Therapeutics, Diagnostics	TRL 2, TRL 3, TRL 4, TRL 5, TRL 6, TRL 7, TRL 8	Early stage research, Preclinical testing and feasibility, Clinical studies	Infrastructure	Research computing facilities and services Research data management platforms Bioinformatics platforms
University of Technology Sydney (UTS) Centre for Health Economics Research and Evaluation (CHERE)	The CHERE conduct research into health economics, health services, and health policy. The centre runs two programs funded by Cancer Australia to support cancer research. The Cancer Research Economic Support Team (CREST), which provides expert advice to the cancer cooperative trials groups (CTGs) on the use of health economic approach, and economic evaluation, to evaluate the costs and outcomes of interventions being tested in cancer clinical trials. Similarly, the Cancer Quality of Life Expert Service Team (CQUEST) provide high-quality advice and support to the CTGs about the inclusion of patient reported outcomes in their clinical trials and other studies.	Therapeutics	TRL 5, TRL 6, TRL 7, TRL 8	Clinical Studies	Infrastructure, Education and training	Health economics Cancer clinical trials Patient reported outcomes in cancer clinical trials
University of Technology Sydney (UTS) Good Manufacturing Practice Courses	UTS, in partnership with SeerPharma, provides various programs designed to provide knowledge of regulations, compliance, and process development and quality assurance in the pharmaceutical, medical device, and biotechnology sectors. These programs can be accessed to gain knowledge of Quality Good Manufacturing Practice for product development.	Therapeutics	TRL 6, TRL 7, TRL 8	Clinical studies, Product development	Education and training	Quality Good Manufacturing Practice (GMP) education programs Process development and quality assurance Regulations (TGA, FDA, EU and PIC/s) and compliance
VCCC Alliance Consumer Engagement Toolkit	The Victorian Comprehensive Cancer Centre (VCCC) Alliance provides toolkit resources to support organisations to engage with consumers effectively and enhance their quality of engagement and partnership. Resources such as the ‘Consumer engagement in research’ checklist can be useful for researchers looking to build relationships with consumers to enable them to be effective members of their research projects.	Therapeutics, Diagnostics	TRL 1, TRL 2, TRL 3, TRL 4, TRL 5, TRL 6, TRL 7, TRL 8	Early stage research, Preclinical testing and feasibility, Clinical studies	Education and training, Guidelines	Consumer engagement Recruitment Consumer participation requests Checklists Remuneration
VCCC Alliance Investigator-Initiated Trials Toolkit	The Victorian Comprehensive Cancer Centre (VCCC) Alliance, along with the Melbourne Academic Centre for Health, and the Melbourne Children’s Trials Centre, have developed a suite of resources to support researchers conducting investigator initiated trials. This includes information and resources associated with outlining roles and responsibilities in conducting these trials, preparing clinical trial budgets, risk management of these trials, and data management.	Therapeutics, Diagnostics	TRL 6, TRL 7, TRL 8	Clinical studies	Education and training, Forms and templates	Investigator-initiated trials Clinical trials budget Clinical trial agreement Risk management Data management
Venture Capital (various)	Venture Capital is a type of funding that provide private capital for early-stage companies in exchange for equity. Whilst there are over 100 venture capital organisations active across Australia, due to the unique considerations associated with investment into life science technologies, only a limited few typically invest in this sector. Companies which are active in life science investment include (however are not exclusive to): Brandon Capital UniSeed OneVentures BioScience Managers The IP Group	Therapeutics, Diagnostics	TRL 1, TRL 2, TRL 3, TRL 4, TRL 5, TRL 6	Early stage research, Preclinical testing and feasibility, Clinical studies	Funding	Funding Private capital
VicHealth Partnerships Analysis Tool	A resource for organisations entering into or working in a partnership to assess, monitor, and maximise ongoing effectiveness. This resource is useful for understanding the purpose of collaborations and determining ways to strengthen new and existing partnerships.	Therapeutics, Diagnostics	TRL 1, TRL 2, TRL 3, TRL 4, TRL 5, TRL 6, TRL 7, TRL 8	Early stage research, Preclinical testing and feasibility, Clinical studies	Education and training, Guidelines	Partnerships analysis tool Assessment and monitoring of partnerships and collaborations Checklists and assessment tools
Victor Chang Cardiac Research Institute, Biomedical Data Science Facility Services	Aids in the generation, interpretation, and analysis of large biological data sets, which may be useful in identifying and validating product hypotheses. These services are likely to be useful during the early research and Preclinical testing and feasibility stages of the value chain where one may be developing large datasets for analysis, such as from imaging, multi-omic research, and high-throughput screening.	Therapeutics, Diagnostics	TRL 1, TRL 2, TRL 3, TRL 4	Early stage research, Preclinical testing and feasibility	Infrastructure	Data science services Software development Genomic analysis Fee-for-service

About this navigation tool

This navigation tool is a supporting resource to the NSW Health Translating Genomics Research into Clinical Practice Framework that maps supports (services, infrastructure, capabilities, resources) across the genomics translational value chain in NSW.

Researchers can view and export resources relevant to the maturity of their genomic technology along the Technology readiness level (TRL) development pathway.

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We provide this navigation tool for genomics researchers to access a summary of resources available that could help progress their research.

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