There is growing demand in the medical research and health industries for graduates with the skills to understand and use a range of techniques and technologies, to interpret medical and research data, and to translate scientific and laboratory findings into clinical practice. By undertaking this unit of study you will hone and expand your skills and knowledge in analytical and clinical laboratory techniques that apply to a range of specialisations and workplace settings, including hospital, forensic and veterinary biotechnology laboratories and clinics, industrial research and medical biotechnology laboratories. Your learning will take place in state-of-the-art teaching laboratories utilising techniques and equipment relevant to your chosen area of specialisation. The skills you learn will equip you with the methods and theoretical underpinings of tools required in the analysis, detection, diagnosis, treatment and research of disease across a range of settings.

There is growing demand in the medical research and health industries for graduates with the skills to understand and use a range of techniques and technologies, to interpret medical and research data, and to translare scientific and laboratory findings into clinical practice. As a student with experience in relevant settings, this unit of study will help you further develop and expand your skills ad knowledge in analytical and clinical laboratory techniques that apply to a range if specialisations and workplace settings, including hospital, forensic and veterinary laboratories and clinics, industrial research and medical biotechnology laboratories. Your learning will take place in state-of-the-art teaching laboratories utilising techniques and equipment relevant to your chosen area of specialisation. The skills you learn will further equip you with the methods and theoretical underpinnings of laboratory techniques and tools at the cutting edge if detection, diagnosis and treatment of disease across a range of settings.

Diagnostic sciences are continuing to evolve at a rapid pace and provide the cornerstone of our health care system. Effective diagnostic assays enable the identification if people who have, or are at risk of, a disease, and guide their treatment. Research into the pathophysiology of disease underpins the discovery of novel biomarkers and in turn, the development of revolutionary diagnostic assays that make use of state-of-the-art molecular and cellular methods. In this unit you will explore and expand a diverse range of diagnostic tests and further valuable practical experience in a number of core diagnostic methodologies, many of which are currently used in hospital laboratories. Together we will also cover the regulatory, social, and ethical aspects of the use of biomarkers and diagnostic tests and explore the pathways to their translation into clinical practice. By undertaking this unit, you will further your technical expertise in, and theoretical underpinnings of, diagnostic assays and biomarkers, and further the skills needed to embark on a career in diagnostic sciences.

This unit of study will provide students with knowledge about detection, monitoring and control of existing and emerging pathogens, and with the necessary skills to plan epidemic preparedness strategies, to identify optimal approaches for communicable disease prevention, containment or eradication and to evaluate their effectiveness. This module offers a multidisciplinary framework for understanding the principles of interventions against infectious diseases and focuses on the study of global infectious disease threats in the context of their routes of transmission and potential intervention strategies, as well as the reasons for the success or failure of control programs. The core of this unit is a series of lectures, practical demonstrations and problem­ solving tutorials describing real-­life examples of diagnostic and surveillance strategies and vaccination policies, community outbreak investigations and epidemic/pandemic control and preparedness planning using COVID-19 examples. A significant proportion of the lectures are delivered by invited expert infectious disease practitioners and laboratory scientists. The main principles will be illustrated using examples from pandemic and seasonal influenza, arbovirus diseases, tuberculosis, zoonotic and food­ and water­borne bacterial infections. A large portion of this unit is based at the State public health reference laboratories of the Institute of Clinical Pathology and Medical Research (NSW Health Pathology) at Westmead Hospital, Sydney Medical School ­ Westmead Campus.

Effective prevention and treatment of disease requires early, accurate and specific diagnoses. Biomedical advances in disease diagnosis and treatment are underpinned by the fundamentals of physics, cell biology and biochemistry. New imaging modalities for example, allow us to diagnose neurological diseases earlier and track the course of metastic cancers. New discoveries about how our genes contribute to disease enable design of novel intervention strategies that are leading to cures for some genetically-based diseases. And break-throughs in immunology mean we can now harness the power of our immune system to fight disease. In this unit, you will hear from clinician scientists at the frontier of biomedical research and translation. Working independently and in groups, you will deepen your knowledge and applicationn of the theory and technologies that underpin disease diagnosis and treatment. This will equip you to participate in the latest developments to diagnose and treat diseases.

Recent technological advances in genetics and genomics have had a significant impact on medical care This unit provides an introduction to the detection of genetic variation in the context of human disease and an overview of bioinformatics techniques and approaches for the analysis of genomic and other omic data Technologies include types of deep resequencing including whole exome and whole genome sequencing the library preparation methods and sequencing chemistries and platforms Methodologies and applications to diseases discussed include detection of base substitutions and splicing variants copy number variants and other structural variants An understanding of which methodologies to be used to detect different types of genetic variants will be developed Cases will be used to illustrate the importance of integrating phenotypic data genomic information and variant interpretation for accurate diagnosis You will discuss techniques to prioritise variant pathogenicity and the application of new technologies in gene editing as well as omic technologies including transcriptomics proteomics and metabolomics and their current and future application to medical care

Genomics has revolutionised medicine, providing information on a scale not previously available. Pathogen Genomics is part of this revolution and the applications of this technology have provided crucial information on pathogen discovery, new drug development, control of outbreaks and antibiotic resistance. This unit of study will introduce students to analysis of bacterial and viral genomes and main applications of genomics for translational research, precision medicine and control of diseases with epidemic potential. Students will learn how DNA is sequenced in the laboratory and develop analytical skills in microbial genomics, using public databases and the University of Sydney's high­performance computing cluster. A combination of lectures delivered by domain experts and interactive practicals will provide detailed understanding of the key concepts of genomics utilized in research and clinical practice. Case studies will enable students to perform genomic analyses and apply the technological knowledge gained from the unit to examine virulence, drug resistance and evolution of pathogens with epidemic potential. This unit will equip students with knowledge and skills important for careers in biomedical research and healthcare.

This unit of study aims to introduce the student to the strategy of the Charles Perkins Centre to ease the burden of obesity, diabetes and cardiovascular disease. While other approaches would focus on these diseases as purely medical conditions this unit will challenge the student to focus on an interdisciplinary approach, bringing together medicine, biological science, psychology, economics, law, agriculture and other disciplines to understand how real world solutions for these diseases might be developed. Students will be exposed to the world-renowned researchers based in the Charles Perkins Centre and will gain insight into the research strategy of the Centre. Students will also have the opportunity to develop a new interdisciplinary project node for the Centre in collaboration with one of our research leaders.

This unit of study provides a broad overview of the processes involved in translating a new drug, formulation and/or medical device from a laboratory setting to an approved product. It is targeted at people interested in or already working in the pharmaceutical or medical device industries, and advisors in the regulatory sector. Three core areas are covered: (1) the regulatory organisation, (2) requirements during drug discovery and device conception, manufacture and clinical trials, and (3) post-registration pharmacovigilance and pharmacoeconomics . Students will gain knowledge of the Therapeutic Goods Administration (TGA) and guidelines for the registration and regulation of medical devices and medicines. Students will also learn the importance of international regulations, harmonisation and application to the Australian market. The unit covers R and D; manufacturing and clinical trial requirements; the concepts of good laboratory and manufacturing practices (GMP, GLP) and quality by design (QbD); as well as regulator accepted laboratory methodologies used for submission of product dossiers and medical device documentation. The basics of clinical trial design will be analysed, as well as concepts of pharmacokinetics, dynamics, pharmacoeconomics and clinical endpoints for registration of new products using case studies and online tutorials. Special requirements for the registration and testing of generic medicines will also be part of the unit.

This unit of study develops knowledge in current state­ of ­the ­art therapeutic technologies. The principles of mode of action are investigated, along with methods of manufacture and registration. The unit is targeted at people already in or interested in the pharmaceutical and medical devices industries, and advisors in the regulatory sector. It covers 4 core areas of regulation in Australia: (1) biologicals and personalised medicine, (2) cell based products, (3) medical devices and (4) classical formulations. The principles that underpin these innovative therapies are covered in terms of development, targeting and manufacture along with the application of genomics in personalised medicine. Classical formulations (i.e. oral, respiratory and injectable dosage forms) will be covered and advances within the field such as regulation of nanotechnology will also be discussed. Students will investigate the processes of manufacture, verification and validation testing to ensure regulations are met. The emerging area of cellular immunotherapy for cancer treatment will be discussed. Students will gain knowledge of the different types of therapies within this space. Case studies will be evaluated, including the challenges associated with bringing these therapies and devices to market.
Classical formulations (i.e. oral, respiratory and injectable dosage forms) will be covered and advances within the field such as regulation of nanotechnology will also be discussed.

This unit of study will focus on the strengths and weaknesses of different clinical study designs. Designs considered will include cohort (retrospective and prospective), cross-sectional, case-control and randomized controlled designs. The different phases of clinical trial designs in the development of therapies will also be examined including phase I (first in man), phase II/pilot and phase III comparative designs. Extension and adaptation of randomized designs will also be covered including cluster and factorial designs and adaptive pilot studies. Students will gain the skills necessary to choose between these designs for best practice. Types of outcomes (continuous, categorical, time-to-event) will be discussed. Methods of allocating participants to interventions (randomization), as well blinding and allocation concealment will be covered together with aspects of protocol development. On completion of this unit, the student will be familiar with the differences between study types and study designs, as well as the principles and practice of randomisation. It is also expected that the candidate will be able to develop stratified randomisation schemes for their own studies.

Candidates will be taught skills to design and interpret equivalence trials, non-inferiority trials and cluster randomised trials. Specialised designs including enrichment and discontinuation designs will be discussed and special aspects relating to cross-over studies will be taught. Techniques to validly incorporate composite, co-primary and surrogate endpoints will be covered. Distinctions between event and chronological time directed outcomes will be discussed. Skills to incorporate sub-studies into clinical research projects will be covered in this unit.

Information technology (IT) has significantly contributed to the research and practice of medicine, biology and health care. The IT field is growing enormously in scope with biomedicine taking a lead role in utilising the evolving applications to its best advantage. The goal of this unit of study is to provide students with the necessary knowledge to understand the information technology in biomedicine. The major emphasis will be on the principles associated with biomedical digital imaging systems and related biomedicine data processing, analysis, visualisation, registration, modelling, retrieval and management. A broad range of practical integrated clinical applications will be also elaborated.

Undertaking the biomedical research project is your first step toward becoming an independent research scientist. You will be immersed in a research environment and work towards solving an important issue related to your area of specialization and in a field of interest to you. You will design and carry out experiments and communicate your findings through a thesis. Successfully completing the research project capstone will prepare you for undertaking higher degree research (e.g. a PhD) or a variety of careers in the medical sciences.

Undertaking the biomedical research project is your first step toward becoming an independent research scientist. You will be immersed in a research environment and work towards solving an important issue related to your area of specialization and in a field of interest to you. You will design and carry out experiments and communicate your findings through a thesis. Successfully completing the research project capstone will prepare you for undertaking higher degree research (e.g. a PhD) or a variety of careers in the medical sciences.

In this unit of study you will work collaboratively on authentic, complex problem-based projects developed with the University's external Partners and driven by industry and community needs. You will work in teams to identify a unique issue or opportunity wthin a broader problem relating to your areas of interest, bringing your disciplinary knowledge to real-world problems in biomedical sciences and health. You will engage in self-directed, inquiry-based research and problem solving with the support of a Project Supervisor. Your Project Partner will provide valuable insights into the industry as well as access to information that will assist you with your investigation and provide context for your final recommendations. In addition to deepening your understanding around project-related issues, you will further develop your skills in critical reflection, collaboration, complex problem solving and interdisciplinary effectives through evidence-based teaching approaches and workshop. By undertaking the industry and community project as your capstone experience in your current program you will be equipped with the adaptability and agility to successfully navigate contemporary issues in your area of specialisation.

In this unit of study you will work collaboratively on authentic, complex problem-based projects developed with the University's external Partners and driven by industry and community needs. You will work in teams to identify a unique issue or opportunity wthin a broader problem relating to your areas of interest, bringing your disciplinary knowledge to real-world problems in biomedical sciences and health. You will engage in self-directed, inquiry-based research and problem solving with the support of a Project Supervisor. Your Project Partner will provide valuable insights into the industry as well as access to information that will assist you with your investigation and provide context for your final recommendations. In addition to deepening your understanding around project-related issues, you will further develop your skills in critical reflection, collaboration, complex problem solving and interdisciplinary effectives through evidence-based teaching approaches and workshop. By undertaking the industry and community project as your capstone experience in your current program you will be equipped with the adaptability and agility to successfully navigate contemporary issues in your area of specialisation.