Level 7 Monash Health Translation Precinct Translational Research Facility Hudson Institute of Medical Research Melbourne Australia

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1 Level 7 Monash Health Translation Precinct Translational Research Facility Hudson Institute of Medical Research Melbourne Australia Monash Health Translation Precinct: A partnership of Monash University, Hudson Institute of Medical Research and Monash Health.

2 2 Executive Summary and Background The Monash Health Translation Precinct (MHTP) brings together the largest health service in Victoria, Monash Health, with the largest university in Australia, Monash University, and the world-renowned Hudson Institute of Medical Research, to translate innovative scientific research into clinical practice. Together, they are a major contributor to Monash Partners Academic Health. United in the vision to be world leaders in translational research, MHTP partners have created a unique environment, which thematically co-locates our research and facilities at Monash Medical Centre (Figure 1). The MHTP s Translational Research Facility (TRF) is a purpose-built research space designed to drive research-based healthcare and provides a unique site for multidisciplinary, translational medical research in partnership with commercial entities such as Miltenyi Biotec. Recently launched, the $84 million, six-storey MHTP-TRF hosts a centrally positioned, Technology Platform floor with state-of-the-art capabilities to underpin research excellence and clinical translation. On this flagship floor we have co-located medical genomics, cell therapies, bioinformatics, mass spectrometry and micro-imaging; and together with histology, flow cytometry, animal model and biobanking capabilities, they create an integrated network of world-class capabilities. Our MHTP Technology Platforms are also closely affiliated with the extensive Monash Technology Research Platforms (MTRP) located at Monash University. The Technology Platform floor is ideally positioned within the MHTP-TRF between the Clinical Trials floor, the Ritchie Centre (specializing in the health of women and babies), the cancer research floor and a translational research floor in which Cartherics Pty Ltd is located. The fully-integrated Clinical Trials floor contains eight clinical beds and 21 chairs, is available 24/7 and is dedicated and increasingly accessed to a suite of rapidly expanding Phase 1 and Phase 2-4 trials. Importantly, the MHTP-TRF is directly linked by bridge connections to the clinical departments of Monash Health and to the Hudson Institute of Medical Research laboratories. The 7 th floor is occupied by companies involved in translation of discoveries to the clinic. Cartherics Pty Ltd are developing immune stem cell therapeutics for the treatment of human cancer. The focus is on an off the shelf product that includes gene edited chimeric antigen receptor expression in cytotoxic T cells derived from induced pluripotent stem (ips) cells and selected TCR expression of key tumor antigens. Further exciting developments, and integrated alongside the MHTP-TRF, is the $250 million, 239 bed Monash Children s Hospital scheduled to open in early Creating Australia s third largest children s hospital, the Ritchie Centre is a major research partner of Monash Children s. The Ritchie Centre and the MHTP are also strategically positioned more broadly within the South East Melbourne Innovation Precinct, which includes the Australian Synchrotron (with its medical beamline), Monash Biomedical Imaging, the Commonwealth Scientific and Research Organisation (CSIRO) and the Melbourne Centre for Nanofabrication (Figure 2). The MHTP is perfectly poised to embark on an exciting new era of translational cell therapy research as part of the newly launched Translational Research Facility.

3 3 Figure 1. Monash Health Translation Precinct (MHTP) has established the $84 million MHTP Translational Research Facility (TRF) and $250 million Monash Children s Hospital. The clinical departments (blue) are directly connected to research areas (orange) and the new MHTP-TRF (green). Figure 2. South East Melbourne Innovation Precinct hosts the Australian Synchrotron, CSIRO s largest research and development site, and Monash University, Australia s largest university. Monash University also hosts an array of national facilities, including the Monoclonal Antibody Technology Facility, the Australian Regenerative Medicine Institute and Melbourne Centre of Nanofabrication.

4 4 Monash Health Translation Precinct (MHTP) MHTP is a partnership between: Monash Health Victoria s largest public health service providing integrated care across the entire lifespan. Hudson Institute of Medical Research Improving global wellbeing through excellence in medical research and clinical application. Monash University Australia s l a r g e s t u n i v e r s i t y w i t h a n i n t e r n a t i o n a l r e p u t a t i o n f o r innovative health research. MHTP is also a critical component of Monash Partners Academic Health Science Centre. Through these partnerships, leading researchers have direct access to clinicians and patients and biotechnology companies, enabling scientific breakthroughs to reach the bedside more quickly and effectively than ever before. Figure 3. Translational Research Facility The new six-storey Translational Research Facility contains: A public café and seminar spaces on the ground floor A dedicated clinical trials floor with MRI and pharmacy A superfloor of platform technologies including cell therapies, bioinformatics, micro-imaging, medical genomics, mass spectrometry and clinical cell production facilities A dedicated floor for women s and children s research A boardroom and commercial partner Cartherics Pty Ltd occupies the top floor

5 5 Our Vision The vision of the Monash Health Translation Precinct (MHTP) partnership is to be a world leader in translational research, generating innovative scientific discoveries and revolutionising clinical care in a dynamic and collaborative environment. Our Purpose The MHTP: Is dedicated to translating medical research to improve healthcare Uses clinical insights to focus the agenda of basic research Is committed to innovative research development Enhances research collaboration locally, nationally and internationally Connects with industry and accelerates translation and adoption of discoveries Our Aims Develop the Precinct s capacity for world-leading innovative translational research Identify new opportunities for the translation of research into advances in healthcare Improve the health and wellbeing of the population Attract world-renowned research talent Encourage collaboration and partnerships between clinicians and researchers Optimise productive interactions between MHTP partners, industry and external stakeholders Increase efficiency by sharing resources and cutting edge platform technologies with researchers and industry partners Our Location The MHTP is based in Clayton, within the South-East Melbourne Innovation Precinct. Its location creates new opportunities for collaboration and commercialisation with some of Australia s leading research organisations and companies, including the Australian Synchrotron, the CSIRO and emerging biotechnology entities. Our Researchers Together we harness the combined research talents and innovation of over 500 scientific and clinical staff, including more than 200 postgraduate students, for basic and clinical research. We attract internationally recognised researchers, clinicians and collaborators to engage in research and innovative clinical practice development aligned to improve patient outcomes through early diagnosis, targeted and effective treatments as well as prevention of disease.

6 6 Our Focus Research undertaken at MHTP responds to national health priorities by focusing on health conditions and diseases recognised as having major social and economic impact. These include: 1. Cancer and Immune Stem Cell Therapies 2. Cardiovascular 3. Diabetes, Obesity, Men s Health and Endocrinology 4. Infectious and Inflammatory Diseases 5. Neuroscience and Psychiatry 6. Women s, Children s, and Reproductive Medicine (The Ritchie Centre) MHTP Technology Platform network To achieve the highest level of quality, the MHTP Partners have made significant investments in our technology capabilities that operate within a unified strategy, governance and quality framework. Several platforms have already achieved NATA accreditation promoting shared research and clinical utilisation. Access is available via a collaborative or fee-for-service model throughout the MHTP as well as to national scientific communities. Medical Genomics hosts a broad range of specialist genomic services that include Next Generation Sequencing, High Content Screening, Microarray, Real-Time qpcr and Fluidigm Single Cell technologies. The Medical Genomics core is fully integrated with the Monash Bioinformatics Platform for bioinformatic analysis and the Monash e-research for data processing and storage. Most recently, the Facility was awarded Australia s only Fluidigm Single Cell Centre of Excellence establishing strong collaborative ties with this world leading microfluidics and genomics company. Mass Spectrometry provides protein identification from samples such as SDS PAGE gel pieces, LC- MS/MS analyses for samples in solution or more complex samples such as cell or tissue lysates, accurate mass measurement for characterising recombinant proteins and identifying impurities and specialised sample fractionation techniques. The Facility provides a direct pathway to promote the translation of research findings from bench-to-bedside though collaboration and co-location with Monash Pathology s Biochemistry department. Flow Cytometry research flow cytometry capabilities are co-located with Monash Pathology s diagnostic flow laboratory promoting translational research activities. Through a partnership of Monash Pathology s Immunology and Clinical Haematology departments, more than 1500 Leukaemia, Lymphoma and Myeloma panels are performed annually to aid in the diagnosis and management of patients with suspected haematological neoplasms.

7 7 Histology offers both a Professional service provided by specialist staff, and a DIY service that provides access to laboratory facilities, specialist equipment and consumables. The Facility provides advice, training and research assistance and operates as a node of the Monash Histology Platform at Clayton Campus. Micro-Imaging provides consultation, instrumentation, services, training as well as collaborative research and project development in the areas of optical and fluorescence microscopy, confocal microscopy, live cell imaging and digital imaging and image analysis. The facility is also a part of the Monash Micro Imaging network, and as such has unfettered access to additional suites of imaging platforms, training, analysis and expertise located on the Monash University Clayton campus and Alfred Medical Research and Education Precinct. Animal Models Monash Medical Centre Animal Facilities (MMCAF) operates as an integral component of the Monash Animal Research Platform (MARP) dedicated to providing best welfare practices for all animals under our care whilst supporting the various scientific research groups at the MHTP. Monash Bioinformatics Platform has a wide range of expertise in biological research fields requiring cutting edge computational techniques such as genomics, proteomics and structural biology. Monash Biobank is an initiative established by Monash Health s Pathology department to support translational research through procurement of human samples. For more comprehensive details of platform capabilities, expertise and technologies, pleaser refer to MHTP Technology Platform brochure.

8 8 Clinical Translation (cgmp) Human Cell Therapy Facility The Miltenyi Biotec Cell Therapy Platform has been established to develop shared, cost effective facilities, capabilities and infrastructure for research and clinical translation to deliver accredited, cgmp compliant cellbased products and therapies to the clinic. It has been designed with a footprint of approximately 100sqm of Clean Room space and is situated on the Technology Platforms floor of the Translational Research Facility. Specialist equipment housed within this new Facility include: MACSQuant Tyto Cell Sorter co-located within this facility, the Tyto is a fully closed, droplet free, microchip-based 8-colour cell sorter capable of high-speed sorting under gentle conditions. CliniMACS Prodigy owned by Cartherics Pty Ltd, the Prodigy enables standardized and automated manufacture of gene modified T cells in a completely closed and sterile system. Figure 4. The CliniMACS Prodigy The Clean Room has been designed to achieve ISO Class 8 cleanliness specifications (AS/NZS ISO14644 Cleanrooms and associated controlled environments) and, as such, comply with TGA cgmp environmental requirements for the use of isolators for aseptic processing of human cells and tissue. The core of the Cell Therapy Platform is a unique ISO-5 ex-vivo cell processing chamber that has been developed with BioSpherix Ltd in the USA. This state-of-the-art unit will replace the need for expensive traditional ISO-5 Clean Rooms for cgmp activities and is ideally suited for small scale research and translation activities. Figure 5. BioSpherix setup within the Miltenyi Biotec Cell Therapy Platform

9 9 Cartherics Laboratories Located on Level 7 of the MHTP, the Cartherics Laboratories are fully equipped with the latest equipment and resources to enable our scientists to develop cutting edge technologies to fulfil the company s aim of stem-cell based off the shelf CAR-T cell products. Our team of dedicated, highly qualified and experienced scientists work directly under the supervision of the Chief Scientific Officer, Professor Richard Boyd, with guidance from the Chief Executive Officer, Professor Alan Trounson and a panel of Scientific and Corporate Advisors.