Medical Technologies & Pharmaceuticals: A Growth Sector for the Hunter Central Coast Region

NATIONAL CONTEXT | MEDTECH AND PHARMACEUTICALS.............................................. 1

CENTRAL COAST HUNTER SNAPSHOT................................................................................ 2

WHY IS MTP A FOCUS FOR THE CENTRAL COAST HUNTER?.............................................. 3

WHY CENTRAL COAST HUNTER AS AN MTP BASE?........................................................... 7

THE CENTRAL COAST HUNTER MTP ECOSYSTEM............................................................ 16

CCH MTP INDUSTRY CAPABILITY....................................................................................... 18

CCH MTP EXPERTISE......................................................................................................... 24

CLINICAL TRIALS IN THE CENTRAL COAST HUNTER....................................................... 26

CCH MTP MARKETS........................................................................................................... 27

OPPORTUNITIES FOR MTP GROWTH IN THE CCH............................................................ 28

CASE STUDIES................................................................................................................... 29

Contents

MedTeCCH

During the COVID-19 pandemic when PPE and medical equipment was in short supply, Australia’s reliance on medical products imports was highlighted. Strengthening and growing the nation’s manufacturing base including in the medical products sector, it is widely agreed, will help build resilience to future shocks and supply chain disruptions.

Medical Technologies and Pharmaceuticals (MTP) is an important growth sector for Australia. It:

• was its 8th largest export in 2019 (measured by value)

• is economically significant: $5.5 billion contribution to the economy—equalling 0.3% of total GDP and 41,000 jobs

• is growing globally: in 2018, global spending on health reached US$8.3 trillion, or about 10% of global GDP. By 2050, the United Nations estimates 37% of the world’s older population (65+) will reside in Eastern and South-East Asia, necessitating increased health care

• has untapped potential: Australian businesses already spend big on research and development with 2019 expenditure totalling $1.6 billion

a highly skilled workforce; proximity to emerging markets and world-leading science; and research and innovation capabilities. Importantly CCH demonstrates the collaborative spirit that helps businesses successfully scale design, production and distribution.

Medical Technologies & Pharmaceuticals: A Growth Sector for the Hunter Central Coast Region details Central Coast Hunter as a viable MTP precinct and outlines opportunities to boost its future growth. It also highlights MedTeCCH, a co-ordinator of the CCH MTP ecosystem, that is working to align activities with the strategies, plans and programs being implemented by NSW and Australian governments and have the CCH precinct recognised as a viable contributor in the national MTP industry.

Source: Click here to view >

The Australian and NSW Governments are acting to seize growth opportunities in the medical products space and have released strategies to guide activity. The Australian government’s Medical Products National Manufacturing Priority Road Map includes a vision: to see Australia recognised globally for a medical products industry with the capability, capacity and expertise to locally manufacture advanced and high-value medical products using sophisticated processes.

Governments suggest that medical and innovation precincts can produce a network-effect that will help achieve this vision by increasing collaboration and building scale. These precincts rely on large successful medical companies, proximity to a hospital precinct, and access to research spaces and shared infrastructure. Vicinity to transport routes, and packaging and distribution warehouses are also important. Central Coast Hunter boasts all these attributes: an MTP ecosystem of 50 businesses and organisations; leading medical research; global companies; local manufacturers with the ability to pivot and scale rapidly;

NATIONAL CONTEXTMEDTECH AND PHARMACEUTICALS

“Medical Technologies and Pharmaceuticals (MTP) is an important growth sector for Australia. It was the 8th largest export in 2019”

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CCH’S EXISTING MTP AND ADVANCED MANUFACTURING CAPABILITY

Central Coast Hunter (CCH) is a geographically and demographically significant region situated on Australia’s east coast. Located north of Sydney, the region is NSW’s second most populated area with more people than both Tasmania and the ACT. It generates approx. $30B in exports annually and is one of Australia’s top performing regional economies with GDP estimated at around $40B (8% of the State’s). It is a growing Medical Technologies and Pharmaceuticals (MTP) precinct offering investment opportunities in digital health, medical devices, rapid prototyping as well as product development partnerships in biotech and pharmaceuticals.

The region offers investors MTP-specific advantages including:

• research excellence• diverse therapeutic-area expertise• clinical trials capability and

infrastructure• collaborative culture• accessible world-class clinicians +

health and research infrastructure• a track record of commercial

success • a test market for new medical

products and technologies

driver in the CCH and is recognised for the quality research and services it provides locally, and across NSW and Australia.

Health also provides a plentiful source of ‘wicked problems’ that the region’s industry base is actively collaborating to solve. Advanced manufacturers, technology providers, researchers, engineers, project managers and design thinkers are teaming up to innovate and commercialise solutions. They are delivering sophisticated responses in the areas of point-of-care testing, medical devices, process improvements and telehealth services, just to name a few.The region has the proven smarts, track record, and infrastructure to deliver new-to-the-world innovations. Combine this with a dynamic, collaborative, future-focused attitude and the Central Coast Hunter establishes its value as a niche location for MTP.

CCH is a strategically located, economically complex region offering a forward-thinking, collaborative business environment.

It proffers the services and infrastructure of a metropolitan centre but with the cost structure and business-community familiarity only a region can provide.

It is well serviced by transport infrastructure with daily flights to Australia’s east coast hubs from Newcastle Airport; integrated supply chain solutions to service international markets through the Port of Newcastle; and proximity to Australia’s capitals via the national freeway/highway and rail networks.

The University of Newcastle, TAFE NSW and a range of private providers deliver career-ready graduates. Long running, successful education-industry partnerships result in the provision of current, contextualised curriculum that leads to a motivated graduate pool.

With a combined population of just over 1,000,000 people, CCH is a centre for manufacturing, mining, logistics, education and health. Its largest and fastest growing sector is Health which employs 48,500 people across a large public and private network of providers and specialists. Health is an important economic and social

CENTRAL COAST HUNTER SNAPSHOT

MTP INDUSTRY BASE

From Gosford in the south to Taree north and Murrurundi in the west there is a concentration of over 50 companies operating in the MTP sector (Figure 1). The density of these firms creates a defined precinct on Australia’s east coast, north of Greater Sydney that has access to world class research facilities, two Local Health Districts and the benefits of simple logistics and supply chains.

These companies work to improve human and animal health, are highly collaborative – 88% collaborate with universities, and have established local, national and global markets. They directly support 8,187 jobs (headcount not FTE) while many more thousands of people are employed in the public and private health services, the University of Newcastle and medical research institutes.

431 active clinical trials are currently underway in the Central Coast Hunter (Source: ClinicalTrials.gov). 80% are industry-sponsored, including by large multinationals like Johnson & Johnson, GSK and Novatis. There is a 10% paediatrics 90% adult split with a diverse therapeutic-area research focus. To address the recent growth in clinical trials, private providers have been created and join hospital-based trials units to ensure compliance and to drive growth and access to the latest clinical trials for people in regional and rural locations. See page 26

ADVANCED MANUFACTURING AND MTP CAPABILITY

The Hunter has a strong and prolific history as a manufacturing hub. Shipbuilding was a mainstay of the region’s thriving manufacturing base until 1987; steelmaking underpinned its economic strength until 1999 and

It incorporates the John Hunter Health complex which comprises John Hunter (JHH) Teaching Hospital - the busiest trauma centre in NSW and the second busiest nationally, John Hunter Children’s Hospital (JHCH), Newcastle Private Hospital, the Hunter Area Pathology Service which provides tertiary level pathology testing, The Royal Newcastle Centre, Rankin Park Hospital (Rehab), and the Hunter Medical Research Institute (HMRI).

The John Hunter Health Innovation Precinct project is currently being developed on the site. It will support the expansion of clinical and non-clinical services and will increase the capacity at the John Hunter and John Hunter Children’s Hospitals. It will also facilitate collaborative innovation between health, education and research partners.

Central Coast Health (CCHLD) comprises two acute hospitals – Gosford and Wyong. Gosford Hospital is the principal referral hospital and regional trauma centre for the Central Coast, Wyong Hospital is a major metropolitan hospital while Woy Woy Hospital and Long Jetty Healthcare Centre provide sub-acute care. Additionally, there are eight community health centres and other community-based services.

The Ideas Hub is a research and development facility situated within Gosford Hospital. It brings together Health, education, research and industry to collaborate on solutions for Health’s needs.

now, in 2021, its billion-dollar mining and defence sectors continue to call on the region’s high-performing SME base (e.g., Newcastle Machine Shop, Ampcontrol) to produce vital equipment and technology.

The region’s history in traditional industries and regulated fields means it has an increased concentration of people with engineering skills at both technical and trade levels. These skills, coupled with a track record of adaptability due to economic shocks like we saw when BHP’s steelmaking ceased in 1999 and the steady transition to Industry 4.0 processes, has increased the ease with which CCH industry is able to pivot and apply transferrable skills and knowledge into new, high-tech industry sectors like medical technology. The region’s engineering pedigree delivers an experienced approach that results in smart, technically sophisticated solutions.

The regulatory/governance/quality management systems skills essential in the CCH’s traditional industries is another set of transferrable skills and a key asset.

HEALTH

Central Coast Hunter is represented by two health districts, Hunter New England Health and Central Coast Health.

Hunter New England Health (HNELHD) provides services to:

• 920,370* people, including 52,990* Aboriginal and Torres Strait Islander people across 25 local government areas Source: Click here to view >

• 169,846 residents who were born overseas

• Employs 16,033 staff + 1,600 volunteers

WHY IS MTP A FOCUS FOR CENTRAL COAST HUNTER?

“Central Coast Hunter (CCH) is a geographically and demographically significant region situated on Australia’s east coast.”

< Central Coast Hunter

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JOHN HUNTER HEALTH INNOVATION PRECINCT

The NSW Government’s $780 million John Hunter Health and Innovation Precinct project will transform healthcare services for Newcastle, the greater Hunter region and northern NSW communities. Infrastructure will be delivered to support the expansion of clinical and non-clinical services and will increase the capacity at the John Hunter and John Hunter Children’s Hospitals.

The John Hunter Health and Innovation Precinct project will deliver an innovative and integrated precinct with industry-leading facilities. The project will work in collaboration with health, education and research partners to meet the current and future needs of the Greater Newcastle, Hunter New England and Northern NSW regions.

CENTRAL COAST CLINICAL SCHOOL AND RESEARCH INSTITUTE (CCCSRI)

The $72.5 million Central Coast Clinical School and Research Institute (CCCSRI) is a partnership between CCLHD and the University of Newcastle. Currently under construction, the state-of-the-art Medical School and Research Institute within a new Health & Wellbeing Precinct at Gosford Hospital aims to establish Central Coast Local Health District as a global leader in integrated medical research. CCLHD is building its research leadership and expanding its research capacity to see research become core business in all aspects of healthcare.

These centres of excellence will deliver world-class medical training and research on the Central Coast. They will have the capacity to transform the regional economy and develop new career pathways for health professionals in the region.

Regional Development Australia (RDA) Hunter is part of a national network of Committees made up of local leaders who work with all levels of government, business and community groups to support the economic development of their regions.

RDA Hunter has an active and facilitative role in the Hunter. Its clear focus is on growing a strong and confident regional economy that harnesses its competitive advantages, seizes economic opportunities and attracts investment.

In 2015 RDA Hunter undertook a strategic study to inform its activities to support economic development in the region. Based on an OECD framework and launched by Prime Minister Turnbull in 2016, Smart Specialisation for the Hunter Region identified seven sectors of competitive advantage. Medical Technologies and Pharmaceuticals was included because of the region’s strong, health and manufacturing capability and the sector’s propensity to deliver innovation-driven jobs growth.

Australian Industry (Ai) Group is a peak national employer organisation and has worked with members for almost 150 years. Our members include some of Australia’s largest Medical and Pharmaceutical companies.

The Newcastle office of Ai Group supports many businesses with a history of operating within highly regulated markets and supply chains. The establishment of a cluster will serve these organisations well as they embark on a path of growth and diversification through collaboration with some of Australia’s preeminent medical research institutions.

This connection between research and industry will serve the nation through establishment of new capability and increased capacity, contributing to both sovereign security and economic prosperity for the region.

STATE AND FEDERAL GOVERNMENT STRATEGIC FOCUS ON MTP

In 2021, Governments are focused on building the economy and

renewable energy sources, have led to a more immediate focus on shoring up homegrown, local capability, seizing opportunities to diversify, transferring and applying existing skills in new areas and creating high-value jobs of the future.

Regional Development Australia (RDA) Hunter and the Hunter office of the Australian Industry (Ai) Group, given their complementary remits to support regional economic development and industry growth aligned thinking and initiated actions in these areas.

They formed MedTeCCH: a collaboration of Central Coast Hunter-based MedTech and Pharma companies, national industry associations, sector specialists, and education & research organisations, to strengthen the region’s diverse MTP cluster and raise the profile of the region and its industrial capabilities.

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creating jobs. They are developing policies which play to Australia’s strengths, and funding activities to improve collaboration and commercialisation. They are shaping modern, dynamic and highly skilled industry sectors that build the country’s sovereignty and self-sufficiency.

Australian and State governments have identified priority sectors which reflect Australia’s established competitive advantages and emerging areas of strength. Medical Technologies and Pharmaceuticals is one of the sectors identified and supported by plans like the NSW Government’s Accelerating R&D in NSW and the Federal Government’s Modern Manufacturing Initiative.

The NSW Government’s 2018 NSW Medical Technology Industry Development Strategy headlined five key areas of focus:

1. Support industry in commercialising R&D and to bring new products and services to market

2. Grow exports and attract investment into the NSW medical technology sector

3. Support skills development to train and grow a specialised medical technology workforce

4. Improve connectivity and collaboration within the NSW medical technology industry

5. Improve the business environment and create a highly productive commercialisation environment

The Strategy is positive acknowledgement of the value of MTP to the NSW and Australian economies and the important role the sector will play in the State’s future. However, the Strategy also clearly highlights a need to increase recognition of the contribution of regions in NSW’s economic and industrial success. Central Coast Hunter, through MedTeCCH, is addressing this gap by building mutually beneficial partnerships with the NSW Government and its agencies that aim to raise the public profile of the region and its capability.

TIMELY CO-ORDINATION OF MTP CLUSTER (MedTeCCH)

In 2020 world events like COVID-19, the economic pressures it catalysed and the impacts of a shift to new

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An excerpt from the Federal Government’s Medical Products Roadmap …

Quality medical products are at the centre of a healthy society. They can also be the centrepiece of a dynamic economy based on translating smart ideas into globally competitive manufactured products. Medical products make a significant contribution to Australia’s economic prosperity. The sector is responsible for some of Australia’s most innovative commercial successes.

Australian medical products making a global impact include the cochlear implant, green whistle and cervical cancer vaccine. Medical product manufacturing covers businesses and enterprises that develop regulated human and animal medical products. Medical products also include associated activities with a clear health focus, such as digital health equipment and applications. Manufacturing includes pre-production activities such as R&D, design and logistics, and post-production activities such as distribution, sales and services.

Research and innovation are key drivers of economic growth - an excerpt from the NSW Government’s Turning Ideas into Jobs Accelerating Research and Development in NSW ACTION PLAN…

A strong, vibrant and high-quality research and innovation ecosystem is vital for driving future economic and social wellbeing in NSW. Research delivers new ideas, products, services and skills in areas including advanced manufacturing, digital technologies, aerospace and defence, energy transition and decarbonisation, and medical technologies.

The take-up of technological innovations in these and other areas is essential to NSW’s future economic and productivity growth, the attraction of international investment and the creation of high-value, sustainable jobs.

CCH’S EXISTING MTP AND ADVANCED MANUFACTURING CAPABILITY

The Central Coast Hunter (CCH) has a small but growing cluster of more than 50 medical technology, biotechnology, pharmaceuticals, digital health and wellness companies supported by a robust Health system, a world-renowned research sector, first class education providers, proactive government support, regulatory experts and experienced contract research organisations.STRONG ECONOMYCentral Coast

The Central Coast is well serviced by road and rail infrastructure, with passenger and freight connections through the region. Strategically located for logistics such as warehousing, distribution and movement of freight, the Central Coast has cost-effective access to key consumer markets and export opportunities.

The Central Coast is home to several household food manufacturing brands and agricultural production industries specialising in poultry, citrus and horticulture. Overseas and domestic demand will support growth in these sectors.

The region’s strong services base will continue to drive employment opportunities in health, education, retail and other service sectors.

The region has an estimated 322,000 jobs projected to increase to 384,000 by 2036. There is potential to achieve higher jobs growth by planning for more diversified use of employment land.

The economy is increasingly diversified, with strong growth occurring in health care, social assistance, accommodation, food and professional services. This growth demonstrates the region is well placed to benefit from the macro trends affecting the Australian economy, such as the ageing population and greater exposure to the global economy.

The Hunter is strategically situated to leverage proximity to Asia and the region’s growing agricultural, health, education and tourism sectors to supply developing Asian economies with resources and products.

The development of strategic employment centres is a priority and includes specialist centres like the University of Newcastle, John Hunter Hospital, the Port of Newcastle and Newcastle Airport. Growth in these centres will expand the regional economy and support more jobs close to where people live.

The Upper Hunter will undergo a transition in the context of a changing industry environment, particularly in mining and power generation, and emerging trends in agribusiness.

Source: Click here to view >

Growth is expected in knowledge-based industries, which can provide more opportunities for professional, technical and scientific services, and the education and training sectors.

By 2036, the Central Coast’s population is expected to grow to more than 415,050, driving the need for employment, investment in infrastructure and housing construction growth.

The region’s ageing population means 27 per cent of people will be aged above 65 by 2036, placing demand on health care and social services, which is already the largest sector of employers on the Central Coast.State-of-the-art medical facilities and a diverse range of primary and secondary health care services provide high-quality health care within the region. Ongoing investment in these sectors will be critical to meet the needs of the growing population.

Source: Click here to view >

Hunter

The Hunter is the largest regional economy in Australia, ranking above Tasmania, the Northern Territory and the Australian Capital Territory in terms of economic output. It drives around 28 per cent of regional NSW’s total economic output and is the largest regional contributor to the State’s gross domestic product.

WHY CENTRAL COAST HUNTER AS AN MTP BASE?

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NSW

At more than half-a-trillion dollars, New South Wales is Australia’s largest state economy, accounting for around a third of the nation’s economic output and home to nearly a third of Australians.

The NSW population, which currently stands at 8.1 million people, has grown at an average of 1.1 per cent over the last 30-years. NSW population experienced a more rapid rise in the seven years leading up to 2018-19 as a strong labour market attracted workers from other states and a larger share of overseas migrants.

The state’s more than four million strong labour force is employed across this diverse range of industries, the largest employers being the health and social care, professional, scientific and technical services and retail trade sectors.

New South Wales has a diverse export base of manufactured goods, natural resources and services. Major merchandise exports include coal, copper, beef and aluminium. The primary export destinations for goods are Japan, China and the Republic of Korea, while the major suppliers of imported goods are China, the United States and Germany.Source:

Source: Click here to view >

and production and meaningful collaboration. The CCH boasts world renowned clinical experts who are delivering medical breakthroughs; doctors, and researchers many of whom trained at the well-respected College of Health, Medicine and Wellbeing at the University of Newcastle; patient-facing nursing and support staff - graduates of the University of Newcastle and TAFE NSW; Medical Engineering graduates from the University of Newcastle; researchers engaged in new to the world projects at HMRI and CCCSRI; international industry cluster development experts; industry and manufacturing leaders; and many others.

CCH’s expert workforce engages at all levels to identify and solve patient-centric problems, unmet clinical needs and industry sector challenges.

INTERNATIONAL PRESENCE

CCH is seeing an increase in international MTP focused companies establishing offices or operating locally. Bosch Manufacturing Australia and Phastar have Central Coast Hunter based representatives who are engaging in the MTP ecosystem through MedTeCCH.

Australia

According to Austrade, Australia is a trading nation, with exports and imports of goods and services making up 42 per cent of our gross domestic product in 2018–19. With 14 free trade agreements in place, approximately 70 per cent of Australian trade enjoys liberalised access to overseas markets. Twelve of our 15 largest markets are in Asia and Oceania, generating a trade value of around A$577 billion in 2018–19. Trade in services has grown at 6.3 per cent per year for the past two decades, helping to steadily broaden our export mix beyond resources and agriculture.

Growing 8.5 per cent per year since 2011, foreign direct investment (FDI) inflows help power our capital-intensive industries. In 2019, the mining sector accounted for 35.3 per cent of the total stock of overseas investment in Australia, worth A$360 billion. This FDI directly contributes to Australia’s minerals and energy exports, which reached around A$280 billion in 2018–19. Australia’s thriving manufacturing sector attracted A$131 billion of overseas investment in 2018–19.

Source: Click here to view >

PEOPLE AND EXPERTISE

People are the key ingredient for industry success: a skilled, motivated workforce underpins quality service

ENABLING ORGANISATIONS

The CCH combines deep sector expertise with strong, supportive collaboration to deliver successful, commercial outcomes. Its MTP precinct offers a unique enabling environment with a combination of high-profile and high performing organisations that nurture and enable success. They include:• University of Newcastle• Two engaged Local Health

Districts (Hunter and Central Coast Local Health Districts)

• Hunter Medical Research Institute

• Central Coast Clinical School & Research Institute

• R&D labs + Innovation hubs• Industry specialised service

providers (CROs)• Connecting/co-ordinating

organisations

University of Newcastle

University of Newcastle researchers drive discoveries that challenge conventional thinking and change lives. 95% of its research is rated ‘at or above world standard’ by the 2018 Excellence in Research Australia evaluation of research quality in Universities, administered by the Australian Research Council.The University of Newcastle applies engineering, science, medical and research skills to solve a broad range of problems in collaboration with its industry and local area health partners. Its MTP research areas of focus include:

Priority Research Centre for Drug DevelopmentThe Priority Research Centre for Drug Development is committed to providing innovative therapeutics for the treatment of human disease by bringing together research teams of international excellence from chemistry, biology and medicine. The Centre focuses on unravelling the causes of disease, identifying crucial biological targets and pioneers the rapid development of novel drugs for the fight against disease.

The Priority Research Centre for Physical Activity and NutritionThe Priority Research Centre for Physical Activity and Nutrition investigates physical activity and nutrition for population health. The Centre targets “at risk” populations, multiple levels (individual, social, organisational, population) and

of social elements of health and illness. Together, neurobiologists, psychologists, and mental health researchers use the most advanced techniques to explore brain-behaviour nexus.

The Priority Research Centre for Reproductive ScienceThe Priority Research Centre for Reproductive Science creates new knowledge in how successful reproduction occurs in humans and animals. Key areas include Aboriginal health and the male and female factors that lead to birth of a healthy baby. Through close collaboration with industry, the Centre develops diagnostics and therapeutics. The Centre for Reproductive Science targets the future health of all Australians providing key information on the determinants of a healthy start to life.

The Centre for Resources Health and SafetyThe Centre for Resources Health and Safety provides leadership in the growth of interdisciplinary activities in resources, health and safety. The CRHS recognises expertise across a range of disciplines including workplace health and safety, respiratory studies, psychology, psychiatry, and environmental/social science to benefit industry and community health and safety. A program provides leadership in the growth of interdisciplinary activities in resources health and safety, recognising expertise across a range of disciplines including workplace health and safety, respiratory studies, psychology, psychiatry, and environmental/social science to benefit industry and community health and safety.

The Centre for Advanced Training SystemsThe Centre for Advanced Training Systems (ATS), creates training platforms that empower trainees, trainers and their host-organisations. It has worked with major partners in Defence, Health and Education to design, deliver and deploy digital training systems. ATS specialises in developing scalable training interventions that incorporate the inner world (attention, memory and emotions) of trainees into the training process.

within various settings (schools, clinics, workplaces, communities). The primary aim of the Centre is to achieve high quality research, training, and knowledge translation in the development and testing of efficacious/effective, theory-driven, multi-level, population-based physical activity and nutrition-related interventions and natural experiments.

The Priority Research Centre for Cancer ResearchThe Priority Research Centre for Cancer Research, Innovation and Translation integrates basic science & clinical research bi-directionally, to facilitate rapid development and implementation of its research discoveries, and to stimulate lab research on priority questions generated from the clinic. The PRC CaRIT offers an integrated program of basic science and clinical trials, linked with histo- and molecular-pathology to research diagnostic, prognostic and therapeutic strategies precisely tailored to individual requirements.

The Priority Research Centre for Healthy LungsThe Priority Research Centre for Healthy Lungs focuses on understanding the cellular and molecular processes that are associated with the development and progression of respiratory diseases, such as asthma and chronic obstructive pulmonary disease (COPD). These are the two major chronic respiratory diseases in Australia, with the incidence of asthma among the highest in the world, and COPD a major cause of death. The Centre acts as a national training centre for clinician scientists, postdoctoral fellows, PhD scholars and undergraduates in respiratory medicine.

The Centre for Brain and Mental Health ResearchThe Centre for Brain and Mental Health Research (CBMHR) is focused on increasing its understanding of the brain and mind across the lifespan, in the absence and presence of disease. The Centre hosts three platforms for research: Preclinical Neurobiology, Psychological Processes and Mental Health. The Centre for Brain and Mental Health Research (CBMHR) is a cross-disciplinary group of leading researchers from diverse fields that bridge brain science with the study

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The Priority Clinical Centre for Cardiovascular HealthThe Priority Clinical Centre for Cardiovascular Health research spans basic science, clinical and translational studies to identify therapeutic targets and enhance clinical outcomes for cardiovascular health across the Hunter region. The PCC CVH has state of the art research facilities at the Hunter Medical Research Institute, at the University of Newcastle Callaghan Campus, and within the Hunter New England Health service at the John Hunter and Calvary Mater Hospitals.

The Clinical Nutrition Research Centre The Clinical Nutrition Research Centre (CNRC) is a unique multi-institutional collaboration in preventive health research. It seeks to capitalise on the collective strengths of University of Newcastle, University of South Australia, University of Southern Queensland and Swinburne University of Technology to generate evidence to optimise physical and mental fitness and counteract chronic non-communicable diseases. It comprises leading Australian expertise in the design and conduct of human intervention trials to evaluate cardiovascular, metabolic, anti-inflammatory and mental health benefits of specific diet modifications and physical activity programs.

The Priority Research Centre for Digestive Health and NeurogastroenterologyThe Priority Research Centre for Digestive Health and Neurogastroenterology brings together multi-disciplinary team which aims to effectively diagnose and treat common functional gut disorders (dyspepsia and IBS), neuromuscular diseases of the gut and eosinophil-driven chronic inflammatory gastrointestinal conditions through technologically advanced research which has identified novel pathophysiological mechanisms.

The Medical Imaging and Radiation Therapy Research groupThe Medical Imaging and Radiation Therapy Research group focuses on research into the use of both ionising and non-ionising radiation in the diagnosis and treatment of disease. This group brings together academic staff and researchers from the discipline of Medical Radiation Science. Our researchers have expertise in medical physics,

and incubators that provide support and commercialisation advice to the region’s strong start-up sector and established firms. The Melt, Eighteen04, I2N, Dashworks and Fastlab provide R&D as a service, physical spaces for collaboration and access to expert advice and support for commercialisation.

Contract Research Organisations and Professional Services

The Central Coast Hunter has a strong professional services sector with representation by leading national and international firms like PwC as well as locally-grown firms that provide support to the region’s industry base.

The region is also well represented by a growing group of Contract Research Organisations that provide expertise and experience in a broad range of MTP related fields. CCH’s CROs like Genesis Research Services and Paratus Clinical enable and support clinical research providing confidence to the international companies and local SMEs that conduct their research in the region.

NSW HEALTH PATHOLOGY (NSWHP) POINT OF CARE TESTING (POCT)

Central Coast Hunter area provides a fantastic test bed for MedTech development. It is supported by University research across multiple campuses, Medical Research Institutes and Local Health Districts that provide care to adults and paediatric patients, and patients who experience trauma in large referral centres, and regional and rural hospitals. The John Hunter Hospital manages the most emergency department presentations in the state. The NSWHP PoCT Service supports over 34,000 clinical staff to operate PoCT technologies and has developed a group of over 900 “superusers” who provide onsite assistance for the PoCT team in training and device management. In addition to this the PoCT Service has well-established technology evaluation and clinical trials programs. These can provide access for technology providers to compare against gold standard diagnostic platforms and the opportunity to evaluate the clinical utility of equipment through a formal clinical trial.

radiation therapy and medical imaging techniques; including radiography, CT, nuclear medicine, ultrasound, MRI, mammography, PET imaging, and DEXA bone and body composition analysis.

The Centre of Excellence in Severe AsthmaThe Centre of Excellence in Severe Asthma brings together researchers from across Australia. It is developing innovative approaches to understand why severe asthma occurs, developing tools and programmes to improve disease management and improving access to new therapies. In Australia, 10% of the population have asthma, and a subset have severe asthma.

The Hunter Medical Research Institute (HMRI)

HMRI, located within the John Hunter Hospital Precinct, is a collaboration between the Hunter New England LHD and the University of Newcastle to increase the pace of research translation from discovery to clinical practice. It is a network of over 1500 researchers, students, and support staff from HNELHD and the University, inspiring new discoveries to deliver a healthier future. The key areas of focus include brain and mental health, cancer, cardiovascular, pregnancy and reproduction, public health, viruses, infections/Immunity, vaccines, and Asthma (VIVA).

The Central Coast Clinical School & Research Institute (CCCSRI)

The new $85million Central Coast Medical School and Research Institute (CCMSRI) will open at Gosford Hospital in 2021. A joint project with the Central Coast Local Health District – and funded by the Federal and NSW State Government – the CCMSRI, for the first time, allows students studying medicine to complete the full Bachelor of Medicine program on the Central Coast.

R&D Strength + Innovation Hubs

The Hunter’s innovative business environment supports collaboration between enterprise, tertiary education, research and government. This ensures knowledge sharing, technical development and a positive attitude to new ideas is translated into commercial products.

Partnerships are evidenced in the range of innovation and R&D hubs

Ideas Hub at Gosford HospitalThe new technology and innovation ‘Ideas Hub’ has recently been launched by Central Coast Local Health District (CCLHD). The aim of the hub, located within Gosford Hospital, is to identify and address healthcare challenges and work with all CCLHD facilities, local businesses, entrepreneurs and health staff to improve staff and patient experiences.Health staff is heavily involved in generating ideas that will improve day-to-day processes as well as patient experience.

Beyond the dedication of doctors and nurses - there’s a lot that goes into the day to day running of Gosford Hospital. A new ‘Innovation Hub’ has been set up to tackle common problems behind the scenes - and it’s all in a bid to improve patient care.

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GOVERNMENT SUPPORT

MTP ConnectThe CCH is supported by Australian government initiatives like the Industry Growth Centres that are helping build connections and leverage partnerships. MTPConnect, the Medical Technologies and Pharma Industry Growth Centre, is a strong supporter and contributor to the growth of the Central Coast Hunter’s MTP sector and efforts to co-ordinate the ecosystem.

MTPConnect is actively calling for change to support the MTP sector, raising awareness, fostering collaboration and competition, and sharing knowledge with the broader sector. It also jointly funds projects that address the Sector Growth Priorities and the constraints and gaps identified in the sector.

MTPConnect’s work is focused in four key areas:• Increasing collaboration and

commercialisation across the sector

• Improving management and workforce skills

• Improving access to global supply chains and international markets

• Optimising the regulatory environment

AMGCThe Advanced Manufacturing Growth Centre (AMGC) was established in 2015 as a key plank of the

Hunter New England Local Health District and 12,500 in Central Coast Local Health District - 27% of the NSW indigenous population.Approximately 20% of the CCH population was born overseas and 15% speak a language other than English at home. The region’s median age is 40.Source: Click here to view >

DIVERSE LOCATIONS

The CCH has a diversity of settings providing opportunity for a range of clinical applications, delivery and testing. Across the xxxsqkm region there are cities and metropolitan areas, urban, rural and remote locations each with access to health infrastructure and services.

COLLABORATIVE ENVIRONMENT

The CCH is proud of its collaborative business and industry environment - demonstrated by long-established and successful network organisations like Hunternet which were founded when competitor companies joined forces to facilitate knowledge exchange, and together solve industry problems and plug skills and intelligence gaps.

In recent times swift and effective collaboration has resulted in solutions to such problems as ventilators for COVID-19 patients, in-hospital tracking systems and point of care testing devices.

Australian Government’s Industry Growth Centre Initiative. Its goal is to drive innovation, productivity and competitiveness across Australia’s manufacturing industry.

AMGC is an industry-led, not-for-profit organisation. It is connected with a nationwide network of manufacturers, universities and research institutions, and export hubs.

The Centre’s role is to share its respected research on how the industry can transform to become more advanced. AMGC puts its research into action by engaging with manufacturers and universities in high-impact projects and export hub opportunities.

Australian and NSW Government SupportStrong bi-partisan connections with Members of Parliament and departmental representatives ensure the Central Coast Hunter is recognised for the contribution it makes to the national economy and the potential for increased its burgeoning industries can make.

DIVERSE POPULATION

The region is large and diverse with a combined patient population of approximately 1,000,000 people and a large indigenous population - approximately 60,000 Aboriginal and Torres Strait Islander people live in

The Ventilator Innovation Project, led by Health Infrastructure, was initiated to rapidly develop contingency ventilator solutions in response to the COVID-19 pandemic. The landmark innovation project, in partnership with Government, university, industry, and business, is a formidable success story.

Ampcontrol designed the ventilator in collaboration with Hunter-based specialist electrical engineering companies NewieVentures and Safearth Solutions, rapidly swinging our advanced manufacturing capabilities and engineering excellence to respond to the NSW Governments call-to-arms in March 2020. This significant pivot resulted in the development of a fully functional emergency ventilator prototype in less three weeks.

In the world of medical engineering, projects are measured in the order of years. Ampcontrol, who had never previously worked in this sector, brought together a group of local companies including Newieventures, Safearth, ResTech, and The University of Newcastle to deliver prototype ventilators for NSW Health in 18 days and commenced clinical trials only one week later.

VENTASYS VENTILATORINNOVATIONPROJECT

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LIVING LAB

The Central Coast Hunter Health industry is pro-active and focused on innovation, teaching and research. The region has a large and diverse population which is often referred to as a microcosm of Australia. As such, the region has been a go-to test bed for companies like McDonalds and for products like driverless cars and parking sensor apps. The region is large enough to have a complex economy and a self-sustaining marketplace, but small enough that business, education, research and government communities are known to one another making collaboration natural – it’s a “Goldilocks City” according to Hunter advocate, electrical engineer and co-founder of Eighteen04, Dr Gunilla Burrowes

and “an ideal candidate to be a “living lab” – a place where companies can trial their inventions to see how they perform in the real world” according to The Guardian.

The region’s capital, Newcastle, is a smart city. It has adopted and developed a range of initiatives that are creating a smart, liveable and sustainable global future.

When the entrepreneur Dr Gunilla Burrowes reaches for a metaphor to describe Newcastle, she comes up with “the Goldilocks city”. She means that like the middle bed in the fairytale, it is just the right size to be able to get things done. “That has really powerful implications for business,” she says.Read The Guardian articleSource: Click here to view >

The Goldilocks City

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COLLABORATION

The Central Coast Hunter benefits from effective collaborative partnerships that result in commercial outcomes. Driven, in part, by the size of the region which is large enough to support the innovation environment but not too large that networks, firms and institutions are disconnected, collaboration is a common approach to complex problem solving.

88% of CCH’s MTP companies suggest they actively collaborate with other organisations to add value to their products and services. Importantly, 85% found their collaboration partner/s within the region. The ability to take advantage of local capability to meet business goals is key to the long-term success of the Central Coast Hunter ecosystem.

HIGHLIGHT: SPOTTO + CCLHD Revealed: First look inside $72.5M doctor factoryFresh off a world leading idea’s hub announced at Gosford Hospital we can now take you inside the $72.5M new `school’ that will educate the first generation of locally trained doctors.Source: Click here to view >

In terms of research, 77% of companies have created a partnership with the University of Newcastle and/

consultantsWhen all organisations are in close proximity and collaborate, such as in the CCH precinct, rapid acceleration of innovation, entrepreneurship and innovation is enabled.

Source: Hunter and Central Coast capability audit of the medical technology and pharmaceutical sector, by Mark Flynn, PhD, MBA of Global Edge MedTech Consulting

or HMRI. This demonstrates the effectiveness of centrally located University campuses that enable it to play a proactive role in research, innovation and commercialisation.

The University of Newcastle and Health Services provide the requisite research and clinical validation capability required to enable the region’s MTP companies to deliver relevant products and services.

The importance of the University investing in the Gosford Hospital’s new medical facility and the Central Coast Clinical School Research Institute is key to ensuring that the impact of research and clinical expertise is precinct-wide.

The Central Coast Hunter’s MTP ecosystem comprises:

MTP Sector Capability: companies that produce and/or manufacturer biotech and medical technology

Enablers: organisations that facilitate or enable translation from invention to clinical innovation such as research organisations, industrial prototyping labs and health systems

Supporting Organisations: that offer professional support and increase the sector capability such as governments, incubators, clinical research organisations and

THE CENTRAL COAST HUNTER MTP ECOSYSTEM

“A strong, vibrant and high-quality research and innovation ecosystem is vital for driving future economic and social wellbeing …” NSW Government’s Turning Ideas into Jobs Action Plan, January 2021

ECOSYSTEM CO-ORDINATION

In June 2020, Regional Development Australia (RDA) Hunter and the Hunter office of the Australian Industry (Ai) Group established MedTeCCH to co-ordinate and support the Hunter’s burgeoning MTP sector.

The MedTeCCH industry network brings together Central Coast Hunter-based MedTech and Pharma companies, national industry associations, sector specialists and education and research organisations. It was formed to strengthen the Central Coast Hunter’s diverse cluster of medtech companies through collaboration.

MedTeCCH identifies medtech as the application of knowledge and skills to develop devices, medicines, procedures, and systems to solve human and animal health problems. It is taking a whole of supply chain approach to growing the sector by collaborating to solve patient-centric health needs.

Bosch Manufacturing Australia and Emeritus Prof Roy Green. Inside its first year, it includes 50 companies and organisations across industry, research, government and education plus affiliates & supporters.

To better understand the breadth and competencies of the Hunter Central Coast MTP industry base, MedTeCCH undertook a capability audit in the last quarter CY 2020. Responses to a survey of 27 known MTP companies across the region provide insights to the sector’s scope, capability and capacity. A set of regional data has been produced.

MedTeCCH is:• The local voice and champion

for the Central Coast Hunter MedTech sector

• Leading the development of a sustainable, commercially successful MedTech ecosystem to create and capitalise on research and innovation opportunities

• Building direct links to end-users and investors, including local and global health systems, with support for infrastructure, skills and research translation

MedTeCCH Membership/Affiliation

MedTeCCH is supported by MTPConnect, AMGC, NSW Health Pathology, Ampcontrol, Global Edge MedTech Consulting, Jurox, Whiteley Corporation, University of Newcastle, Hunter Medical Research Institute (HMRI), JHH-IP, The Ideas Hub (CCLHD), RDA Central Coast, Genesis Research Services, Paratus Clinical, Logikal Health, NSW Smart Sensing Network,

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The CCH offers end-to-end MTP capability with a proven track record spanning 87 years (Whiteley Corporation established 1933) and a large, skilled and adaptable workforce. The CCH’s MTP ecosystem is a diverse mix of mature and start-up companies supported by people and organisations with a collaborative, and future-focused mindset that inspires innovation, growth and competitiveness.

CORE CAPABILITY

Medical technology, as expected, is well represented by established firms such as Logikal as well as newer success stories such as Holland Healthcare. Twelve companies or 26% of the participants identify with medical technology as being their primary market. Much of this capability is built on the historical proficiency of the region for advanced manufacturing and the capability

and rural communities where delivery of services is challenged by distance, isolation and limited infrastructure.

Innovative products such as Mobito and FaceMatch are developing business models and leveraging close collaboration in the region. It is expected that given the increasing digital capability combined with a focus on health beyond COVID-19 this area will continue to expand. Similarly, NSW Health Pathology continues to investigate innovation beyond pathology services into areas like digital health through its Point of Care Testing (PoCT) and Hospital in the Home (HitH) projects.

Similarly, NSW Health Pathology continues to investigate innovation beyond pathology services into areas like digital health through its Point of Care Testing (PoCT) and Hospital in the Home (HitH) projects.

of firms to address needs in the health industry. Demonstrating this proficiency and the continuation of its long-term commitment to the CCH, Whiteley recently announced development of a human therapeutics plant.

Biotech with its long lead times to market and capital costs such as laboratory space, is represented by three firms in the region: Jurox, Whiteley and ImmVirX.

Importantly, much of this capability is assisted by the facilities and expertise of Hunter Medical Research Institute (HMRI), University of Newcastle (UON) and two local health districts (CCLHD & HNELHD).Recent developments in eHealth and digital health provide opportunities for fast growing digital companies to join with health professionals to address unmet medical needs. This area is especially relevant in regional

“A strong, vibrant and high-quality research and in-novation ecosystem is vital for driving future economic and social wellbeing …” NSW Government’s Turning Ideas into Jobs Action Plan, January 2021

ViralyticsIn what is one of the biggest biotech transactions in Australian history, Viralytics – an oncolytic virotherapy firm originating from the University of Newcastle based on the work of Associate Professor Darren Shafren and his team, has been acquired for $502 million by world-leading pharmaceutical company, Merck.

Read the article hereSource: Click here to view >

ImmVirXThe team behind the successful development and sale of Virolytics has established a new venture (ImmVirX) to continue to discover and commercialise future pharmaceuticals. The team will be based at the Hunter Medical Research Institute (HMRI), and support from the University of Newcastle Research Associates (TUNRA) will assist with its commercialisation objectives.

Read the article hereSource: Click here to view >

Point of Care Testing TeamNSW Health Pathology’s innovative Point of Care Testing team is relocating its research and development centre from Royal North Shore Hospital pathology laboratory to Maryville, Newcastle from March 2021. The centre will have dedicated space for: Device and IoT configuration; Device evaluation and performance testing; Simulation activities including environment, workflow and manual handling assessment; Digital solutions simulations and demonstrations; Virtual reality development and testing; and Showcasing events and customer demonstrations.

Read the article hereSource: Click here to view >

CENTRAL COAST HUNTER MTP INDUSTRY CAPABILITY

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There is an opportunity, given the proximity of healthcare and innovation providers, for the rapid validation and clinical input into ehealth solutions that quickly adapt and translate solutions into the health system. The strong bridge between idea and clinician is key to success – often determining what does not work is just an important as validating what does.

While not as regulated as other medical areas, several firms offer solutions focussed on general wellness which are designed to improve the health and wellbeing of people. Examples include Compeat Nutrition, Stryke Recovery, Chezleon and Shiane Wellness that offer solutions designed to improve quality of life and general wellness.

Source: HUNTER AND CENTRAL COAST CAPABILITY AUDIT OF THE MEDICAL TECHNOLOGY AND PHARMACEUTICAL SECTOR, by Mark Flynn, PhD, MBA of Global Edge MedTech Consulting 2020

ENABLERS

While there is an impressive diversity of companies, the support and presence of both a vibrant and innovative health system, and a strong research capability, underpins the successful CCH ecosystem.The health system comprises two local health districts (Hunter New England LHD & Central Coast LHD), private hospitals and the Hunter New England Central Coast Primary Health Network (HNECCPHN). Significant hospital and clinical trials resources and infrastructure exist in the region to support world-class clinical trials for technology approvals.

These systems and a variety of institutions such as the Ideas Lab at Gosford Hospital and the NSW

incubators and accelerators offer both the opportunity for incubation of ideas and early-stage companies as well as programs and events designed specifically to build and attract innovation capability in the region.

Source: HUNTER AND CENTRAL COAST CAPABILITY AUDIT OF THE MEDICAL TECHNOLOGY AND PHARMACEUTICAL SECTOR, by Mark Flynn, PhD, MBA of Global Edge MedTech Consulting 2020

REGULATORY SYSTEM COMPLIANT & ACCREDITED COMPANIES + PEOPLE

Companies and organisations in the CCH have the required certifications to conduct business in a compliant method according to international regulations and required certifications. Several have the required clearance from the TGA, FDA and other international bodies for the sale and distribution of their medical products and services.

Medical Device design and manufacture quality management certification, ISO 13485, and the non-medical device specific quality management certification, ISO 9001, has been achieved by a variety of large and small companies in the CCH while others are examining the business case to undertake it.

Importantly, there is a strong history and expertise in heavy industry and engineering in adjacent highly regulated fields (e.g. mining, defence) which increases the motivation and speed at which industry can transition into the highly regulated medical and bio technologies fields.

Regional Health Partners support the development of the health system. We note that the John Hunter Health Innovation Precinct will increase this capability further.

Both HMRI and the University of Newcastle provide capabilities and world leading expertise in the areas of research, teaching and laboratory space that can be utilised for discovery, as well as to support established and emerging firms.

Source: Hunter and Central Coast capability audit of the medical technology and pharmaceutical sector, by Mark Flynn, PhD, MBA of Global Edge MedTech Consulting 2020

SUPPORTERS

Supporting the CCH’s vibrant ecosystem are several support service companies who are specifically located in the region because of the opportunities it presents for MTP. For example, companies that address regulatory (e.g., Critical Compliance), and commercial strategy (e.g., Global Edge MedTech Consulting) offer bespoke services to firms in the region with sector specific capability. Genesis Research Services and Paratus Clinical provide services to enable the delivery of clinical trials services for companies both in and outside of the region who wish to conduct trials according to GCP and ISO14155.

The innovation ecosystem is well supported through at least five incubators and accelerators (I2N, The Melt, Ideas Hub, FastLab, Eighteen04). Newie Ventures, after three years in Eighteen04, recently ‘graduated’ and is now operating independently in new state-of-the-art facilities. These

Logikal and Whiteley CorporationISO 13485 certification is in place at manufacturers such as Logikal and Whiteley Corporation. Logikal is also accredited with a TGA conformity assessment as well as a TGA GMP licence. The non-medical device specific quality management certification, ISO 9001 has been obtained by Whiteley and Humanomics and AmpControl.

Logikal is also accredited with a TGA conformity assessment as well as a TGA GMP licence. The non-medical device specific quality management certification, ISO 9001 has been obtained by Whiteley, Humanomics and AmpControl.

NSW Health PathologyNSW Health Pathology is NATA accredited against ISO 15189. lau, a veterinary pharmaceutical company is accredited and audited by the USA FDA CVM as well as the TGA. The University of Newcastle has a desire to achieve NATA accreditation to complement its PC2 laboratories operated in combination with HMRI.

Various service providers have relevant qualifications in Good Clinical Practice and/or ISO 14155 (Genesis Research Service, Global Edge MedTech Consulting, and Paratus) enabling the provision and support of clinical trials for global markets. Electronic and eHealth is well supported through companies such as Assemblient being an Atlassian solutions partner.

HMRIHMRI is a registered Medical Research Institute, with both the University of Newcastle and Newie Ventures accredited as a Commonwealth Research Services Partner. Similarly, plans for the Central Coast Medical Research Institute focusing on integrated care solutions will further increase the regional health research capability.

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SIZE OF COMPANIES

The 50 companies that currently comprise the CCH MTP sector directly support 8,187 jobs. This excludes the tens of thousands of people who are employed delivering public and private health services to the population – in the health system and in enabling and support organisations.

There is a combination of sole traders (e.g., Critical Compliance, Global Edge MedTech Consulting, NewEye Business), start-ups and SMEs (e.g., Chezleon, Creatures & Co, Holland Healthcare, MyoMunchee, Genesis Research Services, Mollii Australia, Stryke Recovery, Laughing Mind) and larger organisations (e.g., Whiteley, HMRI, NSW Health Pathology, Jurox, Ampcontrol).

Source: Hunter and Central Coast capability audit of the medical technology and pharmaceutical sector, by Mark Flynn, PhD, MBA of Global Edge MedTech Consulting 2020

CCH WORKFORCE CAPABILITY

Large, Skilled, Adaptable WorkforceThe CCH workforce is large. Hunter data supplied by the Australian Government’s Labour Market Information Portal suggests:

EMPLOYED FULL TIME 209,600

EMPLOYED PART TIME 99,400

UNEMPLOYED 24,100

January 2021Source: Click here to view >

technology. The region’s engineering pedigree delivers an experienced approach that results in smart, technically sophisticated solutions.The regulatory/governance/quality management systems skills essential in the CCH’s traditional industries is another set of transferrable skills and a key asset.

MATURE WORKFORCE DEVELOPMENT PROGRAMS + PROVEN INDUSTRY & EDUCATION PARTNERSHIPS

The CCH has a pro-active approach to workforce skilling and an established industry-education partner culture. Since 2009, RDA Hunter’s Skilled Workforce Initiatives have partnered industry and schools to develop a cohort of future employees that have technical and enterprise skills, are familiar with industrial workplaces and are motivated to pursue STEM careers.

The initiatives build a skilled, job-ready, homegrown workforce tailored to industry’s needs. They provide students with contextualised skills that Hunter industry has specified it requires, in-industry experiences, and pathways to real jobs, while providing industry with a pool of local, qualified and motivated people from which to choose its staff.

Programs have partnered companies from the defence, mining and health sectors with students from Hunter schools, TAFE NSW and University of Newcastle.

The Hunter’s MTP sector is represented across the region’s largest employers by industry:

INDUSTRY JAN 2021

HEALTH CARE AND SOCIAL ASSISTANCE

48,500

PROFESSIONAL SCIENTIFIC AND TECHNICAL SERVICES

23,100

MANUFACTURING 16,900

January 2021Source: Click here to view >

The Australian Government projects that the country’s employment will increase in 16 of its 19 broad industries in the years to May 2024. Health Care and Social Assistance is projected to make the largest contribution to employment growth (increasing by 252,600), followed by Professional, Scientific and Technical Services (172,400)

Source: Click here to view >

ENGINEERING PEDIGREE AND MANUFACTURING HISTORY

The region’s long history in traditional industries and regulated fields such as heavy manufacturing, mining and defence, means it has an increased concentration of people with engineering skills at both technical and trade levels. These skills, coupled with a track record of adaptability due to economic shocks like we saw when steelmaking ceased in 1999 and the steady transition to Industry 4.0 processes, has increased the ease with which CCH industry is able to pivot and apply transferrable skills and knowledge into new, high-tech industry sectors like medical

Whiteley Corporation’s $10 million+ investment Whiteley Corporation’s $10 million-plus investment in a human therapeutics plant to be built at its expanding Tomago base has been bolstered with a research collaboration with the University of Newcastle. A $100,000 federal government research grant will see UoN assist Whiteley to develop an “Industry 4.0 solution” - using the Internet of Things, digitisation and automation - to boost advanced manufacturing processes at the plant, set to open in 2022. Read the Newcastle Herald article,

A $100,000 federal government research grant will see UoN assist Whiteley to develop an “Industry 4.0 solution”

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CCH’S EXISTING MTP AND ADVANCED MANUFACTURING CAPABILITY

The CCH has access to all the key MTP specialty areas of expertise:

• Advanced Manufacturing• AR/VR• Sterilisation• Drug Synthesis• Project Management• Chemistry• Clinical Trials and Ethics• IVD• Regulatory• R&D• Marketing/Product

Management• Supply Chain/Procurement/

Inventory• Reimbursement• Health Economics/HTA• Market Access/Business

Development• Training and Workforce

Readiness• App Development• Human Centred Design• Start-up Incubation/

Acceleration

Matching the CCH’s industry capabilities with its research and health system enables a vibrant setting where ideas with commercial potential can be rapidly identified and supported. This match-up can also help solve unmet medical needs and convert University inventions into revenue positive health innovations.

Source: Hunter and Central Coast capability audit of the medical technology and pharmaceutical sector, by Mark Flynn, PhD, MBA of Global Edge MedTech Consulting

• Image Processing• QMS

And applies this expertise in:

• Electronic and Industrial Design

• Digital (including cloud)• Project Management• MedTech• BioTech/Pharma• Digital/eHealth• General Wellness• Research• Health Providers

Importantly, although the region boasts all the key areas of expertise, there is a need for companies to collaborate on big ‘problems’ as no single company has a complete set of skills across all application areas. Consortia can and have been effortlessly created to partner on nationally competitive grants and specific initiatives, evidenced in times of high need like COVID-19.

Click here to see Central Coast Hunter expertise by company.

CENTRAL COAST HUNTER MTP EXPERTISE

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The Central Coast Hunter is home to leading scientists, physicians and healthcare professionals. It boasts world-class medical research and healthcare infrastructure, a stable socio-economic environment, a diverse population and is supported by Australia’s strong intellectual property regime.

CCH Clinical Trials situation:• 431 clinical trials currently

underway • Existing proven clinical trials

infrastructure• 80% of clinical trials sponsored by

industry• 10% paediatric/90% adult

population split• Ready access to experienced,

renowned clinicians• Diverse therapeutic-area clinical

research experience• A diverse, stable population

including regional, rural and remote communities

• Additional clinical trials capacity due to the process improvements currently underway

Source: Hunter and Central Coast capability audit of the medical technology and pharmaceutical sector, by Mark Flynn, PhD, MBA of Global Edge MedTech Consulting

• Proximity to Asia• Australia’s Medical Research

Future Fund that supports research projects and infrastructure

Global companies benefit from streamlined processes and clinical trial protocols which are immediately globally transferable, ensuring outcomes that are reliable, highly respected and can be made readily available in other jurisdictions.

The Australian Government, in partnership with industry and other stakeholders, has introduced a number of reforms to make Australia an even more attractive place to conduct clinical trials whilst maintaining the highest quality and ethical standards. They include initiatives to improve the speed of study approvals, boost patient recruitment and standardise and reduce costs associated with clinical trials in Australia.

WHAT MAKES CCH AN IDEAL DESTINATION FOR CLINICAL TRIALS?

• Quality medical research infrastructure and a skilled, experienced workforce

• Clinical leaders in diverse therapeutic areas

• A world-class healthcare system• A diverse, English-speaking

population • Clinical data which complies

with the highest international standards

Additionally, Australia’s efficient regulatory system, including a rapid clinical trial approval system, well-established clinical trial infrastructure, experienced and well qualified personnel and globally competitive tax incentives for research and development (R&D) investment, all help make Australia a leading destination for clinical trials.

Source: Click here to view >

Australia offers:• Attractive research & development

(R&D) tax incentives for clinical trials

• A fast, pragmatic regulatory pathway

• A strong intellectual property system

• A national focus on continuous improvement through government reform and policy innovation

CENTRAL COAST HUNTER CLINICAL TRIALS

Australia is a highly globalised economy, with trade accounting for 44% of nominal GDP. The Asian region saw almost three quarters of the two-way trade in goods and services in 2019–20 with the value of exports reaching almost A$475 billion.

Central Coast Hunter (CCH) is contributing nationally with the region’s MTP companies having both local and global reach.

Firms offer products and/or services throughout NSW with most also trading Australia-wide. Importantly, 58% of firms offer products and/or services beyond Australia, primarily to

New Zealand, USA, and Europe (incl UK) (e,g., Whiteley, Jurox, MyoMunchee).

The importance of this is crucial given the logistical and regulatory hurdles required for the export of highly regulated medical devices and biotechnology products to overseas markets.

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1. Key MTP Precinct TenantAn anchor tenant is key to the success of any industry cluster/precinct. Although Central Coast Hunter boasts global companies and a range of SMEs as well as all the attributes of a well-functioning medical precinct, the establishment of a large multi-national in the region would underpin future holistic growth of the MTP ecosystem.

2. Digital Health – Coalition of Health and Technology PartnersThe Central Coast Hunter is a compelling destination to test, develop and commercialise digital health solutions. The region has adopted digital health to help deliver services, improve processes, and increase efficiencies. With a strong commitment to Health and technology partnerships that lead to Health-led, effective solutions, the CCH is looking for opportunities to expand its reach in digital and e-health.

3. Clinical trialsThe CCH has a strong clinical trials sub-sector that delivers a range of device and pharmaceutical trials. It has the skilled workforce, dedicated infrastructure and clinical expertise to support a complete clinical trials service. Opportunities exist to

additive manufacturing processes in more CCH production facilities. 6. Small batch pharmacology production for clinical trialsThere is support from CCH clinicians to increase the CCH’s capability to enable the production of clinical trial size batches of pharmaceuticals for studies occurring in the CCLHD and HNELHD as well as for health researchers and private clinical trials providers. 7. Rapid prototyping, production and testingRapid prototyping production and testing facilities are important for bringing products to market. An opportunity exists to grow and better utilise the CCH’s existing capacity for R&D and rapid prototyping to improve the efficiency of the pipeline from unmet need to commercialisation. 8. Research funding (e.g) ARC, Federal and State GovernmentsThe CCH is exploring avenues for funding to contribute to the growth and improvement of all aspects of its MTP ecosystem. The region is collaborating to identify joint, regionally significant projects that will unlock opportunities for government funding.

expand into Phase One and First-in-Human trials as well as to develop educational courses to upskill the workforce in the provision of clinical trials.

4. Workforce Development – Quality Management Systems. Cyber SecurityQuality Management Systems and regulation is a key component of the MTP environment. But, with the creation of new and development of existing IP, interest from unwanted competitors and unscrupulous speculators is inevitable. Training to upskill the MTP workforce in quality management is an urgent industry requirement and an opportunity in the CCH. Increasing awareness and vigilance of Boards, business owners and the MTP workforce needs to be embedded in the sector to protect competitive advantages and maintain CCH’s reputation for delivering best-in-class solutions.

5. Additive ManufacturingThe creation of lighter, stronger parts and systems is important to medical device production. Additive manufacturing, or 3D printing, is being taught in some CCH schools and at TAFE and University. An opportunity exists to upskill the existing workforce and implement

OPPORTUNITIES FOR MTP GROWTH IN CENTRAL COAST HUNTER

CASESTUDIESWHITELEY CORPORATION >

JUROX >

MYOMUNCHEE >

AMPCONTROL >

CENTRAL COAST HUNTER CLINICAL TRIALS >

NSW HEALTH PATHOLOGY/PoCT >

LOGIKAL HEALTH >

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Whiteley Corporation is a leading global innovator in infection prevention solutions. It is a family-owned Australian business, that has been operating since 1933. Its TGA licensed manufacturing facility is based in Newcastle, NSW. Research and Development is a major focus for the company, with resources dedicated to internal research as well as external research conducted in conjunction with international partners. It has achieved award-winning success in the chemical manufacturing industry and world leading research and product development.

Whiteley Corporation manufactures a range of Infection Prevention products that are classified as Medical

Devices and is licensed by the TGA to manufacture Instrument Disinfectants and Sterilants. Whiteley Corporation is currently in the process of building a new Class Three Flammable Human Therapeutics Plant to manufacture over-the-counter medicines.

Visit Whitely Corporation >

WHITELEY CORPORATION

Jurox is an integrated developer of animal health products which are sold worldwide, all made in its plant in Rutherford, NSW. It develops and researches its own products and has a regulatory team that takes it through to product registration in North America, Japan, Asia, UK and Europe. It also synthesises its major products in a plant at Rutherford, its raw material being Alfaxalone. It has approx 300 international registrations globally for a range of products that it sells, both in companion animals (ie) dogs and cats and farm animals – dairy, beef cattle, sheep etc.

Jurox collaborates with Universities and research organisations to generate research for global markets. It has a

close relationship with the University of Queensland as well as relationships with many overseas universities through its Head of Research, located in Vancouver, Canada.

Visit Jurox >

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Myo Munchee is a Newcastle based company that manufactures and exports a soft silicone chewing mouthguard designed to help with nasal breathing and chewing, while assisting facial growth and tooth development. It encourages improved breathing patterns and healthier teeth and gums.

The Myo Munchee device is based on research into how chewing affects every aspect of health and decades of clinical dentistry experience to bear on making and refining the small device. All Myo Munchee’s products are made from non-toxic medical grade silicon. Munchee’s active chewing approach gets the body’s innate optimal functioning back on track. The reflexive response Munchee triggers helps with

jaw and mouth function, breathing, posture and sleep.

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MYO MUNCHEE

Employing approximately 1000 people worldwide, Ampcontrol delivers integrated electrical, electronic and control solutions to improve safety and efficiency in mining, renewable, infrastructure and industrial applications.

What sets Ampcontrol apart is its ability to engineer unique solutions that deliver both performance and reliability. To achieve this, it works in partnership with its customers, lending electrical engineering expertise to their operational challenges. From the most complex electrical infrastructure to the most hazardous industrial environments, Ampcontrol engineers solutions that focus on whole-of-life optimisation.

Drawing on the multi-disciplined technical resources within our business, we step outside the conventions of traditional problem solving, and seek new ways to improve electrical infrastructure design through smart electronics, intelligent data gathering, and operational networking and control. This is backed-up with inhouse manufacturing, commissioning, testing, electrical engineering and maintenance support teams.

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AMPCONTROL

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Paratus Clinical is working with Pharmaceuticals, Biotechnology, Academic sponsors to perform clinical research studies involving both healthy people and those with underlying illnesses (chronic and acute) for new medicines, vaccines and diagnostics. Paratus offers vaccine refrigeration, ECG, laboratory-grade freezer, spirometer, centrifuge, continuous temperature monitoring with 24 hour alarm and back up and each site has an Office of the Gene Technology Regulator (OTGR) accredited PC1 Facility, enabling the conduct of trials with a GMO

Genesis Research Services offers a range of clinical trial opportunities including world-first studies for pain management and healthy volunteer studies. It provides pharmaceutical, biotechnology and clinical research organisations with a dedicated team of professionals and a purpose-built facility designed around the needs and requirements for conducting clinical trials. It offers complete ethical oversight, pre-screening and referral, study advertising material and management.

HMRI Clinical Trials Unit focuses on swifter translation of health research

types including Brain, Colorectal (bowel), Lung, and Ovarian.

into the clinic. The Unit provides clinical trial coordination as a service. It offers: Clinical trial conduct from beginning-to-end; Consulting to assist existing teams; Discrete services within clients’ current trial.

The HMRI team brings knowledge and skills to complement those of its partners to support its clients to prepare, design, secure approvals, recruit, execute and evaluate successful clinical trials. Its consultative and collaborative approach is designed to build capacity in teams and across the clinical trials sector.

Newcastle Private Hospital Clinical Trials has over 10 years’ experience conducting clinical trials in the private setting.With the ongoing support of the NPH management and Healthscope executive teams, clinical trials are now seen as a standard part of the care provided for oncology patients at NPH. The clinical trial unit is supported by a Chemotherapy Day Unit, Medical Centre, Oncology Ward, ancillary services (e.g. physiotherapy, pathology) as well as an onsite oncology pharmacy. NPH clinical trial unit participates in local, national and international studies, conducting trials for a variety of cancer

CENTRAL COAST HUNTER CLINICAL TRIALS

NSW Health Pathology was formed in 2012. It protects and enhances the health, safety and wellbeing of our communities at all stages of life and is a trusted partner and committed to excellence in quality, safety and innovation. It leads the way in training, education, research and policy creation to meet the diverse, evolving needs of its communities.

NSW Health Pathology Point of Care Testing is the world’s largest accredited managed service with more than 750 point of care devices installed over 200 metropolitan, regional and rural hospital settings. Point of Care testing groups include: coronary, diabetes, infection, general health status, blood gas/acid base, reproduction.

NSW Health Pathology’s key capability areas include: Scientific IP; Digital solutions development (IT development); Patient testing – hospitals, mobile, community, companion diagnostics; Technology evaluation; Clinical trial services; R&D; Prototype manufacture.

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NSW HEALTH PATHOLOGY/PoCT

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Logikal is an experienced, TGA audited, contract manufacturer of therapeutic products (medical devices, liquids & topical creams), based in the Hunter Valley (NSW, Australia). The company was founded with the aim of growing Australian manufacturing & providing regional employment opportunities.

Quality is at the forefront of Logikal’s overall philosophy & daily actions. The company has built its reputation, & customer relationships, on a foundation of continual improvement & a commitment to high quality control.Logikal manufactures both Medical Devices and Listed Medicines through its TGA manufacturing experience and vast experience in sterilisation processes and controls. Medical

devises (usually sterile disposables for hospitals and medical industry); liquids and creams (including surface and hand sanitisers) for Pharma industry, including sterile creams are its core products.

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LOGIKAL HEALTH

AmpcontrolAssemblientAustralian Industry (Ai) GroupBosch Manufacturing AustraliaCentral Coast Clinical School & Research InstituteCentra; Coast Local Health DistrictChezleonCreatures & CoCritical ComplianceFaceMatchFASTLabGenesis Research ServicesGlobal Edge MedTech ConsultingHunter Medical Research Institute (HMRI)HMRI Clinical Trials UnitHunter New England Health Local

NSW TreasuryParatusPhastarRegional Development Australia (RDA) Central CoastRegional Development Australia (RDA) HunterSafearth SolutionsShiane WellnessSpottoStryke RecoveryTAFE NSWUniversity of NewcastleWhiteley Corporation

Health DistrictHolland HealthcareHumanomicsI2NIdeas LabInvestment NSWJohn Hunter Health Innovation PrecinctJuroxLaughing MindLogikal HealthMollii Australia/Metier MedicalMTP ConnectMyo MuncheeNewEyeBusinessNewcastle Machine ShopNewie VenturesNSW Health Pathology (PoCT)

CONTRIBUTORS

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COPYRIGHTThis publication is protected by copyright. Regional Development Australia (RDA) Hunter requires that it be attributed as creator of the licensed material. You may also use material in accordance with rights you may have under the Copyright Act 1968 (Cth), for example under the fair dealing provisions or statutory licences.This report should be cited as;O’Mara, K. & Flynn, M. (2021) Medical Technologies & Pharmaceuticals: A Growth Sector for the Hunter Central Coast Region, prepared for Regional Development Australia (RDA) Hunter. Newcastle, Australia

DISCLAIMERThis report was produced by RDA Hunter and does not necessarily represent the views of the Australian Government, its officers, employees or agents. The information contained is provided by RDA Hunter in good faith. The information is derived from sources believed to be accurate and current as at the date indicated in the respective sections of this publication. Neither RDA Hunter nor any of its directors or employees give any representation or warranty as to the reliability, accuracy or completeness of the information, nor do they accept any responsibility arising in any way (including by negligence) for errors in, or omissions from, the information.

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