An Australian-first approach to cancer clinical trials – called registry-based randomised controlled trials or registry trials – will enhance the ability of clinicians to select the right treatments for patients

Working with partners across the Victorian Comprehensive Cancer Centre (VCCC) alliance and private health services, the first Australian cancer-focused registry trials will investigate and evaluate promising new cancer treatment strategies for bowel cancer and brain tumours.

Registry trials are facilitated by the comprehensive clinical data captured in clinical registries at many hospitals, including VCCC partner hospitals, enabling researchers to compare the impact of different treatment strategies on large numbers of patients in a real-world setting.

Conventional cancer clinical trials typically have strict patient eligibility criteria, limiting patient access. For less common types of cancers, this can restrict researchers’ access to enough patients to draw statistically valid conclusions.

Previous international research in cardiovascular-focused registry trials has shown that, as well as accelerating patient recruitment, registry trials cost much less than conventional cancer trials and are also much simpler to conduct.

At a glance

• Registry trials bring together data from a range of patients at multiple hospitals, enabling researchers to better evaluate the impact of different cancer therapy strategies in the real-world setting.
• Australian-first cancer randomised registry trials have been initiated within the framework of the VCCC alliance, with plans underway to extend the trials to other health services.
• Registry trials can simplify trial conduct, test different treatment strategies in a routine care patient population and increase patient recruitment while evaluating efficacy and safety.

Enhancing clinical trials

Registry-based randomised controlled trials or registry trials have many advantages over conventional randomised clinical trials, according to Professor Peter Gibbs, clinician-scientist at the Walter and Eliza Hall Institute, medical oncologist at Western Health and the VCCC Research & Education Lead – Gastro-Intestinal Cancers, and Walter and Eliza Hall Institute PhD student Siavash Foroughi. Mr Foroughi, Professor Gibbs and colleagues reviewed the promising data related to registry trials in an article recently published in Asia-Pacific Journal of Clinical Oncology.

Mr Foroughi found the potential of registry trials had recently been demonstrated in cardiovascular trials and had potential across other disease types.

“We concluded registry trials provide a timely and cost‐effective solution to answering important clinical questions for cancer patients, many of which are not being addressed by conventional trials. Outcomes could assist clinical decision-making for cancer treatments while bridging the gap between randomised clinical trials and observational studies, including phase IV clinical trials,” Mr Foroughi said.

New clinical trials starting

Registry trials have recently been initiated for two cancer treatment strategies:

• ALT-TRACC – investigating alternating two cycles of doublet chemotherapy versus standard continuous doublet chemotherapy as a new treatment strategy for newly diagnosed metastatic colorectal cancer
• EX-TEM – examining the effectiveness of six months versus 12 months of post-radiation chemotherapy for glioblastoma, an aggressive form of brain cancer

These trials will soon open at multiple Victorian health services, with support provided through the VCCC alliance. Clinicians will have access to the data in existing cancer registries to evaluate patients’ treatments and outcomes. Several more trials are in development, aimed at improving the care of patients with other tumour types, including pancreas and prostate cancer. Registry trials will also, in the near future, enable other underserviced areas of research, such as optimising palliative care and surgical interventions.

Professor Gibbs said the registry trials were an exciting new development for understanding how treatment strategies impact patients.

“Despite statistical advances, comparative observational registry studies have not been widely accepted by the cancer research community as sufficient to change standards of care,” he said.

“We believe there is enormous potential for registry trials to enhance and accelerate cancer research and to bridge the gap between conventional clinical trials and purely observational studies.

“These trials will enable us to evaluate multiple treatment strategies and give oncologists more insight into the best approaches for improving health outcomes for individual patients.

“As for all clinical trials, informed consent, high quality data collection, careful data analysis, data security and patient privacy will be of paramount importance,” Professor Gibbs said.

In summary: key strengths of the registry-based approach

• High external validity through inclusion of real‐world patients and smaller centres
• Can answer simple, pragmatic questions that are otherwise unlikely to ever be explored
• Rapid patient recruitment due to broad eligibility criteria
• Data collection is integrated into routine care
• Substantially lower costs than conventional randomised clinical trials.

Professor Peter Gibbs, image credit: Walter and Eliza Hall Institute

Siavash Foroughi, image credit: Walter and Eliza Hall Institute

Article source: Victorian Comprehensive Cancer Centre

Well known Melburnian, businessman, philanthropist and Precinct advocate, Harold Mitchell AC will assume the role of Chair of the Melbourne Biomedical Precinct for the next six months, following the departure of our Executive Chair Professor Gareth Goodier last month.

Gareth has taken on a new role as CEO of Abu Dhabi’s health system after two years at the helm of the Melbourne Biomedical Precinct Office. During this time, he’s been a driving force for change in the Precinct overseeing both the establishment of the Office and the delivery of the strategic plan for the Precinct. We wish him every success in his new role.

Harold Mitchell is Chair of the Premier’s Jobs and Investment Panel, which recognised the importance of the Precinct in its 2016 report to the Government. The recommendations of this panel were fundamental to the establishment of this Office and the development of the Strategic Plan for the Precinct. In addition to other roles, Harold is also Chair of the Florey Institute of Neuroscience and Mental Health.

Harold will be a great asset for us during the next important phase of working with the partners to implement the strategic plan. In particular he will explore opportunities to increase the international profile of the Precinct and champion new partnerships and investment.

A search for a new Executive Chair will commence in the new year.

Land Use Framework Plan Project Update

The Melbourne Biomedical Precinct Office continues to work closely with the Victorian Planning Authority (VPA) on the development of a land use framework plan for the precinct. The Framework Plan will set out the land use strategies which will support the objectives of the strategic plan, released in April.

The VPA has released a project update to bring stakeholders up to speed on its progress.

You can find the VPA’s project update here

Australian Museum Eureka Prizes

Presented on 29 August 2018, the annual Australian Museum Eureka Prizes reward excellence in the fields of research & innovation, leadership, science engagement and school science.

A number of our Precinct Partners were represented in the teams and individuals shortlisted as finalists this year, including Associate Professor Alan Duffy from Swinburne University of Technology who took home the 2018 Celestino Eureka Prize for Promoting Understanding of Science.

Congratulations to Alan and the other Melbourne Biomedical Precinct finalists:

• The Biopen Team shorlisted for the UNSW Eureka Prize for Excellence in Interdisciplinary Scientific Research
• Dr Jason Brouwer shortlisted for the 3M Eureka Prize for Emerging Leader in Science
• Jo Chandler shortlisted for the Department of Industry, Innovation and Science Eureka Prize for Science Journalism

Read more about the Precinct’s Eureka Prize finalists here

Building international partnerships – Sky Gross and Nathan Elia visit Melbourne

We were delighted to introduce Nathan Elia and Dr Sky Gross to the Precinct in July when they visited Melbourne for a series of meetings, workshops and presentations with government, industry and Precinct Partners.

Nathan is the Victorian Government’s Investment & Trade Director in Boston, where he focuses on biotechnology, life sciences, medical R&D and tech. Sky is the inaugural Biomedical Director at Victoria’s new trade and investment office in Tel Aviv and will be instrumental in not only building relationships between here and Israel, but also in facilitating a more commercial approach to the translation of our research.

Read more

Collaborate + Connect + Commercialise Networking Series

In July, more than 150 people attended our third networking event which showcased a panel discussion on the opportunities and challenges facing scientists in the quest for commercialisation and the translation of research into patient care.

Dr Sky Gross was joined by Professor Andrew Nash from CSL, Nathan Elia from the Victorian Government’s Trade and Investment Office in Boston, and Professor Aleksandar Subic – Deputy Vice-chancellor (Research & Development) at Swinburne University for a robust discussion and reflection on the topic.

These events continue to bring together industry and the sector to help build further impact for the Precinct.

Read a full overview of the event here

Events and opportunities

You may be interesting interested in attending one or more of the following events taking place in the coming weeks:

• Eliminating Hepatitis C – is it actually possible? On Thursday 6 September, Dr John McHutchison AO, Chief Scientific Officer and Head of Research and Development at Gilead Sciences, will talk about his experiences and hopes for HCV patients. This is a fantastic opportunity to learn from someone who had significant global impact through the commercialisation of their research.
• I can save lives! How to take medical research to the market. On Monday 10 September, life science venture capital expert Brigitte Smith will profile some recent commercialisation success stories, giving you the chance to imagine the real-life impacts of your work from bench to bedside and beyond. This is a VCCC Monday Lunch Live event.
• Culture of Medical Research – Where Are We Heading? On Monday 17 September, join WEHI Director Professor Doug Hilton for a conversation about where the culture of medical research is heading. This is a VCCC Monday Lunch Live event.

Did you know?

On Friday 17 August, a social football game was held between Peter Mac and the Walter and Eliza Hall Institute at Princes Park. The event was a great way to meet colleagues from other institutions, and the organisers hope to broaden the community aspect of medical research and foster wider inter-institute collaborations. While everyone’s a winner at these friendly events, for the record WEHI won the game on the day!

Stay informed

The Melbourne Biomedical Precinct Office was established by the Victorian Government to drive economic development in the Precinct and strengthen its position as a world leader in biomedical research, development and innovation.

Do you know someone who would like to know more about our work and stay informed? Please direct them to this website or sign up here

The Victorian Planning Authority (VPA) has released a project update regarding its work to develop a land use framework plan for the Parkville National Employment & Innovation Cluster (NEIC).

The VPA is working with the Melbourne Biomedical Precinct Office, City of Melbourne and government agencies to prepare the Parkville NEIC Framework Plan.

The VPA has released a project update which provides an overview of what has been learned since the project commenced in July 2017, including the stakeholders engaged thus far, how the Framework Plan relates to the Victorian Government’s 10-year strategic plan for the Melbourne Biomedical Precinct and the City of Melbourne’s work on the Melbourne Innovation Districts.

It also includes more information about the timelines for project timeline for the development of a draft plan for consultation (expected in early to mid 2019).

You can download the project update here.

You can read the Victorian Planning Authority’s work on the Parkville National Employment and Innovation Cluster here.

Media contact: Julie Browning 0419 003 063

We were delighted to introduce Nathan Elia and Dr Sky Gross to the Precinct in July when they visited Melbourne for a series of meetings, workshops and presentations with government, industry and Precinct Partners

Nathan is the Victorian Government’s Investment & Trade Director in Boston, where he focuses on biotechnology, life sciences, medical R&D and tech. Sky is the inaugural Biomedical Director at Victoria’s new trade and investment office in Tel Aviv and will be instrumental in not only building relationships between here and Israel, but also in facilitating a more commercial approach to the translation of our research.

Sky and Nathan met with more than 100 people during their visit and were both impressed with the breadth of experience and talent in the Precinct, and the world-class work we are doing here.

“There’s no doubt about the exceptional calibre of the work and people within this precinct, who are all united in creating better patient outcomes. What we now need to foster is a better relationships internationally and with industry to ensure not only patient success, but commercial success. Israel is the world’s leader in this regard and now I’ve seen first-hand the Precinct at work here, I think there are significant opportunities for growth,” Sky said.

Thanks to all those who gave of their time so generously to meet with Sky, Nathan and our team during their visit.

The Victorian Comprehensive Cancer Centre’s first Investigator-Initiated Trial Capacity Building support package has been awarded to Professor Geoff Lindeman, clinician scientist at the Walter and Eliza Hall Institute, Royal Melbourne Hospital, Peter MacCallum Cancer Centre and The University of Melbourne.

The forthcoming trial aims to evaluate the effects of adding a new anti-cancer drug to the current gold standard therapy used to treat estrogen receptor (ER) positive metastatic breast cancer, the most common type of breast cancer.

Victorian Comprehensive Cancer Centre (VCCC) Executive Director, Professor Grant McArthur said, “The VCCC is delighted to support Professor Lindeman’s breast cancer trial. The trial has great potential to transition into a clinical setting and it is an excellent opportunity to explore the impact of a new anti-cancer drug on certain breast cancers through an investigator-initiated trial.”

Professor Geoff Lineman. Image credit: Walter and Eliza Hall Institute 

Investigator-initiated trials benefit patients by asking important clinical questions that pharmaceutical or biotech industries are less likely to invest in. Professor Lindeman said, “The VCCC’s clinical trials programs are innovative at a number of levels and provide direct benefit to patients with cancer. Investigator-initiated trials allow the laboratory and clinical researchers to extend and explore new ideas. They also provide patients with early access to promising drugs.”

Victoria’s health and research delivers successful trials through established structures

In Victoria, 70 per cent of all cancer clinical trials are conducted at either Western Health, Royal Children’s Hospital, Royal Women’s Hospital, Royal Melbourne Hospital, Peter MacCallum Cancer Centre, St Vincent’s Hospital or Austin Health. These hospitals are partners in the VCCC alliance, working together to accelerate and amplify leading-edge cancer research, knowledge and clinical care.

Investigator-initiated trials are established and managed by non-pharmaceutical researchers, who also retain responsibility for legal and regulatory requirements. VCCC alliance partners provide a critical mass of successful clinical trial facilities and clinician researchers, with proven infrastructure and established governance methods.

Backed by Victorian Government funding, the VCCC introduced the Investigator-Initiated Trials Capacity Building program to address the number one unmet need in the cancer clinical trials field. Professor Grant McArthur said, “This new program provides access to resources to support development, application and management of selected trials and will also teach us how to generate and assist more of these trials in future. This is a key strategic priority for the VCCC and will enhance the overall clinical trials capacity across our alliance and across Victoria.”

Support mechanisms provide a coordinated approach

The VCCC Investigator-Initiated Trials Capacity Building program is being rolled out in stages to allow for a robust assessment of the support mechanisms. This first Investigator-Initiated Trials Capacity Building support package has been launched with the intention to enhance a partially-funded concept; led by an investigator with a track record. Professor Lindeman’s trial will be provided with access to statistical support from Murdoch Children’s Research Institute (MCRI) and the University of Melbourne, clinical trial management services through the Peter MacCallum Cancer Centre, Centre for Biostatistics and Clinical Trials (BACT) and site management services through Cancer Trials Australia (CTA).

Cancer Trials Australia CEO Dr Kurt Lackovic said, “We are excited to be a part of this important program; helping to remove barriers by coordinating agreements, developing budgets and ethics submissions, as well as aiding reporting processes, to ensure more Victorian patients benefit from our cutting-edge research sooner.”

Stage 2 of the program will provide support throughout the breadth of the clinical trial process, from idea generation to protocol development, and grant application.

For more information about Investigator-Initiated Trial Capacity Building

For further information regarding the Investigator-Initiated Trial Capacity Building program, contact Kate Khamly, Program Manager via email kate.khamly@unimelb.edu.au or call on 03 8559 8872.

Article source: Victorian Comprehensive Cancer Centre

With release of our Strategic Plan in April, the Melbourne Biomedical Precinct Office has been focused on developing an implementation plan with Precinct Partners.

In particular we have seen a lot of activity around our strategic directions 1, 2 and 3 which focus on commercialisation, digital health, and talent attraction and retention.

New Precinct Partners

Since establishing the Melbourne Biomedical Precinct Office last year, we’ve been delighted with the response and interest in our work, as well as the  many groups who have come to us actively wanting to be involved. The Precinct Leadership Group discussed this recently and as a result we are welcoming a number of new organisations to our already strong stable of biomedical partners.

The addition of these new partners further showcases the breadth and depth of the Precinct’s work and complements our existing relationships. We believe it is clear further evidence of the strong contribution the Precinct makes to Victoria’s reputation and success.

It’s important to note that new partners must satisfy a number of key principles, including that they are active in the areas of biomedical research, product development, healthcare delivery, tertiary education, or biomedical advocacy. In addition they must have a strong brand and be active in the Precinct – though not necessarily headquartered here.

The membership of the Precinct Leadership Group will remain unchanged.

Meet our new partners here.

New Biomedical Director appointed to Tel Aviv

As the next important step in building international industry collaborations, Dr Sky Gross has been appointed inaugural Biomedical Director of the Victorian Government’s new trade and investment office in Tel Aviv.

The office opened in late 2017 and with Israel’s reputation as a leader in translation and commercialisation, this is an incredible opportunity for the Precinct. It will help open doors to Israel-Victorian biomedical research partnerships and related commercial opportunities, as well build and strengthen our knowledge and skills. This is all consistent with a key direction of our Strategic Plan and provides a wonderful marketing opportunity for the Precinct and its work.

Dr Gross will work closely with our office and also visit Melbourne in coming months to meet with Precinct Partners. Her career has been built on strong collaborations  in health and social sciences, more recently reporting directly to Israel’s Chief Scientist focusing on research funding, policy and priorities.

A corresponding liaison officer will also be based in the Melbourne Biomedical Precinct Office. Scott Edwards has been appointed to the role of Principal Adviser, International. With an initial focus on Israel, Scott will seek to grow the international recognition of the Precinct, and foster new research collaborations and industry partnerships.

Read more about Dr Sky Gross  and Scott Edwards here.

Connecting Care in Parkville – Electronic Medical Records

The Connecting Care Electronic Medical Record (EMR) Project is now well underway, following the Victorian Government’s budget announcement of $124 million to fund a fully-integrated EMR for the Precinct.

EMR was a key recommendation in our Strategic Plan and essential to patient quality and safety, as well as to research across the Precinct.

Jackie McCleod has been appointed as Executive Director of the project team and with her experience in leading EMR projects at Austin Health and the Royal Children’s Hospital, is well placed to lead this project to its go-live date of 2020.

The project team has representation across  the key health services, Peter MacCallum Cancer Centre, the Royal Women’s Hospital and Melbourne Health, as well as the Royal Children’s Hospital.

For those interested in working on the project, roles will be advertised via Seek and the recruitment sites for the hospitals listed above.

Advisory Groups

At our last Precinct Leadership Group meeting, it was agreed to establish a Precinct People and Culture Advisory Group. We know that people are at the heart of the Precinct’s success, so it’s critical that we continue to work together in the important areas of attraction, development and retention of staff. We will be meeting with Precinct Partners in coming months to establish this group and agree an approach..

New early learning centre opens at WEHI

This week the Victorian Minister for Early Childhood Education the Hon. Jenny Mikakos officially opened the new Professor Lynn Corcoran Early Learning Centre at Melbourne’s Walter and Eliza Hall Institute (WEHI).

Named after Professor Lynn Corcoran, a senior scientist at WEHI and advocate for gender equity, the new centre is a clear show of support for female scientists in the Precinct. Access to quality childcare was seen as a major barrier for women continuing their careers in medical research, so this is an important step forward to enable a balance between family and work life.

The $9.9 million, 100 place centre will cater for children aged three months to six years and has been funded through a mix of philanthropic, government and institute support.

Read more about the Professor Lynn Corcoran Early Learning Centre here

CSL seeking 2019 fellowship applicants

CSL is inviting Australian biomedical researchers to apply for one of two of the company’s Centenary Fellowships worth $1.25 million over five years.

Applications opened this week for outstanding mid-career scientists seeking to undertake work-class medical research at an Australian academic institute.

The fellowships aim to boost the medical research community by supporting the development of Australian science.

Learn more about CSL’s Centenary Fellowships here.

Did you know?

If you’ve noticed a lot of happy student faces in the Precinct, you shouldn’t be surprised – Melbourne has been voted the best student city in Australia and third in the world, according to  the QS Best Student Cities 2018 ranking.  This is no small feat and to say the least we are in good company, just behind London and Tokyo at number 1 and 2 respectively.

Stay informed

The Melbourne Biomedical Precinct Office was established by the Victorian Government to drive economic development in the Precinct and strengthen its position as a world leader in biomedical research, development and innovation.

Do you know someone who would like to know more about our work and stay informed? Please direct them to this website or sign up here

Dr Sky Gross has been appointed as Biomedical Director

The Melbourne Biomedical Precinct will have increased opportunities to build valuable relationships with Israel with the appointment of Dr Sky Gross to the Victorian Government’s new Trade and Investment Office in Tel Aviv.

In her role as the new Biomedical Director, Dr Gross will focus on translating Victoria’s world-class medical research into commercial opportunities, creating jobs and growth and increasing the collaboration with Israel.

The Trade and Investment Office opened in late 2017 and is the only Australian state government office of its type in Tel Aviv. Professor Gareth Goodier, Executive Chair, Melbourne Biomedical Precinct Office said the appointment of a Biomedical Director in Israel was an unprecedented opportunity for the Precinct.

“Israel is the recognised leader in translation and commercialisation and this will not only help open doors to biomedical research partnerships and related commercial opportunities, but also build and strengthen our knowledge and skills,” he said.

“This is a chance to learn from and work with the best. Dr Gross knows the people, the businesses and the approach that will make a difference to our discoveries – taking them that step further through clinical application and commercialisation to add even more impact to patient care and the Victorian economy.”

Dr Gross’s  background is in research and professional roles in health and social sciences, particularly in medical sociology and anthropology.

The Melbourne Biomedical Precinct Office will work actively with Dr Gross and the team in Israel to market and showcase Victorian discoveries to this very lucrative market. The appointment  is a joint initiative between Victoria and the Israel-Australia Chamber of Commerce. Paul Israel, Executive Director of the Chamber, recognised the importance of the partnership.

“The Chamber is most excited by the appointment of Dr Gross, the Melbourne Biomedical Precinct is the jewel in the crown of the emerging Australian innovation eco-system and the opportunity to combine efforts with Israel will create a powerful partnership that will only strengthen and enhance both economies, ” he said.

Media contact: Julie Browning 0419 003 063

From research engine to economic powerhouse

The Executive Chair of the Melbourne Biomedical Precinct Office, Professor Gareth Goodier, today welcomed the release by the Victorian Government of a ten-year strategy for the precinct, saying it will drive better patient outcomes, as well as economic and jobs growth for the state.

The Special Minister of State, the Hon Gavin Jennings, the Minister for Health, the Hon Jill Hennessy and the Chair of the Premier’s Jobs and Investment Panel Harold Mitchell met today with precinct leaders to launch the strategy.

A commitment of $124 million towards electronic medical records across Melbourne Health, the Royal Women’s Hospital and the Peter MacCallum Cancer Centre was also announced, as well as continued support for the work of the Melbourne Biomedical Precinct Office.

“This is an important and exciting milestone for the Melbourne Biomedical Precinct and indeed all of Victoria,” said Professor Goodier.

“There is no doubt that this precinct is Victoria’s, and Australia’s, biomedical powerhouse.

“We attract more competitive national biomedical research funding than any other precinct in Australia, our publications have twice the citation rate of anywhere in the world and our work has fundamentally changed and improved patient outcomes, for individuals and communities for more than 160 years.

“This strategy will help build on this success and will ensure Victoria remains at the forefront of biomedical care, discovery and education, creating even greater impact, in particular through the commercialisation of research.”

The strategy, From research engine to economic powerhouse identifies four key areas of focus for the precinct over the next ten years – increasing impact through commercialisation of research, creating value through the collection and use of the best data, ensuring the best facilities and infrastructure are in place, and having the best people to deliver care, make discoveries and train future generations of biomedical professionals.

“This framework for the Precinct’s future would not be possible without the vision of governments current and past that have invested in this precinct and biomedicine across the state,” Professor Goodier said. “It’s also testament to the collaborative approach that this precinct is known for.”

The Melbourne Biomedical Precinct is made up of more than 30 hospitals, medical research institutes, biotechnology organisations and universities largely collocated to the north of Melbourne’s CBD. It employs around 49,000 people and educates more than 7,000 biomedical students annually.

The Melbourne Biomedical Precinct Office led development of the 10-year strategy and was established by the Victorian Government in late 2016 to drive economic development in the Precinct and strengthen its position as a world leader in biomedical research, development and innovation.

You can download the plan here.

You can read the Victorian Government’s media release here

Media contact: Julie Browning 0419 003 063

Dr Gareth Goodier has been appointed Executive Chair of the Melbourne Biomedical Precinct.

The new Executive Chair role was created following recommendations from the Premier’s Jobs and Investment Panel to strengthen governance and drive economic development in the Precinct which is centred in Parkville.

Dr Goodier has been the Chief Executive of several major health systems and academic hospitals for the last 25 years, including at the Royal Melbourne Hospital and the Cambridge University Hospitals.

Role of the Executive Chair

The new role will help Australia’s leading biomedical health precinct to compete globally alongside world leaders Boston, Cambridge and San Francisco.

The Executive Chair will be responsible for driving increased collaboration between precinct partners and the commercialisation of research.

The Executive Chair will also play an important role in promoting the precinct nationally and overseas, particularly in key markets such as the USA, UK, EU and China.

Read the Media Release: Appointment of Executive Chair, Melbourne Biomedical Precinct (Word 41KB).