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Applications Open for Round 9 of the Medical Devices Fund

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The Medical Devices Fund is a competitive technology program which helps encourage and support investment in the development and commercialisation of medical devices and related technologies in NSW. The Fund aims to provide support to individuals, companies, public and private hospitals, medical research institutes, universities and the medical devices industry to take local innovation to market.

Since its launch in 2013, the Fund has provided over $60 million to 37 projects. These technologies have now treated over 47,000 patients and are delivering better patient outcomes for NSW.

More than $8 million in funding is available for this round.

For further details regarding the Medical Devices Fund including the preliminary application form, guidelines and application kit, please visit https://www.medicalresearch.nsw.gov.au/medical-devices-fund/ .

The Office for Health and Medical Research will also hold an online webinar for the Medical Devices Fund in late February 2021.

To apply, please review the eligibility and selection criteria and email your completed preliminary application form to MOH-OHMRGrants@health.nsw.gov.au. Preliminary applications close on Monday 1 March 2021 at 5pm.

Concerns Over Rushed Prostheses List Changes

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[vc_row][vc_column][vc_column_text]This week the Department of Health issues a consultation paper discussing options for reforms and improvements to the Prostheses List.

The Department said it was seeking the input from stakeholders to support an evidence base for future Prostheses List reforms and improvements. The consultation paper contains a number of questions for consideration by stakeholders.

The consultation process announcement follows the recent release of two reports: Options for a Revised Framework for Setting and Reviewing Benefits for the Prostheses List and the Review of the General Miscellaneous Category of the Prostheses List.

The reports acknowledged the significant risk of unintended consequences that could arise because of poorly planned Prostheses List reform including limits to patient access and choice, and the increased risk of cost shifting onto patients. Neither report was able to reach a definitive conclusion about the future direction of the Prostheses List.

The chance to engage in constructive Prostheses List reforms were welcomed by a range of industry groups including the Australian Private Hospitals Association (APHA), Catholic Health Australia (CHA) and the Medical Technology Association of Australia (MTAA).

APHA CEO, Michael Roff, said APHA welcomed the opportunity to be part of the discussions, which to-date have not fully involved private hospitals, consumer, or the medical profession.

“Considering doctors determine which prostheses they use in surgery, particularly in the private setting, it is important this anomaly is corrected,” Mr Roff said.

The message from stakeholders is clear: any reforms need to ensure they do not lead to a ‘managed care’ system where the ability to pick a doctor, medical device, or the procedure that’s best for the patient is compromised.

Concerns have been raised over the weight being given to the Private Health Insurance lobby’s position to transition Australians’ health to a system where insurers can refuse to allow patients access to devices they deem unnecessary for them to have to pay for.

MTAA CEO, Ian Burgess, said the consultation process was an important first step in the process to carefully consider positive reforms to the Prostheses List that genuinely reflect the considered feedback of all stakeholders, and the timeliest way to implement them.

“It’s vital that any reforms put forward by the Government do not remove the protections the Prostheses List provides for surgeon choice and patients access, or result in further out-of-pocket costs,” Mr Burgess said.

The Department set the submission close date for 15 February, meaning doctors, hospitals and MedTech innovators will be forced to work through the Christmas and New Year period (on top of managing the COVID pandemic) in order to ensure their voices are heard.

The decision by the Department to rush the consultation period over the holiday break has raised questions about whether Health bureaucrats have already decided on the reforms they want to implement.[/vc_column_text][/vc_column][/vc_row]

MND AUCTION TRUCK RAISES $200,000 FOR MEDICAL RESEARCH

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[vc_row][vc_column][vc_column_text]The auction of a restored 1946 Ford Jail Bar has seen Motor Neurone Disease (MND) researchers in Brisbane presented with a $200,000 cheque to continue exploring ways to treat the disease.
It’s the latest donation from Australia’s largest transport and logistics specialist, NTI, and brings the total the organisation has raised for MND research to almost $534,000 in four years.
The cheque was handed over at MND and Me’s Christmas event where medical experts pitched their research ideas in a ‘Shark Tank’ style presentation.

NTI’s donation will fund two research grants for Dr Shu Ngo and Dr Adam Walker at The University of Queensland. Dr Ngo was also named the recipient of the 2021 Charcot Award which is presented to the highest ranked innovator grant applicant.

“Everyone is driven to see a world free of MND and funding from the NTI research grant gives young researchers an opportunity to push harder and go further with their ideas. That will be so valuable to finding a cure for MND and I feel humbled and privileged to be able to carry out this research,” Dr Ngo said.

“With these funds, we will be embarking on a research project that is the first of its kind for MND. Using mini 3D spinal cords that we have generated from MND patient skin cells, we will study how neurons and their support cells interact over time to give us insights into how we can save neurons.”

MND and Me CEO Jane Milne said Motor Neurone Disease claims the lives of two Australians every day.

“There are currently more than 2,100 Australians living with MND and the disease can affect adults of any age,” Ms Milne said.

“The commitment NTI has shown to funding MND research is unique in Australia and means researchers can continue their work to find a cure or effective treatment for MND. These two grants have been awarded to researchers who are in the process of moving to clinical trials and are finding promise in treatments in mouse models, or who are working towards a better understanding of the cause of MND.”

NTI CEO Tony Clark said “Black Beauty” was the third truck NTI had restored since 2016 to fundraise for MND research.

“NTI is committed to supporting MND research in honour of our late CEO Wayne Patterson who was diagnosed with the condition in 2015 and tragically lost his battle soon after,” Mr Clark said.

“This research grant is about supporting research but also promoting awareness of MND, of which two Australians are diagnosed every day.

“NTI will continue its support of this incredibly worthy cause and has plans to restore another truck in 2021.”[/vc_column_text][vc_single_image image=”4844″ img_size=”full” alignment=”center”][/vc_column][/vc_row]

Call for Industry Sponsors to Apply for REDI Fellowship Funding

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The REDI program is providing grants of up to $250,000 to industry to secure one of up to 40 industry Fellowships in the medical technology, biotechnology and pharmaceutical (MTP) sector.

This unique workforce initiative is giving industry the opportunity to select a researcher, academic, clinician or technology transfer professional to collaborate on distinct projects involving discovery, translation and commercialisation.

REDI is calling for Australian industry organisations, including multinationals and ASX-listed companies, to apply for a Fellowship, with funding available for up to 40 places.

“Creating links between industry and research is critical for the growth and success of the MTP sector. Our new REDI Fellowships program provides companies with the financial support to bring academics and clinicians in-house for up to twelve months to work on priority medical research projects,” said MTPConnect Managing Director and CEO Dr Dan Grant.

“Our Fellowship program will require that the researcher or clinician return to their home institution for a period at least equal to the term of the fellowship.

“This will help address the issue of ‘brain drain’ of researcher talent into companies and ensure we embed high-level commercial experience in the research sector,” Dr Grant said.

The Fellowship application process is industry-led, so an eligible industry sponsor (company/organisation) needs to submit an application which identifies a Fellow and matches it with a specific research and development project.

Eligible Fellows are medical technology, biotechnology and pharmaceutical sector researchers, academics, clinicians and professionals (technology transfer organisation professionals, entrepreneurs, business development/commercialisation staff, administrators and executives) from academic/public research organisations/hospitals/technology transfer organisations.

Eligible Sponsors are industry organisations defined as a research-intensive organisation such as biotechnology, pharmaceutical, medical device and digital health companies, specialised best practice organisations such as a Venture Capital (VC) firm, regulatory affairs consultancy, medical affairs consultancy, etc. For clarity, universities, medical research institutes and hospitals are not eligible Sponsors for this program.

Sponsors can select three types of Fellowships to apply for:

  • One-year full time
  • 6 – 12 months full time
  • 6 – 12 months where the fellow spends 50% of time working with the sponsor.

Subject to COVID-19 restrictions, domestic and international Fellowships will be considered.

Applications open on 15 December 2020 and will remain open until either the funds are fully committed or until October 2022, whichever is first.

To find out more, MTPConnect is holding an Information Session on 17 December 2020 from 11am-12pm AEDT – register now and check our website for further information to have your questions ready.

INNOVATION PARTNERSHIPS : HOW AUSTRALIA CAN LEAD IN 21ST CENTURY HEALTHCARE

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[vc_row][vc_column][vc_column_text]A new publication in Science Magazine, sponsored by Abbott, shows how Australia can create more value from its enviable biomedical R & D effort by promoting partnerships across industry, research and health services to address our healthcare priorities.  

The COVID-19 pandemic has been a high point in the recent history of Australian medtech. The urgency of confronting a novel virus put a major premium on agile collaboration.  Arms of the Australian healthcare system that typically operate in competition found themselves working alongside each other to get the most important job in the world done quickly, and right.  We can be proud of the fact that, in Australia, we delivered on the task.  Our testing rates are among the world’s highest; our hospital bed and ventilator capacity scaled up in record time; and normal elective surgery schedules were quickly re-established. 

The important lesson is that healthcare works best when its stakeholders have aligned interests. The urgency of the COVID challenge broke down institutional barriers to collaboration – between the Commonwealth and states, between private and public hospitals, between competitors in industry, and between government and the private sector.  

After the pandemic, there is no need to reinstitute those barriers.  

That is the motivation that inspired Abbott to sponsor a major new publication in the prestigious journal Science, focused on how Australia can, and should, take a partnership approach to the innovation challenges necessary to address our 21st century healthcare needs.  

Australia’s public and privately funded medical research effort is impressive by world standards, at well over $A6 billion.  Yet less than 2% of our R & D spend ends up focused on translating insights from basic science into new therapies, new services or updated clinical guidelines. A key deficiency contributing to that gap is the lack of emphasis on bringing commercial and clinical expertise together with research skills in a coherent way. This insight is not new; it was a key focus of the McKeon Review of Health and Medical Research back in 2013. Not enough has changed since, despite some initiatives from governments and research institutions. 

The Science supplement draws together the major peer reviewed studies conducted over the last decade on what differentiates successful translation efforts. Some of the major findings include: 

  • The role of time. Responsive regulatory and path-to-market systems attract translational investment 
  • Incentives for localisation: where the intellectual property is registered is a complex decision, based not just on market size but other factors including expected returns from reinvestment, relative taxation of IP, and successful examples of win-win outcomes from IP collaborations 
  • Recognition that translation is a specialist skill: integrating it into research institutional structures and incentivising direct funding of translation initiatives. The Medical Research Future Fund does some of this, but added scale will create better results. 

We also highlight two examples of “self-starter” collaborations in Australia with great promise: the Australian Cardiovascular Alliance (ACVA) and Australia’s National Digital Health Initiative, ANDHealth. 

The post-COVID environment is an ideal time to revive the impetus for change in our health innovation effort. We can already see what happens when we all pull together.  [/vc_column_text][/vc_column][/vc_row]

BACK TO BASICS – HTA EXPLAINED

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[vc_row][vc_column][vc_column_text]HTA has been growing in popularity among reimbursement agencies worldwide in the last 20 years. Its application to medical devices has been slower for a range of reasons. Its popularity has a number of drivers including the desire to find an objective basis for funding decisions for health technology.

A cost-effectiveness or a cost-utility evaluation seeks to measure the additional clinical benefit and cost of using a new medical product compared to what is now used for the same condition. In cost-utility analysis, patient quality of life and length of life is combined into a single ‘utility’ measure. This is the analysis most commonly used by the Department of Health and its major committees.

To operate effectively, HTA generally requires two major components: firstly, clinical evidence that can be used to compare products; and secondly: an economic analysis of benefits and costs. It therefore requires research – usually by the sponsor – to gather and present data as well as a systematic process of evaluation.

When assessing whether HTA is being done properly, questions can be asked such as:

  • Is the process fair and transparent?
  • Is the depth and complexity of the process suitable for the expected clinical risk and cost?
  • Are the correct outcomes being evaluated?
  • Is there a reasonable way of dealing with uncertainty given data is never perfect?

Australia was one of the first countries to use HTA to assess reimbursement for pharmaceuticals through the Pharmaceutical Benefits Advisory Committee (PBAC). Typical submissions grew from a few dozen pages in the early 1990s to thousands of pages currently.

This was followed by assessment of other medical procedures and technologies through the Medical Services Advisory Committee (MSAC) starting in the late 1990s.

The Prostheses List Advisory Committee (PLAC) and its subcommittees also assess relative cost and effectiveness for prostheses to go on the Prostheses List where a higher benefit is requested. When a medical device is on the Prostheses List, private health insurers are required to pay for it if they have relevant hospital cover for the procedure.

The Australian Government has a policy of making assessment for reimbursement of medical technology and procedures more uniform. To this end it amalgamated the Department of Health sections responsible for supporting assessment process for the Pharmaceutical Benefits Scheme (PBS), Medicare Services Schedule (MBS) and the Prostheses List into one Branch – the Office of Health Technology Assessment.

The MedTech industry, through the Medical Technology Association of Australia (MTAA) is supportive of the appropriate use of HTA for Prostheses List applications but it needs to be undertaken with care. Medical devices are different from pharmaceuticals in that:

  • They are dependent on operator skill
  • Blinded trials are often not practicable
  • Short life cycles/incremental improvements narrow the evidence window
  • Low volume reduces the quantity of evidence
  • The effect on the patient is usually physical not chemical
  • They may require much more company support to use

PulseLine understand that MTAA is now in a process of Prostheses Reform discussion with the Australian Government and other stakeholders. The correct use of HTA for prostheses is a key part of that discussion. The industry has recommended that a ‘prostheses-specific pathway’ be developed that bolsters the capacity of PLAC to evaluate relative effectiveness and cost of new prostheses without requiring a full MSAC deliberation that is resource-intensive and lengthy.

HTA for medical devices is here to stay. Time will tell if the processes put in place by for the Prostheses List enable patient access to good technology or hinder it.[/vc_column_text][/vc_column][/vc_row]

Australia secures a further 50 million doses of COVID-19 vaccine

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[vc_row][vc_column][vc_column_text]Two more COVID-19 vaccines have been secured for the Australian population under new agreements, bringing the Australian Government’s COVID-19 vaccine investment to more than $3.2 billion.

Under the agreements, Novavax will supply 40 million vaccine doses and Pfizer/BioNTech will provide 10 million vaccine doses, should the vaccines be proven safe and effective.

Prime Minister Scott Morrison said the Government’s COVID-19 Vaccine and Treatment Strategy had now secured access to four COVID-19 vaccines and over 134 million doses.

“By securing multiple COVID-19 vaccines we are giving Australians the best shot at early access to a vaccine, should trials prove successful,” the Prime Minister said.

“We aren’t putting all our eggs in one basket and we will continue to pursue further vaccines should our medical experts recommend them.

“There are no guarantees that these vaccines will prove successful, however our Strategy puts Australia at the front of the queue, if our medical experts give the vaccines the green light.”

The Novavax and Pfizer/BioNTech vaccines are expected to be available in Australia from early to mid 2021 – subject to approval by the Therapeutic Goods Administration (TGA) for use in Australia.

The Pfizer/BioNTech is a messenger ribonucleic acid (mRNA) type vaccine and the Novavax vaccine is a protein vaccine containing an adjuvant (Matrix-M) which enhances the immune response.

Health Minister Greg Hunt said Australia’s COVID-19 vaccine portfolio now had two protein vaccines and one mRNA and one viral vector type vaccine, strengthening Australia’s position to access safe and effective vaccines as soon as available.

“The goal and the expectation is that Australians who sought vaccination will be vaccinated within 2021,” Minister Hunt said.

“There are no surprises, health and aged care workers and the elderly and vulnerable will be the first to gain access to a vaccine that’s deemed safe and effective.”

These new agreements build on the Australian Government’s existing commitments to purchase the University of Oxford/AstraZeneca vaccine and a local candidate from the University of Queensland together with Australian manufacturer CSL Limited (Seqirus).

Subject to the vaccine being registered by the TGA as safe and effective, preliminary advice from the Australian Technical Advisory Group on Immunisation is that the priority groups for the COVID-19 vaccine are those people who are at increased risk of exposure, such as health and aged care workers, the elderly and those working in services critical to societal functioning.

The Australian Government is currently consulting with the states and territories, key medical experts and industry peak bodies on the framework for the initial roll-out of the COVID-19 vaccination program in early 2021.

Key vaccination sites will initially include GPs, GP respiratory clinics, state and territory vaccination sites and workplaces such as aged care facilities.

Australia has a world class vaccination program with world leading vaccination rates. The COVID-19 vaccine will not be mandatory and individuals will maintain the option to choose not to vaccinate. The vaccine will be available for free to those who choose to be vaccinated.

This commitment forms a crucial part of the Australian Government’s response to COVID-19 and the strategy to protect the health and wellbeing of Australians and the national economy.

Internationally, Australia has also joined the COVAX facility, which will provide access to a large portfolio of COVID-19 candidates and manufactures around the world for up to 50 per cent of the Australian population.

The Australian Government has also committed to support access to safe and effective COVID-19 vaccines for the Pacific and Southeast Asia, as part of a shared recovery for the region from the pandemic, as well as $80 million to the international COVAX Facility for the benefit of high-risk populations in developing countries.

The Government’s agreements allow Australia to donate to partners in the Pacific and Southeast Asia, should these vaccines prove safe and effective, and units are available above domestic needs.

The Government is contributing significantly to vaccine research and development both in Australia and around the world, investing $363 million in vaccines, therapeutics and COVID medicines – including $257 million in vaccines.

The roll-out of a potential COVID-19 vaccine is a significant logistical challenge, suppliers that have a proven track record in vaccine logistics and distribution or booking systems, tracking and reporting of vaccines are being invited to participate in a limited tender process.

As part of Australia’s COVID-19 vaccines strategy and broader vaccines strategy, the Australian Government is considering an amendment to the Australian Immunisation Register Act 2015 to mandate reporting of all vaccinations to the Register.[/vc_column_text][/vc_column][/vc_row]

AAMRI WELCOMES MEDICAL RESEARCH FUTURE FUND COMPETITIVE FUNDING OUTCOMES

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[vc_row][vc_column][vc_column_text]The MRFF investment includes grants for:

  • Biologics for the prophylaxis and treatment of COVID-19
  • Ovarian cancer: investing variations in care and survival, aetiology and risk factors to improve outcomes in Australia via national data linkage
  • A randomised control trial of positive end-expiratory pressure levels during resuscitation of preterm infants at birth.

More than 90% of the grants and three quarters of the funding awarded to date have been through competitive funding rounds.

“This shows the MRFF is investing in the highest quality research and I applaud the Government for building competitive and robust funding structures,” said AAMRI President, Professor Jonathan Carapetis AM.

“It is great to see this new investment in medical research, the scale of which is unprecedented and will in turn deliver huge economic and health benefits for the nation.

“The value and trust that the Government has placed on research will enable some of our best and brightest minds to make life-changing medical discoveries which will help protect and save lives.

“I’m also very pleased to see the rapid investment in COVID-19 and bushfire health research. This fits with the vision of the MRFF, to include an ability to respond quickly to emerging health threats,” Professor Carapetis.

The MRFF is a once-in-a-generation funding opportunity that will make Australia a world-leader in medical research. It will invest an additional $650 million per year in medical research, which is on top of the near $900 million invested through the NHMRC.[/vc_column_text][/vc_column][/vc_row]

TTRA for Diabetes and Cardiovascular Disease Announces Research Plans and Partners

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[vc_row][vc_column][vc_column_text]The $47 million TTRA initiative, supported by the Medical Research Future Fund (MRFF), is providing a new integrated research program to improve the prevention, management and treatment of diabetes and cardiovascular disease (D&CVD) in Australia. Research efforts will focus on the most pressing areas of unmet clinical and research needs in D&CVD, which are leading causes of death and disability in Australia.

The TTRA program is designed to support and incentivise translation as a natural course of activity for those applying and receiving funding.

MTPConnect is pleased to announce partnerships with ANDHealth, Medical Device Partnering Program (MDPP) and UniQuest to provide advice and mentoring for funding recipients.

MTPConnect Managing Director & CEO, Dr Dan Grant, has welcomed the TTRA partners, citing their credentials as preeminent organisations specialising in translation and commercialisation of digital health, medical technology, medical devices, biotechnology and pharmaceuticals.

“We are delighted to announce our partnerships with ANDHealth, MDPP and UniQuest for the TTRA as we embark on a mission to improve the prevention, diagnosis, treatment and management of diabetes and cardiovascular disease in Australia,” Dr Grant said.

“Our experience leading a number of Medical Research Future Fund programs has proven the value of building in a component for guidance and support for research applicants,” he said.

UniQuest is Australia’s leading technology transfer company, whose innovation portfolio includes Australia’s first blockbuster vaccine Gardasil®. UniQuest’s Executive Director of Commercialisation, Dr Mark Ashton says bringing commercialisation experience to early stage research will transform ideas to impact.

”We are looking forward to drawing on the industry expertise of our team at the Queensland Emory Drug Discovery Initiative (QEDDI) and our 35 years’ experience in commercialisation to support applicants in the translation of their research, with the view to improving the outlook for patients with diabetes and cardiovascular disease around the world,” Dr Ashton said.

MDPP Executive Director, Professor Karen Reynolds leads the ideas incubator to support the development of novel medical devices and assistive technologies.

“MDPP is honoured to once again partner with MTPConnect and support the development of novel preventive, diagnostic and therapeutic approaches and products to improve outcomes for diabetes and cardiovascular disease. With the rapid changes within the community, health and business environments, the TTRA will provide a strategic and coordinated effort to translate cutting-edge research to knowledge for two disease states that affect millions of Australians each year,” Professor Karen Reynolds said.[/vc_column_text][/vc_column][/vc_row]

MEDTECH20, A VIRTUAL SUCCESS

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The annual conference brings together industry leaders, innovators, academics, policy-makers, researchers and clinicians to share their insights, experiences and achievements in new and cutting-edge MedTech that’s helping to improve the lives of everyday Australians.

This year’s conference was help virtually, due to the ongoing COVID-19 pandemic, and included 17 different sessions and multiple streaming options focused on particular topics that attendees were able to choose from.

MTAA’s CEO, Ian Burgess, said that MedTech conference was continuing to lead by example during the pandemic, by showing just how the MedTech industry had adapted to the challenges posed by the virus, not just with a reformatted virtual conference, but also with a once in a 100-year industry effort, with government, to coordinate Australia’s response to the global pandemic.

“MTAA took this opportunity to transform how our conference was conducted, tailoring every session to make it easily accessible to participants, including live recording for attendees to stream back later,” Mr Burgess said.

In an address to conference-goers, Minister for Health, Greg Hunt, who opened the conference acknowledged the “profound role of the medical device and technology sector in helping Australia through COVID in a way very few other countries have been able to achieve.”

Also speaking at the conference was Minister for Industry, Science and Technology, Karen Andrews, who said “the MTAA led the effort to ensure we had the essential medical equipment to meet a worst case scenario” during the pandemic.

This year’s conference featured a whose-who of industry leaders and experts, including:

  • Dr Sarah Aitken, Vascular & Endovascular Surgeon, Concord Repatriation General Hospital and Clinical Academic, University of Sydney
  • Mr Andrew Frye, Senior Vice President & President, APAC, Baxter Healthcare, Chairman of APACMed
  • Prof. John Skerritt, Deputy Secretary, Health Products Regulation Group, Therapeutic Goods Administration

If you missed the conference, don’t worry, MTAA says on-demand streaming of sessions is available anytime, anywhere, click here.[/vc_column_text][/vc_column][/vc_row]