Author: Team

Clinical trials and disruptive technologies: a case for collaboration

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Introduction: clinical trials in Australia

Technology is significantly transforming the clinical trials landscape, as businesses in the life sciences recognise the benefit of leveraging new technologies that improve clinical data quality and reduce the overall trial timeline.

A 2017 report from the Australian New Zealand Clinical Trial registry revealed that Australia ranks in the top tier of national clinical trial activity, estimated to be worth around $1 billion to the Australian economy.[1]

Indeed if Australia is to cement its expertise in the Asia-Pacific region, and continue to prove itself a popular destination for early phase studies, it must ensure that clinical trials are intertwined with technology that enables more efficient trials and smarter drug development.

As clinical trials in Australia already enjoy myriad domestic advantages, including a diverse population as well as strong government support and incentives, harnessing new technologies and big data will ensure these circumstances are long-lived.

Beyond the new technologies enabling the clinical trials sector, there are other important trends at play.

Globally, collaboration in life sciences is allowing businesses to solve problems that are too large and complex in nature for single companies to solve alone. The combination therapies that will result are expected to become extremely powerful.

Recruitment into clinical trials remains a challenge for the sector, however, the disruptive technologies currently being embraced will allow for more personalised solutions that improve the patient experience.

Technology and clinical trials

Exactly how technology is improving clinical trials and enabling a higher standard of healthcare is in part, through its ability to make sense of the growing volumes of data being produced every day.

The clinical trials process involves having to accommodate an incredible variety of data and content from various sources; from traditional clinical data, to real world data, to high-resolution images and so on.

Embracing technologies that are able to capture and utilise these large data sets assists in managing the growing complexities of clinical trials, namely the standardisation, reconciliation and integrity of data.

The role of intelligent clinical solutions must also be acknowledged, which utilise new technologies such as artificial intelligence and machine learning to analyse and detect anomalies in data.

An example of these nascent capabilities includes the identification of novel biomarkers for Castleman disease by Medidata and the Castleman Disease Collaborative Network (CDCN).

The discoveries provided novel insights into treatment response and potential new drug targets, demonstrating the benefit of harnessing data for smarter drug development.

Likewise is the recent launch of Medidata’s AI-as-a-Service outfit, Acorn AI, which leverages the business’ standardised clinical data storehouse and AI capabilities to personalise and optimise clinical trials, and support decision making.

It is disruptive technologies like these that businesses in the life sciences must continue to embrace in order to drive meaningful transformation and add value for clinical trials, the patients involved and the entire healthcare system.

What’s ahead for clinical trials in Australia

 According to Deloitte’s 2019 Global Life Sciences outlook report, life science businesses that adopt digital technologies and platforms will benefit from stronger engagement with patients, deeper insights from clinical trials and a shorter clinical trial timeline.

However, to ensure we’re realising the full potential of disruptive technologies in life sciences, regulation must become more agile and evolve to foster innovation.

Similarly, an interoperable system that facilitates information sharing will ensure Australia is making the most of big data and analytics.  Data sharing through modern platforms such as wearables and social media supports greater engagement and understanding of patients who are participating in clinical trials.

These developments redefine the role of trial participants – from subjects to collaborators – enhancing their overall experience and helping to overcome challenges associated with recruitment into clinical trials.

Beyond digital transformation, collaboration across life sciences will also play an integral role. In 2019, collaborative approaches will be key for working with patients and regulators, advancing drug development and the Internet of Medical Things.[2]

Big data-driven insights will transform patient care and enhance the productivity of trials.

As Australia looks to establish itself as a popular destination for early phase studies, the future of the Australian clinical trials sector must be intertwined with technology.

[1] http://www.health.gov.au/internet/main/publishing.nsf/Content/Clinical-Trials

[2] https://www2.deloitte.com/global/en/pages/life-sciences-and-healthcare/articles/global-life-sciences-sector-outlook.html

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ABOUT THE AUTHOR

Andrew Gebbie, Principle Solution Consultant, Medidata Solutions APeJ[/vc_column_text][/vc_column_inner][/vc_row_inner][/vc_column][/vc_row]

Establishment of Australia’s First Cystic Fibrosis Unit

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[vc_row][vc_column][vc_column_text]The Cystic Fibrosis unit will be co-located within the hospital’s respiratory unit and contain:

  • A 16-bed inpatient unit with single rooms, including four isolation rooms
  • Specialist research zone
  • New consultation rooms
  • New work spaces for clinical staff
  • An upgraded outpatient service including day stay rooms for procedures and outpatient physiotherapy and respiratory testing.

This funding announcement has come off the back of two medication listings for Cystic Fibrosis on the PBS over the last two years. Orkambi® in 2018 costing $250,000 annually and Kalydeco® in 2017, costing $300,000 over the same period. Now costing $40.50 or $6.50 a script.

Cystic Fibrosis in considered the most common chronic illness affecting young Australian’s today.[/vc_column_text][/vc_column][/vc_row]

Ground Breaking Heart Surgery Performed for First Time In Australia

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[vc_row][vc_column][vc_column_text]The procedure has only been performed 100 times internationally and took lead surgeon Dr Matthew Brooks and his team two hours to complete.

The patient who had previously undergone heart surgery, had developed complications after a valve failed and resulted in leaking. In this case the coronary artery was too closely located to the leaking valve to attempt the traditional style of surgery.

Director of Cardiology, Associate Professor, Leeanne Grigg, “this procedure gives another option for patients, it’s really incredible and it’s great because it is the first in Australia and it’s very new worldwide, with only 100 known cases done, this is really early on and has big potential,” A/Prof Leeanne Grigg said.[/vc_column_text][/vc_column][/vc_row]

Labor Pledges $20 Million in Clinical Drug Trials for Cancer Patients

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[vc_row][vc_column][vc_column_text]The right to Trial initiative was established after research from the Leukaemia Foundation found that one in five blood cancer patients tried to access a clinical trial but there either weren’t any trials available or they weren’t eligible. With less than 30 per cent having access to genetic and genomic testing to inform their diagnosis and treatment.

The initiative will allow 1,800 blood cancer patients access to emerging treatments specific to the genetic markers relevant to their individual disease. Under current clinical trial schemes, these same patients would be waiting potentially five to ten years longer for access to trials.

Current figures by the Australian Institute of Health and Welfare 2019 Cancer in Australia Report, predicted over 17,000 new cases of blood cancer will be diagnosed this year. With more than 6,700 dying from a blood cancer disease in the same period. Partly due to the ongoing issue that whilst game-changing treatments are being developed, there are often too slow for patients to fully utilise their potential.[/vc_column_text][/vc_column][/vc_row]

1000 of the Nations Caravan Parks to Have Defibrillators Installed

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[vc_row][vc_column][vc_column_text]Roll out of the defibrillators will be organised by the Caravan Industry of Australia who will also be contributing half the cost of each device.

There had been previous petitioning to the NSW Government to have mandatory laws requiring all parks in NSW to install the life saving devices. After an incident on New Year’s Day this year resulted in a man dying, after suffering a cardiac arrest in a NSW caravan park and no access to a defibrillator was available.

Minister for Health Greg Hunt stated, “research shows that if a person is defibrillated within the first five minutes of collapse, their chance of survival is around 90 per cent and for every minute that this is delayed, the chances of survival decrease by up to 10 per cent.”[/vc_column_text][/vc_column][/vc_row]

Device Technologies launches new campaign, ‘A Day in the Life…’

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[vc_row][vc_column][vc_column_text]Device Technologies has launched a new social media campaign, giving professionals in the healthcare sector a greater understanding of the extensive range of career opportunities within medical distribution.

The first short film, ‘A Day in the Life of a Product Specialist’, focuses on Joelle Winderbaum, who provides Theatre Solutions to regional hospitals and clinics throughout NSW and the ACT. The film serves as the first part in an ongoing social media campaign, to not only give insights into the company culture, but also to the opportunities available at Device Technologies.

Be sure to follow Device Technologies on LinkedIn to see the latest installments of ‘A Day in the Life.’[/vc_column_text][/vc_column][/vc_row]

AUSTRALIA’S HEALTH MINISTER

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[vc_row][vc_column][vc_column_text]Election 2019 will be the seventh consecutive election Greg Hunt will be contesting for his House of Representatives seat of Flinders in Victoria.

Born in Victoria’s Mornington Peninsula, Hunt graduated from Melbourne University in 1990 with a First-Class Honours Law Degree, deciding to continue his studies at Yale University in the United States after being selected for a Fullbright Scholarship.

Back in Australia, Hunt worked as an associate to the Chief Justice of the Federal Court, before entering politics for the first time as a senior advisor to the Minister for Foreign Affairs, the Hon. Alexander Downer MP. During his work with Downer, Hunt was appointed to head Australia’s electoral mission to Cambodia in 1998.

Hunt later moved to the private sector where he worked for the management consulting company McKinsey & Co, becoming an engagement manager specialising in telecommunications, start-ups, government reform and banking.

In 2001, Hunt returned to his hometown in Victoria to campaign for, and be elected as, the Federal Member for Flinders in the then government of Prime Minister the Hon. John Howard MP. Following the 2004 election, Prime Minister Howard appointed Hunt as the Parliamentary Secretary to the Minister for the Environment and Heritage.

Following the 2007 Federal Election which saw Labor form government under then Prime Minister the Hon. Kevin Rudd MP, Hunt was appointed Shadow Minister for Climate Change, Environment and Urban Water by then Opposition Leader the Hon. Brendan Nelson MP. Throughout the tenure of Opposition Leaders Nelson, the Hon. Malcolm Turnbull MP and the Hon. Tony Abbott MP, Hunt held the Shadow Ministry role with slight tweaks to his title by each incoming Opposition Leader.

After the Coalition’s successful election victory in 2013 under then Prime Minister Abbott, Hunt was appointed as Minister for the Environment. During this period, Hunt declared his greatest achievements in the portfolio were to establish Australia’s Emissions Reduction Fund, develop the Great Barrier Reef 2050 Long-Term Sustainability Plan and invest $1 billion into the Reef Fund.

In 2016, Hunt was recognised internationally by Thomson Reuters as the ‘Best Minister in the World’, during that year’s World Government Summit in Dubai.

After the ascension of Malcolm Turnbull as Liberal Party Leader and Prime Minister and following then Health Minister Sussan Ley’s resignation from Cabinet, Hunt was elevated to Minister for Health. Upon being promoted Hunt stated that his vision as minister was to guarantee Australians’ access to health services and affordable medicines with the establishment of the Medicare Guarantee Fund, as well as ensuring the security of the ongoing funding of Medicare and the Pharmaceutical Benefits Scheme.

Since inheriting the Health portfolio, Hunt has announced the extension of the Health Care Homes program to June 2021, to help with coordinating the care for patients with chronic and complex conditions, and brought mental health to the forefront of the healthcare discussion, by investing a record $1.45 billion for community mental health services.

During a 2010 speech, Hunt explained that his mother Kathinka suffered a form of bipolar disorder.

“It’s not something about which I have talked much about. He condition was not preventively debilitating but it was significant,” Hunt said.

One in five Australians experience a common mental disorder each year. Nearly half of the Australian population experiencing a mental illness at some point in their lives, with less than half accessing treatment for it.

Hunt has a personal passion for Genomics, a type of study that address genes and their inter-relationships within the body to better identify their influence on how these organisms grow and develop. In an interview given on the subject he said, “This is one of my great personal passions and priorities for the transformation, not just of Australia’s medical research but our health system and our treatment over the coming decade.”

Health is always a key issue in every Federal Election, however with the massive spending announcements from the Opposition in the first week of the election campaign, it has become even more prominent. The Government’s, and to a large extent Minister Hunt’s, vision and record in Health will be put to the test by voters when it comes time to cast their vote.[/vc_column_text][/vc_column][/vc_row]

AUSTRADE ASSISTANCE FOR EXPORT AND INVESTMENT IN AUSTRALIAN MEDTECH – By Shelley Jackson

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[vc_row][vc_column][vc_column_text]Austrade is the federal government agency responsible for trade and investment promotion, and we have a particular focus on promoting Australian health and medtech industry capabilities to international customers, key opinion leaders and investors. As we talk to these people we hear that Australia’s strong economic position – our economy is in its 28th year of consecutive annual economic growth[i] – is a powerful driver of local growth and an incentive for investment.  Australia is also one of the largest healthcare markets in the Asia-Pacific region, with an ageing and affluent population.

Austrade has staff in around 80 international offices, so we know that while our medical devices and diagnostics are globally regarded, this is a fast-paced and competitive industry. Whether you’re an Australian company ready to internationalise your business or an international company looking for productive foreign direct investment opportunities within Australia, Austrade can assist.

For Australian export-ready companies, Austrade has a range of information tools and customised services to help you do business overseas and understand foreign regulations and business practices. With experienced local staff in offices around the world, we can provide market information and insights, and facilitate connections through our extensive global network.

For international companies, we provide the contacts and information (in partnership with State and Territory governments and allies) to establish or expand your business successfully in Australia, and have assisted companies such as Fresenius Kabi Australia to build their investment presence here.

Support for exporters to go global

Austrade is focussed on helping Australia’s innovators access international market opportunities by linking Australia and Australian entrepreneurs with innovation ecosystems, or niche centres of excellence, around the world.  This includes the Bio-Bridge Initiative, a partnership between Australia and the Texas Medical Centre (TMC) in Houston, USA that fosters a two way flow of capital and resources, through collaborations in research, clinical trials and commercialisation.

Another example is the Landing Pads program, which provides market-ready startups and scaleups with the opportunity to land and expand in global innovation hubs. In San Francisco, Tel Aviv, Shanghai, Berlin and Singapore participants have access to:

  • a 90-day residency in a co-working space
  • introductions to networks of investors, mentors and strategic partners
  • access to a community that supports Australian entrepreneurs
  • business advice to help grow their business.

For detail on Landing Pads and how to apply visit https://www.austrade.gov.au/landingpads/landing-pads

The Export Market Development Grants (EMDG) scheme is a key Australian Government financial assistance program for aspiring and current exporters. Administered by Austrade, the EMDG scheme:

  • encourages small and medium-sized Australian businesses to develop export markets
  • reimburses up to 50 per cent of eligible export promotion expenses above $5,000 provided that the total expenses are at least $15,000
  • provides up to eight grants to each eligible applicant.

For detail on the EMDG scheme and how to apply visit https://www.austrade.gov.au/Australian/Export/Export-Grants/About/what-is-emdg

Please contact our International Health team in Australia for export and investment assistance.
Tel: 13 28 78. Email: info@austrade.gov.au.

Our website also provides further information, such as specific export market information https://www.austrade.gov.au/Australian/Export/Export-markets/Countries[/vc_column_text][vc_separator][/vc_column][/vc_row][vc_row][vc_column][vc_column_text]

[1] Worldwide Medical Devices Market Factbook, p. 4, Fitch Solutions Macro Research, 2019.

[1] Australia Medical Devices Report, Q1 2019, Fitch Solutions Macro Research, United Kingdom, 2018.

[1] Why Australia Benchmark Report 2019 https://www.austrade.gov.au/International/Invest/Resources/Benchmark-Report

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One Down, Four to Go!

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[vc_row][vc_column][vc_column_text]This week started with the first Newspoll of the campaign showing Labor maintaining its lead 52 to 48 on a two-party preferred basis – Labor’s 53rd favourable poll in row.

However, in a boost for the Government, polls are now showing them level pegging with the Opposition, with both parties on a primary vote of 39.

This week has seen the campaign played out over both sides’ preferred turf; For the Liberals it’s all about economic management, tax cuts and ‘who do you trust on the economy?’ And for Labor, it’s been health and their follow-up announcements for their Cancer Care Plan that included $200 million for pathology bulk billing and $20 million to allow patients to have access to cancer drugs that are still in clinical trials.

It is fair to say that at the end of week one, the Government has come out on top.  The Prime Minister was on the front foot on his preferred issue of tax cuts and the economy, while Opposition Leader Bill Shorten was under pressure over his ‘no more taxes on superannuation’ gaffe as well as his struggle to explain how much Labor’s climate change policy will cost.

All in all, a good week for the Government. Labor will welcome the Easter weekend and a short reprieve so they can regroup and iron out their messaging.

Labor want to fight this election on health, and not questions about taxation, and in particular their proposed taxation changes.

In other developments, Clive Palmer, who has been blasting our TV screens with ads for the last couple of months at a claimed cost of a $1 million a week, has announced he is running for the Senate.

Palmer has also promised to pay to outstanding worker entitlements from his failed nickel refinery of $7 million, although this has nothing to do with the fact that there is an election happening.

Is Anybody Listening?

While not a great week for Bill Shorten and Labor, they will be thankful it was week one and not the last week of the campaign.

Campaigns are always about issues, policies and personalities but they are also about momentum.

If a campaign is to have bad week, the earlier the better.  Labor will not want a repeat of the week just gone.

As they say, you want to be heading into election day with a wet sail and not a head wind!!  Just ask Michael Daley, former leader of the NSW Labor Party.

From a campaign perspective, other than those that the Prime Minister would refer to as ‘being in the bubble’, the vast bulk of the electorate are probably not even tuned-into the election yet.

In all likelihood, the electorate probably won’t begin to tune-in until after ANZAC Day – week 3 of the campaign.

At that point, the advertising carpet bombing I suspect will begin.

Happy Easter All![/vc_column_text][vc_zigzag][vc_row_inner][vc_column_inner width=”1/4″][vc_single_image image=”1915″ img_size=”full”][/vc_column_inner][vc_column_inner width=”3/4″][vc_column_text]

ABOUT THE AUTHOR

Jody Fassina is the Managing Director of Insight Strategy and has served as a strategic adviser to MedTech and pharmaceutical stakeholders.[/vc_column_text][/vc_column_inner][/vc_row_inner][/vc_column][/vc_row]

Federal Government has Followed Victorian State Policy and Announced Free National Flu Vaccination Program

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[vc_row][vc_column][vc_column_text]The Federal Government has invested an additional $12 million across the next three years in expanding and extending the reach of our current Get the Facts about immunisation campaign. In an attempt to maintain last year’s record 11 million Australian’s that received a flu vaccine.

The National Immunisation Program is linked the Pharmaceutical Benefits Advisory Committee and by law requires independent medical experts to list vaccines on the list. The Government lists all medicines and vaccines recommended by the independent expert committee.

To address the over representation of elderly Australians that contribute 75% of the influenza deaths last year occurring in those over 65 years, an enhanced vaccine has been created.

This vaccine will be specifically targeted at this age group, offering better protection than other available vaccines. With clinical experts advising that optimal protection against influenza occurs within the first three to four months following vaccination. By getting vaccinated from mid-April allows protection during the peak influenza transmission period, from around June to September in most parts of Australia.[/vc_column_text][/vc_column][/vc_row]