Accelerate Issue 3 Q2 2021 by German-Australian Chamber of Industry and Commerce

Accelerate

— magazine of the AHK Australien

H E A LT H

2021

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Welcome to the Q2 2021 issue of Accelerate – magazine of the AHK Australien www.germany.org.au

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A message from AHK Australien’s Executive Director

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Dear Reader, Change is the wind in the sails of success, they say. It is in the same spirit that we proudly announce our recently finalised new strategic direction for the German-Australian Chamber As a bilateral chamber, our mission is to be a trusted partner, enabler, and accelerator of business relations between Australia and Germany. Our new strategic plan will allow us to improve on the value for our members, customers and relevant stakeholders. The new strategy plan focuses our industryspecific outlook with the inclusion of four industry clusters that were identified based on their market openness, business potential and political support, all in a bilateral overlap sense: Energy, Health, Mining & Resources, and Food & Beverage. The clusters will be led by our own industry experts and will bundle policy outreach and market intelligence in an unprecedented way, for the benefit of our cluster members and the aim of fostering German-

Australian collaborations a spotlight on bilateral business opportunities. in these growth sectors. Dear Reader, I suggest In parallel to the you begin with our industry clusters, we Cluster Manager Hannah have introduced our new Niederbuchner’s title AHK Customer Success story ‘Health Industries Team. The team will combine their experience Weathering the Storm of a Global Pandemic’ for and extensive industry a great overview on this expertise to augment topic. our membership and Thank you all for your consulting services for our valued members and ongoing support and engagement. Please get customers in Australia in touch with us if you and Germany. The have any questions or just Cluster Managers and fancy a good chat! Customer Success Team will be working closely Kindest regards, with our Governmental Affairs, Events and Communication specialists to facilitate sustainable business relations between our countries. In this issue of Accelerate, we dive deep into the Australian health sector. We share information CHRISTOPH VON about its enormous SPESSHARDT market potential and Executive Director recent technological christoph.spesshardt@ developments and place germany.org.au

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Table of Contents G

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Governmental Affairs Events Update Customer Success

Partner organisations (

Title story & member articles

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Health, Hannah Niederbuchner: Health Industries Weathering the Storm of a Global Pandemic

Bayer:

Cell and gene therapy: The next milestone in fighting diseases

Dr Wolff Australia:

Germany Trade & Invest:

Dr Wolff’s taboo-breaking mission to improve women’s lives

Digital Health – Digital Solutions for Today’s Health Care Challenges

The Role of Big Data in the Fight Against COVID-19

Who we are and what we do

Health Made in Germany: Medical Technology The ABSs of the CBD Bayer teams with CureVac

CLAAS Regional Centre South East Asia:

Fresenius Medical Care:

Hall & Wilcox:

The dangers of making therapeutic claims in relation to retail products – The Lorna Jane Case and the Peptide Clinics Case

medi vision:

ClAAS supports “Clean Air Initiative” by offering practical solutions and alternatives

contactless, fast, precise innovation for creating a smart future – medi is making it happen

Membership profiles & offers

Technology for washing reusable takeaway dishes

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Member4member offers New members

Contents

AHK Australien News

MEIKO TEAM:

Merck Life Science ANZ:

Merck – the engine Behind the COVID-19 Solution

Waldner:

Australian-German partnership for global biotechnology leader

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AHK Australien news

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Governmental Affairs

Substantial dialogues during the Canberra Delegation 2021 By Dr Michael Zettinig, German-Australian Chamber

Canberra Delegation 2021 participants group photo

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The focus of the delegation program was on the following topics: - energy, including hydrogen and energy efficiency, - the Australia-EU Free Trade Agreement negotiations, and - cybersecurity / advanced manufacturing. This year’s delegation coincided with the first-ever Chamber Board meeting in Canberra, and most Board members were able to participate. We want to thank all delegates and our insightful discussion partners and collaborators, especially the German Embassy in Canberra, the Konrad Adenauer Stiftung Regional Program Australia and Pacific and Dr Hannelore Duczek. The delegation program kicked off with a reception by German Ambassador H.E. Dr Thomas Fitschen in his residence for the delegation and key policy stakeholders from Canberra. Before going into details of Tuesday’s day program, I want to thank Dr Beatrice Gorawantschy and her team at the Konrad Adenauer Stiftung Regional Program Australia and Pacific for organising the dinner discussion on Tuesday evening at the impressive

Boathouse. The keynote speaker was Peter Jennings, Executive Director of the Australian Strategic Policy Institute. Peter outlined the defence and national security risks created by China’s strategic advances, and we discussed the impact of this development on international businesses. Please find the report from Konrad Adenauer Stiftung about this fascinating discussion here. Our sold-out delegation had several other insightful roundtable discussions, including with Trade Minister The Hon Dan Tehan MP at Parliament House. The Minister mentioned his recent exchange with Peter Altmaier, German Federal Minister for Economic Affairs and Energy, and how the Australia-EU Free Trade Agreement negotiations progress. Energy collaboration is another bilateral economic opportunity. Earlier that day, the delegation participated in a roundtable discussion with H.E. Dr Michael Pulch, Ambassador of the European Union to Australia. The main topic was again the EU-Australia Free Trade Agreement negotiations that happened virtually during the delegation. The Ambassador discussed with the delegates the updated EU trade policy, the role of trade in the strategic partnership, the importance of climate action and what can be done for small and mediumsized enterprises (SME) in particular to benefit from trade agreements. On top of all of that, the Hotel Realm also provided a delicious lunch. The afternoon roundtable was around cybersecurity, especially regarding advanced manufacturing. We were delighted to welcome Dr

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Governmental Affairs

Following the COVID-related break, there has been strong interest from GermanAustralian Chamber member companies in engaging with policymakers in Canberra during the Canberra Delegation 2021.

Governmental Affairs

“The delegation sparked expert discussions and provided insights from both policy and industry on bilateral opportunities.” Tobias Feakin, Ambassador for Cyber Affairs and Critical Technology from the Department of Foreign Affairs and Trade, Shadow Minister for Industry and Innovation The Hon Ed Husic MP and Tom Uren, Senior Analyst International Cyber Policy Centre at the Australian Strategic Policy Institute (ASPI). The importance of cybersecurity was apparent during the discussion, chaired by Stephen Pratt, Managing Director Australia/NZ at Leonhard Kurz Australia. Prof Bronwyn Fox (Swinburne University of Technology) and Karen Zwissler (SAP, Board member of the Chamber) gave impulse statements on the subject. The delegates enjoyed the opportunity to discuss energy topics with two outstanding experts from the Department of Industry, Science, Energy and Resources (DISER).

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Duncan McIntyre is the Head of the Energy Efficiency Division, and Kushla Munro is Head of Division, International Climate & Technology. Both were very knowledgeable and discussed bilateral energy collaboration with our industry delegation. As expected, the topics of hydrogen and energy efficiency dominated the discussion. Bilateral opportunities are strong in both sectors. The discussion participants welcomed several initiatives in this field, such as: - the German-Australian Energy Working Group with its hydrogen and energy efficiency sub-working groups, - the HySupply bilateral hydrogen feasibility study, - the German-Australian Hydrogen Alliance Energy will stay an important topic and business opportunity for years to come. That extends to possible supply arrangements and technology exchanges. Of course, all activities were COVIDsafe, including following all relevant regulations and using the CheckIn CBR app. It was a packed schedule – Chamber staff will be busy following up on the many discussions during the 1 1/2 days. We cannot wait to invite our members to the next Canberra Delegation in 2022.

Governmental Affairs Canberra Delegation luncheon discussion with Ambassador of the European Union to Australia, Dr Michael Pulch, in the presence of German Ambassador Dr Thomas Fitschen. Topic of the discussion was the EU-Australia Free Trade Agreement negotiations.

Discussion with Australian Minister for Trade, Tourism and Investment The Hon Dan Tehan MP at Parliament House about the bilateral trade and investment relationship.

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Events

AHK Australien Events Review By Mathias Suter, German-Australian Chamber

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Events

Left: Participant of the Behind the Scenes at Hydac event, trying out Hydac’s leading edge virtual reality training system Right: During the Business After 6 event at the Goethe Institut, attendees made sure to network and foster their connection among the German-Australian business network

2021 has started with a blast. The AHK Australien was delighted to welcome its members to, once again, in-person events. The AHK Australien network started promisingly into 2021 with the first quarter being dotted by events, in particular in-person events. Brisbane, Melbourne and Sydney all started with a celebration of the new year, with separate New Year’s Receptions, giving AHK members a great opportunity to meet again and reconnect after the Christmas break. Furthermore, whilst in Melbourne, we got to visit Hydac Group for a Behind the Scenes Event. The Sydney members were invited to a Business After 6 networking evening at the Goethe Institut. However, there were, of course, also informative topical events on offer, with a mini webinar series with the German Ambassador to Australia, as well as the Australian Ambassador to Germany who spoke about the recently released German Government’s policy

guidelines for the Indo-Pacific and the German-Australian relationship, respectively. After the great start into 2021, we continued in the same way, with a workshop in Sydney with our member Always Up IT, followed by a Behind the Scenes event at Metz Group and our AGM, hosted by Deutsche Bank in Melbourne. Premium Partner Weidmueller also opened its doors for members of the Chamber in Sydney. Take a look at our events calendar.

“In-person, COVID-safe events are our focus in 2021”

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Events Clockwise from top left Mark Keen (Managing Director Hydac Australia) showing attendees the Hydac Melbourne facilities during the Behind the Scenes Event H.E. Philip Green (Australian Ambassador to Germany) & Christoph von Spesshardt (Executive Director, AHK Australien) during the webinar on the German-Australian Relationship Christoph von Spesshardt & H.E. Dr. Thomas Fitschen discussing the German Government’s Policy guidelines for the Indo-Pacific Christoph von Spesshardt (Executive Director, AHK Australien) and Steven Zabeti (Audit Partner, Accru Felsers) welcoming AHK member to the Sydney New Year’s Reception

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Events Clockwise from top left: Melbourne New Year’s Reception host Philipp Hockenberger (Brand Manager, The Hof Group) together with Christoph von Spesshardt (Executive Director, AHK Australien) and Michael Pearce SC (Honorary Consul-General of Germany) AHK Australien Members enjoying the unique setting aboard the James Craig, sailing on the Sydney Harbour during the Sydney New Year’s Reception Tea Dietterich (CEO, 2M Language Service & AHK Australien Board Member) addressing the attendees at the Brisbane New Year’s Reception

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Customer Success

Your Member Journey in 2021 No two customer journeys with AHK Australien are the same, and our new Customer Success Team is committed to making sure your business can access the full range of services on offer.

AHK Australien Members enjoy a raft of benefits. We will introduce many additional benefits in the coming year that deliver a more tailored service to our network. From events to consulting services, AHK Australien is here to connect you with the German-Australian business community. There has never been a better time to be a member with us. The last 12 months have highlighted the importance of physical events and connecting with others in person. As 2021 progresses, there will be many exciting opportunities and developments. With a renewed focus

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on strategic industries between the German and Australian economies, AHK Australien is hosting a Growth Summit on 7 October at the International Convention Centre Sydney. This flagship event will bring together the brightest German and Australian minds to discuss the latest developments in our bilateral economic relationship. Online components will undoubtedly remain a feature of our events calendar. But we encourage everyone to reconnect, come to our next networking event or get in contact with us for a coffee, catch-up or otherwise!

TINA THOMS

LENA MEISS

Customer Success Manager & Head of Melbourne Office

Customer Success Manager

T +61 (0)3 9027 5615

lena.meiss @germany.org.au

Customer Success

CONTACT OUR CUSTOMER SUCCESS TEAM

T +61 (0)2 8296 0443

tina.thoms@germany.org.au

ANDREW DONNI

FLORIAN MILLER

Customer Success Consultant

T +61 (0)2 8296 0403

T +61 (0)2 8296 0454

andrew.donni@germany.org.au

florian.miller@germany.org.au

JOIN THE GERMAN-AUSTR ALIAN GROWTH SUMMIT 2021

Topic:

When:

Where:

Enablers for Growth

7 October

International Convention Centre Sydney

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Customer Success

OUTLOOK 2021 To give our members a better idea of what they can expect from AHK Australien in 2021, the year will be characterised by four focus industries:

ENERGY

FOOD & BEVERAGE

MINING & RESOURCES

HEALTH

In addition to servicing all our existing members and their respective industries, we have identified areas of growth and increased bilateral opportunities. These areas will be reflected in the events, delegations and social occasions taking place. We encourage you to get in contact with the Customer Success Team for more information, or if you have your own ideas you would like to discuss.

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We thank all our Premium Partners for their support.

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Title story & member articles

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Lead Article

Health Industries Weathering the Storm of a Global Pandemic By Cluster Manager – Health, Hannah Niederbuchner

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Watch the webinar held by German Australian Chamber of Industry and Commerce, in cooperation with Germany Trade & Invest (GTAI) exploring the significant opportunities in Digital Health

With Australia’s borders still closed and key industries struggling with the impact of missing cross-border movements, the Australian economy weathered the storm, increasing by a steady 3.1 % / 3.4 % in the last two quarters, with growth rates across various health segments. For example, there was an increase of 2.7% in telehealth1, 5.0% in pharmaceuticals manufacturing 2 , and 4.7% 3 in medical equipment manufacturing. The Australian Health Sector is worth approximately $5.7 billion. Healthcare is the largest employing industry in Australia with 1.7 million employees. Health expenditures per capita equalled $7,485 in 2017-18, making Australia one of the world’s top 10 countries in terms of per capita expenditure. Notably, Australia relies heavily on imports to cover the market demand for medical technology products: 85% of medical technology devices are imported, with Germany being one of the main supplier countries.

Lead Article

Almost 18 months after Australia identified the first COVID-19 cases, the country has shown resilience and undergone many fast-paced developments in the Health Sector.

1 https://www.health.gov.au/ministers/

COVID-19 accelerated change across the health ecosystem and sped up adaptation to a new global reality.

the-hon-mark-coulton-mp/media/ regional-australia-hits-10-million-telehealthservices#:~:text=Audience%3A-,Ten%20 million%20telehealth%20services%20have%20 been%20delivered%20to%20more%20 than,pandemic%2C%20Medicare%20data%20 has%20shown. 2 IBIS World, Pharmaceutical Product Manufacturing in Australia, April 2021 3 https://www.statista.com/statistics/716902/ medical-equipment-market-size-inaustralia/#:~:text=Total%20medical%20 equipment%20market%20size%20in%20 Australia%202017%2D2020&text=In%20 2020%2C%20it%20was%20 estimated,production%20and%20imports%20 minus%20exports.

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Lead Article

Australian Treasurer Josh Frydenberg announced government funding for essential services and the investment of $17.7 billion to overhaul and reform the aged care sector. In addition, $503 million will go into transforming digital health in Australia 4

4 https://www.news.com.au/finance/

economy/federal-budget/federal-budget2021-government-announces-largestpackage-10b-aged-care-funding/news-story/ b641610cba7c5e88d34cf1dd04955fd0

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Despite non-negligible struggles and disruptions such as forced pauses of clinical trials, COVID-19 also accelerated change across the health ecosystem and sped up adaptation to a new global reality. The Australian society faces internal pressures driven by: - rising chronic disease rates, - an aging population - inequitable access to services, and - gaps in the highly casualised workforce, infrastructure and across the clinical supply chain. However, the pandemic response has highlighted opportunities in the Australian Health Industry, particularly telehealth and virtual care, leveraging technology to support patients and practitioners. A temporary change in the Medical Benefits Scheme (MBS) for telehealth arrangements has enabled widespread adoption, welcomed with broad support from the Australian public. A study by the University of Sydney found that 62% of respondents rated their telehealth experience as good as or better than traditional in-person medical appointments. At the end of last year, the German Australian Chamber of Industry and Commerce, in cooperation with Germany Trade & Invest (GTAI), held a webinar exploring the significant opportunities in Digital Health, with guest speakers from Coviu and our Premium Partner SAP. The online event highlighted the positive impact of telehealth platforms and digital applications in the health and hospital setting.

5 https://www.news.com.au/finance/

economy/federal-budget/federal-budget2021-government-announces-largestpackage-10b-aged-care-funding/news-story/ b641610cba7c5e88d34cf1dd04955fd0 6 https://www.pulseitmagazine.com.au/ australian-ehealth/6055-budget-2021-govtpromises-503m-to-transform-digital-healthin-australia?utm_source=Pulse%2BIT++eNewsletters&utm_campaign=df3afac5e5PulseIT_eNews_13_05_2021&utm_ medium=email&utm_term=0_b39f06f53fdf3afac5e5-413233288&goal=0_ b39f06f53f-df3afac5e5-413233288&mc_ cid=df3afac5e5&mc_eid=e077a9addf

With health being one of the Chamber’s industries of expertise with a diverse member base from various segments, this issue of Accelerate focuses on our member companies’ stories and innovative concepts to modernise the health industry. Our member companies reach across all sectors of health: Medical Technology, Life Sciences, Pharmaceuticals, Hospitals & Aged Care Services, and the Digital Health space. In this magazine, find out how hygiene technologies offer critical safety solutions for the care service industry (Meiko), how life sciences businesses leverage their expertise to fight devastating illness (Merck) and to gain insights into cell and gene therapy (Bayer). Our members’ feature articles also showcase the digital future of taking precise patient measurements (medi) and demonstrate how big data analytics have improved infection predications during COVID-19 (Fresenius). Read on to find out about Federal Court action against companies in breach of the Therapeutic Goods Advertising Code (Hall & Wilcox) and learn more about pharmaceutical tendering (Waldner). The remarkable diversity and continuous innovations highlight the resilience and fast adaptation of the sector, leaving us excited for the future of Health in Australia.

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Lead Article

Federal funding made available by the Modern Manufacturing Initiative, open for medical product manufacturing projects as one of the National Manufacturing Priorities, further supports developments in the industry. Furthermore, the Entrepreneurs’ Programme grant stream recently awarded matched funding to two innovative Australian medical manufacturers, helping them complete clinical trials and establish local manufacturing facilities. Governmental funding and grant programs are continuously strengthening Australia as a lucrative target market for industry players. Another boost to the industry came from the Federal Budget 2021, with Australian Treasurer Josh Frydenberg announcing funding for essential services, including mental health, disability support and providing $17.7 billion to overhaul and reform the aged care sector. 5 In addition to that, another $503 million will go into transforming digital health in Australia.6

Gene Therapy

Cell and gene therapy: The next milestone in fighting diseases By Bayer

Our approach to medicine and how we diagnose, treat, and beat diseases has changed remarkably over the last hundred years. From X-rays to DNA sequencing, rapid advances in both our knowledge and technology have meant illnesses that were once considered life sentences can now be overcome or at least managed more effectively. However, despite this incredible improvement, there remain many diseases and disorders that are incurable and continue to be hugely destructive to so many people’s lives. One in five people in developed countries, for example, will develop heart failure, while around 50 million people suffer from Alzheimer’s or related dementia worldwide. But what if there was a way of beating these previously untreatable illnesses?

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What if we could get to the root cause of the illness and stop it at its source? This is what cell and gene therapy seek to do. Scientists are on the cusp of huge breakthroughs in a new field of medicine that would create a new paradigm for healthcare – one that could potentially cure even the most difficult diseases by focusing on the building blocks of our bodies, our genes and cells. Cell and gene therapy looks at illness at a molecular level, seeking to replace damaged or dysfunctional molecules.

See how cell and gene therapy could change the way we treat diseases

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Gene Therapy

WHAT ARE IPSCS?

What is cell therapy? Simply put, cell therapy is the use of living cells to make people better. In reality, of course, it is rather more complex. The idea of transferring viable cells to a patient in order to lessen or cure a disease is not new – blood transfusions have been around for almost a century and the first bone marrow transplant was more than 50 years ago. But in the past couple of decades, major advances in research around stem cells have made it possible to grow and reprogram cells to help the body repair itself by replacing damaged cells with healthy new ones. The human body is made up of around 200 different types of cells,

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each specialised to carry out a particular role. Stem cells are cells that have not undergone differentiation. They are the all-rounders of the body, from which all types of cell tissue are formed. This makes them incredibly valuable. The pioneering work of John Gurdon and then Shinya Yamanaka has meant that scientists are now able to convert adult cells, such as skin cells called fibroblasts, into what are called induced pluripotent stem cells (iPSCs). These reprogrammed cells can theoretically then be differentiated into almost any type of cell and, therefore, almost any tissue type. This has laid the foundations for the rapidly growing and exciting field of regenerative medicine – where cells

What is gene therapy? Many diseases are caused by a dysfunctional gene and/or a mutation that leads to a certain condition such as haemophilia, Huntington’s disease or sickle cell anaemia. Gene therapies focus on the use of genetic material as a drug, correcting or replacing the abnormal gene function causing it. Gene therapy can take several forms. Ex vivo gene therapy works by isolating cells with a genetic defect from a patient, growing these cells in a culture, introducing the therapeutic gene to the cells and then transferring these into the body to help fight a disease. In vivo gene therapy, on the other hand, sees a functioning gene inserted into a carrier or vector (such as a non-pathogenic, non-replicating virus) and this is then injected directly into the bloodstream. Asklepios BioPharmaceutical (AskBio), for example, is a pioneer in

vivo gene therapy. AskBio’s scientific co-founder, Jude Samulski, was the first to demonstrate that an adenoassociated virus (AAV) could be cloned for therapeutic purposes. AAV is a harmless virus bioengineered to carry a healthy gene to target cells in a patient with a genetic disease.

Gene Therapy

that may originate from the patient (autologous cells) or a donor (allogeneic cells) are engineered and cultivated outside the body and then transferred to the patient in order to repair or replace damaged ones. BlueRock Therapeutics, for example, is using iPSCs as a platform to manufacture and replace lost or damaged cells that the body needs to repair itself due to neurological, cardiovascular or immune disorders. The company’s goal is to reverse the symptoms of devastating conditions like Parkinson’s disease – the fastestgrowing neurodegenerative disorder in the world.

Curing the incurable? Together, cell and gene therapy could change the way we approach defeating a disease. So far, some of the biggest strides in this new field of medicine have been in oncology. For example, CAR-T therapies, which involve extracting and re-programming T-cells (a type of immune cell), to equip them to more effectively detect and kill cancer cells, have shown huge potential. The future is enormously exciting – cell and gene therapy could lead to far more targeted, personalised treatment. It could also mean we find a way to finally defeat diseases that we once thought incurable.

About us Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to drive sustainable development and generate a positive impact with its businesses. For further information visit www.bayer. com.au

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Menopause

Dr Wolff’s taboo-breaking mission to improve women’s lives By Rueben Hale (Oh & Hale PR), Linda Siekdrees (Dr Wolff Australia)

From left: Dr Jonica Newby, Dr M Talat Uppal, Jo Pybus and Caroline Baum.

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Vaginal dryness is a taboo topic which affects almost one in four women during perimenopause, with that figure climbing to nearly one in three during the menopause transition.1 Common symptoms are burning, itching, or pain during sexual activity. Women also suffer from a wide range of additional symptoms, mostly hot flushes, insomnia, and reduced sex drive. Most concerningly, stigma is considered the main reason why almost half of women experiencing symptoms don’t report it to their healthcare providers. Even more concerning is that less than 4% of affected women actively use any of the many proven therapies.1 With the number of women not receiving treatment, Dr Wolff explains that education has become a critical part of breaking down menopause stigma to improve health and wellbeing outcomes. Linda Siekdrees, Head of Business Development Australia & New Zealand at Dr Wolff Australia, launched the ‘Break The Taboo’ campaign in Australia last November with an online discussion about menopause, attracting more than 300 registrations. “It is Dr Wolff’s mission to guide and educate women that there are solutions and that they are not alone. It was heartening to our cause when

Menopause

Getting women to talk openly about stigmatised symptoms of menopause once seemed out of the question. Dr Wolff Australia says old taboos are fading, and the time is right to educate women and #breakthetaboo of menopause.

1 Waetjen LE, Crawford SL, Chang PY, Reed BD,

From left: Caroline Baum and Jane Caro

Hess R, Avis NE, Harlow SD, Greendale GA, Dugan SA, Gold EB; Study of Womenʼs Health Across the Nation (SWAN). Factors associated with developing vaginal dryness symptoms in women transitioning through menopause: a longitudinal study. Menopause. 2018 Jun 18. doi: 10.1097/GME.0000000000001130. [Epub ahead of print]

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Menopause

“As a doctor, I want to empower women, not tell them what they should do.” Dr M Talat Uppal

people from across the country and from diverse backgrounds joined in our conversation. The engagement with the keynote speakers was a little slow initially, but soon people relaxed and asked lots of questions. For us, it was immediately clear that information about vaginal dryness and other taboo topics were in high demand. We realised that these open talks and education need to be ongoing to drive change.” On May 5, Dr Wolff launched ‘Get On The Couch’ social movement, aiming to encourage women to start talking more openly about their menopause journey. Host and author Caroline Baum was joined on the couch by feminist social commentator Jane Caro AM, TV presenter and author Dr Jonica Newby, obstetrician & gynaecologist Dr M Talat Uppal, and columnist and writer Jo Pybus for frank open and conversations about their peri-menopause experience and leaving no taboo topic intact. Dr Talat, OBGYN, VMO, Director at Women’s Health Road, explains

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that by empowering women to have conversations about menopause symptoms it will become routine. “There is a huge shame and taboo in our culture that we need to fix, and we need to make it more normal to articulate these difficulties women have in perimenopause and menopause. As a doctor, I want to empower women, not tell them what they should do.” The other guests echoed the fundamental need for education and communication to break down outdated stigmas and free ideas and experiences amongst women. Caro and Dr Newby explain that old ideas and misinformation about menopause persist in an environment of shame and silence. Caro: “Women are conditioned to the fact that from an early age, our bodies will hurt, so we get used to pain. We think menopause is just another one of those things we need to put up with.” Dr Newby: “We need to get rid of the terms “sex drive” and “libido” in our conversations. I lost the sensitivity on my skin. This reduced the effectiveness of my orgasm. I couldn’t trust my body to be able to respond.”

About vaginal dryness Perimenopausal and menopausal vulvovaginal dryness usually occurs for the first time between the ages of 41 to 55. This vulvovaginal dryness is the result of hormonal changes, especially

“Women are conditioned to the fact that from an early age, our bodies will hurt, so we get used to pain. We think menopause is just another one of those things we need to put up with” Jane Caro

It is normal for women to experience vulvovaginal dryness at some stage of their life, but the good news is your doctor or pharmacist can help.

Menopause

the decline in estrogen. Many women experience dryness in the genital area –the vaginal skin becomes thinner and more fragile. This process is quite normal but can bring considerable discomfort, especially during sexual activity. Younger women can also experience vaginal dryness e.g., after uterine or ovarian surgery, during pregnancy and lactation, when taking the pill or with sexual anxiety. Some medications and stress can also be associated with vaginal dryness.

Moisturising Cream for vaginal dryness Dr. Wolff’s Vagisan Moisturising Cream is a hormone-free cream for vaginal dryness. It alleviates symptoms like burning, itching and pain caused by vaginal dryness. It also helps against pain during sex. Unlike other products for vaginal dryness Dr. Wolff’s Vagisan Moisturising Cream is a real cream and not a gel (aqueous preparations). Its dual effect provides moisture AND soothing lipids (fats) to the skin in the vaginal and external genital area.

About us Dr. Wolff Australia is part of the Germanybased Dr Wolff Group. The company employs around 675 people across its medical and cosmetics division, producing Dr Wolff’s Vagisan, Alpecin, Alcina, Plantur, Karex, Bioniq RepairToothpaste and Linola. We are proud to tackle issues that no one else dares to tackle, and we take paths that no one else treads.

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Big Data

The Role of Big Data in the Fight Against COVID-19 By Caitlin Monaghan, PhD, Senior Data Scientist, Applied Data Science, Biostatistics, and Epidemiology, Global Medical Office, Fresenius Medical Care and Len Usvyat, PhD, Vice President, Applied Data Science, Biostatistics, and Epidemiology, Global Medical Office, Fresenius Medical Care

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Worldwide, around 3.7 million patients regularly undergo dialysis, a treatment for end-stage renal disease that filters the blood. Providing dialysis creates a unique opportunity to gather unusually detailed patient data. When this data is combined with machine-learning tools that can function like brain neurons, artificial intelligence (AI) models can be created. These allow new insights to be obtained from data and to predict outcomes based on these insights. With a wide array of global patient data sets now available, Fresenius Medical Care explains how this data and advanced modelling have been successfully used to predict patients who were infected with SARS-COV-2 virus before they tested positive for COVID-19, and how other analyses helped to identify patients who were at greatest risk of severe complications from COVID-19. Caitlin Monaghan, PhD, and Len Usvyat, PhD, explain the value of this data for patients, clinicians, governments and businesses, especially as we have entered the post-first waves stages of COVID-19 in some countries and regions. Fresenius Medical Care is a vertically integrated healthcare company and the world’s leading provider of dialysis products and services. The company provides dialysis to more than 346,000

RELATIONSHIP OF ARTIFICIAL INTELLIGENCE, MACHINE LEARNING, AND DEEP LEARNING

Big Data

How Big Data Analytics Have Improved Infection Predictions and Supported Patient Care during COVID-19

Artificial Intelligence A program that enables computers to mimic human behaviour.

Machine Learning Subset of AI that uses statistical methods to build programs and whose performance improves when exposed to large amounts of data.

Deep Learning Subset of machine learning in which multilayered neural networks learn from vast amounts of data.

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Big Data

patients with kidney disease through its more than 4,000 clinics worldwide, as well as by offering products to partner hospitals and clinics. Dialysis therapy gives a unique opportunity to collect data and view what happens to patients over time at a level of granularity unseen in any other healthcare environment. In North America, the company has collected significant amounts of treatment data on over 1.1 million patients, 110 million dialysis treatments, and 1.2 billion laboratory tests. This data is extraordinarily detailed, with hundreds of data elements collected per dialysis treatment, some on a per second interval. Globally, the company has access to dialysis patient data on an even larger scale, covering 1.9 million patients, 503 million dialysis treatments, 1.7 billion laboratory tests, and almost 4 billion administered medicines. Data of this magnitude and complexity is often referred to as ‘big data’ and grows continuously.

How the Data is Used Using cutting-edge data science and machine learning methodologies, Fresenius Medical Care is able to leverage this data to help develop new benchmarks in dialysis patient care and conduct research that advances medicine. Artificial intelligence (AI) is a data science discipline that combines traditional statistical methods with sophisticated machine learning tools to gain insights and predict outcomes from big data. The company has successfully constructed a range of AI models that

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use its own clinical and non-clinical data from external sources. These models have predictive capabilities that provide support in making clinical decisions and help to direct patient interventions. Modelling can be used to identify which dialysis patients are most likely to be hospitalised in the next seven days and in the next 12 months, and which patients are at greatest risk of infection. Other models predict the progression of chronic kidney disease before patients start dialysis, allowing for a much more successful transition that reduces emergency interventions. Overall, these modelling approaches allow more precise personalised care for the company’s global patient populations.

Extending this Modelling to COVID-19 Dialysis patients often have other co-existing health conditions, known as comorbidities. These increase their risk of complications from infections. During the global COVID-19 pandemic, Fresenius Medical Care has been able to use its large global databases to assist at-risk patient populations. As a rapid response to the pandemic, the company developed machine learning predictions about which counties in the U.S. and which dialysis clinics globally were likely to be affected by a new COVID-19 outbreak in the next one to two weeks. This model allowed clinicians to identify specific patients who had early changes in laboratory values or vital statistics before they tested positive for COVID-19, alerting clinicians to infections before the virus became more widespread.

Big Data FIGURE 2 | Graph showing how patient temperatures can be used to predict the likelihood of a future positive COVID-19 test

FIGURE 3 | Dialysis treatments where Fresenius Medical Care patients in North America had a fever and cough

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Big Data

“Future predictive models will need to be even more comprehensive and responsive, and data will be a crucial resource to fuel these models.” One of the variables included in the model showed the relationship of patients’ body temperatures to the likelihood of having an infection. In the figure below, the horizontal axis shows the distribution of patient temperatures. Values on the vertical axis that are above zero show an increase in patients’ likelihood of having COVID-19, while values below zero show a decrease in that likelihood. These are known as SHAP values, an acronym for SHapley Additive exPlanations. Notably, the mean temperature for COVID-19-positive patients was only 0.2° Fahrenheit higher than the mean temperature of patients who were not diagnosed with COVID-19 (97.7° F [36.5°C] v 97.5° F [36.39°C]). This further illustrates the importance of comprehensive data-driven

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approaches to identify patients at risk of COVID-19: with such small differences in temperature, clinical observation is unlikely to result in screening for COVID-19, while very small changes in several patient parameters can be picked up by a computer algorithm. Other analyses helped to identify patients who were at increased risk of severe complications if they were to acquire COVID-19. While limited data exists on which patients are likely to die or be hospitalised with this virus, realtime monitoring of data allowed for early understanding of patient characteristics that are most likely to be associated with negative outcomes. Real-time data surveillance also helped to identify geographic areas with COVID-19 spread. The illustration below compares the number of dialysis treatments where patients had a fever and cough by week in 2018, 2019, and 2020. The graph clearly demonstrates the real-time spike in these symptoms. These tools can be used and adjusted over time, making them extremely valuable for any future waves of COVID-19 and other pandemics.

The Value of AI in Post-COVID Healthcare In the United States, the government supports the use of big data in improving healthcare delivery through a variety of initiatives. Dialysis is mostly funded by the federal government through the Medicare program and all providers, including Fresenius Medical Care, share data through a formal network system. The data is

About us Fresenius Medical Care is the world’s leading provider of products and services for individuals with renal diseases of which around 3.7 million patients worldwide regularly undergo dialysis treatment. Through its network of 4,110 dialysis clinics, Fresenius Medical Care provides dialysis treatments for 344,476 patients around the globe. Fresenius Medical Care is also the leading provider of dialysis products such as dialysis machines or dialyzers. Along with its core business, the Renal Care Continuum, the company focuses on expanding in complementary areas and in the field of critical care.

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Big Data

de-identified to protect patient privacy. In 2019, the United States launched the American AI Initiative, the country’s national AI strategy. This directs the government to pursue investment, training, and the development of an international environment that supports AI innovation. In the regulatory landscape, predictive modelling such as the work we have described, is categorised as Clinical Decision Support Software (CDSS). As the products of these models are suggestions, such as lists of patients at high risk, and not actual prescriptions or orders for clinical care, they are generally exempt from regulation as a medical device. For medical innovations built on big data and automation to thrive, it is crucial to improve societal understanding and the regulatory environment for data sharing. In order to ultimately improve patient quality of life through these regulatory changes, we must actively promote innovation using data. The COVID-19 pandemic, unprecedented in scope and severity, has also led to unprecedented uses of clinical data within and across countries. Given the current environment of uncertainty, healthcare systems are under pressure to deliver more and better care with limited resources. Future predictive models will need to be even more comprehensive and responsive, and data will be a crucial resource to fuel these models.

Legal Matters

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Legal Matters

The dangers of making therapeutic claims in relation to retail products – The Lorna Jane Case and the Peptide Clinics Case By Alison Choy Flannigan, Partner, Leader Health & Community, Hall & Wilcox

In Australia, the marketing and labelling of ‘therapeutic goods’ are regulated by legislation. Manufacturers, retailers and advertising companies must exercise care when making claims in relation to products which are ‘therapeutic claims’ under the Therapeutic Goods Act 1989 (Cth) (Therapeutic Goods Act) and which may be misleading and deceptive under the Therapeutic Goods Advertising Code and the Australian Consumer Law. Making ‘therapeutic claims’ can make a product a ‘therapeutic good’ and therefore subject to registration or listing on the Australian Register of Therapeutic Goods if not exempt.

Regulatory Framework In Australia, the marketing and labelling of ‘therapeutic goods’ are regulated by legislation including: 1. Therapeutic Goods Act 1989 (Cth) (‘the Therapeutic Goods Act’); 2. Therapeutic Goods Regulations 1990 (Cth) (‘the Regulations’); and 3. Therapeutic Goods Advertising Code (No. 2) 2018 (Cth) (‘the Therapeutic Goods Advertising Code’). The Therapeutic Goods Advertising Code ensures that the marketing and advertising of therapeutic goods to consumers is conducted in a manner that promotes the quality use of the product and does not mislead or deceive the consumer.

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Legal Matters

Additionally, any claims in relation to COVID-19 will also be subject to the Therapeutic Goods (Prohibited Representations-Disinfectants) (COVID-19) Permission 2020. Under this instrument, the Secretary of the Department of Health must approve any advertisement or representation that a therapeutic good has a ‘virucidal effect’ against the COVID-19 virus. Under the Therapeutic Goods Act, ‘therapeutic goods’ means goods that are (inter alia): “(a) represented in any way to be, or that are, whether because of the way in which the goods are presented or for any other reason, likely to be taken to be: (i) for therapeutic use; or (ii) for use as an ingredient or component in the manufacture of therapeutic goods; or (iii) for use as a container or part of a container for goods of the kind referred to in subparagraph (i) or (ii);..” ‘therapeutic use’ means ‘use in or in connection with: (a) preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons; or (b) influencing, inhibiting or modifying a physiological process in persons; or (c) testing the susceptibility of persons to a disease or ailment; or (d) influencing, controlling or preventing conception in persons; or (e) testing for pregnancy in persons; or (f) the replacement or modification of parts of the anatomy in persons.’ The definition is very broad. Further, even if therapeutic goods are registered or listed on the Australian Register of Therapeutic Goods (ARTG), certain representations are restricted. ACCELERATE

The Lorna Jane Case Lorna Jane is an Australian-owned company that manufactures and retails women’s activewear, founded by its codirector Lorna Jane Clarkson. It has 108 stores in Australia, as well as a number of international stores, including in the USA and New Zealand. Lorna Jane allegedly claimed, on its website, that its ‘anti-virus activewear’ prevents and protects against infectious diseases, implying it is effective against COVID-19. The promotion included the following image:

ACCC Action

On 17 July 2020, the Australian Therapeutic Good Administration (TGA) issued three infringement notices to Lorna Jane, totalling $39,960 for alleged unlawful advertising in relation to COVID-19.1 The TGA alleged that Lorna Jane represented its ‘anti-virus activewear’ for therapeutic use and therefore believe that it is a therapeutic good within the meaning of the Therapeutic Goods Act. The advertisement referred to therapeutic goods that were not included in the Australian Register of Therapeutic Goods (ARTG). This is required before they can be lawfully supplied or advertised in Australia. Under the Therapeutic Goods Act, any references to COVID-19 (and related terms) in the promotion of these types of goods are restricted representations. A restricted representation refers to a serious form of a disease, condition, ailment or defect. The use of restricted representations in advertisements for therapeutic goods is unlawful without a prior formal approval or permission from the TGA. It is also a breach of the Therapeutic Goods Advertising Code to promote a therapeutic good as being safe, harmless or without side-effects.

In December 2020 the Australian Competition and Consumer Commission (ACCC) instituted proceedings in the Federal Court against Lorna Jane Pty Ltd for alleged false or misleading claims about its ‘Anti-virus Activewear’, in breach of Australian Consumer Law.2 Most of the claims were removed in mid-July, but until at least November 2020 Lorna Jane continued to represent on garment tags that the garment permanently protected the wearers against pathogens. It is alleged that Lorna Jane (a) engaged in conduct that was misleading or deceptive or likely to mislead or deceive, in contravention of section 18 of the Australian Consumer Law (ACL) (contained in Schedule 2 to the Competition and Consumer Act 2010 (Cth)); (b) made false or misleading representations that LJ Shield Activewear had a standard or quality which it did not have, in contravention of section 29(1)(a) of the ACL; (c) made false or misleading representations that LJ Shield Activewear had performance characteristics, uses and/or benefits which it did not have, in contravention of section 29(1)(g) of the ACL; and (d) engaged in conduct liable to mislead the public as to the nature, characteristics and/or suitability for purpose of LJ Shield Activewear, in contravention of section 33 of the ACL.

1 https://www.tga.gov.au/media-release/lorna-

jane-fined-almost-40000-alleged-advertisingbreaches-relation-covid-19-and-anti-virusactivewear

Legal Matters

TGA action

2 https://www.accc.gov.au/media-release/

accc-takes-lorna-jane-to-court-over-anti-virusactivewear-claims

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Legal Matters

It is also alleged that Lorna Jane director and chief creative officer, Ms Lorna Jane Clarkson, was knowingly concerned in the alleged conduct, including by personally making false or misleading claims about the LJ Shield ‘Anti-virus Activewear’ in a media release and a video posted on Lorna Jane’s Instagram account. Ms Clarkson was a party to or knowingly concerned in Lorna Jane’s contraventions of sections 18, 29 and 33 of the ACL, for the purposes of section 224(1). The ACCC also alleges that Lorna Jane represented that there was a scientific or technological basis for these claims at the time they were made, when no such testing had been carried out. The ACCC is seeking declarations, penalties, injunctions, corrective notices, and an order to implement a compliance program.

Peptide Clinics Case Similarly, in 2018-19, the TGA investigated one company (Peptide Clinics Pty Ltd) for breaches of the advertising rules for medicines, including the ban on advertising prescription-only medicines to the public and the Federal Court of Australia and ordered a $10 million penalty against the company.3 The contraventions included advertising Schedule 4 substances on the website and on social media 3 https://www.tga.gov.au/media-release/civil-

penalties-ordered-against-peptide-clinics-ptyltd-advertising-breaches

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channels, advertisements using the word “peptides”, advertising prohibited and restricted representations, and more. The Court found Peptide Clinics contravened the Act and the Advertising Codes each day the advertisements appeared on the website and on social media channels. The website advertising peptides also included references to inappropriate and misleading uses, such as for anxiety, anti-ageing, body building, tanning, weight loss, premature ejaculation, hair loss and insomnia relief. The TGA advised that interfaces that allow consumers to review and self-select prescription-only medicines for subsequent prescribing and supply, and websites that promote general classes of prescription-only medicines, will generally be considered in contravention of the Act.

Legal Matters

Commentary

About us

Since the onset of the pandemic, there have been a plethora of new technologies and innovations brought to market. Particularly, ‘antibacterial’ and ‘antiviral’ consumer products. The substantial penalties imposed reflect the very real dangers to public health and safety and demonstrate the dangers of making therapeutic goods in relation to retail products. The maximum penalties per breach of the ACL including unconscionable conduct, making false or misleading representations, and supplying consumer goods or certain services that do not comply with safety standards or which are banned: For corporations, will be the greater of: (a) $10 000 000 (b) three times the value of the benefit received, or (c) 10% of annual turnover in preceding 12 months, if court cannot determine benefit obtained from the offence. For individuals: $500 000. This article was written with the assistance of Lauren Krejci paralegal.

Hall & Wilcox is a leading Australian independent business law firm with offices across Australia: Melbourne, Sydney, Brisbane, Perth, Newcastle, Canberra and Darwin. For over 100 years, Hall & Wilcox has been advising businesses and people, including public and private companies, public sector organisations and business owners. At Hall & Wilcox, we deliver ‘Smarter Law’. This means being smarter across our entire business by being progressive, by our commitment to excellence and by our focus on building great relationships. For our clients, this translates to better quality, better value, improved efficiency and greater ease of doing business.

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Contactless Measurement

medi vision – contactless, fast, precise innovation for creating a smart future – medi is making it happen By Alex Carver & Klaus Hones, Managing Directors – medi Australia

Together with specialist retailers, medi wants to revolutionise everyday care and always be one step ahead. As a manufacturer of medical aids, medi develops innovative products, intelligent solutions and holistic care concepts. One example: the smart medi vision. medi vision makes it possible to take measurements and order the precisely fitted round knit compression garment in less than five minutes.

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It is all about time! The experts at medi work every day to offer solutions that make the work of specialist retailers easier and faster. The time saved by taking measurements digitally can be invested in advising and supporting the customer. Digitisation has become indispensable: the smart tool medi vision optimises everyday care for specialist retailers. It goes without saying that their expertise remains invaluable. Because working digitally will never replace one thing: The empathy of the experts and their proximity to patients and users. New technologies, expertise, and connection to the customer go hand in hand and are the key to success. With medi vision, medi wants to create a digital ecosystem that significantly simplifies – and accelerates – the processes in the daily life of specialist retailers. From receiving the

Contactless Measurement The future of taking measurements digitally: medi vision enables the fitter to take measurements in a digital, contactless and hygienic way and provides the patient with an ideal round knit or flat knit compression garment. For flat knit leg garments, some measurement points still have to be checked manually, but direct contact with the patient is reduced to a minimum. A great advantage – especially in times of COVID-19. (© www.medi.de)

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Contactless Measurement Thanks to its compact size, medi vision, the innovative system for taking measurements digitally, can be used in a variety of ways: at medical retail stores and care facilities, or during home visits. (© www.medi.de)

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prescription, taking measurements, configuring the right product, individual consultation and documentation to sustainable customer retention: medi vision conveniently links the individual steps on the path from prescription to a satisfied customer. In less than five minutes, the digital tool enables the process from measuring to ordering the perfect circular-knitted fitting. Taking measurements is consequently supported by smart-scan technology and the easy handling of the new contactless technology. medi vision combines a tablet with a 3D camera and custom-made software. The determination of measures is digitally captured and runs automatically into the online ordering process. There is no need to measure manually anymore. The technology of the digital assistant enables almost contactfree, hygienic measurements of

All eyes on medi vision:

Contactless Measurement

Working digitally will never replace one thing: The empathy of the experts and their proximity to patients and users.

medical compression stockings – a great advantage especially in times of COVID. Manual measurements are also significantly reduced for flat-knit leg fittings (soon to be available); only isolated measurement points have to be re-examined manually.

The digital tool for innovative measurements, medi vision, received the German Innovation Award in category #W2 Excellence in Business to Business – Information Technologies | Industry Specific and Service Software. It impressed the German Design Council with its added value for both the medical professional and the patient. medi was also awarded the German Brand Award 2020 in the category “Excellence in Brand Strategy and Creation – Brand Communication – Integrated Campaign” for the 360-degree campaign for medi vision. If you want to know more about medi vision, please contact our Australian medi group company at www.mediaustralia.com.au

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Clean and Reusable

Technology for washing reusable takeaway dishes By MEIKO TEAM

Finding solutions for hotels and food service businesses so that they can keep their reusable cups and glass bottles in circulation. Reusable is the future – this is the clear message from authorities and experts worldwide. Now the challenge is to find solutions for hotels and food service businesses so that they can keep their reusable cups and glass bottles in circulation. Experts say that cups must be used at least 40 times before the lifecycle assessment is in the green. The M-iQ and M-iClean are MEIKO’s way

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of mastering hygienically clean washing and quick drying to keep the catering in motion at parties and festivals, all without the environment having to suffer. Reusable cups are the clean solution but washing plastic cups poses particular challenges. Sebastian Hainz, Executive Vice President Sales and Marketing at the MEIKO Group, explains, ‘The largest challenge here has always been the drying process, because plastic is significantly worse at storing heat than, for example, porcelain, and dries only very slowly.” The M-iQ Cup is designed for washing and drying plastic cups. It uses vibration drying

for flawless drying results with 0% residual moisture. That enables cups to be stored immediately without sticking together or causing hygiene problems. Ready to take the next festival or event by storm! With a capacity of up to 8,400 cups per hour, this is the professional solution for large catering or festival food service projects. For smaller events, MEIKO has equipped the M-iClean series to optimally wash plastic cups or bottles.

The cycle: washing bottles As part of the drive to add value and experience, bottles are in more frequent use. Hotels and

Clean and Reusable Mirza van Meerwijk (left) and Gawein Hamers (right) of CupStack provide innovative solutions for reusable dishware in the catering industry. Thanks to the Meiko M-iQ, they are able to wash up to 10,000 cups per hour.

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Clean and Reusable Top: Michael Andresen developed a mobile solution for cleaning large quantities of dishware: a Meiko M-iQ on the back of a lorry Above: The MEIKO bottle washing system is suitable for all M-iClean UM/UM+ machines. This efficient system can wash up to 16 glass bottles while also ensuring no detergent residue is left in the bottles.

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food service establishments fill glass bottles or carafes with drinks prepared onsite or tap water. This is becoming much more popular and, of course, these containers have to be washed hygienically clean. The MEIKO bottle washing system takes a total of 16 glass bottles in all standard shapes and sizes. It even makes it easy to clean lab bottles. The best part is that the bottle rack can be fitted – or retro-fitted – in any M-iClean UM or UM+ model from 2013 onwards. This means that existing kitchen and food service equipment can easily and sustainably be retrofitted. Just a few movements can turn your glass and dishwasher into a machine specially designed for cleaning reusable bottles: simply replace the bottom wash

Good ideas by the cupful Two projects with reusable cups have caught our eye recently: the company CupStack in the Netherlands washes up to 10,000 cups per hour in their M-iQ Cup. And German company Cup & More takes premium MEIKO ware washing technology right to the action. Their M-iQ is installed on a semi-trailer so it can be driven onto the festival site. Professional hygiene on wheels: the smart, mobile solution for festivals and large events. We are certain that even more clever ideas are yet to come. MEIKO technology for washing reusable takeaway dishes is limitless.

Bottled cocktails Here is another example from the food service industry: some shrewd bar owners started filling glass bottles with their cocktails and selling them on the street during the coronavirus lockdown. That way, they were able to take some sales cash even with the bar closed. Of course, the bar uses MEIKO technology for washing reusable takeaway dishes.

“The largest challenge here has always been the drying process, because plastic is significantly worse at storing heat than, for example, porcelain, and dries only very slowly.”

Clean and Reusable

arm with the adapter included – that’s it! This system uses separate, sealed channels to send first wash fluid and then rinse aid to specially designed nozzles which spray them directly into the bottle interior, along with water. The result: totally hygienically clean bottles. The innovative process facilitated by this system is sustainable and resource efficient, reduces payroll costs, saves time and assures hygiene safety.

About us MEIKO is committed to make the world a cleaner place by using innovative technology for warewashing, cleaning and disinfection. It started out 90 years ago in Germany and now has production sites in China and the USA as well. MEIKO Australia Pacific has been committed to giving comprehensive hygiene solutions to various types of industries making sure we exceed expectations and help businesses flourish.

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Vaccine Development

Merck – the engine Behind the COVID-19 Solution By Merck Life Science ANZ

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Vaccine Development

The Life Science business of Merck has rapidly leveraged its science and technology expertise to fight this devastating illness— COVID-19.

Merck and Baylor College of Medicine Collaborate to Advance a Vaccine Manufacturing Platform to Fight COVID-19

Today, Merck, in collaboration with our customers, is the engine behind the solution, working on COVID-19 projects through our products and services including: some 50 different vaccine programs; more than 20 treatments, like antibodies, plasmas and antivirals; and 35 testing solutions, such as PCR tests. We have also brought forward expansion plans around the world, as well as expedited the launch of new

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Vaccine Development

COVID-19 related products to meet the unprecedented demand brought forth by the virus. Many ask, how was it possible to provide the raw materials, products, and equipment so rapidly, given it can take a decade or more to develop vaccines and related treatments? The good news was that several developers were able to leverage already approved virus platforms to accelerate this complex development process from ten years down to one, applying existing technology from previous vaccine development programs to this novel coronavirus sequence. For example, our collaboration to support Oxford University’s vaccine candidate leveraged an existing platform that was used for vaccines against rabies and Ebola, among others. Similarly, our support for Baylor College of Medicine’s vaccine candidates both repurposed a SARS vaccine candidate and stemmed from our previous collaborative work to develop a vaccine targeting schistosomiasis, a deadly waterborne disease carried by parasites. This strategy will undoubtedly continue to accelerate numerous vaccine development processes while preserving their safety and efficacy going forward. Pivoting development programs was only one part of the already highly complex task of creating a vaccine for this novel virus. The need was – and still is – at a global scale. For vaccine developers to manufacture the billions of doses needed to vaccinate a global population, competitors became partners, generating a demand surge for the critical products used in vaccine

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manufacturing. That is where the Life Science business of Merck, one of the world’s largest producers of single-use assemblies, plays a key role. In just six months, we added to and staffed a new single-use-assemblies plant in Massachusetts, USA (single-use assemblies are semi-custom, highly engineered plastic bags and filters that are used to mix vaccine material) and, in New Hampshire, USA, we expanded production to boost capacity to make the filters crucial to ensuring the purity of vaccines and other medicines. In March, we announced the building of another production facility dedicated to manufacturing single-use assemblies in Molsheim, France, the first facility of its kind for Merck in Europe. This facility, which

At Merck, we could not be prouder to work with these heroes. They, and so many others, reflect our commitment to leave the world a better place than we found it.

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Vaccine Development

will be online by the end of 2021, will add much-needed capacity for customers in various regions around the world. In addition, Merck is continuing to lead and invest in mRNA and support mRNA manufacturers, including our extended partnership with BioNTech, building upon a strong existing collaboration to supply lipids for the drug delivery of BioNTech’s mRNA-based COVID-19 vaccine. While supporting the roll-out of vaccines is priority number one, Merck is also playing a critical role in the testing space for COVID-19, supporting more than 35 solutions. We are collaborating with clinical testing labs and diagnostics manufacturers in addition to key players such as Mammoth Biosciences Inc. of California, USA, for which we serve as contract manufacturer and support the development, scale-up and commercial production of their CRISPR-based diagnostic test. Specific to PCR tests, we supply critical raw materials across all key steps involved in diagnosing COVID-19 infections with PCR tests, in addition to manufacturing and supplying key products, such as Hi-Flow membranes, for serologicals that enable testing for the presence of COVID-19 antibodies. We also supply critical raw materials across all three key steps involved in diagnosing COVID-19 infection, including viral transport media for patient sample collection, reagents for RNA extraction and key components for RNA amplification/detection. Indeed, it has been a challenging year but, for Merck, a fulfilling one. We, along with countless individuals across

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academia, biotech, and pharma, as well as governments around the world, never stopped working in the quest to stem the global proliferation of COVID-19. Our colleagues, particularly those on the front lines of manufacturing, came in every day to make the products needed for vaccines, treatments, and testing. We continue to do everything we can to keep them safe – measures include enhanced and rigorous cleaning schedules, staggered shifts, social distancing, and providing vaccines on-site where available. At Merck, we could not be prouder to work with these heroes. They, and so many others, reflect our commitment to leave the world a better place than we found it.

About us Our purpose is to solve the toughest problems in life science by collaborating with the global scientific community – and through that, we aim to accelerate access to health for people everywhere. We provide scientists and engineers with best-in-class lab materials, technologies, and services. With the 2015 combination of Merck Millipore and Sigma-Aldrich, we now have a broad portfolio of 300,000 products, an expanded global footprint, and an industry-leading eCommerce platform – SigmaAldrich.com

Vaccine Development

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THe enGIne BeHInD THe SOLUTIOn in times of crisis and beyond

We are dedicated to helping solve the toughest problems and accelerating access to health — that’s why we’re driven to aid in the response to COVID-19.

Leveraging our key strengths OUR PRODUCTS

OUR RESPONSE

Delivering

150+

Working with the global community in times of crisis and stability

OUR PEOPLE

OUR GLOBAL PRESENCE

essential products

Supply chain expertise with 100+ distribution points, speeding access for research and development teams around the world

22,000+ employees

helping to solve the toughest problems in life science

OUR PeOPLe SAFETY SAFETY

22,000+

We’ve We’ve implemented implemented measures measures to keep to keep ourour employees employees safe safe while while continuing continuing to to power power the the scientific scientific community community

employees are the backbone of our organization. Their

1 Site de-densification and social distancing 2 Additional precautionary personal protective equipment 3 Regimented cleaning schedules at all locations

safety and wellbeing remains our top priority; creating a safe workplace ensures our ability to manufacture & distribute

DIGITAL SOLUTIONS

DIGITAL SOLUTIONS Leveraging technology to collaborate Leveraging to collaborate with and with and technology support those those responding support those responding to COVID-19 to COVID-19

solutions driving the COVID-19 response.

1 Dedicated customer & technical service teams 2 Virtual customer meetings 3 Expanded webinars and online trainings

OUR GLOBaL PreSenCe OUR GLOBAL TASKFORCE

is actively monitoring and solving potential disruptions, so our global supply chain continues to meet critical customer needs

• Increasing stock and activating secondary suppliers

MANUFACTURING 59 SITES 100+ DISTRIBUTION CENTERS

• Dedicated import and export teams to speed the time of receipt and delivery • Business continuity plans in place for pandemic scenarios ensuring supply chain security

In the past 30 years every drug approved by the US FDA included our products

OUR PrODUCTS Each of these areas will be critical in slowing the progression of COVID-19 and ultimately protecting the world in the future

VIRUS DETECTION

• We’re a leader in providing critical components for development of diagnostic kits • PCR reagents, kits and tools for all stages of assay development

VIRUS CHARACTERIZATION

OUR ReSPOnSe

We’re virtually connecting students with at-home, hands-on science lessons:

Responsibility is one of our core values, and we're responding in more ways than our products and services. We're helping solve the toughest problems by supplying key products for COVID-19 response to:

>20

monoclonal antibody, plasma products, and antivirals

>50

Different vaccine

VACCINE & THERAPY PRODUCTION

• Effective vaccines and therapies • We support the global effort start with reliable virus to research, test and scale characterization vaccine and therapeutic re – sponse to COVID-19 with: • We offer one of the largest • Upstream & downstream portfolios of biologic reagents process development and hardware and scaling • Understanding viral attachment • Biosafety Testing Services and entry, viral genomics, or viral proteomics requires the • Comprehensive contract highest quality reagents manufacturing solutions

>35

Testing Solutions

• At-home Curiosity Labs™ experiments

We’re supporting ongoing efforts with donations beyond our portfolio contributions

• Supporting expansion of STEM e-learning by our NGO partners

• Personal Protective Equipment for medical aid and frontline health care workers • Products to local institutions and in-vitro diagnostic manufacturers in China

The life science business of Merck operates as MilliporeSigma in the U.S. and Canada.

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Biotechnology

Australian-German partnership for global biotechnology leader By Maximilian Englisch, VP Global Sales, Waldner

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The life science industry is one of the fastest growing sectors in Australia. This development was already obvious before the COVID-19 pandemic hit the world, but the urgent demand for local solutions fuelled the growth in the past 18 months. With leading research and development institutions, both private as well as public and a world-renowned university landscape, Australia is globally recognised as one of the leading nations in developing treatments and diagnostics to detect and cure COVID-19 and other diseases. The term life sciences is often used as an umbrella term for sectors including medical technologies, pharmaceuticals, diagnostics as well as digital health and biotechnology. With the latter being considered a game changer in the development of not just lifesaving drugs but also in innovating for example healthier and more resistant crops and more sustainable fuel. Biotechnology is a technology based on the biology of living organisms such as bacteria and has been researched for decades. Synthetic Insulin for example was one of the first large developments and many have followed. Dedicated and personalised gene therapy and medication to treat certain cancers is a major focus as well as curing rare diseases. Due to their revolutionary mRNA technology, Biotech companies such as German BioNtech and Curevac

Biotechnology

Waldner is fitting out the R&D laboratories at the new CSL headquarters in Melbourne

are at the forefront of the fight against the current pandemic and their vaccinations are helping to save lives. Vaccinations is also how one of Australia’s leading life science companies started over 100 years ago. CSL – Commonwealth Serum Laboratories – was established in 1916 to support the health needs of a young nation. Today, CSL is one of the leading global life science companies with R&D as well as production locations around the world. This includes the locations of CSL Behring, a German company

The life science industry is one of the fastest growing in Australia. ACCELERATE

Biotechnology

Waldner supplies state-of-the-art laboratory infrastructure for CSL.

founded by Emil von Behring who won the first Nobel Prize in Medicine

in 1901. CSL acquired Behring 15 years ago and the company has since developed into a global leader in many different fields of medicine – a great example of a truly successful Australian-German partnership. CSL is currently building their new global headquarters in the Parkville biomedical precinct in Melbourne. This state-of-the-art 35.000 square metres facility unites both the HQ functions as well as research and development on 17 floors. Trusted with the design and delivery of the scientific infrastructure is Waldner, a global leader in fitting out laboratory facilities hailing from Wangen in the South of Germany. Until completion in 2023 Waldner will be part of this exciting project and will fit

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out all the research areas with state-ofthe-art laboratory infrastructure after having done so in other CSL locations across Europe. Another great example of Australian-German collaboration.

About us Waldner is a global leader in scientific infrastructure with a focus on sustainable and futureproof laboratories. Headquartered in Germany, Waldner has a global presence in all major regions worldwide, supporting clients in the life science, chemical and medical industry as well as universities and other educational institutes. Waldner has been involved in various projects in Australia over the past 20 years and maintains an office in Brisbane. www.waldner.de

We pioneer motion

Optime - Plug. Play. Predict

Condition monitoring can be expensive. Which is why up to 95% of all machines inside factories are only sporadically monitored, or often not at all. This can lead to unplanned breakdowns and downtime. OPTIME from Schaeffler allows for comprehensive condition monitoring that is both easy and affordable. Thanks to its simple plug & play installation, OPTIME allows you to start monitoring hundreds of rotating machines in just a few hours. www.schaeffler.com.au

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Partner organisations

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G e r m a n y Tr a d e & I n v e s t

The economic development agency of the Federal Republic of Germany Visit our website to find out more Germany Trade & Invest

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G e r m a n y Tr a d e & I n v e s t

Who we are and what we do By Heiko Stumpf & Carola Jäger

You want to locate to Europe’s most important market? Then we are your first point of contact. We inform you free of charge with current industry analyses, individually tailored tax and legal information as well as financing and funding opportunities in Germany.

Germany Trade & Invest is the economic development agency of the Federal Republic of Germany. The company helps create and secure extra employment opportunities, strengthening Germany as a business location. With more than 50 offices in Germany and abroad and its network of partners throughout the world, Germany Trade & Invest supports German companies setting up in foreign markets, promotes Germany as a business location and assists foreign companies setting up in Germany.

Please feel free to contact us!

HEIKO STUMPF Director Australia & New Zealand +61 (0)2 8296 0494 heiko.stumpf@gtai.com

CAROLA JÄGER Consultant Australia & New Zealand +61 (0)2 8296 0417 carola.jaeger@gtai.com

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G e r m a n y Tr a d e & I n v e s t

Digital Health – Digital Solutions for Today’s Health Care Challenges By Germany Trade & Invest

Steps taken by the German Ministry of Health open up the German healthcare market to a digital transformation that will provide 73 million insured Germans access to digital health application on prescription.

Since 2018, the German Ministry of Health has pushed forward a great number of legislative actions to digitalise the health care system. In 2019, the German parliament passed the Digital Care Act (DVG) to accelerate digitalisation and innovation within the German health care market. The act also paves the way to broad usage and reimbursement of digital health applications – so-called “DIGAs.” Find out more about - Digital Health Applications - “Fast Track” into the DIGA Directory - Video: Smart Hospitals in Germany - Latest Publication - Digital Health Market - Telemedicine - Smart Solutions for Heart Failure Management - Smart Solutions for Diabetes Management on our website.

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G e r m a n y Tr a d e & I n v e s t

Health Made in Germany: Medical Technology By Germany Trade & Invest

Medical products “Made in Germany” are used worldwide.

Watch our video to learn more.

In the current corona crisis, German medical technology companies have proven that the industry is able to react extremely quickly to extraordinary situations and meet global requirements at short notice. The German federal government is strengthening this innovative power through targeted stimulus. Watch our video to learn more.

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S TA R T- UPS G e r m a n y Tr a d e & I n v e s t

The ABSs of the CBD By Germany Trade & Invest

One hot start-up sector in Evidence suggests that CBD can alleviate disorders ranging from Germany – products made from the cannabidiol or CBD. anxiety and insomnia to epilepsy

Accelerate Issue 3 Q2 2021

Articles inside

Clean Air Initiative ClAAS supports “Clean Air Initiative” by offering practical solutions and alternatives

Germany Trade & Invest

Australian-German partnership for global biotechnology leader

Merck – the engine Behind the COVID-19 Solution

Technology for washing reusable takeaway dishes

medi vision – contactless, fast, precise innovation for creating a smart future – medi is making it

The dangers of making therapeutic claims in relation to retail products – The Lorna Jane Case and the Peptide Clinics Case

The Role of Big Data in the Fight Against COVID-19

Dr Wolff’s taboo-breaking mission to improve women’s lives

Cell and gene therapy: The next milestone in fighting diseases

Health Industries Weathering the Storm of a Global Pandemic

Your Member Journey in 2021

Events AHK Australien Events Review

Substantial dialogues during the Canberra Delegation 2021

A message from AHK Australien’s Executive Director