Adelaide, AUS, Apr 9, 2020 – (ACN Newswire) – Leading Australian CRO Avance Clinical said there was still strong demand from Asian and US sponsors, and commended Australian sites that had risen to the challenge to deliver for Avance Clinical clients during this difficult time.

Avance Clinical is a medium-sized full-service CRO known for its nimble and collaborative approach, with more than 20-years of experience in managing early phase trials.

Avance Clinical's Chief Strategist Ben Edwards said a key factor in sponsor demand is the speed and attractive cost of running trials in Australia. In particular, they include:

– The Australian Government financial rebate of more than 40% on clinical trial spend
– No IND required for clinical trials and streamlined regulatory processes
– Advanced medical, research and scientific community, leading investigators and KOLs, and modern medical facilities

Watch video – how we work here https://www.avancecro.com/

Avance Clinical CEO Yvonne Lungershausen, who has a background in pure research, said sponsors saw the value of running studies in Australia.

"In addition, Australia is not as hard hit by the COVID-19 crisis which has meant we can work with sites to deliver studies that might otherwise be put on hold, costing time and money and causing crippling delays to drug pipelines," said Ms Lungershausen.

"We are pleased to be the Australian CRO of choice for international sponsors," she said.

"Australia's reputation for FDA compliant scientific and research excellence, its advanced healthcare, and the opportunity to access patients in a less clinical trial competitive environment further reinforces its advantage as a destination for clinical trials."

For more information about the benefits of running your next study in Australia contact us: https://www.avancecro.com/contact-us/

About Avance Clinical

Avance Clinical has more than 20-years of experience and is now one of Australia's leading Contract Research Organisations. Avance Clinical facilitates quality drug development by aligning people, skills, and expertise in the pursuit of drug development for a healthier world.

Avance Clinical is committed to providing high-quality clinical research services with its highly-experienced team. The collective pool of knowledge and experience at Avance Clinical continually grows through the careful selection of experts who also demonstrate passion in their chosen field.

Avance Clinical offers high quality services in an established clinical trial ecosystem, that includes world-class Investigators and Sites able to access specialised patient groups. Other benefits include:

1. The Government R&D grant means more than 40% rebate on clinical trial spend
2. Telehealth pivot during COVID-19 pandemic – speed and continuity
3. Site Initiation Visit (SIV) and Study Start achieved in 5 – 6 weeks
4. No IND required for clinical trials
5. Full GMP material is not mandated for Phase I clinical trials
6. Established clinical trial environment with world-class Investigators and sites
7. Established healthy subject databases and specialised patient populations
8. Five independent Phase 1 facilities across Australia including hospital-based units for critical care
9. Major hospitals with world class infrastructures and dedicated Clinical Trial Units with a long track-record in FDA compliant research
10. Seasonal studies: Northern hemisphere Sponsors can conduct their studies year-round by taking advantage of Australia's counter-flu and allergy seasons.

Media Contact:
media@avancecro.com
Chris Thompson

Copyright 2020 ACN Newswire. All rights reserved. http://www.acnnewswire.com

SYDNEY, Apr 9, 2020 – (ACN Newswire) – Asia-Pacific's largest specialist biotech CRO Novotech said the top 10 biotech sites in Australia were open for clinical trial activity with many sites modifying their practices to ensure continuity of operations.

View and Download the COVID-19 Australia Data Bulletin here. https://novotech-cro.com/covid-19-notice

The data is part of a new series prepared for Novotech clients detailing the current status of trials in the Asia-Pacific during the global COVID-19 crisis.

Novotech CEO Dr John Moller said the Bulletin series taps local knowledge of fundamentals in the sector and shows which countries in the region are able to support clinical research for Novotech and its clients during this time.

"While the situation is always evolving, Australia appears to be managing the crisis well. Our sites have changed how they manage trials in line with Australian Government health guidelines and most are still able to deliver the clinical trial services we need for our clients," said Dr Moller. "Study delays caused by COVID-19 can be rapidly addressed by activating new sites in Australia and Asia."

Australia has attractive start-up times, world leading investigators and research teams, and valuable rebates of up to 43.5% on clinical trial spend.

About Novotech

Novotech, established in 1996, is internationally recognized as the leading full-service contract research organization (CRO) in Asia-Pacific. Novotech provides clinical development services across all clinical trial phases and therapeutic areas and has been instrumental in the success of over a thousand Phase I – IV clinical trials for biotech companies.

Novotech obtained the ISO 27001, the best-known standard in the ISO family, providing the requirements for an Information Security Management System. Together with the ISO 9001 Quality Management system, Novotech aims at the highest IT security and quality standards for patients and biotechnology companies. Visit http://novotech-cro.com.

For RFP enquiries: Please fill out the form available at https://novotech-cro.com/talk-to-an-expert

Media Contact
Susan Fitzpatrick-Napier
communications@novotech-cro.com
AU: +61 2 8218 2144
USA: +1 415 951 3228
Asia: +65 3159 3427

Copyright 2020 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Mainz, Germany, Apr 8, 2020 – (ACN Newswire) – A new type of sensor device from the German health technology company Digital Diagnostics AG can be used for immediate tests for the new SARS coronavirus. The SARS-CoV-2 MEMS 5 Minute Test(TM) is created as a pocket-size lab and can be used in four steps anywhere on-site by general practitioners, paramedics and nursing staff without any training. The first prototypes of the biosensor will be available by end of April with first production devices by mid-May.

Compared to previously known rapid tests looking for the presence of antibodies in the test-liquid, the SARS-CoV-2 MEMS 5 Minute Test(TM) leads to a clear "YES" or "NO" result regarding the presence of the actual virus in the test fluid and eliminates the time and cost consuming transport of samples to a laboratory. The great advantage of this method is that the virus can be detected directly with a very high accuracy. In contrast, all other rapid tests known to date are based on the detection of antibodies. But antibodies are not detectable in plasma until 7 to 10 days after infection.

With the 5 Minute Test developed by digid, the SARS-CoV-2 virus can be measured using micro-electro-mechanical systems (MEMS) without the need for time-consuming sample preparation. The SARS-CoV-2 MEMS 5 Minute Test(TM) is based on cantilevers, which are integrated onto a microchip with the size of a fingernail. These nanomechanical spring bars made of silicon are extremely thin and can be bent by the application of even a tiny force. This makes them highly sensitive biochemical sensors. The cantilevers are coated with a capture layer of antibodies. When applied to the chip, these antibodies bind any viruses contained in the test fluid. When the SARS-CoV-2 virus binds to the capture layer, changes in surface tension cause a mechanical bending of the cantilevers, which generates an electrical signal on the chip.

By connecting the digital sensor to a secure analytics platform, the numerous sensor data can be linked with geodata and processed anonymously for big-data applications. This would enable the creation of truly accurate tools to detect emerging regional hotspots of virus spread in near-real-time. Newly emerging chains of infection can then be effectively contained. Restrictions on freedom of movement could also be much more flexible and regionally limited, and the scarce resources of health administrations and hospitals could be used much more purposefully and efficiently.

Press contact
Thomas Huber
semanticom GmbH
+49 151 14 96 58 10
digid-pr@semanticom.eu

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To view the source version of this press release, please visit https://www.newsfilecorp.com/release/54256

Copyright 2020 ACN Newswire. All rights reserved. http://www.acnnewswire.com

SYDNEY, Apr 8, 2020 – (ACN Newswire) – Asia-Pacific's largest specialist biotech CRO Novotech said the top 10 biotech sites in Australia were open for clinical trial activity with many sites modifying their practices to ensure continuity of operations.

View and Download the COVID-19 Australia Data Bulletin here. https://novotech-cro.com/covid-19-notice

The data is part of a new series prepared for Novotech clients detailing the current status of trials in the Asia-Pacific during the global COVID-19 crisis.

Novotech CEO Dr John Moller said the Bulletin series taps local knowledge of fundamentals in the sector and shows which countries in the region are able to support clinical research for Novotech and its clients during this time.

"While the situation is always evolving, Australia appears to be managing the crisis well. Our sites have changed how they manage trials in line with Australian Government health guidelines and most are still able to deliver the clinical trial services we need for our clients," said Dr Moller. "Study delays caused by COVID-19 can be rapidly addressed by activating new sites in Australia and Asia."

Australia has attractive start-up times, world leading investigators and research teams, and valuable rebates of up to 43.5% on clinical trial spend.

About Novotech

Novotech, established in 1996, is internationally recognized as the leading full-service contract research organization (CRO) in Asia-Pacific. Novotech provides clinical development services across all clinical trial phases and therapeutic areas and has been instrumental in the success of over a thousand Phase I – IV clinical trials for biotech companies.

Novotech obtained the ISO 27001, the best-known standard in the ISO family, providing the requirements for an Information Security Management System. Together with the ISO 9001 Quality Management system, Novotech aims at the highest IT security and quality standards for patients and biotechnology companies. Visit http://novotech-cro.com.

For RFP enquiries: Please fill out the form available at https://novotech-cro.com/talk-to-an-expert

Media Contact
Susan Fitzpatrick-Napier
communications@novotech-cro.com
AU: +61 2 8218 2144
USA: +1 415 951 3228
Asia: +65 3159 3427

Copyright 2020 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Tel Aviv, Israel, Apr 7, 2020 – (ACN Newswire) – via NEWMEDIAWIRE — SuperTrans Medical ("SuperTrans"), a privately held biopharmaceutical company with initial focus on the discovery and development of novel antibiotics, today announced that leading South Korean biopharma Mediforum Pharm (KOSDAQ: 047920) will make a $2M investment in SuperTrans. In return, Mediforum will collaborate with SuperTrans in the manufacturing and commercialization of SuperTrans' products in Asia, including South Korea, China, and Japan. Additionally, Mediforum will fully commit and support SuperTrans' future drug development programs.

The SuperTrans technology was discovered by chemists Prof. Paul A Wender (Professor of Chemistry, School of Humanities and Sciences, and by courtesy, of Chemical and Systems Biology Stanford Medical School, Stanford University) and Prof. Lynette Cegelski (Professor of Chemistry, School of Humanities and Sciences), both on the Scientific Advisory Board of the company. Professor Wender's guanidinium-rich, molecular transporter technology, inspired by nature, is licensed from Stanford University by SuperTrans Medical and its partner, Mediforum. This technological approach could help bridge a gap to deliver urgently needed antibiotics to thwart multi-drug resistant bacterial pathogens.

In addition, SuperTrans is completing candidate assessments for the treatment of COVID-19 based on its transporter technology. The candidate compound will be aimed in preventing both viral and bacterial pulmonary infections. The company is currently preparing its drug development program.

SuperTrans Medical's R&D team consists of individuals from Major Pharma' with drug development successes, including antibiotics and HIV inhibitors. These are Dr. Lewis Neville, CEO, Dr. Jacob Rendell, CTO (Ex-Teva), Dr. Patricia Bradford (Ex-Wyeth, Novartis and AstraZeneca), Dr. Joseph Vacca (Ex-Merck and WuXi Apptec), Dr. Peter Warn (Ex-Evotec) and Prof. Itamar Shalit, a pediatric clinical infectious diseases specialist.

Mediforum is a Seoul-based pharmaceutical company which is specialized for researching and developing novel drugs against neuro-degenerative disease such as Alzheimer's disease and Parkinson's disease. "SuperTrans Medical is thrilled to partner with Mediforum as our lead strategic investor. We are looking forward to a long-term partnership to further develop and commercialize the SuperTrans technology," commented Lewis F. Neville, CEO of SuperTrans Medical. "In a short period of time, we have made significant inroads into the design and evaluation of different FDA-approved antibiotics that were conjugated to the company's unique transporter technology. This has already resulted in the identification of a number of compounds worthy of late stage development. Mediforum has identified the strength of our platform technology to improve the properties of existing FDA-approved antibiotics. Mediforum's investment will allow a lead antibiotic-conjugate to enter Phase 1 testing within 12-15 months."

"We are delighted to invest in SuperTrans. We have been impressed by their rapid progress during the last number of months that has culminated in the development of a number of lead compounds. We believe that their transporter technology can represent a paradigm-shift for the accelerated development of much needed antibiotics into human trials. Mediforum will proactively play its role as a strategic partner through the co-exchange of all research and development efforts. Although SuperTrans' technology is at a relatively early stage of development, we anticipate the launch of a new generation antibiotic for testing will be relatively fast. This is because the technology can be easily conjugated to existing FDA-approved antibiotics," commented Mr. Park Jaehyung, CEO of Mediforum. "Furthermore, SuperTrans is strengthening its pipeline through its support of Stanford University and other scholars. Also, SuperTrans is preparing for a Hong Kong IPO in 2022, which is highly attractive for Mediforum," further commented Mr. Park Jaehyung.

About SuperTrans Medical

SuperTrans Medical is a biopharmaceutical company developing novel antibiotics by improving the properties of existing, FDA compounds following chemical conjugation to a unique transporter technology called Guanidinium-Rich Molecular Transporter (GRMoTr). A main obstacle in the development of effective antibiotics is to effectively overcome the structural complexities of the outer bacterial membrane. This is particularly pertinent for Gram-negative bacteria. The GRMoTr bestows upon antibiotics, a vastly improved capability to breach the outer membrane and effectively eradicate Gram-positive and Gram-negative pathogens including multi-drug resistant strains.

About Mediforum

Mediforum Pharm is a brain healthcare specialized pharmaceutical company that discovers and develops treatment for degenerative brain diseases such as Alzheimer's and Parkinson's diseases among others. Currently, the company is aggressively expanding its R&D pipeline together with its rapidly growing prescription drug sales. Furthermore, Mediforum is actively engaging with overseas research institutes in order to expand operations beyond domestic borders and penetrate the global market.

For more information, contact:
Lewis F. Neville, PhD
CEO
SuperTrans Medical
lewis@supertransmedical.com

Eran Gilboa
CFO
SuperTrans Medical
eran@supertransmedical.com

Copyright 2020 ACN Newswire. All rights reserved. http://www.acnnewswire.com

HANOI, VIETNAM, Apr 4, 2020 – (ACN Newswire) – In response to the call of the General Secretary, the President, the Prime Minister of Vietnam for the whole country's participation in supporting Covid-19 fight and under the drastic guidance of Deputy Prime Minister Trinh Dinh Dung; on April 3, 2020, Vingroup announced its decision to produce (invasive and non-invasive) ventilators of all types and body thermometers to the domestic market.

At 12 PM on March 30th, 2020, the Group's Leaders convened an emergency meeting and requested all of its Research Institutes to stop daily tasks and focus on finding and researching methods to produce ventilators. The units assigned the main responsibility include Automobile R&D Institute 1, Automobile R&D Institute 2, Mobile Device Research Institute, Smart Home Appliances R&D Institute, Telecommunication Equipment R&D Institute, Smart Battery R&D Institute, VinFast Automobile Factory and VinSmart Electronics Equipment Factory. All Group Leaders and specialized departments are responsible for coordination, support and are required to work directly via telephone on a 24/24 hour basis.

After just one day and night, they found a lot of partners willing to share their design and necessary information to start production. Soon after that, Vingroup entered into a license agreement with US-based Medtronic to use their design for the PB560 invasive ventilator and at the same time began researching a non-invasive ventilator based on the community-shared design by Massachusetts Institute of Technology (MIT).

The supply is divided into 2 categories. The former includes components that can be purchased on the market and the later includes components which must be self-made by Vingroup or made with Vingroup's cooperation or support to manufacturing partners because of their limited production capacity. "Vingroup has an advantage of having both automobile factory and electronics factory which enable us to manufacture both large and mechanical parts as well as rare and smaller parts at the same time such as electronic boards. Our excellent design engineers are capable of transforming the conceptual and 2D designs into detailed and complete designs required by the manufacturers" – said Mrs. Le Thi Thu Thuy, Vice Chairwoman of Vingroup.

It is expected that the first batches of components for non-invasive ventilators will arrive in two weeks and components for invasive ventilators will arrive in another two weeks. The group claimed that with enough components, it can produce ventilators in one day and transfer them to the Ministry of Health and the Ministry of Science and Technology for appraisal and quality tests before they are distributed to health facilities nationwide.

The group has successfully tested and produced their body thermometers with the component cost at VND16 million, about ten times lower than other body thermometers on the market. The group estimated the component cost for a non-invasive ventilator at about VND22 million and for an invasive ventilator at VND160 million.

"We expect to supply these devices to the Ministry of Health at their component cost. We won't include the costs of transportation, labour, production and other costs as well as taxes into the price. In the immediate future, we will give the MOH 5,000 non-invasive ventilators to timely treat COVID-19 patients" – said CEO of Vingroup Nguyen Viet Quang. He added that "In addition, with the capacity of VinFast and VinSmart factories, the group can produce up to 45,000 non-invasive ventilators and 10,000 invasive ventilators per month and we can support other manufacturers around the world by processing equipment for them, or providing part of the demand – any specific quantity depending on their ability to supply components".

Copyright 2020 ACN Newswire. All rights reserved. http://www.acnnewswire.com

KUALA LUMPUR, Apr 3, 2020 – (ACN Newswire) – Australian-listed companies Skin Elements Limited (ASX: SKN) ('Skin Elements') and Holista Colltech Limited (ASX:HCT) ('Holista') announced today a Binding Collaboration Term Sheet (Agreement) to launch a natural alcohol-free hand sanitiser that combines Skin Elements' new skin-sensitive anti-microbial formula with the Path-Away(R) active ingredient distributed by Holista.

Skin Elements is leveraging on its research into skincare formulas which has already achieved global market recognition. This will make the Invisi Shield(R) Natural Hand Sanitiser a world-first in combining advanced natural skincare formulations with the Path-Away(R) active ingredient.

Skin Elements' Invisi Shield(R) Natural Hand Sanitiser will hit stores in Australia and New Zealand this month ahead of other global markets as part of an accelerated collaboration between both companies to meet the increased global demand for sanitizers.

The all natural product will address a major concern faced by the repetitive use of alcohol based sanitisers. Many Australians are increasingly concerned about skin sensitivity due to high alcohol content in sanitisers. Invisi Shield(R) Natural Hand Sanitiser does not use alcohol.

Skin Elements' Invisi Shield(R) Natural Hand Sanitiser is a plant based formula incorporating the Path-Away(R) active ingredient. The Invisi Shield(R) Natural Hand Sanitiser is currently being formulated by Skin Elements using third party independent test results on ingredients. Once this product has been finalised the assessment of applicable regulatory framework and further appropriate independent laboratory testing will be undertaken as required.

The Invisi Shield(R) Natural Hand Sanitiser is not required to be registered by the Therapeutic Goods Administration (TGA) as it is deemed personal cosmetics products which comply with the Therapeutic Goods (Excluded Goods) Determination 2018.

The Path-Away(R) active ingredients are listed as Generally Recognised as Safe (GRAS) under the Code of Federal Regulations and Federal Drug Administration (FDA) and have been successfully tested at several laboratories approved by the World Health Organisation.

Holista has exclusive rights to distribute in Australia the Path-Away(R) sanitiser ingredient developed by Global Infection Control Consultants LLC based in South Carolina in the United States. Holista also sells under the brand Natshield.

Skin Elements has the capacity to initially produce up to 20,000 100ml bottles Invisi Shield(R) Natural in the first month at its West Perth facility, and will review quarterly its capacity to assess if additional contract facilities are required to increase production to meet increased future demand.

As part of the Agreement, Holista will ship Path-Away(R) as a concentrate to be included in the manufacture of the Invisi Shield(R) Natural sanitizer. This will be made in Australia by Skin Elements in accordance with the unique dilution recommendations for the Path-Away(R) concentrate provided by GICC. Skin Elements will allow its production outputs to be independently verified by competent auditors of HCT, or as the case may be, by GICC.

The initial order of the Path-Away(R) ingredient under the Agreement is for a minimum of $600,000 in the first year. Payment terms will be 50% on order and 50% before shipment. The minimum order quantities will be reviewed on a quarterly basis, in order to assess capacity to increase order quantities as required to meet increased demand.

It will be available in Australia and New Zealand through its network of four distributors which service in excess of 10,000 retail outlets. It intends to introduce other bottle sizes for handheld or table-top use and can increase production to meet demand in Australia and New Zealand and from the global markets.

"We are excited by the collaboration with Holista and the launch of Invisi Shield(R) Natural which will position Skin Elements as a global leader in providing high-quality hand sanitisers. This new sanitiser significantly strengthens our range of existing sanitisers which is being unveiled after two years of product development and test marketing to independent pharmacies, and selected schools and day-care centres in Western Australia," said Skin Elements' Executive Chairman Peter Malone.

"It extends Skin Elements' portfolio of award-winning nature-based healthcare and skincare products researched and developed over the past 20 years. These include the Soleo Organics sunscreen, which has won multiple awards as the world's best natural sunscreen, including being rated the number one natural sunscreen by the Environmental Working Group of the United States, PapayaActivs natural therapeutic skincare, and the Elizabeth Jane Natural Cosmetics brand," he added.

"Our partnership with Skin Elements places Australia on the global map in terms of innovation. The inclusion of Path-Away(R) combines trusted skincare solutions developed by Skin Elements with a powerful active ingredient that has been tested as a sanitiser. Life after COVID-19 will see more use of sanitsers at a personal level and I am happy to see two Australian companies take the message of "all natural and "alcohol free" to the world as an alternative to alcohol," said Dr Rajen Manicka, CEO of Holista.

This announcement is authorised by the Board of Directors of Skin Elements Limited and the Board of Directors of Holista Colltech Limited.

For further information, please contact:
Peter Malone
Executive Chairman
Skin Elements Limited
T: +61 439 430 770
E: peter@skinelementslimited.com

Media and Investor Inquiries
James Moses
Mandate Corporate
T: +61 420 991 574
E: james@manadatecorporate.com.au

About Skin Elements

Skin Elements is an ASX listed skin care company focused on the development of natural and organic skin care products, as an alternative to current chemical-based products. It has developed a portfolio of products which includes its lead product, the Soleo Organics 100% natural and organic sunscreen, pawpaw based PapayaActivs natural therapeutic skincare, and the Elizabeth Jane Natural Cosmetics brand. The Company has completed a highly successful test marketing phase in major international markets for Soleo Organics and has regulatory approval with the USA FDA, TGA and other significant regulators. Skin Elements aims to become the number one recognised international natural products brand. Further information is available via the Company website: http://skinelementslimited.com

About Invisi Shield(R)

Invisi Shield(R) Natural is a proprietary all-natural hand sanitiser formulation which uses a combination of the key ingredient, Path-Away(R), with organic plant extracts being olive leaf, echinacea, Manuka honey, Kakadu Plum, papaya, chamomile and thyme.

About Holista Colltech Ltd

Holista Colltech Ltd ("Holista") is a natural wellness company, the result of a merger between Holista Biotech Sdn Bhd and CollTech Australia Ltd. The company has 3 main divisions:
– Dietary supplements and personal care
– Food Ingredients
– Ovine collagen

Listed on the Australian Securities Exchange ("ASX"), Holista researches, develops, manufactures and markets "health-style" products to address the unmet and evolving needs of natural medicine. Holista's suite of ingredients includes low-GI baked products, reduced-sodium salts, low-fat fried foods and low-calorie sugar without compromising taste, odour and mouthfeel. Holista remains the only company to produce sheep (ovine) collagen using patented extraction methods. For more information, please refer to http://www.holistaco.com

Contact:
Corporate Affairs & Business Opportunities
Dr Rajen Manicka: rajen.m@holistaco.com
General Enquiries: enquiries@holistaco.com

Media and Investor Relations:
WeR1 Consultants Pte Ltd
E: holista@wer1.net; P: +65 67374844

About Path-Away(R)

Path-Away(R) is the active ingredient in the Invisi Shield(R) Natural hand sanitiser. It is a powerful plant-based anti-microbial compound, developed by US-based Global Infection Control Consultants LLC (GICC) in South Carolina under the leadership of Dr. Arthur Martin. GICC is the premier private company in the United States that specialises in the dynamics of the pathogenic bioaerosol connection to the human infection matrix. Further information on GICC is available via the website: https://www.giccllc.com

Path-Away(R) is an all-natural, alcohol free, rinse-free multi-purpose sanitiser which is proven effective for a broad spectrum of pathogens. It is environmentally safe with a very low toxicity (especially relative to competitor products), and has been tested, proven and approved by numerous laboratories and agencies globally.

Path-Away(R) is the result of years of research leading to the company's proprietary plant-based active ingredients. The products and processes are wholly owned by GICC. The Company's aim to provide cutting-edge solutions organic solutions to bacteriological, biological, and viral pathogens affecting home and personal life. Further information is available via the Path-Away(R) website: https://path-away.com/

Copyright 2020 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Adelaide, AUS, Apr 2, 2020 – (ACN Newswire) – Leading Australian CRO Avance Clinical today detailed the top reasons its APAC biotechs selected Australia for their early phase clinical trials, based on client onboarding feedback. Avance is a specialist Australian CRO with more than 20-years of early phase clinical trials expertise.

Avance Clinical said a primary reason that APAC biotechs chose Australia was the attractive Australian Government financial rebate of more than 40% on clinical trial spend. Avance Clinical CEO Yvonne Lungershausen said this makes good financial sense for biotechs in early clinical phases.

Another key factor is that, during the current COVID-19 pandemic, sites can pivot to patient video visits or telemedicine, which this week got a Government funding boost as part of a AUD$1.1 billion COVID-19 package.

Watch Avance Clinical COVID-19 capabilities video here: https://www.avancecro.com/

Ms Lungershausen said:

"This additional funding into an already high-tech medical environment means sites are rapidly able to incorporate telehealth visits to overcome challenges faced by patients not wanting to visit clinics during the pandemic."

"Australia's reputation for FDA compliant scientific and research excellence, its advanced healthcare, and the opportunity to access patients in a less clinical trial competitive environment further reinforces its advantage as a destination for clinical trials."

"Avance is the CRO of choice for clinical trials – as well as those targeting COVID-19."

The top reasons for selecting Australia are:
1. The Government R&D grant means more than 40% rebate on clinical trial spend
2. Telehealth pivot during COVID-19 pandemic – speed and continuity
3. Site Initiation Visit (SIV) and Study Start achieved in 5 – 6 weeks
4. No IND required for clinical trials
5. Full GMP material is not mandated for Phase I clinical trials
6. Established clinical trial environment with world-class Investigators and sites
7. Established healthy subject databases and specialised patient populations
8. Five independent Phase 1 facilities across Australia including hospital-based units for critical care
9. Major hospitals with world class infrastructures and dedicated Clinical Trial Units with a long track-record in FDA compliant research
10. Seasonal studies: Northern hemisphere Sponsors can conduct their studies year-round by taking advantage of Australia's counter-flu and allergy seasons

For more information about the benefits of running your next study in Australia contact us: https://www.avancecro.com/contact-us/

About Avance Clinical

Avance Clinical has more than 20-years of experience and is now one of Australia's leading Contract Research Organisations. Avance Clinical facilitates quality drug development by aligning people, skills, and expertise in the pursuit of drug development for a healthier world.

Avance Clinical is committed to providing high-quality clinical research services with its highly experienced team. The collective pool of knowledge and experience at Avance Clinical continually grows through the careful selection of experts who also demonstrate passion in their chosen field.

Avance Clinical offers high quality services in an established clinical trial ecosystem, that includes world-class Investigators and Sites able to access specialised patient groups. Other benefits include:

– Access to independent Phase 1 facilities across Australia including hospital-based units for critical care
– Dedicated Investigators committed to clinical research
– Major hospitals with world class infrastructures and dedicated Clinical Trial Units
– Expedited clinical trial start-up timeframes

Media Contact:
media@avancecro.com
Chris Thompson

Copyright 2020 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Adelaide, AUS, Apr 2, 2020 – (ACN Newswire) – Award-winning Australian bioanalytical laboratory Agilex Biolabs announced today it has appointed US-based Dr Caroline Popper, MBBS, MPH as Board Chair as part of its APAC clinical trials bioanalytics growth plans.

More than 38% of Agilex Biolabs' biotech clients already come from the APAC region – primarily from China and South Korea. APAC clients are particularly attracted by Agilex' FDA-inspected status, and the more than 40% rebate on clinical trial spend that applies in Australia.

Agilex Biolabs specializes in bioanalysis of small molecules and biologics for PK, immunogenicity, biomarkers and immunological pharmacodynamics assessments, and the only FDA-inspected lab of its type in the region, is located in Adelaide, South Australia in a science and biotech specialist hub.

Dr Popper was first appointed to the Agilex Biolabs Board in July 2019.

Agilex Biolabs CEO Jason Valentine said:

"We are extremely pleased Dr Popper accepted the Board Chair role and we look forward to an exciting phase of growth under her guidance."

"Dr Caroline Popper is a medical doctor, pathologist, health economist, medical consultant and experienced company director, with over 20 years of hands on experience in the healthcare, medical devices and drug discovery fields.

She has managed a wide range of diagnostics, device and drug discovery businesses in both Fortune 500 and start-up settings, at amongst others, Becton Dickinson, bioMerieux, and MDS."

Dr Popper said:

"My clinical experience enables me to help interpret relevant market forces, develop strategies and create partnerships that thrive in the global and fast changing and challenging health care landscape."

"Agilex Biolabs is a stand-out leader in the pharma services space and I look forward to taking on this significant role and being part of the next phase of growth for the company, leveraging its position in the important APAC region."

"The Aglilex Biolabs team of scientists and specialist PhDs is quite exceptional making it well positioned to rapidly deliver bioanalytics for biopharma clients running clinical trials in Australia, Asia and the US, and the EU."

The company specialises in bioanalysis of small molecules and biologics for PK, immunogenicity, biomarkers and immunological pharmacodynamics assessments utilising LC-MS/MS, immunoassay (Mesoscale, Gurolab, Luminex) and flow cytometry (BD FACSymphony A3, 20 colour cell analyser).

Agilex also offers pharmacodynamics services that include immunobiology services using the latest state-of-the-art technology to support immunology, cell biology and mode of action assays, including:
– Immunophenotyping
– Receptor occupancy
– Cytokine release assays (whole blood or PBMC stimulation assays) and cytokine/biomarker profiling
– PBMC assays and cellular mechanism of action assays (eg: ADCC)

CEO Jason Valentine said:

"Our FDA-inspected facilities have more than 65 dedicated laboratory staff, and annually support more than 80 clinical trials. This year we will analyse more than 60,000 samples for pharma/biotechs from US, Europe and APAC."

"By combining specialised expertise, technological innovation and a 20-year track record, we have supported hundreds of preclinical and clinical trials around the world."

"Our world-class bioanalytical facilities have OECD GLP Recognition with NATA (Australian Government OECD GLP Compliance monitoring authority) and ISO 17025 Accreditation for global recognition."

Learn more about Agilex Biolabs in this Video: https://youtu.be/3lyodiqqM_k

About Agilex Biolabs

Agilex Biolabs began as a group of academic scientists providing clinical trial and bioanalytical services to the local Australian pharmaceutical industry in the 1980's, and has now grown into a global business for early phase clinical trials. In our 20 years of performing regulated bioanalysis of small and large molecules, we have accelerated hundreds of preclinical and clinical trials around the world. Today, our clients include many of the leading pharmaceutical and biotechnology companies in Asia, Europe and the USA. Call +61 8 83028777 or +1 800 247 1909 or visit https://www.agilexbiolabs.com/.

Agilex Biolabs is built upon four core values that drive our performance:
– Scientific excellence and technological innovation
– Customer focus
– Data integrity and quality assurance
– Timeliness/speed

See us featured in Endpoints https://tinyurl.com/uqmkzcu

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David James
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