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Avance Clinical’s USA Biotech Survey Finds 21% Not Aware Australian Clinical Data is Accepted by the FDA and Other Major Regulatory Authorities

By Company NewsNo Comments

The leading Australian CRO for biotechs and Frost & Sullivan Asia-Pacific CRO Market Leadership Award recipient Avance Clinical announced the results of their Australian Clinical Trials Knowledge Survey with Endpoints News as part of their presence at BIO Digital 2021.

Results from the survey found:

 

  • 21% were not aware Australian data is accepted by the FDA and other major regulatory authorities
  • less than half of respondents were aware of Australia’s 43.5% rebate on clinical research spend
  • only 52% knew that studies could achieve regulatory approval in under 5 weeks in Australia

The survey was sent to Endpoints News subscribers in biotech hubs on the USA east and west coasts.

The Avance Clinical team is attending BIO Digital 2021 virtually and is available on the BIO One-on-One Partnering™ platform to discuss the benefits of conducting trials in Australia.

Avance Clinical CEO Yvonne Lungershausen, said the survey was designed to determine awareness levels among biotech companies around the key benefits of conducting clinical trials in Australia.

“Sponsors are well aware of the quality of research from Australia however it seems from the survey that some key benefits including data acceptance, the rebate, and accelerated regulatory approval are still not widely known,” said Yvonne Lungershausen.

“The clinical trial environment in Australia supports rapid regulatory approval and includes one of the most attractive rebates on clinical costs as part of the Australian Government’s clinical trial attraction incentive program.”

Avance Clinical has recently won the BDO Excellence in Business Award 2021 for rapid managed growth and attracting and nurturing experienced staff in a competitive global environment. The mid-sized CRO has a reputation for going beyond the industry standard time and support for Sponsors and providing staff the training and resources needed to deliver excellence in clinical research management.

About Avance Clinical
Avance Clinical, Australia’s CRO for biotechs, has more than 20-years of experience providing excellence in clinical research services for biotech companies from around the globe. Avance Clinical facilitates quality drug development by aligning people, skills, and expertise in the pursuit of drug development for a healthier world.
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 specific patient groups. Visit http://www.avancecro.com for more information.

Recent Awards:

Excellence in Business Award 2021

Frost & Sullivan Asia-Pacific CRO Market Leadership Award 2020

 

June 20, 2021
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TrialTrove Data Shows Australia is Open for Business says Avance Clinical at BIO Digital 2020

By Company NewsNo Comments

The leading Australian CRO for biotechs, Avance Clinical announced at BIO Digital today that Australia currently has 2,413 trials planned or ongoing.

Importantly in Australia, despite the global COVID-19 pandemic, no healthy volunteer studies have been suspended, and only 27 Phase 1 or 2 studies were temporarily put on hold for various reasons (TrialTrove, 9 June 2020).

Avance Clinical commended the Australian industry for exceptional COVID-19 management which has meant Australia leads the world in maintaining clinical trials business as usual.

Avance Clinical’s Chief Strategy Officer, Ben Edwards presented at BIO Digital 2020 today on the many benefits of running trials in Australia.

Watch the Avance Clinical BIO Digital presentation On Demand here.

https://www.bio.org/events/bio-digital/sessions/search?name=Avance%20Clinical

Mr Edwards said:

“Approximately 96% of our work is supporting small to medium-sized biotechnology companies executing Phase 1 and Phase 2 trials. Our client base currently extends across North America, Canada, New Zealand, Europe and Asia.

Australia is a well-established location for international clinical trials and our management of the COVID-19 crisis has made it an even more attractive trials destination.”

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.

In addition to the impressive COVID-19 management, a key factor in sponsor demand is the speed, access to high quality sites and attractive cost of running trials in Australia including:

  • The Australian Government financial rebate of 43.5% 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 during the COVID-19 pandemic here. https://www.avancecro.com/news/news-about-avance-clinical-covid-19-capabilities/

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.

June 10, 2021
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Avance Clinical’s USA Biotech Survey Finds 21% Not Aware Australian Clinical Data is Accepted by the FDA and Other Major Regulatory Authorities

By Company News, Conference NewsNo Comments

The leading Australian CRO for biotechs and Frost & Sullivan Asia-Pacific CRO Market Leadership Award recipient Avance Clinical announced the results of their Australian Clinical Trials Knowledge Survey with Endpoints News as part of their presence at BIO Digital 2021.

Results from the survey found:

  • 21% were not aware Australian data is accepted by the FDA and other major regulatory authorities
  • less than half of respondents were aware of Australia’s 43.5% rebate on clinical research spend
  • only 52% knew that studies could achieve regulatory approval in under 5 weeks in Australia

The survey was sent to Endpoints News subscribers in biotech hubs on the USA east and west coasts.

The Avance Clinical team is attending BIO Digital 2021 virtually and is available on the BIO One-on-One Partnering™ platform to discuss the benefits of conducting trials in Australia.

Avance Clinical CEO Yvonne Lungershausen, said the survey was designed to determine awareness levels among biotech companies around the key benefits of conducting clinical trials in Australia.

“Sponsors are well aware of the quality of research from Australia however it seems from the survey that some key benefits including data acceptance, the rebate, and accelerated regulatory approval are still not widely known,” said Yvonne Lungershausen.

“The clinical trial environment in Australia supports rapid regulatory approval and includes one of the most attractive rebates on clinical costs as part of the Australian Government’s clinical trial attraction incentive program.”

Avance Clinical has recently won the BDO Excellence in Business Award 2021 for rapid managed growth and attracting and nurturing experienced staff in a competitive global environment. The mid-sized CRO has a reputation for going beyond the industry standard time and support for Sponsors and providing staff the training and resources needed to deliver excellence in clinical research management.

June 6, 2021
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Avance Clinical Releases Industry Survey Results at BIO Korea 2021 – Data Quality the Top Criteria for Selecting a CRO

By Company News, Conference NewsNo Comments

The leading Australian CRO for biotechs and Frost & Sullivan Asia-Pacific CRO Market Leadership Award recipient Avance Clinical shared results of a recent industry survey conducted by the company that found data quality to be the most important criteria for selecting a CRO for Phase ll studies in Australia.

Results from the survey found 63.64% of respondents selected data quality as the Key operational consideration when planning Phase II, followed by access to patients, then CRO therapeutic area expertise, cost, and access to KOLs.

Avance Clinical is attending BIO Korea 2021 virtually and is available via the Partnering platform to discuss the benefits of conducting trials in Australia. Avance Clinical has extensive experience in conducting trials in oncology, CNS, cardiovascular, infectious diseases and dermatology.

Avance Clinical CEO, Yvonne Lungershausen, said South Korea is recognised globally for its thriving biotech sector and the CRO is keen to connect with companies wanting regional alternatives for their clinical development.

“As Australia’s CRO for biotechs, we are seeing an increasing number of South Korean biotechs selecting Australia to accelerate their Phase I and II trials,” she said.

“The high-quality of our data for FDA and other regulatory authority approvals is a key factor in the decision-making process.”

The clinical trial environment in Australia supports rapid startup and a rebate of more than 40% on clinical costs as part of the Australian Government’s clinical trial attraction incentive program.

In addition, Avance Clinical is accredited by the Office of the Gene Technology Regulator (OGTR) so it can manage gene technology trials in Australia.

This accreditation recognizes that Avance Clinical has the CRO resources and internal processes in place to effectively manage pre-clinical and clinical trials for products involving genetically modified organisms (GMOs).

May 29, 2021
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Avance Clinical Wins Excellence in Business Award 2021

By Company Awards, Company NewsNo Comments

The leading Australian CRO for biotechs and Frost & Sullivan Asia-Pacific CRO Market Leadership Award recipient Avance Clinical has won the Fast Movers SA Excellence in Business Award 2021 sponsored by international accounting and business advisory firm BDO.

According to BDO the Fast Movers SA Excellence in Business Award, recognises a company that has achieved exceptional and sustained growth year on year, and demonstrates innovative strategies and market leadership, as shown by leading CRO Avance Clinical.

“BDO is proud to be involved with an awards program that recognises South Australia’s fastest growing, most innovative and arguably smartest businesses. Avance Clinical CEO Yvonne Lungershausen and her team focus on providing quality services while maintaining a global perspective but also a local South Australian focus – particularly as an employer of choice, making them a worthy winner of this award,” says Rudy Pieck, Managing Partner, BDO South Australia.

Avance Clinical CEO Yvonne Lungershausen, said

“As the Australian CRO for biotechs we are very pleased to be recognised for our business excellence,” she said.

“The Fast Movers Excellence in Business Award is recognition of the quality work conducted by Avance Clinical, and how we manage our growth trajectory as we continue to attract biotechs from around the world for clinical research services.

It really is all about our staff and how we support and nurture them with a team environment, training, and career progression and, most importantly, the time and resources to deliver the very best for our clients.

Australia is highly regarded around the globe for quality clinical research, rapid start-up, and the world’s most attractive rebate of 43.5% on clinical trial spend.

Biotechs from the US, Asia and EU are discovering the enormous benefits of conducting their clinical research in Australia and, perhaps most importantly, that our clinical data is accepted by all the major international regulatory authorities.”

 

May 21, 2021
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Avance Clinical Expands Gene Technology Clinical Trial Services to Meet $17.4 billion Market Demand

By Company Awards, Company NewsNo Comments

The leading Australian CRO for biotechs and Frost & Sullivan Asia-Pacific CRO Market Leadership Award winner, Avance Clinical, has expanded its gene technology clinical trial services to meet the increasing global demand predicted to reach $17.4 billion by 2023.

Avance Clinical is accredited as a gene technology CRO under the Office of the Gene Technology Regulator (OGTR).

This accreditation recognizes that Avance Clinical has the CRO resources and internal processes in place to effectively manage pre-clinical and clinical trials for products involving genetically modified organisms (GMOs).

In Australia, dealings with GMOs in clinical research requires authorisation under the Gene Technology Act 2000. The OGTR administers the Gene Technology Act 2000, and has specific responsibility to protect the health and safety of people, and to protect the environment, by identifying risks posed by or as a result of gene technology, and by managing those risks through regulating dealings with GMOs.

The global market for genetic modification therapies is expected to grow from $2.3 billion in 2018 to reach $17.4 billion by 2023, growing at a compound annual growth rate of 49.9% (BCC Research, 2018). The utilization of gene modification technologies used in COVID-19 vaccine products is likely to translate in further growth in this field of therapeutics.

Avance Clinical CEO Yvonne Lungershausen, said OGTR accreditation is important for our international clients. “Our clients need to know that their CRO has all the necessary credentials and is capable of delivering the highest of clinical research standards in this exciting and rapidly evolving sector,” she said.

Avance Clinical currently has a number of GMO studies underway and is expanding its services further to accommodate increasing global demand.

May 6, 2021
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Avance Clinical Invited to Present “Decentralized Trials – No Going Back” for Oracle Health Sciences Connect

By Company News, Partner NewsNo Comments

The leading Australian CRO for biotechs and Frost & Sullivan Asia-Pacific CRO Market Leadership Award winner Avance Clinical has been invited to present on the future of decentralized clinical trials at the Oracle Health Sciences Connect conference.

Title: Decentralized Trials – No Going Back

Time: 23 April, 2021 – 3.05 pm (Australia/Adelaide ACST).

Avance Clinical CEO Yvonne Lungershausen, shared the company’s insights on the future of Decentralized Clinical Trials (DCTs) and the technology and patient factors that will determine success.

Avance Clinical uses the full range of eClincial technologies to support clients wanting DCTs or a site-based approach while still leveraging advance technology including ePro, eSource  and eConsent.

“DCTs are fast becoming the new norm and this is an incredible opportunity for the drug development sector as well as the diverse and remote patient populations that will now have access to clinical trials,” said Lungershausen.

“The pandemic has been the catalyst in speeding up the adoption of decentralised clinical trial methods, as people stopped participating in trials and visiting clinics. Trials have stalled putting lives and significant investments at risk.”

Yvonne Lungershausen said there are considerable benefits to DCT’s including:

  • Reduce the scheduling and travel burden on patients – providing care from the comfort of the patient’s home.
    • Connecting patients to trials on a global scale – patients that were otherwise inaccessible under more traditional trial protocols are now available

And she said challenges include:

  • Missed human-to-human contact and continuity of patient care
    • Investigational product distribution to more remote destinations
    • Oversight of compliance and study procedures in the patient’s home

The presentation also covers advances in artificial intelligence (AI), machine learning, cloud computing and blood self-collection devices which are all revolutionising the decentralized clinical trial process.

  • Wearable devices are demonstrating enormous potential whether worn as a wrist strap or as an adhesive patch on the body.  AI-embedded capabilities allow these devices to measure a patient’s heart rate or metabolism remotely. Linked to the cloud through secure networks, clinicians can receive and analyse the data in real time.
  • Video calling and electronic reminders, can improve patient compliance in trials – prompting participants to take their medication at the right time or to record in their electronic diary development.
  • Technologies are developing to allow patient centric sampling (self-collection of specimens) with devices that require either the use of a lancet and a finger prick whereas others do not, making clinical trials even more convenient.
April 22, 2021
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Avance Clinical Client Atossa Therapeutics Announces Final Results from Phase 1 Clinical Study Showing Safety and Tolerability of AT-301 Nasal Spray Being Developed for COVID-19

By Client NewsNo Comments

The leading Australian CRO for biotechs and Frost & Sullivan Asia-Pacific CRO Market Leadership Award winner Avance Clinical congratulated Atossa Therapeutics on the announcement of their Phase 1 final results for the AT-301 nasal spray being developed for COVID-19.

Atossa Therapeutics, Inc. (Nasdaq: ATOS) is a clinical-stage biopharmaceutical company seeking to discover and develop innovative medicines in areas of significant unmet medical need with a current focus on breast cancer and COVID-19.

Yvonne Lungershausen, CEO, Avance Clinical said:

“As the CRO for this important study, we congratulate Atossa Therapeutics on these impressive safety and tolerability clinical results. Atossa Therapeutics have tapped the full scope of our CRO services including ClinicReady, our scientific and medical affairs specialist team. Australian clinical trials are recognized globally for their speed and accuracy and the fact that the clinical data is accepted by all major regulatory authorities including the FDA. Increasingly our clients are also tapping the generous 43.5% Australian Government rebate to support their clinical research.”

According to Atossa Therapeutics:

Atossa Therapeutics today announced final results from its Phase 1 double-blinded, randomized, placebo-controlled clinical study using Atossa’s proprietary drug candidate AT-301 administered by nasal spray. AT-301 was considered to be safe and well-tolerated in healthy male and female participants in this study at two different dose levels over 14 days. AT-301 is being developed for at home use for patients recently diagnosed with COVID-19. There are currently no FDA-approved therapies to treat COVID-19 at home.

Final analysis of the data from the study indicates that there were no serious adverse events, no discontinuations, no bronchospasms, and only one subject of the 32 subjects in the study experienced adverse events that were considered moderate in severity and all other adverse events were considered mild.

Atossa’s assessment is that AT-301 nasal spray was safe and well-tolerated in this study. The most common treatment-related adverse events observed with AT-301 treatment with either single or multiple doses were nasal discomfort and sneezing.

“The results from this study are very encouraging and we look forward to quickly commencing the next study of AT-301,” commented Steven Quay, M.D., Ph.D., Atossa’s President and CEO.

Atossa believes that AT-301 nasal spray will play an important role alongside the traditional vaccines now being deployed, particularly as it becomes clear that it will take months or years for vaccines to be administered around the world.

The Phase 1 study was a double-blinded, randomized, and placebo-controlled safety study of AT-301 nasal spray in 32 healthy adult subjects who were divided into two study groups.

Part A consists of two single-dose cohorts receiving either active therapy, AT-301B, or the placebo comparator AT-301A at two different doses. Part B was a multiple dose arm with cohorts receiving either AT-301A or AT-301B for 14 days at two different doses.

The primary objectives of the study were to evaluate the safety and tolerability of single and multiple doses of AT-301 administered via nasal instillation to healthy volunteers. Secondary objectives were to assess the incidence and severity of local irritation and bronchospasm following administration of AT-301 via nasal instillation.

The study was being conducted in Australia

See full announcement here

ABOUT ATOSSA THERAPEUTICS

Atossa Therapeutics, Inc. is a clinical-stage biopharmaceutical company seeking to discover and develop innovative medicines in areas of significant unmet medical need with a current focus on breast cancer and COVID-19. For more information, please visit www.atossatherapeutics.com.

 

March 14, 2021
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Avance Clinical Joins Industry Leaders at Conference Discussing The Future of Medicinal Cannabis

By Other newsNo Comments

Australian CRO Avance Clinical Chief Scientific Officer joins industry leaders and Federal Health Minister Greg Hunt today at a conference discussing research opportunities in the fast-growing medicinal cannabis therapeutics sector held in Melbourne. https://www.acannabis.com.au/

The conference is the ideal forum to share a deep understanding of the latest research and global trends regarding the clinical applications of medicinal cannabis.

Conference topics include:

  • The current research activities and clinical trials involving medicinal cannabis
  • Patient and doctor opportunities and barriers relating to the use of medicinal cannabis
  • Discussion of the challenges and solutions in regard to access and education relating to medicinal cannabis

Medicinal cannabis is prescribed to relieve the symptoms of medical conditions, such as epilepsy. For some patients suffering chronic or terminal illnesses, conventional medicines are not effective, or are not as effective as medicinal cannabis. Furthermore, for some patients, conventional medicines may cause side effects that cannabis can help to relieve.

In 2017, Australia joined 20 other countries who have legalised cannabis for medical use and in 2019, it legalised medicinal cannabis exports, priming it to become a significant player in the global cannabis market.

Avance Clinical Chief Scientific Officer, Gabriel Kremmidiotis,said the conference offered new opportunities for collaborations as part of the global push for research and therapies.

“The global medicinal cannabis market is poised to explode in value, with an estimated projected worth of $55 billion by 2025. Avance Clinical recognises this as a fast growing space of clinical research and development activity where it can support development of new products through its range of clinical CRO services.”

Avance Clinical CEO Yvonne Lungershausensaid “biotechs around the globe recognise the value of conducting their trials in Australia given the local support of scientific and research excellence, Australia’s advanced healthcare, and the opportunity to access patients in a less clinical trial competitive environment.”

Avance Clinical offers 20-years of experience in the CRO sector with most biotech clients coming from the US and, increasingly, the EU and Asia.”

“Perhaps the biggest drivers are that Australia offers the world’s most competitive R&D rebate grant of 41% on clinical trial spend, and that the regulatory environment affords for faster clinical trial approval timeframes compared to other countries.” Ms Lungershausen said.

March 2, 2021
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