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Avance Clinical Featured in Endpoints News on Cell & Gene Therapy Capabilities

By Company NewsNo Comments

The cell and gene therapies (CGT) sector offers unprecedented opportunities for patient disease management across virtually all therapeutic areas. However, finding the right accredited clinical teams to take a therapy through to the clinic and manage the regulatory process can be a major challenge for biotechs with a CGT product.

According to a recent Global Data and the Alliance for Regenerative Medicine (ARM) report the sector raised a record $14bn in H1 2021, compared to $19.9bn for all of 2020.

The report also highlights that 2021 is on track to have the highest number of regulatory approvals of gene therapy and gene-modified cell therapy products, with Europe at risk of falling behind the US and Asia in terms of number of developers and new clinical trials.

Avance Clinical Awarded Frost & Sullivan 2021 Asia-Pacific CRO Best Practices Award for Customer Value Leadership

By Company Awards, Company NewsNo Comments

Avance Clinical, the largest premium Australian CRO for international biotechs, has been awarded the prestigious Frost & Sullivan 2021 Asia-Pacific CRO Customer Value Leadership Award, the second consecutive Asia-Pacific (APAC) CRO Best Practices Award for the company from Frost & Sullivan.

Avance Clinical is an Australian owned Contract Research Organisation (CRO) that has been providing high-quality clinical research services fit for global regulatory standards to the local and international drug development industry for 24 years.

Frost & Sullivan says the Asia-Pacific’s CRO market value, currently at $6.01 billion, is estimated to reach nearly $11.04 billion in 2026, growing at a compound annual rate of 12.2%.

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Avance Clinical Congratulates Client Tetherex Pharmaceuticals on Initiation of Dosing in a Phase 1 Clinical Study Using a Novel Single-Cycle Adenovirus Vaccine Strategy in Australia

By Client News, Company NewsNo Comments

The largest Australian full-service CRO for international biotechs and Frost & Sullivan Asia-Pacific CRO Market Leadership Award winner Avance Clinical today congratulated client Tetherex Pharmaceuticals on first patient dosing for its Phase 1 vaccine clinical trial.

Tetherex Pharmaceuticals, Inc. is a privately held, clinical stage biopharmaceutical company focused on development of selectin inhibitor therapeutics for the treatment of a broad range of inflammatory diseases and single-cycle adenovirus vaccines for multiple infectious diseases and cancer indications.

Avance Clinical Chief Scientific Officer Dr Gabriel Kremmidiotis said:

“The exciting aspect of the Tetherex product is the potential to vaccinate using a nasal spray. Administering the vaccine via the same route that the virus uses to get into our bodies, may result in more effective protection compared to the first generation Covid-19 vaccine products currently being administered as injectables. Commencement of dosing with the Tetherex Covid-19 vaccine product constitutes a major achievement for the Avance Clinical team who played a key role in supporting Tetherex in gaining regulatory approval to conduct the First-in-Human trial with their exciting vaccine candidate.”

According to Tetherex Pharmaceutical’s announcement:

Tetherex Pharmaceuticals has executed an exclusive worldwide license with Mayo Clinic for the development and commercialization of a novel single-cycle adenovirus vaccine platform. The platform will be used to target multiple infectious diseases, beginning with a Phase 1 clinical study investigating a vaccine for COVID-19. Dosing of the initial cohort of the Phase 1 study is underway in Australia.

“Current adenovirus vaccines under investigation for COVID-19 and other infectious diseases are highly restricted in the amount of vaccine antigen they can deliver to cells,” said Dr. Russell Rother, President and Chief Operating Officer of Tetherex. “The single-cycle adenovirus platform allows one round of robust vaccine antigen expression to occur without the generation of infectious virus particles which, in preclinical models, translates to a marked improvement in the ensuing immune response.”

About the Single Cycle Adenovirus Vaccine Platform

The single-cycle adenovirus platform was developed to enhance the expression of target antigens, amplifying immune responses to infectious disease targets. Preclinical studies have demonstrated that the single-cycle adenovirus can increase target antigen expression up to 100-fold over currently utilized replication defective adenovirus vaccines. Intranasal administration of single-cycle vaccine elicits both systemic and mucosal immune responses. A mucosal response allows the immune system to encounter respiratory viruses like SARS-CoV-2 at the site of entry while the viral titers are lower. The platform also provides a robust manufacturing and supply chain paradigm relative to other vaccine platforms, such as mRNA.

Tetherex’s Phase 1 open label study, designed to assess safety, reactogenicity and immunogenicity of the single-cycle adenovirus vaccine, is expected to recruit a total of approximately 80 healthy volunteers and includes both a single ascending dose group and a multiple dose group. Subjects will receive the vaccine via either intramuscular or intranasal administration.

The study site is Nucleus Network in Brisbane, and Dr Paul Griffin Nucleus Network’s Principal Investigator said:

“The covid 19 global pandemic continues to impact lives around the world. We are very fortunate to have developed a number of vaccines for Covid-19 already that are safe and highly effective. These vaccines are beginning to give us the capacity to start to reduce the impact of this viral infection, however it’s clear there are certain properties of these vaccines that we would ideally like to improve upon such as having a vaccine that could be given via a route other than needle and syringe and perhaps a vaccine that could further reduce the ability for a vaccinated individual to become infected in the first place, a so called transmission blocking vaccine. A vaccine given intranasally has the potential to achieve some of these objects hence I am very excited to be the principal Investigator on the Tetherex clinical trial.”

“The addition of this novel vaccine platform to the Tetherex portfolio significantly expands our ability to leverage our scientific and clinical development expertise and broadens our overall technology base. This reduces risk to our investors while providing the potential of significant upside,” said Dr. Scott Rollins, Chairman and Chief Executive Officer of Tetherex. “The platform will be utilized to target multiple infectious diseases which allows Tetherex to seek partnerships and alliances for the ever-expanding infectious disease marketplace.”

Avance Clinical Announces Appointment of Asia Biotech Specialist to Support APAC Growth

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The leading Australian CRO for international biotechs and Frost & Sullivan Asia-Pacific CRO Market Leadership Award recipient Avance Clinical today announced the appointment of APAC expert Andy Hu as Business Development Manager APAC to support increasing biotech clinical trial demand from the region.

Andy Hu, formerly with international biopharma data firm Informa Pharma Intelligence, will head-up the business development program in APAC for Avance Clinical.

Andy Hu said the main drivers for Asian biotechs looking to Australia is speed, data quality and access to international regulatory authorities.

“They select Avance Clinical in Australia because the CROs’ data is accepted by the FDA, and it gives them a rapid pathway for international licensing, investment and ultimately drug approvals,” he said.

“I wanted to work with Avance Clinical because it’s a mid-sized CRO that offers deep therapeutic experience, expedited timelines, and exceptional support to APAC biotech clients.”

Avance Clinical has grown significantly over the past two years with an increasing number of clients coming from APAC to conduct their trials in Australia.

Chief Strategy Officer Ben Edwards said the appointment of Andy Hu, will further support our growth and strengthen relationships with our clients in the region.

“Andy Hu is multilingual, being fluent in English, Mandarin and Korean, and has completed both a Bachelor of Korean Language and Culture as well as a Master of Translation and Interpreting. He will be responsible for developing business across the APAC region to better serve our clients operating in the region,” he said.

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 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 time and support for Sponsors, and for providing staff the training and resources needed to deliver excellence in clinical research management.

About Avance Clinical
Avance Clinical is the largest specialist Australian CRO delivering quality clinical trials in Australia and New Zealand for international biotechs.

Avance Clinical has been delivering CRO services in the region for the past 24 years.

Our clients are international biotechs in their early phases of drug development that need fast, agile, and adaptive solution-oriented clinical research services.

Avance Clinical delivers customised solutions designed around specific client needs rather than a one size fits all approach.

As a company we have focussed on state-of-the-art technology and systems across all functional areas to provide our clients with the most effective processes. Medidata, Oracle, and Medrio are just some of our technology partners.

The collective pool of knowledge and experience at Avance Clinical continually grows through the careful selection of candidates who demonstrate passion and expertise in their chosen field.

Visit https://www.avancecro.com for more information.

Recent Awards:

Excellence in Business Award 2021

Frost & Sullivan Asia-Pacific CRO Market Leadership Award 2020

 

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

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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 https://www.avancecro.com for more information.

Recent Awards:

Excellence in Business Award 2021

Frost & Sullivan Asia-Pacific CRO Market Leadership Award 2020

 

TrialTrove Data Shows Australia is Open for Business says Avance Clinical at BIO Digital 2020

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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.

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.

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).

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.”