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Avance Clinical Sponsors China BioPharma Award at the Global Scrip Awards, London

By Other newsNo Comments

Adelaide, Australia/San Diego, USAAvance Clinical, the leading Australian-based biotech CRO with US operations will sponsor and present the China BioPharma Award at the global biotech Scrip Awards in London next month.

Avance Clinical congratulates the China BioPharma Award shortlisted companies:

  • Anticancer Bioscience
  • BeiGene China
  • Brii Biosciences
  • Clover Biopharmaceuticals
  • Everest Medicines

Avance Clinical CEO Yvonne Lungershausen will present the award at the official ceremony on 30 November 2022. Avance Clinical’s Global Head of Business Development Liahna Toy will also attend the event which brings together more than 400 biotech companies.

Discussing the China BioPharma Award Yvonne Lungershausen said:

“With more than 20% of our biotech clients coming from China, we are sponsoring this award to shine a global spotlight on the calibre of innovation we see first-hand from the region.

Many of Avance Clinical’s biotech China clients are planning FDA approval in North America. Working with Avance Clinical, our clients execute on that strategy by starting their drug development program in Australia and pivoting to North America for greater site and patient access in later phase trials. These clients are already benefiting from Avance Clinical’s recent expansion into North America and the new GlobalReady service which enables them to work seamlessly with our data and project teams across all phases and regions.

Avance Clinical’s Australian operations offers clients the opportunity to maximise on significant rebates of up to 43.5%, expedited approvals, and world-class trial data for their early phase clinical development. Our GlobalReady service supports biotechs’ progress through later phases in North America for FDA approvals.

We have shown, with our high growth and industry-leading repeat business rates that our focus on gold-standard technology paired with solution-orientated clinical experts is the mix our biopharma clients need for clinical success.”

Now in its 18th year, the Scrip Awards brings together industry leaders to celebrate and recognise the very best innovations and achievements in global biopharma. Winners will be celebrated across 15 categories.

Avance Clinical is the leading Australian-based biotech CRO with US operations providing global regulatory standard clinical research services across all phases for the international biopharma industry.

The company has a global reputation for agile clinical solutions to support accelerated clinical development for international biotech clients.

Avance Clinical is also accredited as a gene technology CRO under the Office of the Gene Technology Regulator (OGTR) for vaccines and GMO therapies clinical trials.

Avance Clinical has been recognised for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award.

Find out more:

About Avance Clinical

Avance Clinical is the largest premium full-service Australian and US CRO delivering quality clinical trials, with globally accepted data, in Australia, New Zealand and the US for international biotechs. The company’s clients are biotechs in their early phases of drug development that need fast, agile, and adaptive solution-oriented clinical research services.

Frost & Sullivan Awards

Avance Clinical, a Frost & Sullivan Asia-Pacific CRO Market Leadership Award recipient for the past two years, has been providing CRO services in the region for more than 24 years.

Pre-clinical through to Phase 1 and 2

Avance Clinical offers pre-clinical services with their experienced ClinicReady team right through to Phase 1 and 2 clinical services leveraging significant Government incentive rebates of up to 43.5% and rapid start-up regulatory processes.

With experience across more than 110 indications, the CRO can deliver world-class results and high-quality internationally accepted data for FDA and EMA review.

Technology

Avance Clinical uses state-of-the-art technology and gold standard systems across all functional areas to provide clients with the most effective processes. Medidata, Oracle, IBM Watson and Medrio are just some of the technology partners.

Avance Clinical Wins International Health Award for Biotech CRO Services

By Company AwardsNo Comments

Australia – Avance Clinical, the leading Australian-based biotech CRO with US operations has won the South Australian Premier’s Export Awards – International Health category. The award recognises excellence in clinical services exports.

The Premier of South Australia Peter Malinauskas, and Minister for Trade and Investment Nick Champion, presented the Premier’s Export Awards to Avance Clinical CEO Yvonne Lungershausen at the awards industry event today.

This follows Avance Clinical’s selection as finalist for the Informa Pharma Intelligence Awards 2022 Best Contract Research Organization in APAC.

Avance Clinical, which is backed by global private equity firm The Riverside Company, recently acquired a leading CRO in North America to expand services and offer their biotech clients US sites for later phase studies.

CEO Yvonne Lungershausen said Avance Clinical is now the leading Australian-based biotech CRO with US operations.

“We are honoured to be selected for the award. We are a major employer with more than 220 staff and we bring significant biotech clinical research business into South Australia and Australia.

Clinical research is a high-value export that keeps our medical, research, and biopharma sectors at the forefront of international knowledge and innovation.

The majority of our clients are from North America, the EU, and Asia so we really are an internationally-focused organisation.

Avance Clinical has a global reputation for agile clinical solutions to support accelerated clinical development for our international biotech clients and we are very proud of our growth and success in recent years.”

The company provides global regulatory standard clinical research services across all phases to the international biopharma industry.

Avance Clinical is also accredited as a gene technology CRO under the Office of the Gene Technology Regulator (OGTR) for vaccines and GMO therapies clinical trials.

“We have shown, with our high growth and industry-leading repeat business rates that our focus on gold standard technology paired with solution-orientated clinical experts is the mix our biopharma clients require in this fast-moving, competitive and high-stakes sector,” said Lungershausen.

Avance Clinical has been recognised for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award.

Find out more:

About Avance Clinical

Avance Clinical is the largest premium full-service Australian CRO delivering quality clinical trials, with globally accepted data, in Australia and New Zealand for international biotechs. The company’s clients are biotechs in their early phases of drug development that need fast, agile, and adaptive solution-oriented clinical research services.

Frost & Sullivan Awards

Avance Clinical, a Frost & Sullivan Asia-Pacific CRO Market Leadership Award recipient for the past two years, has been providing CRO services in the region for more than 24 years.

Pre-clinical through to Phase 1 and 2

Avance Clinical offers pre-clinical services with their experienced ClinicReady team right through to Phase 1 and 2 clinical services leveraging significant Government incentive rebates of up to 43.5% and rapid start-up regulatory processes.

With experience across more than 110 indications, the CRO can deliver world-class results and high-quality internationally accepted data for FDA and EMA review.

Technology

Avance Clinical uses state-of-the-art technology and gold standard systems across all functional areas to provide clients with the most effective processes. Medidata, Oracle, IBM Watson and Medrio are just some of the technology partners.

AVANCE CLINICAL ANNOUNCES NORTH AMERICAN CRO ACQUISITION TO EXPAND LATER PHASE SERVICES FOR BIOTECHS

By Company NewsNo Comments

Sydney, Australia/San Diego, USA – Avance Clinical, the Australian CRO for biotechs, has expanded into North America with the acquisition of CRO partner company C3 Research Associates to enable biotech clients a seamless journey from early phase to later phase studies. Avance Clinical has backing from private equity group Riverside Company for their global expansion program.

Avance Clinical is the largest and most established full-service Australian and New Zealand CRO with a proven track-record of data acceptance by the FDA and all other major regulatory bodies.

The combined Avance Clinical Australia, New Zealand, and North American operations deliver a unique GlobalReady drug development model for biotechs.

Avance Clinical’s CEO Yvonne Lungershausen said:

“Avance Clinical has been working with C3 Research Associates in recent years and they share a similar culture and focus on customer service and clinical excellence. This strong relationship made C3 Research Associates a natural acquisition choice for Avance Clinical’s expansion plans into North America. The due diligence process has taken more than 6 months and we are excited to now welcome our US team and offer the GlobalReady model for our clients.

This acquisition gives our biotech clients conducting their early phase studies in Australia and New Zealand a seamless journey into the US to continue their clinical development programs, retaining the same high-quality CRO, which reduces time and cost and delivers quality FDA accepted data. This GlobalReady model is designed to extend biotechs’ investments so they can achieve greater clinical development milestones with reduced spend, all with the assurance of FDA accepted data.

In addition, the attractive 43.5% rebate on clinical spend in Australia, offers our clients the opportunity to utilize our North American operations expertise and team, whilst maintaining services in Australia to maximise their rebate potential.

We often point to the fact that there are currently more than 280 Phase III global trials that have conducted their Phase I study in Australia, which again demonstrates Australian data acceptability with the FDA and other major regulatory authorities.

We will be making significant investments in our US operations including growing the team to more than 120 people and leveraging their deep industry experience across a broad range of therapeutic areas, in particular oncology.

Clients can be assured the world-class best practice technologies, systems and processes will be integrated across all regions.”

This seamless GlobalReady journey is designed for success whereby biotechs can:

  • Take advantage of the Australian early phase clinical trial landscape (No IND and 43.5% tax rebate)                   
  • Transition or expand into North America for later phases – without changing CROs (retain study knowledge and processes/team)
  • Seamlessly operationalise global dose-escalation and dose-expansion trials across the two regions
  • Harness significant speed and cost advantages
  • Be assured of quality data – transferable and readily acceptable by the FDA and other regulatory authorities

The Avance Clinical team offers exceptional study approval and success rates which can be attributed to its deep scientific expertise, advanced data technologies, knowledge of the Australian, New Zealand and North American regulatory environment, and its extensive relationships with sites and KOLs.

The company is also accredited as a gene technology CRO under the Office of the Gene Technology Regulator (OGTR) which allows it to manage pre-clinical and clinical trials for vaccines and GMO therapies.

Avance Clinical has achieved high growth and industry-leading repeat business rates with its focus on gold standard technology paired with solution-orientated clinical experts. This is the mix that biopharma clients clearly require in this fast-moving, competitive and high-stakes sector.

Avance Clinical has been recognised for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award.

Learn about the Australian Advantage here https://www.avancecro.com/the-australian-advantage/

Meet the North American leadership team here https://www.avancecro.com/avance-clinical-north-america-operations/

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

About Avance Clinical

Avance Clinical is the largest premium full-service Australian CRO with operations across Australia, New Zealand and North America delivering quality clinical trials with globally accepted data for international biotechs. The company’s clients are biotechs in their early phases of drug development that need fast, agile, and adaptive solution-oriented clinical research services.

Frost & Sullivan Awards

Avance Clinical, a Frost & Sullivan Asia-Pacific CRO Market Leadership Award recipient for the past two years, has been providing CRO services in the region for 24 years.

Pre-clinical through to Later Phase

Avance Clinical offers pre-clinical services with their experienced ClinicReady team right through to later phase clinical services leveraging significant Government incentive rebates of up to 43.5% and rapid start-up regulatory processes.

With experience across more than 110 indications, the CRO can deliver world-class results and high-quality internationally accepted data for FDA and EMA review.

Technology

Avance Clinical uses state-of-the-art technology and gold standard systems across all functional areas to provide clients with the most effective processes. Medidata, Oracle, IBM and Medrio are just some of the technology partners.

Avance Clinical MedTech Featured in Endpoints News – Most read article for the month

By In the NewsNo Comments

Innovative MedTech Demands Specialist Clinical Trial Regulatory Affairs and Design

As technology becomes increasingly ubiquitous in our lives, the demand for remote or home-based MedTech for real-time condition detection, monitoring or management presents vast market opportunities. This paradigm shift is precipitating the increased development of easy-to-use medical devices (including software as a medical device), for the diagnosis, treatment and management of lifestyle and chronic diseases.

Innovative MedTech covers everything from physical devices, artificial intelligence (AI) and machine learning and digital healthcare, including biosensors in wearables like a watch, to a skin patch, or ingested or implanted devices. It includes monitors that release medications, to more advanced products like implanted neurostimulators, through mobile phone apps that can diagnose a COVID cough or analyze speech to predict neurodegenerative diseases.

It can also include our everyday medical devices such as dentures, surgical equipment, 3D printing, robotic surgery, laser surgery, artificial organs, pacemakers, inhalers, and stents.

“The global medical devices market size has been valued at USD 488.98 billion in 2021 and is projected to grow to USD 718.92 billion by 2029.” Fortune Business Insights

Read more at Endpoints News

Avance Clinical Finalist for Informa Pharma Intelligence Awards 2022 – Best Contract Research Organization in APAC

By Company Awards, Company NewsNo Comments

Adelaide, Australia – Avance Clinical, the largest premium Australian Contract Research Organisation (CRO) for international biotechs, has been selected as a finalist for the Best Contract Research Organization in APAC by Informa Pharma Intelligence.

Avance Clinical has undergone significant expansion in recent years, including new offices in Sydney and Melbourne to accommodate the growing clinical team in Australia.

The award winner will be announced on 1 September 2022. The finalists are:

  • Avance Clinical
  • Calyx
  • CMIC Group
  • EPS
  • ICON
  • Parexel
  • Syneos Health

Avance Clinical’s CEO Yvonne Lungershausen said:

“Avance Clinical is extremely pleased to be selected as a finalist for this prestigious award. It is a credit to our amazing customer-focused team for delivering the CRO excellence that has been recognized by the Informa Pharma Intelligence award judges.

“Avance Clinical has a global reputation for agile clinical solutions to support accelerated clinical development for our international biotech clients. We are very proud of our growth and success in APAC in recent years.”

According to Informa Pharma Intelligence:

This Award is to recognize CROs that provide full or specialist services to their clients and which have an office in either in Japan or the Asia region including Australia.

Judging considers the quality of services and relationships built with clients and pays particular attention to the innovative patient recruitment strategies the CRO has brought to the table.

The award is based on achievements in the 2021 calendar year.

Core areas judged include:

  • The particular capabilities and strengths the CRO offers
  • How the company has delivered results that exceed sponsor expectations
  • Innovations in patient recruitment strategy has the CRO brought to its partner
  • How it has improved its performance, for example, in its quality of data, timelines and transparency
  • The steps the company is taking towards streamlining data collection and reporting

To find out more please visit: https://pharmaintelligence.informa.com/events/awards/japan-awards-2022/shortlist-2022

Avance Clinical recently secured a significant investment from global private equity firm, The Riverside Company (Riverside), to support further regional and global expansion.

The investment values the company in excess of $200m.

 “With the support of Riverside and its powerful global footprint and deep healthcare experience, Avance Clinical will execute on its regional and international expansion plans organically and via acquisitions,” said Lungershausen.

Avance Clinical is the Australian-owned CRO that provides global regulatory standard clinical research services across all phases to the local and international biopharma industry.

The company is also accredited as a gene technology CRO under the Office of the Gene Technology Regulator (OGTR) which has allowed it to expand into clinical trials for vaccines and GMO therapies.

“We have shown, with our high growth and industry-leading repeat business rates that our focus on gold standard technology paired with solution-orientated clinical experts is the mix our biopharma clients require in this fast-moving, competitive and high-stakes sector,” said Lungershausen.

Avance Clinical has been recognised for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award.

Find out more:

About Avance Clinical

Avance Clinical is the largest premium full-service Australian CRO delivering quality clinical trials, with globally accepted data, in Australia and New Zealand for international biotechs. The company’s clients are biotechs in their early phases of drug development that need fast, agile, and adaptive solution-oriented clinical research services.

Frost & Sullivan Awards

Avance Clinical, a Frost & Sullivan Asia-Pacific CRO Market Leadership Award recipient for the past two years, has been providing CRO services in the region for 24 years.

Pre-clinical through to Phase 1 and 2

Avance Clinical offers pre-clinical services with their experienced ClinicReady team right through to Phase 1 and 2 clinical services leveraging significant Government incentive rebates of up to 43.5% and rapid start-up regulatory processes.

With experience across more than 105 indications, the CRO can deliver world-class results and high-quality internationally accepted data for FDA and EMA review.

Technology

Avance Clinical uses state-of-the-art technology and gold standard systems across all functional areas to provide clients with the most effective processes. Medidata, Oracle, and Medrio are just some of the technology partners.

Avance Clinical Announces New Office Opening in Melbourne

By Company NewsNo Comments

Melbourne, Australia – Avance Clinical, the largest premium Australian Contract Research Organisation (CRO) for international biotechs, has opened new offices in Melbourne to support its growing clinical team in the greater Melbourne region.

The formal opening event was attended by all the Melbourne staff, as well the Avance Clinical executive team, and Board Members.

Avance Clinical’s CEO Yvonne Lungershausen said: “We continue to offer a hybrid working environment for our team however, they are increasingly wanting more in-office face-to-face time with colleagues and clients – while still having the flexibility of working remotely”.

“Avance is continuing to experience significant growth facilitating our expansion in the Melbourne CBD with new offices to accommodate our growing team,” she said.

Check for our latest positions open and join our Melbourne team here.

Avance Clinical recently secured a significant investment from global private equity firm, The Riverside Company (Riverside), to support further regional and global expansion. The investment values the company in excess of $200m.

 “With the support of Riverside and its powerful global footprint and deep healthcare experience, Avance Clinical will execute on its regional and international expansion plans organically and via acquisitions,” said Lungershausen.

Avance Clinical is the Australian-owned CRO that provides global regulatory standard clinical research services across all phases to the local and international biopharma industry.

The company is also accredited as a gene technology CRO under the Office of the Gene Technology Regulator (OGTR) which has allowed it to expand into clinical trials for vaccines and GMO therapies.

“We have shown, with our high growth and industry-leading repeat business rates that our focus on gold standard technology paired with solution-orientated clinical experts is the mix our biopharma clients require in this fast-moving, competitive and high-stakes sector,” said Lungershausen.

Avance Clinical has been recognised for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award.

Learn about the Australian Advantage here https://www.avancecro.com/the-australian-advantage/

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

About Avance Clinical

Avance Clinical is the largest premium full-service Australian CRO delivering quality clinical trials, with globally accepted data, in Australia and New Zealand for international biotechs. The company’s clients are biotechs in their early phases of drug development that need fast, agile, and adaptive solution-oriented clinical research services.

Frost & Sullivan awards

Avance Clinical, a Frost & Sullivan Asia-Pacific CRO Market Leadership Award recipient for the past two years, has been providing CRO services in the region for 24 years.

Pre-clinical through to Phase 1 and 2

Avance Clinical offers pre-clinical services with their experienced ClinicReady team right through to Phase 1 and 2 clinical services leveraging significant Government incentive rebates of up to 43.5% and rapid start-up regulatory processes.

With experience across more than 105 indications, the CRO can deliver world-class results and high-quality internationally accepted data for FDA and EMA review.

Technology

Avance Clinical uses state-of-the-art technology and gold standard systems across all functional areas to provide clients with the most effective processes. Medidata, Oracle, and Medrio are just some of the technology partners.

Media Contacts:

Avance Clinical

media@avancecro.com

Chris Thompson

Avance Clinical Announces Appointment of Liahna Toy as Head of Business Development

By Company NewsNo Comments

Avance Clinical, the largest full-service Australian Contract Research Organisation (CRO) for international biotechs, announced today the appointment of Liahna Toy to the new senior executive role, Head of Business Development.

Avance Clinical’s CEO Yvonne Lungershausen said: “We are extremely pleased to have Liahna join the team and we know our clients will benefit from her extensive experience and industry knowledge”.

“Avance is continuing to experience significant growth and Liahna is a valuable member of the team to support clients and the team as we expand our services,” she said.

Liahna has more than 11 years of industry experience working across local and global CROs in various proposal management and business development roles focused on attracting early phase trials into Australia and the Asia Pacific region.

As the Head of Business Development, Liahna will work closely with Avance Clinical’s business development and leadership teams to establish and maintain client relationships and strategic partnerships, providing clients with optimal solutions to execute their clinical development programs.

Liahna has completed her Master of Business Administration (MBA).

Check for our latest positions open

Avance Clinical recently secured a significant investment from global private equity firm, The Riverside Company (Riverside), to support further regional and global expansion. The investment values the company in excess of $200m.

 “With the support of Riverside and its powerful global footprint and deep healthcare experience, Avance Clinical will execute on its regional and international expansion plans organically and via acquisitions,” said Lungershausen.

Avance Clinical is the Australian-owned CRO that provides global regulatory standard clinical research services across all phases to the local and international biopharma industry.

The company is also accredited as a gene technology CRO under the Office of the Gene Technology Regulator (OGTR) which has allowed it to expand into clinical trials for vaccines and GMO therapies.

“We have shown, with our high growth and industry-leading repeat business rates that our focus on gold standard technology paired with solution-orientated clinical experts is the mix our biopharma clients require in this fast-moving, competitive and high-stakes sector,” said Lungershausen.

Avance Clinical has been recognised for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award.

Learn about the Australian Advantage here https://www.avancecro.com/the-australian-advantage/

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

About Avance Clinical

Avance Clinical is the largest premium full-service Australian CRO delivering quality clinical trials, with globally accepted data, in Australia and New Zealand for international biotechs. The company’s clients are biotechs in their early phases of drug development that need fast, agile, and adaptive solution-oriented clinical research services.

Frost & Sullivan awards

Avance Clinical, a Frost & Sullivan Asia-Pacific CRO Market Leadership Award recipient for the past two years, has been providing CRO services in the region for 24 years.

Pre-clinical through to Phase 1 and 2

Avance Clinical offers pre-clinical services with their experienced ClinicReady team right through to Phase 1 and 2 clinical services leveraging significant Government incentive rebates of up to 43.5% and rapid start-up regulatory processes.

With experience across more than 105 indications, the CRO can deliver world-class results and high-quality internationally accepted data for FDA and EMA review.

Technology

Avance Clinical uses state-of-the-art technology and gold standard systems across all functional areas to provide clients with the most effective processes. Medidata, Oracle, and Medrio are just some of the technology partners.

Media Contacts:

Avance Clinical

media@avancecro.com

Chris Thompson

Avance Clinical Announces New Office Opening in Sydney

By Company News, We are hiringNo Comments

Sydney, Australia – Avance Clinical, the largest premium Australian Contract Research Organisation (CRO) for international biotechs, has opened new offices in Sydney to support its growing clinical team in the greater Sydney region.

Avance Clinical’s CEO Yvonne Lungershausen said: “We continue to offer a hybrid working environment for our team however, they are increasingly wanting more in-office face-to-face time with colleagues and clients – while still having the flexibility of working remotely.

“Avance is continuing to experience significant growth facilitating our expansion into North Sydney with new offices to accommodate our growing team,” she said.

Check for our latest positions open and join our Sydney team here.

Avance Clinical recently secured a significant investment from global private equity firm, The Riverside Company (Riverside), to support further regional and global expansion. The investment values the company in excess of $200m.

 “With the support of Riverside and its powerful global footprint and deep healthcare experience, Avance Clinical will execute on its regional and international expansion plans organically and via acquisitions,” said Lungershausen.

Avance Clinical is the Australian-owned CRO that provides global regulatory standard clinical research services across all phases to the local and international biopharma industry.

The company is also accredited as a gene technology CRO under the Office of the Gene Technology Regulator (OGTR) which has allowed it to expand into clinical trials for vaccines and GMO therapies.

“We have shown, with our high growth and industry-leading repeat business rates that our focus on gold standard technology paired with solution-orientated clinical experts is the mix our biopharma clients require in this fast-moving, competitive and high-stakes sector,” said Lungershausen.

Avance Clinical has been recognised for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award.

Learn about the Australian Advantage here https://www.avancecro.com/the-australian-advantage/

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

About Avance Clinical

Avance Clinical is the largest premium full-service Australian CRO delivering quality clinical trials, with globally accepted data, in Australia and New Zealand for international biotechs. The company’s clients are biotechs in their early phases of drug development that need fast, agile, and adaptive solution-oriented clinical research services.

Frost & Sullivan awards

Avance Clinical, a Frost & Sullivan Asia-Pacific CRO Market Leadership Award recipient for the past two years, has been providing CRO services in the region for 24 years.

Pre-clinical through to Phase 1 and 2

Avance Clinical offers pre-clinical services with their experienced ClinicReady team right through to Phase 1 and 2 clinical services leveraging significant Government incentive rebates of up to 43.5% and rapid start-up regulatory processes.

With experience across more than 105 indications, the CRO can deliver world-class results and high-quality internationally accepted data for FDA and EMA review.

Technology

Avance Clinical uses state-of-the-art technology and gold standard systems across all functional areas to provide clients with the most effective processes. Medidata, Oracle, and Medrio are just some of the technology partners.

Media Contacts:

Avance Clinical

media@avancecro.com

Chris Thompson

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 Client News: XWPharma Initiates First-in-Human Studies of XW10508, in Development for Fast-acting Relief of Treatment-Resistant Depression and Chronic Pain

By Client NewsNo Comments

Avance Clinical, the largest premium Australian CRO for international biotechs, is pleased to share the news that its client XWPharma Ltd. has announced dosing of subjects in its first-in-human study evaluating XW10508, the Company’s novel, patented, glutamatergic NMDA antagonist and AMPA activator in development as an oral, once-daily therapy for the treatment of treatment-resistant depression and chronic pain.

Read More

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%.

Read More

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 Client XWPharma Announces Positive Results from Phase 1 Clinical Trials of XW10172, in Development as Once-Nightly Therapy for Sleep Disorders in Patients with Neurodegenerative Diseases

By Client NewsNo Comments

The leading Australian CRO for international biotechs and Frost & Sullivan 2020 Asia-Pacific CRO Market Leadership Award winner Avance Clinical today congratulated client XWPharma on receiving positive results from its Phase 1 clinical trial of XW10172.

XWPharma is a biopharmaceutical company dedicated to the discovery and development of novel therapeutics, utilizing its proprietary platform chemistry. XWPharma’s expertise in drug design is focused on providing potential first- and best-in-class medicines with differentiated features to address the unmet medical needs of patients suffering from debilitating neurological diseases.

Avance Clinical Chief Scientific Officer Dr Gabriel Kremmidiotis said:

“We are very pleased with the positive results announced by XWBiolabs on their product XW10172. Our team has been responsible for the trial management, monitoring, biometrics and medical writing elements of this trial. These results provide further validation of Avance’s strong reputation and deep expertise in executing early phase clinical trials which include pharmacokinetic endpoints as part of the trial’s main objectives.”

According to XWPharma:

XWPharma Ltd. today announced that XW10172, an internally discovered, novel, patented conjugate of the GABAB agonist oxybate, demonstrated in Phase 1 clinical trials multiple features that support development for treatment for various sleep disorders. The results of these studies were presented by Daniel Canafax, PharmD, Chief Medical Officer of the company, in a podium presentation at virtual SLEEP 2021, the annual meeting of the Associated Professional Sleep Societies.

“We are excited to have this opportunity at the SLEEP 2021 meeting to share promising clinical data from our lead drug candidate, XW10172,” said Leonard Blum, XWPharma’s President and CEO. “We are extremely encouraged by these Phase 1 results, which support XW10172 as an innovative treatment to address the debilitating symptoms and underlying fragmented sleep architecture seen in patients with sleep disorders that are common across many CNS disease states. In addition, we believe these results reflect the strength of our expertise in novel chemistry, neurobiology, and development that enable the creation of drugs that are uniquely fit for purpose and will make a difference in patients’ lives.”

“For patients with a variety of sleep disorders, these results establish desired drug properties, including a favorable safety profile and optimal pharmacokinetics suitable for once-nightly dosing of XW10172,” said Dr. Canafax. “Based on these data, we believe the drug offers potential as treatment in sleep disorders in patients with Parkinson’s disease and patients with other neurodegenerative diseases, for which no drugs are currently indicated despite the high unmet medical need. Additionally, once-nightly dosing and the absence of sodium are features that support XW10172 as potential best-in-class treatment for patients with narcolepsy.”

In healthy volunteers an immediate-release oral formulation of XW10172 was rapidly absorbed and metabolized to release oxybate at concentrations that matched equal molar doses of sodium oxybate, currently approved for treatment of narcolepsy. In addition, XW10172 was generally well-tolerated and adverse events seen are known effects of oxybate. Reports of somnolence, which is the desired pharmacological effect of XW10172, showed a concentration-effect relationship.

In a crossover study in healthy subjects that evaluated multiple time-based modified-release formulations of XW10172, each of these formulations delivered oxybate at concentrations considered to be effective at promoting sleep, increasing slow wave sleep, and consolidating sleep stages that are associated with improved sleep quality and reductions in excessive daytime sleepiness and cataplexy. The modified-release formulations maintained those desired concentrations over 6-7 hours following oral ingestion. Concentrations quickly declined below target levels 7-8 hours after dosing, the desired waking time.

These data support progression of XW10172 for further clinical evaluation. The Company plans to initiate a Phase 2 study in the coming months in patients with Parkinson’s disease suffering from sleep disorders, followed by a single Phase 3 pivotal study in narcolepsy patients.

The abstract and poster presentation of these data can be found on the SLEEP 2021 website at https://www.sleepmeeting.org/.

About XWPharma www.xwpharma.com

XWPharma is a biopharmaceutical company dedicated to the discovery and development of novel therapeutics, utilizing its proprietary platform chemistry. XWPharma’s expertise in drug design is focused on providing potential first- and best-in-class medicines with differentiated features to address the unmet medical needs of patients suffering from debilitating neurological diseases.

See the full announcement here https://www.globenewswire.com/news-release/2021/06/14/2246472/0/en/XWPharma-Announces-Positive-Results-from-Phase-1-Clinical-Trials-of-XW10172-in-Development-as-Once-Nightly-Therapy-for-Sleep-Disorders-in-Patients-with-Neurodegenerative-Diseases.html

About Avance Clinical
Avance Clinical is the largest full-service 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.

The company’s 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 Avance Clinical has focussed on state-of-the-art technology and systems across all functional areas to provide 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 http://www.avancecro.com for more information.

Recent Awards:

Excellence in Business Award 2021

Frost & Sullivan Asia-Pacific CRO Market Leadership Award 2020

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

By Company NewsNo Comments

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 http://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

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