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Enveric Biosciences Selects Australian CRO, Avance Clinical, in Preparation for Phase 1 Study of EB-373

By Client News, Company NewsNo Comments

EB-373, a proprietary psilocin prodrug, is on track to start its first-in-human clinical trial in the fourth quarter of 2023

CAMBRIDGE, Mass. –
Enveric Biosciences, Inc. (NASDAQ: ENVB) (“Enveric” or the “Company”), a biotechnology company dedicated to the development of novel small-molecule therapeutics for the treatment of anxiety, depression, and addiction disorders, today announced that it has entered into an agreement with Avance Clinical, an Australia-based contract research organization (CRO) with US operations, for its planned Phase 1 clinical trial of EB-373, the company’s lead candidate targeting the treatment of anxiety disorders. The Phase 1 clinical trial is expected to initiate in the fourth quarter of 2023.

Under the agreement, Avance Clinical will manage the Phase 1 clinical trial of EB-373 in coordination with Enveric’s newly established Australian subsidiary, Enveric Therapeutics Pty, Ltd. The Phase 1 clinical trial is designed as a multi-cohort, dose-ascending study to measure the safety and tolerability of EB-373. EB-373, a next-generation proprietary psilocin prodrug, has been recognized as a New Chemical Entity (NCE) by Australia’s Therapeutic Goods Administration (TGA) and is currently in preclinical development targeting the treatment of anxiety disorder.

“With our Australia subsidiary established, we are actively preparing to initiate the planned Phase 1 trial of EB-373 and are pleased to have Avance Clinical as our CRO partner, given the company’s proven expertise and experience managing early-stage clinical programs in Australia,” said Joseph Tucker, Ph.D., Director and CEO of Enveric Bioscience. “EB-373 has the potential to bring much-needed innovation to the treatment of anxiety disorder, which is underserved by current therapeutic options. We are eager to evaluate the potential of EB-373 in this first-in-human Phase 1 clinical trial as an initial step towards building a broader pipeline of proprietary psilocin prodrugs and other innovative, psychedelic-inspired compounds for a range of mental health conditions.”

“We are excited to work with Enveric and are eager to leverage the expertise we’ve gained from managing early-stage clinical programs in Australia to empower the development of EB-373,” said Yvonne Lungershausen, Avance Clinical CEO. “We look forward to being a valued partner to Enveric in the execution of the EB-373 clinical program and ensuring the highest quality data is generated to support global regulatory filings.”

About EB-373

Enveric’s lead drug candidate, EB-373, is a New Chemical Entity (NCE), designed as a next-generation proprietary psilocin prodrug and developed leveraging its Psybrary™ drug discovery platform to target anxiety disorders. In preclinical studies, EB-373 interacted effectively with different types of serotonin receptors, including the serotonin 5-HT2A receptor resulting in the induction of the characteristic head twitch response in mice. In an animal behavioral model of anxiety, the Marble Burying Test in chronically stressed mice, EB-373 was able to promptly rescue the rate of marble burying on day 1 in line with the control rate at baseline, with lasting benefits up to the end of the experiment 7 days post-dose.

About Enveric Biosciences

Enveric Biosciences (NASDAQ: ENVB) is a biotechnology company dedicated to the development of novel small-molecule therapeutics for the treatment of anxiety, depression, and addiction disorders. Leveraging its unique discovery and development platform, The Psybrary™, Enveric has created a robust Intellectual Property portfolio of New Chemical Entities for specific mental health indications. Enveric’s lead program, EB-373, is a next-generation prodrug of psilocin, the active metabolite of psilocybin. EB-373 is the lead drug candidate from the EVM201 Series, currently advancing through preclinical development to treat anxiety disorders. Enveric is also advancing its third generation of therapeutics, the EVM301 Series, which aims to eliminate the psychedelic experience and remove unwanted effects, reduce safety concerns, and offer a novel and holistic approach to treating central nervous system disorders. Enveric is headquartered in Naples, FL, with offices in Cambridge, MA, and Calgary, AB, Canada. For more information, please visit www.enveric.com.

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 that need fast, agile, and adaptive solution-oriented clinical research services. For more information, please visit www.avancecro.com.

Forward-Looking Statements

This press release contains forward-looking statements and forward-looking information within the meaning of applicable securities laws. These statements relate to future events or future performance. All statements other than statements of historical fact may be forward-looking statements or information. Generally, forward-looking statements and information may be identified by the use of forward-looking terminology such as “plans,”” expects” or “does not expect,” “proposed,” “is expected,” “budgets,” “scheduled,” “estimates,” “forecasts,” “intends,” “anticipates” or “does not anticipate,” or “believes,” or variations of such words and phrases, or by the use of words or phrases which state that certain actions, events or results may, could, would, or might occur or be achieved. Forward-looking statements consist of not purely historical statements, including any statements regarding beliefs, plans, expectations, or intentions regarding the future. Such forward-looking statements are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including, but not limited to, the ability of Enveric to successfully spin-off its cannabinoid assets; the ability to achieve the value creation contemplated by technical developments; the impact of the novel coronavirus (COVID-19) on Enveric’s ongoing and planned clinical trials; the geographic, social and economic impact of COVID-19 on Enveric’s ability to conduct its business and raise capital in the future when needed; delays in planned clinical trials; the ability to establish that potential products are efficacious or safe in preclinical or clinical trials; the ability to establish or maintain collaborations on the development of therapeutic candidates; the ability to obtain appropriate or necessary governmental approvals to market potential products; the ability to obtain future funding for developmental products and working capital and to obtain such funding on commercially reasonable terms; Enveric’s ability to manufacture product candidates on a commercial scale or in collaborations with third parties; changes in the size and nature of competitors; the ability to retain key executives and scientists; and the ability to secure and enforce legal rights related to Enveric’s products, including patent protection. A discussion of these and other factors, including risks and uncertainties with respect to Enveric, is set forth in Enveric’s filings with the Securities and Exchange Commission (SEC), including Enveric’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Enveric disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Investor Relations

Tiberend Strategic Advisors, Inc.

Daniel Kontoh-Boateng

(862) 213-1398

dboateng@tiberend.com

Media Relations

Tiberend Strategic Advisors, Inc.

Casey McDonald

(646) 577-8520

cmcdonald@tiberend.com

March 27, 2023
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Avance Clinical Appoints North America SVP with Global Contract Research Organization, Data Quality and DCT Expertise

By Company News, New Team MembersNo Comments

Adelaide, Australia | San Diego, USA – Avance Clinical the leading award-winning Australian and North American biotech CRO that offers the GlobalReady program for biotech companies to speed up the path to regulatory approval, today announced the appointment of John Mann as Senior Vice President, North America Operations.

John Mann has over 24 years of working in CROs and 15 years of experience working in senior leadership roles including Quintiles (now IQVIA), INC Research (now Syneos Health), PRA Health Sciences, and ICON. He has worked across a diverse range of therapeutic areas and business groups, most recently as Vice President of Emerging Biotech and Rare Disease Operations, and Vice President of Decentralized Clinical Trials (DCTs) Operations at ICON.  

John Mann will lead a team of more than 30 clinical trial specialists in North America and report to the CEO, Yvonne Lungershausen.

 “John has a passion for quality and process improvement, leading people, project management, and change management within clinical operations, and is well placed to support the team and our biotech clients to achieve drug development success in North America,” said Yvonne Lungershausen.

She said: “Importantly John also brings the latest DCT technology and operations experience which offers cost and time benefits for our biotech clients.”

Avance Clinical has recently been ranked as the world leader in DCT technology adoption by GlobalData and Clinical Trial Arena in the CRO sector. The report found 46% of Avance Clinical’s trials incorporated some elements of DCT technologies in 2022 including telemedicine, remote monitoring, and digital data collection.

The DCT report also noted that Avance Clinical’s staff training in the latest technologies was a key factor in the ranking. See the full report here

John Mann said he was “extremely pleased to join such a world-class CRO with decades of experience and an exceptional reputation among US biotechs for early to late phase trials”.

“I am looking forward to applying my skills and knowledge in US-based global clinical trials as well as DCT enablement to support the biotech community which is increasingly under pressure to deliver results in a tough financial environment,” he said.

See more about John’s expertise here

“The US team is attracting biotechs wanting an experienced CRO that can deliver locally conducted trials with the highest reputation for quality data, outstanding site relationships, and rapid timelines,” commented Yvonne Lungershausen.

Avance Clinical’s GlobalReady enables biotechs that have completed early to mid phases in Australia to rapidly and seamlessly transition to the US in preparation for FDA approvals, all with the one CRO and dedicated teams across both regions, which reduces time and cost and delivers quality data.

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

More than 40 biotech clients are now taking advantage of Avance Clinical’s GlobalReady program.

This seamless GlobalReady journey is designed so 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 operationalize 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

Find out more:

  • Learn about the Australian Advantage here 
  • Learn about the GlobalReady model here
  • For more information about the benefits of running your next study with Avance Clinical contact us: enquiries@avancecro.com

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 three 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.

www.avancecro.com

March 1, 2023
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Avance Clinical Expands Biometrics Team into India to Support Biotech Trials Demand in US and Australia

By Company News, We are hiringNo Comments

Award-winning CRO Avance Clinical, which currently has the largest Biometrics team in Australia, is expanding further with global hires and a specialist hub in Bangalore, India to support growing demand.

Avance Clinical Director Biometrics Paul Donnelly said: “India has an exceptional reputation for biometrics specialists, in particular Statisticians and Statistical Programmers, and Bangalore is very much a centre for world-class biometrics talent.”

“Our biometrics team ensures biotech clinical research is regulatory ready for agencies like the FDA and the EMA, and so we need the best. This is therefore an obvious choice to supplement our Australian team of more than 60 biometrics experts with new colleagues in India,” he said.

Avance Clinical has been developing Biometrics expertise globally, with team members joining from South Africa, UK, Taiwan and US, all collaborating as one team.

Avance Clinical has been ranked as the global leader in Decentralized Clinical Trial (DCT) technology adoption by GlobalData and Clinical Trial Arena. The report found 46% of Avance Clinical’s trials incorporated some elements of DCT technologies in 2022 including telemedicine, remote monitoring, and digital data collection.

The DCT report also noted that Avance Clinical’s staff training in DCT technologies was a key factor in the ranking. See the full report here

Avance Clinical which is globally recognized for quality data, delivers cost and time benefits for clinical-stage biotechs. The company’s GlobalReady model supports biotech clinical development from early to late phase across Avance Clinical’s operations in Australia, New Zealand, and North America.

More than 280 Phase III global biotech have conducted their Phase I study in Australia and then expanded globally, which demonstrates the quality of Australian data with the FDA and other major regulatory authorities.

Avance Clinical CEO Yvonne Lungershausen, said:

“Having an expert team trained in the latest technologies is key to success for a CRO working across regions with multiple regulatory authorities and requirements.”

Find out more:

  • Learn about our Biometrics services here
  • Learn about the Australian Advantage here 
  • Learn about the GlobalReady model here
  • For more information about the benefits of running your next study with Avance Clinical contact us: enquiries@avancecro.com

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.

GlobalReady 

GlobalReady gives 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.

Frost & Sullivan Awards

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

“Avance Clinical remains a trusted partner, earning a reputation for delivering the overall best in the CRO industry. With its strong overall performance, Avance Clinical earns Frost & Sullivan’s 2022 Asia-Pacific Customer Value Leadership Award in the contract research organization industry.” Frost & Sullivan

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.

February 13, 2023
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Avance Clinical Celebrates GlobalReady Success as More Than 40 Biotechs Enter Program

By Company NewsNo Comments

More than 40 biotech clients are now taking advantage of Avance Clinical’s GlobalReady program which delivers streamlined clinical development from early phase in Australia expanding to sites in North America for later phases. All with the one CRO and dedicated teams across both regions.

Avance Clinical made the announcement at Biotech Showcase 2023 where the team is available for meetings via PartnershipOne.

“Given this successful early adoption of GlobalReady we are expecting more than half of our biotech clients to join the program within the next six months, said Avance Clinical CEO Yvonne Lungershausen.

GlobalReady biotech clients are primarily biotechs from the US and Asia, with an increasing number expected from Europe over the next few months.

Avance Clinical is the leading Australian-based biotech CRO with US operations, which has been recognized by Frost & Sullivan for the past 3 years with the prestigious CRO Leadership Award.

CEO Yvonne Lungershausen said:

“These biotech clients are already benefiting from our expansion into North America and GlobalReady.

The 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.

GlobalReady 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.

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 maximize 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.”

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 operationalize 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

“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 biotech clients need for clinical success,” commented Yvonne Lungershausen.

According to Frost & Sullivan as part of the independent analyst review of the company for the CRO Award:

“Avance Clinical remains a trusted partner, earning a reputation for delivering the overall best in the CRO industry. With its strong overall performance, Avance Clinical earns Frost & Sullivan’s 2022 Asia-Pacific Customer Value Leadership Award in the contract research organization industry.,”

Find out more:

  • Learn about the Australian Advantage here 
  • Learn about the GlobalReady model here
  • For more information about the benefits of running your next study with Avance Clinical contact us: enquiries@avancecro.com

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 three 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.

www.avancecro.com

January 11, 2023
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Avance Clinical Wins Frost & Sullivan Customer Value Leadership Award 2022

By Other newsNo Comments

Adelaide, Australia/San Diego, USA – After an extensive review by CRO industry analysts comprising executive interviews and background sector research, Frost & Sullivan has recognized Avance Clinical, the leading Australian-based biotech CRO with US operations, with the Frost & Sullivan’s 2022 Asia-Pacific Customer Value Leadership Award.

“Avance Clinical remains a trusted partner, earning a reputation for delivering the overall best in the CRO industry. With its strong overall performance, Avance Clinical earns Frost & Sullivan’s 2022 Asia-Pacific Customer Value Leadership Award in the contract research organization industry,” said Frost & Sullivan as part of the independent analyst review of the company.

“With over two decades of experience, Avance Clinical assists biotechnology (biotech) sponsors in the early phases of their drug development. It delivers prompt, adaptive, client-oriented solutions and customizes its solutions based on its client’s needs rather than the “one-size-fits-all” approach, which is a key differentiator,” noted the report.

Frost & Sullivan identifies APAC as one of the fastest-growing CRO markets globally with an estimated value of nearly USD$8 billion in 2021.

Frost & Sullivan said the main market drivers in APAC included a significant cost advantage, supporting infrastructure, and wide-ranging patient diversity mirroring western nations’ disease prevalence. Frost & Sullivan forecasts a compound annual growth rate of 15.9% from 2021 to 2027.

The Frost & Sullivan analyst report on Avance Clinical also said:

“Avance Clinical’s approach goes beyond its extensive expertise and best-in-class capabilities, with customer value as a strategic imperative. Through the years, the company has earned an outstanding reputation supporting clients’ path toward seamless clinical trial execution.”

The report identified the following further benefits of working with Avance Clinical:

  • Price/Performance Value: Products or services provide the best value for the price compared to similar market offerings
  • Customer Purchase Experience: Quality of the purchase experience assures customers that they are buying the optimal solution for addressing their unique needs and constraints
  • Customer Ownership Experience: Customers proudly own the company’s product or service and have a positive experience throughout the life of the product or service
  • Customer Service Experience: Customer service is accessible, fast, stress-free, and high quality

Brand Equity: Customers perceive the brand positively and exhibit high brand loyalty Avance Clinical CEO Yvonne Lungershausen said this is the third consecutive year the company has been recognised by the analysts at Frost & Sullivan and the team should be proud of their work supporting our global biotech clients.

“This recognition is extremely important for our company because it reinforces the value of our agile clinical solutions that support accelerated clinical development for our international biotech clients.”

“Our US team should also be commended because this award is for the entire company,” said Yvonne Lungershausen.

The Australian and US capabilities feature in the analysts’ findings:

“Avance Clinical’s Australian operations offer clients the opportunity to maximise 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.”

Frost & Sullivan applies a rigorous analytical process to evaluate multiple nominees for each award category before determining the final award recipient. The process involves a detailed evaluation of best practices criteria across two dimensions for each nominated company. Avance Clinical excels in many of the criteria in the contract research organization space.

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 three 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.

www.avancecro.com

December 7, 2022
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Avance Clinical Sponsors China BioPharma Award at the Global Scrip Awards, London

By Other newsNo Comments

Adelaide, Australia/San Diego, USA – Avance 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.

October 27, 2022
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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.

September 28, 2022
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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.

September 6, 2022
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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

August 24, 2022
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