Skip to main content
All Posts By

News Editor

LATEST WEBINAR: PSYCHEDELICS IN FOCUS

By Other newsNo Comments

In this informative webinar, we delve into the world of psychedelic trials and the evolving regulatory landscape surrounding these transformative therapies. Explore the promising efficacy of psychedelics like psilocybin, MDMA, 5-methoxy-dimethyltryptamine, and ibogaine in treating conditions such as depression, PTSD, anxiety, and substance use disorder.

During this webinar, we will:

  • Examine the diverse mechanisms of action underlying these psychedelic compounds, with a focus on serotonin 5HT2a receptor signaling.
  • Discuss the important results observed in clinical trials, showcasing the potential for durable effects lasting over a year post-dosing.
  • Highlight the pivotal role of organizations like MAPS (Multidisciplinary Association for Psychedelic Studies) in shaping the regulatory landscape for psychedelic medicines.
  • Explore the pipeline of next-generation psychedelic medicines engineered for improved pharmacodynamic and pharmacokinetic effects, reduced toxicity, and a potential for retained efficacy without the hallucinatory aspects of current psychedelic compounds.
  • Gain insights into the recent guidance issued by the US FDA and explore the regulatory pathways for the clinical study and approval of psychedelics in both Australia and the United States.

Our panel of scientists and clinicians from Australia and the US will provide invaluable insights into ongoing trials, innovations in psychedelic therapies, and the regulatory pathways shaping the future of mental health treatment.

Don’t miss this opportunity to stay informed about the latest developments in psychedelic research and regulatory advancements.

SPEAKERS:

Jorgen Mold, Senior Director of Scientific & Regulatory Services, Avance Clinical

Jorgen Mold is the Head of Scientific and Regulatory Affairs at Avance Clinical. Jorgen has worked within the clinical trial industry for over 25 years. Jorgen has prior experience as a Principal Scientific and Regulatory Affairs Specialist in a CRO environment. Additionally, Jorgen has prior experience in drug discovery and academic research positions at Northwestern University (USA), The University of Queensland and the Australian National University as well as 12 years in the biotechnology sector leading several ion channel/CNS drug discovery programs. Jorgen also spent four years working in medical affairs (neurology) at Merck Healthcare in Australia before joining Avance Clinical in August 2020.

Kevin Leach, Senior Vice President, Scientific & Regulatory Affairs, Avance Clinical

Kevin Leach has worked broadly in the biotechnology industry with hands-on experience in early and late-stage drug discovery and development. Through positions at Merck, Shire, Retrophin, Spring Bank, Quralis and Enveric as well as several other companies through consulting interactions, Kevin has worked in and led the ADME, toxicology, pharmacology, clinical pharmacology and bioanalysis functions.

Kevin has been responsible for leading discovery and development programs, the nominations of development candidates as well as multiple regulatory filings for molecules at the IND, BLA and NDA stages. He has also been part of teams that raised funding for public and private companies and has worked at mature and very early-stage companies with experience in many different indications and molecular platforms. Kevin is a member of the Boston Psychedelic Research Group and has worked on and led teams on multiple psychedelic compounds for psychiatric indications.

Kevin has recently joined Avance Clinical, an Australian and North American biotech specialist Clinical Research Organization as Senior Vice President of Scientific and Regulatory Affairs, based in Massachusetts, USA.

Who Should Watch?

This webinar will appeal to VPs, Directors, Managers, Department Heads, Scientists and Researchers working within the Biotech industry in the following areas:

  • Clinical affairs/Phase I unit
  • Clinical R&D/research
  • Clinical pharmacology/pharmacovigilance
  • Clinical operations/site selection and start-up/site management organization
  • Project management
  • Regulatory affairs
  • Medical affairs/medical research
  • Bioinformatics
  • Scientific affairs/study conduct
  • Business operations
  • Business development

What You Will Learn

Viewers will gain insights into:

  • Various psychoactive substances and promising therapeutic benefits for the treatment of psychiatric conditions
  • Explore the specific aspects of psychedelics crucial for orchestrating clinical trials
  • Examine the regulatory landscape governing novel psychedelic clinical studies in Australia
  • Delve into the outlook for emerging psychedelic compounds and their potential impact on the future

Avance Clinical Earns Frost & Sullivan’s 2023 Best Practices Customer Value Leadership Award for Delivering High-quality Clinical Trials Based on Globally Accepted Data

By Company Awards, Company NewsNo Comments

Avance Clinical is an Australian and North American market-leading Contract Research Organization (CRO) that provides international biotechs with customized solutions. For the fourth consecutive year, Avance Clinical has been awarded Best Practices Customer Value Leadership awarded, by Frost and Sullivan, for its exceptional performance

San Antonio, TX — 7 August 2023 Frost & Sullivan recently researched the Asia-Pacific biotechnology contract research organization industry and, based on its findings, recognizes Avance Clinical with the 2023 Customer Value Leadership Award. The company is a leading CRO with over 20 years of experience and provides comprehensive clinical research services to drug sponsors worldwide.

Avance Clinical’s services span the entire clinical trial process, from early-stage development to late-stage studies, supporting the ever-evolving demands of biotechnology research and development. It offers up-to-date strategic guidance on study design, regulatory compliance, and protocol development, ensuring trials comply with the rigorous requirements of regulatory authorities globally.

With its commitment to delivering first-class services, Avance Clinical has a strong track record of achievement in biotechnology research, and its unwavering devotion to quality has earned it a reputation as a trustworthy partner in pioneering biotech innovations. The company consistently forms strategic partnerships with leading academic institutions, research organizations, and clinical trial sites to gain access to innovative technologies and a network of experienced professionals. Through these partnerships, Avance Clinical incorporates the latest developments into its offerings and stays abreast of emerging biotechnology and clinical research trends.

“The company understands the intricacies of conducting clinical trials for innovative biopharmaceutical products, gene and cell therapies, and other advanced therapies. Its experts possess deep scientific knowledge and expertise in handling biotech’s clinical trial complexities, including specialized protocols, biomarker analysis, and pharmacokinetics/pharmacodynamics assessments,” said Azza Fazar, Best Practices Research Associate at Frost & Sullivan.

As a reflection of the tremendous value the company delivers to its customers, Avance Clinical’s flagship program, GlobalReady, has gained traction among biotech stakeholders. GlobalReady provides customers with substantial benefits, including time reduction, cost savings, and high-quality data generation, approved by the United States (US) Food and Drug Association (FDA).

Furthermore, with the newly opened North American headquarters in Wake Forest, North Carolina, Avance Clinical offers enhanced services in Australia, New Zealand, and the United States. The GlobalReady program streamlines the process and minimizes disruptions, cutting clinical trials’ time and cost by seamlessly facilitating the transition of early-to-late phase studies from customers in Australia and the US.

“The GlobalReady program has gained significant traction, embraced by over 50 biotech clients. In addition, the attractive 43.5% rebate on clinical spending in Australia allows the company’s clients to utilize its expertise and team in North America while maintaining services in Australia. This strategic approach enables clients to maximize rebate potential while leveraging Avance Clinical’s North American operations knowledge and capabilities,” noted Umesh Lal, Industry Analyst at Frost & Sullivan. With its strong overall performance, Avance Clinical earns Frost & Sullivan’s 2023 Customer Value Leadership Award in the Asia-Pacific biotechnology contract research organization industry.

Each year, Frost & Sullivan presents this award to the company that demonstrates excellence in implementing strategies that proactively create value for its customers, focusing on improving the return on the investment that customers make in its services or products. The award recognizes Avance Clinical for its unique focus on augmenting its customers’ value, beyond simply good customer service, leading to improved customer retention and customer base expansion.

Frost & Sullivan Best Practices Awards recognize companies in various regional and global markets for demonstrating outstanding achievement and superior performance in leadership, technological innovation, customer service, and strategic product development. Industry analysts compare market participants and measure performance through in-depth interviews, analyses, and extensive secondary research to identify best practices in the industry.

About Frost & Sullivan

For six decades, Frost & Sullivan has been world-renowned for its role in helping investors, corporate leaders, and governments navigate economic changes and identify disruptive technologies, Mega Trends, new business models, and companies to action, resulting in a continuous flow of growth opportunities to drive future success.

About Avance Clinical

Avance Clinical is the largest premium full-service Australian and North American 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 drug development phases that need fast, agile, and adaptive solution-oriented clinical research services.

Pre-clinical through to Phase I and Beyond

Avance Clinical offers pre-clinical consultancy services with their experienced ClinicReady team right through to Phase I and beyond clinical services leveraging significant Government incentive rebates of up to 43.5% and rapid start-up regulatory processes that are available in Australia.

With experience across more than 110 therapeutic indications, Avance Clinical can deliver world-class, high-quality, internationally accepted data suitable 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, Zelta, Veeva and Medrio are just some of Avance’s technology partners.

www.avancecro.com

Avance Clinical Opens New North American Headquarters

By Company NewsNo Comments

 

Adelaide, Australia | North Carolina, USA – Avance Clinical the leading award-winning Australian and North American biotech CRO that offers the GlobalReady program to speed up the path to regulatory approval, has opened new North American headquarters in Wake Forest, North Carolina.

Avance Clinical expanded operations in the US last year to offer its clients a seamless drug development journey from Australia to the US with the same CRO.

Avance Clinical CEO Yvonne Lungershausen (3rd from right) and Executive Vice President, North American Operations, John Mann (2nd from right) celebrate the opening of the new US office with team members.

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.

Avance Clinical’s Executive Vice President, North American Operations, John Mann, said he was proud to launch the company’s new North American headquarters.

“Avance Clinical has a fantastic reputation within the biotech industry and I am pleased that we have selected North Carolina for our North American headquarters.

“The Research Triangle Area (Raleigh, Durham, and Chapel Hill) is home to more than 600 life science companies.

The North America team will significantly increase in size over the next 12 months and this prime location will support that growth.”

Avance Clinical CEO Yvonne Lungershausen recently travelled to North Carolina to officially open the new office and welcome new staff members.

“Our North America operations offer 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.

More than 50 biotech clients are now taking advantage of our GlobalReady program.

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 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.

Our North America operations team has deep industry experience across a broad range of therapeutic areas, in particular Oncology, Central Nervous System (CNS) and Rare Diseases.

In addition, the world-class best practice technologies, systems and processes are integrated across all regions,” she said.

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 is at the cutting edge of clinical trial technology and 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

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 at ASCO & BIO 2023: Early Phase Oncology Trials Increasingly Elaborate and Demand More Patients

By Company News, Conference NewsNo Comments

Adelaide, Australia | San Diego, USA – Avance Clinical the leading award-winning Australian and North American CRO that offers ClinicReady and GlobalReady for early-phase biotech companies to speed up the path to regulatory approval, says early-phase oncology studies are increasingly more complex and demand more patients.

Avance’s ClinicReady and GlobalReady service platforms offer significant benefits to product development in oncology.

Book a meeting with Avance Clinical at ASCO

Book a meeting with Avance Clinical at BIO Booth #2884

According to Avance Clinical’s Chief Scientific Officer Gabriel Kremmidiotis who is part of the Avance Clinical team attending ASCO:

“Recently, Phase I clinical trial designs in Oncology patients have become more elaborate and include elements of dose escalation, dose expansion, and assessment of drug combinations.

This, in addition to the increasing number of new emerging therapeutics, has increased the demand for fast progress through the early phases of development and a greater demand for access to patients.

Utilizing Australia’s regulatory environment and high-quality oncology experts, Avance Clinical is able to facilitate a fast project launch and seamless transition across different parts of modular oncology protocol designs.

Studies start in Australia and, at appropriate stages, expand to the US as determined by patient accrual number requirements for each study.

Retaining the majority of backend services (biostatistics, data management, pharmacokinetics and medical writing) in Australia ensures the highest degree of financial benefit for our clients through the Australian R&D tax incentive.”

Avance Clinical CEO, Yvonne Lungershausen, Chief Scientific Officer Gabriel Kremmidiotis, and Head of Scientific and Regulatory Affairs Jorgen Mold are featured in a new Global Health video on Reuters news service about the importance of quality clinical trials as part of the drug development process.

The Global Health program brings together 100 leaders and executives from various sectors of the Private and Public Healthcare Industry.

Avance Clinical CEO, Yvonne Lungershausen and Executive VP North American Operations John Mann attended the Global Health Summit and Yvonne was a leading panelist.

Avance Clinical is at the cutting edge of clinical trial technology and has recently been ranked as the world leader in decentralized clinical trials (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

Avance Clinical’s unique GlobalReady offering enables biotechs that have completed early phase trials 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 

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 North American 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 drug development phases 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 I and Beyond

Avance Clinical offers pre-clinical consultancy services with their experienced ClinicReady team right through to Phase I and beyond clinical services leveraging significant Government incentive rebates of up to 43.5% and rapid start-up regulatory processes that are available in Australia.

With experience across more than 110 therapeutic indications, Avance Clinical can deliver world-class, high-quality, internationally accepted data suitable 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, Zelta, Veeva and Medrio are just some of Avance’s technology partners.

www.avancecro.com

 

Avance Clinical Joins Global Health Summit Campaign for Faster Access to Life-Changing and Life-Saving Therapies

By Company Awards, Company NewsNo Comments

Adelaide, Australia | San Diego, USA – Avance Clinical the leading award-winning Australian and North American CRO that offers the programs ClinicReady and GlobalReady for early-phase biotech companies to speed up the path to regulatory approval, has been invited to join the Global Health Summit campaign which will be featured on Reuters.

https://youtu.be/KFYbDAOlb5U

Avance Clinical CEO, Yvonne Lungershausen, Chief Scientific Officer Gabriel Kremmidiotis, and Head of Scientific and Regulatory Affairs Jorgen Mold are interviewed in a new Global Health video featured on Reuters news service about the importance of quality clinical trials as part of the drug development process.

The campaign is a collection of interviews and video documentaries, highlighting international business leaders and healthcare specialists from various industries. The series will showcase organizations spearheading specific health initiatives, developing ground-breaking medicine and complex health technologies, and taking on the challenges of both physical and mental health globally.

The Global Health program launches at the upcoming Global Health Summit on 25-27 May 2023 at the prestigious Intercontinental Hotel in Geneva, bringing together 100 leaders and executives from various sectors of the Private and Public Healthcare Industry.

The event will feature round table discussions where participants will discuss strategies, share knowledge and expertise, and identify opportunities for collaboration. This will be complemented by keynote speeches and panel discussions that will explore the latest trends and emerging issues in the healthcare industry.

Avance Clinical CEO, Yvonne Lungershausen and Executive VP North American Operations John Mann will be attending the Global Health Summit and Yvonne will be a leading panelist.

Avance Clinical is at the cutting edge of clinical trial technology and 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

Avance Clinical’s unique clinical offering 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 ClinicReady model here

Learn about the GlobalReady model here

or 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

Media Contact:

Avance Clinical

media@avancecro.com

Kate Thompson

Avance Clinical CEO Joins Global BioPharma Panel for Evolution Europe Summit 2023

By Company News, Conference NewsNo Comments

Adelaide, Australia | San Diego, USA – Avance Clinical the leading award-winning Australian and North American biotech CRO that offers a GlobalReady program to early-phase biotech companies to speed up the path to regulatory approval, has been invited to join the Evolution Europe Summit 2023 (Montreux, Switzerland 20 April – 21 April 2023). The panel discussion is focused on the evolution of clinical trials including technology, DCTs, reducing time and cost, drug development planning for approvals, and scaling globally in later phases.

Avance Clinical CEO, Yvonne Lungershausen has been invited to share the Australian and US CRO experience and future projections with a focus on patient-centricity and Decentralized Clinical Trials (DCTs) at the Evolution Europe Summit 2023.

Avance Clinical was recently identified by GlobalData as a global leader in DCT technology.

The Evolution Summit is an invitation-only, premium forum bringing leading clinical research executives and innovative solution providers. The summit’s content is aligned with key clinical R&D challenges and interests, relevant market developments, and practical and progressive ideas and strategies adopted by successful pioneers. See full details here

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

Avance Clinical’s unique clinical offering 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

Avance Clinical Leads DCT Technology Adoption Globally

By Company News, In the NewsNo Comments

 

Adelaide, Australia, North Carolina, USA – GlobalData and Clinical Trial Arena have identified Avance Clinical as the global leader in Decentralized Clinical Trial (DCT) technology adoption with 46% of their trials incorporating 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.

According to the report:

“Clinical Trials Arena has established an exclusive taxonomic approach that involves reviewing thousands of drug trial public records from 2022 that mentioned decentralization terminology in the study protocols, as curated in the Clinical Trials Database by GlobalData, the parent company of Clinical Trials Arena. Decentralization terminology includes DCT elements such as telemedicine, remote monitoring, digital data collection, and more.”

Priya Nair, senior clinical trial analyst at GlobalData said this was a rapidly growing offering in CRO. “The US has a massive push to use DCTs because the FDA guidance wants more diversity in trials, and diversity goes hand in hand with DCTs,” she explained.

Avance Clinical CEO Yvonne Lungershausen, said Avance Clinical uses the full range of eClincial technologies including ePro, eSource  and eConsent to support biotech clinical trials.

“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.”

“DCT elements are being incorporated in trials to further manage biotech time and budget challenges and to offer diverse and remote patient populations access to clinical trials,” said Lungershausen.

The pandemic has been the catalyst in speeding up the adoption of decentralized clinical trial methods including home-based and remote monitoring options.

There are considerable benefits to DCT’s including:

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

Advances in artificial intelligence (AI), machine learning, cloud computing, and blood self-collection devices are all revolutionizing the decentralized clinical trial process.

  • Wearable devices are demonstrating enormous potential whether worn as a wrist strap or as an adhesive patch on the body.  AI-embedded capabilities allow these devices to measure a patient’s heart rate or metabolism remotely. Linked to the cloud through secure networks, clinicians can receive and analyze the data in real-time.
  • Video calling and electronic reminders, can improve patient compliance in trials – prompting participants to take their medication at the right time or to record in their electronic diary development.
  • Technologies are developing to allow patient-centric sampling (self-collection of specimens) with devices that require either the use of a lancet or a finger prick whereas others do not, making clinical trials even more convenient.

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

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