Skip to main content
Category

Other news

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

LIVE WEBINAR: PSYCHEDELICS IN FOCUS

By Other newsNo Comments

Monday, November 27, 2023 | 10am PST / 12pm CST / 1pm EST 

Join us for an informative webinar as 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.

Secure your spot now for this enlightening webinar with Avance Clinical.

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 Attend?

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

Attendees 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

Register now!

Avance Clinical Finalist In The 61st Australian Export Awards 2023

By Other newsNo Comments

Adelaide, Australia | North Carolina, USAAvance Clinical, the award-winning Australian and North American market leading CRO for biotechs, has again been recognized for its contribution to International Health in the 61st Australian Export Awards 2023. 

The Australian Export Awards ceremony will be held on 30 November in Canberra at Parliament House. 

CEO Yvonne Lungershausen said, “Winning an Australian Export Award would be an incredible honor in recognition of Avance Clinical’s rapid growth, high quality service delivery and continued innovation in the clinical trials sector.” 

Avance Clinical’s primary focus is to find the best solutions for biotech’s drug development programs by offering deep scientific knowledge and execution experience. The companies agile and compliance-focused approach ensures the efficient access of medicines to patients with unmet needs.  

“We pride ourselves on being nimble and adaptive while focusing on operating to the highest standards of quality and compliance required by global regulatory agencies to ensure acceptance of data and subsequent drug approvals,” Ms Lungershausen said. 

Avance Clinical has experienced significant growth since being established in 2019, with its primary market being the United States, followed by Asia and Europe. Recently, the company established a North Carolina office, and a biometrics hub in Bangalore, India, to support its global biometrics team. 

“Avance Clinical now offers a specialized service, the GlobalReady program, which takes clients into Australia to commence their early phase clinical trials and reaps the benefits of the R&D Tax Rebate, and then seamlessly transitions them into the US for their later phase trials through Avance Clinical’s North American operations team,” she said. 

About Avance Clinical 

Avance Clinical is a full-service CRO for biotechs with a proven track-record for delivering clinical excellence in Australia, New Zealand, India and North America. As the largest premium full-service CRO in Australia and North America dedicated to biotechs, Avance Clinical specializes in delivering top-tier clinical trials that yield globally accepted data.  

Award-winning CRO for Biotechs 

Avance Clinical has been recognized for the fourth consecutive year by Frost & Sullivan in 2023, being awarded the Best Practices Customer Value Leadership for Biotech’s award, for its continuous exceptional performance. 

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 all major regulators, including FDA and EMA. 

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 Clinical’s technology partners. 

Biotech CRO Leader, Avance Clinical, Backs California Life Sciences Entrepreneurship Program With Gold Sponsorship

By Company News, Other newsNo Comments

Adelaide, Australia | North Carolina, USA Avance Clinical, the award-winning Australian and North American market-leading CRO for biotechs, is proud to announce its gold sponsorship of California Life Sciences (CLS) Innovation and Entrepreneurship programming.

Liahna Toy, Vice President, Commercial Business Development at Avance Clinical, said the sponsorship was an ideal way of supporting early phase biotech companies in California.

“Avance Clinical has been delivering clinical drug development services for biotechs for FDA and EMA regulatory approval, for more than two decades, with a significant client base located in the US.

“CLS is a life sciences membership organization, supporting companies of all sizes, from early-stage innovators and startups to established industry leaders in the fields of biotech, pharmaceuticals, and medical technology.

“Avance Clinical is very proud to be a Gold Sponsor of CLS to support early phase biotechs by providing insights and education around the benefits of commencing their early phase, healthy volunteer studies in Australia and the benefit of our GlobalReady program which focuses on taking biotechs from Phase I in Australia through to later phase studies in the US,” she said.

About Avance Clinical

Avance Clinical is a full-service CRO for biotechs with a proven track-record for delivering clinical excellence in Australia, New Zealand, and North America. As the largest premium full-service CRO in Australia and North America, Avance Clinical specializes in delivering top-tier clinical trials that yield globally accepted data.

Award-winning CRO for Biotechs

Avance Clinical has been recognized for the fourth consecutive year by Frost & Sullivan in 2023, being awarded the Best Practices Customer Value Leadership award, for its exceptional performance.

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 Clinical’s technology partners.

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 maximize 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

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 caliber 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 maximize 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 recognize 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 recognized 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 Joins Industry Leaders at Conference Discussing The Future of Medicinal Cannabis

By Other newsNo Comments

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

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

Conference topics include:

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

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

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

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

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

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

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

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

Mike Watson Appointed Avance Clinical Director, Business Development, USA

By Other newsNo Comments

Mike Watson has joined Avance Clinical as Director, Business Development, USA.

It is our pleasure to announce that Mike Watson has joined the Avance Clinical team as Director Business Development, USA.

Based in Raleigh North Carolina, Mike is a seasoned business development professional having spent the past 12 years in the clinical research space.  Mike came to Avance from Nucleus Network, a Phase 1 unit in Australia, where he was the Senior Director of Business Development.

His experience extends from the pre-clinical research setting and into clinical from Phase 1 to Phase 4. He has a very strong working knowledge of Australia’s world-class early phase clinical trial ecosystem.  Prior to his experience in the life science industry, Mike served in the United States Navy for 20 years. Welcome to the team Mike!