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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 STRENGTHENS ASIA-PACIFIC NETWORK WITH DIGITAL TECHNOLOGY COMPANY JNPMEDI INC

By Company NewsNo Comments

Adelaide, Australia | North Carolina, USA – Avance Clinical, the Australian and North American market-leading CRO for biotechs, has signed a strategic technology MOU with leading Korean decentralized clinical trials (DCTs) and eClinical technology company JNPMEDI Inc. The agreement expands Avance Clinical’s capabilities in the Asia-Pacific biotech clinical trials sector.

Anne Sim, Associate Director, Technology, and Innovation said, “Avance Clinical is focused on growing our networks with technology companies which offer high-quality innovative solutions designed to further accelerate the delivery of quality data to our biotech clients.

As we continue to invest in digital capacity, JNPMEDI is one company we are exploring. They are also located within the important Asia-Pacific region which really helps that relationship.”

Upon signing the MOU, Jae Hyun Lee J.D., D.D.S., Chief of Staff at JNPMEDI, expressed, “JNPMEDI is excited to partner with Avance Clinical. Korea biotech industry is an exciting and growing one, and one whose needs are uniquely answered by Avance Clinical and the Australian clinical trial market. The partnership will provide a turnkey answer to the biotech market.”

JNPMEDI’s core technology is Maven Clinical Cloud which offers a singular ecosystem for digital clinical solutions capable of streamlining activities from protocol to CSR. This ‘one stop shop’ supports subject participation while delivering efficiencies to study sites, sponsors and CROs.

The Avance Clinical Technology and Innovation team identifies and reviews the latest technology solutions including machine learning and artificial intelligence applications to support global systems integrations.

JNPMEDI and Avance Clinical connected recently at the KoNECT Korea conference in Seoul where Avance Clinical presented to over 45 Korean biotechs at a clinical trials symposium event. The presentation focused on Avance Clincial’s GlobalReady drug development acceleration solution.

The Avance Clinical team, including CEO Yvonne Lungershausen, and Vice President, Commercial Business Development, Liahna Toy shared drug development options including conducting clinical trials across Korea, Australia, New Zealand, and the United States to support fast tracking clinical trial development programs.

Andy Hu, Business Development Manager for Asia, said Avance Clinical offers two critical solutions for biotechs.

“Avance Clinical in Australia can maximize the 43.5% rebate on clinical trial spend, and in the United States can provide high quality trials following the FDA pathway. Both approaches were received as attractive propositions for biotechs wanting to maximize their data captured and conserve funding,” he said.

Liahna Toy, Vice-President, Commercial Business Development said:

“Our Avance Clinical teams in Australia and the United States offer world-class quality data and cultural alignment for Korean biotech clients designed to make their drug development programs seamless and successful.”

“Avance Clinical’s study data is accepted by all the main regulatory authorities including the MFDS and FDA; and conversely the Therapeutic Goods Administration (TGA) in Australia recognizes data generated in Korea.”

“The Korean biopharma companies we met at KoNECT Korea Conference were outstanding and we are extremely excited to be part of their clinical program as they expand to the United States.”

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 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 and highly qualified sites and networks within the United States. 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.

www.avancecro.com

 

Media Contact:

Avance Clinical

media@avancecro.com

 

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. 

Avance Clinical Invited To Brief 45 Korean Biotechs On Their Globalready Drug Development Pathway From Korea And Australia To The Us

By Company NewsNo Comments

Dt & SanoMedics Chairman, Charles Park (Park, Chae Gyoo) and Avance Clinical CEO Yvonne Lungershausen co-hosting the Global Clinical Trial Strategy Symposium in Korea last week.

Adelaide, Australia | North Carolina, USA – Avance Clinical, the Australian and North American market-leading CRO for biotechs, was asked to present their GlobalReady drug development solution to more than 45 Korean biotechs and pharmaceutical companies in Seoul, Korea last week as part of a special symposium at KoNECT Korea Conference. 

Avance Clinical’s Korean CRO partner Dt & SanoMedics initiated the Global Clinical Trial Strategy Symposium and invited Avance Clinical to co-host.

The Avance Clinical team, including CEO Yvonne Lungershausen, and Vice President, Commercial Business Development, Liahna Toy discussed drug development options including conducting clinical trials across South Korea, Australia, New Zealand, and the United States to support fast tracking clinical trial development programs.

Yvonne Lungershausen said Avance Clinical offers two critical solutions for biotechs.

“Avance Clinical in Australia can maximize the 43.5% rebate on clinical trial spend, and in the United States can provide high quality trials following the FDA pathway. Both approaches were received as attractive propositions for biotechs wanting to maximize their data captured and conserve funding,” she said.

“Our Avance Clinical teams in Australia and the United States offer world-class quality data and cultural alignment for Korean biotech clients designed to make their drug development programs seamless and successful.”

“Avance Clinical’s study data is accepted by all the main regulatory authorities including the MFDS and FDA; and conversely the Therapeutic Goods Administration (TGA) in Australia recognizes data generated in Korea.”

Yvonne Lungershausen thanked Korean CRO partner Dt & SanoMedics for arranging the Global Clinical Trial Strategy Symposium.

“This was an impressive group of biopharma companies and we are extremely excited to be part of their clinical program as they expand to the United States.”

“Thank you to Chairman of the Dt&C group, Charles Park and Yujin Lee, Vice-President of Dt & SanoMedics, and the entire team for welcoming and hosting Avance Clinical in South Korea.”

Dt & SanoMedics VP Yujin Lee said the partnership with Avance Clinical has been further strengthened with the team providing valuable international drug development strategies for the Korean biotech community.

“We are pleased to introduce the Avance Clinical team because we know they stand for quality. Importantly, they have the experience and track-record especially in the United States which is where most biotechs will be conducting their later phase trials.”

“We believe this has been an important visit which has enabled us to enhance our partnership and actively help Korean companies enter the US and Australian pharmaceutical markets,” 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 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 and highly qualified sites and networks within the United States. 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.

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 Appoints US-Based Executives – SVP Scientific And Regulatory Affairs, And Director Business Development

By Company News, New Team MembersNo Comments

Adelaide, Australia | Raleigh, North Carolina, USA – Avance Clinical, the award-winning Australian and North American market-leading CRO for biotechs, announces two key appointments in the US to support its continued global growth.

Kevin Leach joins as Senior Vice President of Scientific and Regulatory Affairs, based in Massachusetts, USA. Kevin has a background in the biopharma industry with experience in early and late-stage drug discovery and development.

Madison Esely-Kohlman has joined as a Director of Business Development based in Salt Lake City, Utah and is focused on partnering with biotech companies on their Phase I-III clinical trials.

In welcoming both Kevin and Madison, CEO, Yvonne Lungershausen said they bring significant expertise that will support Avance Clinical’s expanding US and Australian operations as well as our global growth plans.

“We are seeing increasing demand for our biotech-specific services such as ClinicReady and GlobalReady which are designed for pre-clinical, early phase and later phase clinical development. GlobalReady is a unique offering enabling biotechs to start rapidly and cost effectively with Avance Clinical in Australia and transition with our team in the US for later phase trials, with all the benefits of retaining the one CRO,” she said.

Kevin Leach PhD, DAB: Senior Vice President, Scientific and Regulatory Affairs

Kevin Leach has more than 20 years of experience working in drug discovery and development in the pharmaceutical industry and will provide exceptional knowledge and experience to Avance Clinical’s biotech clients. He has a PhD in biochemistry and molecular biophysics at Medical College of Virginia and completed his Post Doctoral Fellowship in Biological Engineering at Massachusetts Institute of Technology.

“Previously, I was on the client-side working with Avance Clinical. As we were considering the best CRO for our non-clinical and clinical programs Avance was consistently suggested to us as the premier partner in Australia. Once we started working together it was clear to me that the Avance team had a wealth of experience and expertise broadly in drug development and that we were in good hands at Avance.

“I joined Avance because I wanted to be part of an organization that was considered the gold standard in their field, and I felt comfortable that I would be working with highly intelligent, motivated, and experienced colleagues in our shared mission of bringing transformative medicines to patients.

“I am looking forward to applying my past experiences by working with the Avance team to enable sponsors developing diverse medicines of various molecular platforms, for different disease indications to deliver therapies that change and enrich the lives of the patients,” Kevin said.

Madison Esely-Kohlman: Director of Business Development

Madison Esely-Kohlman has considerable experience working in specialty drug development services, including in vitro DMPK testing and regulated bioanalysis, and GLP preclinical studies. Madison’s expertise includes engaging with clients early in their clinical development journey and supporting them into clinic. In her new role at Avance Clinical, she is looking forward to assisting clients navigate their clinical programs.

“Clinical trials bring not just tangible and thoroughly vetted medicines into the world; they can bring hope to families and individuals. Clinical trials run with expertise and efficiency mean faster access for those patients, and by joining Avance I am part of an organization dedicated to that outcome,” she said.

Madison is motivated by assisting US biotech companies to understand and take advantage of the benefits afforded by the Australian clinical pathway.

“A game-changer that really drew me to Avance Clinical as a CRO specifically is their ability to support sponsors in the longer term. The GlobalReady offering empowers our customers to maximize benefits of the Australian clinical network and transition into a global program with teams in the US and elsewhere in the world. My goal is to connect those companies to the resources and expertise available at Avance Clinical, so they have a trusted and capable partner in their programs,” Madison said.

Meet Madison in-person at COG West Coast on 7-8 November in Burlingame, CA.

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 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 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.

CEO Of Avance Clinical Nominated For Executive Of The Year In 2023 Citeline Pharma Intelligence Awards Japan

By Company Awards, Company 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 that Chief Executive Officer Yvonne Lungershausen has been nominated for Executive of the Year in the 2023 Citeline Pharma Intelligence Awards in Japan.

The Citeline Pharma Intelligence Award will be announced on October 17, 2023 in Tokyo. According to Citeline, the award, “is designed to acknowledge excellence in leadership, career achievements, influence within the industry and the key characteristics that make a good leader, such as decisive and clear strategy, team building and employee welfare.”

Avance Clinical has achieved outstanding success guided by Yvonne’s leadership, global vision and passion for quality and customer service. The company’s staff numbers have grown significantly by approximately 85% since Avance was established in 2019. In the last 12 months, Avance Clinical expanded its operations into the US, opened a North Carolina office and a new biometrics hub in Bangalore, India.

With her experience of over three decades in the Australian, New Zealand and US clinical trials drug development environment Yvonne has not only put Avance Clinical on the global map but hired and retained some of the best talents from across the globe.

Yvonne has helped champion a culture of innovation and adaptability within the company -successfully embracing emerging technologies and capitalizing on new market opportunities, hence strengthening its competitive position. Yvonne’s exceptional leadership has not only driven the company’s growth but has also positively impacted the lives of Avance Clinical’s employees, shareholders, and biotech clients.

She is highly regarded within the industry and is renowned for her exceptional expertise in addressing complex clinical trial challenges. She sees the importance of preparing for change fostering an adaptive and forward-thinking mindset within the organization. Her leadership is defined by a deep commitment to cultivating relationships and driving positive industry change.

CEO Yvonne Lungershausen said, “I am honored to be nominated for this award. It reflects not only my accomplishments as leader of the organization but our entire team’s efforts at Avance Clinical globally. Our team’s dedication and commitment to quality clinical research is what makes us so successful. We take pride in servicing the needs of our biotech clients and providing them with the very best, customized solutions.

“I am looking forward to attending the Citeline Pharma Intelligence awards ceremony in Tokyo in October – there is also the added benefit of being able to meet with and connect with our regional biotech clients,” 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 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 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.

Join Avance Clinical In Seoul At KoNECT Korea 2023

By Company News, Conference NewsNo Comments

Adelaide, Australia | North Carolina, USA – Avance Clinical, the award-winning Australian and North American market-leading CRO for biotechs, will visit Seoul in October to expand on collaborative opportunities with South Korean biotech companies. 

Avance Clinical’s delegation, including Chief Executive Officer Yvonne Lungershausen, Vice President, Commercial Business Development Liahna Toy, and Director of Business Development Cameron Williams, will participate in the prestigious KoNECT Korea Conference in Seoul, October 10-12 2023.

KoNECT Korea is a prestigious gathering of industry leaders, researchers, and innovators in the biotechnology and pharmaceutical sectors. This conference provides a unique platform for Avance Clinical to engage with South Korean biotech companies and experts, fostering collaborations and knowledge exchange.

Avance Clinical CEO Yvonne Lungershausen said they looked forward to expanding the company’s Korean client base and the opportunity to further establish and cultivate valuable relationships and connections with leading Korean biotech companies.

“We are looking forward to meeting with Korean biotechs to discuss the benefits of working with Avance Clinical,” commented Yvonne Lungershausen. “Korean biotechs can benefit from the Australian Advantage, which includes a fast start-up, no IND required, and up to 43.5% saving off clinical trial spend with the Australian R&D tax incentive.

“Korean biotechs then have access to the US via our US team based in North Carolina for later phase studies and ultimately FDA engagement,” she said.

“Avance Clinical’s Australian team has been supporting a number of Korean biotech companies through their clinical development programs offering a favorable regulatory environment, quality data, efficient processes, diverse patient populations, access to experts, stable political environment, strategic location, robust research infrastructure, and financial incentives. These factors collectively make Australia an attractive destination for biotech research and development.

“In fact, we are seeing increasing demand for our biotech specific services such as ClinicReady and GlobalReady which are designed for pre-clinical, early phase and later phase clinical development. GlobalReady is a unique offering enabling biotechs to start rapidly and cost effectively with Avance Clinical in Australia and transition with our team in the US for later phase trials, with all the benefits of retaining the one CRO,” she added.

Conference Information:

KoNECT Korea, October 10-12 2023 at the Conrad Hotel, Seoul, South Korea

https://avancecro.121group.dev/event/konect-korea/

Book a meeting with Avance Clinical:

https://www.konectintconference.org/web/Partnering/partneringRegistration.do

 

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 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 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 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.

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Daniel Kontoh-Boateng

(862) 213-1398

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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

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 center 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.