Skip to main content

Avance Clinical Expands Further into APAC with New Clinical Operations in South Korea – Seoul Office Announced at BIO Korea 2024

By Other newsNo Comments

Adelaide, Australia | North Carolina, USA – Avance Clinical, the award-winning Australian and North American market-leading CRO for biotechs, will attend BIO Korea (May 8-10, 2024) and formally open new clinical operations in Seoul, South Korea.

Meet the team at BIO Korea.

Avance Clinical CEO, Yvonne Lungershausen said the decision to open clinical operations in Seoul followed increasing demand from later phase US biotechs, as well as CRO partners for access to the region’s scientific excellence and patient populations.

“In addition, feedback from a recent presentation of our GlobalReady drug development solution to more than 75 Korean biotechs and pharmaceutical companies in Seoul showed a real need for Korean clinical operations with a global pathway,” said Lungershausen.

“It’s clear there is a demand for a mid-sized, agile, and responsive CRO with an in-house regulatory affairs team, and a proven track record of swiftly advancing high-quality clinical programs. This makes us an ideal CRO partner for later phase biotechsthat are seeking access to significant patient populations,” she said.

The new South Korean operations also offer a strategic presence for Avance Clinical’s CRO partners conducting multi-regional or global trials.

In addition, Korean biotechs are utilizing our Australian and United States clinical services as they progress their drug development programs,” said Lungershausen.

“Our Avance Clinical teams in APAC, Europe and the United States, offer our biotech clients world-class quality data and seamless geographic expansions to accelerate their drug development programs and position for success.”

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

“Biotechs are looking for a partner that can start fast with high-quality data that is readily accepted by the US FDA and other regulatory agencies. Backed by our in-house global regulatory affairs team, we can navigate biotechs through regulatory complexities with confidence including FDA, EMA, MFDS and TGA submissions,” she said.

“In addition, our GlobalReady Site Partnership Network of over 2,000 highly qualified sites across the globe ensures maximum efficiency and effectiveness for our biotech client’s trials,” she said.

Avance Clinical is focussed on accelerating drug development for its biotech clients, from preclinical stages through to Phase III.

“This is our GlobalReady program and we have more than 90 biotech clients leveraging this unique, streamlined multi-phase and multi-region process. With a globalized strategy, we ensure efficiency every step of the way,” she said.

Book a meeting with the team at the Australian Pavilion at BIO Korea to meet with our team of clinical trial experts.

Find out more:
• Learn about the GlobalReady model
• For more information about the benefits of running your next study with Avance
Clinical contact us
Request a Proposal here

Avance Clinical Welcomes Alex Kavros as Executive Vice President of Scientific & Regulatory Affairs

By Company NewsNo Comments

Avance Clinical, a leading Contract Research Organization (CRO) renowned for its innovative solutions in the biotech industry, is excited to announce the appointment of Dr Alex Kavros as the new Executive Vice President of Global Scientific & Regulatory Affairs. With an impressive career spanning nearly two decades in drug development, regulatory science and operations, Alex brings a wealth of knowledge and experience to the Avance team.

Before joining Avance, Alex held significant roles at Ergomed, Worldwide Clinical Trials and Vifor Pharma, where he led clinical development campaigns, spearheaded global regulatory operations and optimized business processes and workflows . His expertise encompasses a broad range of pharmaceutical products, including biologics/ATMPs, small molecules and vaccines, across various stages of development from clinical development to marketing authorization and product launch.

Alex’s academic credentials are equally impressive, with a BSc (Hons) and PhD in Chemistry from Lancaster University, UK, followed by a Post-doc in Macromolecular Engineering at Carnegie Mellon University, Pittsburgh, PA. His robust scientific background   has been instrumental in his professional achievements and in shaping his approach to regulatory science.

In his previous roles, Alex has been a pivotal figure in driving business growth, enhancing regulatory service capabilities, and ensuring operational excellence and compliance within complex regulatory environments. His leadership in overseeing 5,000 regulatory submissions globally underscores his capability to manage and navigate the intricate regulatory landscape effectively.

Residing in Zurich, Switzerland, Alex is poised to leverage his extensive experience at Avance Clinical. His responsibilities will include developing and maintaining a proactive, solution-oriented team of regulatory experts, fostering a strong culture of compliance and customer-centricity, and spearheading regulatory operations for clinical trials. Alex’s role is crucial in ensuring that ‘ClinicReady’ and ‘GlobalReady,’ align with Avance’s commitment to supporting the development of products that significantly improve patient outcomes and quality of life.

Alex finds the integration of ‘ClinicReady’ and ‘GlobalReady’ concepts within Avance’s development strategies compelling. This approach not only enhances Avance’s domain expertise in scientific and regulatory field but promotes the development of innovative products that meet critical patient needs.

“I am thrilled to join Avance Clinical, an organization that stands at the forefront of innovation in the clinical research field,” Alex states. “I look forward to contributing to our clients’ success by navigating the regulatory landscape with precision and strategic foresight, ensuring that we continue to deliver solutions that advance patient care and improve quality of life.”

Please join us in welcoming Alex Kavros to the Avance Clinical team, where his expertise and leadership are anticipated to drive significant advancements in the biotech industry, reinforcing Avance’s position as a trailblazer in scientific and regulatory services.

 

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.

Introducing William Faria, the New Vice President of Biometrics at Avance Clinical

By New Team MembersNo Comments


Introducing William Faria, the New Vice President of Biometrics at Avance Clinical

Avance Clinical, the Australian and North American market-leading Contract Research Organization (CRO) for biotechs, proudly welcomes William Faria as its new Vice President of Biometrics. With an extensive background in data management within the biometrics sector, William brings a wealth of experience and a global perspective to his new role.

William’s journey in the clinical research industry commenced in 2002 in the bustling hub of Boston, where he worked with distinguished organizations including Parexel, Wyeth, Biogen-Idec, and Boston Scientific. His dedication to advancing healthcare also led him to collaborate with the Harvard Clinical Research Institute. In 2007, driven by a passion for humanitarian causes, William embarked on a transformative journey with Doctors Without Borders, rendering healthcare support in Haiti, Nigeria, South Sudan, and Ethiopia. This enriching experience prompted his relocation to Europe, where he assumed leadership roles at Keyrus Biopharma in Paris and Galderma in the south of France.

A graduate of The Johns Hopkins University, where he studied Behavioral Biology, William’s academic foundation further enhances his multidisciplinary approach to biometrics. In his previous role, William contributed significantly to the early phase group of Syneos Health, focusing on biometrics optimization across various functional areas.

What drew William to Avance Clinical was its forward-thinking leadership and remarkable growth trajectory. Currently based in Gap, France, William is poised to spearhead the biometrics division, steering the team through a period of expansion, and implementing cutting-edge technologies to enhance efficiency and quality.

“I am thrilled to join Avance Clinical, where innovation thrives in a dynamic environment,” William expresses. “My key focus will be on guiding the team through this period of growth and leveraging emerging technologies to drive excellence.”

The most intriguing aspect of Avance Clinical for William lies in its potential for innovation within a rapidly growing organization. As the new Vice President of Biometrics, William is poised to lead Avance Clinical towards new horizons, fostering a culture of excellence and innovation in biotech drug development.

Please join us in extending a warm welcome to William Faria as he embarks on this exciting journey with Avance Clinical. Together, we look forward to advancing healthcare solutions and making meaningful contributions to the biotech industry, to support areas of unmet need.

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 completing Phase I to Phase III of their drug development program that requires 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 four years, has been providing CRO services in the region for more than 26 years.

Pre-clinical through to mid to late phase

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

With experience across more than 120 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, TrialHub, Certinia, Salesforce, Zelta and Medrio are just some of the technology partners.

www.avancecro.com

Avance Clinical at the World Vaccine Congress 2024

Avance Clinical at World Vaccine Congress to Share Latest Vaccine Clinical Trial News Including an HIV-1 Study

By Conference NewsNo Comments

Adelaide, Australia | North Carolina, USA – Avance Clinical, the award-winning Australian and North American market-leading CRO for biotechs, will attend World Vaccine Congress in Washington DC (April 1-4, 2024) and share the latest clinical trial client news including the Uvax Bio announcement. (Booth #267)

Avance Clinical CEO, Yvonne Lungershausen said the World Vaccine Congress was an important event for the company’s US and Australian teams as they continue to excel in biotech vaccine CRO services.

Lungershausen said Avance Clinical is a mid-sized, agile, and responsive CRO with a proven track record of swiftly advancing high-quality clinical programs. “This makes us an ideal CRO partner for vaccine focussed biotechs,” she said. Lungershausen said the company has had significant vaccine client successes in infectious diseases, including COVID-19 and RSV, as well as other diseases such as Hypertension and Psoriasis.

She said Avance Clinical is proud to be working with many innovative vaccine biotech companies including Uvax Bio who have just announced another milestone in their Phase I HIV study. Mary Giffear, Uvax Bio’s Director of Clinical Operations reported, “we have completed enrolment in our Phase 1 study of the Company’s HIV-1 vaccine candidates, UVAX-1107 and UVAX-1197, and the Australia-based trial is on schedule ”.

Avance Clinical CEO Yvonne Lungershausen with Pedro Garbes, Uvax Bio's Vice President, Global Medical Lead at the Avance Head Office in Adelaide, Australia in 2024.

Avance Clinical CEO Yvonne Lungershausen with Pedro Garbes, Uvax Bio’s Vice President, Global Medical Lead at the Avance Head Office in Adelaide, Australia in 2024.

Lungershausen said Avance Clinical is focussed on accelerating drug development for its biotech clients, from preclinical stages through to Phase III.

“This is our GlobalReady program and we have more than 90 biotech clients leveraging this unique, streamlined multi-region process. With a globalized strategy, we ensure efficiency every step of the way,” she said.

“Biotechs are looking for a partner that can seamlessly help transition them with the ability to start fast with high-quality data that is readily accepted by the US Food and Drug Administration (FDA) and other regulatory agencies. Our in-house global regulatory affairs team assists biotechs to navigate regulatory complexities with confidence and work to support our clients with FDA, EMA and TGA submissions,” she said.

“In addition, our GlobalReady Site Partnership Network of over 1,250 highly qualified sites across the United States ensures maximum efficiency and effectiveness in our biotech’s clinical trials,” she said.

Another key advantage for vaccine biotechs is that Avance Clinical is accredited as a gene technology CRO which allows it to manage pre-clinical and clinical trials for vaccines and GMO therapies.

The Office of the Gene Technology Regulator (OGTR) has developed globally compliant regulations and accreditations which are in line with international guidelines.

Avance Clinical’s Chief Scientific Officer Dr. Gabriel Kremmidiotis said: “This means that as an OGTR accredited CRO we can support our international biotech clients with extensive OGTR knowledge and experience to accelerate their clinical research. Indeed, we would argue the clarity around the OGTR regulations makes Australia one of the most attractive destinations for Cell and Gene Technology research,” he said.

Avance Clinical at the World Vaccine Congress 2024

Avance Clinical at the World Vaccine Congress 2024

Find out more:

 

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 completing Phase I to Phase III of their drug development program that requires 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 four years, has been providing CRO services in the region for more than 26 years.

 

Pre-clinical through to mid to late phase

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

 

With experience across more than 120 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, TrialHub, Certinia, Salesforce, Zelta and Medrio are just some of the technology partners.

 

www.avancecro.com

Avance Clinical CEO Talks with SCRIP Intelligence about a New CRO Report and US Biotech Sector “Green Shoots” 

By Company NewsNo Comments

New Biotech Report by Frost & Sullivan

 

Adelaide, Australia | San Francisco, USA – Avance Clinical, the award-winning Australian and North American market-leading CRO for biotechs, has today spoken with SCRIP Intelligence about their positive outlook for the US biotech sector following the J.P. Morgan Healthcare Conference and Biotech Showcase meetings. (read the full article here)

Avance Clinical CEO, Yvonne Lungershausen was interviewed by SCRIP Intelligence about the current biotech financial and drug development climate in the US and signs of growth.

Lungershausen noted there was a positive shift in sentiment compared to the previous year, with some companies even announcing their Series A funding during the conference. However, she emphasized that investors remained cautious, demonstrating a low-risk appetite in their investment decisions.

“We’re seeing green shoots in terms of funding coming through now in the US, but I think it’s still a bit of a tough road ahead. Investors are really being super cautious about where they’re investing and relatively, there’s not a high-risk appetite,” Lungershausen said to SCRIP in the interview.

The Avance Clinical team engaged with industry leaders at the J.P. Morgan Healthcare Conference and Biotech Showcase, sharing insights into the evolving landscape of biotech funding, their strategic partnerships in the AI sector, and groundbreaking developments in oncology study design.

The interview also covered AI saying “Lungershausen indicated that Avance had taken the position of having an innovation and technology group specifically to look at how the CRO can best support clients to get the data that they need for their trials as quickly as possible.

Avance Clinical, she said, is looking at partnerships with companies developing AI and making the assessment of “whether or not that’s something that we should bring in-house and offer to our clients”. It is also keen to work with some of those companies in terms of helping them “understand what the landscape requires”.

According to the interview “Avance’s CEO maintained that Australia also featured “high on the agenda” for a lot of the biopharma companies at JPM “because time is money”.

“That came through over and over again and the ability to start fast with high-quality data that is readily accepted by the US Food and Drug Administration and other regulatory agencies was very important,” she explained.

While a 43.5% rebate on clinical trial costs in Australia provides biopharma clients “a longer runway with their money”, there’s also the exchange rate advantage that typically comes into play.

Importantly, sponsors also don’t require to have an active own-country IND to initiate trials in the island continent. That, Lungershausen stated, is the “biggest advantage” and is possible because Australia has a streamlined and efficient regulatory process.”

According to the interview she said, “that amid the generally tight funding environment what also came through strongly…was the need for biotechs to find the right partner”.

SCRIP Intelligence noted that Avance Clinical presented at JPM and Biotech Showcase a new analysis by market research leader, Frost & Sullivan on the biotech sector and the challenges they have finding the right fit or size CRO.

The analysis has shed light on critical hurdles faced by more than 60% of US biotechs seeking the right CRO partner to propel their drug development programs forward.

SCRIP Intelligence said Lungershausen believes that Avance Clinical “is ideally positioned being able to support biopharma with the advantages of Australia for early phase trials and “start fast but then pivot back to the US very quickly”.

“They’re looking for a partner that can seamlessly help transition them and there’s a lot of excitement about that,” she said.”

The comprehensive report underscores the increasing preference of biotechs to collaborate with mid-sized, agile, and responsive CROs with a proven track record of swiftly advancing high-quality clinical programs. The findings suggest that large multinational CROs may be perceived as less responsive and less adept at adapting to the fast-paced nature of biotech demands.

Key insights from the analysis:

  1. Challenges in Partner Selection: The analysis reveals that 60 to 65% of US biotechs encounter challenges in identifying the right-sized CRO partner capable of delivering at every phase of their drug development program.
  2. Perception of Large Multinational CROs: There is a notable perception among biotechs that large multinational CROs may be less responsive and adaptable to the dynamic requirements of the biotech industry.
  3. Biotech Funding Decline: The report highlights challenges faced by biotechs, including a decline in biotech funding, increased drug development complexity, evolving FDA regulatory review processes, and costly delays due to slow patient recruitment.
  4. Engagement with Multiple CROs: More than 50% of biotechs engage with more than one CRO during their clinical program, leading to increased costs, delays, and challenges in knowledge and data transfer.

Find out more:

 

Media Contact:

Avance Clinical

media@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 completing Phase I to Phase III of their drug development program that requires 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 four years, has been providing CRO services in the region for more than 26 years.

Pre-clinical through to mid to late phase

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

With experience across more than 120 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, TrialHub, Certinia, Salesforce, Zelta and Medrio are just some of the technology partners.

www.avancecro.com

 

Avance Clinical and Ryght Partner to Bring Novel GenAI Technologies to Clinical Research Networks

By Company NewsNo Comments

February 20, 2024

Avance Clinical and Ryght Partner to Bring Novel GenAI Technologies to Clinical Research Networks

Revolutionizing Clinical Research: Accelerate Innovation with GenAI by Ryght & Avance Clinical

Laguna Beach, California – [February 20, 2024] – Ryght, an innovator in generative artificial intelligence (GenAI) technology for the Life Science industry, today announced a strategic partnership with Avance Clinical, the largest specialist Australian and US CRO (Clinical Research Organization) delivering quality clinical trials in Australia, New Zealand and North America for international biopharma companies.

Under the terms of this partnership, Avance Clinical will gain access to Ryght’s advanced GenAI technology, which utilizes various large language models (LLMs) fine-tuned for the sector to process live data streams and complex data, delivering actionable insights to clinical research groups.  Through the integration of Ryght’s sophisticated platform, Avance will boost its GenAI capabilities, enabling its biopharma partners to expedite the workflows of everyday tasks and drive innovation within the biopharma field.

“Our partnership with Avance Clinical allows our adaptable GenAI platform to be utilized to accelerate the productivity of its employees and research networks by meeting the unique needs of its teams, such as streamlining the workflows of time-consuming tasks, including the extensive documentation required for clinical development,” stated Simon Arkell, CEO of Ryght. “This collaboration marks a pivotal moment for the progress of GenAI-powered solutions within the CRO and biopharma sector. Through centralizing collective knowledge and resources, both companies are poised to make a lasting impact on the future of healthcare.”

Avance Clinical, a leading company in the CRO sector, is dedicated to fostering innovation and enhancing patient care with cutting-edge technologies. The incorporation of the Ryght platform into its research networks will enable Avance Clinical to optimize workflows, boost operational efficiency, and unlock new potential for collaboration and discovery.

“We are thrilled to collaborate with Ryght and utilize their GenAI platform to advance our clinical trial processes,” stated Yvonne Lungershausen, CEO of Avance Clinical. “Ryght’s innovative technology complements our dedication to innovation and excellence seamlessly. Through the application of AI, we aim to further support our biotech clients to develop transformative therapeutics in areas of unmet need.”

RSVP for Ryght’s upcoming LinkedIn Live discussion on Thursday, Feb. 29, 2024, to learn more about how GenAI is reshaping the landscape of CROs and clinical development by accelerating innovation and solving age-old challenges. Interested individuals can request access to a free version of Ryght currently available in beta at www.ryght.ai.

About Ryght:
Ryght is a privately held, venture-backed healthcare technology company based in Anaheim, California, dedicated to developing safe and secure generative artificial intelligence (GenAI) solutions for the biopharma, contract research organizations (CROs), and healthcare data organizations. Ryght’s platform leverages multiple large language models (LLMs) and specific, industry tuning to provide actionable knowledge to discovery, clinical, and commercial teams in the healthcare and life sciences industries. With a focus on accuracy, reliability, and efficiency, Ryght empowers professionals to make informed decisions and drive innovation.

Ryght Media Contact:
Brian Dranka
brian@ryght.ai

Learn more about Ryght.

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.

Avance Clinical Media Contact:
media@avancecro.com

See the coverage here on Fierce Biotech – https://www.fiercebiotech.com/cro/avance-clinical-adopts-ryght-ai-tech-streamline-clinical-trial-processes

Frost & Sullivan Analysis Reveals 65% of US Biotechs Struggle to Identify Suitable CRO Partner

By Company News

Latest Analysis Reveals 65% of US Biotechs Struggle to Identify Suitable CRO Partner – Affecting Drug Development Schedules & Financial Plans

Avance Clinical, the leading Australian and North American CRO for biotechs announced today that new industry analysis shows 60-65% of US biotechs face challenges identifying the right sized CRO partner that can deliver at every phase of their drug development program. The report found this directly affected clinical programs and budgets.

The report also found that 50% of biotechs engaged with more than one CRO over the course of their clinical program potentially impacting knowledge transfer, timelines and budget.

To download this white paper, please submit your details on the form.

Find out more:

FILL IN THE FORM TO DOWNLOAD THE WHITE PAPER

By filling in this form you consent to Avance Clinical contacting you. Read our Privacy Policy
This field is for validation purposes and should be left unchanged.

[/one_third]

Avance Clinical Strengthens Asia-Pacific Network with Digital Technology Company JNPMEDI INC

By Company News

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.