Tag: Avance Clinical

Avance Clinical, the award-winning Australian and North American market-leading CRO for biotechs, is sharing new data at BIO 2024 from Frost & Sullivan research showing biotechs save more than 30% in costs and halve start-up times with CROs that have in-house scientific and regulatory affairs.

Meet the team at BIO 2024 Booth #5601

DOWNLOAD THE REPORT HERE

According to the report key benefits for biotechs with CROs that have in-house scientific and regulatory affairs included:

• Decrease trial startup timelines by up to 50% by supporting sponsors in preparing the study protocols, reviewing essential documents and prepping site for activation. 
• Reduced compliance risk and achieve zero errors by preparing necessary regulatory documents, compile submission dossiers and manage responses with regulatory authorities 
• Decreased cost to sponsors by up to 30% by enabling sponsors to leverage benefits of full-service CRO services and avoiding standalone contracts with independent regulatory affairs agency. 

Avance Clinical’s Chief Scientific Officer Gabriel Kremmidiotis said some of the biotech services offered by the Avance Clinical in-house Scientific and Regulatory Affairs team included:

• Regulatory Strategy Development: We devise regulatory strategies to navigate diverse regulatory landscapes, ensuring timely submissions and approvals. 
• Liaison with Regulatory Authorities: We serve as the primary liaison between our clients and regulatory authorities, maintaining open lines of communication and addressing inquiries promptly.
• Surrogate Development: Acting as a surrogate development department, we assist start-up companies in demonstrating safety and preliminary clinical proof of concept of their assets.
• Streamlined Marketing Application: Our medium-term aim is to offer a streamlined and flexible marketing application experience to our clients through our fully integrated functions within SRMA, harnessing our comprehensive global expertise.
• Adherence to GCP Standards: We utilize quality systems that uphold adherence to Good Clinical Practice (GCP) standards, safeguarding the integrity and ethical conduct of clinical trials. 

Avance Clinical recent news:

• Opened clinical operations in South Korea
• Signed an MOU with CNS specialist European CRO Julius Clinical

Avance Clinical is focussed on accelerating drug development for its biotech clients, from preclinical stages through to later phase trials.

Avance Clinical CEO, Yvonne Lungershausen said “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”.

“Our Australian and New Zealand operations have been delivering successful early phase clinical trials for decades, while our European and North American operations as well as our new Asia operations makes us an ideal CRO partner for later phase biotechs that are seeking access to significant patient populations,” she said.

“Our global teams 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 EMA and FDA.” 

“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 2,500 highly qualified sites across the globe ensures maximum efficiency and effectiveness for our biotech clients’ trials.”

Lungershausen said this is our GlobalReady program and we currently 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.

DOWNLOAD THE REPORT HERE

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

Media Contact:
Avance Clinical
media@avancecro.com 
Kate Thompson

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, the award-winning Australian and North American market-leading CRO for biotechs has signed a Memorandum of Understanding (MOU) with Julius Clinical, a leading CNS, cardiometabolic, and rare diseases specialist CRO with extensive site relationships in the region.

Meet the Avance Clinical team at BIO 2024 – Book a meeting now.

Julius Clinical, established in 2008 and headquartered in Zeist, The Netherlands, specializes in CNS, cardiometabolic, and rare diseases. The non-exclusive MOU between Avance Clinical and Julius Clinical offers a streamlined global solution for biotech clients.

Avance Clinical CEO, Yvonne Lungershausen noted that Avance Clinical has expanded globally establishing operations now in Europe, Australia, New Zealand, Asia and North America.

She emphasized, “Avance Clinical is now a global CRO for biotechs. In addition to our existing operations, our specialist partner CROs work alongside our teams to ensure our biotech clients benefit from the most experienced scientific, regulatory, and clinical operations teams across various therapeutic areas and regions”.

“Julius Clinical are an ideal partner for Avance Clinical because they lead with scientific expertise and can support our biotech clients with specialist CNS, cardiometabolic and rare diseases clinical operations and site relationships in Europe,” Lungershausen said.

She added, “Julius Clinical clients can also leverage Avance Clinical operations in Asia, Australia, New Zealand, and North America for their expanded later phase trials”.

Julius Clinical has supported over 380 clinical trials, enrolling more than 220,000 participants in around 39 countries.

Lungershausen said that Avance Clinical teams across Europe, Australia, New Zealand, Asia, and North America provide world-class data and facilitate seamless geographic expansions to accelerate drug development programs, with study data accepted by regulatory authorities including the EMA and FDA. 

Martijn Wallert, CEO of Julius Clinical, added, “We are excited to be partnering with Avance Clinical. Biotechs seek partners that can start quickly with high-quality data accepted by regulatory agencies like the MHRA, EMA, and US FDA. Together with Avance Clinical, we offer a nimble, flexible, and scientifically robust service, providing a tailored global solution”.

Avance Clinical is committed to accelerating drug development for biotech clients from early to later phase trials, allowing clients to remain with one CRO throughout their clinical development program. “This is our GlobalReady program, currently utilized by more than 90 biotech clients. Our globalized strategy ensures efficiency at every step,” Lungershausen concluded.

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

Media Contact:
Avance Clinical
media@avancecro.com 
Kate Thompson

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 consulting and regulatory 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

About Julius Clinical
Julius Clinical, founded in 2008 and based in Zeist, The Netherlands, is a scientifically focused CRO providing end-to-end clinical trial service to pharmaceutical and biotechnology customers, as well as governments and academia. Julius Clinical’s renowned scientific leaders are at the forefront of their fields, which combine with operational excellence and a global network of research sites to deliver tailor-made solution for customers and their clinical trials. With a focus on the therapeutic areas of CNS, cardio-metabolic, renal, and rare diseases, Julius Clinical has grown to approximately 200 employees and has supported over 380 clinical trials, enrolling more than 220,000 participants in around 39 countries.

www.juliusclinical.com

• Seoul Office Announced at BIO Korea 2024
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 with the team at BIO KoreaAvance 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 biotechs that 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 clients’ 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 modelFor more information about the benefits of running your next study with Avance Clinical contact usRequest a Proposal here
Media Contact:Avance ClinicalKate Thompsonmedia@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 AwardsAvance 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 phaseAvance 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.TechnologyAvance 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, the award-winning North American and Australian market-leading CRO for biotechs, will attend World Orphan Drug Conference in Boston (April 23-25, 2024) to share their rare diseases drug development expertise with biotechs (booth #730).

Avance Clinical CEO, Yvonne Lungershausen said that Avance Clinical is dedicated to advancing research and ensuring faster access to therapies that can make a significant difference in patients’ lives.  

“Avance Clinical has deep therapeutic knowledge of this area, completing over 50 trials in rare and orphan diseases globally in the last five years, including Fragile X Syndrome, Duchenne Muscular Dystrophy, Rett Syndrome and Erythropoietic Protoporphyria,” she said. 

Central to the company’s success in this sector is collaboration with disease-specific advocacy groups, patient registries, and tailored recruitment strategies, to enhance patient enrolment and retention.  

Lungershausen said, “We have an extensive understanding of the unique challenges in managing small patient populations. Our patient-centric approach places patients at the heart of our operations, ensuring optimal care through the selection of experienced sites and clinics. 

“Avance Clinical engages with clients early in the planning process to tailor trial designs to accommodate the unique needs and challenges faced by patients with rare diseases, ultimately improving patient access to critical medicines,” she said. 

Avance Clinical is adept at crafting adaptive, patient-focused protocols that adhere to regulatory standards. The company’s innovative approach to study design, combined with over 26 years of experience in delivering FDA and EMA-quality data, positions Avance Clinical as a CRO capable of navigating the complexities of the regulatory landscape efficiently. 

Lungershausen describes Avance Clinical as 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 rare disease-focussed biotechs,” she said.  

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

“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 rapidly with high-quality data that is readily accepted by the FDA and other regulatory agencies. Our in-house global regulatory affairs team assists biotechs to navigate regulatory complexities with confidence and 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, particularly in rare and orphan indications,” she said. 

New analysis by market research leader Frost & Sullivan shows one of the major challenges for biotechs was finding the right biotech aligned CRO partner. 

“More than 60% of US biotechs experience delays seeking the right CRO partner to accelerate their drug development programs,” Lungershausen said. (See report here). 

The comprehensive report underscores the increasing biotech preference to collaborate with the right sized CROs that can accommodate the fast-paced nature of biotech demands. 

Executive Vice President, North America Operations, John Mann, will attend the conference in Boston alongside Avance’s team of clinical trial experts, including Senior Vice President, Scientific and Regulatory Affairs Kevin Leach and Director of Business Development Clint Henry.

Visit Booth #730 to discuss your upcoming clinical trial, and find out more about the Avance Clinical Advantage, supporting biotechs globally in their clinical development programs.

Book a meeting with the team here 

Find out more: 

• Learn about the GlobalReady model here https://www.avancecro.com/avance-clinical-north-america-operations/  
• For more information about the benefits of running your next study with Avance Clinical contact us  
• Visit Booth #730 to discuss your drug development program at the World Orphan Drug Congress in Boston, April 23- 25 

Media Contact:  
Avance Clinical 
media@avancecro.com  
Kate Thompson 

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 consultancy through to Phase III clinical services leveraging global reach, supported by 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, 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 enrollment 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.”

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.

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

Media Contact:
Avance Clinical
media@avancecro.com
Kate Thompson

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, the award-winning Australian and North American market-leading CRO for biotechs, has today spoken with SCRIP 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 ground-breaking 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 (See report here).

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:
Learn about the GlobalReady model here https://www.avancecro.com/avance-clinical-north-america-operations/

For more information about the benefits of running your next study with Avance Clinical contact us: enquiries@avancecro.com

Media Contact:
Avance Clinical
Kate Thompson
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

• Affecting Drug Development Schedules and 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.

View the report here

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.

The new analyst report from Frost & Sullivan examined the challenges biotechs face during the CRO selection process saying “biotechs are increasingly wanting to partner with mid-sized, agile, and responsive CROs with a proven ability to rapidly advance quality clinical programs”.

“There is a perception among biotechs that large multinational CROs are less responsive and unable to adapt to the fast-paced nature of biotech demands,” according to the report.

Additionally, it noted that biotechs currently faced multiple challenges including a decline in biotech funding, a rise in drug development complexity, evolving FDA regulatory review processes, and costly delays caused by slow patient recruitment.

The report concluded that biotechs, especially those aiming to meet investor milestones, need to select the right CRO from the start.

The report outlined the key criteria US-biotechs use to identify the right CRO including:

1.    Established site relationships
2.    Scientific excellence
3.    Quality compliance and data excellence
4.    Cost competitive
5.    Patient recruitment solutions
6.    Agile and responsive
7.    Accelerated timelines
8.    Regulatory approval track-record
9.    Ability to expand to multi-regional global phases
10.    Access to latest technologies (including Artificial Intelligence & Machine Learning)

The report emphasized that biotechs were seeking CROs with established site relationships and highlighted that Avance Clinical now has more than 1,250 US-based sites in their GlobalReady Site Partnership Program to support US biotechs accelerate their clinical trials.

Each site has been accredited by Avance Clinical for data quality, patient centricity, and streamlined processes designed meet rigorous clinical timelines.

In addition, the report found a regulatory affairs track-record was a key selection criteria saying in-house regulatory expertise was the most attractive option for biotechs. It found that Avance Clinical is one of the only Australian/US mid-sized CRO with an inhouse regulatory affairs team experienced in FDA, EMA and China FDA approval processes.

Avance Clinical presented the report at JPM and Biotech Showcase 2024 where the team is taking meetings.

Avance Clinical has been recognised by Frost & Sullivan for the past 4 years with the prestigious Frost & Sullivan Asia-Pacific CRO Best Practices Leadership Award.

CEO Yvonne Lungershausen said “We have shown, with our high growth and industry-leading repeat business rates that our focus on gold standard technology paired with solution-orientated clinical experts is the mix our biotech clients need for clinical success”.

“Avance Clinical’s 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,” she said.

GlobalReady gives our biotech clients conducting their early phase studies in Australia and New Zealand a seamless journey into the US to continue their clinical development programs, retaining the same high-quality CRO, which reduces time and cost and delivers quality FDA accepted data.

GlobalReady also enables US biotechs to conduct their mid to late phase studies in the US and expand to multi-regional locations.

In addition, the attractive 43.5% rebate on clinical spend in Australia, offers clients the opportunity to utilize our North American operations expertise and team, whilst maintaining services in Australia to maximise their rebate potential.

Find out more:

• Learn about the GlobalReady model here https://www.avancecro.com/avance-clinical-north-america-operations/
• For more information about the benefits of running your next study with Avance Clinical contact us: 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 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

Media Contact:
Avance Clinical
Kate Thompson
media@avancecro.com

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 maximise 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 maximise 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 recognises 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 recognised 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
Kate Thompson
media@avancecro.com

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.

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 Mould 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 decentralised 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. https://www.clinicaltrialsarena.com/features/year-in-review-dct-2022/

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

Book a meeting with Avance Clinical at ASCO https://www.avancecro.com/event/asco-2023-chicago-il/
Book a meeting with Avance Clinical at BIO Booth #2884 https://www.avancecro.com/event/4602/

Find out more:
Learn about the Australian Advantage here https://www.avancecro.com/the-australian-advantage/
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

Media Contact:
Avance Clinical
Kate Thompson
media@avancecro.com