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
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.