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

By Company News, New Team MembersNo Comments

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

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

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

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

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

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

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

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

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

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

Madison Esely-Kohlman: Director of Business Development

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

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

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

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

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

About Avance Clinical

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

Award-winning CRO for Biotechs

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

Pre-clinical through to Phase I and Beyond

Avance Clinical offers pre-clinical consultancy services with their experienced ClinicReady team right through to Phase I and beyond clinical services leveraging significant Government incentive rebates of up to 43.5% and rapid start-up regulatory processes that are available in Australia. With experience across more than 110 therapeutic indications, Avance Clinical can deliver world-class, high-quality, internationally accepted data suitable for FDA and EMA review.

Technology

Avance Clinical uses state-of-the-art technology and gold-standard systems across all functional areas to provide clients with the most effective processes. Medidata, Oracle, Zelta, Veeva and Medrio are just some of Avance Clinical’s technology partners.

Avance Clinical Appoints North America SVP with Global Contract Research Organization, Data Quality and DCT Expertise

By Company News, New Team MembersNo Comments

Adelaide, Australia | San Diego, USA – Avance Clinical the leading award-winning Australian and North American biotech CRO that offers the GlobalReady program for biotech companies to speed up the path to regulatory approval, today announced the appointment of John Mann as Senior Vice President, North America Operations.

John Mann has over 24 years of working in CROs and 15 years of experience working in senior leadership roles including Quintiles (now IQVIA), INC Research (now Syneos Health), PRA Health Sciences, and ICON. He has worked across a diverse range of therapeutic areas and business groups, most recently as Vice President of Emerging Biotech and Rare Disease Operations, and Vice President of Decentralized Clinical Trials (DCTs) Operations at ICON.  

John Mann will lead a team of more than 30 clinical trial specialists in North America and report to the CEO, Yvonne Lungershausen.

 “John has a passion for quality and process improvement, leading people, project management, and change management within clinical operations, and is well placed to support the team and our biotech clients to achieve drug development success in North America,” said Yvonne Lungershausen.

She said: “Importantly John also brings the latest DCT technology and operations experience which offers cost and time benefits for our biotech clients.”

Avance Clinical has recently been ranked as the world leader in DCT technology adoption by GlobalData and Clinical Trial Arena in the CRO sector. The report found 46% of Avance Clinical’s trials incorporated some elements of DCT technologies in 2022 including telemedicine, remote monitoring, and digital data collection.

The DCT report also noted that Avance Clinical’s staff training in the latest technologies was a key factor in the ranking. See the full report here

John Mann said he was “extremely pleased to join such a world-class CRO with decades of experience and an exceptional reputation among US biotechs for early to late phase trials”.

“I am looking forward to applying my skills and knowledge in US-based global clinical trials as well as DCT enablement to support the biotech community which is increasingly under pressure to deliver results in a tough financial environment,” he said.

See more about John’s expertise here

“The US team is attracting biotechs wanting an experienced CRO that can deliver locally conducted trials with the highest reputation for quality data, outstanding site relationships, and rapid timelines,” commented Yvonne Lungershausen.

Avance Clinical’s GlobalReady enables biotechs that have completed early to mid phases in Australia to rapidly and seamlessly transition to the US in preparation for FDA approvals, all with the one CRO and dedicated teams across both regions, which reduces time and cost and delivers quality data.

There are currently more than 280 Phase III global trials that have conducted their Phase I study in Australia, which demonstrates Australian data acceptability with the FDA and other major regulatory authorities.

More than 40 biotech clients are now taking advantage of Avance Clinical’s GlobalReady program.

This seamless GlobalReady journey is designed so biotechs can:

  • Take advantage of the Australian early-phase clinical trial landscape (No IND and 43.5% tax rebate)                   
  • Transition or expand into North America for later phases – without changing CROs (retain study knowledge and processes/team)
  • Seamlessly operationalize global dose-escalation and dose-expansion trials across the two regions
  • Harness significant speed and cost advantages
  • Be assured of quality data – transferable and readily acceptable by the FDA and other regulatory authorities

Find out more:

  • Learn about the Australian Advantage here 
  • Learn about the GlobalReady model here
  • For more information about the benefits of running your next study with Avance Clinical contact us: enquiries@avancecro.com

About Avance Clinical

Avance Clinical is the largest premium full-service Australian and US CRO delivering quality clinical trials, with globally accepted data, in Australia, New Zealand and the US for international biotechs. The company’s clients are biotechs in their early phases of drug development that need fast, agile, and adaptive solution-oriented clinical research services.

Frost & Sullivan Awards

Avance Clinical, a Frost & Sullivan Asia-Pacific CRO Market Leadership Award recipient for the past three years, has been providing CRO services in the region for more than 24 years.

Pre-clinical through to Phase 1 and 2

Avance Clinical offers pre-clinical services with their experienced ClinicReady team right through to Phase 1 and 2 clinical services leveraging significant Government incentive rebates of up to 43.5% and rapid start-up regulatory processes.

With experience across more than 110 indications, the CRO can deliver world-class results and high-quality internationally accepted data for FDA and EMA review.

Technology

Avance Clinical uses state-of-the-art technology and gold-standard systems across all functional areas to provide clients with the most effective processes. Medidata, Oracle, IBM Watson and Medrio are just some of the technology partners.

www.avancecro.com