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”.
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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/
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.
