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In Conversation with Gary Quashie, OPIS: Comparing Clinical Trial Landscapes in the US and Europe

The biopharma sector has faced numerous challenges in recent years, affecting clinical trial sponsors and their ability to initiate and continue trials.

To gain a deeper understanding of these challenges and the differences between the US and European markets, we spoke with Gary Quashie, Director of Business Development at OPIS. Across his career Gary has helped over 100 biotechnology & medical device companies with their clinical, commercial, and regulatory strategies across EMEA and US.

Challenges Faced by Biopharma Trial Sponsors

According to Gary, in 2023 the industry was impacted by a 48% drop in biotech funding, with IPO proceeds falling by 93% (source: Labiotech). This, merged with the collapse of Silicon Valley Bank, and the ripple effects of the US 2022 Inflation Reduction Act has impacted every revenue stream for biopharma sponsors; licensing/exit strategies, manufacturing partnerships, R&D grants, and VC funding. These factors have pushed companies to be more strategic with their resources in this highly competitive industry.

Clinical sites have also faced challenges, with site staffing and retention, patient recruitment, and the complexity of clinical trials being the top issues. Gary emphasised the importance of sponsors being aware of these problems and leveraging long-standing relationships with small-to-medium-sized CROs like OPIS Research. Gary referenced WCG’s recent clinical research site challenges survey which shows that sites’ top ranked issues include (1) site staffing & retention, (2) patient recruitment/enrolment with joint third for (3) complexity of clinical trials & study start up. For sites; feasibility surveys, multi-arm complex trial designs are an additional layer of difficulty when admin workload demand is high. Resulting in longer trial start-up timelines for all stakeholders.

Depending on indication, some 40–85% of trials fail due to low patient recruitment, but 80% of trials are severely delayed due to participant dropout. Diving deeper into patient-centric trials, Gary cited a study by The Economist Intelligence Unit, of 4000 patients across phases II and III, that found patient-centric trials completed enrolment 40% faster and were 19% more likely to be launched. Therefore emphasising the importance of including patient advocacy groups and CROs early in protocol development stages (e.g. treatment schedules, screening burden, side effect management, dosage delivery factors, etc) to optimise study designs and reduce costs.

Gary stressed the importance of implementing patient diversity plans, which not only boost overall patient enrolment but have also shown to correlate with better endpoint data (source: Duke University Biostats Unit). The use of AI has also been a hot topic in the industry, with some groups seeing great success from leveraging blockchain technology for optimised study designs, predictive analytics for more precise recruitment (e.g. Datavent, Droice Labs), and sensor/wearable data. However, Quashie noted that it can be expensive for small-to-medium-sized biotechs to implement.

The Appeal of the US Market

Map of USA from International Space Station
Source: NASA

The US remains the number one location for conducting clinical research globally. Gary attributed this to several factors, including the FDA's robust framework, the NIH's support, and the presence of world-renowned medical institutes. The US also has a large, diverse patient population, with comparatively high levels of awareness and acceptance of clinical trials.

The US clinical trials market is valued at $23.8 billion (source: Vision Research), and the FDA's fast-track programs, orphan drug designations, and various other initiatives are seen as incredibly valuable for biotech companies looking to boost their brand and attain further funding. Collaborations with BARDA provide additional support for groups addressing public health needs.

Via the FDA, a single submission allows you to engage with 50 US states, totalling a population of 330 million potential participants. Providing a large and diverse population of patients almost all speaking the same language and sharing relatively similar "American" culture which means you can adopt a similar process and design across all sites. At least in comparison to conducting a multi-country study across other global regions.

In 2022, companies reported being able to get through IND stages in just 37 weeks, including CMC documentation, FDA submission, and IRB protocol submission. Licensing, partnerships, and funding strategies are also boosted by leveraging Key Opinion Leaders and influential researchers in the US.

Impact of US-China Tensions on Clinical Research

When asked about the potential impact of increasing tensions between the US and China on clinical research, Gary referenced Clarivate’s CMR report and UK DSIT's life sciences’ competitiveness indicator report showing that while the number of R&D citations in the US is declining, China has seen a steady increase in recent years. He clarified that political impact data tends to take approximately 3 years to show better accuracy but the trend was noteworthy.

Comparing the US and European Markets

Gary highlighted several key differences between the US and European markets. While the US has consistently accounted for 30% of commercial global studies for novel medicines, European countries have individually accounted for less than 5% each and cumulatively still accounted for fewer trials than the US. However, recent regulatory reforms in the UK and Europe have changed the landscape.

Running a study in Europe can be both faster and significantly more cost-effective, with strong Key Opinion Leader advocates. Especially for specific stratified patient segments as European patient advocacy groups tend to collaborate very well with clinical trial sites. The new European Clinical Trials Information System (CTIS) regulatory process has also streamlined. RAPS (Regulatory Affairs Professional Society have several publications on lessons learned and experiences from the first 18 months of the new framework with positive feedback. The drawbacks being that companies must be prepared to provide more in depth responses to requests for information (RFIs) within 12 days.

Study start-up contract negotiation processes vary by country, which can be challenging to co-ordinate. Gary emphasised the importance of carefully assessing specific sites during feasibility to ensure a smooth start-up phase. Before the pandemic, it took on average 155 days in the US to approve trials and set up a clinical study, including recruiting patients. In the UK, it took almost 100 days longer. However the UK has also made some recent reforms in 2023/2024 as described in a previous interview with Gary Quashie which can be found here:

Gary also noted some pockets of uncertainty for certain companies dealing with how the US FDA has opted to regulate laboratory-developed tests as medical devices, the UK's choice to replace the European Union's "CE" marking with its own "UKCA" mark, and the introduction of the new VPAG system, impacting drug pricing in the UK.

Looking Ahead

As the clinical trials landscape continues to evolve, Gary's pan-Atlantic insights provide valuable guidance for sponsors navigating the challenges and opportunities in both the US and European markets. By partnering with experienced CROs, leveraging patient diversity plans, carefully assessing site feasibility, and embracing patient-centric approaches and emerging technologies, sponsors can position themselves for success in this dynamic industry.

Gary Quashie will be at COG New England, taking place April 23rd & 24th 2024, in Burlington, MA. More information can be found here:


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