Brexit or not, the drug research and development landscape has changed

Zamas Lam, PhD, holds the position of Senior Vice President and Global Head of Preclinical Development for QPS (DE, USA), a global contract research organization providing discovery, preclinical and clinical drug development services since 1995. Lam is one of the world’s few high-resolution mass spectrometrists by training and by trade, with a passion for biologics mass spectrometry and gene therapy. Within QPS, he is an integral part of the preclinical and bioanalysis team supporting a first in the industry – the world’s largest gene therapy trial with patients numbering more than a million. Lam is a regularly published thought leader, with his expert insights appearing in publications such as Bioanalysis, Anal Chem, J Biol Chem, Biochemistry and Carbohydrate Research.

Brexit or no Brexit? The question that has been weighing on the UK for the past 3 years will soon have an answer (hopefully). The final decision regarding Brexit is expected later this month and it will reveal a lot about what lies ahead for the UK. Also, as it relates to the future of drug discovery, preclinical and clinical drug development in the UK and Europe, the Brexit announcement will either offer clarity or even more uncertainty. Unfortunately, regardless of whether the UK’s decision is to stay or leave, damage from the vote to leave the EU has already been done. Lost funding, the move of the EMA headquarters from London to Amsterdam and stories of clinical trials relocating are just a few of the reasons biotech and pharmaceutical companies are now searching for stability outside of the UK.

Here are some notable examples of the impact Brexit has already had prior to an official departure decision being announced:

The number of UK trials declined last year – The number of trials conducted in the UK was down last year. While small fluctuations in trial numbers are not uncommon, the reality is that the overall number of clinical trials conducted in the UK last year appears to have hit the lowest mark in 5 years. A report sharing MHRA data shows that the number of total clinical trials conducted in the UK fell from 1000 in 2017 to 955 in 2018. During that same time period, first-in-human trials (FIH) also fell from 105 to 85, while Phase I trials decreased from 156 to 131 and Phase II and III trials fell from 635 to 630. While some questions remain about the future of trials, these numbers show —at the very least—a lack of stability.

Research locations outside of the UK have become more attractive – Questions about what the future will look like after Brexit have been looming for more than 3 years. Because there has been so much uncertainty for so long, other locations that offer greater assurance of future stability have emerged as attractive options for research. The Netherlands, for example, is now considered a top R&D hub for biopharmaceutical companies. It is now home to the EMA headquarters, a multitude of VC investors, one of the world’s highest-ranking healthcare systems and several research institutes. Plus, as of 2019, the number of biotech companies residing in the Netherlands has grown to 470. Biotech companies leaving the UK as a result of Brexit have had a host of attractive options available for relocation.

Groundbreaking research is now in jeopardy – Research and trials in various stages are now in jeopardy of being disrupted. Sadly, delaying research and relocating trials has threatened progress and could make it much more difficult to maximize the groundbreaking work that has been done in the UK and the expertise that has been built there. Scientists in the UK are at the forefront of developing life-altering gene therapy and stem cell treatments for macular degeneration. Progress delays in this field, or any other area, are devastating, as is the fact that biotechs are laying down roots elsewhere rather than continuing to build on the UK’s established foundation.

These factors and others are leading biotech and pharmaceutical companies to explore new locations for preclinical and clinical research in Europe and the United States. For those weighing their options, money is certainly something to consider. Securing EU funding will become much more difficult for UK-based biotech companies if Brexit becomes a reality, so companies will likely follow the money and position themselves near investors. Again, in Europe, that makes the Netherlands an attractive choice because of its high concentration of VC investors.

Of course, another key consideration for biotech and pharmaceutical companies looking to relocate from the UK is proximity to a research partner. Companies need to look for partners that can support their unique research needs. Since the initial vote on Brexit, QPS has witnessed shifts in trends in terms of the research companies are requesting—and these shifts appear to be driven at least partially by financial factors. For example, qualitative and quantitative analysis of biologics has been in greater demand—as have other areas of research that are typically done by companies internally. When seeking a research partner, companies should look for one whose experience aligns with their particular needs.

Choosing which contract research organization (CRO) to work with is a big decision. Here are a few additional suggestions on what to look for when selecting a CRO:

• Established research facilities outside of the UK – Consider whether a CRO has a long history of success in its current location and if it is prepared to operate without disruption in the EU post-Brexit.
• Scientists trained in your company’s focus area – Scientists have different areas of expertise, so different CROs will have different strengths.
• Customization – A CRO should be willing and able to deliver a customized research strategy. Instead of taking the same approach to every study, a CRO needs to build a custom research plan based on a company’s needs.
• Access to highly specialized technology – A CRO should have (and know how to use) very advanced technology.

Although there is a lot of uncertainty about the future and the inevitable changes that will materialize if the Brexit vote is upheld, it is important to recognize how the drug research and development landscape has already changed as a result of Brexit.

With full-service research facilities around the globe, QPS has the scientists, teams and turn-key facilities needed to take on complex research projects. For more information, visit www.qps.com or email [email protected].