With cutting-edge hospital infrastructure being put in place, government authorities rolling out evermore supportive regulatory upgrades, big pharma championing ‘clinical trial diversity’ with greater non-Caucasian representation in trial cohorts, and a high regional prevalence of genetic diseases, it seems that the stage is set for the UAE to assume a much more prominent role in global clinical research. But is it that simple, and what needs to be done next for the Emirates to truly achieve clinical trial hub status?
Challenging Beginnings
Only one percent of global clinical trials take place in the Middle East and Africa, a number which reflects neither the size of the region, the burden of illnesses that its 1.5 billion-plus population carries, or the medicines they consume. Global biopharma has traditionally situated the in-human testing of its latest molecules in the US and Europe with their large and willing patient populations, closer to headquarters, hospitals and universities with the expertise to carry out such trials, and marketplaces with the financial means to absorb any products that emerge from them.
Even in the region’s most developed markets, like the UAE, challenges abound. Mohamed Mostafa, CEO of full-service MEA-focused clinical research organisation PDC CRO notes that “the UAE’s small population size is a challenge. Additionally, most of the people here are expats, and because they are travelling here for work, they are generally in good health. Also, the population is 70 percent male, so women-specific studies or gender-diverse research becomes more challenging.”
Mostafa continues, “Having worked for Big Pharma companies, I know that headquarters’ decision making around site allocation is based on two areas: operational and strategic. Operationally we are fine in MEA, with a diverse population, rapid site activation, good infrastructure, and strong regulatory bodies. Where we struggle in most of the region is on population and commercial market size. Nevertheless, if we do have a pool of patients, like in rare diseases, it is a lot easier to convince pharmaceutical companies to partner with us here.”
MSD GCC Managing Director Ashraf Mallak adds that “There are several reasons why MSD did not have a clinical footprint in the GCC in previous years. Some of the external reasons include the need for a large population, a large number of patients to conduct trials, as well as an established research infrastructure.”
Changing Times
However, spearheaded by the UAE and its ambitious attempts to climb the biopharmaceutical value chain, there are now hopes that MEA can become a more significant contributor to global clinical research efforts.
Mallak points out that “things are changing. Last year we signed an agreement with the Department of Health of Abu Dhabi (DoH) to start exploring observational research in the UAE. We invited our Global Clinical Research Team for a visit to Abu Dhabi to assess preparedness for clinical trials which showed great promise due to the diversity of the UAE population, the high calibre of the healthcare infrastructure and institutions, the talent and competence of researchers with vast international experience as well as the regulatory environment of the UAE.”
The physicians within MEA have sufficient experience and knowledge gained from working and studying in Europe and the US, the right patient pools exist, and a good enabling infrastructure is there
Hassan Herrou, CSL Behring
Hassan Herrou, general manager for MEA at CSL Behring, which holds a significant portfolio of rare diseases therapies, sees strong fundamentals in place, at least in his company’s therapeutic areas of focus. “The physicians within MEA have sufficient experience and knowledge gained from working and studying in Europe and the US, the right patient pools exist, and a good enabling infrastructure is there. Therefore, there is a fantastic opportunity for CSL Behring to take the next step and conduct more multicentre clinical trials in the region.”
Others foresee more clinical trials coming to the region as part of the UAE government’s drive to achieve life science hub status. “The next stage in the country’s life sciences development, besides being a base for regional headquarters, will be greater investment in innovation and R&D, as APAC hubs like Singapore have already done, to propel the UAE forward,” says Samir Khalil, executive director of PhRMA MEA. “When choosing where to situate a clinical trial, industry sponsors are looking for a favourable ecosystem, which I think the UAE can work on further to attract a proportion of these global trials.”
Finding the Niches
There seems to be broad stakeholder alignment that, with a population of under 10 million, the UAE must focus in on specific niches to compete as a trial destination. “While the population is relatively small, the UAE could be a base for late-stage trials, which have a strong medical impact as well as an impact on employment and the overall economy,” says Khalil.
The Dubai Science Park’s Senior Vice President Marwan Abdulaziz Janahi continues, “We are seeing a growing number of late-stage clinical trials being carried out in the UAE, with the aim of providing access to treatments. This is particularly true for rare diseases, as the Middle East has a higher percentage of patients affected by such diseases than other regions. Several established pharmaceutical companies are investing in rare disease treatments, with companies such as AstraZeneca, which recently acquired Alexion, seeking to identify and treat patients in the region as part of their market access strategy. This is a highly positive trend.”
We are seeing a growing number of late-stage clinical trials being carried out in the UAE
Marwan Abdulaziz Janahi, Dubai Science Park
PDC CRO, which predominantly focuses on infectious diseases, metabolic disorders, and rare conditions, has been able to count on support from the authorities to fuel its clinical research output, especially in the paediatric space. “We have a lot of expertise in genetic, haematological, and neurological disorders, with the majority being paediatric-related,” notes Mohamed Mostafa. “It is especially important that these younger patients are diagnosed early as quick access to therapies gives them a big advantage later in their lives. This is all being fuelled by the government and the Al Jalila Hospital, the leading paediatric hospital in the UAE. We have even been able to conduct trials that involve patients from outside the UAE by having them referred for treatment here.”
Mostafa adds that “many of the trials we do here are extremely complex. The region is typically considered to be a rescue region, as when companies cannot find patients across the world they come here as a last resort. This means we are well prepared and are ready for simpler clinical trials in the future.”
Regulatory Upgrades
An ecosystem of supportive policies and regulations will be crucial if the UAE is to take the next step in its development towards clinical trial hub status. Positive steps have already been taken in this direction, as Mohamed Ezz Eldin, who heads up Novartis operations in the Gulf region, notes.
We have worked hard to ensure our regulatory framework fosters innovation and progress, whilst maintaining exceptional standards of quality and safety
Noura Al Ghaithi, Abu Dhabi DoH
“For a country to attract more R&D investments in areas like clinical trials, it is important to have a supporting regulatory framework to encourage private sector involvement,” says Ezz Eldin. “The UAE is attracting experts to the country by having the right infrastructure in place, collaborating with universities and institutes, and setting up clinical trial centres which will strengthen its position as a clinical trial centre in the region.
PDC CRO’s Mostafa is in accordance, adding that “the UAE government, particularly the Abu Dhabi DoH, has accelerated the development of clinical studies. They have overseen what we are doing and appreciate the importance of building a legitimate ecosystem that meets international regulations.”
The Abu Dhabi DoH’s own undersecretary, Noura Al Ghaithi, proclaims that “We have worked hard to ensure our regulatory framework fosters innovation and progress, whilst maintaining exceptional standards of quality and safety. This has included streamlining the approval process for clinical trials. It takes no longer than 28 days between trial submission and approval which has led us to see a rapid expansion in clinical trials, with a staggering increase in the number of clinical trials conducted locally between 2021 and 2022 – an increase year-on-year of 484 percent.”
The COVID Push
The COVID-19 pandemic and the subsequent rush to test therapeutics and vaccines in record time also had a big effect on the way in which the UAE, and the wider region, conducts and approaches clinical research. “During the pandemic, we adjusted approval timelines to be part of global clinical trials to develop vaccines in collaboration with the US, China, and Russia,” says the Dubai Science Park’s Abdulaziz Janahi. “In just two years, we streamlined our regulatory process, making it more robust and efficient, creating a strong foundation to accelerate innovation.”
COVID-19 was a massive catalyst for growth which has made people understand the importance of research
Mohamed Mostafa, PDC CRO
PDC CRO has seen its own business as an outsourcing partner for clinical research booming post-pandemic. “COVID-19 was a massive catalyst for growth which has made people understand the importance of research,” states Mostafa.
“Our clinical studies within this area have given confidence to pharmaceutical and biotechnology companies to conduct more research and partner with us in the region,” he says. “We partner now with many top 20 pharmaceutical global players through master services agreements or partnerships. Also, we have direct access to biotechnology companies and support them in their programs of clinical development through Phases I, II and III, with clients from the US, Europe, and Asia Pacific.”
Next Steps
While admirable progress has already been made in boosting the UAE’s clinical research output, there remains a long road to travel before the country can call itself a true global heavyweight in the field. For Abdulaziz Janahi, the ultimate goal for the UAE is becoming more than just a global node in the drug development process of innovations emanating from abroad, but instead bringing its own products to market.
“We need to focus on pushing ideas that are being developed at local universities from the lab bench to the market,” he says. “This is a long-term objective that cannot be achieved overnight, as it requires the development of capabilities and talent. I believe this will take place within the next five to ten years but is crucial to take the right measures to ensure it does so.”
