As healthcare systems across the GCC accelerate their focus on innovation, access, and advanced therapies, Novartis is positioning the region at the centre of its long-term strategy. Mohamed Ezz Eldin shares how global priorities are translated into local execution, from rare disease care and genomics to clinical research and innovative access models. The conversation offers insight into why the GCC has emerged as a priority environment for early launches, clinical development, and sustained public–private collaboration.
What have been your main priorities in translating Novartis’ global innovation strategy into action across the GCC, and how is this reflected in the portfolio you are advancing in the region today?
Over the past year, our focus in the GCC has been on disciplined execution. Our role is to translate Novartis’ global innovation strategy into practical, country-level plans that allow innovative medicines to reach patients in a fast and predictable way. Each market operates against a clear roadmap shaped by its healthcare system and regulatory environment. Since taking on the GCC scope, my primary priority has been partnership, working closely with governments, regulators, and healthcare stakeholders to accelerate and broaden access to innovation, not only in terms of speed of launch, but also in ensuring that access remains sustainable over time.
A second area of focus has been strengthening our innovation footprint, particularly in clinical research and evidence generation. We are expanding participation in clinical trials, investing in real-world evidence, and supporting local data generation that reflects the needs and characteristics of patient populations in the region. Alongside this, we continue to invest in data and digital capabilities to deepen our understanding of disease burden and to work with healthcare systems on more effective and sustainable models of care. Capability building underpins all of this, from developing our own teams to partnering with governments on the development of future national leaders across the GCC.
This approach is clearly reflected in our portfolio. Across the region, we have a strong presence in oncology, including solid tumours and haematology, cardiovascular, renal and metabolic (CRM) diseases, neuroscience, and immunology. We also have a significant footprint in advanced therapy platforms, particularly cell and gene therapies and radioligand therapies, which are increasingly important in areas of high unmet need. These include rare diseases such as spinal muscular atrophy, as well as selected cancers and blood disorders where CAR-T therapies play a role. Across all these areas, we work closely with health authorities to enable early and expanded access, while building the clinical, regulatory, and operational foundations needed to deploy advanced therapies responsibly and at scale.
How did the UAE’s approval and first administration of Novartis’ gene therapy for spinal muscular atrophy come together, and what does this milestone reveal about the region’s readiness for advanced therapies?
The spinal muscular atrophy milestone is a clear example of how the UAE’s healthcare ecosystem functions when regulatory frameworks, operational capability, and partnership are aligned. The country has developed a predictable and transparent regulatory and pricing environment that actively supports innovation, underpinned by strong public-private collaboration. In this case, accelerated review pathways enabled approval shortly after the US FDA, positioning the UAE as the second country globally to grant authorisation.
What made this milestone particularly meaningful was the speed with which approval translated into patient impact. The first administration of the therapy outside of clinical trials took place at Sheikh Khalifa Medical City in Abu Dhabi, demonstrating that regulatory readiness was matched by clinical, logistical, and institutional preparedness. For a condition such as spinal muscular atrophy, where outcomes depend heavily on early intervention, this ability to move rapidly from approval to treatment is critical.
Since its establishment, the Emirates Drug Establishment (EDE) has played a central role through accelerated review mechanisms, value-based pricing considerations, and strong operational execution. From our side, we ensured that the therapy was made available to the healthcare system as quickly as possible, working closely with regulators and providers. Taken together, this milestone reflects a clear vision, a mature regulatory approach, and effective partnership, all of which are essential to delivering advanced therapies to patients without delay.
How do you assess the evolution of the rare disease ecosystem across the GCC, and where do you see the most important opportunities to strengthen it further?
The rare disease burden across the GCC is significant, but the pace of progress over recent years has been equally notable. There has been sustained investment in infrastructure, combined with a clear political commitment to prioritising rare diseases across the continuum of care, from screening and referral through to treatment. National genome programmes in the United Arab Emirates, Saudi Arabia, and Qatar are generating large-scale genetic data that support precision medicine, earlier diagnosis, and a deeper understanding of rare conditions. Alongside this, we are seeing a stronger focus on awareness and screening, as well as on ensuring faster and more sustainable access to advanced therapies, which represents a meaningful shift compared with the past.
The next stage of development is less about building capability and more about connecting it. Genomic programmes have advanced rapidly, but the real opportunity now lies in linking these capabilities more systematically to clinical pathways, so that testing, interpretation, referral, and treatment operate as an integrated process. Early detection remains one of the most decisive factors for improving outcomes, particularly in rare diseases where timing is critical. Newborn screening programmes across the region illustrate this well, with genomic screening expanding in scope and enabling earlier identification of treatable conditions. Our role has increasingly been to work with regulators and healthcare systems to help translate genomic insights into practical clinical decision-making, rather than treating genomics as a stand-alone capability.
Advanced therapy platforms add an additional layer of complexity, particularly in terms of infrastructure, expertise, and logistics. Cell and gene therapies and radioligand treatments require specialised centres, highly trained teams, and robust supply chains, often involving complex cold-chain management. It is encouraging to see how heavily countries across the GCC have invested in centres of excellence, regulatory processes, and operational readiness to support these therapies. Considerable progress has already been made, and the opportunity ahead is to continue strengthening awareness, referral networks, and integrated care models so that innovation is consistently translated into better and more timely outcomes for patients.
How are you preparing the GCC for the next wave of launches from Novartis’ global pipeline over the coming years?
Novartis has a strong and well-balanced pipeline, and our approach in the GCC is shaped by a medium-term view rather than a focus on individual products. Over the next two to five years, we expect new medicines across all our core therapeutic areas, including oncology, cardiovascular, renal and metabolic diseases, neuroscience, and immunology. This reflects sustained investment in research and development and a continued focus on bringing differentiated, high-impact therapies to patients. In immunology, for example, we are preparing for new options in immune-mediated diseases, including chronic spontaneous urticaria, following recent regulatory progress at a global level, with similar momentum building across our other therapy areas.
Preparation in the region starts well ahead of launch. We work early with healthcare systems and regulators to ensure readiness from a regulatory, clinical, and operational perspective, so that access can follow without unnecessary delay. This builds on a consistent track record of execution, with an average of two to three innovative medicines introduced in the region each year in recent times. The emphasis is not on volume, but on ensuring that each launch is relevant to local needs and supported by access frameworks that allow patients to benefit from innovation in a timely and sustainable manner.
How is Novartis strengthening its clinical research footprint across the GCC, and how is the region viewed within the company’s global development strategy?
Clinical research across the GCC has progressed materially over recent years, supported by sustained investment in infrastructure, regulatory evolution, and institutional capability. Governments in the region have made clear that clinical research is a strategic priority, and this is reflected in more enabling frameworks and clearer development pathways. In Saudi Arabia, for example, the Saudi Food and Drug Authority (SFDA) has introduced the Research and Investigational Drugs pathway to accelerate the development and review of investigational therapies, alongside orphan drug mechanisms that support research in rare diseases. In parallel, the growth of highly specialised and internationally credible healthcare institutions has created an environment that encourages greater participation from multinational companies, including Novartis, across both established therapeutic areas and advanced platforms such as cell and gene therapies and radioligand treatments.
Our approach is intentionally balanced and long term. We are increasing participation in global clinical trials, including in selected rare diseases and advanced therapy programmes, while also investing in real-world evidence and local data generation that reflects the characteristics of patient populations in the region. Registries and locally relevant evidence are an important part of this effort, ensuring that data generated in the GCC can inform clinical practice and healthcare decision-making in a meaningful way. This work is carried out in close partnership with national stakeholders, not only to conduct trials, but to build sustainable research and development capabilities over time.
At a global level, the GCC is clearly recognised by Novartis’ senior management as a priority region, both for early access to innovation and for clinical development. This recognition is evident in the pace of launches in markets such as the UAE and Saudi Arabia, as well as in continued support for expanding clinical research activity across the region. The combination of ambitious national visions, clear execution plans, and a strong commitment to public-private collaboration positions the GCC as an increasingly important environment for innovation and one where we see continued opportunity to deepen our clinical research footprint.
How are healthcare systems in the GCC approaching access and financing for advanced therapies, particularly gene therapies, and what direction is this taking?
Across the GCC, there is a growing recognition that innovation only fulfils its purpose when patients are able to access it. While the cost of advanced therapies, including gene therapies, remains an important consideration, discussions in the region increasingly centre on the longer-term value these treatments can deliver. In some cases, these therapies have the potential to fundamentally change disease trajectories, and healthcare systems are looking beyond upfront cost to consider the broader clinical and economic impact over time.
In parallel, there is a clear willingness to explore more innovative access and financing models. We are working closely with authorities on approaches such as risk-sharing and outcome-based agreements, with the aim of enabling early access while ensuring sustainability for healthcare systems. These conversations are still evolving, but the openness of the region to pilot and refine such models, supported by strong public–private collaboration, creates a constructive environment for addressing the access challenges associated with advanced therapies and for ensuring that innovation can reach patients in a timely and responsible way.
Looking ahead to the next few years, what are your key strategic priorities for Novartis in the GCC, and what message would you leave with stakeholders shaping the region’s healthcare future?
As we look ahead to the next few years, our priorities remain closely aligned with the areas we have discussed, with a clear focus on execution and long-term sustainability. We will continue to work in close partnership with governments, health authorities, and healthcare systems to accelerate and expand access to innovation, spanning regulatory pathways, reimbursement, and formulary inclusion, while ensuring that this access can be sustained over time. In parallel, strengthening our innovation footprint will remain a priority, through continued participation in clinical trials, ongoing investment in data and digital capabilities, and the generation of evidence that is relevant to local healthcare systems.
People and culture are central to delivering this agenda. We will continue to invest in developing our teams and to work with governments and healthcare stakeholders to support the development of future national leaders across the GCC. The region continues to stand out as one of the most dynamic healthcare environments globally, defined by strong investment, clear strategic intent, and a willingness to collaborate through public–private partnerships. Our purpose at Novartis is to work alongside our partners to ensure that patients across the GCC have early and sustainable access to high-impact innovative medicines, both now and in the years ahead.
