Part 29 of our Bridging the Gap Series (Summary of the webinar session held in April 2026)
For all the scientific progress in cell and gene therapy, one of the field’s biggest challenges remains the same: how to turn innovation into sustainable patient access.
That question is especially important in regions where healthcare systems are growing quickly, unmet need is high, and national investment is accelerating. In April’s Bridging the Gap webinar, the conversation turned to Saudi Arabia, where Vision 2030 is helping drive a deliberate shift from adopting advanced therapies to building the infrastructure, talent, and systems needed to deliver them locally.
Hosted by Olga Bukatova of Azenta Life Sciences, the session featured Dr. Farhatullah Syed, Group Leader and Senior Scientist and Head of the Advanced Cell & Gene Therapy Section at King Faisal Specialist Hospital & Research Centre (KFSH&RC) in Riyadh. Joining the discussion were George Eastwood, Executive Director of the Emily Whitehead Foundation, and Dr. Patrick Hanley, Chief and Director of the Cellular Therapy Program at Children’s National Hospital.
Together, they explored what it takes to build a cell and gene therapy ecosystem in real time – from translational science and GMP readiness to workforce development, regulatory maturity, and regional collaboration.
From First-in-Human Experience to System-Level Thinking
Dr. Syed’s path into cell and gene therapy began in molecular virology, studying how viruses interact with human cells and how they could be re-engineered for therapeutic use. That early scientific foundation eventually led him into some of the field’s most advanced translational work, including first-in-human gene therapy and CAR-T trials in the UK.
Reflecting on those early experiences, Dr. Syed emphasized that one lesson stands above the rest: in cell and gene therapy, the product and the process are inseparable.
A promising therapy is never just about a construct or biological concept. Success depends on the full system around it – starting material, manufacturing consistency, quality control, patient selection, clinical monitoring, and regulatory readiness. Over time, that perspective has helped shift the field from asking whether a breakthrough therapy can be built to asking whether it can be delivered safely, reproducibly, and at scale.
Bridging Research to Clinical Reality
One of the clearest themes from the discussion was that translational success in cell and gene therapy depends on early integration.
Preclinical research may demonstrate efficacy, target engagement, or proof of concept. But once a program moves toward first-in-human studies, the questions become much broader. Can the product be manufactured consistently under GMP conditions? Can it be tested and released with confidence? Can it move through a real clinical workflow without breaking down operationally?
Dr. Syed highlighted three areas that require early attention:
- Science-to-manufacturing translation, including designing manufacturability into the research from the beginning
- Quality and regulatory readiness, such as defining critical quality attributes and developing fit-for-purpose assays
- Institutional infrastructure, ensuring the clinical and operational ecosystem is prepared before the first patient is enrolled
Rather than treating translation as a handoff between discovery and development, the panel emphasized the need to treat it as a platform – one that integrates research, manufacturing, quality, regulation, and clinical operations from the start.
Building the Foundations of a National CGT Ecosystem
Under Vision 2030, Saudi Arabia is making significant investments in biotechnology, genomics, and advanced therapeutics. But as Dr. Syed explained, a sustainable cell and gene therapy ecosystem cannot be built around a single product, a single lab, or even a single clinical trial.
It must be built as a connected system.
According to Dr. Syed, the key building blocks include:
- Translational research aligned to real clinical need, especially in areas such as hematologic malignancies, inherited disorders, and hemoglobinopathies
- Reliable local GMP and ATMP manufacturing capabilities, which support long-term affordability and speed
- Regulatory and quality maturity, including traceability, documentation, pharmacovigilance, and strong quality systems
- A multidisciplinary workforce, spanning clinical care, manufacturing, regulatory science, and quality operations
- Collaboration across institutions and sectors, including public-private partnerships and regional coordination
The discussion made clear that building for sustainability does not mean moving slowly. It means building depth before scale – creating strong, reproducible platforms that can grow over time rather than launching disconnected programs that are difficult to maintain.
As Dr. Syed noted, “we do not need many disconnected programs. We need a few strong platforms that can grow reproducibly and deliver therapies consistently.”
At KFSH&RC, this has meant starting with commercial CAR-T procurement, then gradually strengthening internal capabilities to reduce cost and delay, train local talent, and prepare for in-house manufacturing and clinical translation.
The discussion also highlighted the importance of early and active regulatory engagement. Dr. Syed described the Saudi Food and Drug Authority as increasingly accessible and collaborative, with clearer pathways for advanced therapies and a willingness to engage early in development. That kind of interaction can help programs move more efficiently by addressing questions before they become bottlenecks.
Local Manufacturing, Readiness, and the Workforce Challenge
A major focus of the session was manufacturing readiness – not just constructing GMP facilities, but creating the operational maturity needed to use them well.
As Dr. Syed noted, building a facility is only one part of the equation. True readiness requires talent, training, quality systems, regulatory understanding, documentation discipline, and clinical integration. These capabilities take time to develop, particularly in a field where scientists may be highly trained in research but less familiar with the demands of GMP operations.
That makes workforce development one of the most urgent challenges in cell and gene therapy – not only in Saudi Arabia, but globally.
The panel discussed the need for:
- targeted training in GMP and advanced therapy operations
- stronger MSc, PhD, postdoctoral, and clinician-scientist pathways
- exposure to quality systems, deviations, release processes, and regulatory frameworks
- consortium-building and external partnerships to accelerate learning
Dr. Hanley noted that these are not only rewarding scientific roles – they are also high-value, mission-driven careers. But to scale the workforce effectively, the field must make these opportunities more visible and more accessible, while avoiding unnecessary intimidation around the science itself.
Platform-Based Therapies and the Opportunity in Rare Disease
Another important discussion point was the potential role Saudi Arabia and the wider MENA region could play in advancing platform-based therapies, especially for ultra-rare and monogenic diseases.
Because the region has a meaningful burden of inherited and genetic disorders, it may be uniquely positioned to contribute to the future of reusable gene therapy platforms. Rather than developing one therapy at a time for each rare condition, platform-based approaches could reuse vector backbones, manufacturing systems, analytical methods, and regulatory frameworks across multiple related disorders.
Dr. Syed described this as both a clinical need and a strategic opportunity.
In this model, local manufacturing and strong patient cohorts become assets not only for regional care, but for global innovation. Well-characterized rare disease populations, expanding regulatory frameworks, and growing national investment in biomanufacturing and precision medicine could allow the region to contribute meaningfully to how advanced therapies are developed and delivered worldwide.
This is particularly relevant in pediatric and rare disease settings, where rapid manufacturing and locally tailored approaches may help address unmet need in younger patient populations.
Collaboration That Means More Than a Signature
The session closed with a strong emphasis on collaboration, but not collaboration in name only.
According to Dr. Syed, meaningful partnerships are not just memoranda or commercial arrangements. They are built around co-development, training, technology transfer, and shared long-term goals.
That includes working with early-stage therapy developers, bringing clinical trials into the region, transferring manufacturing know-how, developing local teams, and creating forums where scientists, clinicians, regulators, and companies can mature the ecosystem together.
In that sense, the MENA consortium concept discussed during the session is not just about visibility. It is about reducing duplication, accelerating learning, and building pathways that are locally sustainable but globally connected.
Why This Matters
One of the most compelling themes from the discussion was that countries building advanced therapy programs today have a distinct advantage: they can learn from the successes and mistakes of those who came before them.
That does not make the work easy. But it does create an opportunity to build smarter – integrating quality, regulation, manufacturing, and workforce development from the outset instead of retrofitting them later.
For Saudi Arabia, that means the chance to build a system that is not only capable of delivering commercial therapies, but also of developing and manufacturing homegrown solutions for patients with urgent unmet need. Dr. Syed emphasized that commercial products remain important while local capabilities are being built, but long-term sustainability will depend on developing and manufacturing therapies closer to patients.
And for the broader cell and gene therapy field, it offers something equally valuable: a real-time case study in how national ecosystems can move from ambition to implementation.
Key Takeaways
- In cell and gene therapy, the product and the process are inseparable, making early integration across research, manufacturing, quality, regulation, and clinical operations essential.
- Saudi Arabia’s Vision 2030 is creating the conditions for a sustainable CGT ecosystem, supported by national investment in biotechnology, genomics, and precision medicine.
- Local GMP manufacturing is a long-term strategic priority, not only for speed and affordability, but for national self-sufficiency and clinical readiness.
- Workforce development remains one of the most urgent bottlenecks, especially in GMP operations, quality systems, regulatory science, and clinical translation.
- Platform-based therapies could be especially important in the MENA region, where rare and inherited disorders create both significant unmet need and strategic opportunity.
- Meaningful collaboration requires more than agreements – it depends on co-development, technology transfer, shared learning, and long-term ecosystem building.
Stay Updated
Join us for the next Bridging the Gap webinar, where leaders across the cell and gene therapy community continue to explore the science, systems, and collaboration shaping the future of advanced therapies.
Explore more in the Bridging the Gap Series
About the Guest
Farhatullah Syed, MSc, ADB, PhD, FHEA
Group Leader & Senior Scientist, Head of Advanced Cell and Gene Therapy Section, Cancer Center of Excellence, King Faisal Specialist Hospital & Research Centre
Dr. Farhatullah Syed is an internationally recognized expert in advanced cell and gene therapy, with more than 20 years of experience in translational research across the UK, Saudi Arabia, and India. He is currently a Group Leader and Senior Scientist at King Faisal Specialist Hospital & Research Centre (KFSH&RC), Riyadh, where he is establishing the Advanced Cell & Gene Therapy (CGT) and precision medicine program.
Previously at University College London (UCL), UK, Dr. Syed led multiple autologous, allogeneic, and CRISPR/base-edited CAR T-cell programs for the treatment of hematological malignancies, as well as gene therapies for monogenic and rare genetic disorders. He has played a key role in several first-in-human Phase I/II clinical trials, including the landmark TT52CAR19 and base-edited CAR7 T-cell therapies. His work has been published in leading journals such as The New England Journal of Medicine, Science Translational Medicine, and Blood.
Dr. Syed is widely recognized for his expertise in clinical-grade viral vector production, cell therapy process development, and GMP manufacturing platforms. He has contributed to the establishment of national CAR-T manufacturing infrastructure in the UK. With over 16 years of direct involvement in early-phase (Phase I/II) cell and gene therapy clinical trials, many of them first-in-human; he has supported the full pipeline from process development to vector production and clinical translation.
Notably, Dr. Syed contributed to process development and the successful completion of a Phase I clinical trial for Obi-Cell (AUTO-1 CAR T) at UCL, which later received FDA approval. Alongside his translational work, Dr. Syed has published over 90 peer-reviewed research articles in high-impact journals, successfully supervised and mentored 14 PhD students, and holds several academic and professional appointments, including a Visiting Professorship in Genome Editing.
Dr. Syed combines deep scientific innovation with strategic execution, and his long-term vision is to make precision-engineered cellular therapies accessible to patients worldwide.