The Regulatory Frontier Advancing
Cell and Gene Therapy Policy in
Singapore and Beyond
By Dr Eddie Tan Han Pin
With inputs from Wil Rich, Editor, Cell & Gene Therapy Insights
Wil Rich, Editor, Cell & Gene Therapy Insights, speaks with Eddie Tan Han Pin, Assistant
Professor, Centre of Regulatory Excellence, Duke‑NUS Medical School, about his career
journey from molecular cancer biology through GMP manufacturing and regulatory science
into health policy, the evolving regulatory landscape for cell and gene therapies in Singapore
and the Asia‑Pacific region, the role of regulatory reliance frameworks in broadening equitable
patient access, and the transformative potential of AI across the cell and gene therapy
development value chain.
Question: Your career has taken an arc from molecular cancer biology through GMP manufacturing into regulatory science and now health policy. Was there a single moment or decision that set you on that path, or did it evolve more organically?
Dr Tan: Early in my career as a scientist, more than a decade ago, I was involved in a number of translational studies in the laboratory that showed promising animal data and had published these studies in high‑impact journals, including those in molecular cell biology. When I then had the opportunity to present some of these findings at international society meetings in consecutive years, I realized that in the US and EU, scientists were already well ahead in terms of translating their animal data into early clinical studies. For me, I felt fortunate to attend those meetings in person and hear the plenaries for the original CAR‑T therapy development, as well as the genome‑edited therapies. When I returned to Singapore, this experience really prompted me to actively seek out opportunities within Singapore to help bridge the animal‑to‑human translation gap. Fortunately, that personal realization coincided with the strategic plans at the national level within Singapore’s National Research Foundation to develop the national GMP facility for cell and gene therapies (CGT). I was involved in the pilot implementation of this GMP facility at the Health Sciences Authority of Singapore (HSA). It was during this time that the health products regulatory group at HSA was also developing Singapore’s own version of the regulatory frame-work for cell, tissue and gene therapy products. Being in the same organization as the regulators helped enrich my own scientific training with a great deal of insight into the regulatory science aspect.
Question: Your PhD focused on peroxisome proliferator‑activated receptor activity in tumorigenesis. How did that grounding in fundamental cancer biology inform your later work in cell therapy manufacturing?
Dr Tan: My scientific training was focused on the molecular mechanisms of various diseases. While my primary research project focused on cancer biology, I was also involved in several collaborative projects within my supervisor’s laboratory and with external collaborators, covering a wide range of different diseases, including inflammation, skin disorders, communicable diseases, and metabolic syndromes. The understanding of the mechanistic pathways underlying the broad range of diseases helped me to quickly relate to the new translational GMP projects that came my way for manufacturing process development within the GMP facility. Working on these various projects at the research level also exposed me to a diverse toolkit of molecular, cellular, and biochemical assays, such as sequencing, histology, flow cytometry, and imaging. As you can imagine, these are all important release assays for CGT products. My training in molecular, cellular, and biochemical methods has therefore
prepared me for the analytical development aspect of CGT product development.
Question: What would you say to an early‑career scientist today who is considering a move away from purely lab‑based research toward regulatory affairs or health policy? Is there anything they should protect or hold on to from their scientific training as they make that transition?
Dr Tan: Coming from someone who has done this myself, I would encourage him or her to do so. For me, it has been a fulfilling journey. At the Duke‑NUS Centre of Regulatory Excellence, I have had the privilege to work closely with colleagues from Singapore’s Ministry of Health and the HSA on projects to navigate regulatory science and policy considerations on emerging health technologies. On these policy projects, we review the latest scientific developments and distill them down to recommendations for policymakers. It is particularly fulfilling when I then see the outcomes reflected in regulatory guidelines and policy revisions. However, I would also caution that this might not be a move for everybody. Because this work is really at the forefront of reviewing new technologies, we often find ourselves in uncharted territory, forging ahead while the ecosystem develops around us. Regarding scientific training, the typical scientific approach teaches you to strive for something novel, such as developing an entirely new molecule to target cancer with a complex mechanism of action and sophisticated delivery routes. On the other hand, when thinking specifically about regulatory considerations and quality management concepts, the approach is often rooted in stability and familiarity, to enable comparisons and assessments for patient safety. While a proposed new drug application is meant to address a previously unmet indication, any completely out‑of‑the‑box innovation will invariably require robust validation, with non‑clinical and clinical research to prove its safety and efficacy. In that way, a completely novel drug concept may encounter more regulatory hurdles than something that builds on previously approved drug types. That said, I think curiosity remains one of the most important qualities a scientist can bring to a regulatory role. In a regulatory policy role, it is that curiosity that is important for keeping up with ever‑developing technologies: knowing what is out there, how it works, and what the potential side effects are.
Question: Across your work on regulatory frameworks for innovative therapies, a recurring tension emerges between enabling speed to the patient and maintaining rigorous safety standards. Where do you think that balance currently sits, and is the pendulum moving in the right direction?
Dr Tan: This is a question I ask myself and my colleagues all the time. As with all technologies, whether in the finance sector or, more recently, in AI across multiple domains, there is always tension between the development of disruptive technologies and their governance to ensure public safety. More often than not, regulatory policy and policymakers have been playing catch‑up with technology development. In the last decade or so, since the landmark approvals of Kymriah and Yescarta by the US FDA, we have seen regulatory updates for CGT all over the world. In Singapore, for example, HSA released the Cell Tissue Gene Therapy Product Regulations in 2021, with considerable interest from the local scientific and clinical community. Following that, HSA has been rolling out new guidelines regularly to address many emerging topics as the CGT field continues to develop, taking reference from international agencies such as the US FDA and the European Medicines Agency (EMA), among others. We have also seen regulatory agencies working together to address the unique chemistry, manufacturing, and controls (CMC) questions that advanced therapeutic products pose. Meanwhile, the academic and industry communities have also been vital in enriching the knowledge domain. For example, the International Society for Cell & Gene Therapy (ISCT) has worked with the Standards Coordinating Body for Regenerative Medicine to publish an International Organization for Standardization document on cell counting, which is important for the quantification of cell products. The Alliance for Regenerative
Medicine has also done an important job in the North American region, engaging regulators and industry and producing guidance documents such as A‑Cell and A‑Gene, which are important reference publications for anyone looking to develop CGT, respectively. While we are not quite at the finish line in the way that some other modalities are, the entire CGT community, spanning regulators, industry, clinicians, and academia, is moving in the right direction.
Question: How should we think about the shared responsibilities of regulatory bodies and other stakeholders in broadening access, and does how we frame that responsibility shape the kind of solutions that become possible?
Dr Tan: You can think of the interaction between regulatory and policymakers on one side and stakeholders on the other as a dance. On the regulatory front, national authorities can contribute by providing clear, internationally harmonized regulations. From the stakeholders’ side, there should be clear thinking around reimbursement models, technology transfer partnerships, tiered pricing, and similar considerations. Most importantly, for anything to work, there needs to be two‑way communication for each party to play their respective roles. Professional societies, associations, and academia all play important roles in facilitating such conversations. At the Centre of Regulatory Excellence, we have facilitated such government and stakeholder conversations in our local ecosystem through roundtable discussions, most recently on the topic of AI and machine learning in healthcare services. In these discussions, we involved a wide range of stakeholder groups, including clinicians, researchers, industry, and patient groups, to have constructive discussions around policy considerations, which then informed the Ministry of Health’s revision of the Artificial Intelligence in Healthcare Guidelines (AIHGle 2.0).
Question: Looking at how regulatory frameworks are evolving within Singapore, are there specific models or regional approaches you think the broader field should be paying closer attention to?
Dr Tan: The Singapore government has recently announced a major undertaking to rethink the way health regulations are structured locally. In this proposed model, HSA is positioning itself as a one‑stop health regulatory body, consolidating the governance of health products, health services, and healthcare professionals under one roof within a single agency. In the ideal situation, this will facilitate discussions around emerging, cross‑cutting topics such as point‑of‑care manufacturing, hospital provision models for CGT products, and other emerging health technologies. I must emphasize that this is still a work in progress, but policymakers in Singapore are imagining it as one potential solution to bring together everything under a single governing body. This is important given how technological advancements in CGT and AI are starting to disrupt the boundaries of traditional regulatory processes.
Question: Looking ahead five to ten years, what is the single regulatory or policy change that you believe would do the most to improve equitable patient access to advanced therapies in the Asia‑Pacific region specifically?
Dr Tan: For me, one important regulatory trend that is gaining traction internationally would be the structured, region‑wide adoption of regulatory reliance frameworks for therapeutic products, anchored to the World Health Organization’s (WHO) Global Benchmarking Tool and the WHO Listed Authority (WLA) designation process. In my view, the central barrier impeding access in Asia‑Pacific (APAC) is not the lack of innovation or regulatory systems, but rather the fragmentation of CGT regulations within the region. While the Alliance for Regenerative Medicine’s latest clinical trial activity report already shows that APAC is now second globally in terms of clinical research activity, having overtaken Europe, the APAC regulatory landscape has not been harmonized. Recognizing this, the ISCT APAC Industry Committee has embarked on a regulatory roadmap project. We found that the definitions of CGT and their regulatory frameworks still differ even among the mature authorities within APAC, and this fragmentation creates barriers for a CGT developer seeking approval across multiple jurisdictions, making it harder for product approvals to flow across borders. Regulatory reliance will therefore play an important role, especially in APAC, where there is no harmonized single market. Reliance means that a regulatory authority in one jurisdiction has a formal procedure to adopt the assessment, decision, or inspection outcomes of another trusted reference authority, rather than independently repeating the entire review process. This allows the relying authority to leverage analytical work already completed by a better‑resourced counterpart, and the adoption of reliance approaches has the potential to shorten approval timelines for less‑resourced jurisdictions that lack the organizational capacity to independently assess complete CGT dossiers, which can be technically challenging. This is where the WHO Global Benchmarking Tool and the WLA designation become important, providing an objective assessment of the maturity level of each national regulatory authority. In an ideal scenario, WLA‑designated authorities could lead CGT dossier assessments that regional partners can rely upon, while non‑WLA authorities are able to learn from participating in such reliance models and build toward achieving higher maturity levels themselves.
Question: How do you stay current in such a fast‑moving field, and what trends do you think will disrupt the sector the most over the next five years?
Dr Tan: To stay current, I personally subscribe to the mailing lists of relevant regulatory authorities directly, as well as to many useful newsletters and communities that discuss the latest scientific and regulatory topics across biomedicine. Resources such as BioInsights have been important in curating the most relevant topics for readers. Beyond subscriptions, I am also a firm believer in active engagement. Having participated in professional societies such as ISCT and the Association for the Advancement for Blood and Biotherapies, this is important for keeping up to date with the latest developments in the CGT field. On the question of trends that will most disrupt the sector, I think that broadly across health products development, the topic of AI and, increasingly, agentic AI systems has been quite important in the last two years, proving to be a transformative force across the entire development value chain. On the product development side, generative models have already been applied upstream in CGT, for example in chimeric antigen receptor construct and AAV capsid design, while machine learning is also helping to enable real‑time release testing. These are advances that could meaningfully reduce the developmental and manufacturing costs that have long made CGT economically difficult in lower‑resource markets. On the regulatory side, we have developments in AI‑assisted dossier review, digital surveillance, and pharmacovigilance tools that will help ease the burden on regulatory agencies with limited specialist capacity. This could potentially accelerate the trajectory of less mature regulatory bodies toward higher maturity levels and WLA designation, thereby also helping to broaden the access agenda for CGT. When you look at the clinical and post‑market side, agentic AI systems that can coordinate across hospital networks, manufacturing sites, and regulatory reporting pipelines also have the potential to address the logistical barriers around patient identification, treatment coordination, and long‑term follow‑up for CGT therapies. There is immense potential for AI to transform the way we approach CGT development and regulation. I feel that what we are seeing today is just the tip of the iceberg. As a center of excellence in regulatory sciences, we are closely watching how these applications continue to evolve.
Authorship & Conflict of Interest
Contributions: The named author takes responsibility for the integrity of the work as a whole, and has given their approval for this version to be published.
Acknowledgements: None.
Disclosure and potential conflicts of interest: The author has no conflicts of interest.
Funding declaration: The author received no financial support for the research, authorship and/or
publication of this article.
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