Professor Chee Yam Cheng
Chairman, ACTRIS
Associate Professor Danny Soon
CEO, CRIS and Interim Executive Director, ACTRIS
Professor William Hwang
CEO, National Cancer Centre Singapore
Professor Jonathan Loh
Deputy Executive Director, A*STAR Institute of Molecular and Cell Biology
Friends, colleagues, ladies and gentlemen
I am happy to join you at the first Singapore Cell and Gene Therapy Conference.
2. Today, we are also launching the Advanced Cell Therapy and Research Institute, Singapore (ACTRIS). Not many members of the public will know what ACTRIS is. Suffice to say, it is going to be a very important entity that can contribute to the future of the healthcare landscape in Singapore, with very profound implications. Today, I will explain why it is so and what we are going to do about it. For the learned members of the audience, I seek your patience as I try to explain this in layman terms because it is important for the public to know.
Cell and Gene Therapy
3. To understand ACTRIS we must first understand precision medicine, and one of its subsets, cell and gene therapy.
4. As we know, every one of us is different. This is because the fundamental building blocks of the human body – our DNA – are unique to each of us, just as each of our thumbprints are unique to us. These genetic factors interact with environmental exposures to make an individual more or less susceptible to disease, and have differing clinical responses to treatment.
5. Precision medicine takes our individual uniqueness into account and seeks to personalise treatments to what works best for each of us. Technology, in particular digital technology, makes this possible.
6. An analogy is the way digital technology and AI take into account our search and viewing habits and patterns on the Internet, and push social media content to our smartphones and devicesbased on our unique interests. It is personalised, yet done at a very cheap cost.
7. Cell and gene therapy is a key subset of precision medicine. It involves modifying cells, or DNA or RNA materials, so that they can be used as targeted therapeutic agents.
8. One example is the CAR-T therapy, or Chimeric Antigen Receptor T-cell therapy. This involves extracting a type of the patient’s own blood cells, called T-cells, manipulating them so that they can specifically target and kill cancer cells, then re-infusing these cells into the patient as a treatment. Our own cells become weapons to kill the cancers and malicious cells in our body.
9. Eight years ago, patients who had failed conventional treatments for aggressive leukaemia and lymphoma would have been considered as having a “terminal” condition. Today, CAR-T cell technology is giving them a possible lifeline. Precision medicine even heralds the possibility of regenerative medicine.
The Potential
10. We may well be at the cusp of a major breakthrough in healthcare. This is why words like “medical moonshots” are used to describe this development. It is as significant as 1969 when humans landed on the moon. This is why we are also witnessing a strong flow of global funds into this sector, and witnessing many developmental efforts by both pharmaceutical companies as well as biotech start-ups. As of June 2023, the United States Food and Drug Administration has approved 32 cell and gene therapy products. The majority are in the recent couple of years.
11. However, all breakthroughs come with uncertainties and risks. Many precision medicine treatments are experimental in nature and only work on a select group of patients. They are also very costly, which limits access. In some situations, modifying genes and cells raises ethical questions. Hence there are multiple issues that need to be addressed and overcome.
12. But this does not mean we ignore this major development and simply sit on our hands. Quite the contrary, we need to make it a big part of the public healthcare agenda, so that in time, precision medicine can bring about an advancement in the health of societies.
13. Why? There are two reasons. First, we have invested so much research and development and knowhow in this sector. One major project is the ongoing SG100K project. We have nurtured and attracted a considerable pool of precision medicine talent in Singapore. We should press on.
14. Second and the more important reason is we need to adopt the right mindset and approach when confronting promising but potentially disruptive technology.
15. Take for example, the cultivated meat industry. It involved nascent and promising technology, but also raised concerns, such as food safety and environmental impact. Instead of just taking a wait and see attitude and looking at what other countries do and following them, we proactively built up our knowhow, engaged the players, invested in the technology and set up a robust regulatory framework while the rest of the world was figuring out what to do.
16. In December 2020, Singapore became the first country in the world to approve the use of cultivated meat products in our market. Today, it is a promising sector in Singapore which strengthens our food resilience, and presents new opportunities for enterprises, workers and consumers.
17. The precision medicine sector will most likely be a much more complex sector than the cultivated meat sector. We will adopt the following principles: First, we will try our best to embrace the technology of precision medicine. Second, while doing so, we must ensure sound clinical practices that result in good cost-effective outcomes. Finally, we must ensure that our overall healthcare system remains affordable to patients and sustainable for a system point of view.
18. The Ministry of Health (MOH) has convened a taskforce, chaired by Director-General of Health Professor Kenneth Mak and comprising clinicians, researchers, health economists, regulators etc. The Taskforce will develop the policies and infrastructure needed to support the growth of precision medicine. There are five key aspects to nurture and grow precision medicine. There are five key aspects to nurture and grow precision medicine in the way that will fulfil its potential while safeguarding against the downsides.
Five Key Areas
19. First, is to establish a proper end-to-end clinical governance framework, that adapts research innovations into clinical applications, covers the appropriate use of screening and diagnostic tests and provides safe, clinically efficacious and cost-effective treatments. These particularly apply to cell and gene therapies.
20. In research, we need to identify the diseases with genetic associations that are of importance to our population. Our research infrastructure also needs to be strengthened. This includes growing the capabilities and capacity of our laboratories to support our research and clinical needs and to develop more cell and gene therapies for clinical use.
21. We also need to adopt a framework to manage and safeguard data collected, and strengthen our governance processes when translating research findings into clinical services.
22. In manufacturing cell and gene treatments, we need to ensure that these treatments are engineered in a way that is safe and effective for patients, as well as of high quality. These products need to be made under a Good Manufacturing Practices (GMP) environment. All facilities, equipment, reagents and consumables must be up to standard. All personnel must be properly trained and qualified to have the right competencies.
23. These steps enable the public to have full confidence in the new medical technology. These cannot be compromised.
24. The second aspect is to ensure clinical efficacy and cost-effectiveness which is a tricky subject. This is no different from what we do for all clinical treatments today, but there are more challenges where it comes to cell and gene therapy.
25. The evaluation of clinical efficacy could be harder, because precision medicine so far targets a small segment of patients compared to traditional pharmaceutical products. The database is considerably smaller. While treatments may have immediate or early good results, we also need to see if the good outcomes are sustained over time.
26. It may be even more tricky when evaluating cost effectiveness. We need to recognise that a treatment may give rise to very significant clinical benefits for individual patients. However, the high costs of some precision medicine treatments may mean that they are not cost-effective. In particular, cell and gene therapies are costly because they are often developed for rare genetic conditions, are customised to the individual and do not enjoy the same economies of scale as traditional pharmaceutical products which are for more common conditions.
27. The technology is in its infancy, and it is possible that costs may come down over time. Nevertheless, authorities have to ensure that the benefits to patients must justify the costs. If not, the burden on our society and healthcare system will be too heavy to bear.
28. Notwithstanding all these challenges, we will build up our capabilities and continue our work in these areas.
29. Third, is to develop a sustainable way to finance precision medicine. That is when it comes to policy matters. As the cost of precision medicine will be considerably higher than traditional treatments, it can cause a major disruption to our healthcare financing framework.
30. We will need an appropriate financing framework, that is both sustainable and will prevent a schism between those who can afford precision medicine those who cannot.
31. I don’t think there is a healthcare system in the world which has figured this out and found such a solution, yet. But given the nature of cell and gene therapies – relatively infrequent in deployment and high cost – the solution will likely lie in strengthening national healthcare insurance.
32. Fourth, establish legislative safeguards. New technologies are always double-edged swords. The fact that we can now do something new with technology, does not mean we have to do it. With new territories comes the need for new limits and boundaries, so society can decide what can or cannot be done with the new technology.
33. History has many examples, such as new laws that dictate the proper use of guns or miniature cameras. There is now much discussion on ways to regulate the use of generative AI.
34. Precision medicine too, will require similar legal and social boundaries. For example, we may not want genetic data to be used by employers to make hiring decisions, or insurance companies to underwrite policies. These are policy and legal issues that we need to think through.
35. Finally, we need to continue to build our knowhow and capabilities. This is where ACTRIS comes in.
ACTRIS
36. In 2006 and 2009, the Health Sciences Authority (HSA) and National University Hospital (NUH) had respectively set up small facilities for cell therapy production, to serve our hospitals and the pharmaceutical industries.
37. With the continued developments in precision medicine, we decided to consolidate the facilities and grow it further. To give focus to this effort, ACTRIS was therefore set up in April 2020 as a business unit under the Consortium of Clinical Research and Innovation, Singapore.
38. After extensive collaboration between government agencies, research institutions and industry players , we have arrived at a significant milestone. ACTRIS will consolidate the NUH and HSA cell therapy facilities, and will be established as the national centre for development and production of cell and gene therapy. It will be physically located at the National Cancer Centre, Singapore.
39. By centralising resources, manpower and capabilities, we can scale up manufacturing, develop talent and improve operations. Through the National Medical Research Council, MOH will continue to support good research projects involving cell therapy, to support ACTRIS.
40. ACTRIS will be working with its sister business unit, the National Health Innovation Centre Singapore, on a joint grant call to accelerate the translation of cell therapies from the lab to the clinic.
41. It is also working with A*STAR and equipment companies to develop production capabilities further. We aim to significantly shorten production times and lower costs in the near future, so that cell and gene therapies can become more accessible and affordable to Singaporeans who need it.
Closing
42. This morning, there are more than 700 local and global conference delegates gathered here physically or digitally. These individuals represent patients, caregivers, clinicians, researchers and scientists, insurance companies, biotechnology and pharmaceutical companies, regulators, and governments. I thank you all for your interest and your presence, as we continue to address the scientific, clinical, ethnical, financial, economic, legal and social issues surrounding precision medicine.
43. Finally, it gives me great pleasure to congratulate the Co-Chairs Associate Professor Danny Soon, Professor William Hwang, and Dr Jonathan Loh on the successful inauguration of the first Singapore Cell and Gene Therapy Conference.
44. I would also like to thank the past and present management team of ACTRIS, particularly Dr Tan Lip Kun from NUHS who was the pro-tem lead for ACTRIS, and the Chairman of ACTRIS Board Oversight Committee (BOC) Professor Chee Yam Cheng, who pioneered the building of this facility, which we have completed and are launching today.
45. Together, let’s put our minds and expertise together to unlock this tremendous potential of cell and gene therapy to forge a different and brighter future for healthcare in Singapore and perhaps even the world. Thank you.