Ken Lee, Managing Director for Asia Pacific Clinical Business at Syneos Health, draws on a 20-year career across pharma, medicine, and CROs in Europe and Asia. He highlights Asia Pacific’s shift into a global clinical development hub, the rise of Greater China as a leading source of innovation, with mainland China at its centre, improving data quality, and persistent regulatory fragmentation. He also emphasises AI transformation, India and Australia’s growing roles, and the region’s increasing importance in global biotech pipelines and investment.
You have spent more than two decades in this industry, moving from medical practice through European pharma and into the CRO world. Could you introduce yourself and your career trajectory to our readers?
My name is Ken Lee and I am currently the Managing Director for the Asia Pacific Clinical Business of Syneos Health, based in Singapore. We have an organisation of around 5,000 people in the region focused on clinical trials, alongside a commercial group and the back-end functions that support both. I have been with the company for coming up to five years now, and in the industry since 2002.
About half of that time was spent in pharma – roughly ten years across different European companies, Sanofi, UCB, and Bayer, working in various parts of Asia as well as in Europe, including a period based in Germany with Bayer. I then moved into the CRO industry in 2012 and have been in clinical services ever since, starting at Quintiles – now known as IQVIA – before joining Syneos Health. I am a physician by training, having completed my medical education in Australia before moving into industry in Asia Pacific. So it has been quite a range of environments and geographies over the years, which I think gives you a perspective on how the region has changed that you simply cannot get any other way.
From that vantage point, do you still see a meaningful disconnect between how Western sponsors perceive Asia and what Asia represents today?
It is worth separating Western sponsors into two distinct groups, because the answer is quite different depending on which you are talking about. The large multinationals – the GSKs, the Pfizers, the mid-size players – are already deeply comfortable in Asia Pacific. When I started my career, they were just beginning to place studies in the region, and there were genuine questions about quality and capability. That conversation is over. Today these companies have fully established R&D functions across the key Asian markets, whether they run them independently or through CROs, and they are not asking whether Asia is good enough – they are asking how to do more, how to build more capacity, how to grow. That segment of our business is growing at five to nine percent depending on the year, and the conviction is real and structural.
The biotechs are a different story, particularly the smaller ones. They are still asking some of the questions that large pharma stopped asking years ago – about quality, about reliability, about whether data generated here will be accepted by global regulators. That discomfort is understandable, because they do not have the established presence and accumulated experience that a large multinational has built over decades. But they are learning and shifting rapidly, and the reason for that shift is significant: the bulk of meaningful innovation is now coming from Asia Pacific, and mainland China in particular. The new molecules, the advanced therapeutics, the first-in-class assets – many are being generated at a pace that rivals and in some areas exceeds the US. Western biotechs increasingly realise they have to come into the region, not just to take advantage of cost and speed, but to find the assets they need to compete.
Focusing on data quality: there has historically been a view in neighboring markets that clinical data from mainland China hasn’t met the same standards. Does this perspective still hold true today?
I would say that is no longer true, and I say that as someone who spent three years living in Taiwan and working there for UCB – a market I still consider one of my favourite places to run clinical trials, with fantastic sites, world-class investigators, and a track record across many disease areas that is genuinely outstanding. Taiwan’s quality is not in question, and neither is Korea’s or Japan’s. But mainland China has caught up from a quality output perspective, clearly and demonstrably. The measure I would point to is FDA audit performance: we have supported multiple international studies where mainland China was a contributing site, with data forming part of new drug approval packages submitted to the FDA, and those sites have been audited by the FDA at multiple locations. Their performance, by any metric, is now comparable to the United States. The scale advantage mainland China has always had – which is simply incomparable – is now matched by a quality standard that global regulators accept.
Looking at the regional regulatory landscape more broadly, Asia is often seen as a set of fragmented silos that make multi-country studies difficult. Is harmonisation a realistic goal?
I think we have to be honest: we are still very much siloed, and I do not see meaningful harmonisation happening anytime soon. The conversations about it have been going on throughout my career, and progress has been limited. Every market has its own regulatory framework, its own way of working, its own language and privacy laws and institutional culture – and layered on top of that are genuine geopolitical tensions that make deep cross-border collaboration at the scientific and regulatory level very difficult. These are real factors that operate well outside the sphere of science and that prevent the kind of collaborative infrastructure that Europe has built through the EMA and the EU Clinical Trials Regulation.
The practical implication is that executing a multi-country study in Asia Pacific requires expertise in each individual market and the capability to piece everything together into a coherent global package. That is precisely what organisations like ours exist to do. It is not elegant, and the language barriers alone – with Japan, mainland China, and Korea all conducting early-stage trial work in their own languages before translation for global regulatory submission – add real complexity and cost. But it is manageable, and a capable CRO can navigate it effectively on behalf of a sponsor who would otherwise find it paralysing.
Syneos Health is known for its “label in mind” philosophy—designing early-stage trials with eventual regulatory approval and commercial launch already in view. How do you apply that approach when working with Asian biotechs that may not yet be thinking that far ahead?
With large multinational clients, that kind of strategic consultation is essentially unnecessary – they already know what the FDA wants, they already understand the commercial boundary of their asset, and what they need from us is execution capability. With Asian biotechs, and particularly the wave of Chinese and Korean companies that are now trying to take their assets global, the picture is completely different. Many of these companies were founded by exceptional scientists with deep knowledge of the biology but limited understanding of what a global regulatory authority will require, or of the commercial landscape their product will be entering. So we spend a significant amount of time upstream – helping them understand whether the asset is worth investing in from a commercial perspective, what the unmet need genuinely is, whether payers will value it, and what the regulatory pathway to the US or Europe actually looks like.
One of the structural challenges with Chinese biotechs in particular is that they are able to generate early clinical data very quickly and cost-effectively because of the large patient populations and relatively low operating costs. That is a genuine advantage for proof-of-concept work. But that early data comes from Chinese patients, and if the goal is eventually to get FDA approval for a global population, there are real questions to be answered about bridging – about dosing, about disease presentation across different ethnicities, about the acceptability of that data in a Western regulatory context. A Chinese patient is not the same as an American patient, and the FDA will not simply accept data from one population as proof of efficacy in another. We are spending a great deal of effort helping these companies understand that distinction and build the bridging strategy that will allow their Chinese data to support a global programme.
You mentioned that a large part of large pharmaceutical pipelines now come from in-licensing, largely driven by China. How is the wider region positioning itself to attract and retain global capital and innovation?
The Greater China ecosystem dominates that conversation, driven primarily by mainland China, and it is not hard to understand why. The volume of innovative assets, the speed of development, the cost efficiency, the infrastructure – it functions like a vast department store of innovation, and global capital has responded accordingly. Everyone is going there, which is creating a dynamic where valuations are rising and in-licensing deal prices are becoming, in my view, increasingly stretched.
Korea is an area I find genuinely interesting in that context. The innovation quality is real – there are first-in-class and best-in-class assets there – and the valuations are considerably more attractive than what you are seeing in mainland China precisely because Korea does not command the same level of global attention. We have been making that point to some of our investor clients: there are assets in Korea that are worth examining, and you may be able to acquire them at a price that reflects their merit rather than a premium driven by competitive frenzy.
Japan is a different case again. The large Japanese conglomerates have historically developed assets internally from discovery through to clinical development in a way that many global multinationals have moved away from – they tend to do it the old-fashioned way, relying on internal capability rather than licensing in. That means Japan’s funding needs are different, and the biotech ecosystem, while present, is considerably smaller in volume than mainland China or Korea. The support we provide is similar, but the scale of activity is lower.
Taiwan is also an important source of innovation within the broader Greater China ecosystem – genuinely innovative for a market of its size, with companies that have real science and real assets, but facing the same challenge as Korea in terms of needing to find more international investment and visibility. And Singapore, where I am based, plays a distinctive role as a neutral headquarters and leadership hub for the region rather than as a generator of large-scale innovation itself. The government continues to invest in attracting biotechs and in building advanced manufacturing capabilities for cell and gene therapies, but the biotech ecosystem is small. What Singapore has built very effectively is the infrastructure – connectivity, talent diversity, regulatory stability – that makes it the natural regional headquarters for companies that need a credible Asia Pacific base.
On therapeutic areas – where do you see Asia Pacific genuinely setting the global agenda?
Oncology is the obvious answer and the dominant one. More than half of mainland China’s innovative output is in cancer therapeutics of one kind or another, which reflects both the disease burden and the regulatory and commercial incentives that have been built around oncology development. The other markets are more diverse – Korea and Taiwan in particular show interesting pipelines across multiple therapeutic areas.
Cell and gene therapy is another area where I think Asia is beginning to establish genuine leadership, and not just in oncology applications. The infrastructure for advanced therapeutics, particularly in mainland China, has developed with remarkable speed. The ability to run investigator-sponsored studies across multiple centres, to test assets quickly in small patient cohorts without the overhead of a full company-sponsored trial, has created an agility in the cell and gene therapy space that is genuinely striking. The supply chain and cold-chain infrastructure to support these therapies in a market as large and complex as mainland China has been built out at a pace that surprises people who assume logistics must be a constraint. What I am seeing now, honestly, is the reverse of the old narrative – our global biotech clients are coming to us and asking whether they can run their early cell therapy studies in mainland China, using the infrastructure that domestic Chinese biotechs have already established. Nine months ago those conversations were rare; now we are flooded with them. I would not be surprised if the market is considered a genuine global leader in cell and gene therapy development within a relatively short timeframe, and if the methodologies developed there begin influencing how these therapies are studied and delivered elsewhere in the world.
Biosimilars are another area of clear regional strength that deserves recognition. Some of the world’s most capable biosimilar manufacturers are headquartered in Asia – Celltrion and Samsung Biologics in Korea, Henlius, Qilu, Bio-Thera and others in mainland China. As major biologics reach the end of their patent lifecycles, the ability to produce high-quality biosimilars at scale and at competitive cost is going to be enormously consequential for patient access globally, and Asia is very well positioned to lead that.
You are leading an organisation of 5,000 people through a period of rapid change – innovation accelerating, AI emerging, the business model of CROs under pressure. What is your leadership philosophy in that environment?
We have just launched a new culture framework, and the thinking behind it is straightforward: in order to stay relevant to our clients and to the industry, we have to genuinely care about their assets and treat them as though they were our own. That sounds simple but it requires a real shift in how a service organisation thinks about itself.
One specific change I have been driving is in how we respond to things going well. Service organisations tend to have very good institutional memory for failures – every mistake is analysed and documented – but they are not always as intentional about recognising and celebrating successes. We are deliberately shifting that balance, making sure that every win, however small, is acknowledged and celebrated. In an environment where people are being asked to adapt quickly and try new things, that kind of recognition matters for keeping teams engaged and willing to take risks.
On innovation and the way we work, we have moved deliberately away from a top-down, here-is-the-blueprint approach toward one that genuinely invites ideas from the people doing the work at the interface with clients. We run competitions that reward employees who identify better ways to run processes – the kind of insight that can only come from someone who is actually inside the work, not from leadership looking down at it. That cultural openness is something we are trying to institutionalise rather than just encourage occasionally.
On AI, I want to be direct: it is going to change our business model significantly, and pretending otherwise would be the kind of complacency that has finished other industries. A traditional CRO business model is in part built on the volume of repetitive, labour-intensive work that clinical trial operations require – data management, monitoring, documentation – and if AI agents are able to handle significant portions of that work, the economic basis of the business changes. We are embracing that rather than resisting it, investing in AI capabilities and being genuinely open-minded about what the company will look like in five years. The comparison I keep in mind is Nokia and Kodak – excellent companies that understood their existing business very well and failed to see that the ground was shifting beneath them. We are determined not to make that mistake.
Looking three to five years ahead, what are your key priorities for the region?
The first is continued investment in capability – we recently acquired a local CRO in mainland China precisely because we believe that to genuinely serve Asian biotech clients, particularly as their ambitions become more global, we need deeper local strength than a purely international operation can provide. We are evaluating similar moves in other markets, with Japan, Australia, and India all featuring prominently in that thinking.
The second priority is the transformation of our operating model – integrating AI in a way that enhances the quality and efficiency of what we deliver, not just as a cost-reduction exercise but as a genuine improvement in the product we offer to clients. That is a multi-year effort and it is one we are taking seriously.
Could you share a success story or example from your experience that stands out as particularly meaningful?
The ones that give me the most satisfaction are the cases where we have taken an Asian client with a domestic asset and helped them achieve approval and commercialisation outside Asia Pacific. We have done this now with two Chinese clients on biosimilar projects – companies that, when we started working with them, had no particular intention to go international. It was almost exploratory, a question of whether it was possible. The answer turned out to be yes, and seeing those clients receive European approval, find commercial partners, and begin planning the next wave of assets for international development has been genuinely rewarding. One of them is now working with us on twelve additional biosimilars for international markets, which speaks to what becomes possible once that first bridge is crossed. These are not niche products – they are medicines that are currently very expensive and inaccessible to many patients globally, and bringing affordable biosimilar versions to those markets has real consequences for real people. That is the kind of impact that makes the work meaningful.
I am also watching some of the smaller biotechs we are supporting now with first-in-human studies, and I can see in a handful of them the potential for something genuinely transformative – assets that could, six or seven years from now, change the way a serious disease is treated in the way that medicines like pembrolizumab changed oncology. That possibility, and the privilege of being part of making it happen, is what keeps this work compelling.
Before we finish, is there anything you would like to add for our readers or any final reflections you would like to share?
I would highlight a couple of markets that are often underappreciated in the global discussion. India is critically important and, frankly, underused by the industry relative to what it could offer. The patient population is comparable in scale to mainland China, the cost profile is attractive, and the operational capabilities – particularly for data management, statistics, and now increasingly for technology – are world-class. As AI begins to transform the back-office functions of clinical trial operations, those technology hubs are going to be in India, just as the data management and statistical engine of the industry has been there for years. India is going to matter enormously on both the patient-facing and the operational sides of this business, and I think the industry has not yet fully reckoned with that.
Australia is a different story but equally worth highlighting. For a country of 25 million people, the volume and quality of early-phase clinical trial activity it sustains is remarkable. The government has done an outstanding job of incentivising research through tax mechanisms and building the infrastructure to support it, and the results speak for themselves – we are seeing 20 percent growth in activity year on year in that market, which is extraordinary. Chinese companies, US biotechs, and international investors are all showing increasing interest in Australia as a destination for early clinical work, and for good reason: it provides access to a different patient population, different ethnicities, a world-class investigator community, and a regulatory environment that is genuinely supportive of innovation. It is a small but strategically important part of the toolkit for any international biotech thinking seriously about Asia Pacific.
