Precision for Medicine
Precision for Medicine’s James Cheong and JingPing Yeo on what has actually changed in APAC clinical operations, and what biotechs still get wrong when they arrive.
For years, Asia Pacific sat at the edges of global development strategy: a region sponsors turned to when Western enrollment stalled, not one they built plans around from the start. That calculus has shifted, and the shift is structural. China’s phase three startup time now runs roughly comparable to Europe’s. APAC’s share of global phase three sites has grown by double digits over the past two decades. More than a third of the world’s new drug compounds now originate from the region. Yet many sponsors, particularly biotechs entering APAC for the first time, are still navigating this environment with assumptions that belonged to a decade ago. James Cheong, Senior Vice President for Asia Pacific, and JingPing Yeo, Vice President for Clinical Solutions at Precision for Medicine, sat down with Vanguard to explain what changed on the ground, why adding sites has not always translated to enrollment gains, and where the blind spots are for sponsors who think they already know the region.
How did you both watch sponsor perception of APAC shift during your careers?
James Cheong: When I first started out in the industry, the Asia region was very much a nice-to-have option for clinical trials. Big markets like China existed, but they took one to two years to start, so they never got to engage in global phase three trials. When a new drug had to be launched in China, companies would do a separate, China-only registration trial.
Things have changed a lot over the past 10 years, in a very positive way. China is now considered by default as part of the global development plan by many large pharma companies, no longer a separate plan once the drug is approved elsewhere. That means Chinese patients are able to access new drugs at the same time as patients in the US or Europe, and we are talking about many, many patients who can benefit from this.
JingPing Yeo: The perceptions James described were historical. Sponsors remembered the fragmented regulatory requirements from years ago, the variable site experience with multinational protocols, the translation burden, the limited in-country infrastructure. But those things existed at a country or site level, and they are no longer a reason to exclude APAC as a region.
What we have also seen is a lot of data showing a strategic shift. APAC’s share of phase three sites has increased substantially, while the US share has declined. That reflects how the region has evolved, and how it continues to contribute to diversified recruitment, broader patient population pools, and better alignment of development pathways.
Why has expanding the number of APAC sites not produced a proportional increase in enrolled patients?
James: Trial complexity has been increasing, which makes it more difficult to recruit patients to begin with. And as more sponsors have recognised the advantages of running trials in Asia, there is now more competition for patients, particularly in heavily researched indications.
JingPing: We no longer design studies looking at a volume of 50 separate protocols. We try to minimize the number of studies and add multiple endpoints to each one, which drives protocol complexity. That often leads to identifying only a niche pool of eligible patients, and as a result the number of patients enrolled per site may come down.
There is also the issue of leading investigators becoming oversubscribed. Many sponsors are targeting the same top sites and the same leading investigators, who are then managing multiple competing studies simultaneously. In the past, a site might allocate 10 patients to a single protocol. Now those same 10 patients may be distributed across two or three protocols, which creates a perceived decline in per-site enrollment that becomes increasingly visible.
How did China get its phase three startup time down to where it is today?
James: China underwent significant regulatory reform about 10 years ago, with a very decisive move to strengthen the entire clinical trial and drug registration environment. They made it clear they would not tolerate poor-quality trials or poor-quality dossiers. Penalties for data that did not stand up to scrutiny were severe, and as a result many companies voluntarily withdrew applications that were not meeting global standards. That alone reduced the burden on the regulator. At the same time, they hired more reviewers. With that two-pronged approach, they were already able to speed up the review timeline for INDs and NDAs.
But they did not stop there. They have continuously improved. The latest change, implemented just last September, means that in the best case, an IND can now be approved in 30 days, provided the dossier is already in Chinese and the leading investigator agrees to take on added responsibility in risk management. That applies to Chinese biotech clients where there is no need for translation. For a US company, the timeline still runs two to three months for translation. But the government has been very decisive and consistent in implementation, and that has made a significant difference.
JingPing: The government’s commitment has also come with real infrastructure on the ground. Hospitals are more prepared, investigators are more willing to engage early, and the SMO and recruitment agency ecosystem is now well-established in China to support trial operations.
The other thing I want to highlight is what quality actually means now. As more APAC countries, including China, have become ICH member states, quality is being assessed through inspection readiness, data integrity, source documentation, and patient protection standards. That is being taken seriously at the country and site level. At Precision for Medicine, what we do is continuous central data review and risk-based monitoring so that sites are always ready, not just when an inspection is announced. It is about getting sites ready to do quality work from the start, not just hitting a startup timeline.
Precision for Medicine
How should sponsors weigh the FDA’s different inspection procedures when they are evaluating APAC site data?
JingPing: I do not see that there is much difference anymore. When APAC sites contribute data to global applications, they are already familiar with FDA inspections. And within each APAC country, the local regulators conduct similar inspections and audits under comparable guidelines. Many of these sites have been through it repeatedly and are always inspection ready. At Precision for Medicine, we look at centralised monitoring and continuous data review as day-to-day practice, not something we do only when an inspection is announced.
James: I would add that unannounced inspections are actually very common in China now. The Chinese regulatory agency conducts inspections with very short notice, and the sites are used to it. For US FDA inspections in China, advance notice is still given because of the practical requirements around travel, language, and translation. But what matters is the outcome. We looked at FDA inspection results from 2009 through 2016, across all three categories: no action indicated, voluntary action indicated, and official action indicated. Asia as a whole, a large part of which reflects China given the volume of trials there, fares comparably with the US and Europe. They are not the worst-performing region by any measure. I think that speaks well of how sites across Asia are running trials.
“Asia as a whole, a large part of which reflects China given the volume of trials there, fares comparably with the US and Europe. They are not the worst-performing region by any measure.”
How do you see APAC’s strategic role in global development evolving over the next five years?
JingPing: The shift is most pronounced in oncology. More than 50% of studies globally are looking at oncology indications, and APAC remains critical for the substantial cancer incidence numbers and the strength of its specialty centres, in China and across the broader region. The countries and sites have matured, genomic testing capability is advancing rapidly, and investigators have accumulated significant experience in registration studies.
For China specifically, the China-originated companies are also becoming increasingly important global developers. More than a third of innovative drugs now come from China-based companies, and that accounts for a growing share of early clinical activity globally. For smaller sponsors, the risk is not simply missing a lower-cost geography. It is falling behind larger competitors who are already leveraging first-mover advantages in terms of timelines and the breadth of global evidence they are building. That is the biggest trend I expect to continue. Beyond that, how AI and digital technologies get applied to improve phase three execution is something we will all be watching closely.
James: I am in alignment with JingPing. The APAC market will continue to become more important. China is already the second largest pharma market and the fastest growing. Japan is the fourth largest. Korea and Australia are significant markets. As these markets grow, pharma companies will place more importance on engaging KOLs during the trial phase, particularly in oncology, where there are more pronounced ethnic differences in the types of side effects observed and where physician familiarity with a drug at launch genuinely matters for patient outcomes.
The other piece is the growth in R&D activity across the region. One-third of new compounds globally now come from Asia Pacific, and in some areas, like antibody-drug conjugates, more than half originates from this region. With the research and the originators coming from here, more sites will naturally be involved. I think that trend continues into the foreseeable future.
“You need to change the mindset of APAC as an outsourced geography or contingency plan, and move to seeing it as an integrated engine for your global development.”
“One more point on regulatory planning: some biotechs coming from the US or Europe do not know that China requires local patients in the pivotal phase three trial in order to file for NDA in China.”
Why do biotechs coming to China for the first time often struggle compared to sponsors who know the region?
James: The first thing I would say is that biotechs need to find a CRO with real knowledge, expertise, and an understanding of how trials are run in this part of the world. The culture is very different. How you engage a site in the US or Europe is very different from how you do it in China, and if you take the same approach, it will not be too successful.
I can give a concrete example. Biotechs will sometimes identify KOLs through internet searches and conference attendance, then try to approach them by email out of the blue. They get very little response. But if they engage a local CRO that has the network and can reach out through the right platform, through WeChat, in the local language, the response is immediate. Where a company on its own cannot get an appointment with a KOL, a CRO with established relationships can arrange a meeting the next day. Understanding what works in the US may not always translate to China or elsewhere in Asia Pacific is essential. You have to listen to the experts on the ground.
JingPing: Finding the right service provider is critical, but it has to happen at the right moment. The most important point is before the protocol and operational assumptions are locked. That means starting with evidence-based feasibility: looking at how to build in the right biomarkers, examining standard of care, competing trials, referral patterns, molecular testing availability, sample and support requirements, investigator capability, and building a realistic enrollment forecast.
What is distinctive about working in APAC is the fully integrated nature of what needs to happen: regulatory strategy by country, site activation, lab planning, biospecimen logistics, investigational product logistics, and patient identification, all forming one composite critical path. A good service provider helps smaller biotechs navigate that entire path. Ultimately, the goal is the same regardless of company size: assess the right patients, ensure solid biomarker operations and quality oversight, and avoid late-stage surprises that compromise data quality. The mindset shift that still needs to happen for a lot of emerging biopharm companies is moving away from treating APAC as an outsourced geography or a contingency rescue plan, and toward treating it as an integrated engine for global development.
James: One more point on regulatory planning: some biotechs coming from the US or Europe do not know that China requires local patients in the pivotal phase three trial in order to file for NDA in China. The same applies to Japan, and there are related requirements in Taiwan, South Korea, and India. If a CRO is not advising them on that in the planning stage, they can reach the end of a trial and realise they do not have the data to file for marketing authorization in China or Japan. That is where having expertise on the ground from the beginning makes a real difference.
James Cheong is Senior Vice President for Asia Pacific at Precision for Medicine. JingPing Yeo is Vice President for Clinical Solutions, responsible for clinical delivery across APAC.
Moe Alsumidaie, MBA, MSF, is founder and Chief Editor of Vanguard Publications, which publishes Clinical Trial Vanguard, Pharma Vanguard and BullScope, and Head of Research at CliniBiz. He has two decades in clinical trial operations and data science, with earlier roles at Genentech, Abbott Vascular and Stanford University Medical Center, and is a guest lecturer in clinical trial sciences at Rutgers University.
