Daphne Smyth on the Chinese Drug Development Market Expansion

August 4, 2026

With increasing efforts to scale into international markets, what can we expect from China's drug development industry? Joining the podcast is Daphne Smyth, head of global regulatory programs at Veristat, who shares her experience at this year's BioChina and what to expect for drug development on a global scale. Smyth explains why North America and Europe have been attractive market destinations for the Chinese market now more than ever, the regulatory reforms, and the potential bumps on the road getting Chinese drugs to foreign markets. Plus, host Deborah Borfitz gives you the latest news on the quantified financial value of risk-based quality management, a shingles vaccine for lowering dementia risk, a Parkinson's disease drug for treating depression, an AI for treating neuroblastoma, a link between hormonal birth control and brain health in older age, and Bayer's first strategic alliance with an academic medical center focused on clinical trials collaboration.

Show Notes

News Roundup
Financial value of RBQM

• Study in Therapeutic Innovation & Regulatory Science
• News release from CluePoints

Shingles vaccine may lower dementia risk

• Study in Annals of Internal Medicine
• News on the Brown University website

Parkinson’s drug for treatment-resistant depression

• Study in Nature Medicine
• News on the Lund University website

AI for improving neuroblastoma outcomes

• Research article in APL Quantum
• News on the University of Utah website

Brain-protecting effect of hormone therapies

• Study in NeuroImage
• News on the University of Kansas website

Bayer’s alliance with academic medical center

• News on the University of Colorado Anschutz website

Guest
Daphne Smyth, head of global regulatory programs for Veristat

• Article in Clinical Research News about opportunities in China

GUEST BIO

Daphne Smyth, Head of Global Regulatory Programs, Veristat
Daphne Smyth is a regulatory and drug development leader with over 35 years of experience spanning the pharmaceutical industry, contract research organizations, and regulatory consulting. She has consistently delivered results in high-pressure environments, building and guiding teams to achieve ambitious goals on time and within budget. Currently, Smyth, who is based in Ireland, leads the global regulatory affairs function at Veristat with oversight of regulatory consulting including CMC and drug development, clinical trial support, publishing, and project management functions. 

Prior to joining Veristat, Smyth served as vice president of strategic regulatory services at ICON Clinical Research, where she led the integration of global teams across drug development consulting, medical devices, and clinical trial support into a unified business unit. Daphne was instrumental in implementing new business structures, driving growth strategies, and ensuring compliance. Smyth’s earlier career includes leadership positions at Labopharm Europe, where she established the company’s European operations, and at Bayer, where she managed global regulatory projects and liaised with global regulatory authorities. Her expertise covers the full spectrum of drug development, from early-stage projects to commercial launches, with a proven track record in both large pharma and biotech environments and navigating complex regulatory landscapes, such as in the EU, and is a trusted advisor to pharmaceutical companies seeking to bring innovative therapies to market, especially for Chinese sponsors seeking new global markets. She can be reached at daphne.smyth@veristat.com.

TRANSCRIPT

Welcome And What’s Ahead

Hello and welcome to the Scope of Things podcast, a no-nonsense look at the promise and problems of clinical research based on a sweep of the latest news and emerging trends in the field. What I think is worthy of your 30 or so minutes of time. I'm Deborah Borfitz, Senior Science Writer for Clinical Research News, which means I spend a lot of time with my ear on the ground on your behalf and a lot of hours every week speaking to top experts from around the world. Please consider making this your trusted go-to channel for staying current on things that matter, whether they give us hope or cause for buzz. In a few minutes, I'll be speaking with Daphne Smythe, head of global regulatory programs for Veristaff, about the goldmine of opportunities it has discovered in China. But

News Roundup Sets The Stakes

first, the latest news, including the quantified financial value of risk-based quality management, a shingles vaccine for lowering dementia risk, a Parkinson's disease drug for treating depression, an AI framework for tailoring the treatment of kids with neuroblastoma, the link between hormonal birth control and brain health in older age, and Behrer's first ever strategic alliance with an academic medical center focused on clinical trials collaboration.

RBQM Shows Massive ROI

Expert from Clue Points teamed up with researchers from the Tufts Center for the Study of Drug Development to publish peer-reviewed evidence quantifying the financial value of risk-based quality management, or RBQM. The study demonstrates RBQM-enabled clinical trials achieve up to 23 times the return on investment and 19% shorter phase durations, based on an analysis that combined real-world data from 18 oncology trials with proprietary oncology benchmarks. At the development program level, expected net present value gains range from $3.8 million in phase 1 to $13.8 million in phase three, the largest contributor to the financial value time savings. A new

Vaccines Hormones And Brain Health

study finds that older adults who receive the shingles vaccine of Lex Glaxosmith Klein after a stay in a skilled nursing facility were 24% less likely to be diagnosed with dementia within four years than those who were not vaccinated. The vaccine was first introduced to the U.S. market in 2017, replacing an older vaccine that earlier studies likewise linked to neuroprotective benefits. The latest study used the target trial emulation method, analyzing Medicare claims and electronic health record information for more than 500,000 adults. Vaccination translated to about one in 17 dementia cases potentially being prevented, but clinical trials will be needed to definitively credit the vaccine. A drug repurposing study in Sweden finds that a first-line treatment for Parkinson's disease shows promise in treating treatment-resistant depression, specifically as an add-on therapy for people debilitated by an idonia and unable to enjoy things that they previously found meaningful or rewarding. The Parkinson's drug was linked to a positive effect on the brain's reward system and increased physical activity in everyday life, supporting the theory that it affects the dopamine system. Most study participants tolerated the drug well, and side effects, including sleep problems, nausea, and dizziness, could usually be managed by adjusting the dose. Using

Drug Repurposing AI And Trial Partnerships

quantum mechanical concepts of superposition and entanglement, researchers in Utah have developed an AI framework to tailor the treatment of infants and young children with neuroblastoma to their entire molecular background to improve treatment selections and drug success rates in clinical trials. The approach finds relevant information in every layer of the data, including both the blood and tumors of patients, to make sense of millions to billions of molecular features and understand disease mechanisms and predict drug targets. Notably, the predictions of targets and outcomes were validated experimentally. An analysis of open source data of neuroblastomic cases discovered two new predictors of patients' life expectancy in response to treatment that consistently outperformed standard biomarkers across tumor blood DNA and tumor RNA. Researchers at the University of Kansas have found a beneficial link between the use of hormonal birth control and young adulthood and brain health and older age, as well as a protective cognitive effect from estrogen-based hormone therapy used in midlife, thereby supporting its use during menopause. Women experiencing menopause at a later age and thus exposed to natural ovarian hormones for a longer period were also found to have a thicker cortex in multiple brain regions vulnerable to Alzheimer's disease. The research team is now actively recruiting patients for new menopause-related studies. And finally, BAER has formed its first ever strategic alliance with an academic medical center focused on clinical trials collaboration. The partners include the University of Colorado Enchutes, UC Health, and Children's Hospital Colorado. The alliance is designed to improve clinical trial efficacy, expand efficiency, that is, expand patient access to investigational therapies, and advance new medical discoveries with initial focus on research studies and oncology, cardiovascular disease, chronic kidney disease, neurodegenerative disease, cell and gene therapy, women's health, and ophthalmology. A phase three clinical trial for an investigational cellular therapy for advanced Parkinson's disease is an early example of the alliance's impact. As a reminder, links to the articles, studies, and press releases referenced in this month's news segment can be found in the show notes. It is

China’s Global Push Meets Veristat

now time for my chat with Daphne Smythe, Head of Global Regulatory Programs for Veristat, about her recent eye-opening experiences at Asia's premier biopharmaceutical and life sciences event. Welcome to the show, Daphne. I know listeners are going to be interested in hearing your perspective on China's scaling drug development efforts for European and North American markets.

Thank you, Deb. It's my pleasure to be here and thank you so much for inviting me.

Well, thank you so much for being here. Okay, so earlier this year, on behalf of Veristat, you joined over 30,000 other people and Suzhou for Bio China 2026, which after which the company began upping its game to accommodate the demand among Chinese companies to gain a foothold outside of China. I know the story of that visit has many fascinating and somewhat surreal twists and turns, but perhaps you could start us off with a picture of the situation in the three days you were in the exhibit hall.

Inside BioChina And Suzhou’s Biotech Hub

You're right. We had an incredible time. It was a real experience. We took advice from our current Chinese lines and took a booth at BioChina, like you say, without, to be honest, huge expectations. BioChina itself is a huge event. The attendees were mainly Chinese, and the focus of the conference was on Chinese development, with some focus on expansion into other markets, as well as a very strong focus from an exhibitor perspective on manufacturing. So we had a booth in the international section, which was quite small. So not very many other international CRO or companies, even were represented. However, we were overwhelmed by the level of interest in our services, focused on helping companies get their products approved outside of China. We found the attendees genuinely interested in talking to us. We were on our feet at the booth for three days.

The companies had very specific questions related to their development projects from the need for agency interactions, route to marketing authorization, through need for GCP, GMP inspections. They were fascinated with the work we are already doing and are already doing for other Chinese clients. So altogether we had a thoroughly engaging, active, and exhausting experience at BioChina.

It sounds...

There was a language barrier. Sorry, sorry, Deb.

That's okay, go ahead. Language barrier?

Yeah. Yeah, we did have a language barrier, obviously, because unfortunately I do not speak Chinese, but we overcame this with our brochure, business cards in Chinese, and some help from translator apps. So it was, again, like you say, fascinating experience.

So much so, I could tell. Now, what about the city of Suzhou itself, famously known as the Venice of the East? Did you get a chance to roam and visit the locals much at all?

We did, in spite of our three long days at the booth and talking to people. You got out of it. We did. We escaped. We managed to take a trip to the old city. So the Venice of the East refers to the old city that has romantic canals, absolutely beautiful, and a real tourist attraction. The rest of Suzhou is an ultramodern biotech and innovation hub. It's a real contrast. It's a purpose-built science hub city with research, development, manufacturing, hospitals, universities, schools, housing, all in one integrated environment that even includes a full life science park called Bio Bay. We, obviously, because we were mainly at the conference, we only saw a very small part of it outside the conference center. But as I said, we did see the old city and some parts of the city as we were traveling around. But it's in general, it's ultra modern, purpose-built, busy, commercial, university, residential city, as well as a center of excellence for science and innovation. And all of that about 40 minutes by car from Shanghai. Wow.

Well, that is not the concept I had of China at all. That area, especially.

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Why Chinese Sponsors Target West

Let's back up a minute to review the work Veristat was doing for Chinese pharma companies prior to this visit to Suzhou versus post-visit. How much work has the company historically done in the region or for companies based there? And how much has it ramped up in recent months?

So, yeah, we have been working for Chinese pharma companies. In fact, it was these Chinese companies who recommended that we should go to buy a China. We started providing regulatory magical writing, PV, QA services to one client about four years ago, Seastone. By the time we went to Shanghai and Suzhou in March of this year, we had five clients and had managed to obtain one US NDA, two EU and two UK marketing authorizations on their behalf. So our work has been focused not on working inside of China, but on working with Chinese companies who wish to market the assets outside of China. Based on our initial success and the fact that the Chinese market is very transparent, we have received both referrals from our existing clients and a steady flow of inquiries based on the Chinese media exposure of our success. At BioChina, we were, of course, made many more contacts, some of which we are now working with, some clients we are already working with, and others we're still in discussion with. So, yes, this is a relatively niche area. It has been a huge success story for us, is really interesting and exciting work for our teams.

Why have Europe and North America been attractive market destinations for Chinese sponsor companies anyway? I mean, why more so now perhaps than than in earlier years?

Yes, I do believe it's changing. It is true it is changing. The China local market is, of course, huge, but the result of Chinese government investment in the industry has resulted in a lot more products coming through RD and onto the Chinese market, causing intense internal competition. So we now see companies looking outside the local market to maximize their return on investment for their assets. In addition to this, that China is also opening up to foreign investment. So Chinese development companies are selling airy stage assets to Global Pharma, going into joint ventures for development and commercialization, but also expanding themselves with the help from CRO. Their drive in this case is to add more value to their assets by getting local approval prior to outlicense rather than outlicensing the assets prior to approval. So that's a very interesting development.

Yeah, the the regulatory reforms are they broad or are they in discrete and incremental? Do you know much about that?

Well, quite broad. And it has the process has become much less bureaucratic and much smoother.

Okay.

So yeah. As well as investment, sorry, as well as the investment in the industry itself. So there are more and more products coming through development.

Got it,

Shanghai Office And Regulatory Roadblocks

got it. So Veristat has announced that it'll be opening a location in Shanghai before the end of the year. So I do want to touch on that. I think the idea is to capitalize on this growing interest among companies in China to expand beyond their home market. So, what will the role of that office be and when will it officially be in operation?

Yes, we're hope we are, we are in process of opening an office. We are aiming to have the office open by the year, the end of the year. The role of the office will be to establish local presence and have local staff to deal directly with our current and potential clients, as well as interact with our internal teams to grow our business.

Okay. And I'd like to end with your perspective on where there might logically be some bumps in the road in terms of getting Chinese-made drugs into foreign markets. Where do you think the focus will need to be over the next few years to facilitate the shift from in-country to global market development by these pharma companies in China?

Yeah, it's an interesting, very interesting question. So the the US regulatory environment is more familiar to Chinese-based companies, as it's very similar to their own. However, they do need a lot of support to navigate the complexity of submission approval processes in Europe. So that is that is a barrier that's being overcome. It's something that's developing, and there's more information being made available in the local market. The other thing is obviously that European and North American regulatory agencies do require the clinical trial population to reflect the local market. So either this data needs to be presented or a strong justification for extrapolation provided. From our experience, the initial experience we had was with companies who have largely completed their mainly oncology drug development in China and already have their products marketed.

And they've been looking for approval outside of China with more or less success, due to, as I said, the level of additional data required sometimes by the agencies to reflect the local market. In oncology, which has been the main products we've been dealing with, it is usual to have patient data in early phases. So if some of this patient data was from non-Chinese patients, that obviously helps the approval chances outside of China. And that's what we are seeing: an increase in that the Chinese companies are focusing on this early development and having a truly global development rather than purely a Chinese development. So that is a that's a huge development since what we saw from the early phases. They are looking to conduct their phase one and phase two in the US and Australia and in order to connect the necessary data.

We are definitely going to be hearing more about China in the years, months ahead. It sounds like in Veristat's pretty much leading the way in this arena right now, it sounds like.

I hope so.

The world seems to just keep getting smaller, doesn't it, Daphne? As you've made played. This, you know, the phrase made in China has sort of earned a respect that I think is long overdue. Thank you for sharing all the ways China is a global powerhouse of indigenous research that's worth keeping our eyes on. And thank you for taking the time to be on today's show. Really appreciate it.

Thank you so much. It's been a pleasure, an exciting time to be involved in these developments, really, and to grow and develop with our clients. So thank you.

Subscribe Review And Scope Summit Invite

You're welcome and thank you for being on the show. And as always, a big thank you to everyone out there for listening in. If you're not subscribed to this podcast yet, please consider going to Apple Podcasts and doing so right now. So you don't miss your monthly dose of news and perspectives. You'll be hard pressed to find anywhere else. And if you're up for it, I'd also be so very grateful if you leave a rating and review while you're there. One more thing before we go. I'd like to, if you like today's conversation, it's only a glimpse of what you can expect from Scope Europe presenters and panelists. Please plan to join us October 13th and 14th in Barcelona, when clinical operations executives will be exploring the latest trends in clinical trial innovation, planning, and operations. Save an additional 10% off any current rate by using the code SOT10. For more information, visit ScopesumitEurope.com. Bye for now.

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Deborah Borfitz

Deborah Borfitz serves as host of The Scope of Things podcast. She is also senior science writer for Cambridge Healthtech Institute and is the lead contributor to Clinical Research News, Bio-IT World, and Diagnostics World News. Deborah has a long and varied career in journalism, much of it as an independent writer with a heavy focus on healthcare and clinical research. She was introduced to the world of clinical trials 25 years ago by advisory board member Ken Getz and in 2001 co-authored a book with him on the informed consent process.

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