May 29, 2019 | As Director and Diagnostic Lead of Oncology Programs at Pfizer, Marielena Mata deals with clinical trials on a global scale. Of course, conducting a trial in various countries requires quite a learning curve, from varying regulatory requirements to the simple language barrier.
These obstacles manifest themselves especially in the Asian markets. China, for example, won't allow samples to be taken out of the country, which forces global companies like Pfizer to find creative approaches to global commercialization. That's what Mata does best.
On behalf of Diagnostics World News, Marina Filshtinsky spoke with Mata about the challenges of conducting global precision oncology trials, how she works with diagnostic partners, particularly in the Chinese market, and how to retain continuality between global clinical trials and global commercialization.
Editor's note: Filshtinsky, a Conference Producer at Cambridge Healthtech Institute, is planning a track dedicated to Companion Diagnostics: Strategy and Partnerships at the upcoming Next Generation Dx Summit in Washington, DC, August 20-22. Her conversation with Mata has been edited for length and clarity.
Diagnostics World News: What do you think are the main challenges a company would face with a precision oncology clinical trial outside of US?
Marielena Mata: So there're three main challenges, among a number of other challenges globally. The bigger challenge we encounter first is whether a platform for the technology that we need is available globally.
If we're developing an assay, is it going be in a kit so that it can be distributed globally, or is it going be a single lab so the samples have to be flown into a single site in from across the globe?
The second challenge we encounter regularly is the differences in the regulatory requirements across the globe. In the US, we have a very clear path for supplemental PMA submission for companion diagnostic. That's a very different approach that the European Union uses with the CE Certification, as well as the new regulatory framework that we're still trying to understand how it's going to be implemented.
And then there are parts of the world where there aren't regulatory requirements, they're just starting to catch up with that and their requirements are sort of evolving.
China is a big challenge for us because you can't take samples out of the country and you have to have the technologies available in China, so that presents a number of obstacles we have to overcome in order to have a global solution from a healthcare perspective.
The third one is communication and understanding. Different parts of the world understand things differently or do things differently, and so ensuring that the requirements are harmonized across the world and across cultures, and that the understanding in the different parts of the world is the same so we can execute flawlessly becomes a challenge.
This can affect even the most simple things, like if you're working globally and can't find a time to have a meeting because it's different time zones and there are language barriers. There's just a different understanding of what's needed.
I think that's the problem for anything that we do, but it's certainly a problem in the diagnostics stage in terms of having different terminology for different things. I always say that validation means something for everybody and it's not always the same; I think that's true for a number of terms when we talk about diagnostics.
When you're partnering with diagnostics companies, do you have any special requirements? Are you looking for companies that have a global outreach, or are you looking for local partners?
Usually when we're trying to identify partners, we look for partners that have the global footprint needed for our drugs. With any drug you start with an initial global strategy of what countries are going to do your first submissions. If you can, you find a partner that has a presence in those counties and then you go from there.
Sometimes that's not possible. I think as we're seeing more single site or single lab companion diagnostics that becomes difficult, so we try to work with our partners to understand what their strategies are globally and help them get there.
As a last resort we sometimes have to identify multiple partners. So we may have a primary partner for the bulk of the world and then we may have a local solution for certain submissions.
For instance Korea has very strict requirements about local solutions, and China, because of not being able to take samples out, would frequently require a local solution. It's not ideal but it's what we have to do.
What is your perspective on the market in China? What's your experience with clinical trials in that country?
China presents a great opportunity. It's now considered the second largest healthcare market in the world, and so it presents a great opportunity both for conducting clinical trials and finding patients to support our global studies, but also as a market in itself and being able to submit applications and commercialize our drugs in that market.
But there are certain challenges, obviously. However, the Chinese government is understanding the opportunity and is changing their regulatory framework and becoming a little bit more open. For instance, they will now accept data from outside China to support a submission, and they will also allow data from China to go out to support submissions elsewhere.
That's a big opportunity, but there are still some issues around companion diagnostics, particularly because you cannot take samples out. It's also a very challenging process with the Human Genetics Resources Administration of China (HGRAC), even for internal testing.
But we're definitely getting better. In my experience, the China teamsthat we work with are understanding of what needs to be done to have successful submissions, and that's working.
The other piece to keep in mind around diagnostics in China is that there are two components. The first one is how do we generate data that can be used for the global submission using local testing, but then the second one is what is required for a Chinese submission. Sometimes the two of them aren't exactly the same, and we have to find a way to generate data that supports both the global as well as the local submissions.
I think that there's a long process of educating the global teams on what's required of China and there's some process of educating the Chinese team on what's required for the global submissions. The companies that are exploring this space understand that cross talk is essential for successful incorporation of China's global studies and global submissions, of course.
When you're done with clinical trials and you're starting commercialization efforts, is there any continuality between global clinical trials and the global commercialization of companion assays to guide the actual treatment of regular patients?
Oh absolutely! I think if you want to be successful in putting a drug on the market you have to be very proactive in having continuality between your clinical trial and your global commercialization. By the time you're conducting your clinical trials, ideally, you're working with your IUO (Investigational Use Only assay) so that the assay is going to be commercialized, and you've already established with your partners that there needs to be a commercialization plan for that diagnostic globally.
And you have commercial agreements so that you can have a coordinated effort of commercializing the diagnostic and the drug, and that the commercial team on both sides can work together to ensure that there is a smooth transition.
Concepts we need to start thinking about during our clinical trials are the prevalence of the markers, the prevalence of the populations, what is the access the patients might have to the test once this drug is approved, and how to ensure that we educate physicians so that they test in order to prescribe the drug. So there're several things you need to start doing in your clinical trial in terms of planning for the commercial launch of both the diagnostic, as well as the drug.