Most big pharma are setting up operations in Asia, with China predicted to be the biggest market in pharmaceuticals by 2025. Mark McHale, Chief Scientific Officer at Aslan Pharmaceuticals discusses starting up Aslan in Singapore over two years ago, looking at the advantages and indeed challenges of operating in the East and the opportunities that lie ahead certainly from 2020 on.
Pharma IQ: What’s the attraction of setting up in Asia as opposed to setting up in the US or Europe?
M McHale: Asia is the next big market and it’s the place where most of the big pharma are now investing. There is a great energy there. Somewhere between 2020 and 2025, China’s going to be the biggest market. India already is a large market and will continue growing.
In terms of the regulatory authorities in Singapore, they’re a very progressive authority and we felt placing ourselves in a location where there was a very progressive regulatory authority that we can have a dialogue which would be very, very advantageous to the business. The economic development board in Singapore are again very progressive and really looking to establish businesses like ASLAN.
Pharma IQ: Are you currently doing any clinical trials in the emerging markets?
M McHale: Our strategy is to do as much as we possibly can in Asia; by far the majority of what we’re doing is based in Asia, with Asia based companies.
Our first drug, ASLAN001, that’s in phase II at the moment for gastric cancer, and that study’s ongoing in Seoul in South Korea. For ASLAN002, the study was initially opened in Australia, but we’ve got plans to progress to centres in Asia and South Korea.
In terms of our clinical trials supply, we’re also focussing on Asia. We’ve talked to quite a lot of different CRO suppliers across Asia for drug substance and drug product and our aim is to bring together a small number of quality CROs that we build long term relationships with.
In relation to drug product and the process for developing a new drug product, that seems to be emerging in Asia at the moment and growing. And so, we’d like to identify countries that are keen to occupy this space, it’s something that the West is very familiar with, but it’s less prevalent in the East, I’d say, and that simply is because of the way large pharma have used the CRO business in Asia. I think it will be mature in about two to five years, but there’s a huge appetite to do it as well which is quite exciting. So, I think it’s there, it’s just a little harder to find at the moment.
Pharma IQ: Are there are any challenges of working in Asia?
Language is a barrier, but I am always in awe when I’m in China of people speaking to me in English because my Mandarin’s dreadful but we are working on that on our side and we’re implementing language classes for staff from the West in ASLAN that need it. I think once you start working together, you understand the needs of those parties.
I was surprised over certain things that one would expect to just be done without any kind of consultation in the West; sometimes in the East things will just be done exactly as something says – perhaps it’s a template for a label that has a certain box that needs filling in, one would expect that people would automatically fill that box in with the relevant data but, unless it’s stipulated in Asia, that is not done. And so that’s a different experience, I think, something I haven’t seen before.
Having gone through this a few times now, one learns to be more precise about exactly what you want in certain areas; I think that’s probably a cultural thing but people are very good at doing exactly what they’re told. And that’s a real positive, because, if you ask for something to be done, it will be done very quickly and very efficiently. But just expecting that next level of input, unless that’s requested, it will not happen, but we’d certainly see it in the companies I’ve dealt with in Asia. Whether that will change, I presume it will as we build a better working relationship together that suppliers will understand, after our second or third project, exactly what we require.
Pharma IQ: China versus India: would you tend to favour one over the other and which will be the biggest market?
M McHale: India is a more mature market currently than China, but China certainly has an appetite for growth and just about every company I’ve visited seems to be doubling their capacity, or building a new facility in China. So I’d say China will be bigger in the next five or ten years.
However India’s got a lot of expertise already in terms of drug product. In China that is growing, I see it growing slightly slower at the moment than the drug substance side, actually. So I’d say India certainly for drug product and China for drug substance in terms of expertise and growth.
Pharma IQ: What does it take to ensure a strong relationship between a CRO and a pharmaceutical organisation like ASLAN Pharmaceuticals?
M McHale: Obviously, when you start you’re unsure of the capabilities on both sides; the CRO’s looking at you as a partner and we’re doing the same; we’re looking at a CRO and thinking, “Your people look good, let’s see what happens when you start working!”
I think you’ve got to get to a level of trust, and when you ask for something to be done, it’s done within the right time scale. If you get to a really good relationship, then it’s as such you don’t have to get into tremendous detail, you can say you want a certain area looked at or dealt with and it is dealt with completely. That’s a level we’ve got to get to with all our CROs, and I’ve done it in the past in collaborations. I’ve led in the pharma business, we’ve got to a tremendous level of trust and shared experience, shared expertise, and I think that’s where we’d like to get to with our CRO partners and I’m confident we will get there.
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