INTERVIEW WITH ROGER HAYES
“
...it won’t cost more, in fact it will cost less ”
and that’s always a good thing when you’re trying to keep your budget in check.
Q
What is the biggest challenge microsampling faces today?
I would say getting regulatory approval – certainly this is true in the USA. The US FDA is taking a very conservative approach. For regulator studies, and this is both in GLP toxicology and the clinical space, you need to do complementary assays, both liquid. It’s just the understanding that 25 µl is more than adequate and that this actually qualifies as a microsample.
When it comes to the overall perception, it is the regulatory approval of these DBS that has slowed the real explosion in that technology, but there are ways around that, again the VAMS technology is I think the way that will become very routine. Companies and sponsors are very conservative and if you said you were doing something new or let’s say out of the ordinary they get very nervous and that’s understandable, if I’m spending $1 million on a toxicology study, I don’t want any doubt.
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And so there is that conservatism in the USA, but when we get European sponsors they are a little bit more amenable to focus on the three Rs. But what we’ve seen is a conservatism that shows doubt – “are you sure it’s going to work”? We’ve obviously done all of our due diligence within our laboratory and as I said we’ve been doing small volumes of samples for 20 years. There is no real issue. But it’s the DBS that gets all the press, the issue with hematocrit and things like that creates doubts in peoples mind when you say microsamples. So we just say we do small volumes and avoid that issue altogether.
Q
Despite the countless benefits known of microsampling why do you think it is still taking time for it to be adopted?
I think it is the regulatory approval within the USA, I think in Europe that’s not really there – the regulators are much more amenable to accepting it, and again I’m really talking about dried matrices, and that’s where I think there’s opportunities for clinical studies where you can do home-based sampling. That will force the situation where people will have to do it that way, and as that body of data builds, and certainly there are a lot of large pharmas currently doing a lot of pioneering work in this, regulators will start to get comfortable. It will take a little bit of time to get there; I think in the USA by 2020 there will be enough data for the regulators to say ”you know what this is really routine”.
Certainly in my space, a lot of the work in the nonclinical GLP toxicology is just advancing as instrument sensitivity improves. As we do more and more in biologics, just the assay formats were already in the microsampling paradigm. So that’s been accepted for many years – but it’s the vocabulary around microsampling that is being associated with dried matrices that may really be what’s slowing down the full implementation. That will disappear as people get more and more educated about what microsampling is, there is no mystery around it, it will get comfortable and will become as routine in the clinical space as it is in the nonclinical.
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