INTERVIEW WITH ROGER HAYES
“ There’s nothing to be scared about. There’s no need for conservatism. It works.
”
Q
Where do you see the field in the next 5–10 years?
The conservatism will disappear; I think microsampling will become absolutely routine. Instrument sensitivity will continue to push the vendors for more and more sensitive equipment. In parallel that will reduce the amount of volume that is needed in the bioanalysis. Regulators will start approving, new drug applications (NDAs) or biologics licence applications (BLAs) in the biologics, the concern will vanish and I think that will happen more in the next 5 years.
The tools that become available for handling small volumes, the accuracy of the sampling devices, the automation all of these will continue to improve. It is not trivial to do 384 well plates, we currently do them. It is not yet routine, 5 years from now we would like to say ”well when we are going to move up to the next platform – 384 is easy”. So I think just the ease of that and the workflows, the accuracy of how we go about doing the bioanalysis will improve and with that the regulators will become very comfortable, it will just become part of the normal course of business.
If you could give a piece of advice to fellow colleagues looking to implement microsampling as part of their biosampling strategy in their research, what would you say to them?
Q
First you have got to assure them that the study will be valid. There has been enough out there about regulators not approving it and they have to do all this extra works and so forth. I think the first piece of advice, after doing it for 20 years, would be that it is just the DBS that are the issue at the moment, but even that is being resolved.
Secondly 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. As soon as we have discussion with sponsors and say ”look it’s not a bad thing, the data is valid and it will cost you less”. Also it is not more difficult – again we have been doing it for a long time and devices like the volumetric absorption are making it even easier, and it’s easier for the animals too.
At the end of the day you need an internal champion within the organization to drive it, to be that resource to say ”Can we do this?” You’ve got to get over that activation barrier and that’s true of any incremental changes – you still need someone to push to say let’s give it a go, let’s do the internal due diligence to make sure we can actually take a 10-µl sample out of a mouse, you need that!
And always you have to communicate, you have to communicate with your sponsors letting them know the studies are going along well, that the data quality is there, and then just continue to reinforce those advantages. That’s really the advice you give to anybody about any
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