Xceleron: Changing the Face of Clinical Trials




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Video title: Xceleron: Changing the Face of Clinical Trials
Released on: September 09, 2008. © PharmaVentures Ltd
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  • Summary
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Fintan Walton talks to Professor Colin Garner, founder and CEO of Xceleron, a bioanalytical CRO that is changing the way drugs are developed. Established in 1997 as part of a transatlantic scientific collaboration, the company has taken accelerator mass spectroscopy (AMS) into the drug discovery arena.

Professor Garner talks us through the original aims of the company, its past and present business models and the way it created a market for its services. He touches on the results of the European Union AMS Partnership Programme (EUMAPP) trial and on how AMS technology is radically changing the way in which pharmaceutical companies approach clinical trials and drug selection.
Xceleron's origins.
Fintan Walton:
Hello and welcome to PharmaVentures Business Review here live in San Diego, California. On this show I have Professor Colin Garner, who is CEO of Xceleron which is based both in the UK and the US. Welcome to the show.
Colin Garner:
Thank you.
Fintan Walton:
Colin, Xceleron is a company it has a very specific type of technology which has allowed the company to develop important aspects into the way of drugs are discovered and how drugs can to be dedicated during the clinical phase, could you describe the origins of the company?
Colin Garner:
So the origins of the company, we were founded on academic research which always primarily involved with the University of York who have been academic for far too long. And arouse from collaboration with a group in the United States who had first time used big piece of nuclear physics kit called an accelerator-mass-spectrometry which was originally developed for archaeological dating they had used that for biomedical research and mainly focused on animal research. And in that collaboration with (indiscernable) academic we did some of the first human studies. And that gave us the impetus to think about how this technology could be actually applied in the drug development and drug discovery arena and that was really how we got going.
AMS technology technology and its abilities.
Fintan Walton:
So this technology is this kit that you described, so what can this kit do?
Colin Garner:
So the interesting thing about it is that the original instrument we bought in York occupies about size of two tennis courts, so it's a huge piece it's a nuclear physics particle accelerator essentially. And what it can do is it can measure elemental isotopes at the single atom level and so if we tag a drug with an isotope usually 14 carbon then we literally can measure one atom or 14 carbons in this instrument and that equates to one molecule, so we can't really get any more sensitive detector in that.
Fintan Walton:
So the sensitivity of the detector is the key aspect of the Xceleron's business?
Colin Garner:
Yes I think ultra sensitive analysis allows us to use the technology primarily we're focused on human ADME studies, human ADME/PK studies well this is a what's called I think a disruptive technology and allows you to think about how to do things differently than you might have done conventionally.
Fintan Walton:
So what is it doing differently, what how can you use this technology?
Colin Garner:
Well, so when we started of our business which was actually funded by the pharmaceutical industry we went around to companies and ask them if they were interested in putting money into our pot to buy one of those machines that cost about $5 million so that pretty expensive but commercially relevant, we can buy them off the shelf but it will take you 18 months to have it delivered. So we presided Glaxo, Pfizer, Johnson & Johnson, Novartis to club together and to help fund and purchase one of these instruments and that was how Xceleron was set up as a company they provided it like a startup capital but they have no equity in the company which is quite a nice model for us and then providing the money. So when we started we expected that we would use this technology as a replacement for current methodologies, it's a highly sensitive radioactive detector and therefore we thought it would be used for substitution of current radio active detection methods and the attraction is that you can reduce the radioactive doses at least a 1000-fold, so if you are thinking about human studies you might be able to carry out this that is at a very, very low level, so we thought this would just be a replacement for that, but actually you start off these all these good intentions as a company thinking you know the market but actually the market was completely different. And the market is one that we actually have to create. And we created it on the basis of the ultra sensitive aspects.
Fintan Walton:
So this is the ability to do microdosing?
Colin Garner:
Correct, so this is one of those you have a sort of your weaker [ph] moment and you think well would it be possible to measure trace doses of drugs after human administration and studying lets say their metabolic fate or perhaps targeting to particular tissues and organs, so that's how that concept arouse and very interestingly the regulatory authorities pretty much endorsed the concept almost straight away and so both the EMEA and the FDA have guidance documents in place long before the industry even started to use the technology and use this approach, so for the first time I think the regulators where ahead of the industry which usually happen.
How the technology works in drug discovery applications?
Fintan Walton:
Yeah, yeah. And so clearly it can be applied to that particular aspect of drug testing, it also has other applications in drug discovery as well could you describe how that can work?
Colin Garner:
Well, I think where well lets just finish on the microdosing I mean where does that used, I mean where it's most efficiently used is when you have molecules coming out of discovery and you may have the several of them the difficulty today is how do you decide which ones of those to take forward. So the idea is to take several candidate molecules into a microdose study and select the molecule that looks as if it has the optimum pharmacokinectics properties and that is the one that take you through to Phase I.
Fintan Walton:
Have properties in human being?
Colin Garner:
In humans so you're using humans if it like as a screen for those molecules, so it's much more relevant data than using animal models. Now one of the big questions always that's get asked about microdosing is okay so you get information at these trace doses but what about at therapeutic levels will you get the same information? So we've been spending a lot of time and resource and we had a big EU grant for about $3 million to investigate that and actually we announced this morning the results of that trial which was called the EUMAPP trial and we had seven drugs that we investigated micro dose versus therapeutic dose and five after the seven were predictive. So that was good and we have done similar trials previously, so now we have a database of around about 25 molecules. And the correlation between microdose and therapeutic dose pharmacokinetics is about 80%. So the question that we always get asked is it predictive? The answer is yes it's very predictive.
Fintan Walton:
Right. But I presume also that you are learning from fact that you wasn't, weren't so predictive you are learning more about which ones it can be required to?
Colin Garner:
Correct. And I would imagine that over time we will build up a database and then we can you know say well molecules at this type should not go through this procedure because they are not likely to be predicted. But you asked about preclinical use I mean we found that the greatest utility preclinical where companies have analytical problems, analytical challenges so that might relate to having to detect very, very low levels of drug in animal model or where the amount of tissue available is very, very small so we've done studies let's say on vaccine adjuvant and on polymers and proteins in animals simply because the analytical methods that were available before this technology weren't sensitive enough.
Business model.
Fintan Walton:
So how does what is Xceleron's business model? How does that it relate to technology that you've got?
Colin Garner:
Right, so our business model really focuses on helping companies select their drugs more efficiently and more effectively in other words it's derisking the candidate selection process as you go down. And obviously if you can fail very early on in drug development then you're likely to lose lot less money than if you fail much later down the drug development path. So our business model involves sort of consultancy project management and knowhow, we have in our developing intellectual property we although we are a small company we've employed about 50 people in total of course on two sides, we do put about 5% of our sales into R&D to generate IP.
Fintan Walton:
So when you talk about these two sides and how they are divided, because you yourself are based here in the US?
Colin Garner:
I am currently, so the company started out in York in England as a spin out from the University. We operated there up until 2005 when we set up a business development activity in the United States and that's now being followed on with a lab facility and a second AMS machine fortunately in the intervenient years between when we bought big machine they have become miniaturized and so instead of two tennis courts we now have one squash court's worth of instrument. And these smaller instruments are equally sensitive and reliable interestingly about two or three-years ago now GlaxoSmithKline bought two of the smaller instruments for their own in-house drug development research.
Fintan Walton:
Okay. And these instruments are developed by yourselves?
Colin Garner:
No these instruments actually are commercially available interestingly from a spin out company from the University of Wisconsin in Madison where a nuclear physicist was a accelerator specialist and he couldn't buy good accelerators from other companies so he decided to set up his own company to make accelerators and that's what where we get these things from.
Future plans.
Fintan Walton:
Okay. And for Xceleron itself taking the company forward and where do you want to take this company and where do you see it fitting within or slotting itself in the future?
Colin Garner:
Right. Well, when we started I mean I think you know two, companies have two missions in life one is to make their founders and their shareholders money, the second is actually to have a true impact. And so our goal was to change the way that drugs are developed, so the most gratifying thing I think for us is if there was wide scale adoption of some of our novel approaches interestingly say in the microdosing arena there have been some surveys of pharma and biotech companies as to whether they will adopt these approaches in their opinion going forward and this number for what is worth that's come out of these surveys says about by 2012 I believe 90% of companies will be using microdosing reasonably routine here.
Fintan Walton:
Right. And then hopefully pharmaceutical companies and biotechnology companies will be coming to Xceleron to help them do that?
Colin Garner:
So we, exactly so and they can do that in two ways one is that obviously we can manage projects and do analysis for them. And actually we are discussing with one very well known top five pharma company almost like franchising the technology to them running facility for them, because it's still highly specialist and you need a nuclear physics, well interestingly the company has nuclear physicists, biologists and chemists and an interesting dynamic to get all those to talk to each other. So setting these things up in a pharma company is not trivial activity.
Fintan Walton:
Yeah. Well nuclear scientists are not normally employees of pharmaceutical companies?
Colin Garner:
Not there, they are not. No they live on a different planet to biologist I had to tell you.
Fintan Walton:
Yeah. So Professor Colin Garner, wonderful to talk to you. And thank you very much for coming on the show.
Colin Garner:
Thank you very much for your time.
Richard Seabrook
Chief Executive Officer
Professor Garner's career has spanned both the academic and commercial worlds since he set up the University of York's first spin-out company in 1976. Prior to founding Xceleron in 1997, he founded Biocode Ltd, a monoclonal antibodydiagnostics company and Microtest Research Ltd, a genetic toxicology contract company. He was also the UK's first Professor of Molecular Epidemiology and Director of the Jack Birch Unit for Environmental Carcinogenesis at the University of York. In 1980 he founded the journal of Carcinogenesis and has published over 200 papers and reviews on the environmental causes of cancer. Professor Garnerbecame a Fellow of the Royal College of Pathologists in 1994 and was awarded a DSc in 1995 by the University of London for his scientific contributions to cancer cause and prevention research.
Xceleron
Xceleron is a bioanalytical CRO and spin out company from the Jack Birch Unit for Environmental Carcinogenesis at the University of York. Since 1997, Xceleron has pioneered the application of accelerator-mass-spectrometry (AMS) to biomedical analysis and has highlighted the benefits of human microdosing. First used in 1939, AMS is capable of separating a single molecule of a rare isotope from abundant neighbouring mass, making it 100,000 times more sensitive than mass spectrometry. Its ultra-sensitivity allows human radioactive dosing to be administered on a microdose level, at which regulatory approval for the ionizing radiation is not required. This allows for safer investigation of human ADME/PK, providing more accurate information and allowing trials to be conducted on a wider demographic. Xceleron applies AMS-technology to several key areas of biomedical research: in addition to human microdosing in Phase 0 clinical trials, it is also used in HumanIV-PK,META-ID and Regulatory Mass Balance studies during Phase I trials. Xceleron has bases in the UK and the US and is partnered with over 100 pharmaceutical and biotech companies worldwide.