BioBDx: Byron Hewett explains their mission to change the way that ADHD is managed using their Quotient system.




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Video title: BioBDx: Byron Hewett explains their mission to change the way that ADHD is managed using their Quotient system.
Released on: October 20, 2011. © PharmaTelevision Ltd
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In this episode of PharmaTelevision News Review, Fintan Walton talks to Byron Hewett, Executive Chairman of BioBDx.
Quotient ADHD system in assessment of ADHD
Fintan Walton:
Hello and welcome to PharmaTelevision News Review here at BioPharm America in Boston. On this show I have Byron Hewett, who is the CEO and Chairman of a company called BioBDx , welcome to the show.
Byron Hewett:
Thank you, glad to be here.
Fintan Walton:
Good. Now tell me little bit about BioBDx , what sort of organization it is?
Byron Hewett:
We're private company about 20 employees, venture backed. We licensed the technology from McLean Hospital which is part of the Harvard Partners System here in town and we've been commercializing the technology over the last two or three-years.
Fintan Walton:
Okay, and that technology is applied into a specific product that's called Quotient-ADHD?
Byron Hewett:
Yes it's the Quotient-ADHD-system and the Quotient system is FDA cleared to provide objective measures of inner tension, impulsivity and hyperactivity to be used as an aiding the assessment of ADHD.
Fintan Walton:
Now the whole area in from a therapeutic point of view has been controversial in the sense how do you actually diagnose the disorders itself, so what are you bringing to our understanding of that disorder?
Byron Hewett:
Great question, the current state of the art is to do a clinical interview a company by rating scales, the rating scales are usually performed by the mother, the father, the teacher and then they are provided to the clinician to help them with their assessment of ADHD. In order to be diagnosed with ADHD you have to have six out of nine of the DSM-IV criteria in two different categories, one is inner tension and the other one is hyperactivity impulsivity and so when they go through this process they are looking at a series of behaviors like I said six out of nine and into those two dimensions and then they also need to demonstrate that the disorder or deficit is present in more than one setting and also for more than six months and so often times that's part of where these rating scales because they are trying to get information about another setting. The problems are that it's a very subjective assessment you are getting rating scales back typically from unskilled reviewers you often times have rating scales in conflict the teacher may want the kid to be more compliant in class the parent may not believe their child has a disorder and then the clinician is pretty much left with their clinical assessment based on their interview, the idea of Quotient is to provide them with objective quantitative measures that allow them to have more confidence in their assessments and it's not just to be used at a baseline assessment the test can also be used for follow-up assessment to help optimize treatment.
Basis of Quotient device
Fintan Walton:
Okay, so what is the basis of the product itself what are you bringing? What have you brought along for this particular assessment?
Byron Hewett:
The work that was done at McLean Hospital was designed to look at certain external behaviors and then correlate those two brain function, so studies have been done it show that the dimensions that were measuring correlate with the sections of the brain that are involved in these deficits of inner tension, impulsivity and hyperactivity and that's been demonstrated using functional MRI or Magnetic Resonance Imaging studies. So what we do is we provide an attention task so there is sort of a go/no or go/no-go or vigilance tasks that the patient takes and while they are doing that task we are tracking their motion using an infrared motion tracking system that measures the movements greater than one millimeter 50 times a second it turns that the micro movements are highly statistically significantly correlated to ADHD and likewise in the attention task itself and they've been around for a number of years, but what we've done is taking it to another level we packed it at proprietary approach to this what we call attention state analysis and by running a series of algorithms we can tell in 30 second blocks if the patient is attentive impulsive distracted or disengaged from the test so the clinician now for the first time over the course of 30 blocks or 15 minutes for a child test with these 30 seconds they can see whether or not their child can sustain attention they can see if they are impulsive or they can see if they are distracted or disengaged, the disengagement means it may the performances is no better than chance that could be random, minimal or contrary and so this lines have been very powerful information for the clinician, because it turns out that the number of shifts and attention from these different attention states correlates statistically significantly with ADHD.
Fintan Walton:
Okay, now that's good stuff how does that then translate into a recognized test by clinicians and by organizations of the FDA?
Byron Hewett:
So the performance of the test was submitted to the FDA and then FDA clearance was received so that's sort of I checked the box you know so now it's more about the value of the test in the clinical management of patients by physicians that are dealing with patients with ADHD and so when the test is completed on our Quotient two system we now have a small portable unit that were just introduced into the marketplace this month which is you know really exciting for us, because I think it will help us broaden our penetration in the market much more broadly, but when that test is completed the operator uploads the information over the internet it goes to our company's servers we run it through our series of algorithms and we provide that clinician back with the report in under a minute, our report is about seven pages in length it's got 19 different parameters it's all age and gender matched which means that the reason for that is that a six-year old boy is going to move more than an eight-year old boy, a six-year old boy is going to move more than a six-year girl, because part of this is developmental and so that's accounted for in the way that our test has been developed so the clinician gets back a lot of information that they can use to help themselves assess you know where is this child is really at, so that's one of the idea now our test is also not limited to children we also have a 20 minute test for adults and so we can go from age of 6 all the way up to age 55.
Fintan Walton:
Okay, so obviously in the process of getting this device out and being used by clinicians more and more information is going to come back and presumably you are going to get smarter about you know what the population is looking like?
Byron Hewett:
Yes, that's a really great question and a great point that you've raised, because we are capturing a 100 fields of data on every test, we've now run more than 50,000 test with the Quotient system all that information resides on our servers that gives us a lot of data that we can mine that can allow us to improve the performance of our test over time.
Fintan Walton:
Right, because obviously you may the first time that you use it you may not be quite right but is there a self-improvement in the actual test itself?
Byron Hewett:
You can't exactly do it that way with the FDA, so what you do is you gather a lot of a data then you reanalyze and then you can update but you can't do it on a continues as you go basis because the FDA is concerned that something gets out of whack and then you actually spin off the track instead of getting better. And so you have to make sure that you run what they called a test set and a validation set to make sure that everything ties together.
Applications of Quotient device beyond ADHD
Fintan Walton:
Okay, that makes sense. Now, obviously as you say this device has been launched this month it's going out there in the field, what other applications can you use for this particular Quotient device?
Byron Hewett:
Well the Quotient system because it measures hyperactivity, impulsivity and inner tension it has the potential any time there is an issue with cognition or what we call response inhibition because when you think about sustaining attention it's really means the ability to inhibit yourself to ignore distractions to stay focused on what's in front of you, impulsivity you know it's your ability to inhibit sort of this instinct to sort of respond immediately right it's sort of see, do, think instead of see, think, do right and so the idea is to try to measure whether or not there is this appropriate response inhibition so this is the kid that's bloating out the answers in class and wait to be called upon by the teacher and then in the hyperactivity round people with ADHD their natural state they prefer to be in motion as oppose to being still and so part of this is developmental, but if they are moving right then we can pick that up so you can now think about a whole host of disorders where there are issues with inner tension, impulsivity and hyperactivity and this response inhibition sort of concept and so you have the ability then to look at Quotient and things like the Alzheimer's disease, traumatic brain injury, acataphasia which is a motion dis-control it's caused by certain medications, we've got clinicians looking at post struck attention deficit, we've got people looking at fetal alcohol syndrome and so there is lots and lots of places where Quotient has ask ability beyond ADHD.
Fintan Walton:
Sure and then going back to ADHD isn't it important also from a therapeutic point of view that the type of therapy that the patient may be going through is it can be monitored?
Byron Hewett:
Yes.
Fintan Walton:
To track the change if there is a change in the behavior?
Byron Hewett:
Yes there is a one of the challenges you have with ADHD medications is that most of that time the treatment is a stimulant so it's either methylphenidate or some sort of amphetamine salt and what happens is that the child feels different as soon as they are on that medication, but it does not necessarily mean that they are on a therapeutic dose they can be on subtherapeutic dose and we see this all the time in a follow-up assessments the clinicians perform where the dosing is not correct and some experts in the area have estimated that probably half the people that are receiving ADHD treatment are not on an appropriate dose, so they are either on the wrong drug or the wrong dose, we can help inform the physicians management of those patients by giving them feedback associated with the Quotient test to help them get to a better location.
Fintan Walton:
Right, and then presumably the same test can be used for the development of new drugs?
Byron Hewett:
That's correct and that's a wonderful question a point as well, because one of the things that we demonstrated last year in a study that we are publishing postgraduate medicine is that the Quotient test cuts through the placebo effect this is important because in drug development one of the huge issues in the whole neurobehavioral psychiatry space is that the placebo response is so large that it's hard to show a separation between therapeutic effect and placebo effect and part of this is that when you are using subjective rating scales that are being provided back to people that are performing the clinical trial they tend to overate response, the reason is one of the reasons is that there is a thing they call expectancy if I know you are in pill I think you are gonna do better, right and so if you are being treated you must be doing better and so they tend to overate response, what we able to show with Quotient is that we could cut right through that and we could tell who is on placebo and who wasn't. So this is important for pharma clinical development because one of the benefits here is that we should be able to help them reduce their size of their trial and help them save a lot of money as a result, so the idea is to get to a better outcome faster for less money.
Future goals
Fintan Walton:
So going back to the company and its overall strategic goal you know clearly you've got you've been developed this product clearly there are potential applications for beyond the ADHD therapy areas what is these areas, so where you gonna go? What's the future for your corporation?
Byron Hewett:
Well our mission here is to change the way that ADHD has been managed, today many patients are not on effective treatment there is an enormous turn on these medications it's estimated that only about 50% of prescriptions are refilled at 90 days so well it's a $4.6 billion drug market the amount of turn on the medications is enormous and what this contributes to is poor outcomes so the payers today get the expense without the benefit they are paying for the drug but when people are not treated effectively they are also having more accidents there is more emergency room visits, data shows that ADHD families have higher healthcare costs even when you take the ADHD family member out of the calculation, okay so we have knock on impacts across their family and so our view is that with better management of ADHD meaning we get them on the right drug and the right dose do it faster we can get those healthcare cost under control and get much better health outcomes, these kids need the help the medication can provide that help we can help the clinician get to a better place faster with those patients.
Fintan Walton:
Great. Well Byron, thank you very much indeed for coming on the show.
Byron Hewett:
Thank you, appreciated.
Fintan Walton
Dr Fintan Walton is the Founder and CEO of PharmaVentures . After completing his doctoral research on the genetics of cell proliferation at the University of Michigan(US)and Trinity College (Dublin, Ireland), Dr Walton gained broad commercial experience in biotechnology in management positions at Bass and Celltech plc (1982-1992).
Byron Hewett
Executive Chairman
Byron Hewett currently serves as Executive Chairman of BioBehavioral Diagnostics (BioBDx) . Byron Hewett joined BioBehavioral Diagnostics in November, 2008 as executive chairman. Mr. Hewett has served on the board of directors since July 2006. From 2004 to 2008, Mr. Hewett served as chief executive officer, president, and a director at Immunicon Corporation. From 2002-2004, he served as senior vice president of sales and marketing and general manager, North America for Qiagen, Inc. where he led commercial North American operations. Mr. Hewett has worked in healthcare and life science companies for more than 20 years in general management, strategy formulation, business development and sales and marketing with firms including Bayer Diagnostics, Chiron Diagnostics, Biocircuits Corporation, Stericycle, Inc., and Abbott Laboratories. Mr. Hewett received a Masters in Management degree from Northwestern University's J.L. Kellogg Graduate School of Management and a Bachelors of Science degree from the University of Virginia's McIntire School of Commerce.
PharmaVentures
PharmaVentures is a corporate finance and transactions advisory firm that has served hundreds of clients worldwide in relation to their strategic deal making in the pharmaceutical, life science and healthcare sectors. Our key offerings include: Transactions / deal negotiations; Product / technology valuations; Deal term advice; Due diligence & expert reports; Strategy formulation; Alliance management; and Expert opinion for litigation/arbitration cases. PharmaVentures provides the global expertise to ensure our clients generate the highest possible return on investment from all their deal making activities. We have experience of all therapeutic areas and can offer advice on both product and technology commercialisation.
BioBehavioral Diagnostics (BioBDx)
BioBehavioral Diagnostics (BioBDx) manufactures and markets the Quotient-ADHD-System, a tool that aids in the objective and accurate assessment of ADHDsymptoms. BioBDx are dedicated to providing physicians, parents and patients with high-value information to guide personalized strategies and to enhance quality of life for patients with ADHD. BioBDx 's vision is to provide accurate tools for the diagnosis and management of neurological and psychiatric conditions, leading to a transformation of behavioral medicine. Founded in 2006, BioBDx is a privately held company.