AUGUST, 2017

Inaccurate diagnostic tools
Lack of epilepsy specialists
Portable, accurate diagnosis and monitoring technology

Wikihospitals – Today I’m introducing David Lester from NIESM, an Australian entrepreneur. David, welcome to Wikihospitals. 

David, perhaps you can give a brief overview of the product that you’re developing and how it can help people.

David –  We’re focusing on providing solutions to help patients with epilepsy achieve better outcomes. 

At present, the methodology and the clinical practise is very poor. About one-third of patients (are) actually found to be resistant to therapy, which means they don’t have good outcomes. A big part of that, if you talk to clinicians around the world… is that they rely on the patients to keep accurate records on their seizures.

The reality is, patients don’t do that, for a variety of reasons. Consequently, it’s very, very, challenging for the clinician to develop patient management programmes that are personalised and will provide these better outcomes.

We’re using wearable sensors that have been found to be correlated with patient seizures. These are sensors that capture activities such as motion, heart rate, galvanic skin response, transdermal activity, sleep, and a variety of other physiological measures.

What we’re doing is we’re integrating these various solutions, these sensor activities, to come up with personalised methodology for capturing those patient seizures over time. That’s a critical point.

…whereas now days to monitor up a patient for up to five days using EEG, you have to… hospitalised (them).

Wikihospitals – In today’s world, if people are to be diagnosed with epilepsy they have to be admitted to hospital… for a week. (Diagnosis is) a slow process. Even just booking in for an epilepsy unit could take six months. 

David – Yes and there’s a variety of different epileptic seizure types… five or six of them are the dominant ones. Some of them are very, very, difficult to capture.

The other complexity is that every patient will have at least two or three of these different seizure types. Every patient has a different seizure profile.

Wikihospitals – …what percentage of people in the population have epilepsy?

David – It’s pretty much globally uniform at about 1%. Interestingly, a very recent report in the US said it’s gone up to 1.3%. It’s climbing and, because people are living longer now… you actually see higher incidence of epilepsy in people with Alzheimer’s.

Wikihospitals – The reality for them is, if they don’t have a proper diagnosis, if they’re waiting too long, or if the diagnosis is incorrect, then they get incorrect treatment.

David – Absolutely. It’s even more complicated than that, because not all seizures are epileptic. About 25% of those patients that have been diagnosed with seizures are non-epileptic. To your point, Delia, you get a very, very, different intervention treatment for those patients than you would the others. Consequently, you’re getting the wrong patient treatment. 

Wikihospitals – It sounds as though your product is tending towards the new world of using smart wearable devices, sucking in big data, and then giving a much more accurate (diagnosis). Is that the case?

David – Absolutely. The smart technologies and the digital health are the way of the future, whether you’re talking about the location where everyone is closely linked, or whether they’re remotely associated. 

It’s about understanding what the clinician wants and how clinical practises actually works.
David Lester

David – I just came back from a visit to India. If you don’t talk remote monitoring in any management of disease, they’re not going to bother with you. The reality is that translates to better care and lower costs. It’s … a significant improvement all over. 

The challenge is, in the western world when you bring in a new technology there’s a lot of resistance generally to it. The clinician doesn’t want to change their standard of practise or standard of care.

What we’re doing is working very, very, closely with leading clinicians around the world to ensure that we’re giving them services … that will not disrupt what they’re doing. On the contrary, what it’ll do is allow them to analyse a lot more patients than they’re doing now far more effectively, which is what they want. The difference in what we do between us and the normal technology company is we’re clinician-driven, not technology-driven.

Wikihospitals – What sort of device does the patient actually have to wear? Can you give an idea of what this involves for the patient?

David – We like to call it compliant independent. In other words, we rely on the patient as little as possible… it’s a matter of wearing the device and every three to five days you take the device off and then recharge it. At that time of recharge, the information is then being transferred into the network up to our cloud base system. We manage the rest.

What we are doing is very, very simple, putting on the device, and then every three to five days taking it off and recharge it in a docking  station similar to what you see with Fitbit or Apple watch. Then once it’s charged, which doesn’t take long, put it back on again and away you go.

Wikihospitals – What size of a device are we talking? Is it large and bulky or is it small?

David – (It’s a) little bit more cumbersome than like Fitbit or Apple watch. At this stage we opted to use devices that have been proven to be clinically competent and performed at a level that’s required for clinical use.

It’s got an elastic arm band, and a couple of electrodes you got to attach. It doesn’t look that great. But, we expect as we evolve this technology that we will develop devices where the patient feels comfortable just walking around every day and not feel that they are stigmatised, because they are wearing some sort of clinical device.

Wikihospitals – For the viewers, that’s in contrast to waiting up to six months to get into an epilepsy ward and then have an EEG cap with tabs all over your head and then staying there for the weekend or longer and being hooked up to monitor continuously, not being able to leave the unit.

People are non-compliant with medication, I believe up to 50%…
David Lester

Wikihospitals – You can damage your brain if you continuously have seizures. Not having an accurately diagnosed epilepsy could have enormous consequences for people.

David – Absolutely. There’s a chunk of people that actually can’t work because of this… there’s a lot of people have seizures multiple times a week, (they) can’t get them under control (and) consequently have no life… It’s really a devastating disease under certain circumstances.

The other thing that I’d add to that is that because patient diaries are also used in clinical trials, a lot of the big pharma companies that were in epilepsy have moved out. Because they’ve found that the reliability of the data they capture using patient diaries were not acceptable and would not give them the value that would allow them to get new drugs on the market. We also are hoping – we are engaged with pharma that we will see an increase of activity in pharma to bringing better drugs out on the market.

Wikihospitals – How many neurologist who specialise in epilepsy work in the UK?

David –  In the UK there are about 600,000 people with epilepsy and there are an estimated 50 or so Epileptologists. Just coming back from India, it’s even worse, not surprisingly. There’s about up to 14 million, 15 million people with epilepsy and I was told by one of the leading practitioners there, there’s about 500 Neurologists in the whole country that can treat epilepsy.

Wikihospitals – That’s terrible.

David – Look, I think these numbers are pretty much uniform. There’s a dramatic shortage of experts in treating epilepsy. I should point out that there’s Neurologists that’s good, Epileptologist are the best, GP is the worst. A big problem with that is the accessibility the epilepsy expert or even knowing that you’d require an epilepsy expert.

The outcomes very much depended on the present practise – depend on the experience of that doctor that you get.
David Lester

Wikihospitals – Tell me about the clinical trials that you’re about to commence.

David – We’ve decided to initially launch our products in the UK. The reason for that is the NHS is very, very progressive in terms of introducing digital health technologies. The first study that we’re doing is with – in Scotland, with the Scottish NHS. 

Additionally, we’ve got a site in Portugal and we’re working with the leading Epileptologist there to develop an application there.

It’s been tough for me here, because I’ve had some local Australian parents contact me saying the children are suffering with epilepsy, can I help them? The challenges that people have to understand it’s a long task to bring products to the level where they will be accepted in the clinical healthcare market.

The complexity of developing a medical device really influenced the length of time it takes to get to market.

Wikihospitals – So if moms and dads here see this video, (and) they want to access their product, you telling me you got to wait at least a year and a half?

David – Look, we are working and doing some work – some initial studies with the Royal Melbourne Hospital locally.

There will be a stage, I think, because we are seeing such demand, we will be able to release it to the general public. I can’t put time lines on that.

The fascinating thing about the Indian healthcare system, is that many of the leading health care providers have remote hospitals. This is the way it’s managed.
David Lester

Wikihospitals – You’ve spoken a bit about your son. Would you like to re-visit his issues and how he’s reacted to them?

David – Yes, he was at the age (of) seventeen, diagnosed with juvenile myoclonic epilepsy…  it’s interesting talking to him. He noticed that a couple of times he started stuttering and stumbling for words and getting lost. I actually noticed at that time, not knowing as much as I do now about epilepsy, that he would start and suddenly just become immobile for about 60 to 90 seconds. We took him to a Neurologist, who’s local, living in the states at that time… and he… diagnosed him as having juvenile myoclonic epilepsy, and put him on a medication.

I was working at Pfizer headquarters in New York at that time (and) I said, well, let’s get a second opinion. I asked my colleagues and they referred me to the top epilepsy specialist for juveniles in New York, probably in the East Coast. He went through (the history) and said the diagnosis was correct but the drug was wrong. He… would not provide that drug to (young people) because they have all sorts of side effects that are really horrendous. He put him on a different drug.

It took my son having a grand mal, to realise you’ve got to take the drugs every day, which is very important. When I talked to him (my son) said it took about five years until he felt good… and we don’t quite know what feel good means because it’s not just the seizures… there’s other activities because you’re dealing with the brain, obviously, that we just can’t really quite get a handle on. That makes it a challenge.

But, to be honest Delia, our platform… is agnostic… to… technology… 

We are capable of integrating imaging very high powered imaging data, genomics data, any form of data that we want we can integrate into it. Why I mention that is because when you start putting all this data together you start to get a better picture of what that person’s phenotype in terms of the disease actually is.

We are very, very optimistic… You will start to see this more generalised overview of a patient. It’s almost like a portal. 

Wikihospitals – That’s a huge difference of what we currently have, which is really hit and miss… patients come in… for appointments, maybe every two months. Like you said they present a diary, not very scientific, and they… might or might not (get) the correct treatment.

David – That’s right. And, they’ve got to keep coming back for appointments. That is what happened with my son, it was every six months. It took a long time till he basically became seizure free.

Another challenge, I noticed, that caused the patient – the patient’s not getting good outcomes in a timely manner. If you don’t trust the doctor, you are not going to get good care. That relationship is also another added impact we can have (with our) technology.

Wikihospitals – So, better outcomes for the patient means more compliance with their treatments.

David – Absolutely. It’s generally found that the young, the teenagers – are least compliant. Because they don’t want to be labelled as having some disease.

Wikihospitals – Can you talk about the data that this is… going to pick up.

David – Yes, the basic unit that we’ve got… is a very high powered Fitbit, if you want to talk about simply. It catches motion three different ways; it catches it through accelerometry, it catches through magnetometery and it catches it through GPS. What you end up is with an XY and Z axis for each one of those different types of activity captured. That means you’ve got nine axis of motion. It’s a lot of information.

Then there’s the ability to capture heart rate through pulse oximetry. You can get heart rate variability which a lot of people talked about as a very good measure for certain seizures.

There is, as you mentioned, skin temperature…, (there are) heart rate are sensors that you plug in…. You can also plug electrocardiogram leads… if you want to get very accurate cardiovascular measurements… (also) electromyogram, which is muscular activity.

You can (also) do a whole variety of different monitoring of activities including sleep. What we see is a combination of two or three of these activities that will be specific to that type of epilepsy that you’re looking at. That distinguishes us from anyone else.

“Healthcare should be a lot better than it is. It’s just a giant behemoth. (There is) so much money behind it. It’s very resistant to change.
David Lester

Wikihospitals – Can you give us a little bit about your background. You’ve been a serial entrepreneur.

David – I didn’t start as a serial entrepreneur. I started in the basic research.

I started in Australia went to Israel, went to the States. After about 15 years, I came to the conclusion that there are better researchers than I am, even though I was successful at it. So, I said let’s try something else.

I was in the US at the time and I got accepted into the US Food and Drug Administration doing what’s called regulatory research, and I spent time there and moved up the ranks. I was trying at that time also to bring new methodologies into clinical trials to help move them along. I realised it was very hard to be innovative in the FDA at that time. I then moved into the pharmaceutical world. I was responsible for introducing new technologies into clinical trials. I moved to Pfizer headquarters in New York… we (were) looking at clinical practice (and realized that) if we add healthcare technologies such as diagnostics to a drug, we (might) end up with better outcomes.

I left them and… joined a couple of companies, one of them was very, very controversial. I learned a lot… on how not to run a company. Then I started up on my own. Had a few attempts. There’s one that’s still ongoing, a Boston based company, called Inside Tracker, which is focusing on health and wellness.

I came back to Australia for personal reasons. I tried working with the CSIRO, and realised that I’m not suitable for large organisations. After advising and mentoring some people said, get back to what you do (best). Hence, about two and a half years ago I started NIESM.

It’s been a long journey. I think the cause of all experiences I’ve had, good and bad, this is going to be the best. Very, very exciting the response we’ve seen globally from the missions around the world. I think, this is a long haul and we’ll take it all into the finish line.

Wikihospitals – You also have the power of relatives lobbying for better treatments…  they are are becoming willing to argue and look around see what else is available.

David – You raise a great point… – those advocacy groups play a major role in expressing the voice of the patient. In Australia, they’re active. They just don’t have the power and the money that you see in the UK or the US…  The Epilepsy Foundation is very big in the States.

It’s just tough in Australia, because people don’t give enough money to support these charities. They’re spending too much on horse racing and gambling… where as, actually providing money… will help them and their families and ultimately the community. It’s a shame you don’t see more of that sort of giving in Australia.

Get prepared to fail. Because it is going to happen time and time again.
David Lester

Wikihospitals – Do you have words of wisdom for Australian entrepreneurs?

David – First of all, (in) biotech’s… Australia’s had limited success. It’s (now) med tech… medical devices…that’s the key thing you hear anywhere in the world.

First of all, it’s your management team. I’ve got two people in the US, two people in the UK and one in Portugal. Right? And why I got those people is because they’re the best around. That’s the first thing.

Secondly, your investors. You need investors that are going to give good value, not just money. Because there is good and bad money. Some investors can drive you nuts. They can ask for the wrong terms for investment. That can do a lot of harm.

The third thing is the board of directors and the advisory boards. Get the best people in the world that understand from day one you’re in a global community that’s trying to provide global resources. …that… helps you to identify your market…

So… I’d say, (don’t just concentrate on) the Australian market… because that’s really messy and complex. That’s probably the biggest challenge… Then the other thing is putting the components together to make sure you’re setting the company up right.

Focus on the need. Forget about building a product and then forget what you’re going to do it for.
David Lester

David – Even though you’ve heard me talk technology, as I said before, I’m driven by the clinicians, I’m driven by the clinical need. I can generally find a technological solution, even if I have to compromise sometimes, that will serve that purpose. That’s the key thing.

Wikihospitals Okay. So, look for the problem to solve, rather than the product to present?

David – Absolutely.

Wikihospitals – Do you think that you have some way that we could improve what we support or encourage entrepreneurs in Australia?

David – Yes, look investments a big, big issue. I think the Australian governments don’t have long term views of this industry, as you see in countries like the US and Israel, and now in the UK. But, I think we need more Angel Investors that understand healthcare because a lot of them come from engineering backgrounds don’t understand clinical. We know there’s a lot of wealthy doctors out there, it would be great if they could set up some sort of consortium.

In general, I think, (we need) the high net worth people. If they could be a little bit more risk taking, that would make a huge difference. They’ll actually end up in better returns. It would make a big difference on the local environment in terms of successes. There’s a lot of activity going on, but most of (it) will fail. Largely (because if you) don’t have the management team, you don’t have the money.

Wikihospitals – When do you think your product might be coming to Australia?

David – Keep your fingers crossed, one and a half to two years could well be in Australia as well.

Wikihospitals – Could we say that neurologists if they’re interested could contact the Royal Melbourne Hospital, because some (the) trials are going through there?

David – Yes. I think you can. They’re very busy. It may be easy just to contact me via our site or on info@niesm.com and then we’d be happy to refer them to those clinicians. I’m happy to do a bit of a screening for them.

Wikihospitals – Well, thank you very much for this interview David. We look forward to your product coming onto market and giving people with epilepsy and their families much, much, much more diagnosis and treatment.

David – Thanks for the opportunity Delia.