Changing epilepsy care through entrepreneurship: D

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When Dr. Cook’s father was diagnosed with epilepsy, he realized that a system to identify and predict seizures could improve care and change people’s lives. Dr. Parthvi Ravat talks with Dr. Cook about entrepreneurship in epilepsy and ways to advance the field through innovation.

 

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Podcast Transcript

[00:00:00] Dr. Parthvi Ravat: A very warm welcome to the listeners of the Sharp Waves podcast. I’m Parthvi Ravat. I’m a neurologist from Australia, and today we are meeting someone very interesting. There are so many people involved in epilepsy innovation, all of us need guidance on how to bring a good innovation to millions of people with epilepsy out there and actually make a difference. Today, we have someone who has done that, and we are very excited to welcome Professor Mark Cook from Melbourne, Australia with us today.

Professor Cook, would you like to introduce yourself?

[00:00:32] Dr. Mark Cook: Sure. Thanks for the invite, Parthvi. I’m Mark Cook. I’m a neurologist at St. Vincent’s Hospital in Melbourne and the director of the neurology department there and as well a professor of bioengineering at the University of Melbourne.

[00:00:44] Dr. Parthvi Ravat: Oh, great. We’re very pleased to have you.

I’d like to start with a personal question. Professor, you have mentioned in other interviews that your father had epilepsy. So how did this diagnosis affect you growing up as well as the rest of your family and did it influence your professional journey?

[00:01:02] Dr. Mark Cook: My dad developed epilepsy when I was at university. I was just completing medicine, and then it was over the time when I was doing neurology residency as well, that it became apparent that people trying to manage his epilepsy had very little idea of what was actually going on, because he didn’t really know himself what was happening with his seizures. He varied in his reporting to the doctors who were just, as far as I could see, were just changing his medications randomly to try and treat him.

Everyone meant well, but no one really knew what was going on with his seizures because he often didn’t recollect when they’d occurred. And this led to very confusing situations with often too much medication and often not enough. I was very motivated to try and find a way to solve this because it was clear that not only the poor reporting, but also the unpredictability of the seizures, was what was causing him a lot of trouble.

My dad was a chef and you know, kitchens, commercial kitchens, are dangerous places. It meant that he had to stop working and he had to stop driving and we lived some way out of town. So it really changed his life dramatically. And so I thought as well as being able to identify seizures correctly to report back to treating doctors, it would be fantastic if there was a way of predicting seizures. And so predicting them was always something that was on my mind.

[00:02:19] Dr. Parthvi Ravat: That must have been an inspiring journey. So you led the development of an ambulatory EEG system which has almost achieved a breakthrough status right now with the US FDA. So, what role do you see for technology and innovation in improving the lives of people with epilepsy?

[00:02:35] Dr. Mark Cook: Well, these sort of observations about my father’s situation led to my interest in developing an implant, and so I’d always been interested in how you could do that, but obviously I didn’t have the resources myself as a practicing neurologist and someone whose main research interests were around imaging, but I was fortunate in that I was able to meet Graham Clark, who developed the bionic ear, who had technology that I could see was something that we could readily modify to suit the management of epilepsy and record seizures accurately and so on. That was a major turning point. And that would be people at the Bionics Institute that Graham had set up. And we’re obviously intimately involved in developing this at the outset and remain so, so that was really lucky.

So we’ve been developing this this device. Now we’re going through the FDA processes around the implantable ambulatory system at the moment, and we’ve got breakthrough status with the FDA for that. That’s with the implantable system, and we’re working on the process of getting full recognition with the FDA in the months and ahead.

So there’s a lot happening there. I think if we can get this technology out it will make an enormous difference. We’ve been doing a trial here in Australia where we have quite a number of people implanted with the devices now and it’s possible to see the role of the device in recognizing seizures that the patient’s not aware of, recognizing events that the patient reports as seizures that are not seizures and being able to see the effects of therapies that are introduced.

So I think this technology will help enormously in the day-to-day management of epilepsy because you’ll be able to have an accurate marker of what’s actually happening rather than the very imprecise reports that patients give at the moment. And they can’t help that, because the seizures affect memory and often they’re genuinely not aware of the events they’re having. And they often tend to report things that aren’t seizures as well. And we don’t have much insight as clinicians. We’re always trying to adjust people’s treatment according to the reports they provide, which we know to be very inaccurate.

So these devices can have a very dramatic effect on that as well, as I mentioned before, a large part of my dad’s problem was that his work and driving weren’t possible because of the unpredictability of the events. And you know, with these sorts of devices, we’ve shown that it is possible to accurately predict seizures, at least for a lot of people, and that if we can do this, we can give people the sort of freedom and independence they don’t currently enjoy. And that’s such a huge burden for people with epilepsy, particularly those who’ve got young kids and who have got jobs that might involve dangerous activities. And you know, I think to be able to do that with these sorts of technologies will dramatically change how we manage epilepsy currently.

[00:05:23] Dr. Parthvi Ravat: We, as epileptologists and epilepsy researchers might know how to, you know, publish our research, but we are never formally trained and how to write a business plan or launch an invention market it.

And then manage the competition in the commercial market. So how did that process go for you?

[00:05:38] Dr. Mark Cook: No, that’s right. It’s very complicated managing all of those aspects, and most of us with clinical background have no insight or expertise in that. Once again, I guess I was lucky along the way, meeting people who did have those skills. Mostly it was trial and error. So, you know, I spent a lot of time sort of bumbling along trying to figure out how to make all of these things work.

A lot of this came the wrong way around because, in fact, to develop an implantable system, or anything really, from the commercial aspect should involve the recruitment very early on of people who have expertise in reimbursement and the regulatory aspects of all of this, because ultimately, these are the major obstacles to getting something out into the field.

And I guess, you know, a lot of clinicians in whatever area they’re in think that because something’s a good idea that you’ll be able to commercialize it. Whereas in fact it requires a lot more than that. So it can be a good idea, but it doesn’t mean that it’s going to make anyone any money. And although I’ve often had this sort of criticism made, that these sorts of processes are really just about making money, they sort of have to be about making money.

They’ve got to make money for the health system or the patient or the investors or the company, you know, someone has got to be making money out of them, because if they can’t, it means it’s not worth anything and you need money to develop it and these sorts of systems take an enormous amount of money to get out to the market, ultimately, and certainly I never had any real appreciation of that. And I doubt that most clinicians have any real idea just how much skill and expertise is involved in the people who you’re not aware of, managing all the marketing, developing appropriate business plans, commercializing it, and most importantly, sorting out reimbursement.

So it’s really tricky. Competition is a little bit more complicated. So, in fact, having competition is a good thing. Having a competitor out there is extremely useful because it reassures people to some extent that it’s not just a single person’s wacky idea, but that there might be some foundation to it and that other people can see the utility.

[00:07:48] Dr. Parthvi Ravat: So did you train any way how to market it or you just met the right people and gave a lot of those responsibilities to them?

[00:07:56] Dr. Mark Cook: That’s right. Yeah, you’ve got to get the right people and you will be extremely helpful to them in getting the ideas out. But as I say, you know, there are lots of people who you never meet in your normal clinical life who have a lot of skill in areas which you don’t even know exists, who are very good at doing the things that you can’t. The marketing is a key part of that.

You need to go and find them and the people who have adequate skills aren’t cheap. And there’s not a lot of them around and the problem is keeping them busy enough. You know, if you’ve just got one project, it might not be enough to keep their interest and obviously sufficient to fund your own commercialization person.

So it’s great if you can get someone who’s interested enough to want to help you out at the start on the understanding that they’ll be more involved as the process develops. But finding these people is tricky, and so you need to go out and talk to a lot of people, speak to everyone, pitch a case, get people interested, and find the people who can help you make it.

[00:07:48] Dr. Parthvi Ravat: So in your opinion, what are the key factors contributing to successful entrepreneurship in the field of epilepsy for say a clinician? What qualities must he possess to eventually make it as an entrepreneur as well as a clinician?

[00:09:14] Dr. Mark Cook: You need to be motivated and have the time, obviously. But also you need to try and establish a network of people who can help you. And they’re not only the researchers who will get you grants and so on early on that might get things going in its early stages, like we got an HMRC development grant, for instance, and small hospital grants, which got us moving along and you’ll need the research team for that.

But I think very early on, you need to try and find out who is going to be able to help you financially in the longer term, who is going to be able to actually manage it. I was lucky to meet quite a lot of people who helped me to manage it in the early stages, but Rob Klupacs, most importantly, from the Bionics Institute, who understood how the business side of things worked and was able to help me develop all of those parts of the operation early on.

And then, you know, when people can see that you’re serious about it and you’ve got a professional operation, others will, will start to come in and be involved. So I think be prepared to go out and pitch a case often.

And you have to meet an enormous number of people because you have no idea who might be interested to help you unless you get out there and tell your story. So take every opportunity to tell that both to your colleagues, but also to people in the commercial world. Patients are obviously great supporters of these sorts of endeavors, and many of them will help you in all sorts of ways along your path.

You need to get the idea out there and show people exactly what it is you’re trying to achieve.

[00:10:46] Dr. Parthvi Ravat: Right. Did you face a lot of hurdles or rejections, if I may say so, in getting people to listen to your idea and things like that?

[00:10:56] Dr. Mark Cook: Mainly rejections, I think, because most people don’t understand epilepsy very well.

But an interesting thing is when you’re telling the story to people who’ve had any experience themselves or with family members or friends with epilepsy, they understand instantly what it is you’re trying to achieve. And because a lot of people know someone with epilepsy, even if they don’t realize it, getting them on board with that part of the story is very helpful.

But most people will reject you, but that’s what I mean. You need to go out and talk to an enormous number of people, enormous range of backgrounds because finding the right person is often a matter of chance and coincidence. And if you’re not out there, if you’re not out there doing it and talking to enough people, you’re never going to come across them.

[00:11:41] Dr. Parthvi Ravat: Right. Are there any ethical considerations which entrepreneurs in epilepsy should be mindful of?

[00:11:47] Dr. Mark Cook: Well, yeah, I mean the ethical bits, particularly with implantable devices can be tricky. An earlier study we were involved with, with an implantable device to predict seizures was very successful, but the company ultimately collapsed and this generated a lot of discussion about what happens when you develop devices like this—they work, but the company is not successful and you can’t maintain the service in the longer term.

So that’s a tricky thing, but that’s true of just about everything. I mean, that’s true of medications, for instance. If you have a drug trial where only one person in a thousand gets a good result, then the drug won’t be developed. And that’s very frustrating for those who it helps, but it’s a reality of the world that unless things are commercially viable, it’s hard to maintain them.

A lot of people have the idea that the government should step in and do this, but that’s in practice extremely difficult to do. But a lot of people come to me with ideas that these things should be somehow guaranteed. This does bring up significant ethical issues, but I think as with all work that we do in research and trials involving patients, it’s a matter of ensuring that patients are adequately informed at the outset and that the ethical part I think is sufficiently covered if you made people aware of all these possible outcomes and that they have a genuine understanding of it. It’s still going to be frustrating if it doesn’t work out for them, but I think that’s much the same as much of clinical research.

You’ve got to admire the bravery of a lot of patients going into these sorts of processes where they really have no guarantee that it will work in the first place or that you’ll be able to provide it in the long term.

[00:13:21] Dr. Parthvi Ravat: We also wanted to understand your thoughts on role of universities and academia in promoting entrepreneurship, because there’s a lot of encouragement and funding for scientists to develop research, but what is the next step?

Do you think the universities and the people sitting in the ivory towers have a role in encouraging or maybe training the young leaders in epilepsy about entrepreneurship?

[00:13:45] Dr. Mark Cook: Yeah, absolutely. And a lot of the universities have recognized this and have set up. programs to develop entrepreneurship and so on in clinical medicine.

I think that’s absolutely critical. I don’t think Australian universities have been very good at that. You know, when you compare them to counterparts in the United States, for instance, it’s not something they’ve been very good at and clinicians haven’t very well understood exactly the role of universities and so on.

One of the big problems is that people in academia often see that commercialized, or commercialization, is a bad thing, or it’s the enemy, or it’s evil somehow. I think that’s actually quite a big problem, you know. There’s a reluctance often to engage in commercial industrial programs because they see that they’re somehow not completely honest or something.

But as I mentioned before, unless you can demonstrate how someone’s going to make money out of this, it’s very hard to make anything work. So having academia understand that this is a good thing and being able to commercialize the ideas and get money for them is a good thing. Universities can help support that enormously by improving and many of them have. Certainly the University of Melbourne has improved its processes dramatically over the last few years to facilitate this. And I know that’s true at many other centers.

The universities need to be able to support people and give them the skills and give them the necessary time.

Advocacy groups are absolutely critical. So, you know, I mean, they’re often your greatest supporters in these things because they understand the nature of the problem and can help often get you to different groups of people who you wouldn’t been able to make contact with otherwise, who may help you along the path, commercial folk. And many of the people perhaps who are already donors to their situation and even supporting these sorts of activities themselves commercially and advocacy groups may have sufficient funds often to invest in these projects themselves, if they can see that there might be a long-term benefit from that for them.

And I think that’s an excellent model if you can find suitable advocacy groups because, you know, they just want to see things happen. It’s like patients, they just want to see things happen. They want to know people are working on it. And if it might help them in the long run as well, that makes a great combination.

[00:16:08] Dr. Parthvi Ravat: Yes, very true. And now this is my favorite question. There are so many things on your plate. So how do you balance all this? You’re a clinician, you’re a researcher, you are an entrepreneur, and then you might have interests outside your career as well with your family or any hobbies. So what is a day in the life of Mark Cook?

[00:16:29] Dr. Mark Cook: Well, I wish I could say it was very straightforward and I had lots of free time, but there’s a lot going on with all of this and you’re spending a lot of time. I was late this morning for this meeting because I was in a board meeting which ran over and these things are starting at 7:30 in the morning and often many times during the day, you’ve got to attend to it – critical issues around the commercial side of things or the regulatory aspects. And there really isn’t any flexibility about that.

I enjoy very much my time in clinical medicine and I see having a significant clinical element to my day-to-day life assists me enormously in understanding what we’re trying to achieve and how best to achieve it through the development of the device and so on. That’s really important. But yeah, there aren’t many free hours in the day.

Family and interests outside. Well, the interests outside I guess have thinned out a little bit, you know, I try and keep as active with the family as I can, but yeah, they’re long days. And unfortunately, I think, unless you’re really committed to these things, it’s hard to make them work.

A day in my life, what does it look like? Well, it usually starts around 7:30 and continues to about 6:00 or 7:00, and then I might have a couple of hours’ break and try and finish off a bit more work or reading before going to bed and start the process again the next day.

[00:17:50] Dr. Parthvi Ravat: On your toes all day long. And so finally any message or word of inspiration for the individuals who are personally affected with epilepsy.

[00:18:01] Dr. Mark Cook: You know, for people with epilepsy, I think the most important thing to know is that there are a huge number of people out there at the moment who are developing good and new things, better treatments, different ways of approaching the situation, which are really making a big impact.

I mean, we’ve seen such a tremendous improvement in the development of drugs over the years, which I think has dramatically changed life. You know, when my dad had epilepsy, really, there were just three major anticonvulsants that we used and they all had significant side effects, and you really didn’t have much flexibility with it.

So it’s an enormously different landscape for people with epilepsy now, but unfortunately, we still have about the same proportion of people who have seizures that aren’t adequately controlled. They don’t have anything like the side effects or problems from the old medications, perhaps, but many of them are still having as many seizures.

So we desperately need new solutions. But I think people with epilepsy can be reassured. There are a huge number of new solutions being worked on from stimulation devices to novel drug delivery systems to dietary therapies. To devices like ours, which will monitor seizure activity constantly and provide better ways of managing the condition.

And these are just a few. So there’s enormous amount happening. And, you know, in Australia, there’s an enormous amount of epilepsy research. And you know, I think people with epilepsy can be reassured that unlike when I started doing epilepsy, which was really because there was a position available in epilepsy and I was interested because of my father’s experience to try and do something useful—now, epilepsy is a very popular subspecialty within neurology and there’s a huge number of epileptologists, both around now and developing, but still way short of the demand, but it is happening.

So my words of inspiration would be “Hold tight, things are happening and things are coming.”

[00:19:53] Dr. Parthvi Ravat: And one last thing for the researchers and the clinicians like us who are trying to make it just what was your motto that you told yourself when you faced those rejections, as you said, what kept you going so that we can take inspiration from your journey?

[00:20:10] Dr. Mark Cook: Well, I guess you’ve got to believe in your ideas, right? So I think if you’ve got a good idea you’ve got to stick with it, whether it’s a clinical thing or research or trying to develop something commercially and, you know, often you’ll be wrong or you’ll only be partly right and other people and the activities that develop out of the course will point you in the right direction.

But you need a good deal of persistence and determination to make these sorts of things happen, whichever the area they’re in. And I think for the clinicians, you know, I think doing these things, it gives another dimension to your life and it makes it really interesting. And we have an enormous amount to offer as clinicians because we can understand aspects of the situation which aren’t evident to other people and the only way you achieve that is by seeing a lot of patients and getting good at your clinical work.

And so you have an enormous amount to bring to it and I think people often don’t recognize that you don’t have to just be seeing patients and providing that kind of service. You can think about the condition and the treating and other ways of dealing with it.

Talk to others who have different perspectives. You know, I mean, most of my advantages have come through being able to work with a lot of engineers and seeing the different approaches that they have to problems and understanding different techniques and different kinds of treatment.

So mix with different people and get different ideas and accept that a lot of the criticism you get or when people don’t understand you, it might mean that your idea is still not properly formed or that you’ve just not explained it properly.

I think a real minefield for clinicians and researchers is that they tend to overcomplicate the descriptions of what it is they’re trying to do. And I see this a lot when people give presentations to investors and so on, they give them very complex scientific information, and the investors are really not interested in it. They’re interested in the practical aspects of it and how it will work and who will fund it and what money it will make in the long run.

The rest of the scientific part, the clinical part, these are what let you get the idea there, but they’re not what you’re actually selling.

[00:22:24] Dr. Parthvi Ravat: Yeah, that’s that that might be very important. We tend to overcomplicate stuff for the people who are not in our core field.

Thank you so much, Professor. It was wonderful talking to you.

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Founded in 1909, the International League Against Epilepsy (ILAE) is a global organization with more than 125 national chapters.

Through promoting research, education and training to improve the diagnosis, treatment and prevention of the disease, ILAE is working toward a world where no person’s life is limited by epilepsy.

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