Trials with Maya Z

Maya Zlatanova, CEO TrialHub (00:00)
Hello everyone and welcome again with Maya Z. This is Maya and you already recognize my voice. And today I am with a very interesting patient advocate, Joy Milne Joy, I actually met Joy. She proactively reached out to me saying, I want to volunteer. I want to say more about the standard of care and...

patient engagement and what's wrong with research in Parkinson's. And then we had a brief conversation that totally confirmed for me that Joy is someone that I need to interview and probably we won't have enough time for just one interview. But why? Because Joy, first of all, she's working at the University of Manchester and for many, many years has been struggling to first having

different family members struggling with Parkinson's, so having to take care of them on one side, but on the second, on another side, to actually speak loud about the issues of the disease and the issues around research, the issues around patient engagement. Second, because Joy is a trained patient, let's put it that way. So it's not only that she's been doing this work for quite some time, but actually Joy is a part of an institution called EUPATI.

for those who don't know that are outside of Europe, EUPATI's, like the easiest way to explain that is the patient's academy. An academy that's whose mission is to raise the patient's voice and to educate more patients to become patient advocates in a more meaningful way so that they can actually contribute with their knowledge to the industry and to research in general. So that at the end of the day, we have a better alignment between

both and it's actually one stakeholder, two different separate voices that don't speak the same language. So Joy, I'm extremely happy to have you aboard. Thank you for making the time. Welcome once again. And yes, please start with a short introduction when you're on.

Joy Milne (01:59)
My name is Joy Milne. I was a carer for 49 years with my mother -in -law and my husband with Parkinson's. Just before he died, I walked in for our first meeting of Parkinson's UK and promptly walked out again. I have what is called hereditary hyperosmia.

And I knew my husband's smell had changed before 12 years before he was diagnosed. And but I didn't have a place to put that smell. I had been a nurse and I had only had one contact with a female with Parkinson's. But females with Parkinson's smell slightly different from males. I'll tell you about that because I did quite a bit of work on that.

So having found that there was this smell, my husband was a consultant anaesthetist he decided that we had to do something about it. It was urgent to him. I mean, he was in his last few years with Parkinson's, his health was failing rapidly. But he chose Professor Tilo Kunath, went to one of his meetings and I stood up and said, why are you not using the smell of Parkinson's to diagnose earlier? And I do wish I'd had the camera because Tilo's face.

Tilo and I are good friends now, but his face was, what are you talking about? Since then, he introduced me to Professor Perdita Barran and I work at Manchester University within the Biotechnology Unit. However, I also became involved with the PD Avengers. We formed another group, women's group, to identify that women aren't little men in Parkinson's. We are different, or they are different.

Maya Zlatanova, CEO TrialHub (03:40)
and

Joy Milne (03:41)
and that the difficulties my mother -in -law had, we were soon to discover, because I openly spoke about it, that we were soon to discover that many other women had the same problems, especially around the week before their period, and going through the perimenopause and the menopause. And men don't have that, so they don't have those hormones that interfere with the neurological setup of their body.

Maya Zlatanova, CEO TrialHub (03:50)
Mm.

Hmm.

Joy Milne (04:03)
And so it was that was very interesting and some very good papers, especially with Dr. Sonia Maither and the CEO of Cure Parkinson's Trust, Helen Matthews. We did a very good job there in in making it apparent that there was this difference and it had to be catered for. I've done other things like doing the studying in your party because I found

It was a friend, Mark van Grieken, who encouraged me to do it. But in actual fact, the course itself was so illuminating. It was fantastic. And it has helped tremendously towards my advocacy on how I look at things. I've also done, I'm helping to, I'm head PPI in a study for Carers for Parkinson's as well. So I am forwarding this all the time, but I have been to the

the first person -based approach conference in Gothenburg last year and met Janna Berkelewits and we are forming a group to forward this person -based approach and how medicine should be looking at this. The Philippines have done it, they're doing it in Australia, Canada, New Zealand and we're having superb results.

Maya Zlatanova, CEO TrialHub (05:12)
Hmm, that's interesting.

I have lots of questions there, but let's first start. Yes, I'll make a note to ask you about that a little bit later, but first tell me, I'm listening to your story and now you're sharing even more details than the last time we spoke. And I'm thinking, what is it like to be on the biotech side of things where you're literally working towards the discovery of new technologies and new medicines, hopefully cures?

and at the same time being a caregiver. How is it like to be on the side of two different metals? how do you feel about

Joy Milne (05:49)
I think on my husband's, how I feel about it is on my husband's deathbed, he said to me, you must do this, you must follow this, you must keep going. And I think because he was, he was an international swimmer, he was looking at the Olympics now and he have loved, we did go to a couple of Olympics to see the swimming. And so it was for him,

It was a must. So I live with that inside of me because really I don't think people have understood Parkinson's at all up until now. The normal, you know, it's like one of my friends that I work with in Parkinson's, Matt. Matt has a t -shirt that says, I am not drunk, I have Parkinson's because he's been accused in the street of being, you know.

Maya Zlatanova, CEO TrialHub (06:21)
Yeah.

wow. Yeah. Well, something you said last time, which was absolutely striking was that we don't have a new medication approved for the last 60 years, 65 years. Is that correct? Like for Parkinson's, mean. Do you know why? Like, yeah. How come? 65 years, we speak all the time about innovation and

Joy Milne (06:48)
Yes. Yes. Yes.

is

Maya Zlatanova, CEO TrialHub (07:00)
technology and AI and everything. And then again, 65 years, 60 years later, we have nothing new for a such a serious disease.

Joy Milne (07:07)
And

and it has terrible side effects. mean the off periods with it are horrendous. You can be one minute, you know, as normal as you are in Parkinson's and getting on with your life and then all of a sudden you have an off period. And it can be so sudden that you are absolutely, completely washed out. So it's not a medication that has a, you know,

period that you think, I'm safe, I'm going to be all right taking this medication, like lot of, you know, like diabetes and insulin or cardiology and some of the tablets, et cetera, your high blood pressure, that doesn't exist in Parkinson's. And the off periods, you don't know when they're going to come. And they can be really extreme. Some of them aren't, but

some people have extreme, you must take your tablets on time, you must take them at the same time every day. The technology scene has become, know, things beep to tell you that you have now to take your tablets, which is very good because when Les was first diagnosed all those years ago, there wasn't anything like that. And we were not told, I think one of the worst things about

Well, there are several, but one of the worst things is the diagnosis. You go in to see an urologist, you're there for 20 minutes perhaps with your first diagnostic interview and you're told you have an incurable disease.

And people write

Maya Zlatanova, CEO TrialHub (08:34)
So, what's up?

Yeah, I was wondering what stops research from progressing, Joy? What is it about Parkinson that, I mean, I probably said a very vague question, but really, like what stops research for progressing in Parkinson? I know Parkinson is not the only disease like that, but 60 years.

Joy Milne (08:52)
I have been involved on two camps. So alpha synuclein is the protein that is supposedly causing the problems. Manchester worked with Professor Daniela Berg and I've listened to Professor Reeder at the World Parkinson's Congress speaking about, and they work together, speaking about the fact that is alpha synuclein a goodie or a badie?

The majority of people in researching in Parkinson's and you're all just think it's a baddie. However, for me, with my hereditary sense of smell, we know that in the sebum, that is where the professor did this lecture at the World Parkinson's Congress saying that the highest amount of alpha synuclein is found at the back of the neck.

around this area here, around your neck, on the back. Where do I find the smell is worse?

around the back of the neck.

Maya Zlatanova, CEO TrialHub (09:48)
Hmm... Okay.

Joy Milne (09:49)
That's where we take the swabs. Now on the testing with Manchester, they found that the sebum in these swabs, which is taken there by alpha -synuclein, is showing the dysregulated lipids, how ill a person is, how good they are, and what the problems are in

Maya Zlatanova, CEO TrialHub (10:07)
Hmm, super interesting. And you mentioned that Parkinson's is very different with women and with men. So I wonder, since you're also a patient advocate, what work is out there to actually recognize these differences? Is industry working towards recognizing that, first of all, and you as a patient advocate, do you feel

you've contributed somehow so that we can have different type of research for both women and

Joy Milne (10:37)
The response has been fantastic. Simply because there have been a set of women with Parkinson's in the world. Sonia Maither and Rachel Flanagan. There are many of them actually. I could take up the whole hour mentioning that we rallied a body of people or we maybe instigated a sort of revolt.

Maya Zlatanova, CEO TrialHub (10:49)
Hmm.

Joy Milne (11:00)
because it was, the meetings were fantastic. The paper was fantastic that Sonia wrote with many of our other women with Parkinson's. But we did a huge study with Michael J. Fox. We're speaking about, I can't remember how many thousand questions in it, and you could go back and go back into it and go back into it. And we went literally from having your period.

to after the menopause. So we had different sections that were filled in and the results, you know, we were getting feedback on results and it's phenomenal and there were I think there were 10 ,000 within the first few months of women

Maya Zlatanova, CEO TrialHub (11:38)
wow.

Joy Milne (11:39)
So it sparked something that was needed. However, what happens is women go to the GP or what you call your general physician and they would have been told, well, you've your periods, you've got problems with your hormones, you've got it, your skin, well, you've got this breakout on your skin, well, you know, that's just, you know.

around your period time and you're, well that's normal probably and they get treated for that and they get treated for feeling down about it all and they get treated because they're not sleeping properly and they get diagnosed later than men unless you get a very good...

Maya Zlatanova, CEO TrialHub (12:15)
Yeah, you know, I've heard somewhere lately, I watched a video actually explaining that the women in general get under diagnosed because when they go to the doctor, they are being explained, that's your period. That's just like normal with women. you feel like anxious. You have like young kids, for example. To be honest, I had like a similar type of thing.

Joy Milne (12:29)
Yes.

Maya Zlatanova, CEO TrialHub (12:44)
a few months ago where I was really feeling down and I couldn't even wake up properly and I was telling my husband, there something wrong? And everyone, I was saying that too. They were like, you have small kids and you like with the company and all the things that you're doing, you're just tired. I'm like, guys, when I'm doing that, it's not the first time I'm doing that. I'm doing it all the time. But now I feel way more tired. So it took me months actually.

and one really diligent doctor who actually got my lab test during a preventative check to realize that actually I did have some issues with my, don't like, some vitamins basically that are critical for you feeling well and energized and having proper sleep. But for months I was thinking that I'm crazy and something's wrong with me. Literally, and nobody really paid any attention.

And I can imagine like when it comes to something even more serious, what it's like. So how can we address that Joy? How can we address, how can we encourage earlier diagnosis in Parkinson's? Because for diseases like Parkinson's, Alzheimer's and many, many others, how early you actually get the diagnosis, it plays a huge, huge role in how you're gonna be treated. Because today we have medications that can...

work when you're in your early days and you can at least slow down the progression and live longer and better quality. So what can we do in order to encourage this early diagnosis within women, but also

Joy Milne (14:18)
Well, there's one big point. The stigma.

Maya Zlatanova, CEO TrialHub (14:21)
Hmm.

Joy Milne (14:21)
The stigma of having Parkinson's slows everything down. And the stigma...

People have to accept and be open. Until this happens that the general public know more about Parkinson's, they know more about the horrible side effects of Parkinson's, they know the stress and strain that go on to your spouse or partner and your family, we have to be more open about it. And we have to appreciate

in universities that there is not enough understanding of that for young medical students. Now, I know in Oxford, they have access to speaking to the medical students. That should be happening all over the world. It should really, so that that side of the young doctor becomes aware that this is really interesting.

Maya Zlatanova, CEO TrialHub (15:04)
Hmm, interesting.

Joy Milne (15:13)
for one, but should be motivated to look at it more clearly. If a patient is coming back person forwards to you and you've seen them maybe in three months, you've seen them four or five times, there should be alarm bells. If you don't see what it is, but they're telling you something. So it would be really good for medicine and the education of medical students within universities to look at this.

That would be one thing. The stigma that the actual person with Parkinson's is more open about it and they can go and speak to the rest of their family and their friends. And I know it's hard. I know it's very hard because the side effects not only of the L-Dopa but also patients are still getting agonists. It's a type of tablet that cause...

Maya Zlatanova, CEO TrialHub (15:49)
Yeah.

Joy Milne (16:02)
causes fixations, gambling, sexual discretions etc. And they're getting this along with the L-Dopa that, there's a, I noticed on my tablet yesterday that somebody was questioning why are we still getting agonists. know, a person, a woman with Parkinson's saying why are we still getting, why is it not being questioned? Why is it not being looked

Maya Zlatanova, CEO TrialHub (16:13)
Ahem.

Mm.

Joy Milne (16:28)
Okay, it gives you hype, it makes you maybe feel a bit better, but the side effects are dreadful!

Maya Zlatanova, CEO TrialHub (16:33)
That actually opens another question. Are people with Parkinson's treated differently in different countries, Joy? mean, are you aware of the standard of care country by country? Is it very different, let's say, in the States compared to the UK, or let's say compared to Russia, or somewhere, China, in another part of the world?

Joy Milne (16:56)
Natasha Misbah, she has done so much to actually bring this forward. Professor Richard Walker and Indiji, a professor in Lagos, the work they are doing is phenomenal. No other country is doing what they're doing.

To see this, that it's being done in six countries in Africa is amazing. They are doing all different kinds of diagnostics. They're doing saliva, they're doing the sebum, they're doing our tests, they're doing genetics. They're looking at care all through it and they are training staff. The staff are going out into these villages on little mopeds and they are really bringing together.

Maya Zlatanova, CEO TrialHub (17:16)
wow.

Joy Milne (17:37)
a vast amount of information. It is an astonishing process and it really is. It's taken them, I think it's taken Indigee and Richard 16 years to put it together. And Natasha actually, Tash as we call her, she is in charge of your running it. She's a young scientist, but she is so dedicated to it. It's really surprising. And people like Albert and...

across in, I think it's Tanzania he's in, they're so enthusiastic. I mean, if we had that all the way through the world, we would sort this out, I assure you.

Maya Zlatanova, CEO TrialHub (18:16)
And Joy, you also gave me, you told me another story as part of your patient engagement experience. Basically, when you were part of a committee providing feedback on clinical trial, what it was like and actually how much does the industry try to understand the patient journey before planning any of the clinical trials that are coming next?

And what is the process like?

Joy Milne (18:44)
Well, yeah, the process is very hard. NIHR, the National Institute for Research in the UK, have a very, very good set up. They really do for PPI. They've been trying to make inroads into industry for many years, 40, 45 years. And the set up should be good. However, the training is not, it is getting better.

But I am head PPI and I didn't not, I have to take some blame myself. I did not understand at first the intricacies of actually training a PPI team and then of bringing together, you're like the thorn in the middle if you're the head PPI. So you've got

Maya Zlatanova, CEO TrialHub (19:28)
And so I'm sorry, can we go one step back? Can you define PPI just to make sure that we understand correctly?

Joy Milne (19:35)
Patient public involvement. In every research for NIHR, they must have a group of patient advocates. People who are actually experiencing what is happening in that disease. So I have a very good group of carers.

Maya Zlatanova, CEO TrialHub (19:37)
Okay, thanks.

Hmm.

Joy Milne (19:53)
dedicated carers who have taken quite a lot of interest in other parts, being head of local groups and other research, etc. So when I started, I didn't realise I had done a lot of education. I had read a lot of... I had gone through EUPATI so I knew there was a grounding that you had to follow and you should be...

What I didn't understand was that the research side were not going to educate the PPI, my fellow PPI group, on what they were doing.

So there is this gap that has to be crossed. There has to be a liaison of education.

Maya Zlatanova, CEO TrialHub (20:33)
Hmm.

So what you're saying, let me see if I understand correctly, let's say the research party will ask you questions without necessarily giving you the context of these questions. And you have to answer these questions, but you kind of like without knowing where this is coming from, you may provide an answer that actually misleading to the researchers without understanding their context. So how do you imagine this training actually happened? It is more of a general type of a training.

Joy Milne (20:47)
Yes.

Maya Zlatanova, CEO TrialHub (21:04)
Or do you imagine a training on the science, like the type of science that the researchers are planning on doing?

Joy Milne (21:10)
Well, there's two things here. The first one is we were going forward and I was getting a little bit of rumbling from my fellow colleagues on the PPI team and I went to a general meeting. was a co -applicant, so went into a general meeting with the researchers and I said, stop, I'm stopping it. And they were like, what? I said, we have to go and educate.

the PPI team to what you are actually doing. How can they understand what you're doing if they don't have the education? Now, this was on think -aloud questionnaires. None of us had dealt with think -aloud questionnaires. And I think it was a misunderstanding between the two groups. Now, I have to say the research group then responded.

But they responded so far, but no further. So we had to go back again. And I had this time, I took it upon myself to find NIHR and various groups, how, what was a ThinkAloud interview, how it ran, what its principles were, what were the, when the questions were there, the answers and how they assess those answers. And there was a

whole protocol for doing it that we knew nothing about.

Maya Zlatanova, CEO TrialHub (22:24)
Hmm. Hmm.

Joy Milne (22:27)
So it's not only, they didn't know about being a carer, but we didn't know what they were doing.

Maya Zlatanova, CEO TrialHub (22:34)
Yeah.

Joy Milne (22:34)
And that gap has to be filled. I think we did it quite well. There are still a few things that have been left behind because we didn't have that good beginning. So it has to be there at the beginning. The researchers have to realise that they must liaise with the PPI group, give them the insight, the full insight into what the research is about and how it's going to be carried out.

On the other side, the PPI team have to understand that the responsibility of the results in the research are left at the door of the researchers. However, they usually want to have a huge input. So there has to be an agreement between the two groups that how it's going to be kind of and that has to be done at the very beginning. You have to

a liaison, a friendly liaison and a respectful liaison between what is for either group and what you do together.

Maya Zlatanova, CEO TrialHub (23:35)
That's very interesting. Not only interesting, very inspiring because I like the word liaison It just comes with synergy. It comes with collaboration, with common goals. And I agree with you, Joy, without having at the very beginning what is the common goal that we try to achieve and without underestimating each

Joy Milne (23:47)
Yes. Yes.

Maya Zlatanova, CEO TrialHub (24:01)
a role and importance in the whole process. If we don't do that, then we'll end up being beslept with wrong expectations. Sometimes, like you said, just to the very beginning to get on the same page and then continue. I just wonder one other question around that. What will happen if the researchers, what will be the implications if the researchers don't get

adequate response from the PPI and from the patients on the other side. Patients' care.

Joy Milne (24:32)
Well, it is well known, it is now very well known and written about the input, the good input, proper input of a PPI team enhances the results of any research. Now, if the researchers don't accept that, they're not going to produce a relevant result. Whether it is

with, as it is for me and them, they're producing an app for carers to help them in their everyday life to cope with Parkinson's. Now, if they don't listen and make assumptions, which they're not liaising with us, things could go a bit awry. But we're going into work stage two, things are far better and I think there's far more understanding.

and how it can be achieved because it is well written. People have researched it. It makes the results of a research study far better.

Maya Zlatanova, CEO TrialHub (25:29)
Do you have the opposite story, Joy, where the researcher didn't really take into consideration the patient's journey and they produced, let's say, a clinical trial, but that goat... Is that what actually happened in the past 60 years or so and therefore we don't have any good results or it's a too big of a statement?

Joy Milne (25:49)
I think they're looking at 56 million or 56 billion dollars have been wasted because they haven't had it. It's in that and it's well written up. That is also well, that has been studied because the incentive to stop this waste of money and research is huge. And they now know that this can be solved by

Maya Zlatanova, CEO TrialHub (25:56)
along.

Joy Milne (26:17)
this PPI input. However, we need to get this liaison, this cooperation, this understanding. It is absolutely crucial.

Maya Zlatanova, CEO TrialHub (26:27)
Indeed. Thank you for sharing that, Joy. I have so many, many questions, but maybe can I have just one last question? Because you started at very beginning about that, and you mentioned some countries where I speak about the person -based treatment. I think you speak about personalized medicine. Is it actually different to personalized medicine, what you're speaking about?

Joy Milne (26:48)
Yes, because doctors and nurses, I'm a nurse and my husband was a doctor, he was very good at the person -based approach. He just naturally had that. And it was lovely how people came back to me said, isn't he good and he's done this for me and that for me. But he saw that because his mother had Parkinson's, he had been a carer from a very young age. And that's where the difference came

Maya Zlatanova, CEO TrialHub (26:53)
Mm

person -based approach,

Joy Milne (27:15)
His father had died when he was 11, by the time he was at 11, 14 years old, he was a full -time carer for his mother, yet he did his tires. He became an international swimmer. He did all the right things. So he had that inbuilt from being a teenager, understood. So, but if you look at the Philippines, they have built a hospital system on it and it

Maya Zlatanova, CEO TrialHub (27:29)
Wow.

Joy Milne (27:42)
It was astounding at the Copenhagen conference to hear what they'd done. And Professor Wolf, who is running it with Jana Berkowitz, they are, we did workshops and I think I gave you the experience. The first workshop I did, it was round tables and the first workshop I did, it was PhD students and patient advocates, etc. And it was loud discussions going backwards and forwards. And the next one.

was receptors. Total silence. And I said to him, well, what do you want to speak about? Somebody mentioned the lay summary. And I thought, yes, that is a very good point. And I have a lot of background knowledge on the lay summary and how it matters and what it should be and how it should not have any scientific speech in it. It is for the people.

Maya Zlatanova, CEO TrialHub (28:30)
Yeah, yeah, true.

Joy Milne (28:33)
who are going to be involved, who are not scientists. And simple things like that. And by the end, yes, I said to them at the end, please come back to me in the four days of the conference if you have any other queries. And we had little tables. I would get a few people together in the day and we'd go and speak about it. it was, the researchers continued to ask the questions.

the PhD students and the patient advocates got it. They were in it. But the researchers had to come back and keep on asking questions. And it was interesting. It worked though. I said to Jana at the end, and I am in this group that we are forwarding the person -based approach with Calgary University Canada. They are a superb group. There were three of them there and absolutely superb group. So it's interesting.

Maya Zlatanova, CEO TrialHub (29:21)
you know, this whole conversation, even though like we had some, yeah, you shared some really tough stories and I'm so thankful for your transparency and your humbleness around all the things that you're doing. But it's very, very positive at the end because if I'm to summarize, even though we didn't have like the progress we needed in Parkinson's when it comes to research

the results we wanted. I kind of feel from your story that we are on a better track now, that at least in this area, patients and carers are way more engaged and there are people to listen and people to really drive forward this liaison, people like you. And I just hope that this will be across every single disease, no matter which, because...

Yes, no matter what type of disease you have, no matter how severe it looks on the outside, it is something that you struggle. So I respect every single person in their own battles. And I even more respect people like you who despite the battle, they find strength in the battle and actually make something good for the other people. So thank you very much, Joy, for sharing this and for all the work that you're doing.

Joy Milne (30:32)
It's a pleasure. It's a pleasure.