Trials with Maya Z

Maya Zlatanova (00:00)
Hello everyone. This is Maya from Trials with Maya Z and I'm very excited today to introduce you to Lorna Pender, a patient advocate, a patient engagement director, expert patient board member of multiple organizations. I'll leave her to introduce herself in a little bit, but as you can see, I'm very excited because

I met Lorna maybe two months ago. I met her, she didn't meet me, but I saw her from a distance. She was on stage at one of the European patient engagement events, actually events where a lot of people globally actually come to meet and discuss how can we better engage with patients.

And how can patients better engage with industry? Because the majority of people, unlike other industry events, are primarily patients who are doing their best, overcoming their diseases, their issues, their challenges, to speak as loud as they can and support the industry to make more meaningful decisions, to develop more meaningful treatments, patient support programs. And at the end of the day,

ensure that more patients have access to better treatment, better healthcare. And Lorna is one of the loudest voices that you can find. Someone that's super passionate, someone that has gone through a lot of different experiences. Lorna and I just had a call, brief call, but then the call turned out to be super interesting. So I just asked her, Lorna, can we spend the next 15, 20 minutes max actually recording that because I really wanted to

to share this conversation with all of you. As you know, Trials with Maya Z is exactly out there to spread the word about the good ideas, the real challenges, and basically unite ourselves towards the better solutions. Lorna, welcome once again. You can start with briefly introducing yourself.

Lorna Pender (01:57)
Thank you, Maya

Thank you very much indeed Maya for this opportunity. So I'm Lorna Pender, I'm the global patient engagement lead with Clinogen and I'm also a few different hat wearers. I'm a retired medic, I used to work in NHS. I'm a patient expert for dermatology and NIHR research champion. So I'm involved in a few different activities and I'm also on the PFMD.

Sustainability and Patient Engagement Task Force.

Maya Zlatanova (02:28)
Thank you, Lorna. Lorna, we had a call today because I wanted to introduce you to my team's mission, which is bringing research closer to patients. And I was complaining, let's put it that way, that I see lately that the industry doesn't always take into consideration the local Standard of Care

Lorna Pender (02:53)
Yes.

Maya Zlatanova (02:54)
Especially when we're speaking about planning of clinical trials, very often this is perceived as something that commercial teams should care about. And when we speak about clinical operations, feasibility, like multiple teams involved in making very important decisions for when and how and where this clinical trial should happen, the Standard of Care is sometimes not really taken as serious as it should.

And so Lorna basically.

So very, let's say, so my mission is something that's very dear to her as well, because she went through such an expertise, like such experiences where I know, Lorna, that you're working as patient engagement leader. So I know that you are speaking with lots of different companies and you're facing similar challenges. Can you tell me more about the challenges you're facing?

Lorna Pender (03:41)
Mm

I think one of the biggest challenges is how to reach as many different representative patient voices as possible. And then how do you then incorporate the insights that you gather? know, the real life scenarios, the patient journey is a very real life scenario. But how do you incorporate the diversity of journeys that people go through, people living with chronic conditions, people

Maya Zlatanova (04:01)
Mm

Lorna Pender (04:10)
and being managed in a multidisciplinary team, people having lots of different healthcare considerations and people facing different geographical barriers, for example. And how do you properly incorporate all of these insights into the design of your program, your clinical program? And that is a challenge and certainly that is an approach that we want to take and we want to adopt and we want to talk about and.

Maya Zlatanova (04:20)
Mm.

Lorna Pender (04:36)
Spread the word essentially, it's very important to go out there and to engage with people where they're at in the community. What is happening with the health journey because the Standard of Care is not equitable, it is not the same everywhere. So you want to understand the key insights about the patient's journey to be able to build a design that actually reaches people who live where they live, for example, and dependent on which hospital they're cared for.

And so these are the key insights that are currently still an unmet need. We still need to be continually building these into our clinical development design of our programs globally.

Maya Zlatanova (05:15)
Lorna, I'm a very pragmatic person myself.

And I like to explain concepts more into practical terms. So I agree with you. It is a challenge, but can you tell me what is the challenging part? Finding the patient voices or making the industry listen to them? Or maybe both.

Lorna Pender (05:35)
Yeah, no, obviously it can be a challenge for lots of different reasons, but certainly in my experience there's a there's a big range of companies who do exceptionally well. So companies who are currently embedding patient engagement into their companies, commercial and whole business operations. These are the companies that do patient engagement. They do it very well. They do go out to communities and they do.

gather insights and not only that, they action those insights. So it's not enough to do a tick box exercise anymore. It's not enough for the global office to say that they have done engagement, but the local affiliate have not done any engagement. So that is not really truly meeting the needs of people around the world. So those types of globally led clinical trial designs are the ones that really let patients down that aren't tailored.

Maya Zlatanova (06:09)
Mm.

Lorna Pender (06:27)
to the particular local geography that that person is based. The other thing is, is the design innovative? Is it decentralized? Does it offer people who live in rural communities access to a clinical trial? Are we incorporating technologies into the design of the clinical trial to allow people to take part in the research from wherever they're based? So these are the other things that when you see companies doing this worldwide, you recognize that they have

Maya Zlatanova (06:53)
Okay.

Lorna Pender (06:55)
taking into account the insights that people are telling them from the community when they do their engagement. And more and more companies are also incorporating the voice of the patient at the board level. So you'll see more and more companies having Chief Patient Officers to give the voice of the patient to the key decision makers on the board when they're deciding about what markets are going to go into next. For example, what

what pipeline developments that they're going to invest in. So these are the types of things that can really drive patient focused medicines development that are really key for industry to take on board moving forward.

Maya Zlatanova (07:32)
Yeah, when I was telling you about our story, I mentioned that I was very surprised. First of all, most people know that I'm originally from Bulgaria and I mentioned that to you. And actually coming from Bulgaria, to me it was very natural to know

that the way that people in Bulgaria are treated is different than the way, let's say, someone in Poland, in Romania, Germany, or the UK are being treated. But you actually gave me even a better point. The UK, for example, it's a big country. And then you have different regions. So even in the UK, you have differences between how people are treated between Scotland, Wales, and England, for example. So...

there is a regional aspect to the Standard of Care that contributes to someone's experience and their patient's journey. But it was, to my surprise, maybe two years ago or maybe even longer to realize that this global planning that you mentioned, in most cases, it does happen, let's say, somewhere in the United States because the US market is the biggest when it comes to clinical research, the running clinical trials. It's the biggest

Lorna Pender (08:21)
Sure. Sure.

Maya Zlatanova (08:45)
any sort of treatment as well. let's say that naturally the people who are involved in this global planning or global engagement sit somewhere in the United States. And when this happens, I mean, not everyone, of course, but the majority of them wouldn't necessarily know that Europe actually, though it sounds like we're different states, we're actually different countries and each and every country takes a different decision on what type of access.

certain treatment, I mean, certain patient will have. the, basically the regions are the so -called states and they actually make even different decisions on what should be accessed at what stage of the patient journey. So that was a surprise to me, but like you said, it's something very common. So at the same time, you're spending this global planning comes from the fact that you have one protocol, this clinical trial, having multiple who create another

Lorna Pender (09:39)
Yes.

Maya Zlatanova (09:41)
regulatory nightmare. So I understand, but then again, we need to balance. And why do we need to balance, Lorna? Can you explain actually why it's so critical to understand the patient journey when you plan clinical trials, patient support program, whatever you're planning that involves patients? In your opinion, your practical experience, if you miss the patient journey, what can happen?

Lorna Pender (10:06)
Well, I think it's very key to understand the patient journey with respect to the design of any clinical program. And it doesn't matter what that looks like. It could be a patient support program. It could be a phase three clinical trial. It could be an early access program. And what is the danger of not engaging with patients is that the program is not designed for the people that actually are going to be taking part.

and this means it's either inaccessible for geography reasons, for travel, but quite often people are considered to have a buoyant family network of people who can drive them to and from hospital visits and be able to take time off work for example. Most of the time there's not any creche facilities so if you're a single parent how can you take part in a program if there aren't any creche facilities?

Maya Zlatanova (10:50)
Hmm.

Lorna Pender (10:56)
And so all of these things really drive the design of any clinical program to make sure that they're actually accessible for the people that you would like to take part in your program. And so it's really driving the success of the number of people that can actually access your clinical program. And secondly, secondly, it also drives

better diversity and inclusion practices. If you do engage, as I said before, with a representative portion of the patient community, before you get into a clinical program stage, we're talking early drug discovery stage, the earliest point possible drives success. And we know that from the data, we know that if you do engage with patients from the earliest stage of drug discovery,

Maya Zlatanova (11:38)
Yeah.

Hmm.

Lorna Pender (11:48)
and the drug goes right through the life cycle process that that medicine is 20 % more likely to launch and actually reach patients. So it's very important from a sustainability perspective, also for companies to have successful programs that are actually reaching people that people can actually take part. And it's not successful to see the program's open

the recruitment is 20 % of expected patient population. If you started to engage with the patients and patient organizations and advocacy groups early on, you would understand where are these people based, for example, which part of the country are they based? And where do we need to open these clinical programs? And these are the things that help people access programs when they're actually based where they are. And so these are the insights that are key to understand.

Maya Zlatanova (12:27)
Hmm.

Lorna, I know that we don't have much time, but I have one last question because it's absolutely crucial. That's a message I want to spread as much as possible. We were discussing that already with you, but also I've been discussing it with lot of other patient advocates and patients and yourself. You're also a patient. We all are, but let's say you're a patient who've been literally faced with the decision, should I go?

and join a clinical trial or should I actually continue with the local Standard of Care? What's accessible is the next step according to, let's say, the established guidelines. And we were even laughing just before we started because I was sharing with you that most of the clinical trial experts planning clinical trials are looking at other clinical trials of the competition because they kind of, and I get

If you go and ask an investigator what will be the competition like to my clinical trial, they'll give you another clinical trial. But if you go and ask the patient who is actually the biggest, who is the actual competition, what's your opinion and learn.

Lorna Pender (13:47)
So I'm actually in this position myself right now. So I could definitely give you some real life example of the decision making process that I've had to go through in this real life setting. And the decision for me is, I suppose, different from people who might not be medically trained, for example. I can search inclusion and exclusion criteria and decide for myself, am I actually

for this clinical trial in the first place and that helps me in my decision making process because I don't want to advocate for myself for a clinical trial for something that I might not be eligible for. That's one thing, it saves you time having to make appointments for doctors when you already know you might not be eligible for a clinical trial. But for me there was lots of considerations and it was about mostly personal considerations about

what will actually suit me in my lifestyle, my work, what can I commit to with respect to hospital visits? And what were the current data and the research on these medicines and way

Maya Zlatanova (14:52)
Hmm.

Lorna Pender (14:55)
the effectiveness versus the safety profile and it had my decision was absolutely nothing to do with the competition for different industry partners who are doing trials for my medical condition absolutely did not factor into my decision whatsoever patients want treatment options plural they do not want

Maya Zlatanova (15:19)
Mmm.

Lorna Pender (15:20)
medicines from a particular firm, unless you're in an ultra rare condition, where there's maybe only one or two companies that are actually making that medicine, you are very unlikely to A know, first of all, or be aware of what companies are doing what research and what medicines and trials and B it doesn't matter to you, it's based on the information and how that weighs up and how that what that means for you in your life. And most people are just

Maya Zlatanova (15:40)
you

Lorna Pender (15:47)
very very grateful to receive any opportunities for any treatment or clinical trial full stop. Just very grateful because most of the time when you're in that patient chair at that point you have been told there are no other treatment options for you or the current reimbursed treatment option for you has been delayed in the HTA decision making at a local level and they will currently not fund that treatment for you so you've been rejected.

to have treatment offered for you. So you've heard no an awful lot of times and you're sitting there thinking I've got options now. It gives you hope, gives you a lot of hope. Very positive.

Maya Zlatanova (16:23)
And like you mentioned, you've been rejected six or seven, eight times to actually receive treatment that you truly believe will be the game changer for you and your condition. And I've been also telling you these stories where you know there is a treatment, but let's it's not reimbursed for you, let's say for your status, like age, whatever. This is the real nightmare actually patients have to go through.

Lorna Pender (16:33)
Yes.

Maya Zlatanova (16:51)
Anyway, Lorna, I know that you have to go, but I'm truly thankful for your time for these insights. I hope this won't be the last time we speak, but thank you for sharing your perspective on why understanding the patient's journey, why understanding the local Standard of Care is so important. And I hope that we all find better instruments and better language and better ways and mechanisms to integrate the patient's voice into any projects, research, commercial, doesn't matter.

Lorna Pender (17:18)
Absolutely,