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Transcripts - FDA and EMA present Conversations on Cancer: Living with Metastatic Cancer

Rea Blakey:

Good day to everyone and thank you for joining us. Welcome to the US Food and Drug Administration Oncology Center of Excellence in conjunction with the European Medicines Agency or EMA presentation of a Conversation on Cancer public panel discussion. I'm Rea Blakey. I'm the associate director for External Outreach and Engagement at the FDA Oncology Center of Excellence. And today marks an historic moment for our conversations on cancer. This is the first ever international collaboration with our colleagues at the European Medicines Agency or EMA and this conversation on cancer will highlight experiences of US and European patients living with metastatic breast cancer. So today, you'll learn about international patient experiences and the differences and challenges that cancer experts face in making medications available to these patients. Attendees, by the way, who are viewing by livestream are welcome to post comments to social media during this discussion using our hashtag, please, ConversationsonCancer, #ConversationsonCancer. Now, I'd like to bring in our co-moderator for this special event, Dr. Asma Dilawari, who, as Asma knows, we've all agreed to call each other by first names just for convenience sake. So Asma, take it away.

Asma Dilawari:

Thanks, Rea. Welcome, everyone, to the Conversations on Cancer for October, 2023. I'm a clinical reviewer at the FDA and a medical oncologist. And on behalf of everyone at the FDA, I just want to thank everyone joining from Europe. Today, we will also be joined by our European regulatory colleagues, oncologists from the US, UK and Denmark and of course some patients who will be telling us about their experience of living with metastatic breast cancer. It is Breast Cancer Awareness Month, but most of us on this panel think about breast cancer all year long. And as many of you know, almost 30% of breast cancer patients globally are diagnosed with advanced stage or metastatic disease and they are on therapies for sometimes years at a time. Today, we will be hearing about some of these therapies and the patients' experiences. And I hope everyone listening will include their perspective and learn from each other. So thank you.

Rea Blakey:

And now to our Oncology Center of Excellence center director, Richard Pastor.

Richard Pastor:

Hi. My name is Rick Pastor. I'm a medical oncologist and also head of the Oncology Center of Excellence. And I really welcome everybody here, both in the United States and in the European continent. We really are very interested in exploring both similarities and differences that may exist both in drug regulation, as well as treatments, as well as perceptions of diseases. So we are very interested in having this kind of inaugural discussion between the two continents with the EMA and the FDA working together to organize this conversation on cancer.

Conversations on Cancer was initiated about five or six years ago really to be an interface between societal issues and the science of oncology, as well as drug regulation. And we've had very interesting conversations that have spanned over the years. As mentioned before, this is the first time that we're having a joint conversation on cancer sponsored by both the Oncology Center of Excellence here at the FDA, as well as the EMA. And hopefully this will be the first of many that we will have as we move forward in building closer relationships on drug regulation on an international basis. So I think most of the topics have been already covered. So I'm going to turn it over to my colleague from the EMA, Caroline Voltz, who will also give you some brief introductory comments. Caroline?

Caroline Voltz:

Thank you, Rick. And good morning and good afternoon to you all. So my name is Caroline Voltz. I work as a team lead in the Oncology, Advanced Therapies and Hematological Disease office at the European Medicines Agency. I joined EMA in 2007. And I'm very pleased to join today's conversation on cancer focusing on metastatic breast cancer. So as Rick mentioned, this webinar marks a significant milestone as it's the first webinar between FDA and EMA, and this underlines our extensive collaboration which has matured over the past two decades and is further expanding. Oncology are the central position with the European Commission's agenda emphasized by the European commitment to combat cancer for the EU Beating Cancer plan. Also, the EMA has embark on the groundbreaking Cancer Medicine Pathfinder Initiative which seeks to expedite the accessibility of safe and effective cancer treatments. In this framework, the EMA is dedicated to incorporating patients' perspective. Today's discussion on cancer represent a significant step in this direction, highlighting a prime example of our commitment to engaging with patients and the broader community. Therefore, we are very pleased to join and undertake this collaborative effort with our colleagues from FDA. Thank you.

Rea Blakey:

Thank you all for those opening comments. We'd love to get to the introductions of the rest of the people who are a part of this panel who are participating in this discussion today. We'll go alphabetically by last names, and so that means that our division director, Laleh Amiri-Kordestani will be the first to introduce herself. Hi, Laleh.

Laleh Amiri-Kordestani:

Hi. Thanks, Rea. I wanted to thank you all for being here today with us. So my name is Laleh Amiri-Kordestani. I joined FDA about 11 years ago after finishing my hematology oncology fellowship at NCI. And our division actually regulates the development of new drugs for several solid tumors, including breast cancer. Today, I'm really happy to actually be here and look forward to hearing your basically perspective on either treating or being a patient with metastatic breast cancer. As you know, we have had really huge advances in the breast cancer, by either earlier diagnosis. The mortality rates of breast cancer has declined significantly in the past decades. However, we are actually now dealing with this issue that essentially patients have to live and tolerate the toxicity of the drugs for much longer time, which is good, to live longer, but also there are some challenges in terms of being on drugs that have toxicities.

So the other aspect is actually being able to enroll on new trials, and that has been an issue since... Actually it's a global issue since majority of our trials are now conducted globally. So that's one of the aspects that we actually look forward to here in this special conversation on cancer that has actually patients and clinicians from both United States, as well as Europe. Thank you, Rea.

Rea Blakey:

Thank you, Laleh. And now Rosa Giuliani.

Rosa Guiliani:

So I borrow this from Rea. Good day to everybody, and it's a pleasure to be here with you today. I'm Rosa. I'm a medical oncologist. I treat breast cancer. And I'm interested in drug development, both from a clinical point of view, from a regulatory point of view, and hence my collaboration with European Medicines Agency. And I'm really looking forward to our discussion today.

Rea Blakey:

And we're thrilled to have you. Thank you. Also, Metta Linnert Jensen. Hi.

Mette Linnert Jensen:

Hello, everybody. My name is Mette, and I'm from the Danish Medicines Agency. I'm a breast cancer oncologist working with approval of new cancer drugs, mostly within the breast cancer field. And I also work with advising companies in the drug development via the European Medicines Agency, where I'm a member of the Scientific Advice Working Party. Yeah. So thrilled to hear your discussions today. Thank you.

Rea Blakey:

Thank you. Tiffany Nicole, who is one of our metastatic breast cancer patients joining us today. Hi.

Tiffany Nicole:

Good day. We are all going to take that from me this morning. I have been diagnosed for now 10 years with HER2 positive breast cancer. It metastasized to my bones first and over the years, it's went to my brain, my liver and my cervix.

Rea Blakey:

We are thrilled to have you here today and look forward to all the comments that you're interested in sharing with the group. Thank you, Tiffany.

Tiffany Nicole:

Thank you

Rea Blakey:

Dr. Ann Partridge. Hi.

Dr. Ann Partridge:

Hi, Rea. Thanks to all of you for having me here today. So I'm Ann Partridge. I'm a medical oncologist at the Dana-Farber Cancer Institute based in Boston, Massachusetts. And I also run the adult survivorship program there. And I'm thrilled that we're having this conversation about living with advanced breast cancer, given we in the survivorship community have often I think not done enough for those living with the disease in terms of the supportive care and the research. I also with another hat work as the co-chair of the Alliance Breast Committee for the National Cancer Institute, where we work to help to develop later phase studies. And in particular when we're thinking about in the metastatic setting, the NCI supports studies that the industry, pharmaceutical industry, is not incentivized to do, things like comparing drugs for both quantity of life and quality of life and toxicity and potential studies to tailor treatment so that we try and rightsize it for patients.

Rea Blakey:

Great. Looking forward to your comments as well. Hi, Lesley, joining us from Scotland. How are you today? Oh, you're on mute. We'd love to hear you. There we go.

Lesley Stephen:

Very sorry. Thanks, Rea. I'm Lesley Stephen and I live in Scotland, in Edinburgh, in the UK with my family of four, not children, young adults. I was diagnosed with metastatic breast cancer de novo out of the blue nine and a half years ago, and generally been living well with it. I've spent that time doing a lot of patient advocacy work. I'm a trustee of a charity called Make 2nds Count, that supports women and men with breast cancer through funding research, support and education. And I'm looking forward to today's call. Thank you.

Rea Blakey:

Thank you. We're really happy we have two US patients and two European patients. So the other European patient is Jo Taylor. Hi, Jo.

Jo Taylor:

Oh, hi. I'm Jo Taylor. I am 54 years old. I've been living with metastatic breast cancer for the last nine and a half years but originally diagnosed 16 years ago, primary breast cancer, was 38 with two very young children and now again, like Lesley, I've got older children and they're young adults. Yeah, I have two organizations called After Breast Cancer Diagnosis and METUPUK, which I'm founder of both. I'm very interested in these conversations about living with the disease and how we can help ourselves to have better outcomes and better survival.

Rea Blakey:

Thank you, Jo. A very active community among metastatic breast cancer survivors, and Stephanie Walker is no exception. Stephanie has actually been on a Conversation on Cancer with us before. So we know, Stephanie, that your advocacy extends far and wide and a lot of it really from your personal experience. Hi. Welcome.

Stephanie Walker:

Thank you so much for this opportunity again. I am Stephanie Walker. I'm living with metastatic breast cancer now for a little over eight years, de novo. I'm hormone receptor positive, HER2 negative, still on my first-line treatment. I am a mom and a [inaudible 00:13:06], a retired nurse, a caregiver also of a patient that has cancer, my husband. And so I coin us as the Two Can Family right now. And I am very active in the advocacy space here with Metastatic Breast Cancer Alliance, which I've done a lot for them, I hope to talk about that a little later, and also with Living Beyond Breast Cancer and Project Life. So I am always anxious to hear what is new, what's old and how I as an individual advocate can help others. Thank you.

Rea Blakey:

We're grateful for everybody on the panel today. At this point, Asma, I'm going to hand it over to you to really get the discussion going. So thank you all, and welcome. Asma?

Asma Dilawari:

Yes. So thank you, everyone, for those introductions. I'm going to start out by... When someone gets this diagnosis of metastatic breast cancer, I imagine after the initial shock, there's a search, a search for information, for therapies, for a healthcare team. And some of you have spoken publicly about the barriers you tackled when you were first looking for therapies, especially newer therapies. So I think, Jo, maybe if you could start by sharing what you experienced and I'd love to hear from Stephanie as well.

Jo Taylor:

Yeah. I think there isn't enough information out there. I actually created ABCD because I wanted the patient voice to come through. A lot of the time when you're in hospital, you get handed leaflets and that's kind of all you get, nothing that you can relate to specifically. And if you're able to talk to with the patients about this, then I think it's massively beneficial. I'm sure Lesley, Tiffany and Stephanie found exactly the same when they were diagnosed. And just to have that interaction with somebody else I think is a huge support to patients.

Tiffany Nicole:

[inaudible 00:15:20]... Oh. Go ahead, Stephanie.

Stephanie Walker:

My situation is I was diagnosed in 2015 and for the first three years, I really did not have any interaction with the community at all, primarily, because I didn't know it existed. And I say that is because I did not have any needs that weren't being met at that time working full-time as a nurse, end of life care and actually living my best life at the age of 56 until obviously this diagnosis derailed that a little bit. But I continued to live until 2018 when complications forced me to stop working after relocating out of state, so didn't have benefits. So that was a challenge to me trying to find financial assistance and such care like that.

Healthcare didn't derail and find issues until COVID hit. And I chose to get care closer to home instead of driving an hour and 45 minutes. And that's when I realized that there truly were barriers and it was due to the color of my skin. I had never experienced that myself even as a nurse. And I couldn't believe it, that would happened in the world in which we lived in at that time in 2020. So my goal is to do my part on trying to eliminate those barriers. And I don't want access to care. I want access to quality care. Quality of life is important to all of us. And I think that just because my skin happens to be a little bit darker than someone else's doesn't mean that my care should be subpar, period.

Tiffany Nicole:

Yeah. I was going to chime in on that. And I think I was just in a or put in a great position with a great team that saw that I really was struggling. I had just given birth to my daughter a year before, my last daughter. And the nurse basically told me, she was like, "If you want this little girl to know you, to actually know you, you got to fight every day." And I think if it wasn't for that leading and leadership, mentally I could have gave up, because I wasn't in the best situation personally.

I do have two other daughters. One was just starting high school. The other was in middle school. So it was just like being pulled as a mom, now having this put on you and in a relationship that wasn't supportive. So I'm grateful that I was put with the right team. And I think that's why I try my best to when I see it in other people that are struggling or don't know or kind of in this state, because you can tell when someone's giving up or they don't want to fight anymore and they'll look at me and be like, "Hold up. Are you here with someone?" And I'm like, "No. I've been fighting for 10 years." And they're like, "Well, you don't look like you have cancer." I said, "Well, neither do you because what does looking like cancer look like?" We all have to be there as a supportive voice and give whatever we can to each other in this community, no matter the skin color.

Asma Dilawari:

Yeah. I think those are great points. And when you're talking about accessing these new therapies, do you think that some of it was where you were in the country? I know Jo and Lesley, you both started your treatments in different countries in Europe and Stephanie and Tiffany, you live in different regions of the US. Do you think there's a little bit of a differential access to quality care based on region?

Lesley Stephen:

[inaudible 00:19:34].

Jo Taylor:

Well, if I can say, absolutely. I think when we were talking earlier about this, people don't realize in the UK, because there are four different devolved nations within that, that there are different accesses to care. And then Lesley has a different access because it's under the Scottish Medicines Consortium. And I have different access because it's under NICE, the National Institute of Cancer. Thought that that is different and some drugs get approved under NICE and not under the SMC and vice versa. And again, I don't think people around the world are actually aware of that because there seems to be a two tier situation. And also not just that, you've got private healthcare, as well as people accessing the National Health Service, which is a free access at going into getting any treatment. It's just different. And people can pay to get drugs. People can't pay to get drugs. And that's the system that we have.

Lesley Stephen:

Yeah. I mean, just to add to Jo's point, I've had personal experience on several different occasions about what we call the postcode lottery here, where a treatment hasn't been available in Scotland and I've had to go to England to get it or to pay privately for it. So even though we're a tiny country, these divisions exist.

Asma Dilawari:

Caroline, I know you want to jump in here because as a regulatory agency, you approve these drugs, but the process is different in Europe then. It sounds like there's variability with access. What do you want to say here?

Caroline Voltz:

Yeah. Thank you, Asma. And I think that's a very, very important point because we acknowledge that there are differences across European countries. So it's maybe worth mentioning that EMA with its network of European experts is primarily responsible for the evaluation of medicines. And maybe one key distinctions between EMA and FDA lies in our organization structure. So at EMA, we are responsible for the evaluation process, and this relies on scientific committees and a network of experts from European countries. So usually companies can seek scientific guidance regarding their product developments before comments in clinical trials. And for that, we play a key role in ensuring that the standards of good clinical practice are applied in cooperation with the European countries, but we are not responsible. And that's the key difference between the US FDA, is that we do not oversee the approval of clinical trials as this is a responsibility allocated to each European country. And what has just been described by patients is that also the decisions about price and reimbursement take place at the level of each European country and this is in the context of the national healthcare system of that country-

PART 1 OF 4 ENDS [00:23:04]

Caroline Voltz:

This is in the context of the national healthcare system of our country. So recently we have been actively exploring avenues to collaborate with the relevant Health Technology Assessment bodies. And mainly to ensure that we have streaming access to novel medicines because it doesn't make sense. But at TMA, we approve a product, but then it's not available to all European patients. So we have really tried to have this discussion with Health Technology Assessment bodies to ensure patient success. So yeah. Thank you.

Asma Dilawari:

That's a helpful for context. Lesley and Jo, you both mentioned something called a postcode lottery. I think if we were extrapolating in the US, we would call it a zip code lottery. Rick, do you think we have a zip code lottery in the US and are you getting all these new drug approvals everywhere?

Richard Pastor:

No. Obviously there's healthcare disparities that exist in the United States, that's obvious. However, it's not the same as what the Europeans face in the sense that usually... and I [inaudible 00:24:11] the word usually when we approve a drug, a cancer drug, it is approved by... it is then paid subsequently for that indication by the third party payers, whether they be government or private entity. So it is a bit different, but no, there are obviously healthcare disparities that even are beyond the payment of these drugs that do occur. But I really had a question for both the clinicians and the patients because here again, we generally get the applications first here in the FDA before many times they go to the EMA. And then our patients obviously get the drugs much sooner than in Europe because we don't have to go through another process. How is that perceived in Europe, basically?

Because if I was sitting in Europe, I'd be kind of mad about this, so to speak. I just wondered, that's kind of a statement of the obvious, but how do you deal with this frustration? And also for the investigators that are on the call, you don't have access necessarily to the drugs that are approved immediately to treat patients. So there must be some frustration when you know that there's a drug out there that's effective and may be actually a blockbuster drug or a breakthrough therapy drug and you can't give it to somebody that actually needs it. So could we hear from the patients from Europe and also the investigators? I'd be really interested in hearing that.

Lesley Stephen:

Yeah, I think Jo would agree with me. It's incredibly frustrating. I'm very jealous when I see all these new drugs getting approved in America that we can't access. And often, even if they are submitted to the two regulatory bodies in the UK, one might, as Jo said, one might get approved and the other one might not. And often it's just based on cost reasons. But yeah, very frustrating because there could be drugs there that would help all of us live a lot longer and a lot better, but we can't access them.

Jo Taylor:

I think that the biggest problem is data. We don't have the data. We don't have real world evidence of even older drugs of how they're working. We haven't got a system that is collecting that data at all. We're not counted. And it is the same in America, and it's the same all around the country. I think Metta, you mentioned this the other day, so yeah, it's massively frustrating. It's not just frustrating. It's hugely upsetting because patients are dying, not being able to get access to these drugs. And what is the point of creating a drug if patients cannot then access them? It's having something on a shelf and not being able to get hold of it.

Yes, it's down to cost mainly, especially within our systems. We don't have the systems like you have in America. I mean, I've heard as well that, "Oh, well, the FDA, they just willy-nilly will prescribe whatever and it's not particularly correct or approved correctly like we have to approved them." But there's a different layer then in approving the drugs in Europe or within the UK. So hugely frustrating. I am pretty angry and have been for a number of years about this. And why not be angry? We should be angry. We haven't got the outcomes, we haven't got the survival. I think in the UK we're with the 11th in the table of outcomes and survival. Well, we shouldn't be like that. We should be up at the top.

Asma Dilawari:

Yeah-

Richard Pastor:

Do any of the investigators from Europe want to comment on this because you face the patients.

Rosa Guiliani:

Well...

Asma Dilawari:

Metta, and Rosa?

Richard Pastor:

Patients are generally now more informed both in the United States and in Europe. So they know what's going on worldwide. And I would imagine, "Why can't I have this drug? It's approved in the United States and I fit into this category."

Rosa Guiliani:

Well, I think that I totally support and echo the discussion that we have so far. It's frustrating for patient and of course this is very easy understandable, but it's also, trust me, it's frustrating also from people on the other side of the desk because I know it's not true for every drug. So there are different type of, let's say, benefits that are associated with drugs. But it's true that when there is a drug that is really good, and of course drug development I think is global, should be global, but also access should be granted globally. And Rick was mentioning before the inequalities that are clearly present in US. There are also a lot of inequalities in U there are maybe different root causes because it depends on the system that delivers care. So national health system supported by taxpayers in U different system in US. But at the end of the day, basically the bottom line is that many patients worldwide are not getting access to drugs that in some cases may be really relevant. So this is a situation that is frustrating for everybody.

Richard Pastor:

It's interesting, I was recently in Croatia during the summer and one of the things... Talking about cancer care there in the Eastern European areas, and one of the things that was really brought out was the issue of really the poor healthcare outcomes when it comes to cancer in the former Eastern Bloc countries. And they're quite pronounced. So here again, we have in the United [inaudible 00:30:17] many reasons for healthcare disparities, not only racial and ethnic differences, but even geographic differences can play here.

Rosa Guiliani:

But if I may, I mean the situation is even more complex than that. So it's just not a matter of there are macroscopic inequalities if you want Eastern versus Western Europe. But there are inequalities even within a country as we heard as well. So sometimes within same cities because then there is a difference... I mean there is a different granular level, but inequalities are at many levels and this is really frustrating for everybody.

Asma Dilawari:

Metta, you're in Denmark. Do you see this drugs approved and then you're waiting in Denmark for the official okay?

Mette Linnert Jensen:

Yes, yes, unfortunately. I share some of the frustration you have. I'm sorry. Maybe there's something with the connection right now.

Richard Pastor:

We hear you.

Mette Linnert Jensen:

Okay. Okay. Yeah. So yes, as a regulator, I approve drugs based on benefits and risks and I don't even know the cost when we assess the drug. So it has also been a challenge for me the last seven years in the regulatory system to accept that even though we approve drugs very quickly sometimes because of the really added benefit to patient care, to see that it takes years for the HTA bodies in the separate countries to actually give patients access to the drugs later on. And also, as Jo mentioned, we had a pre-discussion yesterday about collecting data. We are very good at collecting data in Denmark, but it's mostly in the adjuvant setting in the early breast cancer setting and not for the metastatic setting. So that is also a challenge. We need more data from that setting. That's true. Thank you.

Asma Dilawari:

When we're talking about these new therapies and getting data, the backbone for oncology therapies is really clinical trials. We have most patients in this country do not get their care on a clinical trial. Ann, you work at a center that is very good at putting patients on clinical trials and opening trials, but that is not the case. And sometimes patients are driving hundreds of miles to see someone like you and getting access to a trial. Where do you see the problems from just your work?

Dr. Ann Partridge:

Yeah, I think in the US that's a critical issue both for drug development and for individual patient care. And I struggle with this regularly in my practice as I know all of my colleagues do, because we have the trials. There are a lot of exciting things coming down the pathway. And I actually think... And I'm not just saying this to get in your good graces, Rick and team, I think our FDA does a pretty good job getting things through when they should get through in the US-

Richard Pastor:

[inaudible 00:33:40] be back again?

Dr. Ann Partridge:

Yeah, yeah, yeah. We're coming back. But no, seriously, and with accelerated approval and then not everything should get through. And we want to be careful not to expose people to something that's eh and may not really improve important outcomes to patients. And so I think our biggest issue though is connecting patients both with trials and then once patients are candidates for us, for a drug that's been approved, there's the racial ethnic disparities that you heard about. But then there's this large kind of geographic and financial toxicity issue. Again, to get on trials, but also to even access care that is beyond bread and daughter care.

Because as you get further down the line in terms of living with advanced breast cancer, there are many things that a community oncologist can do perfectly well. But then there are some more nuanced thing where you might benefit from seeing a specialist, someone who that all they do is breast cancer and they know some of the tricks and have access to some of the oldies and goodies and thinks about it all day long. And I always have a hard time when someone can't get in to see one of us because we're here waiting and because they're from North Dakota or because they're from an hour away but can't get childcare. And then of course if we prescribe a drug, some of these new fancy drugs have huge copays that we're going to get less and less help with I understand in the near future to kind of cover some of that delta so that patients can afford to get the care that might benefit them that's been proven. It's really tricky.

Richard Pastor:

Tiffany and Stephanie, and Ann you could comment this from a US perspective. But drug companies have this patient assistance programs, et cetera, but a lot of patients don't qualify. So it's kind of, yes, it exists, but if you're caught in the middle so to speak, it doesn't help you. Okay. And I don't know, Stephanie, can you comment on it? Because you said you have experienced this.

Stephanie Walker:

It's hard because when we do have those drugs, and if you have worked all your life and paid into a system that you thought that would take care of you, oh guys, it doesn't. Just thought I'd let you know. So y'all keep working hard because you're going to need your dollars for retirement, I'm telling you, because the US government doesn't take care of you after that. But just being able to afford the medications, I don't understand how come they're so expensive. I know they're expensive to develop, but once you get them out there, you got somebody to make them.

I have fallen in that hole this year with two medications that I'm on I can no longer afford. So tomorrow I go to my doctor and say, "Look, is there something else? Is there another alternative because I can't afford it anymore." And one medication that I'm on now that my first line treatment will be no longer covered by the pharmaceutical company where I was getting assistance. As of December the 31st, they no longer will help me. So it's like, "Where do I go now? I've been on this medicine for seven and a half years, so what do I do?" It's almost like you are having your mortality in your face every day when you're begging and pleading for help and you're not getting it. And I don't know what the answer is. I wish I did know what we could do, but there's got to be something you-

Asma Dilawari:

Yeah, I think Stephanie-

Stephanie Walker:

Lower costs on insulin for the elderly with the cap. Why can't we do some of that for some of these medications that are for oncology care?

Richard Pastor:

And here again, as you know, that requires Congress to step in and legislation and [inaudible 00:37:32]-

Asma Dilawari:

Well, and Stephanie I don't think it's even just the drugs, isn't it... Patients are going in for scans, there's copays, there's time off work. I think this is sometimes rate limiting factor for participation in trials too.

Stephanie Walker:

Oh, definitely. You have your logistics that you have those financial barriers. You think as a single mom that you have to go to work to have insurance and to put food on the table now. And if you want me to be in this clinical trial, you're telling me that I'd have to go every so often. That means missed day work. So that means no pay. Who's going to pick up my kids from school? Who's going to provide the meal for me that I can't cook if I'm going to be there all day? Are you going to feed me? Are you going to pay for my parking? Parking is expensive at these NCI designated centers. Unfortunately, as a patient, I still have to pay for my parking. That can be upwards to 15 to $20 a day. And you're expecting me to do that every week for at least six weeks to get me enrolled into a trial. It seems like it's those little things, but those little things impact a lot of people in horrible ways.

Tiffany Nicole:

They all add up.

Stephanie Walker:

And if I live in a rural community, how am I going to get there?

Asma Dilawari:

Right. Right. And I think we see clinical trials come through with three to five black women in a breast cancer study. And I think there's a lot of people... "What's the problem here?" And then drug companies are saying, "We're paying for transportation or we'll pay for parking." But I don't think it's getting to patients.

Stephanie Walker:

It's not.

Asma Dilawari:

And I know Tiffany, you've participated in a trial and you had your own experience too.

Tiffany Nicole:

Yeah, and it's kind of almost like that crab in a barrel kind of scenario. It's like, you know you need to get there to get this new drug approved that'll work with you or give your feedback on how it's working for you. But when you say, "Okay..." Like me, I've been stage four since I was diagnosed. So immediately after my first round of treatment, I was like, "Whoa, okay, total life changer." That means being with these three young girls, they're looking like, "Okay, what's going to happen? How does this happen now?" Every kid wants to do the sports, they want to do this.

And it's like from... I think my team that I've been blessed with, they've always kind of helped me find ways or navigate. But as I'm hearing other people's stories, everyone doesn't have that. I call my nurse navigator "my guardian angel" because she has just showed up in my life so many times, even unexpectedly, I would just be sitting in treatment. I always fall asleep and wake up and even if it's just a little note or a cupcake or something, just to show that you're not in this alone. Because a lot of times when you're just sitting there and that day someone couldn't come with you, your mind is wondering wherever. And it's so hard to just be dealing with what we're dealing with on the cancer side, on the diagnosis side, or to also travel into our finances, our personal life, our kids' lives. It's like it definitely affects the whole community or your whole family.

Lesley Stephen:

Can I add in a little bit about my personal experience. I was on a clinical trial for seven years, which was a real game changer for me. But during that time, I was astonished to find out how few patients, other patients had even had a conversation with their clinician about a clinical trial. So I think the issue starts way back and nobody... And I was involved in a survey, a UK-wide survey where we got a very, very good response. And that that data confirmed the kind of anecdotal stories that I'd heard that many patients thought that going on a clinical trial with advanced cancer, that you get a placebo, which we know is not true. You'll always have minimum standard of care. Many people thought it was a last resort, which again is you don't leave it till the end of the line. People thought they'd be using a guinea pig that it was really experimental.

So a lot of misunderstanding about patients and the data suggested that I think only 23% of the patients that responded... We got well over 800 responses, had had a conversation with their clinician about a clinical trial. And of that 23%, only 14% had taken part in a trial. But the majority had had a very positive experience. But there were so many other barriers that came out of that survey cost. We've already talked about eligibility criteria being excluded. They expect you to be a kind of-

Richard Pastor:

[inaudible 00:42:48].

Lesley Stephen:

I think Jo and I have both talked about cancer Olympians, and I think it's, there's just so many different aspects that patients aren't aware of. And I think we really need to start educating and raising awareness of the potential benefits of a clinical trial, which could give you another treatment line as it did for me, but perhaps just as important, give you hope as a patient that there's something else out there.

Stephanie Walker:

Honestly, we did that here in the US too with the Metastatic Breast Cancer Alliance, did the Become Project. And with that project, seeing about black men and women with their experience of clinical trials also noted that eight out of 10 black women would have a consent to participating in a clinical trial, but they lacked the conversation with the healthcare provider. I, as an RN to this day, have never had a conversation with the healthcare provider regarding a clinical trial. So even if I haven't, I know they have... It starts in the community. I believe especially since 80% of us here in the US get cancer care at a community cancer center. Those oncologists can't be versed in every clinical trial for every patient, for every subtype, even in breast cancer.

So I think we need to figure out a way to have the conversation with our healthcare team to don't have... And this came out of black women speak last year, do not have those biases when you walk into the room initially to talk to me about a clinical trial, don't look at me and think, "Okay, she's a black woman, she's not going to understand it. She probably doesn't even know what a clinical trial is. She probably will be non-compliant and not completed. And then if we piss her off, she'll become that angry black woman." So you have those explicit organizational biases before you even talk to me about a clinical trial. So introduce yourself, talk to me about a clinical trial and let it go.

Tiffany Nicole:

I also feel that it's like a lot for a lot of black women that I've talked to, I call it the social media doctors. People scare them that... And these people have never had cancer, never had a chemo treatment or anything. "Girl, don't let them put that in your body. You need to do it like this and you need to do it..." No, I always say... Like I said, I keep talking about my team because I think that God just put me in that situation with these people, and I've been truly blessed. And I'm over here kind of feeling a little selfish because I'm hearing other people's journeys and it's like, it's so easy for me to have a conversation with my doctors. It's so easy for me to have this access. And I hate for Jo, and I forgot the other lady name, but you guys don't have that... Lesley, it's like, it's just heartbreaking because I'm like, "I don't think I could be sitting here 10 years later if it wasn't for my team."

Jo Taylor:

I think it's really, really important to look...

PART 2 OF 4 ENDS [00:46:04]

Jo Taylor:

I think it's really, really important to look, actually, back at why this is happening. And yeah, I mean, I totally agree with what Lesley's saying. Clinical trials are basically seen as a last resort, but then when you get to the last resort, you have so many problems that you're not even accepted on a trial. You may have pre-treatments that restrict you from actually accessing the result, or you have brain metastases, and that's then another added problem.

But it's actually going back to looking at where are these trials coming from, and how effective is this information that is provided? Because we know with MET UP UK and the work that we're doing with looking at the trials, and we have a database now that pulls together the information around the country that is provided by huge, big organizations like Cancer Research UK, the NCRI, the government. Whoever is providing this information, they're not effective and they're not giving the right information.

They don't list all the trials effectively. That is a big problem when you've got big organizations. It's also then empowering people to be able to access that, and if they can't access that and they don't know how to do that, if the clinical person isn't providing information, then they're stuck, then, being able to access trials.

Asma Dilawari:

I think you're right. I think-

Jo Taylor:

My oncologist doesn't talk about-

Richard Pastor:

Why don't we go to the physicians and hear from them. [inaudible 00:47:46].

Asma Dilawari:

... what Ann says about this because I know that we've all been trying to have trials in the community and have them everywhere. Ann, what do you think about that?

Dr. Ann Partridge:

Well, I couldn't agree more with what everybody's saying, and it's frustrating. I think that there's a push and a pull here. I think in groups are trying to get trials out to the community, and our community colleagues are putting people on trials through the NCORP and through many different groups.

That being said, it makes me so sad to hear that people are not having conversations about trials. And so, one of the good things that can come out of this great conversation is to empower women themselves. When you come in with a new diagnosis or you're somewhere further along in the journey of metastatic breast cancer, a disease that as of 2023, for most women, we don't have a cure yet, then you want to say, okay, what are the most important questions you have? Am I going to see my children grow up? How long am I going to live?

"What do you got for me?" should be one of those questions. And inside that should be, "And what about clinical trials?" As we've just discussed and you just heard, it's not just about the end of the line. It should absolutely not be that. There are many first-line trials going on, and of course, second line and things like that.

And so I think that should be part of the opening conversation. And if the doctors aren't doing it, then women should feel empowered to ask those questions. And if they don't feel like they're heard from their oncologist, get a second opinion. Go to a nearby city, go to a major cancer center, and your insurance should cover that.

Stephanie Walker:

Where do they get that information, though, to ask? If you have somebody that's newly diagnosed, that don't know what they don't know, where do they go to get that?

Asma Dilawari:

Can they trust their doctors? Can they trust their doctors?

Stephanie Walker:

I know. I know. But where would you send them to get that information to be empowered?

Dr. Ann Partridge:

Yeah, so I think conversations like this. I'm going to tweet this out later today when you guys send me the recording. I'm kind of joking because nobody's on my Twitter or whatever it's called now. But the point is, I think we all need to push it out from you guys talk to the patients, right? They're coming to MBC, they're coming to patient organizations. I agree, sometimes they're not coming early on, but the more we can do to push it in both directions and get patients and the public to demand it, the more likely that doctors...

And of course, where I sit, I train people every day. I sit with our fellows, and if you come into my clinic and the 30 breast oncologists I work with, it's part of our repertoire. When we think about what we're going to treat someone with and offer them as an option, we go through the algorithm with them, and we say, "Standard or trial?"

And in my spiel, the first day I see a patient, and I know it's true for the people that mentored me and for my colleagues is, we're going to incorporate research if that makes sense for you along your journey. So I think it can go in both directions. But I hear you. We need to push in both directions. The doctors need to be pushed to do it, and patients need to be empowered to ask for it.

Asma Dilawari:

But I think a lot of doctors aren't pushing to do it because they don't have the trials, too. I mean, I wonder in Europe, like Rosa and Mettie, are your trials in the big cities and the big centers? Or are you really trying to get them out into the communities, the rural areas? Because I think that's, a lot of times, what's lacking.

Richard Pastor:

Centralization of trials, basically.

Rosa Guiliani:

Basically, I was thinking, I mean, having a balance of the day, so I am very frustrated at the moment and now also very sad because I'm hearing that one of the reason, and a very important reason, why patients do not have access to a clinical trial is that us as a care professional do not focus on that discussion. I mean, this point really makes me sad because in my mind, the problem was... I mean, I found other explanations for that.

To begin with, in Europe, we have, I think, the same low rate of recruitment overall that in other countries, in other parts of the world. This is something that, again, is a global issue, is a global problem. And I think it's important to reflect what we are discussing on this side of the ocean. On the other side of the ocean, we are basically experiencing the same problem, so this should be something that for us to look for a common solution.

Now, for instance, there was a trial that was about access to clinical trials, a survey that was done and presented a couple of years ago at ESMO that actually showed a low rate of participation all over Europe. And on average, clinical trials are more likely to happen in richer countries and in urban areas. It means that we are not decentralizing enough, and so offering the option of clinical trials to patients.

In my mind, the problem of access to clinical trial, but I may be wrong, listening to you today, is a problem that is more related to, for instance, to the bureaucracy around clinical trial that is making the job more difficult for everybody, physician, patients, everybody. The fact that some countries are in the position to offer a more favorable environment because they are richer countries. And again, we go back to the discussion about inequalities. Then there is also the problem of the workforce, that it may be not well balanced in different areas, in different regions.

So I think that bureaucracy, workforce, and try to understand which are the favorable situation that can actually bring trials to patients. This is the problem, that now we've reason in the way of bringing patient to trials, so centralizing, but actually, we need to shift in my mind our position. But this requires workforce, for instance, because colleagues in the community, hospital, in the community, I mean, may be more in trouble compared to colleagues working in a big research center. This is something that we need to reflect on.

Caroline Voltz:

And I would like to add to what Rosa has mentioned. I fully agree with the comments made. At EMA, we have launched now a new initiative on ACT EU, and this is exactly to address all the issues which have been described, and promoting clinical trials, and also facilitating the process of clinical trials with the new regulation in Europe.

So yes, I fully agree with what has been said and hopefully, all the initiatives in this regard should help.

Richard Pastor:

Some of the things that we have done, obviously, there's been a lot of discussions about healthcare inequity, but discussions are discussions, and it's talk, but what are really the actions? And one of the things that we would like to see is, for example, pharmaceutical firms paying for incidental expenses such as parking, such as hotels, such as childcare, et cetera.

Those are not inducements to go on clinical trials, in a sense of making people lose the objectivity of whether they want to go on a clinical trial, but they're just a practicality of trying to meet patients halfway to get them access to clinical trials. This has been done at the National Cancer Institute for many years, so we really are advocating that pharmaceutical companies also look at this.

In addition to this, the eligibility criteria. We've worked very hard, and I know the EMA has also worked with us on this as far as broadening eligibility criteria because at the end of the day, we want clinical trials that will reflect patients that are actually getting the drug, not as was mentioned, some patient that is an Olympic athlete, so to speak. We want to see patients that represent patients both from physical parameters, racial-ethnic parameters, that are actually receiving the drug, so to speak. We have heard this, but there's a lot of, here again, work to be done.

I guess one of the questions that I have, we have had over the past two years, as our US colleagues know very well, a lot of discussions and spotlights on healthcare inequities here in the United States, extensive discussions. And here again, discussions are discussions, I'm more interested in actions, but have those same discussions occurred in the EMA, in the European patient communities? I'd be interested to hear that.

Caroline Voltz:

Yes, definitely. Yeah, definitely. I think that's really a problem because we have seen that some medicines, although they're approved at a European level, they are not necessarily given to all European patients. We have seen that, and that's sometimes linked to the decision, as I mentioned before, on price and reimbursement. That's why we really would like now to work collaboratively with health technology assessment bodies to have this joint assessment and also very early on, so we have also now developed parallel scientific advice so that the clinical development plan from the very beginning will not only meet the needs of our regulators, but also the decision-making bodies for pricing and reimbursement, and therefore, will likely reach patients.

I don't know what, Rosa, you think about this.

Rosa Guiliani:

Yeah, yeah, absolutely. I mean, the discussion is very much lively in Europe, and now we have been having this discussion for a few years with the data that clearly stated there is a clear problem in terms of access to trials, in terms of access to genomic testing, for instance, in terms to access to drugs.

This is something else that I think we need to reason a change a little bit because it's never, or is not anymore, the single drug, the single intervention. There is some more, again, global or broader view that we need to have because it's the whole trajectory. And so we need to think also in this term.

And I'm very much hopeful that the initiatives that Caroline mentioned in terms of collaboration and preparing the discussion with the technology agency, and it is something that EMA is really working on at the moment, and for a while now. It will possibly help in having a sort of harmonization at the European level. However, we will be left in a way with, let's say, with the price discussion that will not completely be solved, but all these initiatives.

But nevertheless, I mean, this is very important that having this dialogue will help in speeding up, in smoothing the-

Richard Pastor:

Caroline, this initiative in the EU is for oncology drugs and neurodegenerative drugs, right?

Caroline Voltz:

Yeah, so in fact, it will start already as soon as 2025 for oncology. So again, oncology will be the first products for which we will have joint assessment with health technology assessment bodies, and this is really piloted with oncology, yes.

Asma Dilawari:

Part of our discussion, I know we've focused a lot on newer therapies, clinical trials. One thing we all look at is what toxicities and side effects come from these treatments. I am just curious from all of you, there's things that we measure on a trial and then there's some hidden toxicities. If you all could point to something that's really stuck with you as a result of your therapies, I'd really be interested in hearing this because I'm sure it informs your decision whether to go on the next therapy, and the next therapy, and you're in a unique situation where you might be on multiple therapies. I don't know who, Tiffany, if you want to start.

Jo Taylor:

I think there's a problem there because we don't have enough therapies to think that there's lots available in the future, and that's the problem that we have in the UK. There are certain treatment lines that are approved via the approval system, and you go onto the next treatment line. If you fail on that one, you're on the next one or the next one, and there's not enough personalized care within that.

Genomics. Rosa just mentioned that we're not genomically testing patients every single time that they progress. And I think that's a problem. We see it within our community. One patient in particular, she'd been through five lines of treatment within a year and a half and then died. There's something wrong going on, though, when she's not tested and these drugs are not effective. And if they were tested properly, then I think there may be clinical trials that they could go on, for example, that might target a specific mutation.

There's another patient as well who had a specific mutation, but because she'd had two prior lines of therapy, she was told no, she couldn't go on it even though she had that mutation, and then died three months later. Patients are dying because of the criteria and the restrictions within these trials. It's heartbreaking, and patients don't want that to happen, obviously, but something has got to change.

I mean, the ONS figures in 2020 is that, and the ONS is the Office of National Statistics, is that breast cancer, secondary metastatic breast cancer, is the biggest killer of women from age 35 to 64 in the UK. Now, that is a huge number of patients in that age range, and it's patients with children, it's patients who have professions, it's patients who have careers, not even getting to the age of getting their pension.

Asma Dilawari:

I think you're bringing up a great point, also, that a lot of women are in a very active part of their lives. They're active professionally and personally, and then they get this diagnosis. I think that is a big part of taking care of them. Ann, you've done a lot of work with survivorship care. How should we be taking care of patients who get this diagnosis, especially those getting it at a young age?

Dr. Ann Partridge:

Yeah, I think first and foremost, you want to be plugged in with a care team, and it's not just the doctor. We all know it's the whole team to support our patients. And then there are a lot of resources out there, and we have a problem with disconnects between patients and resources. There are a lot of things that your groups offer, webinars like this or through different advocacy groups that are available to inform and support patients.

At Dana-Farber, we have a navigation program that's about getting people into trials, but it's also about supporting the doctors to support the patients better for getting ports or getting a biopsy or getting their genomics, whether it's for a trial or not. But there are also patient-facing resources, webinars and support groups and things like that. And I know that a lot of the advocacy groups, Susan G Komen, CancerCare, Living Beyond Breast Cancer, I don't know all the European ones and elsewhere in the world, but I know you guys do a ton of work around that.

And I think just trying to help to connect the dots and partnering with our social workers, in particular. I think every patient who has metastatic breast cancer should be offered a mental health provider for support for them or their family because we know it's hard. We try to do that at our center. Not everybody has the resources, and so figuring out where in your community you can help patients to tap into is just critical.

Richard Pastor:

One of the questions I have, because people have asked about availability of drugs that are not approved, is we have a program here called, euphemistically, compassionate access or single-patient INDs. We've spent a lot of time in the OCE, the Oncology Center of Excellence, on a project facilitate to help patients and their doctors access unapproved drugs. And I'm wondering, in the EU, is this handled by the individual countries? I think it's called named access or something rather than compassionate care. And here again, that probably represents a lot of problems if you're dealing with individual countries along the way. I don't know if Caroline or some of the patients want to comment on that.

Caroline Voltz:

Yeah, maybe I can start. You're right, it's named-patient basis program or it's called differently depending on the country. Yeah, that's actually nationally based. The decision would be up to each country to decide whether they want to treat patients. I don't know if, Rosa, from your side, your experience, maybe you would like to comment as well.

Rosa Guiliani:

I mean, I think that there is no doubt that being a European Union that is not so united after all poses some issues. There is no discussion about that, and this is the reason why when there is a discussion at supernational level that hopefully we will have a positive input as a sort of cascade at the national level. I think it's one of the ways we can bypass all this fragmentation that actually we are seeing in different countries.

Jo Taylor:

I think from what I've heard is that it's really hard to get compassionate access for certain drugs. I think oncologists find it really frustrating with the actual format of applying.

Richard Pastor:

Yeah, that's why we actually launched this project to have pharmacists sit down with the patient and with the physician to walk through the process. If you don't do it on a daily basis, it's a daunting task to try to get one of these drugs. You have to get IRBs online, you have to get the drug companies online, the FDA, et cetera. We generally are very supportive of this program, but it is a cumbersome program, but it's out there.

Jo Taylor:

I think you know how to do that, but I don't think in the UK they know how to do that. I think they find it really difficult.

Lesley Stephen:

Can I just add, I think an issue in the UK is that the healthcare professionals are so overwhelmed with work as well. It's maybe the same in the US and other countries in Europe. There's a real shortage of staff, so they no longer have the time to spend on these sorts of issues.

Stephanie Walker:

See, and that's where I think here in the US, like Dr. Partridge said that, or Ann, I'm sorry, that you have a team. I do. I'm fortunate that I do go to an NCI-designated center, and I have a great team that consists of a mental health provider, which is very important. But in the initial stages of my diagnosis, I wasn't even offered a navigator, so I had to navigate by myself. I went to a community cancer center in another state.

Navigating the system and trying to figure out what you need and what you don't need or what's available, what you're allowed to have or not allowed to have. I have been listening today and I really, I'm thankful sometimes that I'm in the United States of America with the shitty system we have sometimes. But I'm curious, and I've always wanted to ask this question. I'm going to ask it right here. In the UK with clinical trials, you know how I've been fussing today about not having a-

PART 3 OF 4 ENDS [01:09:04]

Stephanie Walker:

I've been fussing today about not having a large participation numbers for black men and women or women of color in clinical trials. In the UK, all I see are white people. And I'm sorry, what about your clinical trials? Do you have a diverse clinical trials for your drugs or is it like what we have over here?

Rosa Guiliani:

I'd love to know.

Lesley Stephen:

I think diversity, inclusivity, all that is a really big issue in the UK and I'm not sure we're making very much progress with it. So I mean, just an example of this survey I mentioned earlier, of the 800 patients that responded, I think only three were women of color. In the charity that I work with, we've started up a service to match patients to clinical trials. The patient has to contact us first. I'm not sure how many, we've worked with over 400 patients now. I suspect we keep numbers. I should have checked maybe before this call. Suspect very, very, very few, in fact, the majority will all be white patients. So there's a big issue. But diversity I think for me also is about location. So when we talked a little bit about the US and-

Stephanie Walker:

Zip codes are very important.

Lesley Stephen:

... Areas, but in Scotland we've got the Highlands and islands, you're hundreds of miles from a hospital. It won't be a research hospital. So there's lots of other issues about including patients as well.

Stephanie Walker:

I mean, I truly agree. I was just really curious because you were talking about location. That too is our case here, especially in the Midwest, in the Dakotas, how far away they are from cancer centers. Even here in where I live, it's called east of I95. If you're familiar with the territory, Eastern North Carolina gets dropped off once you pass Raleigh Durham, there's nothing. But I was just curious. Thank you, France-

Speaker 1:

I think it's a huge problem. Diversity, for sure.

Rosa Guiliani:

Can I say something? So I'm European at heart. This is my disclosure, but the more we talk and the more we discuss, I have the impression that we are experiencing very similar problems. It really does not matter where we are. So I think that we should have this more global view. In a way, I mean maybe for, there may be some nuances in the causes for this problem, depending on the system, depending on many factors. But the core problems, so access, diversity and so on, unfortunately something that is experienced, let's say worthwhile. Now we are talking of these two macro areas. I have the impression that we are talking of the same issues here. So maybe it is a good point to have this discussion to understand how to address the problem. Because indeed much in favor of the navigator process and everything that is happening in the perfect way at the national cancer centers, in the big centers.

But my problem as oncologist is that I want this to happen also in, I do not know, remote highland or not even so remote because the problem is maybe just under kilometers from the urban area. So I think this is a discussion that we want to have.

Asma Dilawari:

What are the issues-

Stephanie Walker:

This discussion that we're having though we've been having this discussion since forever, and more so since the pandemic, we've been having the discussion. Now I want actions, just for shift and giggles I would like to have something done, but it seems like that we are beating a horse, a dead horse, having the discussion. We know they exist, they know they exist. So people that are creating the clinical trials, they need to get off their hines and realize what needs to be done and they shouldn't have their head in the sand about what needs to be done. They've heard it. I know for a fact they've heard it from me. So we need to start doing something. I'm thankful that 31% of us lived five years, only 31% of people diagnosed with metastatic breast cancer lived for five years. All four of us in this group have lived past that. So in the United States we're called unicorns for some reason, I don't know. There's nothing magical about it.

But anyway, we are here and if we are going to continue to live, quality of life is important to all of us. I've not had extensive conversations with anybody, but quality of life. That means quality of life, the drug's got to work, they've got to have less toxicities and give us a quality of life.

Asma Dilawari:

Well, Stephanie, you basically summed up our messages. I know the FDA, the EMA, we are all emphasizing this too, but you're right, it's not enough and you've all given us a lot to go back to think about how we can get more action.

Laleh Amiri-Kordestani:

As my view, I want to actually say that this is great hearing perspective and we keep learning from you all. I mean Rick is here, so I don't want to basically talk a lot about the projects that OCE is doing, but actually since launch of OCE, which was about five, six years ago, we have now numerous projects and initiatives that started essentially one of the most important one from I think is patient voice, which we like to hear your thoughts and perspectives and then take it into consideration. See what we can do from FDA review division perspective. One of the things that I heard, for example, this access to the trials, there are several actually projects and initiatives like project equity, diversity that OSMA can maybe talk about it. And as well as project pragmatical, which essentially the goal is to make trials easier, less burdensome for physicians and patients and bring them to their community so they can easily get on trial and actually streamline and just not to ask patients to, for example, go every week to a center. Just really focus on collecting the essential things that are necessary.

Richard Pastor:

I think our clinical trials have just gotten way too complicated.

Laleh Amiri-Kordestani:

Exactly.

Richard Pastor:

I hear them and I can't understand them. I have to sit down and like, okay, what's happening here? It's like I can't get my head around this, so to speak. And if I can't do it or I have to sit down and think about it, I can't imagine how a patient could. How a patient can't actually read a 20 page informed consent that has all this garbage in it that means nothing to anybody, so to speak. And then at the end it says, you could die from this treatment. Why would you go on?

Stephanie Walker:

Right.

Richard Pastor:

We're trying to make things as simple as possible, and we have some projects that are going with the NCI and they're going out into the communities too, these easier trials because they don't require a lot of data to be collected. Sometimes we got to step back and ask, what is one question that we want to answer about a disease and a clinical trial rather than what are 10 questions? And all 10 are never going to get answered because the protocol is so complicated. So what we do is really focused on one question.

Asma Dilawari:

I think as we draw to a close, I would love to hear all of you tell us one thing you wish would happen or for all the women out and men out there who are getting these diagnoses, if you have something to say or a word of advice, please share. I'll start with Tiffany just because she's up on my screen.

Rea Blakey:

And can I just interject? Because we are short on time, if everybody can keep it to a minute so we can hear from all on the panel, that'd be great. Thank you.

Tiffany Nicole:

Okay. So I would love for it just every person diagnosed with cancer to be able to receive the best quality of care, the best team, just everything. It's already hard going into hear that diagnoses and just trying to reinvent yourself of how to deal with it and tell your family how to deal with it. So if the Lord said be could just to grant access to actual people that's on this panel that are trying to help, I think that would be the most greatest gift that this world can get because it affects everybody, every race, every age, everything.

Asma Dilawari:

Joe, why don't we go to you?

Jo Taylor:

I learned so much in the past from BCSM, breast cancer, social media. Social media has been a game changer for me. But not everybody can access that kind of information and have this patient voice, this advocacy that we are having here. But it's something that you actually said Asma as well. I mean, I want for everyone to have access to clinical trials within the UK. That should be standard, but actually it's even going back further. And Asma, you mentioned that 30% of early stage patients will develop metastatic breast cancer and actually patients knowing that should be on the list of things that people should know when they've had primary breast cancer. So that's my message as well, as well as getting access to these drugs. We need that-

Asma Dilawari:

Yeah. Get information and get good information. Stephanie.

Stephanie Walker:

I just wish that everybody all over the world had access to quality healthcare when they need it, not when their number comes up. Also to the creators of the clinical trials, to have patient involvement early on in these trials to hear what we have to say and not use us as a checkbox on your projects. And to the pharmaceutical companies, please price your medications in which I can afford them and take a look at me buying a pair of shoes versus my medicine. I would love to have my medicine as opposed to a pair of shoes. So if you could price them accordingly, that would be wonderful. And to all of you guys, I really appreciate you giving us the opportunity to verbalize our frustrations. And I know that it's not aimed at any one person here.

It's just I think this year's the first year after all this time I've become angry at the disease that I have and the lack of care that I see other people getting because I'm blessed that I have a great team and that mental health, as Anne said, and clinical trials should be the part of the standard of care plan for every patient diagnosed with cancer, period. All over the US and the world.

Asma Dilawari:

Matta, do you have anything to add? I know you're on both sides of things. The regulator, the patient and researcher.

Mette Linnert Jensen:

Yes. Yes. I'd really like to bring some hope really to the European patient population because we do already now give advice to the companies developing drugs that they should really include patients that mimic the real world and they should not complicate things as Rick says. They should really focus on answering important clinical questions. And also we are more and more taking into account what the HTAs want. I mean, of course we have to assess the drugs benefit risks and so on. But we also are increasingly aware that when the HTAs, they want randomized clinical trials. So we also have that knowledge in the back of our head with which kind of quality of data do we want, both from the regulatory point of view, but also from reimbursement point of view?

Not to risk getting in this limbo where we approve drugs, but they are never getting to the patients because the quality of the data is apparently not good enough for the HTAs. And as Carolyn said, there's these projects underway starting in 25, but just to let you know that we are already now advising the drug companies to do a better job. Thanks.

Asma Dilawari:

Thank you. Lesley, would you have any closing thoughts to share?

Lesley Stephen:

I'll keep it very brief, and I agree with everything that's been said so far in terms of what people want. I think all metastatic breast cancer patients they want to live better, less toxicity and to live longer. And I think sometimes we feel like we're almost the forgotten, invisible patients with breast cancer. So I'd love to see as much time and money spent on metastatic breast cancer research and education and awareness as is spent on primary breast cancer.

Asma Dilawari:

Anne and then Rosa, please share your thoughts on what you think should happen now.

Rosa Guiliani:

If I can ask what I want, I would like to have a flexible system that is really looking at the best way to generate evidence, which does not stop at the clinical trial conclusion. It goes beyond that. I want a system that is based on common sense, and ultimately what I think everybody wants is for patient to have access to quality care, which includes basically access to clinical trials, access to cancer medicines, access to diagnostics, access to genomics. So it's not only one intervention, but it's more than that. And they should be inclusive for everybody no matter where they lives, no matter who they are. I think basically we want the same thing.

Asma Dilawari:

And Anne, do you agree too?

Dr. Ann Partridge:

I just want to share that I too, like everyone on this call, I'm angry at breast cancer and metastatic breast cancer in particular. And I think we can all stay focused on that and keep pushing in the directions that we can push. And I appreciate all the sentiments that have been shared, particularly from people living with the disease, because most of us can't know it until we're in your shoes or if ever. And so I appreciate people sharing their experiences and I so appreciate the frustration personally and the frank anger and it's well deserved. And so I think we all need to continue to push and step on the gas and not let up for you and for others like you now and in the future.

Asma Dilawari:

Caroline and Lale and Rick, please let us know your last thoughts, action plans.

Caroline Voltz:

Yeah, no, I think it has been a very, very interesting meeting. And I think hosting webinars like this not only provide a deep understanding of what patients go through from the time of diagnosis to treatment. And this insights or relevance when aiming to highlight and bring patients' perspectives into regulatory decisions for EMA, it's very important to be part of this collaborative initiative with our colleagues at EFDA today. So we eagerly anticipate future discussion on concern. And for EMA, I would like really to extend our heart and gratitude to today's panelist, especially the patients for their invaluable contribution to the discussion. Thank you.

Asma Dilawari:

Rick, do you want to...

Richard Pastor:

Why is doesn't Lale go next?

Laleh Amiri-Kordestani:

Sure. I want to echo everything that was just said. I really appreciate actually Ria's group to help us to actually start this collaboration with EMA. And it was a big effort having patients from Europe and United States and clinicians from both sides of the ocean. So it was really great hearing all of their perspectives and we're hoping that we can actually take you all of what we learned today and make some future changes as well. Thanks everyone.

Richard Pastor:

I guess I am next. One of my biggest, and here again, I totally agree with all of the comments that are made. And I think it's important that people understand that from a drug regulatory point of view, our staff has faced cancer in their families and personally. And so we are well aware of on a personal level, many of the same problems that have been discussed today. So I just want to emphasize this because many times people paint the FDA and the EMA and these bureaucratic terms, but we're agencies that are comprised of people that face the same problems that everybody faces, so to speak. And I think it's important for us to realize this and the general community to realize this. And when we approve a drug or don't approve a drug, we really have the best interest of patients. And when I talk about patients, I'm talking about patients that are immediate needs, but also the long-term interest of patients, generations of patients to come, so to speak, that need appropriate information on how a drug works or doesn't work. So I'm happy that we've had these conversations.

We're also very interested in a global perspective toward health. And that's why we've initiated here at the OCE numerous projects in dealing with many of the drug regulatory authorities throughout the world on trying to get greater harmonization of drug approvals and thinking about how we develop drugs. And I think we've been quite successful. But with every success, there's also additional challenges that have to be made. And here again, this discussion that we had started out earlier this year when we took a personal trip to the EMA and met our colleagues and had discussions on greater collaborations. And this is only one of these collaborations, and this will be only one, hopefully, of many future conversations on cancer that we will do with the EMA because they do represent the other major regulatory agency in the world. And we are cognizant of that and working with them to achieve the greater harmonization of regulatory aspects.

But really, all of our problems are global, as was pointed out. And equity here in the United States can only be achieved if we recognize that this is a global problem and really work together to get appropriate information and also look at different ways of getting information by encouraging companies to seek sites outside of the conventional sites, both in urban United States, rural United States, places such as Central America, places such as Sub-Sahara Africa to give us additional information. So we have to think of the problems as globally, but again, I'd like to thank the EMA and their staff and also our staff here at the FDA, our technical staff as well as administrative staff, and all of you that have participated in this conversations on cancer. It's been just a really fast going one and a half hours. And I think everybody would agree to that. And I think we all came out better here listening to each other.

Asma Dilawari:

Yeah, I just want to say a special thanks to Maria for organizing and for all of you for joining. We heard a lot about access to care and barriers, and I hope that hearing from everybody's struggles and successes will change things and help inform all of our work in oncology. And to everybody listening who is living with breast cancer, thank you for joining us and I hope that listening to these conversations will help get to some solutions in the future. Maria, I'll let you close out.

Rea Blakey:

I just want to thank everyone. I will not belabor the point, but you know how great this is. I think our action plan for everybody on the panel and listening in attendance and who will watch the recording later is to take action. We cannot be still. Enough talking, let's get to the action. So we all have our marching orders. We will meet again soon in some way, shape, or form. I'm certain of it because we have a global mission. I just want to thank you all. Have a fabulous day. Really appreciate all of this discussion and what we will do in the future. Take good care of yourselves. Bye-Bye.

PART 4 OF 4 ENDS [01:31:44]

 
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