Podcast: Importance of Diversity in Clinical Trials and Genetic Testing

Shawna Watley: Welcome everyone to the Holland & Knight Public Policy and Regulatory Group podcast, Eyes on Washington. In partnership with the Rare Disease Diversity Coalition (RDDC), this is the first podcast in a three-part series. Today's discussion will discuss the importance of clinical trials and genetic testing in the context of research and development, and for patients receiving care. Joining us today is my guest co-host, Deanna Darlington with the Rare Disease Diversity Coalition; and guest Dr. Jonca Bull, Strategic Regulatory Consultant, former Assistant Commissioner/Director, Office of Minority Health at the Food and Drug Administration; and Dr. Heather Hain, Genetic Counselor at Children's National Rare Disease Institute. I would like to get right into the first question. Deanna, please share with us about the origins of our and the work you all do there on behalf of rare disease patients.

Deanna Darlington: Sure. Thank you so much for partnering with RDDC and this podcast today, Shawna. We really appreciate your engagement and your reach to Rare Disease Diversity Coalition. Our roots is that we really started under the Black Women's Health Imperative umbrella. We're very fortunate that our leader, Linda Goler Blount, at Black Women's Health Imperative was approached by a number of diverse stakeholders to have a dialogue and to engage on issues that impact rare disease patients, but those rare disease patients that live in diverse communities. And our whole mission is to identify evidence-based solutions that will provide, that eliminate and reduce the barriers that our diverse rare patient communities experience on a day to day. Also, we feel that, we believe that our greatest strength is the diversity of our coalition. Well, as I mentioned, we're a multi-stakeholder coalition in which we engage patient advocacy organizations. We work with professional societies, researchers, governmental agencies, as well as industries. So, we're very proud to have the different perspectives, but also that will support us in identifying solutions to the challenges that our diverse communities face and the rare disease space.

Shawna Watley: Thank you, Deanna. You all are doing some amazing work, and I count it an honor to be a part of the team. Dr. Bull, could you please spend a few minutes explaining to us what is clinical trial research, including the phrases who can participate and why is diversity so important, both in the participants of the research itself and those working in the field of clinical research?

What Is Clinical Trial Research?

Dr. Jonca Bull: Certainly. Any product prescription medicine that is prescribed in the United States has to go through the regulatory process, which is through the development of clinical trials. So, the clinical trial process is initially based on identifying a molecule that has promise to treat a particular disease during preclinical testing to ensure that the safety of the drug is such that if you introduce it into humans, that you're not introducing undue risk, that there's the potential of the benefit outweighing the risk, and then undergoing the clinical trials to determine whether or not the drug will actually do what its mechanism of action promised that it would do. It's also important — and this is where diversity in clinical trials really is quite critical — to ensure that the range of patients that will be anticipated to use the drug have been studied adequately. And this includes looking at factors such as other co-morbidities. You wouldn't want to study, for example, a drug for HIV without also looking at background Hepatitis C. You wouldn't want to look at a drug in diabetes without taking into account BMI and the impact of obesity, or the different body sizes in looking at dosing. So, it's very, very critical, if drugs are going to be used safely and effectively, to ensure that the patients that are the likely ones to use the drug have been included in the clinical trials.

It's also important — and this is where diversity in clinical trials really is quite critical — to ensure that the range of patients that will be anticipated to use the drug have been studied adequately.

Shawna Watley: Thank you for that explanation. So, Dr. Bull, we know that, unfortunately, there has been some issues within the African-American community as it relates to diversity in clinical trials. It's been very challenging, and we saw that even during the COVID, during the pandemic, coming up with the vaccine. Problems have been documented and solutions have been presented. However, the culture remains the same. What are the missing pieces to the puzzle to obtain a different outcome?

Dr. Jonca Bull: Yes, well, actually, the COVID experience is one that I think is instructive. That if the mandate is that trials have to have inclusion, that there's careful monitoring of the inclusion in the trials. I actually worked for a company that was instrumental with one of the larger development programs, and when issues were identified with low inclusion of African Americans specifically, there were strategies put in place that expanded the number of sites, expanded the number of investigators, went into the community, talked to patients. And I think something that's really, really important that I think the RDDC is doing a superb job of, is bringing together all of the stakeholders. You can't talk about diversity in clinical trials without referencing back to the experiment, the experience with Tuskegee. And you could even go back in history where African Americans specifically were literally used as guinea pigs in trials. So, you have to overcome a history of a lack of trust and building trust, and that begins with engaging with the community. I think one of the positives that came out of this very tragic legacy is that we have informed consent now. We have institutional review boards, so there's a lot more oversight to ensure that trials are being done ethically. So, I think the element of design of the trial has to take into account how do you plan for inclusion. Because you can't get to the later stages of development, what are known as phase three, and then say, oh my goodness, we don't have enough minorities or demographic subgroups that are important to the safe and effective use of the drug included. So, what is happening now — and I think it's going to take time because you really are changing in green practices —  is that you've got to begin by expanding sites, you've got to train investigators, investigative sites have to be equipped and qualified to do studies. Not everybody wants to be an investigator, but we certainly want to broaden that opportunity. And then building trust in the community that clinical research can be done safely, ethically, and communicating to patients how important it is because one of the things that you don't want to have happen, all of us that are likely to have something happen with their health or have loved ones that are impacted. I had a question posed to me years ago at a medical meeting. An African-American physician came up to me, this is while I was serving in FDA, and he said, Jonca, what I want to know is, have these drugs been studied in patients like mine, like the patients that I take care of? And I think that's the piece that you want clinicians who are making these critical prescribing decisions to have confidence that the process has included patients like their patients, so that they have confidence when they prescribe a drug that they can identify the benefits as well as identify the potential risk.

Shawna Watley: Thank you, Dr. Bull. So, Deanna, Dr. Bull mentioned some of the work that you all are doing. Can you share with us a little bit in more detail what RDDC is doing to kind of tear down some of these barriers and challenges as it relates to clinical trials and communities of color?

RDDC's Efforts to Improve Clinical Trials for Communities of Color

Deanna Darlington: Absolutely. RDDC is really comprised of a number of work groups, five in total. And these work groups are based upon a consensus of our broader stakeholders really identifying what are the challenges, what are the barriers to rare disease patients living in diverse communities and how can we address them. We thought the best way and best approach was to look at all of the challenges we identified as an expert group of individuals that are patient-focused, but also research-focused as well, and health-equity focused, quite honestly. And what we did is we identified and developed five working groups. The first working group was diversity in clinical trials. We really start on that point that Jonca double clicked on as it pertains to the need to have diverse clinical trials to treat our diverse patient populations and particularly in the rare disease space. Because when you look at rare disease and diversity and health equity, you really see rare disease being treated much like the disparities that exist from a health equity standpoint, and with communities, diverse communities, I should say. So, we're really dealing with two dual verities within our healthcare system, within the healthcare ecosystem. So, what we did is we identified these five work groups, the first one, again, being the diversity in clinical trial. We really look at the need around having diverse patient populations in clinical trials, but we've also looked at ways that we could actually address that and engage patients and support trust. One project that we're working on is called Gene Clips. Dr. Summer at the Children's Hospital in Washington, DC., Brooke, is our chair of this particular committee and really worked really closely with us to identify and develop a tool that we could allow patients to feel much more comfortable with. And the way that we, the approach that we took, was to diversify that tool and to make patients feel welcome and to have patients and faces that look like diverse patient communities. Also, to have Spanish speaking being a component of that tool. So, we gave it a freshened up look, and really proud to release that tool at the end of the year. Also, we're working very closely with NIH and looking to work with the RDRCN to look at that database. And in that database, we would like to extrapolate key information as it pertains to rare disease and then develop a white paper that will assess some of the diversity that exists within this database, but then also provide potential solutions as to how we can help to diversify the clinical trial research that's currently being done. We also have another work group, and that's the patient and caregiver. We really focus on the needs of the patient and the caregiver. We have two research surveys coming out of that work. We look forward to better understanding from an institutional standpoint what institutions are doing to support DENI internally, but also what are they doing externally as they reach out to diverse communities. What are the tools that they're using to diversify their membership? And we're also looking at a patient and caregiver survey so we can assess the gaps that exist, so that we can be better stewards as RDDC and other organizations to support the needs of rare patients living in diverse communities. We have another work group, a provider education, where we're looking to identify resources that will support provider education and address some of the conscious or unconscious bias that makes us as a provider treat various diverse patients. This program currently has a fellowship program in which we're identifying fellows to help introduce them to rare disease, but also help with introducing them to some of the health equity issues that exist within this space. And we're working with diverse patient advocacy organizations to host those fellows, so we're really excited about that program. We also have a delay in diagnosis work group in which we really look at why we have this delay in diagnosis. We examine family history. We sort of pull that back a bit and try to get to the root of helping diverse communities, really encourage them to have that conversation so that we understand, sort of, some of the genetic issues that may exist within us. But more importantly, we understand our history from a healthcare standpoint and we're able to address that in a more timely manner. We take this approach by creating educational awareness and sharing that with community health centers, also by translating our materials into Spanish and then partnering with Global Genes, another rare patient advocacy organization, and creating a campaign around knowing your family history. And then, finally, we have a policy work group. We also feel very strongly that changing policy is another avenue and a must into creating equity within the rare patient community living in diverse communities. So, we're working on some key legislation that will help support sickle cell disease, patients diagnosed with sickle cell, help encourage more young physicians to practice in hematology, and also looking at the diversity in clinical trials and working to improve that at a policy level. So, we just don't take one approach, Shawna. We take a very broad approach because we believe that it's important to deal with all of the challenges I identified by a work group in order for us to be successful, and creating answers and opportunities for the challenges that exist in the rare patient community, particularly those living in diverse communities.

Shawna Watley: Well, that's amazing the work that you all are doing, and I commend you all because I know that, you know, that Rare Disease Coalition is a relatively new organization. And so, Dr. Bull, I would love to hear, given your experience in this space and your tenure with FDA, what are some of the things that you've seen over the years that you believe are exceptional tools, or tools that you that definitely do work in tearing down some of these barriers?

Dr. Jonca Bull: Yes. Deanna touched on the need for policy because these things have to be articulated, but they also have to also build in accountability. And accountability almost has a trickle-down effect. You can be an advocate for clinical trial diversity, but if that's not also being communicated to the developers of new drugs, to the farm and biotech companies, and the interaction with regulatory agencies such as the FDA, in Europe with the EMA, if these things aren't being communicated in a consistent manner, you won't see the diversity happen in the clinical trials. That also means that there's a need to build infrastructure, expanding the number of investigators, building relationships with patients in disease areas before you need them to be in a trial, because trust doesn't mean that you show up when you need them to be in a trial. You really have to build those relationships ahead of time. I'd also like to cite the fact that patients have to be engaged to participate in trials. There was a study done at NIH several years back that looked across a range of studies and diverse inclusion. And it's interesting to note that the main reason that patients weren't being included in trials was they weren't being asked. There was also a survey done a few years back by Research America that looked at the willingness to participate in clinical trials. And guess what group scored a little higher than everybody else to participate in trials? African Americans. So, the willingness is there. I think when it's conveyed in a way that demonstrates that there's value in participation, and that your rights from an ethical standpoint will be protected. I think it's also, as I cited before, all of us are going to have health issues. We're going to have family members that have health issues that occur. And what you want to know is that the drugs that you're going to take, be it everything from chemotherapy to management of high blood pressure, that it's been studied in patients like you, and that the balance of benefit and risk has been assessed so that you can maximize the opportunity for it to improve your health.

Shawna Watley: Well, that's very helpful to know that we are making progress. Maybe not as fast as we would like, but it's hopeful that things are moving in the right direction. So, I'll turn it over to Deanna. I know she has a few questions for Dr. Hain.

Deanna Darlington: Thank you, Shawna. Dr. Hain, thank you so much for joining us today and being part of the podcast. My first question to you is regarding genetic testing. I'd love for you to talk to us about, or walking us through, what that process would look like as a patient.

What Is Genetic Testing?

Dr. Heather Hain: I'd be happy to. So, the majority of the time, we see the patients either in-person or in telemedicine now, and we discuss their full medical picture. So, you know, often specialists are only looking at one area of the body or one system of the body. And we as geneticists want to make sure that we're looking at the full picture. So, we gather all the information from all their other doctors and their health records. And then we also take a full family history. You were both kind of talking about that for patients. That's really important to us because it also not only helps us see, again, the full medical picture, but it also helps us decide sometimes what type of testing to do. So, we make sure that we get as much information as we can from both sides of the family and usually two or three generations back even, to make sure that we're understanding everything that's going on. So, once we do that, genetic testing can actually be several different things. So if there are some, we call them metabolic diseases, where people have problems processing food and making energy for their body. So, a lot of times those are just simple blood — I say "simple" — but with their blood tests we can look at proteins and enzymes, which are what break down food and create energy in our body, to see if there's any differences that may explain what's going on. Sometimes we do have to do what we call molecular testing, which can look at DNA and genes and chromosomes, to decide whether there's any differences in any of those. And often that can tell us what's going on as well. We talk to the families. We explain about genetics. Often families only learn, you know, high school biology genetics. And so we make sure that they understand what DNA means, what chromosomes mean, what a gene is. We go through the results —  positive, negative and confusing — and what that could mean for them and their family. We really try to incorporate the family as much as possible because often genetic testing, if we see a positive or a confusing result, we'll follow up in family members. So we want to make sure that they understand, you know, what does this mean for not only in my case, I'm in pediatrics, of course, so what does this mean for my child, but what could it mean for the rest of my family? And, you know, genetic counseling is a part of that word. And as a genetic counselor, we want to make sure that they understand the psychological impacts and social impacts of that as well. We never want to do testing if people don't think that it's going to be helpful for them. It's a choice for them, right? Sometimes families decide not to do genetic testing. In a lot of cases, genetic testing is just giving them a reason for what's going on, and it won't change any of the medical practice or treatments that they're doing, so some parents decide, well, if it's not going to change my child's medical treatment or my medical treatment, then I don't think that I want that information. We have the opposite spectrum too, where parents want all of the information they can get and so they'll do as much testing as possible, or as either insurance covers or they can afford, to get that information. So, it looks different for each person and for each family. And once we have results back, of course, we can go through if there is a genetic condition found, we go through what that looks like. What does it look like in the future for them and their child? Do we need to do any follow up for the rest of their family? What's the risk for future children or future generations? So that information is, of course, important to families and patients. And as always, we want to make sure that they're taking the best care of themselves and their families, too. So, how does it affect it? Is there a new treatment that they could be using? Is there additional testing that would help with that? So, all of that is part of the discussion for genetic testing and making the right decision, the ideal genetic testing for each individual and family.

Deanna Darlington: We know that early genetic testing can lead to better health outcomes, yet patients of color are not tested at the same rate as other groups. Can you tell us what is being done to reduce the barriers to genetic testing for patients of color?

Dr. Heather Hain: Oh, yeah, absolutely. I think one of you had mentioned just even realizing what the barriers are is part of the issue, right? You know, we often, I think, assume or infer what the barriers are, but really asking our patients and asking our families, you know, what is preventing you from getting this testing? You know, is it just having privacy? Is it you're afraid that somebody is going to use it against you or are you afraid? So, just realizing a lot of times what the barriers are is really helpful. One of the barriers that has come up a lot is just access to genetic testing. So this can be as simple as primary providers just not even understanding that genetic testing is an option for patients and having, educating providers, of course, is helpful for that very reason. So I think, you know, the more that we're putting out there online and on apps like Gene Clips here at Children's, that's helping educate not only the public but also providers. And they're like, oh, this is something I hadn't thought about. So it becomes more of routine care rather than this special circumstance that is kind of an afterthought. I think that's really helping break down barriers for everybody to get that access. One of, I joke with a lot of my parents, is there's only a couple of good things that have come out of the pandemic, and one of them is the creation of more telemedicine. There's often, patients often have a very difficult time getting to appointments. You know, they have other children that they have to provide, have child care for. They can't take off work for the entire day. So telemedicine, I really feel, has helped us be able to reach patients who otherwise wouldn't be able to make it to a genetics appointment. So, I think that's really helped us. The other thing is molecular testing, and testing used to only be a blood test. Because of the pandemic, a lot of people couldn't even make it into the laboratories. Laboratories just weren't open. So, a lot of the labs have perfected techniques to get DNA from saliva, from cheek swabs, from other means, which means we can actually send those test kits to parents' homes and they can do the testing at home and send it back to the testing companies. So I think that has really reduced barriers as well. Again, for the same reason that telemedicine has, really reaching out to a diverse community, and that can be people in rural areas, people in metro areas, anywhere. So, I think it's really important that continues, and I'm hoping the policy helps that continue too. We were talking about policy a little bit earlier, that providers can get as much back for telemedicine visits as we can for in-person visits. The cost of testing has come down quite a bit, and that's a lot due to the technology and new technological advances in molecular testing in particular. And we actually have some companies that offer no-cost testing to our Medicare and Medicaid patients. And boy, has that just reached a whole new level of patients. Often, those two government agencies don't cover genetic testing, in particular genetic testing. So, that is really valuable to a lot of our to our patients and also sponsored testing. So, some of our labs work with pharmaceutical companies because they want to learn more information about genetic conditions so they can create better treatments. And so, they'll sponsor certain testings, which, of course, is also at no cost to our patients. So that has greatly helped a lot of our patients as well. I think part of what's going on, too, to reduce the barriers is encouraging and educating and enticing more providers that are also minority, bilingual, multilingual, culturally competent to become geneticists and other doctors as well. I think by diversifying our provider population, that is also reducing the barriers because they're seeing people like themselves that they can talk to, that they know are going to understand them, that they know have the same background as them. And I think that is really helping to reduce or to people gaining access to genetic testing. We were mentioning the mobile apps and education. There's so much more out there than when I started in genetics that is available to people. And most people have phones now. So, you know, even for telemedicine, they can use their phones even if they don't have a computer, right? So, being able to access that, even if you don't have a computer, I think is, has been really helpful as well. I'm seeing more and more, maybe related to genetic testing in particular, but more and more community-based outreach programs. Just talking to the public about genetics, about testing, about research. And I think that's helping more too, because it's not this black box anymore. And we're gaining back the trust of people that were very much, rightfully not trustful of doctors and research and clinicians. So, I think that's helping us a lot. We still have a long way to go, you know, I think that each of those pieces is very helpful and learning, again, what the barriers are for people is extremely helpful as well.

There's so much more out there than when I started in genetics that is available to people.

Deanna Darlington: You know, in our policy work group, I talked about our signature legislation that our DD's working on, but I do want to double click a little bit on some of the other policy issues that, since you raised the whole telehealth, that is very key. To your point, now, from an access standpoint, we think about where patients should think about diverse communities, how do they see a doctor, or how do they go to an organization that may be, you know, in four or five states across from them?

Dr. Heather Hain: Exactly. Yeah. 

Deanna Darlington: It's been a real lifesaver. So, we're going to have to advocate telehealth and telemedicine. Accelerated approval is another policy area that we have been fighting very diligent on because it's so important to the rare disease community to have accelerated approval. These patients have waited so long to have treatment, and to provide a viable pathway that would support those patients gaining access at a much sooner pace is key. So, that's another policy priority for us. Copay accumulators. And you look at these copay accumulators, it's restricting access to patients. And some research, recent research was done that shows that patients of color are often hard, harder hit than any community when restricted through a copay accumulator or maximizer program. And when insurance companies are creating these types of policies that will not allow patients to actually access their prescription benefit under their programs. So, that's another area that we feel is key to the rare patient community. And again, in those rare communities, newborn screenings is another issue of ours that we're very passionate about and that we feel there needs to be some changes, the state and federal level, to ensure that we have this tool to use for diagnosis of newborns. So, we really want to be able to further the education and awareness, but also to speak to policymakers that can really educate them on it, but also make a difference in how we're accessing this. So, I have one final question for you. Historically, there's been a cultural mistrust around minority involvement and number of healthcare issues. And I know we've talked about that, Dr. Bull, she spoke to that. The whole trust issue, you spoke to that. Well, how does having diversity in the patient ecosystem help break down the mistrust in genetic testing, research and clinical trials?

Benefits of Diversity: Genetic Testing and Clinical Trials

Dr. Heather Hain: I love this question, actually. You know, I think it really allows us to see how many similarities there are. You know, we always talk about the differences, I feel like way too much, rather than the similarities. I think that there's potential differences. But again, you know, we were talking about evidence-based. I think a lot of things were assumed or inferred about different ethnicities and minorities that really were not driven by evidence-based research. And I think the more we include diverse populations in our research and our clinical settings and our clinical testing, that allows us to really break down those old myths, if you will, and really focus on what the true differences are. What is really the difference between these different groups? Are there any differences? You know, we may find when once we have an extensive database of genetic information that there's really not as many differences as we thought there were. And it's just based on the populations that we were testing and not testing. So I think that the more diverse our population is, the more diverse our researchers are, the more diverse our providers are, the more we start to break down all of those assumed differences and really get to the crux of what is going on. Who are the populations that we need to be doing better screening on for things like cancer? Who are the populations that, you know, we know some of our populations have more blood disorders, more sickle cell disorder, more traits than that? And I think that sometimes we assume that certain populations don't have certain genetic disorders, and we're finding they do. I never forget, I was rotating when I was a genetic counseling student through cystic fibrosis, and I remember one of the providers telling me that — we were talking about this very issue —  that you don't see a lot of African-American kids with cystic fibrosis. And he said he'll never forget there was a conference or whatever they call it, where a bunch of doctors get together. And there just happened to be some chest X-rays sitting out. And one of the doctors picked it up and said, hey, who's this kid with cystic fibrosis? And the other doctors looked at him like, what do you mean? And he's like, this kid has cystic fibrosis. Look at this X-ray. It's like our cystic fibrosis kids. And he was African-American and nobody had thought that's what it was because he was African-American. And that just really hit me in the heart, like somebody thought that kid didn't have it, not because of the evidence, but because he was African-American. And I think that is such a detriment to our patients, that we're not paying attention to what the actual symptoms and signs are, that they just presumed just that was the case because of his race and color. So, you know, I think that the more of us that are pushing for that and the more of us who are looking at different things and really pushing the envelope and saying, now, wait a minute, what is the evidence to show us that there's differences or similarities, I think that the more of us that are, that we're only going to get better at this. We're only going to provide better healthcare for everybody, and that will change the whole scenery.

You know, we may find when once we have an extensive database of genetic information that there's really not as many differences as we thought there were. And it's just based on the populations that we were testing and not testing. So I think that the more diverse our population is, the more diverse our researchers are, the more diverse our providers are, the more we start to break down all of those assumed differences and really get to the crux of what is going on.

Deanna Darlington: Thank you for that amazing story. Thank you for sharing. I'm going to pass the baton back over to my co-moderator, Shawna, and ask her to continue the dialogue with her questions.

Shawna Watley: So, we have two last questions that I'd like to just address to Dr. Bull and Dr. Hain, but Dr. Hain really kind of touched on this. The question is, what does equity in rare disease clinical trials in genetic testing look like? What you just talked about really speaks to that. These are some of the things that are being uncovered by having equity. I would love for you both to speak to that.

What Does Equity in Rare Disease Clinical Trials in Genetic Testing Look Like?

Dr. Jonca Bull: Well, I can start. So, in terms of what equity looks like, I think it really speaks to a world where you don't have preconceptions guiding clinical decisions, that we approach these things with an open mind. I remember being at a sickle cell conference once and one of the speakers was a white family with a child with sickle cell disease. And it does happen, just as the example of a child with cystic fibrosis being an African-American child. So, I think, what we want to do is to ensure that we're bringing literally our A-game to patient care and that these preconceptions are not guiding clinical decision-making. And I think that's the real key piece. The other part that Heather touched on is that you've got to have data. You've got to, you know, in terms of looking at genome-wide association studies, and there have been some instances where there have been misdiagnoses because there were not enough African-Americans, for example, in the trials. And so, looking at the balance of the data that informs genetic testing is also really important. We all win when we all win, when we all participate. So, I just think that, you know, building the trust, encouraging participation, providing settings where participation is facilitated, access to clinical trials, access to testing, is really, really critical. So, for us to get to a position of equity, we really have to look at access at every level. Thank you for that question.

So, I think, what we want to do is to ensure that we're bringing literally our A-game to patient care and that these preconceptions are not guiding clinical decision-making. And I think that's the real key piece.

Dr. Heather Hain: Be that everybody has access to genetic testing no matter what their ethnicity, ancestry, disability insurance, income, no matter what they can afford, the right genetic test for their symptoms, not one that the insurance will cover, which often happens, unfortunately, based on their signs and symptoms and their family history. It also means having an extensive genetic information database that includes all ancestral populations from every continent all around the world. That way our testing is the most accurate for each individual and each family.

Shawna Watley: Well, thank you. That's certainly a goal for us to reach for, continue to do the hard work. I'll turn it over to Deanna so we can close out. But thank you so much for your participation, and what a wonderful type of discussion.

Deanna Darlington: Thank you, Shawna. Well, I found this discussion and dialogue to be very interesting, thought-provoking, and I'd like to thank our two panelists for the contributions that they've made, to Shawna, for her expert moderating skills, and finally, I'd like to thank the audience for taking the time to share into this dialogue with the Rare Disease Diversity Coalition. We hope that you all enjoyed and engaged our Rare Disease Diversity Coalition dialogue today. You can find us on social media platforms such as LinkedIn, Twitter, Instagram and Facebook. Also, please feel free to visit us on our website, which is rarediseasediversity.org, or if you simply type in RDDC and do a Google search, it'll take you right to Rise for Rare. And then finally, I'd like to thank our sponsors for supporting this event. We could not do this type of work without our sponsors. So, heartfelt thank you to Vertex Pharmaceuticals and to Travere Therapeutics for supporting this educational event today.

Shawna Watley: Well, thank you so much, Deanna. Thank you, everyone, for joining us today. Don't forget to listen in on the other two podcasts as part of the three-part series, and we look forward to continuing this very important discussion. Thanks so much.