Council in washington, d. C. If everyone can take their seat, that would be great. Thank you. We had to get pictures taken, didnt get a selfie but anyway, welcome, everyone. My name is kenny mendez the president and ceo of the foundation of america. Also the current nih seaboard chair and on behalf of the board, welcome to todays event. Its great to see everyone. And before i turn it over to randy i just want to make a quick pitch. I dont think youre going to find an organization like us in this area that brings together Patient Organizations and our mission is to amplify the patient voice and other stakeholders in the Health Ecosystem under one roof. So, theres a membership tableand registration you can ak about membership but really appreciate everyone here and hopefully todays event you will see is exactly what the nhc does, bringing together diverse stakeholders, amplifying the patient voice and bringing in terrific speakers that you can learn from, so with that im going to turn it over to the nhc president and ceo, randy. Thank you. [applause] good morning, everyone and thank you for your inspiring opening. Our kick off to an exciting day and for your leadership at the National Health council and strong Patient Organization. Thank you all for coming together today on this really crucial discussion the engagement into Digital Health. Im the ceo of the National Health council and i believe that we will access to highquality Affordable Health healthcare priority for every american especially true for the constituency that we represent so well here in the room, 160 million americans with chronic conditions into disabilities. Today is symposium first the importance of patient centricity and in the Healthcare System putting patients first which is our tagline and i would say in this context is a call to action. From Clinical Research, diagnosis, treatment and discharge the growing role of lifesaving digital and Technology Innovations are fueling hope and health for patients, their families and stakeholders. Optimizing the full value and the impact of digital and artificial application requires active engagement of patients at every step. We must listen and compassionately deploy a new technologies consistent with who our patient priorities concerning equity, dignity and privacy. This is what todays symposium is all about, inviting strategic invites from leaders, experts and advocates to assure our collective understanding and progress on all fronts of a very promising and dynamic Digital Transformation four, with and benefiting patients. As we get started, i want to thank the distinguished chairs and Committee Members of the Research Program committee for their Strategic Direction and planning and todays event. You will hear from in a minute serving as the cochairs and then our Committee Members, irene, cynthia, andrea farris, doctor devon and a big thank you to the sponsors for their support to the symposium. We could not have developed such a robust and timely event without their generosity and support. Bio scientists, merck, eli lilly and pharmaceuticals all provided support for us to come together here on this topic. And last i am pleased to acknowledge the National Health council Research Program staff whove done an incredible job planning this event and coordinating an amazing series of speakers to explore critical topics on Digital Health and the science of Patient Engagement and they are doctor omar, lillian and karen. So let me say this with sincere gratitude that all of the National Health council has engaged in todays discussion. I look forward to speaking with you today. And at the reception at 4 30 tonight. Where he assured me there will be more discussion, great food and a lot of networking opportunities. So with that let me call on doctor omar the National HealthCouncil SeniorVice President of equity, Research Program to discuss our agenda and keep us going. Thank you. Thank you all. [applause] good morning everyone and thank you, randy. I would like to begin by acknowledging the land which we stand first every committee owns a vitality to generations from around the world who contributed to their hopes, dreams, energy and making the history that led to this moment. Some brought here against their will drawn to sleep and hope of a better life and some have lived in this sense recounted. Truth and acknowledging of a critical Building Mutual respect and connection across all barriers and in different. We begin this effort to acknowledge what has been buried by honoring the truth done on the land up our people with respect to those elders past and present we take a moment to consider the many legacies of violence disappointment and the settlement that brought us here together. So thank you again. I would like to spend a moment addressing the significance and importance of the symposium speech. Patient empowerment and the digital welfare. We all know that the pandemic brought a new perspective and urgency to understanding and incorporating the patient voice into Digital Health. No research should be accomplished without the consent, perspective and comprehension of the patient and family caregivers it is meant to serve. I will repeat that, who it is meant to serve. This should also include the voices of historically underrepresented groups and in research including the differences by sex, gender, sexual orientation, racial and ethnic backgrounds, geography, Different Countries and languages of origin, the stability and health status. Digital health is a very broad concept. However our definitions take a twopronged approach to look at both the technological and accessibility aspects. This includes applications, artificial intelligence, medical devices and Machine Learning and more. Throughout the symposium today, we have a couple of objectives, to understand the applicability of Patient Engagement research and to action and practice in a digital age illustrate the importance of Health Equity integration and Patient Engagement research, identify the Research Opportunities between scientists and Patient Advocacy groups and also exchange innovative thoughtprovoking Research Ideas and agendas. Now onto some housekeeping items. Please as i respect the delivery for the content of the speakers, take the time to silence or phones and or other Electronic Devices at this moment. Restrooms are located at the end of the hallway to the right outside of this room. Breaks and lunch will be available in the foyer, which is where we walked in for registration and the reception will be held at the lounge which is located next door in the room to the right. As a reminder, please use the elevators you used to enter the venue at the front of the building. The elevators you saw at the station only take you down but not up. Complementary wifi is available for the event and instructions are located on your table. You are also welcome to live tweet this event please use the hashtag 2023 or putting patients first. We have multiple members of the media attending this event. They are identified by the name on their name badge and very importantly, we placed qr codes on each of your table so at the end of the day or before you leave please complete the validations at the end of the day. Your feedback is extremely valuable and to the plans for future events. We will kick off with our keynote speaker the commissioner doctor robert. Over the course of the day we will also have six sessions with ten minute breaks between them where refreshments will be available in the foyer. As mentioned, the reception will be this evening from 4 30 to six and at the end of the program. We hope that you will have a wonderful and engaging networking with your colleagues and perhaps some new bases. Have your business cards ready to go. Last i would like to acknowledge the Patient Group and members in the room. Your research, advocacy and patient centered initiatives are admirable and we thank you for your passion and dedication. Dedication to the patient centered is more critical than ever and for the first time all sessions of the symposium are moderated by patients or Patient Advocates from all walks of life and experiences. We also thank them for all they do so please help me give them a round of applause for all the work. [applause] and now it is my pleasure to turn it over to the cochair of the research and Prayer Committee and member of the board of directors. Thank you everyone. Thank you for the wonderful introduction. My name is leah howard the president and ceo of the national foundation. And i am so excited to be here at the 2023 science of Patient Engagement symposium. The topic of this meeting is very exciting and important. At a time when Healthcare Innovation is advancing at such a rapid pace it is imperative that we guarantee patients a voice in their own healthcare. The National Health council provides leadership in protecting patients rights and todays event helps establish a blueprint for the future when it comes to how we interact with of the patient fairly, equitably and ethically. I am honored to introduce doctor robert the 25th commissioner of the food and drug administration. As commissioner, dr. Califf oversees the full breath of the fdas work portfolio and the execution of the federal food, drug and cosmetic act and other accessible laws that includes assuring the safety, effectiveness and security of human and veterinary drugs, vaccines and other biological products for human use and medical devices, the safety and security of the nations food supply, cosmetics, dietary supplements, products that gave off electronic radiation and the regulation of tobacco products. He said a long and distinguished career as a physician, researcher and leader in the field of science and medicine. Internationally recognizeda natt in some cardiovascular medicines, Health Outcomes research, healthcare, quality and Clinical Research and as the leader in the growing field of Translational Research which is key to ensuring the advancements in science, translate into medical care. We are very excited. [applause] thanks for that kind introduction. If i seem a little sluggish today i spent the weekend down at a funeral in my hometown in Columbia South carolina. And its not a bad thing. My uncle died at age 90, had a great life and as i heard many times at the funeral, hes gone on to greater things meeting old friends hes known for a long time. What happened to me is after i ate the fried chicken, broccoli casserole, corn pudding what was served for dessert was chocolate pound cake, coconut cake and banana pudding all that one table so my act of holding back was i didnt eat the banana pudding but Everything Else i had a taste. [laughter] so, i am delighted to be with you. This is i think a lot of you know this is like my favorite topic. Our synergistic not independent. The understanding many ways. It is tremendous opportunity raises a number of serious questions about our approach the clinical so the concept of Patient Engagement. Working in any time of uncompressed mythological breakthroughs. We have a deepening understanding of the underlying mechanism with genetics and the enormous opportunities afforded through the development application. Including to digitally share data. Allows us to envision and explore creating a untreatable diseases. He is we need to do this together. In combination with these more biologically oriented scientific advances, we are also breaking new ground and understanding human behavior. Social interaction tell the internet with Health Outcomes. Many people expect rapid growth in technology and knowledge, uncomfortable questions are raised as we delve into an exciting area with so much potential but also in so much risk. One of the most important aspects is to incorporate the perspective because of the bishops. Should the offense reflects what matters most is the most effective for patients and their character but it seems obvious to say if you want essential insights about what its like to live with the disease the outcomes that matter and the adequacy of Treatment Options which ask People Living with the problem or at risk of experiencing the problem. Both patients and caregivers were to focus on the issue with improved Digital Technology we should be able to design a more accurate complete risk framework that help us better evaluate the safety and the effectiveness of a medical product across a vast expanse of patients and consumers. I may have different values, educational levels, living in healthcare environments. We need to ensure the experience of living with the disease has factored explicitly in the development programs. For all medical products including measures that benefit harms within Clinical Trials. Also entering a new ability to assess and improve the fit between the product people who could benefit or be harmed from its use. Other known as human factors. We are Getting Better at this as we gain experience with explicit integration of the voice into our work. For example our Patient Focus Drug Development patients and caregivers are facilitated dialogue on the variety of diseases develop rigors and objective methods. I can measure Patient Experiences and perspectives in a reliable way. This could include the development of methods for the identification of key impacts elements of disease experience that matter most to patients. The translation of those elements into measurement tools that are clear registering change improvement valid and reliable capturing patients reported experience in Clinical Trials and clinical outcome studies. Our patient represented Program Brings patient voice to the discussion about new and already approved drugs and devices. As well as duos are currently being considered for approval. It also allows for input earlier in the regulatory Product Development and repute process. Representatives can serve on fda advisory committees as consultants for the review divisions in the determination of whether medical products benefits outweigh potential risk at as presenters fda meetings and workshops on disease specific or regulatory to help issues. These and many other models of Patient Engagement are being used across the fda are making a real difference. This is where the rapid advance of Digital Technology slightly to disrupt our current methods. We have enormous potential to traverse an Industrial Revolution in which rich and diverse sources of digital data are available at scale in real time with the potentially Unlimited Storage capacity. These data are becoming widely available as part of the Clinical Care system. Large language models are the next step. It appears to be ushering in the revolution many of us were hoping for. I toiled in the clinics for 35 years and as time went on i spent more and more time clicking buttons and documenting incentive talking with patients. Maybe that is coming to an end now. Throughout my career focus on strengthening systems for generating gathering better data. Analyzing those data to provide reliable evidence to inform and improve the many decisions that we make. As consumers, patients, families, clinicians and regulators. This kind of information supports fdas work. The ultimate goal gathering all the stated evidence is to better inform our knowledge but the benefits and risks of Health Interventions and to assure they can be used to improve health relative the risk or harm. Of course our focus at fdas on medical products, nutritional interventions of death and disability from tobacco products. But as we expand capabilities with Digital Technologies, the previous line between the individual product on the environment both human and technological only makes sense in the early phase of development. Ultimately the benefits and risks of the use of a product depend on whether and how it is used in the context in which it is used. Digital Health Technologies provide opportunities to foster more efficient conduct of clinical investigations the operating characteristics of specific digital measurements and their context of use. For instance they can be used to remotely recorded analyze data directly from participants throughout the day. Never it made sense to me as a cardiologist to have someone come in every three months for six minute walk test if you could measure how much walking theyre able to do in daily life. The use of dhd clinical investigation can improve Patient Access and participation in clinical investigations. By potentially reducing the burden of required business to a research site. As many of you know multiple projects underway to generate greater volumes of highquality relevant Digital Health data. Including the facilitation of efficient streamline randomized controlled trials and registries. By extending the use of existing Digital Health data. For example one focus of our products grant is to support the develop in a virtual or Digital Health platforms and models that can integrate data and serve as monitoring tools inform good clinical practice. I should also point out will the impact of this data is significant for the development of medical products and treatments, but has important applications supports regulatory decisions in food safety, tobacco products, and all of the products we regulate. Now, the hard part let me identify some questions i hope you will salted in your discussions. Because i do not know the answers to these problems. The first is disparities which is already been i think very accurately referred too. We are experiencing a dramatic decline in Life Expectancy in the united states. Only partially due to covid but also including gun violence, suicide, and opioid overdose. We are talking less about another lurking problem ongoing rise in chronic diseases. For problems like stroke and heart attack something as a cardiologist i thought we had sold 20 years ago. It is now on the resurgence. This alarming situation is not uniform in the u. S. Differences of function of race, ethnicity, sex, education, and rural living status are starred in many of them are diverging, not coming together in the way we would hope they would. Ive been unable since i first read it a few months ago. Technological solutions drift into societys penthouses. Diseases seep its cracks. Think about that for a minute and five years and i know youre going to hear from alphabet later on today, the smartest people in the world as far as i am concerned in terms of software engineers, spend tremendous effort to make a Product Available for all people. But inevitably the wealthy, the highly educated would make best use of the product right out of the hat its a problem as far as i am concerned we have not solved. So i urge you to think beyond the hypothetical or Laboratory Assessment of how new drugs devices and foods will be used across our society. Second is representativeness. It is obvious we have the ability to interact with the almost the entire spectrum of people with the disease at risk. Represented so well here today patient focus groups, advocates and representatives are phenomenal. We will eventually need to address the diversity of ink circumstances and economic factors by directly measuring them in broader populations. As evidenced by the ubiquity of cell phones, companies with billions of users our challenge and limitations are no longer technological. They are embedded in our human interactions. I would urge you to look at cpra which is on fabulous work dating back to 2015 and before that showing the balance of benefits and risk with the device look quite different for a product depending upon the preference that vary across the population. That is given exactly the same date at the benefit risk equation may be positive for some people given their values and negative for others. The third problem is al gore bias. Algorithms include new Large Language Models evolve after their put into practice. It is unlikely again i want to say this clearly, unlikely and accurate algorithm will stay accurate when deployed in real life over time. It needs adjustment and measurement of its operating characteristics, continuously throughout its lifecycle. I want to give credit here again interventions if you look at their diagram going back to 2014 the most important part with algorithms is not the free market component it will what happens after its put out there. How do we get that done because were not doing it now . The nexis Large Language Models other than his check gpt. If we are not nimble in the use of regulation of large language products we will be swept up quickly by something we hardly understand. The great things are really great to imagine in which her questions were answered immediately and language appropriate for your literacy. Also your clinician can talk with the resident spending all the time cutting, pasting and writing clinic notes. I could go on and on i see that regulation of Large Language Models critical to our future. Almost done for the next one is misinformation. Many americans die or experience serious illness every year due to bad choices by false and misleading information. This trend is accelerated social networks and driven communication based on Common Social identities. But ripe for exploitation but spending time with my South Carolina relatives reminded me of how different the universe of information is they are exposed to compared to i see every day. This new digital era can connect us but Technology LikeLarge Language Models give almost everyone the potential to produce a false narrative or even fabricated images and voices. Do not be surprised if you see images of me speaking on the internet when it is not me but it looks like me, completely as my voice completely in it. A key part of transitional transitions to rebut your health is to guide Digital Technologies to improve outcomes and interactions. The last promising confidentiality but its abundantly clear at least to me effluent the best treatment for ourselves, we better hope others to put their data and their participation on the line so our clinicians simply want to know and have confidence about how People Like Us is a common phrase we have not reached the right balance on these issues. The advantage of resource participation data sharing and the reciprocal obligation to collect the data. Across industries digitalization insertion of Machine Learning, other types of mathematical algorithms in everyday life just making a profound and different Government Agencies and private industry. Quite simply we need to assemble the resources and put in place policies and tools adaptively align our Digital Health efforts to support Public Health and regulatory innovation in a world that is changing rapidly. The potential certain exists that we have good reason to hope that we will fulfill the enormous potential additional Health Technologies. Consumer Innovative Solutions that can result to improved outcomes would better also preempt the risk. Thank you and i look forward your questions. [applause] thank you. Fastening talk we obvious have a lot of work to do today for going to solve all those questions by the time of the reception. Carson counting on it. Let me ask you, your reference, and earlybird Digital Health technologies and interest in devices and apps has surged during the covid pandemic. Because the fda being responsive to these fastmoving issues and making sure patient preferences and desired outcomes are prioritized . Is like trying to say diplomatically, i think we are hyperaware of the changes and we have adapted many more Clinical Trials have substituted digital measurements were what used to be important measurements were going to continue guidance on decentralized trials. It came out for example. I also do not to pretend as i said i think we are behind was going to be really hard to catch up. I cannot stress enough and i tend to get overly excited about these things. I actually really think Large Language Models are exponential factor we have been waiting on. But it has a life of its own that we better get out in front of. I would also stress fda has a very Important Role to play but we need you all to have a lot of discipline because ill just give the example i gave as a cardiologist it seems silly to do periodic assessments of exercise capacity but on the other had when you really grapple with issues of missing data artifacts, we had the thing at Cleveland Clinic i will never forget its not issue both the Activity Trackers were put on employees there is a whole business that developed a people learning Activity Tracker so it look like youre doing more. [laughter] two theres a lot to do to get it right nobody denies he potential but weve got to have discipline. Ill ask one more question number one open it up to your questions weve got a couple of microphones. Please feel free to step up to one of those 50 would share your name and the organization that you represent before you ask your question, that would be great. You gave us some big challenges. Some Big Questions that we should think of it. You have a room full of amazing Patient AdvocatesPatient Organization representatives. Let me ask the flip side to challenge question about opportunities. As you look at the future looked in the next three years for Digital Health and Patient Engagement. How can patient advocate help alleviate some these challenges . I think the main thing is i said we have to do this together. You need to be very activated very energized, insistent. Avoid the trap, this is a hardwood avoid the trap of jumping to a conclusion about whether a treatment work since ive done the work to show up. I am so impressed the numbers remain pretty much the same fda if you look at drugs that make it into phase one. Closed at 90 do not make it to market because Mother Nature is a lot more complicated and smart than we are. One 100 of the said really smart people who thought investors who put tons of money into it. I arbys that approved the human studies. Fda said go ahead. I think park hard core sure you get it right. But not letting people say this is the way we used to do it so were going to keep doing it that way. The dumped any questions ill ask one more. I cannot believe theres a questions. I cant either. You talked earlier about the patient focused drug Developer Program and some of the other Patient Engagement opportunities and resources the fda has. Many of us are familiar with the committees and listening sessions, various programs and collaboration. Do you think this has changed industry standards and Digital Health and if so, how . Because i think Patient Involvement overall has changed industry standards but not enough yet. I think one of the really hard things about it is for things to really change multiple components at the change at the same time. It may be a group within a company that makes a change in the way things are done. But that youve got the rank of terry consultants inc. Wait a second at the end they does not go along with the money spent a lot of money and at the end of the date netgear product approved. Youve got other people think wait a minute if you really measure things you much of this problems with the product that were not anticipated. So theres obviously a lot of opportunity. We have to get get everything in sync. I also want to stress something i said just to meet one of the most interesting challenges. I used to work in my previous job. When you are working in a company that has over billion users a month you get a sense how technologically easy it would be for example ill pick on type two diabetes. It should be able to look the whole of people are thinking about their problem. Not just representatives. Representatives do a good is drama sick and how it represent 50 Million People . But if we cut the rules right we could ask 50 Million People how would you value these various outcomes . What is bothering you the most in your daily life . These are questions marketeers are using every day in business. But in healthcare we do not use them effectively. No one im very happy to see a cardiologist in your position as someone who does not have a treatments right out the fda to vary fantastic. As we have been discussing medicine it is advancing we have a lot of Great Technology that is advancing a pediatric patient into adulthood. Is there anything from a data perspective the fda is looking at is hard to help with transitional care. A lot of data is being left off when patients have to transition into an adult center. Is that something the fda is looking into . First of all i have a daughter with congenital Heart Disease myself. Its not reason i went into cardiology it just sort of happened after i decided to become a cardiologist but she is 44 now and has a daughter herself was a freshman in college. Im fully aware of the wonders of technology. Im also very aware just for those who are not in this arena generally has with congenital Heart Disease which is about 1 of our population is the pediatric care is pretty well regulated and dispersed across the country but i will also point out most all these centers are in big cities or University Towns so rural people are disadvantage. But someone passes the year of 18yearold threshold now you are in the adult world. There are not enough experts to deal with it. I know you can handle this i get the sense. But you would not be alive and my daughter would not be born alive today if she would been born a couple years earlier. Whole group of people that did not exist before but this plays into one thing i was trying to say. The minute you get into Digital Technology you see that what used to be a clear swim lane for the update youve got a product, you access the risk and benefits an experiment which is done in the research setting. Im hot you throw that over to society and say good luck basically. The digital sphere gives us a chance to bridge that divide. Its really critical i say we do have a swim lane. So what you describe is not an fda swim lane. But we are accountable to the safety and appropriate use of products for their entire duration. We have a seat at the table. Ill just say the u. S. Healthcare system we are spent 4. 3 trillion Life Expectancy is five years shorter than the average of high income families. We are in last place to high Income Countries but whatever were doing we need to do Something Different break works great this will be her last question goahead. X National Multiple Sclerosis society. My question is how do we achieve authentic asian engagement with fda, with industry et cetera et cetera not just checking the boxes . Not just say i contacted the national ms society. But you did not actually speak to the patient. But something i can say is be insistent and have courage. It is my genuine experience. I am old enough now at age 71 to separate a much better on the block of all the healthcare spheres. 99 of people really want to do the right thing. But they exist in an environment where the outcome of interest are financial profit, while statements given notforprofit Health Systems. The soap box checking becomes a fine art just like a dozen any bureaucracy. I felt medical students is, undergrads would all say the same for Patient Advocates for you had the courage to speak out and identify lip service where it exists. The problem is lipservice is in great abundance right now but not because people dont want to do the right thing, of you want to read with like on the other side of the equation out encourage you to read the literature on moral injury which is a condition you know youre doing the wrong thing over and over but you cant do the right thing because the conditions of your job prevent you from doing it. Its easy for me too say i wake up early every morning and get a list of all people call me stupid and crooked and all that stuff. [background noises] we can take it at the fda we are used to being criticized. Keeps us on our toes. I would urge you to look at the other players in the ecosystem when the Health Systems is really setting up a great plan for this or that, ask are they doing it for patient good or are they looking at profit loss statement . Obviously got to account for both. Youre going to lose money are not g