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