Webinar: The Role of Digital Health in Outcomes and Early value generation (Feb 2019, 2019)

Webinar: The Role of Digital Health in Outcomes and Early value generation (Feb 2019, 2019)

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Good afternoon to, all of you, based, in in Europe and good morning to our us participants. And Phil Clemens I'm your host. For today and I'm really happy to welcome you, all to this webinar. So. Let's begin with a few housekeeping notes today's, conversation is being recorded and, will be distributed, after the webinar, if. You have any questions during the webinar please, use the questions pane in the control panel on the right hand side and questions. Will be answered during during. The Q&A session. Towards. The end of the webinar, so. Now let's meet our first featured. Speaker. And panelists, in read Mass and. It is the co-founder of inuvik, 8 Life Sciences consulting, her, clients include the top 20 pharmaceutical, companies as. Well as med tech and digital, health companies, ingrid, helps them strategize. Their product and service, offerings in the ever-changing, healthcare. Ecosystem, so. Ingrid please, your. Honor, Thank. You Phillip for the introduction, and in, fact today I will talk about the role of digital health in outcomes, and early value, generation. So, a quick introduction of. Who. We are what, we do then, we, will zoom in into what are today's, digital, health needs and more specifically, in terms of outcomes, and valchek value generating, opportunities. Also. We'll talk about what, should be then a good digital health solution. And what are the key requirements, and finally. We'll talk about the benefits of a digital health solution, and some, key takeaways. So. Like. Phillip has introduced, we are specialized, strategy, and management advice, company, and we. Are helping clients to innovate, and navigate. In an ever, complex. Health, ecosystem, and, today's challenges. And changes are, changing, in fact the health ecosystem drastically. And we. Helped in fact multiple, stakeholders to. Be. An active and winning. Player. In this space. We. Are based in Antwerp, in Belgium and, also based in Basel, in Switzerland and. We, work throughout, an extensive, network of, sector. Specialists, to, help companies. And stakeholders, to further, develop. Their businesses. We. Work for the, pharmaceutical, companies, for biotech, companies, but also for medical device and medical, product players, we. Also work for the health and academic research. Companies. Or players, and also, for clinical, apps and diagnostic, care players and nowadays. A lot of new players coming, into the healthcare, ecosystem. Everything, starts with very deep industry, insight and doing. Deep insight, analysis, is the core of our business and based, on that we develop, strategy, business, plans and also support, in valuation of businesses.

Beside. That we help with program, management and change management also. Business, model design and realignment, and also. Business. Process designs. Now. Moving into the digital healthcare, space well we see that nowadays multiple. Players are focusing. On the development of the digital health strategies. Digital. Health. Offers. New opportunities and especially. In the area of outcomes, and value generation. We. See four main forces, that are shaping the held, ecosystem. On one, side we see more and more a need for evidence and outcomes. And we, can say that the healthcare space is more driven by outcomes, based and, evidence. Based decisions. And it's. Also referred, very, often as value-based, healthcare. Secondly. We see that, integrating. Technology, and also. Aggregating. And combining, this first data is a next, trend, to, be observed and that's, by the way all, over the globe and we see that more and more data is combined, is aggregated. Is further enriched, and the use of technology, and especially digital technology, to further collect, information, collect, data to further, and. And which existing. Databases. As. A third major, driver that, we see is further, ecosystem. Stakeholder. Collaboration, none. Of the stakeholders. Can act on themselves and more and more collaboration, is required and also, on top co-creation. Is required and. I will explain, a bit later how. Exactly, and which kind of stakeholders, should, co-create. And worked further, together and as. The fourth driver, and trends. In the sector is more, and more consumer, and. Consumer engagement which, is required each, of us is acting, more and more as a consumer, in the health ecosystem and. We have our own preferences, our. Own way. Of living and thinking and acting so. More and more we, act as a consumer. And decide, on what our preferences, are and which type of health care or treatments, that we want and this. Shifts. In fact also decision, making more and more to the patient, so. We can say that these four driving forces are, putting more and more the patient at the center of the ecosystem. Now. This means also with all this changes, and all this strong. Drivers, that are acting together today, that, we have to move in fact or will move more and more towards, a world where everything will be around outcomes, the, outcomes will be the key central, point, that. Will organize. The whole ecosystem, this. Also means that companies, will have to switch from just selling products, to more and more selling, and managing outcomes, and also. Care providers, will have to shift from delivering, interventions, to delivering outcomes. So. The need is in fact for, all the players and. The problem, originating. This need well, we see that today, to. Be able to deliver personalized, health care different. Stakeholders, will have to work together, digital. Health will be a major enabler, in that although care, collaboration, is not that easy. We, also see the data collection, and monitoring with a patient, at the centre is difficult, especially for, pharmaceutical. Companies that are prevented, to contact, patients and. Obtain patient's data, directly. It's. Not allowing them or if make it very difficult to, do, also. We see the data ownership, privacy. Data privacy, protection. Of personal data especially. In, Europe than the GDP our regulations, and also, data security, makes. It more complicated. Also. More effective, and efficient, health and disease management is. Needed and especially, patients, are requesting, this but also our health care budgets, require, a more effective spending, and, then. The last topic also faster. Patients access to new treatments we, have we're dealing with now new, innovations, that are coming to the market think, about cell and gene therapies. Patients. Want to have access to this potentially, curing, and true curing treatments. And of, course, it. Implies a lot of or high, spending. On healthcare budgets, and of course this has to be further, supported. And facilitated. So. We can see that Ceyda the need in fact for precision, medicine to, treat the needs of each individual, patient is, required, but, also outcomes, business, model is required which means data collection, and monitoring with the patient at the center also. With integrating. Solutions along, the whole patient pathway, and care, collaboration. And coordination along. This patient. Pathway but, certainly, also and that's more important, for patient, for care, providers patient. Experience, and satisfaction. Also. Important, is a move towards, dynamic. Patient-centered. Consent management and. We've seen today. Also big, issues with some of the digital. Health or digital players and, in a broad sense and patients.

Request More and more to organize their, data themselves, and decide. Themselves whether, they want to share their data on a dynamic. In, a dynamic way and, patient. The engagement, of course as is. Important, especially when it. Has to be used or digital help that firms have to be used as health, coaches. Applying. Digital, health is. Is, not that easy there are a couple of challenges however. There are also a lot of advantages, that. Little healthcare now can offer it first. Of all personalization. And patient. Engagements, are all possibilities. To. Be delivered. True and. And, and, digital, helped solution. Also, better outcomes, and disease management can. Be offered together. With effective, prevention. On the longer term and also, more efficient, and sustainable healthcare. Especially, then. To. Manage better the healthcare cost on. The, other side like I mentioned earlier there are a couple of challenges, associated. With, data and data, protection data, ownership, but. Also the legal framework, digital. Health is a new topic in the healthcare space which, requires also further a legal, framework to be developed, and also. Patient safety and liability issues, can. Pose some problems a very. Important, problem is the interoperability. Especially. Between, digital health solutions and, existing, and let's. Think about hospital. Management systems electronic, medical records, and, so interfacing. And is absolutely. Required and also. Adoption. Among the healthcare professionals, some. Are very advanced, and are very, open to it outer cell s. Now. Looking to what are. The requirements, for a good digital healthcare, solutions, well. If we look to today's. Situation a lot of the pharma companies, and of course also health medical. Device companies, they, have their portfolios, of. Products. And. Solutions and, also healthcare providers, hospitals, home hospitalization. Or home care providers, have of course their range. Of services, that they offer, now. Without a patient, centric digital health solution, that accompanies. In fact their portfolio, it will be extremely difficult to obtain the best health outcomes, for patients so. The digital health solution. Is a necessity. In. Being, able to achieve the. Best outcomes, for patients and, also. To be able to build. A patient, centric outcomes, business model, the.

Future In the future healthcare, ecosystem, companies. Healthcare providers, will have to compete on outcomes. With more and more pressure on healthcare budgets, the only way to win this market, will be based on being. Able to deliver the best outcomes, for each of the patients that are treated with, their portfolio, so. You can say that in fact an integrated, digital patient, centric solution, is required. As a kind, of, 360-degree. Toolkits, for value-based healthcare. There. Are multiple applications, along the product lifecycle for, a digital health it, can start from research, for. Instance information. On or data on, digital. Biomarkers. Collection. Of biomarkers. Investigation. Of biomarkers, and. The use of these insights, could, already be very helpful, in research, and especially, also for. Retrospective. Analysis. In. Clinical, development, digital. Platforms, and digital health solutions are, very valuable to collect a patient, information patient, reported, outcomes, but, also all kind of key opinion leader, information. Or investigator, engagement. Also, for real-world evidence, of course or, monitoring, in a broader sense. Also. In market access the role of digital health solution, is very critical or will become more critical especially. To populate, registries. To demonstrate, real, world evidence and performance. Or even outcomes. Also. To collect. Patient-reported, outcomes. And in general to perform value-based healthcare. In. Commercial, there are multiple, applications. For digital health solutions for. Instance as a complement, to a product as more like a be on the pill solution, but, also in case of disease. Management and truly, supporting. Our patients. In reaching. Better health, outcomes. Also. To collect patient-reported outcomes. And real-world evidence but, also to apply, in practice digital. Biomarkers, to support, better disease management and many, more other, applications. Also. Towards, end of product lifecycle. Digital. Health solutions can provide additional benefits. More and more companies, are looking for, earlier. Value generation, and value creation, so, how to create more value around, a product or a portfolio, of products well there are multiple options. There. Companies. Could think about the use of digital health and also called digital digits. Articles, as a complement, to their product or portfolio, but. Also patient, data, and evidence, integration. Is another, opportunity. Together. With the use of digital health in a, complement. To breakthrough. Innovations, and think about gene and cell therapies for example, our. Also, party or, immunotherapies. And, also, to support further funding, models. Another. Option could be innovative. Care models remote. Care but, also a home hospitalization. Where. Literal, platforms, is, a, mandatory component. Also. Conditional, approvals, think. About life licensing, and life approvals. Of products, onto the market and lastly. Also in the area of prevention and early disease interception. Where. Earlier, and. Earlier diagnosis. Can be made compared. To today by, monitoring, patients, status and monitoring. Certain, biomarkers. Or even digital biomarkers, so. These six components. The, six of opportunities. Are. Essential. Will become essential, for value-based healthcare. In further, delivering, and improving, outcomes but, also in general in increasing, value for all the different stakeholders involved. To. Be valuable in fact we. Have to consider, about building. A more generic. Solution. If, we look from the perspective also, of, hospitals. That have to integrate multiple. Digital. Health solution, solutions. It becomes, very.

Complicated, Challenge. So. We have to think about building. A more patient centric, digital health solution, as a kind of platform solution. On which, multiple. Applications. And use scan, can, run. That, means also supporting, the, along the whole patient journey and the, whole product lifecycle, but. Also a. Good. Platform to apply, outcomes, and disease management based. On the collection, and analysis of various types, of parameters, like physiological. Performance, with also mental data. And also. To organize. Care. And organize. Care, collaboration. Or coordination, and of, course also to demonstrate value. And offer. Or deliver value for, only involved players, around, the patient. Now. Looking for. Such further in detail for such a platform or, a solution, there. Are a couple of very important, functions, that have to be supported, think. About patient, interaction, and engagement, keeping. Patients, motivated. To further be. Adherent. To their treatment, but. Also care, pathway, optimisation. In terms of as well clinical. Performance as cost elements, also. Care collaboration. And workflow. Efficiency. For especially. Healthcare professionals, and also. Disease and medication, management, which. Is of course a very important, function in going forward and of, course also data collection, and reuse, of data so. This will be very, important, patient, centric. Solutions. And functions, that have to be built on a digital health, platform. What. You see here on this scheme is an overview of how. Such a platform might, be a central. Use. Or central tool from. Multiple, players, around, the patient of course it has to provide. Collaboration. And coordination with. Care providers, but also with, providers. Of products. Like pharmaceutical. Products or medical devices and it, has of course also to be integrated. In electronic, health records, or in. A patient. Personal. Health record, the. Various functions, that I explained, in previous slides are of course to, be delivered on this solution. In fact the solution can, then act as a digital patient, coach of. Course very much tailored to the individual, patient which means, adapted.

To The, patient's, personal preferences, these behaviors. Motivations. And needs so. That the. Platform can be used a regular, base and can really help and support the patient at each time motivate. Them also to keep on using it so that the, best outcomes, for his treatments, can be realized, so. We can say that this solution should be really, integrated. Into a patient, centric care provision, around. The patient and this. Requires, also a more eCos ecosystem. Approach along. The patient journey. Now. Looking to the last topic which is more on the benefits, of such a solution, so. A couple of things in, fact are the benefits, there are benefits for each of the involved stakeholders. For, patient it allows them to have ownership of their data and participation, also. It provides, personalized, information and, personalized, care and. Personalized information especially, then. Depending. On where they are in their care pathway. Information. Adapted, to their situation and and. What, their needs are but. Also convenient. Access to healthcare professionals if. They want to interact and, also. And. Clear focus on what is most important, to them which is their quality, of life and we could think about integrating. Patient. Reported, questionnaires, or even mobile health solutions focusing. On quality. Of life for. Healthcare. Providers hospitals. But, also individual. Doctors data, integration, and analysis, is, a way for them to further, do care pathway, optimization. But, also in terms of care coordination, providing. Remote care home. Care but, also in terms of more medication, and better or improve medication, management and as, a last point very important, for healthcare professionals also, fully. Integrated, in their workflows, which allows them also to have an optimal, workflow, efficiency, and that, means performing. Certain tasks, already before, a doctor, meets the patient, collecting. Already certain information certain. Data that, makes in fact its. Interaction, with the patient and the interaction between the healthcare provider and the patient way, more valuable and then. The last group, of stakeholders the. Benefits for industry and that can be of course pharmaceutical. Companies medical devices but also, clinical. Research organizations it, allows, them to collect patient-reported, outcomes. And, real-world evidence also. Supports. Industry. To further improve outcomes. Based, on a better disease management but. Also earlier. Value creation, and improved. Patient engagement, so. We can say that the, solution, improves. Outcomes for, all the different players, for. Each of the different stakeholders involved, in, the health ecosystem, so. We can say that digital health solution offers a lot of benefits. And opportunities in, going forward and meeting, in fact the, different challenges. And trends in in the sector. So. Five key questions, for.

Yourself. To ask to shape your own digital, strategy, and become further more, successful. So. You have to think about how can I demonstrate value, to each of the stakeholders. And. What can the role of digital help be in that context. Secondly. Also how, do i leverage digital platforms, to harness, new sources, of data and get insights. In fact to power my clinical research and improve patient outcomes. But. Also as a third point how, can I use digital, platforms, to create new relationships and, more intensive, relationships, there, are engagements. Promote. Further conversation. And interactions, with customers, and, as. A fourth question, also. To consider is and how can i deploy commercial. Engagement model innovation especially. For pharmaceutical, companies and also, for medical, device companies, it's, important, that, new. Commercial, engagement models can, be applied to meet the changing needs of, patients. And healthcare providers and as. Last topic is them to, consider how to navigate this, changing, landscape and, to, gain access to both providers, and also. A greater. Patience, volume. So. That means that there are five main, elements. That needs to be further. Focused, on and we can say this is in fact a kind of. Toolbox. A business toolbox based on five key instruments. That should be used, to become further successful. In the, future heal health ecosystem. Digital. Health can support. To demonstrate, value to each of the stakeholders. Of. Course and it'll help leverages, technology and. Those new. Data sources, to power, outcomes, also. Of course to engage, and enable shared decision-making with, the patient's with payers, and providers and. Also. Promote. A new. Type of commercial, engagement model, and innovate, in fact on the, commercial, engagement model, and last. But not least also to improve, navigation and, setting. Of new partnerships, and collaborations, across, multiple, stakeholders to. Gain access to patients, and and. Provide, the best outcome. For them. So. Each. Of these five, tools. In the toolbox will support, improve outcomes for patients and, also a true consumer, centric, ecosystem. So. With, that I would like to end the, presentation, so. I hope, you find this. Presentation interesting, and I especially them, to. See how digital, health platform, is an essential part of the new business toolbox doing. Business in the future in the health ecosystem without, the digital health component, will, be extremely difficult to. To. Demonstrate outcomes, or, to even compete on outcomes. So. Philippe I would like to hand over to you it back again. Thank. You very much in great thank you so. Dear, participants as already mentioned, if. You have any questions for Ingrid please type them in the questions pane in the webinar a control. Panel on the right hand side and Ingrid. Will answer them during the Q&A session towards, the end of the webinar I'd. Like now to move, on to our second, speaker whose, fan. Sunken-in our CEO. And the foul of annamund seven. Stooges. Yours, so. Yeah I'm the founder of Enderman 7 and, I'm very happy to be. Here with you today I am currently, in, Boston so there's. A lot of snow here and we. Have arranged two national webinar. Today with a part. Of the team from Brussels part of the team in San Francisco, part of the team in Boston so yeah. Thanks thank you tech to technology. To. Show, you to, tell you a bit about a story. Behind and mn7 and why we started all of this we prepared. A small video we. Saw, that it with the, different. Media and an interesting, for you to watch. It's very short it's two minutes and a half and. The. Team will will start the video in in a few seconds and of. Course, I will be here for the or webinar. And I would. Be answering, your questions, at the end of the webinar so as, Phillip said please. Ask. Your, questions, through through the tool and. Yeah. We'd be happy to answer so. Yep. You can talking. To the team now you can launch the video. Explaining. The. Story. Of Enderman to them. Hello.

I'm Vincent, on the founder of under Mancera and today, I want to tell you about the use of an immense event for medical research and for. The pharma industry. First. It's very important, to strike the, right balance between, privacy, and data, availability. So, all, the data that the patients share is, go. All the way through, the consent, of the patient if, a pharma industry is, sending questionnaires, to a patient, the, patient is presented, with a consent, form, which. They have, to sign, and that will, keep, them very clearly. Information. About what data they, will share with the research, with. The researcher, so. It's very important, to have that right balance, now. Why. Is it important, to add another, information. Well to find new medication, it's. Very important, to collect a very, important, data not, only miracle, did that but also real world evidence objective. Data quality. Of life data more, and more patients are chronic, patients, today and some, of them have multiple. Conditions so. This is why Handelman is not a one condition, solution. It's, a global solutions, to allow the connection on schlissel, all that correction in patients, and the research missions, and the reason, is because so, we're going to return some position before those arms. Can. Very important people can't even. Even. As, a plasma if you have a project, if you're a little, jiggle trial to try. And work consistently. Over a transpose, market, study people, Marcus turn people, to contract has more, than happy to say when you get a trial and save money with the trial and is significant. HP here. So. Let's now move on to our third panelists. David Levesque is an, immense Evans VP of Sales for North America, and he's based in Silicon Valley. And. We are now making David, our presenter. And. He will explain you how an immense Evan brings value in the ePro space so, David it's, yours, once. Again thank you much so much for joining us I am David Levesque from man-to-man 7 it's great to be connected with you and thank you for joining us today I'll. Be sharing about an immense Evans current projects, and the benefits of our unique health platform for sponsors CR, OS and patients. N7. Is a unique digital health platform for empowering patients managing. Diseases, and measuring, outcomes it. Is used for clinical trials and care, delivery, for all healthcare conditions. An. Immense, seven works with all data types such, as images, documents surveys. And structured, data the. Platform, handles all data, formats, such as text, PDFs, and video it. Also works with many protocols, such as fire, hl7. And. Codification. Systems such as link and sno-med. Additionally. An immense 7 integrates data from many sources including EHRs. Labs, connected. Devices and of course from patients. This. Diagram also shows that, the advanced health information exchange, platform. Manages. Pseudo, anonymous ation, for clinical trials and non, anonymization, for. Care delivery. Here. Are three screenshots, of the patient's experience, unless. In the left most image you, can see the personal health record that empowers, patients with, access and control of their health information, the.

Middle Screen shows our customizable, ePro. Clinical, trial data collection, ability that, makes study participation, easy for patients CR. OS and sponsors. Any. Man 7 s advanced approach solution, can integrate end points, from, the PHR, such, as images weight and heart rate as you see here. The. Image on the right shows why patients and sponsors trust an immense Evan to manage their sensitive health data, this. Simple green toggle, button shows, how easy it is for patients to control who has access to, their health data, here. You can see the, patient has stopped sharing their data with dr. Jim Jones they, are sharing their data with a pharma company because they're in a trial, and. With their doctor dr. Smith. Nmn, 7 is perfectly suited to help CR OS and sponsors handle, the increasing privacy, security, and, traceability requirements. Through. Our health intermediation platform. Here's. Another screenshot to show how. Easily the app displays, it manages many different types of data, whether. You're collecting sleep steps. Images. And documents and rest assured the annamund 7 will get you the data you need to make your study and treatment a success. In. The men sevens current customers and partners appreciate. Our focus on making research faster, more, cost-effective. And, more patient centric we. Are working with Big Pharma and med device companies, as well as research institutions, such, as the world-famous you RTC. We. Are also helping the European Commission and the US government, achieve their goals and empower patients, health. Data liquidity, and improved, outcomes. To. That end the andaman 7 is a technical, partner on a 7 country european commission project, for interoperability, and. We're also weeks away from launching integration, with over 280, US health system EMRs. Here. Are just a few of the u.s. health systems we were integrating with. Ok. Let's go ahead and take a look at the, patient's, experience in the Animas have an application I'll just take a moment here to bring. Up my phone screen. Philip. Ferm you can see my phone screen. Yes. We see your move are those cream babies, thank. You. So. Here you see I have the app on the phone I'll go ahead and tap on and man 7 and. This. Is the home screen for any patient using. The app and here, you see my record at the top and our demo record which is identified, as Paula Adams when. I tap on Paul Adams you'll see the categories, of health data that she has access to and. Will go ahead and click on drugs where. You can see Paula's, current and past medications. When. I tap on blood tests our test. Results you can see here we have a list of structured. Data from the lab and also images, I'll go ahead and tap on cholesterol and then. Tap on year, so you can easily look at a history of Paula's. Cholesterol, over the past year. Data. Private data. Traceability is of course important, so I want to click on the history I can, know the, source of every, piece of data in, the system. I'll. Go ahead and click back again and take a look at the mammogram, here and zoom, in on the area of interest and. Of course again the history is available here on where. That image came from you can see it's dr. Smith at Sutter Health. So. That gives you a sense of how easy it is for patients, to see and manage their health data in. The personal health record inside of and immense oven and now let's go ahead and take a look at how. We help. Life, science sponsors, in clinical trials since I was invited, to the, trial. I'm gonna click on my record now and. You, can see the screen looks very similar to pollow screen with, the exception, of a tile, down below which, is the you, RTC. Quality. Of life study and here is the study questionnaire, and I. Can easily tap and answer the questions and go to the next screen. And. Of. Course if there's any data that you need for your study that comes from the, personal health record which is attached to the EMR we, can collect that during the questionnaire, as well I'll. Just show you one our screen here and then we'll open the floor for questions. This. Is a clinical. Trial, process. Walking. Through the patient through every step of the trial so you here you can see their profile information, which.

Questionnaire, Is due when at what time and the upcoming questionnaires, and just. One more note for, a current trial that we're doing we. Have built this interface, where patients can. Make. A notification if they have any flare-ups any particular. Experiences. With. Their disease that the, trial sponsor wants to to. Record on a regular basis for instance here they were asking for temperature, so. I can either enter that manually, or get, it from a connected, thermometer. So. This concludes my demonstration for, our presentation, today I look forward to answering all of your questions, and thank, you for joining us thank you, Davies, for. This presentation, let's, now move on to the question. And answers, session. We. Have a few questions that came in first. One from Valerie maybe, to you Ingrid, how. To start with digital health. What. Companies, do first and what next to be prepared I. Think. Companies. Have first. Of all think about what kind of data they need to demonstrate value, or demonstrate, outcomes so, they have to build an inventory of their data needs and. When. They have done that they have to look to where, the role of digital health can. Come in for, missing data that they need in fact to perform, better, outcome, or to do outcome, management or disease management they, can then look to what are them the data requirements, that a digital solution. Has have to provide so. It starts old from of course the product. Portfolio their, specific, product needs the, data that is already available and, the elements, of data, that are missing and that should be the starting point in defining, the digital health solution. Thank. You then, we have a question from Avinash. Which. Is maybe. For you a Vincent. You. Touched upon data and privacy can, you elaborate more on what, exactly is done to enter a user's, data is, owned by the user and used, responsibly by, companies, and how is this different from what it all used to be in the past. Yes. Sheriff so, when the, in demand solution, is has, been designed from, the start to be. On. Those. Two principles that the, gt3-r. Made made very famous its privacy. By the by. Default, and the, security. By design so everything, in Andaman has been has been built around these two principles. Now, the, data that, the, user enters, or collects, is always. Comes. With a trace, of the, data so we know exactly what, data, who. Has entered the data and when he was entered no data can ever be modified, or removed there, is a very strong traceability, mechanism. In in Andaman servant for that and since. The data is collected by the patient, automatically. The, system is very well aligned with, all. The privacy laws right, because all privacy laws, apply. Mainly, to people, or companies using. Data from a given patient or citizen, in our case the patient. Or the citizen, is the one centralizing. The data collecting. The data he is the hub of the system and it, decides, if he wants to share the data there's, two ways to hear they've got either by. By a decision, that the patient is, making. Like for example I'm sharing the data of my, children. Health. Record with my wife I decide, to share it I push the data to, my wife phone. And the, second way is to be invited, typically, by a. CRO. Or Pharma, medical, researcher, actor, or or a hospital and there, they are asking. Permission or. From. Me to get a copy of my data and I will see very clearly on the the Handelman screen what's data and sharing with. With. The. Entity that the, research now. Regarding, the the use that will be done with that of course there's always a very. Strict, constraint. With it, you. Know that GD P R and upcoming. Laws in the u.s. always say that you have to clearly, specify Dwight, type of the task is shared and for what purpose, right if you have to use the same data for, another purpose you cannot do that you have to ask for new concepts, so andaman has been built to be able to provide, those consent, and those recurring, consents or dynamic, consent if you want and to, remove. The consent if you don't want to share the data anymore. Now. Will, the companies use it responsibly well, there is a contract, an electronic, contract, between the company and the patient so. Even. If there's technical. Ways to go around that the the, the companies. Are. Under. Contract, with with the patient so that's how it.

Should Be controlled. Okay. So, another. Question coming from Thomas. Could. You please elaborate maybe for you Ingrid, okay. Could. You please elaborate, on how to manage if a patient withdraws, constants, in the middle of the trial or at the end how, does that impact the study yeah, of course yeah. That's Anita, something. That, will happen from. Time to time if we, apply a complete, dynamic consent. Management. So, in going forward we'll have, to deal more with real-world, study. Says so society. Will ask to more, and more and increase the pressure bringing, products. Faster to market and that. Means applying. Principles. Like, life licensing. And. That, it also requires. Of course more intensive, observation, in the market and, thanks. To digital technologies. This, will be possible in fact to collect more information, so. A typical, model as we see today where we have a closed. Environment, where, we do a clinical, trial and, we will move more and more step-by-step, towards. Life, licensing. Type, of trials with. More observational. Studies. Going forward and we. See that already happening, in the, orphan, drug space but, we will, see that this will be further, broadened, also into, the. Traditional. Types, of medicine. Thank. You another, question for you coming from Serge. Serge. Is asking, how. Do regulatory. Authorities, do digital, health. Yeah. Yeah. So also, for the regulators this is something. New as well for email as FDA as, Chinese. FDA or others so, this is a. Normal. Evolution in the market that new innovations, are coming onto. Into. Application, and. Of course regulations, have to adapt to that now. My experience and, working with these our regulators. And preparing, a new type of regulations, for, new innovations, most. Of the time regulators, are not the key barriers. With. Explaining, how. You are doing things and why this is a better way of working, for. Instance in including. Patient. Reported outcomes. That. Makes in fact the. Case a stronger, explaining. In fact why you do it is. A good intermediate step but, with everything which is new it requires, adaptations. Of everybody, it, requires, joint learning also how, to include, this kind of innovations, and. In going forward, also, regulations, will be more. And more adapted, to this this. New way, of working. I'm. Glad to see that we have many many questions I hope that will address be, able to address many. Of those, and, here. We have another, question coming from Avinash. Who. Is asking maybe for you a Vincent. Do. You have any tips or insights, on how young and scrappy startups. Can. Either compete. Or collaborate, with bigger giants, in the health space that. Are often slow-moving but, still controlling a massive. Proportion, of this space and Ingrid. If you want to comment on the X you. Can. Send that's a good, question, actually. We are also. I thought somehow and we we. Also are been. Confronted, to that. Well. I don't think there is a magic, solution, to that I it's, it's part of the. World that it as a chase there's a large. Companies, being very. Strong. And very stable, and. Moving. Less. Fast of course and there are smaller companies. Moving. Faster, but with other. Features, so I think it's just a question of. Being. Relentless, being, patient and maybe, also joining. Forces and partnerships. Which, may, be a way forward where, we're, by a bigger. Entities. Or bigger institutions, can collaborate, with startups. And guide them through the, process and, making sure that regulations. Is taking. Care, of and and. Opening. Their networks, we, see, a lot of innovation, labs, in in those pharma. Companies, or medical device manufacturers. I think that's that's a good way to to. Bridge the gap between the two of, course it's not a magic. Solution obviously. But, it I think it's a step. In the right direction so. Yeah. Okay. Talk. Yes we're, going to conferences, and innovation. Labs may be part, part of the solution, but in great yeah I think yeah absolutely and, that's also what I mentioned during my presentation, and the fifth tool, in the toolbox that's, collaboration, and partnerships, also. For the big companies, that have a lot of resources. Available not, to look, into new innovations, and deploy them we. See that small, companies true collaborations. With digital, health players, can. Advance very quick here so it's not only big.

Players That can apply, this it's certainly. Also a, very, nice opportunity I believe for, small companies to make big steps that, means to. Make steps in terms of clinical development including. Also digital. Help, tools to include patient, outcomes, which is a very important, element. In fact later on in demonstrating, value for the patient so in, setting up collaborations. Of, more Baltics, with digital, health players that can provide the digital health component, also. Small companies, can benefits, of this opportunity. Great. Thank. You we, have two questions, coming from Olga. Really. First one they're short. So I'll give you ended both, questions at the same time if you don't mind I mean, before you in read also what, is critical in, the lounge preparations. Of a new form a product eg oncology, and our. Next question. Is what is what. Are the important differences that we see between. Those solutions in the US and in Europe, yeah. Okay. So in terms of let's, take the example as, you mentioned they have an oncology product. So. There. Are a couple of challenges when. You launch a product s so more, and more payers. Are. Are. Demanding, for outcomes, based payment. Or performance based, payment, schemes which. Means that you have to demonstrate as, a manufacturer. Of the product have. To demonstrate outcomes. In, practice. In real world that. Means you need in fact a component, to complement, your product, to, be able to collect, this outcomes, data so, in that sense for, launching, a product especially, the first couple of years and for instance in Europe this is very, common, that more and more, outcomes. Based payment, schemes are applied and where manufacturers, have to demonstrate outcomes, for the first two years after launch for, example, well, this allows in fact to collect. This data, sometimes. Also pairs demand, to fulfill, or, to populate, a registry. Well, a digital, health solution also can, be the intermediate. In fact to popper to collect information, collect. Outcome data clinical or patient, outcome data and to, populate, the, registry, now. Your your second, question. How. What are the differences between Europe, and US well, in terms of moving. To outcomes based payment, that's very similar and we see that it might away across the globe and that more and more payment. Based on. I'm demonstrated, outcomes is is, becoming, critical, especially. Then for more expensive products, this. Becomes more of your requirement, so. That that, means also for for US or Europe it's a very similar, situation where, the. Ability to demonstrate outcomes, will. Become more and more important, companies. That do that will, be more competitive will, be more able in fact to. To. Compete with others will. Also be able to demonstrate and, optimize, even. Outcomes. For each individual, patient in. The oncology space, in going for it we see more and more also, combination. Treatments. Combination. Of treatments, now. There are no clinical trials set for that so that's something that has to be observed in practice. So. Especially. For combination. Treatments, being, able to monitor, outcomes or, adverse effects, and, also impact, on quality of life of patients is a, requirement, to further optimize the treatment according. To what, the patients, can have. Okay. Thank, you very much maybe, a question which is related to that and which comes from Marie. And. David you will also be able to elaborate on that but maybe even some can start our. Hospitals, opening up to sharing, the data about patients they have I guess the situation is different in Europe and in the States so that's why I think that both of you maybe. Can can give your views share your views it about that. Yes. Sure so. The question is well, there's. No single, answer to that there's a number of hospitals. Which. Are more open, or there. Are less, open. One. Of the big differences between US, and Europe. Is that in the, US there's more standardization. Coming, up with. Fire interfaces. And meaningful. Use 3 being, imposed to hospitals, what. In Europe there is none of such initiatives, yet and there is no standard, protocol, so the situation. Is a lot more as, catered, in Europe or less compatible, and the. Mentality, of people, also it might be different. Yes carries, is more, private. And with private insurance, companies. Well in Europe there's a lot of Social Security or. Nationals. Social. Security so that means, there's different. Speeds. Of movements, I would say that the u.s. is changing faster, than in, you than Europe and. Probably, patients, change change doctors, more often so there is a more. More. Meaning to to open up the data for. For to patients because they need to take their data to a new doctor well, in Europe there's, maybe. A more. Traditional. Approach. So, those would be some of the main elements I would. See David. What would, you say. Excellent. Points Vince and I would just add that you, know to end, data - to, what you're saying with you, can very clear that Apple and other companies, are enabling, patients to access their data so and and as I showed in a man 7 is also being able to do that and so with.

The New meaningful use as you mentioned, and the fire API is it's. No longer the hospital's decision, whether, or not the patient has access to the data it's simply the patient's decision to not. Only access their data but also download, it have it where. They can then control who they share it with and that's, what annemun 7 allows and that's what the federal government the United States wants, to have happen because they know that the. Slowness, or the lack of mental interoperability. Of health, information exchange, is part, of the the challenge of the high costs, and the low outcomes that we're getting here in the States. Thank. You we received a question from beat Peter. Digital. Health solutions are now often implemented, in hospitals, is, there also, in market for independent, care providers, and if yes how would you approach this. Yeah. I can definitely answer that I think also. I like I mentioned. In my presentation it's. Not just a matter of health, of a pharmaceutical, company or medical, device companies, also, healthcare providers, will have to compete on demonstrating. Better outcomes, or making, a better, patient experience so. Also, for them it's a way in fact to be more competitive. More attractive, for patients and. Hands also to be a better in. A better business shape so, that, gave me four hospitals to make the patient, experience, better. Organized, but, also to support. Patients in collecting, their data prior, to the hospital. Visit, so, that doctors. Can have their, data available during. A doctor, visit but, they're also individual. Individual, private. Practices, can benefits of, that in better. Coaching. Supporting, their patients, whether to prepare, a, meeting, with a doctor or whether to further. Surveil. Patients, in, between. Doctor. Visits. Especially. For home hospitalization. Players this is a, very, interesting opportunity it, allows, them also to organize, and coordinate their, care better, and monitor. Their patients remotely. In a, much, more intensive. Basis than, they can ever do without technology. If. I can add something. There's, of course a big trend which is patient, empowerment and, the the the request from patients, to know. More about their their conditions, and to be, able to follow them up so that's one big trend, but the other big trend is also on continuity. Of care and outside. Outside. Of the hospital so there, was a. Seminar. A few, few weeks ago from one of the large hospitals. In Belgium and they were talking about the. Future of medicine which will also which. Will happen a lot more outside, of the hospital and so they were wondering. How they could establish. Partnerships. With individual, doctors with home nurses, and all, of those actors, first-line, actors sometimes, they're called so. There is a better continuity, of care around the patient so that's another big. Trend that that's also happening. Which, will probably. Have things, move. One. Of the things that's happened here in the state's just in the last year is the ability for doctors to, charge for remote patient monitoring, with the new CPT code so that's one way that the, Medicare. Medicaid is encouraging. Doctors, first-line. Doctors and we care doctors, to to. Adapt. Adopt. Digital. Tools for monitoring. Mireille, is asking is also, a question what, is really important, to take into account if you want to change a standard, of care treatment with, your application. With. The typical struggles of reimbursement, prescription. Need and changes, are decided, by each single doctor and not by hospital, policies. Okay. I. Can. Start with that if you want. So, in fact that's Anita had, today's challenge, and where multiple, doctors multiple. Healthcare professionals, are supporting. Patients on. Different aspects, well, this can kind of care collaboration. And care coordination, across different, healthcare professionals, is indeed a challenge today.

Where. Digital, health can come in and support that is in fact to, provide, information, to, each of the healthcare providers that are involved. With the patients so, that in fact, availability. Of the data all. The time on inciting, the patient and and, the data produced, is. Possible, but, also in terms of how to better, organize. Diagnosis. Or even optimize. Disease. Management, also. There the digital health component can play, a crucial role if, you want to further personalize. Treatments, today it's it's complicated, if multiple, doctors are working around the patient in different locations, from. Different organizations. Digital. Health allows. In fact to, cross. Borders between, the different healthcare providers. And. If I can comment on that, also, and, the man is for, me one of the first if, not the first. Electronic. Health record that has been conceived, as a distributed. System, so. It's a real, strong. Paradigm. Shift, actually. Because. Today. You have EHR. In hospitals, that, send, and receive data to other systems, but, they are, considered. That there are systems as the core as the center and then you have individual, doctors, that have also their own software, and then if you have everybody that at their own system, and they, kind. Of talk to each other not very, well today but it's improving and we created. Andaman as a distributed. System from, from from its foundations. So anybody, around. The patient including the patient including, the the spouse, of the parents, of the patient can. Entered, and of course doctor and the nurses can enter data at the same time and all. Of that information will, be gradually, exchanged. With each other or according, to the access, rights of course and so, the the the distributed. Eh artist, is being, enriched, by several, actors at the same time so, this is real really, a change, of path per diagram for for health. Records so, in that sense that underman is according, to me very different it, has a very different approach, to two other systems, that. I. If. I can also add I would say that, if.

I Interpret, the question correctly I, think it's also asking, around how, do you shift, the standard, of care and I think based on Ingrid's comments with better evidence and. More, evidence, you can show. The doctors that the outcomes are in fact better for your treatment, and so, that's how Andaman. 7 or other digital outcome assessment, tools can help you I think another way to, what's, super important, in care as, we've, talked about a little bit is, adherence. To the protocol and so empowering, the patients and getting them involved in their own care, through, a tool like Andaman 7 or other tools you might use is. By. Itself going to increase, the, efficacy. And use, of your treatment, or intervention whatever, it might be and there's data on this you can look at open notes org, which is a nonprofit, that does research on on out. The effect of outcomes, on the patient's being engaged in their care specifically, related to them having access to their data and so. I encourage you to check that out. Okay. Is, these two two questions, and those are other ones coming in but maybe we are closing, to an end now so, this, question maybe for you. Inglot, how, can you make sure that PR oh are reliable, while, they are not validated, by physicians. Well. In fact a patient. Reported, outcomes, it's the word says itself it's reported. By patients it is just a patient feedback it's the voice of the customer the voice of the patients so, that. Means it's just a perception and the input from the patient so, it's a in. Fact very rich to have this kind of information and it's, not, not. Not. A good thing if a doctor will, overrule, this kind of information that doesn't, mean that the doctors, reported. Information, is, not valuable it's, only that the patient reported, outcome, is then additional. Value, additional. Data that is generated and can be made use, of a similar, to other industries more, and more the voice of the customer is, considered, and in, that sense the healthcare is nothing else than the other sectors, it's, important, that the patient is heard it.

Was Right. Away straight, away with. The, data that he wants to provide how. He sees it and how he feels it. Hey. I can make a smaller comment, on that as a patient myself like, I'm. I, have a leukemia right CML. And I've been on on Gleevec which is a very efficient, medication, for for the past 10 years so. It's very obvious that the clinical, evidence of, this medication, is excellent. Right it works for a large number of patients and the, the and the outcomes are extremely. Good and there's two competitors, - - - that -. That magic pill so. How. Does one, reimburse. Those those three pills. Right because they have they, all have the same clinical, evidence what's. Different. Might be the, patient, evidence, although the real-world evidence is sometimes, called so, if if, the patient prefers one, medication to the other because it's there. Are less side effects or it's, easier to take the treatment because it's only one one pill per week, instead of three pills per day I don't know there's many subjective. And secondary. Elements, that come into play and that's, where the, patient, or the real-world evidence is a implement to the clinical evidence especially. For for. Competitive, drugs we which all had the same clinical. Benefits. Think. About them, I'll. Just add two more resources, to help answer that question further, the, ice poor conference, is P o R is excellent, in providing, resources and data around how, much data needs to be collected for. P ro data and all, data but specifically, bureaus for, to, have confidence in the data and also, I Tom I see hom is a great international, organization, that's standardizing. Outcome measurements, around the world and, showing. The efficacy. And value of patient. Reported outcome data. You. I see, a last question, here from Tom which i think is a, good one but maybe too close because it brings you back to the. Reason. Of being a, venom. And seven so to, to to you. Vincent. The question is the. Push towards patient, centric data ownership, model will it happen or not and what, will drive this why, are we convinced, this will become the new norm. Well. I cannot. Read the future but I sure hope that it will. Happen. I, see, very strong trends. Right. The. The patient empowerment, movement. And the. The request for patients, who have all of their data is something, real and very strong of course not, not all patients once, that but on a large number of patients one that survived. Suffice. It to say that or, to realize a patient, look on on Google on Wikipedia, for information, which, is not always a good idea it has to be a. Commented. By doctors, but at least it shows that patients are looking for information and they want information I can, tell you that in my own case and when my son, Pierre was was diagnosed, with bone cancer as, parents, we were really looking for information, and we wanted to have the best information and we, were also asking the doctors to verify that information so, it's not just pushing. The doctors out it's not at all about this doctors. Have a very important. Role but, the patient also has a elder, the care. The carer or caregiver, of the patients, or the spouse of the close ones also. Have a very in. Have. A great importance, because they can collected, it as, a hub and they can transmit the data from one doctor to another and, and, and make, sure that everybody is concerned, and and well-informed, of the problem so I really, think that the the, exchanging. On that point that patients. Are being empowered I also think that very good doctors, one. Wants that for. Example when my son was diagnosed, with a windsock coma which is a pretty. Rare sickness. The. Doctor was, very, open. And was, even asking, us or.

Agreeing, With us to ask for second advice so. We went to another hospitals, in, another. Country, even in, Paris and our. Oncologist. Gave. Us all, the details to share. With the other oncologist, because they wanted to make sure that the diagnostic, was good. Which. Was critical, because for for cancer obviously. You have to go extremely. Fast and and apply the the best treatment, as soon as possible so if you make, a wrong diagnosis, that it's a very significant. Problem, right, so, in this that case the doctors were who were very open to have a second advice too so. I. Don't. Think that that's it's. There's another way around and then going forwards in that direction I think it will happen gradually, of, course and it's faster, with some doctors and with others but, yeah. It's obvious we we are all working for, the health of patients right, doctors, but also research and family companies, there's. One. Goal right to improve health for for every patient so it. Has to go that, way I think, so. This was the last questions we you received so I would like to thank you all our panelists, but also all, our participants for joining. Us today this was our first. Webinar and we were very compelled, with all the reactions, and. And also with. All the people who have supported, us, in organizing, this first webinar obviously. We hope that this is the first one in a long series so we, really look forward to receiving not, only your feedback, also any. Ideas, that you may have about topics that you would like us to to. Address during upcoming, webinar so please do. Not hesitate to send us an. Email with your feedback, if. You are interested, in having a demo, or test. Drive of animun we, are happy to organize that for. You. And. Again we, hope to have. Contacts. With you soon. We. Want we invite everyone to download an immense heaven from from, the iTunes Store or from Google Play it's, available for you and your family to use as a resource for free all, over the world it's been downloaded by in, 35 countries it's, in 20 languages so wherever you are in the world today if you. Are, caring for someone or caring for yourself feel free to download the app and use it for free. So. There's a good webinar, for today Vincente anything to end. Not. Especially I what. What David. Just said is very, true, so install, the app the, app for yourself and your your close one your children and so on and if, you are in the pharma, industry or, medical device industry, then you may be, also interested, in seeing what's specific, about and demand.

For For that industry and for that you have to contact us there's an email there on the screen but, you can also contact us to through, other any, any means you find and we can invite you to a demo. Clinical. Trial so you will see how andaman can combine, both, the. Interest, of patients managing. Their own health and the. Interest, of the research industry by. Collecting, data. From. From the patient, from the connected devices from, the EHRs, that we are compatible with from. Any kind of source of data, lab, results, or so. Every. Participant will receive two more an email with the link to the recording of this webinar and, also to the documents, that were used in support of the presentation, so. Again. Thank you very much and we, hope to see you soon bye-bye.

2019-02-20 03:41

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