Good morning, good afternoon. Depending on from where you're calling and I'm Hilde Vanaken and I joined TCS now already one year ago as head industry leaders, life science and healthcare. Coming from a background of 26 years at the pharma in various leadership roles. Now I'm extremely excited to have the opportunity to present here at the Clinical Trials Europe fifth world Conference on how smart medication can enable through patients centricity because this is also a topic extremely closely to my heart and where I had the opportunity to really lead several first of its kind transformational initiatives in digital label smart packages direct to patient supply in my earlier role at J&J at Transcelerate and now at TCS. Now let's get started. Now first of all, what are for example two key drivers in patient centricity And we see on one hand technology and partnership, 2 key drivers that need to merge together to really enable through patient centricity. Now if we look to technology, we have categorized in two clusters or two layers as you can see in that house. And the first layer is really about technologies. That can incorporate clinical trials in patients, personal life and that of technologies like E consent, wearable telemedicine and so on. And then the second layer of the house is really where we have those kind of fairy novel technologies like artificial intelligence, machine learning, cognitive analytics and so on. And where it moves the clinical trials or clinical research really to another dimension. Examples are for example preventing, so using for example. Then there are changes in the intonation of voice that you can start picking up that there is maybe a change in the patient's condition and a side of an investigator can connect with him and maybe prevent it from occurring a certain event. A second is for example, embedding, because a clinical trial, it's of course very important that with the embedding we say bringing also the healthcare systems in hospitals and so on much more closer or integrating them with the clinical trial systems. And the third element is for Russell's Oak Menting. And that's because there is no such a huge amount of data structured, unstructured data available. How can you use all those novel technologies to really drive novel conclusions, novel decisions. And that's really where we see this is about moving clinical trials to the next or the other dimension. So that's on technology now on partnership equally important. For enabling through patient centricity, there are some partners there included and we're really say it's not about only developing clinical trials for patients, but develop it with patients, develop it with all their stakeholders really from the design phase, so early on and then involve them along the whole pathway examples for example or one core player. There is also ethics committees, health authorities and. Where I had also, from my earlier experiences when going to a lot of health authorities, ethics committees, discussing E consent, where we can really pick up often many misunderstandings that they have about the tool, as well as also pick up items that you had never thought about and that you need to include in your design. Now as we all know, the situation where we are currently in the pandemic environment test has enabled that lot of technologies and partnership now move to the next level. And I also recently published in Pharma Voice and also if you want there is also a webinar, recorded webinar available via our website only. You have clear on patient centricity. Now what are some challenges in mitigation And here are a few challenges in the medication and medication adherence. Huge healthcare issue still at this moment, because if you look for example, on average around 200,000 patients only in Europe every year die because of incorrect medication intake. Or also if you look to the clinical trials and much more structured environment there also we see that after one year there is a drop of 40% in medication adherence. The limited real time insight physicians size don't have insight on what is happening at home. Limited personalized support to the patients, no preventive support to patients. Complex and incomplete medication instructions also very important one because currently traditional and from those multilingual booklet labels are used which can go up to 60 pages. Because for each official language you need to have a label within a patient need to scroll to find his label and once he has found it he cannot read it because the font is too small. So very complex instructions we are giving. Many manual activities are on many systems involved, lot of data and there's a lot of paper involved at this moment. Still. Also accountability remains one of the top five inspection findings. And lastly medication is currently also still prepares to study specific level meaning a high supply waste, so around 20 to 40% of medication prepared for a clinical trial never reach a patient. So a lot of challenges now how can technology and partnership enable through patients centricity as well as resolve several of those challenges. That we had and that I listed on the previous slide. Now this slide, first we focus on the technology and it's categorized in three domains. We have medication kit tools as technologies, as smart technologies. So these are technologies really linked with the package of the kit itself. We have that the medication engagement tools and we have there at the right side above the integrations. Now, if I look to the medication kit tools, there are three core tools, for example, listed first of all the digital label. So instead of that lengthy multilingual booklet label, provide just one label, easy accessible, fully integrated in the patient's own language on his phone. The second tool is for example kit tracking, using scanning technologies to really automatically verify, register, track, control all activities of a kit or of a package along the pathway. So no need anymore for anybody to try to read the small kit numbers, use scanning devices to control the right kit and has been taken. And third item is the pill unit tracking, that's one level deeper and that's for example where you're going to track and verify and register at the pill unit level whether the right pill has been taken and tools which can be used for that or for example smart package tools. Smart packages is the traditional package where electronics are circuits and sensors or added on top of it. So when so that every removal of a pill or a unit is automatically. Highlighted and here. Of course adherence can be a lot improved with, but also a lot of those manual activities can be eliminated. Now we'll go in the next slides a little bit more also in depth in those mitigation get tools. If you see the lower part of the slide, the medication engagement tools. Personalized notifications so personalized treatment notification not only saying take your medication but please take 2 pills with food at 10:00 o clock et cetera. Those kind of notifications can really help a lot of patient with adhering to his treatment regimen. Smart questionnaires for example linked with smart packages and the smart packages is indicating that a pill has been. Pushed out in the wrong window then automatically and additional questionnaire can pop up that ask a reason of this non compliance. Multimedia voice enabled also very core elements that can be used to increase the understanding of a patient like for example, because currently a lot of the technologies are reading or writing but using voice, using audio and so on like audio labels to help also for example, visual impaired patients to better understand what they need to do is very, very valuable. Also complex medication instructions like how opening a child resistant package or how administering a difficult medication can be really enabled or better understood by using a multimedia video. Behavioral insights As for one they are listed and that's one which is going to the level of preventing. Also activities like for example by analyzing the medication intake or how they are responding on notifications you can start picking up early changes in behavior and we had an alert can be sent to the side to interact with the patient and he came for example, maybe prevent a dropout. And has lost medication engagement tool we have there the smart side assistance and that's just because it's of course the patient is the center but also provides size the investigators to nurses easy to use tools dashboards alerts to help them support in their work with the patient and their interactions with their patients. And then as lost course, smart medication technologies is also the integrations. On one hand, because there are so many tools, so many stakeholders also available or a part of the medication and the main and like for example the manufacturers, the depots, the couriers, the size, the local pharmacies and so on, which are all using their own systems, often there are the RTSM systems, EDC systems on the label systems and so on. So seamless integration between with the between those systems is very important to really avoid all those double data entries, those inconsistencies and so on. And this then also integrated of course with the medication kits and providing the information via unified portal or unified app to the patient. To decide is also a very important enabler for patient centricity and to enable also that smart technologies can be really fully rolled out. Let me now dive a little bit more in depth in the three smart medication kit technology. So these are really the technologies linked with the package and this is the first one, the digital label. Now the digital label is one of those. features, which I think of which the value is often not at level of patient centricity, is often underestimated because I'm providing dosing information in an easy accessible, easy readable, all-in-one format to the patient. Is phone can really bring so much value, so no need anymore that they need to try to read and look up where. Is there a label And then they see that there are not all information is present because there are links towards and all the documents for their dosing instructions. The investigator need to write manually on the paper label the subject ID and so on. Very yeah non user friendly label we have currently with this digital label and this can be really enabled and make it much more patient centric also the label always having the latest. Version available on your phone only. One label in the own language is so important. And even on top those labels can even even include an additional quality control, because you can say the integrated label is only. Visible or ticket number is only pushed to the integrated label once it's confirmed that the right kit has been handed out to the right patient. So an extra control step also one hand to ensure that the right kit is given to the right patient, because only then the right label will pop up. Second one to go a little bit more in depth in is the kit tracking kit tracking. So really using scanning technologies to track and verify the flow of a medication. When it leaves the manufacturing unit arrives at the depot with sent to local pharmacies, size patients and so on. Tracking this by using a scanning technology instead of. Basing what is currently done on reading the kit number or trying to read the kit number of a package which is often also very small font and which also often resemble often want to another. So using a scanning technology and that can be very simple standalone scanning device that people attach to their PC or using the scanning technology of the smartphone or the tablet. Using this to verify that the right kit has been picked up and. Given to the right stakeholder and at the kit level, this can be barcodes, this can be QR codes, this can be Bluetooth and NFC. Any identifier in the kit can be used for that scanning technology. And also important for kit tracking is the integration with other systems, so integrations for example with RTSM system, but also something that I highly recommend to always in my role. Transcelerate E consent plus to integrate it also with E consent so that only a kit handout can be done in case the E consent has been completely finalized and all signatures and so on are in place. So also a very important patient technology here ticket tracking. And the last one to go a little bit more in depth is the bill unit tracking. So really about verifying on the level of the medication intake or the pill unit intake removal or intake from a package to this level, automatically verifying and tracking it, registering it. And there are already quite some small packages available on the market. There are blisters available, bottles. Availables Inhaler transform available also working via different technologies. It can be Bluetooth, NFC and so on. And here also integrations with other systems is often very valuable like with RTSM with EDC system, so that also the data is immediately also pushed to those other systems. Now a big advantage also or what many smart packages have is that they automatically also analyse, so automatically analyse whether that bill removal for example was done at the right timing was the correct dose and if not immediately sent alerts to the side to the patients so that proactive actions can be taken and lost item also of those smart packages, most smart packages currently also have. Temperature and storage conditions included, so that not only removal of pills are tracked, but also whether the medication is still stored at the right temperature. So prior to taking the medication intake and automatically scan can also be done or an automatic analysis. This mitigation is still at the right temperature and has been. Missions. So this is all about the right pill unit to the right patient at the right time. That was on technology. Now coming to the second key driver in patient centricity, the partnership and here you see a few partners listed heavily involved in medication got medication that technology suppliers I talked already about them now also here patients and sites involving them from the start from the design in technologies in input when you are creating. Something is so valuable and you see here at the picture at the right side, which is a picture of our TCS user experience lab and where we have brought patients together to really collect their feedback on smart blisters, digital labels, the personalized treatment notifications and so on. And this is really extremely valuable and even you can in these kind of forums also use technology. The off month the feedback of the patient because when you ask them certain items then you can for example see with their eye movements where did they expect it on their phone to find the information. So you can even on top of their feedback also collect other feedback and even augment and improve further your app development, your dashboard development and so on. Other partners they're listed are for example on the home nurses, the couriers very very relevant in the current situation where a lot of direct to patient supplies are taking place and has lost one. Also this the theorem once again health authorities and ethics committees because yeah, it all core players also with from own experience discussing a lot of digital labels, smart packages with individual health authorities. It's so good and important to collect a front and feedback of them and then to really include that also in your final submission package for these kind of novel smart medication technologies and sent it to them. This was a lot of theoretical examples that I gave here on one hand, or you might consider that or theoretical examples. Now what is it in practice? Or where are we and hence why I listed here a few? List of top ten pharma companies. Actually EXPLORE Executed conducted several of those technologies and one of the first studies even conducted with smart blisters was for a phase two Alzheimer's study. By using the smart blister, 2 wrong drug intakes were taken up because the patient had doubled his dose one day because he had forgotten it the previous day. Now by doing that and by using smart lists, immediately an alert went out to the investigator. The investigator could immediately also connect with the patient and re explain the dosing instructions. Now another core item or that second bullet which is often brought up is about all the smart technologies. But what about the elderly population? Will they be able to comply with it? And we have performed the study in an elderly patient population, it was in several Asian countries and where we could see that by using even the personalized treatment notifications and the Diaries which we were using here, that we had an increase. Or that we had plus 90% medication compliance and it was also still there after six months. So also the elderly population is very open for using those smart technologies. Of course, take into account you need to give them very good instructions, hands-on and easy to use training material because they might not be so familiar with using all kinds of different apps. Third one also based on customer stories and experience. By using technologies like the scanning or the smart packages, you can really remove a lot of those manual activities, inconsistence, double data entries and systems and so on. And it could even go here also with an 80% reduction and on site drift monitoring efforts, so the site doesn't, the monitor doesn't need to go anymore. On the side to control a lot of paper documents and this is entity right, etcetera, etcetera. The 4th one also an interesting one and that was where for one of the customers where we linked the RTSM system with the kids scanning system and where we could pick up around an average of 10 kit assignment errors per month so that the investigator was for example planning to hand out a wrong kit or he also performed wrong data entries. In the autism system now with adding that additional control with the scanning device on top of it could be avoided 10 Get assignment errors. And the last one that they get the label, yeah, and I think I already mentioned that also if we collect feedback from patients on the digital label and that was done across several customers, it's often highlighted as one of the most valuable features. And with this I'm coming at the end of my talk. I hope this gave you a little bit insight on how smart technologies together with partnerships can really enable through patient centricity in the mitigation domain. And yeah, I hope you would all that you all also are very open to join us in this journey and to make things which. Previously were maybe thought to be impossible, possible because this is a domain with huge amount of opportunities and I hope you want to join us in this journey. Now in case you have any questions on this talk or also want to know what we are TCS or for example offering in this domain, feel free to contact me. You see there my e-mail listed and happy to answer any questions that you might have. Thank you very much.