PharmaLedger: Bringing clinical trials into the new age with blockchain
European Blockchain Convention·Sun, Oct 9, 2022, 12:00 AM
PharmaLedger: Bringing clinical trials into the new age with blockchain. For more info about PharmaLedger, please visit: https://pharmaledger.eu/ Speakers: -Disa Lee Choun, Head of Integrated Clinical and Operational Analytics - Janssen PharmaLedger -Francesco Spoto, System Support and Integration Manager- Novartis PharmaLedger -Kristina Livitckaia, R&D Project Manager, Centre for Research & Technology Hellas - PharmaLedger -Stephen Leiper, CEO, Onorach Clinical - PharmaLedger -Baldwin Mak, Leader Strategic Feasibility and Manager Clinical Trial Portfolio, Boehringer Ingelheim - PharmaLedger
Transcript
[Music] hello everyone i hope you're doing great now i would like to welcome the next session the next panel on bringing clinical trials into new into the new eight with blockchain from farmer ledger we've been working with farmer ledger since early last year very exciting uh farmer and health consortium i'm now going to give the word to diesel he's the moderator of this panel welcome on board welcome on stage victoria and hello everyone um yes my name is lisa li jung and i'll be your chair for the next hour so today we have a very exciting topic as victor mentioned we will be discussing on former malaysia bringing clinical trials into the new age with blockchain so i'll prove a brief introduction about me i'm the head of integrative clinical and operational analytics at jensen a johnson johnson company and i have over 15 years of experience working in the pharmaceutical industry involved in digital transformation strategies i also have led many various teams in the research and development area i'm proud to join informa i was a co-founder for an ic company and i have been a member of pharma ledger since the beginning so i have been co-leading some of the use cases but also i have i'm also been co-leading the fuse blockchain work group and the interesting part is that some of the use cases have been fair across so that's uh that's great to see that collaboration between pharmacology and other consortiums so today um we'll be discussing that and i'm joined by a panel of experts and they're also my peers working in this exciting project so first of all we have a stephen ripper who is the ceo of anarch clinical a clinical research company managing clinical trials worldwide for clients and conducting clinical research mainly in phase one to four and medical devices and steven began his career over 40 years ago in cells of diagnostic products to clinical labs and he later developed his skills in identifying commercially available molecular products and tools to assist academic in cutting-edge clinical research and work for some of the largest molecule research companies so steven set up onarak back in 2009 and has a long-standing interest in digital data and improving clinical trial process he's also a qualified histologist graduating from the university of sydney and he is a member of the royal society of medicine welcome steven we also have balwin mack who earned his phd in biochemistry and postdoc training oncology he's a digital expert in clinical development and operations clinic of excellence or center of excellence sorry digital labs at berlin ingleham so at bi he is part of the digital labs team within the center of excellence for digital transformation in clinical development and operations prior to this following was part of the clinical operations leadership team at bi canada where he was responsible for assessments of new clinical trials in canada and also their diverse team of clinical leaders and managers bowen led a pilot project ex to explore the kind of clinical trials on blockchain with collaboration um between bi and ibm and currently he serves as the industry co-lead on the pharma use case e-consent next we have francesco's photo francesco is a has a biomedical engineering degree and he's also a emba candidate in 2022 he is the global clinical supply project manager novartis i'm co-lead of the clinical supply chain use case i'm from a ledger and from francesco is a senior life science professional with broad experience in consulting and pharmaceutical companies and he has been managing several in innovation initiatives across europe standing from former r d i t and quality and he's also an early adopter of private blockchains and last but not least we have christine david cayenne she is a r d project manager and a postdoc has a postdoc researcher or does a postal research working at information technology institute center for research and technology helles in other words cell certs iti so christina earned her phd from the aristotle university of thessaloniki hopefully i'm pronouncing it correctly and has an interest in telemedicine and health and e-health also master science in economics and she has experience working academia the industry and already facility in several european countries for the past eight years from projects and product management to execution of scientific work and running and mentoring startup companies so again welcome everyone um and it's again i'm happy to have you all here before we start with this discussion and the panel discussion to share the experiences uh with former leisure um we thought it would be important to dive in into you know what is farm religion what we're trying to bring here so first of all uh formulator for those who are not familiar is part of the innovative medicine initiative it's a consortium of 29 partners so it's composed of pharmaceutical companies hospitals universities patient organizations and also technology companies and we are building a scalable and sustainable blockchain based platform so validated through a use cases in three main domain areas which are in clinical trials health data and also supply chain and this is partly funded by eu and also pharmaceutical companies with a total of 22 million euros and it's a three years project and currently we are in year two so with this said i will hand over now to stephen who will give you a high-level review of the use cases stephen thank you desa um so as as these are said uh what we've done with the project is we've um focused in on a number of use cases that can uh benefit from the the use of blockchain in digital health and as you can see from the screen here there are eight use cases some of which um fall outside of the scope of clinical trials such as anti-counterfeiting but i wanted to talk particularly about how not just the individual use cases are being developed but how as a clinical research organization we see the big benefit of this is that by linking the individual use cases with some of the leads that you will meet on the panel in a few minutes by linking all of those in the process of clinical trials this creates a very powerful uh set of tools that we can use which dramatically transforms the whole clinical trial process so key to this is a use case on clinical trial recruitment which is a very different way of approaching how we might engage with patients and and participants in clinical trials there is the consent use case which it goes beyond the traditional uh formal requirement of consent for a clinical trial and and gives patients control over uh post use of things like specimens and stuff like that [Music] after a clinical trial and then there's uh the clinical supply use case which again um kind of started with a blank sheet of paper and and we looked at how we might do things very different in terms of supplying the components that are required to to conduct the clinical trial specifically the drugs but also some of the other components that are important in a clinical trial and then even if we look outside of the classical sort of clinical trial components of pharma ledger we look at something like e-leaflet which is originally the idea behind that is to replace the leaflets that you get in a packet of medicine whenever you open a pack of medicine you have something that tells you about you know how to use it and everything like that but this is actually because it's um an app that sits on a mobile device it's actually a very powerful way of engaging with patients in a clinical trial to give them the instructions that they need for the investigative product on the clinical trial and because it's an app it's a two-way thing so it's a great tool for us to conduct pharmacovigilance in terms of ensuring patient safety and it can even be used as a patient reported outcomes so there can be some feedback from the patient in terms of what's happening with the with the drug and then there is uh the medical device iot um use case uh which is as it says there this is the only one that specifically focuses on medical devices but again it takes advantage of the power of not just blockchain but other things in order to gather real-time data in clinical trials and when we combine all of those components then that creates something that is extremely powerful in in terms of transforming how we conduct clinical trials at the moment that we believe will be of benefit to not just sponsors but to patients in being involved in clinical trials as well and i think the first of those that we're going to talk about today is the e-consent use case so now i will hand over to baldwin who will talk to you about that so thank you steven um and thank you daisa um so as steven um mentioned he he talked about for the four use cases that we're looking at informal ledger around health healthcare clinical trials and really early on within farm ledger it was recognized that that a key enabler of a lot of these processes especially around healthcare is the consenting element so so the e-consent use case is a critical piece in all of this because as we see in our environment right now especially around the the change in in in our digital world there's a larger emphasis on um customer engagement customer ownership of of of their data so we believe that that it's really important to be able to engage our customers or the people who are actually in the trial in a very direct way and so why why are we looking at blockchain and clinical trials um and for those who may be familiar with that industry and and what how how clinical trials are conducted um they're very manual right now um they can be complex with different systems that don't necessarily interact so there are systems processes that we've built in to address some of the issues that we see such as non-compliances consistency of data and things like that so things like manual checks um and and duplication of uh and transcribing of data from one system to another um and we believe that blockchain can help us with that by creating this central ledger of things that happen within the clinical trial environment the other piece is that it can increase the level of transparency and data integrity within all the stakeholders in the clinical trial as you can see in the diagram on the left and so so if you look at some of the annual reports from from health agencies such as fda and nema one of some of the most common inspection findings greater than 50 percent really speak to inadequate processes to ensure quality accuracy and completeness of data and then five to ten percent of the of the findings are related to non-compliance as a protocol and two to seven percent um are related to uh icf for informed consent issues so we believe that washing can really help to address that um by by reducing and ensuring and reducing the non-compliances and ensuring that quality and so the the e-consent use case is really um not specifically about the consenting per se but it's really around the managing management of the clinical trial and how you conduct it and so what you can see here is it's actually um because e-consent or consenting is an enabling piece um what we've moved for forward with is combining some of the use cases so you'll see here that we're talking about e-consent and how that the implications that i can send to data collection through a device such as iot and what can happen with the data that's collected afterwards so the personalized medicine use case so the vision here is to provide digital solution for clinical trial conduct by leveraging the status of the informed consent on blockchain um and by doing that you can enable automation of processes like data collection appropriate data collection appropriate visits that should be done and the use of that data and so what does this mean to the key stakeholders so we i've shown here three of them the most important one is the trial subjects so this will hopefully increase their visibility to what's happening in the clinical trial and allow them to have some ownership and be a partner in the process of a clinical trial so i think this is a really really important piece moving forward in clinical trial and for clinical sites it can it has the potential to increase efficiency and speed clinical sites would have the confidence that what's being done the material that they're being used is going to be what it should be and then as from a sponsored perspective we see the value of speed so ensuring data quality and compliance and the automation process can replace some of the manual processes processes that we have now in clinical trials and on top of that we see a benefit in being able to access data that we don't necessarily have access to now through this permissioning process so essentially this is what we're trying to work towards within farmledger with these three use cases and we hope to have a pilot by the end of the year great thank you so much uh following for the overview so with that said um and thank you um as well stephen so as next we will now uh go into some of the questions uh for the panel and um one of the first questions we have is regarding you know what is the value for pharmaceutical or industries to come together in this project and and that's something we we've been asked frequently so i will hand over to francesco if you can start yeah sure lisa and hello everyone and hello to the audience i'm very glad to be here um as colleague of one of the use cases that is looking at improving and enhancing the way we run clinical trials and specifically the cli the way we manage clinical supplies i think the major benefit of joining a consortium is possibly twofold on one end you have a sharing of risks and costs and that's very important when you do the discovery phase of your journey where you really come together you you're not working with a super mature technology uh you're working on blockchain that is coming to fruition but you still don't have a lot of standards that are um accepted across the board so you have to still to explore and that can be lengthy and expensive that's definitely one element but the second element is really to drive adoption from the very beginning uh through collaboration so making sure that everybody has a common understanding a common way of calling things and collaborate towards a common objective that may not be the objective of a single actor or pharma sponsor but can be the objective for the industry so in our use case what we gave ourselves as an imperative is provide value to every single actor that we involve from the pharma manufacturer down to patient clinical sites and regulators so we want to give everyone the incentives of adopting a one-stop-shop solution to manage clinical supply across the industry um christina anything to out of manchester yes hello everyone of course always something to add so um actually i wanted to pick up the thought um and what started by uh steven uh the flow and the synergies of the use cases i think it's important so um i'm also collating the clinical supply use case and together we have a panel of um them colleagues of different use cases that somehow is mentioned related to the um to the clinical trials and this is actually uh highly important because when we consider the clinical trial it's a very um complex process that involving many sub-processes uh its own stakeholders involving the patient on different levels granularity with different objects objectives um and how the patient involves in generally so i think that one of the approaches that we follow first of all to start with is we're trying to split this whole process in the clean in them use cases and then going deeper to investigate and study them scenarios under each of the use cases for example what mentioned by francesco was a fantastic point um meaning that we try to bring value to all stakeholders involved and in order to do so we need to investigate not only the use cases but all the possible scenarios that might appear uh within the specific use case and those are very unique to different stakeholders so for example speaking of the clinical supply chain which we have for them sponsors we have couriers we have clinical sites all are looking for them utilization let's say of the blockchain solution from a slightly different angle because they're looking for the support and optimization of their processes that are very unique of course it starts all with a sponsor indeed um let's say it's a controlling point of everything is uh um on track um however um when we talk about utilizations of systems they should bring value otherwise they will not be used and actually speaking a little bit of our experience while the development we can say that taking care of all the requirements from the stakeholders that's one of the key aspects uh to be handled so that's something that i don't know if this can be used as a recommendation though so we start with a baby steps splitting and then investigating all the scenarios and then um going down to the all stakeholders thank you christina yes you have a value point i mean and and also francesco um i think um you know having a consortium like this that we're able to kind of like program partner is so critical because we also you know sharing lessons learned as well uh following and stephen anything that you would like to add to this so hey steven yeah so from our position as a clinical research organization it's actually quite interesting to see the the collaboration of all of these pharma organizations who essentially have independent agendas in terms of what they want to do but it's been really useful to identify common challenges and and to identify the key things that we think will will be quite uh will be of most benefit from having uh adopted blockchain legion technology uh and so i think that's a really powerful aspect of uh all of the pharma companies coming together with this from our point of view we see that there's a lot of common discussion about the vision of what we're trying to do we started with a much larger set of use cases and we honed those down to the point where we had the the eight that we thought were going to benefit most from uh blockchain ledger technology and also the ones that were uh common as challenges within uh within the pharma companies and there's a um for me i think blockchain has the potential to be a transformative technology in our entire industry um because of the of the decentralized nature of blockchain i think it's also really important to have all the key stakeholders in the industry be a part of this transformational change so the value is really to have all the key stakeholders and it's not just pharma it's patient groups it's hospitals it's um it could even be regulatory bodies um every touch point that's in healthcare it's really important to to have their element and their contribution to setting up what the future of healthcare can look like and the other piece of the passion as i sort of spoke about is is the power to connect and automate um because we have so many systems uh between the different stakeholders the value of having the different members in pharma ledger really helps to standardize what that's going to look like in the future all right following and and steven uh i like what you mentioned about you know um having this solution basically focusing on what values they bring to different stakeholders and it's so important that you know in this consortium we're bringing the right people the right um i would say well i would say stakeholders because it's from patients not just on the farmer's side or or the clinical researchers side um the scientists or the technologies but it's also building what the future would look like like you mentioned about something transformational like this type of solution that provides that transparency um in terms of how we conduct clinical trials but also that extra security level that you know blockchain provides and uh potentially basically um helping patients in the in this healthcare ecosystem that you mentioned following so i do agree this is very um again this project for me it's a very interesting in in the sense of there's so many um great cooperation that's happening across the board and the openness because usually like stephen you mentioned usually there's not that type of collaboration but we see this and it's thanks to this type of technology where everyone comes together and think about okay these are the same issues that we have in the different uh companies you know regardless um this is great so thank you um so my next question is regarding the adoption and the experience and of course you know one of the questions that we get asked all the time is you know is formulated you're going to do that and um you know are we going to when is the earliest that we can basically implement formulator in our companies um so i just first of all want to touch on you know what's your experience so far because i know some of you have done proper concepts i mean you can just share your experience on that and how potential that could lead to adoption and how potentially this could you know support formulator going forward um i'll handle refers to uh following may you want to tell us a little bit more about your e-consent project yes thanks i said i was just having a bit of a coughing excuse me oh sorry it's okay um so yeah we found some experience at bi with with single blockchain and clinical trials um we did a pilot um coming out of canada in collaboration with ibm about two or three years ago um and mainly it's it's to test the um the value that it can bring to uh reducing non-compliances reducing costs and also uh very importantly um user engagement and out of that study um we had about nine patients uh no sorry 12 patients uh participate in the blockchain element as a subsidy in the clinical trial um and and we also had monitors monitor the data through the blockchain platform that we had designed and we saw the potential for time and cost reduction and we also had really amazing feedback from from the end users specifically um the the patients and the clinical sites the patients really felt that they were uh involved um they could see what was coming up next in terms of the clinical trials and what was expecting of them for the next visit that that they um that they had to come in for so so i thought that was a really um key and important first step for us as a company to look at blockchain and i i hope that that had sparked additional work in this industry on looking at blockchain when we started it in 2018 i don't think there was a lot of visibility on blockchain but since that time this has been so much done with through fuse through pharma ledger and a lot of the different pharma companies have started to look at blockchain as a as a as a viable next step but i think there's also activity around the clinical trial supply space and uh recently bi has put out a press release on using blockchain for anti-counterfeiting so that's something that we're working on as that's well thank you thank you following um in terms of like uh based on this uh pilot uh any next projects that you are able to share uh or or adoption if if that's the case yeah so so my project with nbi sort of led me to pharma ledger so that's why i'm i'm part of the the consent use case here um so hopefully out of the work that we're doing right now at pharma ledger that will bring us to the next step to broadening what we hope to do so as i described in our use case we're sort of doing the same thing looking at using blockchain in the clinical trial setting managing clinical trial conduct but now we're we're expanding it to look at collection of data and secondary use of data which we didn't do in our pilot so it's been an evolution of an extension of what we've been doing within bi thank you so much for sharing that um and christina i know you mentioned as well in the past about some of the proof of concept that maybe you can also share a little bit more information on the projects yes of course uh well actually i wanted to start um to support the discussion on the adoption if if possible with some um study results that we got so as earth we are part of the uh european blockchain observatory and forum uh supported by the european commission and this is our time to produce the health care and covet report and of course um this massively include the cases um and the use cases of the uh pharmaceutical industry uh of course starting with a clinical um in general supply chain so interesting point um from this report because we we run some surveys uh targeting uh the experts co-working um in one or another way with blockchain and healthcare and we try to investigate uh rather the people i believe people their professionals believe that you know the adoption is uh feasible within the following five to ten years and um the majority i mean it's nearly 80 percent responded to yes and um that actually um interesting uh point of the discussion on its own but i wanted to lead to those 20 who said no and then we further tried to investigate what are the blocking points so today you know we um why i try to touch this subject upon because we discuss generally the proof of concept and many companies in the big pharma the smes um research institutes to trying their best towards proof of concepts are trying to and this is absolutely normal stage or process because we're trying to discover uh what within the blockchain you know what technologies what applications what kind of utilization will work for each specific use case because it's very unique um on its own we cannot compare let's say clinical supply or consent right those are completely different uh flows but we could of course merge so and um coming back to the investigation what would be the blockers i will operate with those that i achieved more than 80 percent of their votes so those are the policy considerations uh which is of course always that i think the policy somehow could be considered as a on one side a blocker on the other side facilitator it depends of course but what um also brought my attention to is the adoption by end users and which is also might be linked to the fact that the stakeholders potential stakeholders might be not informed or aware of such solution but the one of the most popular answers nearly 90 90 something 90 something percent answered uh selected this question uh answer that was um a lack of knowledge or training and i wanted to share this with the audience because i think that even though we live and we um experience this uh very innovative um stream of exploring the technology still imagine that 90 of professionals working in this domain exactly believe that their you know lack of knowledge train that blocks uh the adoption so um i don't know if i answered the question um i think that it's it's important to move on but i wanted to highlight the fact that it's also important maybe to understand and facilitate the um educational learning processes because in the blockchain we have many technologies solutions frameworks to be used right because we say blockchain but what does it mean back there i mean diving a little bit deeper so yeah i think that that would be a point to share concerning the adoption christina you bring a very good point because i mean that's one thing that um some of the other concerns i mentioned earlier that fuse the the first point that we wanted to do was create awareness because we realized that a lot of decision makers yes they're they're more like senior level they might not know the details of you know the technologies and then and the the advancements in this case uh like this type of like emerging technology so it's almost down to you know people like extra scenario where you know be able to inform and then bring awareness and i think through this for malaysia of course that's what we're trying to do i mean i think the former ledger project as a whole we have a workshop with who's basically creating all these different type of materials that we can surface as well through the organization within organization to inform you know what are the potential use cases because what we need to show is the value at the end and i know a lot of times we get the the question about what's the return on investment well it's actually hard to quantify at this stage but you know we do see you know the all the different benefits um as we have described earlier and all of you have described earlier so i think uh yes uh it's a very important uh point and christina thank you for sharing that um the uh the first half of the report or the outcome of that report uh with us because yes um you know awareness training that comes first and basically having that um digital literacy i guess uh in other words yes um so francesca and steven anything to add in terms of like adoption and also any experiences that you would like to share in pure season pilots you want to give a start stephen or should i yeah yeah from from our point of view uh yeah i think as has been mentioned you know there are some challenges at the moment in terms of um sort of the knowledge base of what the potential is with blockchain but i think there is an underlying commitment within organizations like the nhs by the european medicines agency and the fda organizations do recognize that technology and particularly blockchain ledger technology is something that will be of value in terms of improving process and improving uh how we work to regulatory processes and things like that so there is a an underlying understanding but i think we need to probably uh improve on that message as much as we can obviously there's there's a lot of interest here in this particular conference and if we can sort of uh use that as a a chance to pass the message on i think that would be great yeah that's a great point stephen i think adding on on the adoption and proof of concept stage um we used to say that everything works on on powerpoint right so we saw the beautiful slide by baldwin and everything is so clean and neat unfortunately reality as christina was mentioning it's slightly more complicated so you really have to be a great diverse team of people with technological governance business organizational understanding and skills to make it happen and that's again why we decided to start and keep on working on a consortium style or consortium-based approach the main learning from the pocs that we run in the passand of artists i think is more a conceptual approach uh blockchain before the big crash of cryptocurrency the end of 2017 it was seen mostly as a disruptive force and you know every time you want to disrupt something or someone you encounter a lot of resistance right so the famous middleman doesn't want to get cut out of the project so i think the learning there was really a little bit more philosophical we we are not in the centralized finance here we are not trying to [Music] remove with force essential authority but we are trying to create a better way for us to engage with our partners and finally ultimately benefiting our patients so we can do it with a pre-competitive way of collaborating instead of competing and that's that's the main learning so we use blockchain not to disrupt the industry not disrupt our partners and potentially external vendors but integrate them to bring them to a common standard to a common understanding and to potentially bring down costs and timelines to introduce new product to the market and save lives so i think the kind of focus completely shifted from the one that we had three or four years ago yes and thank you uh francesca you bring a good point because you know it's it's removing that middleman right so by removing that you have a more direct you know maybe interaction with the different stakeholders and and it's good that you touch on the patients because at the end you know what we do here is actually to benefit um you know the patients and um and that leads me to the next question you know what is the value for the patients in the clinical trials and uh you know especially when we're looking at you know blockchain and the use cases uh how we're designing it uh if i can hand over first to stephen yeah so i think um the the main benefit to patients is that there is uh there's there's an element of truth trust and transparency as i like to say about this because by having an immutable record of what is going on with every step of the process we can have that level of trust that these new use cases that we're trying to introduce are going to be secure and are going to be trustworthy in terms of what we do with the data and there's transparency because there's vision from the the patient side because we are designing quite deliberately designing the use cases hand in hand with patient representative groups and things like that to ensure that patients get to the visibility that they want from these use cases so i think that's the real strength and in fact i was at a patient uh representative conference a couple of days ago and that was exactly the message that came back to me is that when i was talking about farmer ledger they were very keen to to sort of engage and be involved purely on the basis that they felt that this was something that would give them a different level of trust in in health in general and in clinical trials specifically you uh still anyone uh has anything to add to i can extend on that i'd like to sort of extend those on what francesco had said i totally agree with him it's it's really about transforming the way we do things if um the industry is also moving into and looking at decentralized clinical trials and unfortunately with the pandemic more and more of our trial processes have moved away from the clinic and more to remote interactions um and and with that it it facilitates the the the patient it really brings that that piece home to them but the piece that's missing is the trust and i think blockchain can help with that um can really enable that empowerment that that steven spoke about where patients can be a partner in the process they can see what's going on um and what is expected of them and then if you think about some of the other use cases that we're working on like anti-counterfeiting blockchain can help um bring confidence to the patient that whatever medication that they're taking is the actual medication that they're supposed to be taking so i see a true benefit for all the stakeholders specifically the patients because patients are are the focus of what we do in health care yes great thank you thank you pauline francesca and christina a few final words before we we dive into some of the questions in the chat yeah i mean let me echo what we we just said together i mean at the end we we are not doing it for any external motivation the reason is bring value to everyone and that's our focus and the patient is the ultimate goal so if we can simplify a patient that is already in a potential difficult condition that is taking a clinical product so it will not have so much information about that so it's not a commercial product at least we have to give the guarantee that they can trust the process and that's the reason why we are try to unify standardize and improve the process as much as possible making it homogeneous across the companies right so potentially in the future you will have a single same interface and same modality of onboarding a trial in bi and in novartis and that's that's going to be great for the patient because you don't have to go through the learning process every time you onboard a new trial or the same can be said for a clinical site so you can operate in the same modality with all of us and that drastically reduce the administrative effort that a clinician or a physician can have in managing the trial rather than managing or supporting the patient i mean i think this is the real value on top of everything that we can do on the pharma sponsors end yeah and maybe to add to that as as well francesco if if we're looking at more remote clinical trials more remote interactions i can really see value in in health equity accessing those patients that don't necessarily have access to clinics because of where they are or or whatever situation that they're in um so you really see again great value for for patients from that perspective yeah we got a great presentation internally on diversity on clinical trials and definitely blockchain can help us out because we can reach more remote location with the same level of service and trust so that's going to be great yep i may add some couple hours from my side i think that um what my colleagues are saying is that um generally the blockchain and the application in the industry in the um clinical trials self-evident okay there are many many um prospects and opportunities and um values and but for the patient i think that the public right now becomes more aware of data of privacy many concerns or matters related to that and i think with blockchain um the solutions would be more let's say transparent that the patient could rely more on some solutions um that they're using to be more confident about the flow and the data so when we when it comes to the clinical trials we talk about the data and you know this is them many questions around the data ownership so i think the blockchain and such solutions would actually facilitate this analysis of high value because we are all on some extent patients um i believe all of us use the medical services we want it or not so i think it's um highly important as we're working for the solutions for ourselves as well like then we'll say christina and the great final words on on this topic um thank you everyone so now we're going to jump into some of the questions that we have in chat and we have quite a few um so first of all let me start with pedro silva uh pedro says uh he would like to learn more about the initiative and the plan the plans in the health data track so i wonder one christian stephen can you speak on this i mean the basic suggestion i can give is uh go to pharmaledger.edu and then you will find all the resources and contacts so uh that's another kind of focus we focus mostly on clinical trials today so uh i think it would be better if if better reach out our colleagues in the el data space francesco yes and there's also an a a general email so you can also post questions there to us thank you so robin clements uh which blockchain framework do you use and who operates the notes that probably would be me here okay so we are using opendsu framework and uh the matter of the blockchain it's um the selection of the blockchain and then running the nodes is a unique decision of each use case so we develop all the solutions based on the opendsu so it's um a very strong off-chain solution and then on top of it we put let's say at the blockchain and the specific technology again to be selected by the use case based on the requirements of this case because they are very unique as we discussed uh of course we support highly reusability within the consortium so once someone explored and something is working okay we try to see how that could be reduced in another use case if of course possible and again the nodes for example we have epi use case and the nodes would be run by the pharmaceutical companies because those are the sponsors or main stakeholders the core so that's all depends on the on the use case um i believe okay thank you christina and uh dsu for those who don't know what that stands for it's a data storage unit um yes thank you christina maybe i add that to what christine was saying um the whole uh architecture of of the blockchain network in pharma ledger is meant to be blockchain agnostic so the tsu will allow for that yes thank you so next question also from robin uh will the day of the clinical trials be published um i guess i can take them um clean this i mean i i guess define what you mean by publish i mean usually uh we will just follow the um you know the guidance for conducting clinical trials so that would be the same regardless of what technology we would use um i hope that answers the question um okay the next one um is the work of pharma ledger public yes um and yes that's been already shared robin as mentioned uh please go to farm malaysia dot eu uh another question from the hundred david how to integrate all actors of the ecosystem suppliers medical centers hospitals retail store that that's an interesting one maybe i can try to address that so we know that every single actor have different level of awareness understanding but also technological capacity so if you compare like a big corp to a small clinical site or even a patient of course the awareness understanding and reaching not to mention the the budget availability can be different so we don't foresee a word with where every single actor operates and not a node on the blockchain it may be via a graphical user interface a web application or any other solution that enables data sharing and of course there will be few but enough nodes on the blockchain to guarantee that the network stays decentralized so no we will not ask any single patient to get a node spin up or spin off on the blockchain uh that's that's a given very short answer to a very complex question actually on this some couple of words actually stay tuned for the for the updates from us actually for that and the clinical supply actually use case but though i also wanted to mention that um starting from the requirements i think which we try to it's a combo of the requirements and how we approach the stakeholders understanding for the stakeholders and um understanding uh deeply their flows in order to ensure that what we are doing actually reflects the needs otherwise that will not be just uh you know used and the second point is that as mentioned we're using opengsuse and we work um really hardly on the organization of the data on the back end the off-chain data so this is actually uh partly if you if you would see the architecture of the data you would understand the question though i would recommend also answering the question about them if the data is public we have github where we published openly the progress of our work though we don't reveal everything because um a lot of details uh stays um second credential within the project though some of the solutions if you're learning for example the opengsu you would understand and could be reused even so that would be my answer okay so the next day oh yeah just pretty quickly uh robin's question i wasn't sure whether that was directed to me or former ledger um but if it was related to me because i talked about the pilot that we ran in bi um that is published it's um you can find it on at blockchain and healthcare today thank you thanks for sharing all right so the next question from alison thoughty are your thoughts on the ease of communicating production technology to the relevant stakeholders um can i start with that one um yeah so obviously part of the role of what we do in this uh consortium is to uh try to communicate the message on um on the role of uh blockchain and on the role of what we're doing here um as part of the the deliverables for the project we are creating a collaboration platform where we are engaging with in with stakeholder groups so it's a bit different to a newsletter it's going to be an area where you can sort of have like a community area uh to share thoughts and stories about what's happening both with farmer ledger and for things that go beyond farmer ledger but are related to what we're trying to achieve in the project that's still in development uh and you can access it via the uh pharmaledger website uh so basically keep your eye out there to see uh what which what we're doing with that i know at the moment we're working very closely with uh some patient representative groups to create uh a collaboration platform that's uh targeted at explaining what we're doing to patients maybe i can add to that from from our experience in our pilot um we found that when we started engaging the end users like clinical sites for example we started talking about talking about blockchain technology they just didn't understand that they couldn't relate relate to it um so we we pivoted to talk about the value proposition for them to understand what the technology can bring to them um and and that that really helped really help them to at least be open to testing up the technology um and there's nothing that really uh i guess surpasses um real-life use and actually using the the technology and when we ran our pilot some of the clinical sites when they when they used it really realized the power of what they can bring and they even offered and suggested additional uses with this technology um so to me that that reinforced the approach that we that we presented the the technology to the relevant stakeholders yeah i agree with that i think while with the underlying blockchain is important the best way to get the message across is to talk about the real value that comes from uh what we're doing with the use cases thank you so much and i know we have run out of time and there's a couple more questions in the chat and of course some also comments very positive comments about the word that we're doing um victoria i'm not sure what we will have time to answer those or maybe we answer via the chat we have two minutes left i believe okay great so okay let me move on to eric uh stored up do you don't you offering disrupt existing digital id access solution in healthcare based on centralized databases i would say more more integrated and disrupt going back to my original point uh we don't want to remove or disrupt any central database we recognize that blockchain and you know standard databases have two different functions and different capabilities i think they work better together so the big load of information will stay in the nhs or national health service database in general blockchain may be helping with transactional data and with exchanging data across different stakeholders i mean the major benefit would be to have a clear privacy a clear protection of data and allowing the patient to really own their data so potentially also i have a different incentive to share data with the rest of us yes and thank you francesca i know we run out of time and just the last question from steve burke which is very relevant well you just mentioned about access to data post trial and who will be the owner of the patient data and to your point i mean yes the idea is that when we conduct clinical trials i mean yes we would the pharma companies would have that information but the idea is that we can pass back that data after the clinical trial is done and it's published pass that data back to the patient's electronic medical record so that's the idea that we have and it's being discussed of course within the former legion so hopefully that will be something that we can develop in them in the future um as an industry so i know right now time so victor thank you first of all want to thank all of you uh for participating this panel discussion to our panelists and for the great questions thank you great thank you thank you thank you so much to the five of you amazing panel discussion and yeah guys as it was said you can reach out to them either via their booth or the people's tab if you have more questions or via the website thank you very much guys let's continue with the next farmer panel bye-bye thank you [Music]
Automatic transcript — names and jargon may be misspelled.