Discover the Hospital Receipt Format for Research and Development

Hospital receipt format for Research and Development

okay so hello and good afternoon to all of you joining us today uh for the specialized entity connect session uh this afternoon that that span just started now thank you all for joining us for today's session accelerating development of diagnostics for ntds a virtual biobank to alleviate a critical bottleneck in test development and stimulate collaboration it's a big title but it's it's a it's a big project and we wanted to kind of we're very honored to be able to have this particular uh session with find earlier in the day i i mean i just set the scene before we go into the actual webinar um earlier in the day you might have seen a tweet from us saying it's a big day for diagnostics that was in reference to the launch of the eagerly kind of awaited um lancet commission and diagnostics report um that we've actually just launched a few an hour or so ago so we're just kind of on the back of that launch some of you may have been following finds um twitter feeds with all of the various um authors and speakers of that report on there so it's a very timely kind of uh date to have for this particular session in that particular report in the lancet commission diagnosis report one of the kind of highlights that they did well they really kind of underlined the fact that between in their estimates between 35 to 62 percent of the populations in low-income and middle-income countries don't have anything to the diagnostic resources essential for and then go back on thank you and so 35 to 62 percent of the populations in elmic settings don't have access to the diagnostic resources that are essential across six uh medical common medical decisions uh conditions most of those unmet needs seem to be falling at community level what does that mean in terms of they don't have access to to diagnosis how does that translate all of us are here today simply because we all recognize the fact that diagnostics they are the crucial the foundational kind of step uh needed to allow an effective and high quality healthcare provision within ntds we've been tracking diagnostics for several years every year we have a d3 meeting drug discovery diagnostics and we dedicate the second day to full for uh ntds and diagnostics we there's a huge unmet need there a massive gap we hear about this every year and so we've been kind of really trying to address that by bringing people together for our various panels and addressing that from an advocacy perspective what does it mean in real terms in terms of when you and when patients don't have access to those diagnostic tests what it means is the treatments that they then go on to get are presumptive in nature and it's really it's been shown that those presumptive treatments lead to poor health outcomes um to one for one to a better expression wasting very limited resources chasing the wrong treatment pathway that in itself can have further ramifications so no diagnostic wrong treatment pathway wrong use of available treatments that's contributing to the development of drug resistance acutely antimicrobial resistance massive issues downstream of that and from a patient to population perspective without that diagnostic in place you just simply cannot develop accurate epidemiological data and that's one of the kind of underpinning points of the uh kind of the success that we're all hoping for for universal health coverage so as you see increasing efforts for the advocacy around uhc hand in glove with that you're seeing this growing awareness at policy level that the evidence-based policies that they're they're aiming to form for healthcare can't happen without the correct diagnostic in place you've got growing burdens of in terms of aging populations um you know all of these things are kind of working together to really push the importance of diagnostics uh forward and really you know a lot of there's a lot of positive momentum within this uh area and by that i'm referring to the who's uh essential diagnostics list which was first published back in 2018 uh we've had the pleasure of having that particular team come and have panels at our various meetings as well as connect sessions a few months ago the latest iteration of the edl was uh we'd open that up with with francis moosie the lead at the who for that um why i've mentioned all of that is that from today's lancet commission on diagnostics they're essentially backing the adoption of the edl and it's had a lot of uh countries come and adopt that in the in the last two years since it's uh since its launch last three years so it's gaining a lot of ground they're really backing that in this report that's just come out what they're saying is back that but also use that adoption of the edl as a driver to bring on innovation and embrace new technologies that are there that can address the gaps in the bottlenecks one of those bottlenecks that's kind of come to the fore is the uh the kind of lack of access to samples by the diagnostic development community as a whole and to kind of answer that we had some very interesting conversations in the last few weeks with find with their communications engine so a shout out to flora charbonnier who's probably watching as well in the audience from the infinity communications and the communications effort within find um and they we kind of cut we put this panel together to kind of have a look at open up this uh potential solution to this access to samples problem um a virtual biobank that's been championed uh by find themselves and then we wanted to balance the panel out by bringing on board one of the directors from the uh digital uh diagnostics for africa network based imperial college london as potential user and contributor to that uh by a bank so i think that's kind of that that's kind of the setting uh for today so i'm i'm just going to turn to the palace we're honored today to be joined um by professor joseph nadengu he was the ceo find and led them through to become one of the world's most famous and successful pdps for diagnostics uh professor denver is now in charge of the entire find kenya uh operation so i'm honored to have you on board joseph the last time we met was a few years ago in person when he came and spoke at our d3 meeting and i remember that fondly says i'm very happy to see you there um also from find the actual technical lead for um the biobank project itself dr nick allen who's joining us there at the bottom right and from the and one of the co-founders and directors of the digital um diagnostics for africa network dr aubry canton is joining us in the top right um so hello to all of you and thank you very very much for making time i'd like to turn to the audience for a second before we get before we start off with the presentations we're seeing uh people putting out their names so dr bernard nass hi from the netherlands emmanuel from the nigerian institute for trypanosomosis and on cancer crisis research in koduna in nigeria and we have dr said massive from the research center for a heightened disease in iran we have from uganda dr anatol miranda we have people from the itm a strong showing from antwerp there dr marti van frankenheisen francesco pfeiser from pfeiffer from the imperial college london the digital network digital diagnostics network um helene olyartha from the nih at jakarta the indonesian government tenzin wendy from bhutan from bhutan from tunisia institute pasta icarusiani so we've got a very nice mix i see a nuke for us is here as well from the global sister alliance so hello to everybody and what i'd like to say to the audience is if you could please spare a couple of seconds and just put a quick hello into the chat box your name country and affiliation that would help us immensely thank you very much for that um and so without further ado i think we'll hand the floor over to professor nobingu for the first presentation well first of all thank you very much uh cameron i want to take this opportunity to thank the international society for neglected tropical diseases for giving us this opportunity to give an overview of the efforts that are being made to make diagnostics development easier by making biological samples more easily accessible and today we shall be talking about a collaborative effort on dx connect virtual bank that is being supported by a number of funders and coordinated by fined now but before doing that i want to spread a few moments to talk about find which is a global alliance for diagnostics that was established in 2003 as a product development and delivery partnership and the way we work is that we connect various stakeholders that are in the healthcare system starting from the countries and communities funders healthcare providers diagnostic tool developers in order to spar diagnostic innovation and make testing an integral part of sustainable and resilient health systems we at wasu collaborating center on laboratory strengthening and diagnostics to evaluation and a member of the strategic advisory group or of experts on in vitro diagnostics in addition to that we are co-convener of the access to covet 19 tools known as act accelerator diagnostic pera together with the group of funds over the years we have been collecting and distributing high quality samples to diagnostic developers and this is as far back as 2008 over the last just over one decade ago we have been supporting the establishment of a biobank which by now has more than half a million samples mainly from tb patients malaria fever his tv and some neglected tropical diseases all these are meant to support uh diagnostic stool development now coming specifically to neglected tropical diseases one might ask why is it so important to test for entities looking at the the 2030 roadmap that was launched by a wa show just about a year ago it states that effective diagnostics are a prerequisite for issuing the 20 30 targets for ntds and they do that in a number of ways in screening and diagnosis in disarrance and mapping in monitoring and evaluation in order to accelerate elimination it is necessary to identify cases of a particular disease in order to treat them and therefore remove the reservoir status of those cases that way we accelerate the process towards elimination and zero transmission and this an example is what is happening in sleeping sickness where we go for that individual who is acting as a reservoir of the disease treat the person and remove that reservoir status again without a diagnosis of the disease we reduce the morality morbidity and mortality associated with advanced disease an example is what we see in visceral racial analysis the earlier we identify the disease the easier it is and the higher the chances of recovery again diagnostics are very important in informing and guiding policy decisions if we can have diagnostics that identify where the infected individuals are or where transmission is occurring then we are able to inform and guide policy decisions in in a manner that ensures that we have effective interventions an example is where we have targeted treatment or stopping mass drug administration so if one want to be asked where we start with regards to diagnostics for neglected tropical diseases looking at the 20 30 targets and we ask ourselves how many of the 20 ntds have adequate and accessible tests that will enable achievement of the 20 20 30 targets so the question is are they less than five are they between five and ten or are they more than ten the answer was generated from an expert consultation that was coordinated by the pre-show which revealed that of the 20 entities only two of them have adequate and accessible diagnostics that will enable them achieve the 20 30 targets for the other 18 there is a category of diseases for which there are no diagnostics available that could enable achievement of the 2030 targets while another category of diseases is one which has tests but these tests would require adaptation in order to assist in driving to achieving the 20 30 targets yet if we look at a disease like covet 19 which has been with us for less than two years more diagnostic tests have developed for this disease than for all the 20 ntds over the last 100 years meaning that we can and must do better since this has been demonstrated so what is needed we need new improved and adapted diagnostics we need diagnostics that are accessible and affordable accessible that they can be used as close as possible to where the infected individuals live they should be reliable and of high performance so that they can detect most of the individuals that are infected and if a test is negative it is a true negative and not of course negative it should be efficient in that the renewables to have testing strategies that maximize on the impact now the common denominator in all these requirements is suitable biological samples from patients now biological samples are a vital resource to advance r d for diagnostics development the diagnostic development continuum is one which we refer to as going across the barrier of death there is a process of development which includes biomarker discovery it includes feasibility studies the development process itself a comparison of tests during evaluation and then quality control both at the level of manufacturing at under the laboratories that are using these tests now suitable samples are required every step of that continuum and these suitable samples are important if the results that are going to be generated using those samples can be considered to be relevant in terms of suitability we mean they should be compliant in terms of manner in which they are collected processed stored and even transported they should be well characterized this is in relation to clinical and patient information and they should be fit for purpose a tpp is used to guide the test development and the samples that are required for test development must be suitable for the purpose that the particular test is required to be used in so these are the main reasons why samples are critically required now the process of not only accessing the samples but also making them available for r d and for diagnostic development is quite a lengthy one it involves a large number of stakeholders starting from the patient who has to donate the sample the manner in which it is collected the processing that is done the storage conditions and then how they are accessed by those that need to use them this requires fully documented procedures and approval processes applied by multiple stakeholders to ensure benefit sharing protection of patients rights and sample integrity so what makes it makes it so difficult to access biological samples by rnd or test developers one is limited availability in terms of some of the existing collections beings often small or limited sets of samples if a collection is going to be done prospectively it is quite expensive and it is also complex we are facing a situation now as we are becoming more and more successful in controlling these diseases in having less and less positive samples that can be collected prospectively and then of course potential misalignment of provider and user good the second is poor visibility we have organizations and individuals who have collections across the board but then many of them have not identified them formally as biobanks and they probably are not visible by those that might require them in order to carry out rnd or in order to develop diagnostic tools there's also limited in the connected networks and coordination tools and finally equity of sample sharing and this relates to to transparency and benefit sharing as key considerations so improved access to samples requires cooperation and increased visibility of existing collections and now i'll hand it over to my colleague dominic so joseph thank you very much for uh for this introduction which clearly lays out the needs and the challenges and the difficulties so um i'll talk a bit now about how we are approaching those difficulties and in and hoping to address them directly so introducing dxconnect uh dxconnect is a it's a structured platform hosted by find and to be used by the infectious diseases uh diagnostics community so so um the the dx connect is a a general platform of which the virtual biobank is one component uh it's intended to support the diagnostics community for uh in the area of infectious diseases and uh here we will present the first major tool within this which is the virtual biobank so on the slide there you can see the round circle there and on the left hand side of it a series of potential providers or owners if you like of samples on the right hand side you can see a series of people who are potentially interested in having access to such samples and the dx virtual dx connect virtual biobank is about connecting those two audiences um the uh the the components of it i will uh address in the next slide but in short it is intended there to increase the visibility of the samples owned and controlled by the people on the left to stimulate the collaboration between the two audiences and on the right hand side to act to facilitate the access for those people to the samples on the left hand side just a word on hosting uh this is a this is a platform hosted by find uh supported by grants from the uh the gates foundation and unit aid and uh intended to be a common good if you like for the ntd and diagnostics communities in general if we look here at the two audiences the left and the right on the left hand side we have the sample providers these are the sample owners the people who have control over collections who may be anywhere in the world there are many many collections often we refer to them as legacy collections and in many cases these collections are interested in increasing the visibility of their collections by that we mean letting other people simply know that their collections exist very often these collec these collections are somewhere but are difficult for other people to identify and defined it is important that those who have collections maintain full control of their collections both in terms of what they do with them how they access them the terms in which they collaborate with others and that is fully respected um and the collections are very often interested in exploring ways to collaborate with people who are developing uh kids diagnostic kits which could be anything from a very simple exchange of value in terms of a financial um exchange for supplying samples right the way through to collaborative research where the providing collection and institution is centrally involved in the research and the development and maybe also the evaluation of new diagnostic tools on the right hand side we have the sample requesters where in our interviews it's a recurring theme it's very difficult in many cases for people to for or for requesters to find the samples that joseph earlier described very well being fit for purpose and corresponding to what they need so from their side this allows the um the requesters to see collections anywhere in the world through the platform um and then to search through those by disease and then and other characteristics and to connect with the providers in order to discuss collaboration um um i insist that here that this the idea is to bring people together find is is not um involved in the exchange between these two parties unless unless invited to do so fine has a lot of experience in uh sample quality sample quality control in shipping uh also in access and benefit sharing so the the ways in which uh the requirements of the nagoya protocol can be uh satisfied so if fund can be of use in this discussion find is very willing and ready to be involved but at the invitation of the two parties the idea then is to make this resource available freely it's important that there is no charge to use this platform there's no fee involved all right it's also open so there is no discrimination between academics non-profits industry all right if a collection prefers to work with one type of user that's fine that's up to them to to discuss and the idea being therefore to maximize the use of existing resources okay there are a lot of collections out there which are being are not being used to their full potential these should be they should be made available and visible um if any if only for ethical reasons the um the donors have um have made these samples available and we have a duty to make sure that they are visible and can be used so uh where where are we at the moment i explained on the previous slide um uh that that is where we're trying to go so where where are we um to date we have principally been populating the uh the virtual biobank with covid collections and you can see on the left there some of the information about what is already on the platform today we are working on two things uh connecting institutions that that hold collections connecting to them and inviting them to register uh on the platform and we'll come back to that in the final slide we're also working a lot on defining the sample needs this is a recurring theme that the samples that are needed are actually a complex result of analyzing a series of inputs so that there are it for some of the diseases there are tpps there are the technical requirements associated with the type of platform that the kit is going to be on there is advice coming from experts there are even for example submissions made to the fda which have given information about how many samples of what type have been used for validation but here we are working in parallel and have produced our first two sample needs for shisto and for ango to define what we believe are the right reference panels of samples that are needed and these obviously are ready for discussion and for input and improvement based on any input that you might have you can see at the bottom of the slide there are the 10 ntds that we are focusing on at the moment but if you have collections in any other entities or in fact in any other infectious diseases the uh the platform itself is disease agnostic so if you just tell us that you have got a collection in another area we can very quickly add another disease to the drop down list of diseases within the platform and you can upload information about your collection there a note on what we mean by uploading information we are not asking you to uh give information about the specific samples in other words sample by sample information no what we're interested in generic information roughly how many uh donors there are the types of samples that there are in there the types of information that is annotating the samples um and any other relevant information for example the type of collaboration that the collection is interested in but it's not going down to the specific level of the sample all right that is for the discussion between the requester and the provider so when we say uploading information there is no problem here in terms of um donor privacy or sensitive information this is generic information about the collection so that's what i've just described where we are at the moment so let's look ahead and see where this is going and i think we can already see one looming need which is coming up there which is related to the potential gaps between what they're what we can find in legacy collections on the one side and the needs of developers on the other uh i think we can reasonably say that there are gaps there and that in order to address these we will be needing to do when i say we the community will be needing to undertake prospective collections um feint has done quite a lot of work on this particularly in the area of kovid and has set up prospective collections and so we have already on the horizon the the reality which is that in some areas we will be needing to launch prospective collections these would need to be funded of course but the funding agencies have already indicated that they may be open to funding these sort of collections but we already see this as an extension to the work that we're doing at the moment which is primarily linked to legacy samples so to conclude um what are we asking because yes we're asking um we would like anybody who has a collection or knows of collections of ntd samples uh or other infectious disease samples who might be interested in having those samples more visible than a worldwide basis to register those collections on the platform to do that you can either go to the platform itself click on it and actually upload directly this generic information that i described earlier or if you prefer you can get in touch with the the link there at the bottom and we can do it for you just send us the raw information and we can do the uploading and open the uh the information about your collection which is there so this is a request to anybody who has or who knows of collections please to look at the possibility of registering those and putting them on the uh on the virtual bar bank i repeat the collection stays in control there is no um desire here for any of the the the other stakeholders to be taking control and there is no mechanism by which that can take place i'd add here also there is the notion on the platform of network i'm happy to see the gsa is um uh is uh amongst in the audience here hello there hanukkah and david um there is also within the platform a uh the notion of a network because very often collections are linked they may be in different countries they may be in different institutions but they may in one way or another be linked there is therefore the notion of a network and a network such as gsa or any other [Music] association alliance or whatever can introduce their their information onto the platform and the collections which are part of the network will be linked to that network so the invitation here is open to networks as well as to collections thank you very much um please join thank you very much dominic t joseph thank you very very much both of you for a wonderful presentation um outlining the kind of scope breadth and um kind of quite exciting nature of this project really and a lot of questions have been coming through um from the audience which you say thank you to will weave those into the q a at the end um you mentioned david uh and anuk from the uh gsa we've been joined just after the the first with professor david rollinson by from the global shifter alliance and you mentioned in new governance we've had quite a few other people joining us i'm just giving a quick shout out uh before we go to aubry county's uh talk to eva manpei from the itm uh it's there also um we've got uh quite a few people joining us from africa doctor and from here in london dr amaya bustin dewey um also joining us there so thank you very very much to all of the audience that have come on um and please do feel free to keep your questions uh coming through we've got from baylor college of medicine in the u.s uh hi dr sarah philitoff dr caroline rombotz from the itm in antwerp dr ruth lorimer from the uh fibrous study group at ls htm but then in school again the institute uh pastor in tunis uh dr insaf bell hajj ali and also dr olafemi adidokun from ibadan research foundation in nigeria so quite a north east southwest spread in terms of countries and the questions are coming through so that's great um amazing initiative a lot of people dr majid harandi and iran thank you find great innovative initiative the need is there the unmet needs as joseph would kind of highlight it there so this is really addressing that so a lot of thanks coming through on that basis i mean you talked there about um sample users and sample requesters uh potential users of the platform potential contributors and that's why we wanted to bring in the digital um the the the digital diagnostics um for africa network and the co-founders dr aubry clinton's here to speak about their perspectives on a potential being a potential user and a potential uh contributor so i think that's enough for me and in case anybody's wondering we've got a series in play with the digital diagnostics for africa network and we thought we'd invite them to this so enough from me over to you aubry the floor is yours for your for your presentation so first of all thank you very much uh cameron and is ntd for inviting me to join this connect session and thank you to everyone who has dialed in today to join this really interesting and important discussion and i also want to say thank you to joseph and dominic for a really fantastic and and beautifully clear presentation and actually for i'm a really wonderful initiative that has been set up in this finds dxconnect virtual biobank i'm going to try and give you my candid thoughts from two different perspectives about um the use of a virtual biobank or and participating and make using the biobank as has been um described to you and first of all um from a user perspective and as cameron said i'm representing the digital diagnostics for africa network which is a group of 70 um researchers from really diverse backgrounds 11 countries um represented and we are trying to develop and work out how to implement um a new type of diagnostic which i'll tell you about it in a minute um which we hope has really transformative potential to bring highly accurate diagnosis to the point of care um in places where diagnostics of high quality are not routinely available and to link diagnostics to surveillance in a seamless manner but i'm also going to speak from the perspective of someone who is a potential or potentially in a position to contribute to um by a bank like this virtual biobank um i'm part of a large european funded collaboration um which has undertaken several successive projects and biobanked an awful lot of samples and potentially might be in a position to contribute to something like this and i'll tell you a little bit more about that in a moment as well so first um from the potential user or requester perspective um request being the words that uh dominic used to describe this role um so the digital diagnostics for african network is trying to develop uh diagnostics which are sort of illustrated a little in the in this cartoon here so the ambition is that we have small electronic devices the sort of thing that would fit in the palm of your hand um which provide a sample to answer solutions so the sample goes into the device with no pre-processing all of the sample processing happens within the device analyte detection happens in the the device often using a lab on chip format analysis of results happens within the device integration of results if there's more than one analyte detected happens within the device interpretation of those results happens within the device and an answer comes out either on the device itself or um transmitted to a a user interface which might be a smartphone for example and the idea of having data transfer immediately from the device is incredibly important because that provides an instantaneous link between diagnosis or detection and surveillance which as you've heard cameron explained earlier is incredibly important for us to tackle many of the high burden diseases which exist in africa and elsewhere so we're trying to make these diagnostic devices meet the reassured criteria with real-time connectivity ease of specimen collection affordability sensitive and specific user-friendly rapid and robust equipment free and deliverable to end users and the devices that we have in development and mainly work by detecting currently rna or dna and so have applications to detecting pathogens for high burden or common diseases like malaria where they can detect with high sensitivity to pick up both symptomatic and asymptomatic infections to discriminate between bacterial and viral infection using host biomarkers and potentially to discriminate between different severities of illness based on biomarkers and they have the potential to be applied to neglected tropical diseases and a dengue prototype is already in quite advanced development and we are currently discussing and developing a leash mania test they also have the possibility to be applied to emerging infectious diseases so in under a year a test on this type of platform was developed for covert 19 which is almost um achieving regulatory approval now and there's the ability to quickly change um this sort of diagnostic test to detect the next uh pandemic disease disease x and as soon as we know the sequence we can develop a molecular assay and put it onto this sort of platform there's also the potential to detect mutations in pathogens which confer antimicrobial resistance and even to bring in precision medicine approaches where you can detect features of both host and pathogen to make sure that you give the most appropriate or best treatment to a particular individual for the disease that they have so this is the ambition a small device and probably a smartphone as you can diagnose you can work out severity and you can provide decision support all connected so that information can be used for surveillance instantaneously now with so many different potential applications obviously it would be quite a challenge to run large-scale studies for every single pathogen or disease that we might want to detect and so a virtual biobank and would be a win-win um for this type of device development and for pathogen detection the availability of reference material for assay development and clinical samples to assess the performance of the assay for the host response assays having potentially access to really well phenotype samples relevant control groups and relevant patient characteristics which we would need to be able to determine how well they perform and it would obviously be extremely cost saving time saving and provide often much needed external validation um for tests that were developed on a platform like this so for from the perspective of a user or a requester um this is a highly attractive initiative but what about from the potential of a contributor or a provider um as i think dominic described this role so someone who has a collection of samples um and may be thinking about contributing them so just to very briefly tell you the the two studies that i mentioned earlier perform is a was a big eu funded study which has just finished and um its aim was to develop a test which would discriminate um bacterial from viral infection based on either protein or rna host biomarkers it involved a lot of partners around europe also in the gambia nepal and taiwan and over five years a lot of samples were collected diamonds is the um follow-on study in a way to perform which is taking the same approach and trying to use it to discriminate between a much wider um group of infectious and inflammatory diseases and has even more partners collecting samples and and even greater ambitions and through both these studies there has been a real um effort made to phenotype patient groups really carefully to ensure that the diagnoses that are being ascribed are the correct diagnoses um a huge amount of effort put in by hundreds of people collecting the samples and doing the clinical work up doing the laboratory assay collecting and separating the samples and um resulting in samples from around 10 000 individuals and actually tens of thousands of samples um in total when you look at all the different types of blood stool urine etc that have been collected so a vast undertaking and with this in mind i was thinking about how would we want to become involved in a virtual buyer bank and there are obviously pros and cons here from the provider perspective and so the pros are i think first and foremost it meets an expectation an expectation that funders have increasingly that the work they fund will make samples available to others it meets an expectation from the research community it meets an expectation from the public that the money that's spent on doing research will be used to further research beyond just that particular study and i think a moral expectation for sharing these samples in order to be able to accelerate research progress and reduce the cost of future research and development as well and indeed um being able to say that you will contribute samples to a virtual biobank may be something that is a deciding factor in whether you would receive research funding or not depending on on the particular funder but i think there are some cons or at least concerns that um the holders of these samples might have and i think one of them um is potential loss of control of the samples and data and particularly once they've been passed on to someone else you can't ensure that they are um being used appropriately also depletion of samples that you've spent an awful lot of time collecting and curating and may only be of maximum use once you've built up a very large collection and over the course of 10 years you can imagine the people who've been involved in the performing diamond study have come to regard these samples as a huge resource for their own future research as well and i think um another element is that in maintaining and accessible by a bank uh which is accessible to others um obviously has quite a lot of administrative and cost burden and may need it to extend beyond the duration of the research funding which is often a challenge because institutions don't necessarily support that so some considerations for contributing would be the practical issues like the administrative burden the registration of collections maintaining accurate records material transfer agreements the cost in terms of maintaining long-term storage and the staff needed to retrieve those samples and be able to share them with requesters and also negotiating ethical and legal issues which can be quite complex when samples have already come from a a variety of partners in a network or or collaboration or consortium and then some academic issues as well um which are potential considerations so for example the freedom to decide on how those samples might be used or who might use them the issue of whether you simply provide them or you work in collaboration with the person that you're providing them to whether there are indeed competing interests for example will they be used to develop a competitor product if you're developing a diagnostic test or device and credit in authorship in ip and patents in commercial exploitation of those samples so um the challenge and i think the the finds team have already explained very well how they are addressing many of these challenges but the challenge is balancing both perspectives and for the user you want an easy to find collection you want easy and rapid access you want it to be cheap and you also really need guaranteed quality and for the contributor the ease of registering yourself your your collection the ease of maintaining it um and regulating it and transferring it so help with those things if it may be beneficial the guarantee that there will be credit for it and potentially financial support for maintaining your collection um beyond the end of your research grants that helps to establish it so i'm going to end there and say thank you very much and i'm happy to take questions as well thank you very very much aubrey for that very honest take on the pros and cons and everything so i think that that's generated that's going to generate a lot of q a action as well we're getting some questions coming through from the audience so on that basis i mean firstly thank you to all the presenters for a wonderful explanation and uh from various perspectives on the project as well as the last presentation from aubry there as a potential user and potential collaborator uh we've got plenty of those in the audience and i'm seeing a lot of questions coming through a lot of resonance on that thank you for that i'd like to take the chances just to bring the panelists back so we can have our q a i mean we had in terms of the q a we had questions in mind um and we'd actually put a written interview uh together with uh find uh and we published that i put the link in the chat box earlier the gist of our questions are really gonna focus in on around how does this speak to those shifts that you mentioned joseph earlier in the uh in the who road map not this they've been answered by find to some extent and we've published that uh the link is there for everyone so i just thought because you've got a call to arms in terms of attracting people collections um potential users potential collaborators to the project why aren't we and you're getting a lot of those potential companies on that this on the chat box why don't we just switch directly to the questions from the audience if everybody's in agreement with that it's probably probably better for your call to arms to answer that um some of the questions that we've got in no particular order but firstly thank you to everyone who's putting the questions in we will definitely uh get these asked if you could just add your name country and organization which everybody has so far that would be brilliant and we can uh start with that so um one of the questions i wanted was and this was this popped up in the pros on the cons side and all we were speaking um was one of the the the fears as it were or cons it's been expressed very nicely by dr amaya bustin dewey from the london school how long is the virtual buyer back funded for um a key question given the the cons that opry had mentioned that people might be put off if it's you know you know what happens when the funding runs out so the question from dr russell is how long is the virtual biobank funded for when i'll ask that to joseph first um if that's okay then we'll turn to dominic in case but if we have to for that so her question is best answered by dominic okay can you hear me yeah perfectly good um the virtual biobank is already funded until the end of 2023 the maintenance cost is actually very low we have in any case a uh contract in place or maintenance contract with the university of nottingham who wrote the program which is uh not onerous at all and we have every expectation that we'll be able to maintain this even with core funds over the coming years clearly as we add more uh diseases more infectious diseases then with the ongoing grants that are associated with that work we will be able to put a small amount we will be able to put money aside for the maintenance so for the savable foreseeable future it is funded uh and find is absolutely committed to maintain the availability of the site within the context of the dx connect initiative okay thank you for your answer um dominic thank you for that hopefully that answers your question uh am i uh in terms of uh what you you put forward you mentioned earlier and i see in the chat box that there's a great relationship with the gsa with the global shisto alliance um we have a separate series of connects that are all on our website with the gsa uh in play so you're welcome to have a look at those from the gsa uh dr anu goveras his artwork is saying thanks joseph and dominic fantastic to hear about this quick question what information on the samples will the biobank hold example sample type collection method storage methods associated data what will be those those um labels the domination the um probably the easiest thing is just um go to the site and see what the information is there that is required the first thing i repeat is that there is no information at the individual sample level so there is no issue about data privacy nor about identities of individuals here we're talking about what types of samples so you enter whether it's a blood sample whether it's a plasma sample whether it's a serum sample going down further dna rna pbmcs or whatever the numbers that there may be in the collection as far as the data is concerned there are categories of data there is also um the ability to say what type of consent there is that's a very complex question you know what's the consent but to give it gives you outlet the ability to give outline information about whether it's broad and generic or whether it's limited to the disease or limited to a particular study so i think probably the the the easiest thing is to have a look on the site and it's designed to give you order to give you and to give you the ability to describe your collection without too much time being taken up and for the potential user to get the key information to be able to say am i interested in going further and contacting this collection and i'd repeat one more thing which is to do with the way in which you as a collection want to collaborate and uh aubry brought up some very interesting questions there related to control of samples about um what the samples are going to be used for here you also on the site have the opportunity to give information about what your constraints are in terms of collaborating some people may say we're only going to collaborate with this sort of researcher others will say we're um we'll only collaborate if we're part of the research others can say you know in in response in return for a reasonable fee we can share but it's up to you to share the characteristics of how you want to collaborate [Music] brilliant thank you thank you for that answer i think that's very important so the questions are popping up in various forms um on that uh dr bonnie webster from the natural history museum here in london thanks for the presentation aubry for the diagnostic device that you were showing can you tailor it to different sample types urine stool and also what kind of cost per sample are you aiming for so i suppose that's a specific answer for you a question for you or brief thanks uh cameron so i i don't want to sidetrack things too much by going on to the too much specifics about the diagnostics but very briefly um so blood samples and um saliva or respiratory swabs have been tested at the moment and it should work fine with urine samples as well but we haven't developed a specific um approach for the kind of um sample processing aspect of that yet and yes cost is a you know the the thing that we are constantly sort of worrying about with this um so the the the chips we hope could get down as low as about five dollars per test now that's a lot more than a lateral flow test for malaria but the the question about whether that's worth this or not is how much do you value having instantaneous data available how much do you value the extra sensitivity for some diseases as well and i think that has to be worked out for each disease individually and so it's a it's a dif it's going to be a different economic model to some of the current diagnostic tests great to answer thank you for that aubry hopefully that answers uh that particular question there for dr webster uh dr evie amanpez asked a couple of questions um just on this coming back to the collection and ownership of collection and um as a potential contributor so she's asking and that's from the institute of tropical medicine in antwerp and this is aimed at both joseph and dominic how do you see the prospective collection of samples will they also stay at the providing institutes what are the costs for this perspective for these perspective collections and that will find dx hat we'll find have the privilege to use these samples or can this be decided by the institute that's donating them let's just putting the collection forward um joseph do you want to go ahead or i can i can answer that if you like um yeah you you can although just to point out that the intention and that's why we say that if there is need for prospective corrections then this would be facilitated and there would be a discussion between the partner who wants to conduct the prospective collection but ideally it might be that the collection would be held at the partnership and what would be included in the virtual bank is in the is the information but of course based on the agreement some agreements require that some samples be sent to particular developers so it is all it will be based on the agreement between the partner and the the founder dominic yeah um so it's good question that um of course the the characteristic the fundamental characteristic of a prospective collection is that somebody a generous uh funding agency is paying to establish a collection and therefore i think we can say that it is reasonable that that institution that funding agency um can have say in how the samples are used it's not like a legacy collection where this is something which belongs to if you like to the to the host institution a prospective collection is something which is being funded in order to be able to create a collection and the funding agency i think legitimately can have some say as to how the samples will be used many different ways have been done contractually to put this in place uh it could be anything from um i don't know 50 of the samples being totally under the control of collecting in and the other half being available sharon this is a this is a an exchange it is it is something which is being built for the common good where the collecting institution has absolutely reasonable expectations in terms of access itself to the samples but where the funder also can reasonably expect to have an influence on how the samples are used uh if afterwards you'd like to be in touch and to discuss more about this we can give you specific instances of how uh prospectively funded collections have been structured so that both sides of the equation um are are catered for thank you both of those answers there's another a couple of questions in terms of the samples and the fun and the costs around getting those samples to you one is from dr bonnie obstacle from the nhm saying thank you joseph sorry i may have missed this i had a few connection issues but then she's asking are there funds to help people that have samples for them to transport those samples to the partners or do those costs need to be covered by the user themselves she's made the point that many elmix settings and what country settings have samples but don't have funds to maintain or transport them that's from dr bonnie webster dr stephen bramia from canada had asked earlier in the thread um what's being done to establish this biobank effort in african countries and i think that's that that aspect i'll ask to get find kenya's defined kenya kind of country perspective from joseph then i'll come back to to ask the best factor to dominic so so don't stop joseph do you want to start off or i can i can go as you like yeah just just to yeah that's a very good question and um i i have to say that the manner in which collections have been done has been diverse and the ones that we have been directly involved in have been operations in which we support the stories of those biological samples at the site in the endemic countries that is in the african countries so there are connections there are agreements between us and the particular institution in the endemic country on the use of those samples but yes indeed that has been uh happening i believe that with not only the virtual banking but the biobanking initiative in general their efforts to continue doing the same dominic you answered several questions about the cost of maintenance costs of transport um under normal circumstances we would expect the uh the user the requester the person who's going to use the sample to pay for the direct costs associated with making the samples available so the typical ones there would be the transport itself any uh import exports costs that may be associated uh the providing institution may have fees related to i don't know um use of the software or for selecting samples because it takes it takes fte to decide which samples to to share so we would expect the receiver to pay for the direct incremental costs of samples which are provided to them and i think that's reasonable as for maintenance the of the collection that's more difficult because many of these are in fact when we're talking about legacy collections these are collections which are already within institutions and where they are being made visible to other people so where we don't have a if you like a a an easy solution to say somebody is going to pay for the maintenance of these collections however within the context of um collaborative research projects there is always the possibility of putting in uh a budget for maintaining collections last question was the one what's being done about this in africa um actually there's no there's no difference between africa and everywhere else when we talk about the virtual biobank a collection from anywhere is welcome so um whether it's in africa whether it's in europe whether it's in south america uh all the same collections and networks from anywhere are welcome brilliant that's a great answer from both of you we've had a question on that collaborative framework between biobanks dr evie memphi from the institute of tropical medicine in antwerp will there be a connection with the isber or bb mri virtual guy there we go so that that i'm sure that will ask you dominic firstly yeah yeah um very good you're absolutely right there are there are um there are several organizations internationally that have uh directories of um of collections and you've mentioned isber there i'm not sure that um the second one you mentioned actually has a directory but certainly another one is bbmri um has a directory um the uh there's no if you like competition here this is um i think if i was a if i was somebody with a collection wanting to look for con collaborative projects i'd put my uh information about my collection everywhere and then i did give me the opportunity to be in touch with potential researchers wanting to work with me and then i can take my pick that's what i do that's a great answer um there are some questions coming through for you as well i'll just come to those in a second um there stephen brahma dr brahmi is asking on this uh well he's touching into i guess data ethics the realm of data ethics he's asking in terms of communication links between biobanks diagnostic facilities and then the companies that then the private sector that's developing treatment uh developing um treatment medication diagnostics for the diseases that are diagnosed what are those communication links i suppose dr obama without wanting to put words in your mind you're alluding to the data ethics the data being generated but you know what how does that how does that fall are there links is i suppose that's what you're asking so i suppose we'll ask that is that how are you getting across the data ethics question for the biobank in terms of patient samples i think you alluded to in your slide anonymized and kind of would you like to elaborate on that a little bit perhaps i can ask joseph that first in terms of um off that again okay um the the the the question i mean there are a series of questions that uh actually i'll be referred to on on many occasions which come up um very often as soon as you get into the detail and of course it's easy to talk about the big picture of putting people in touch with with each other for this to work there needs to be an agreement between a a source a collection a provider an owner on the one side and a researcher and a user on the other and the devil is in the detail that agreement between those two organizations needs to cover the all of the issues of ethics of data use of um access and benefit sharing of if necessary putting in place the uh international uh recogni internationally recognized uh certificates of compliance um there is a lot of detail in that um there is no way in which the virtual biobank is imposing anything upon these relationships however we have spent a lot of time and i'll be honest burns a lot of fingers in putting such agreements in place because it's difficult and we would be more than happy to um share experience and possibly to suggest ways through so that the very legitimate uh worries about data about um benefit sharing uh can be can be addressed in a way that is workable for the people who are using the samples and of course let's not forget the n word the the ntds n for neglected and one of the reasons these diseases are neglected is because there are there's not much money being made here which means that there's not a fantastic pot of potential benefits of profits to be shared so we need to have reasonable expectations on both sides in order that both sides can find a win-win outcome i think it's a very honest answer perhaps more room for governments to get involved because in the day you will be ultimately these diagnostics will go into the disease surveillance program of that country as illustrated earlier maybe it's time for governments to step into the breach somewhat especially given the who's roadmap shift of sovereign owned kind of country ownership of disease and that kind of background maybe now is the time to approach them um we've had some questions come through um in terms of still staying in the biobank uh dr lizette van lies out from leiden university is asking in the netherlands it was addressed to aubrey i'm sure you've probably answered that but i'm going to ask this to everybody who determines the infection state of the samples the biobank owner or is there an expert committee does it go to the committee for that or you know and then there's a separate question which kind of alludes in some way to quality as well in a way and that's from professor majid fashi harandi from iran he's asking are there any accreditations in place in terms of controls etc for biobanks to be included in a sort of consortium who determines the infection state of the samples yeah and then this qc question in terms of accreditations yeah yeah oh you you put your finger right like the it's um the question of quality of the samples we we can talk very easily about high quality samples about fit for purpose samples um you have to get down into the detail as to what that means for individual samples that are being made available so you ask quite rightly the questions who determines infectious status now at the moment we are talking about legacy collections which are what they are all right they have a certain amount of annotations to them and those annotations have been um have been added to the samples following a particular local protocol um that should be the subject of a discussion with a potential user for the user to say to discover whether or not that constitutes a sufficiently robust uh annotation of infectious status for the work that that requester is doing um if it's not then obviously there are two ways out one is for that person to go and look for another collection um or to ask for the provider to perform other uh tests which the requester may have to pay for in order to make the annotation more robust but the virtual buyer bank of itself is uh is not involved in that um uh let me come back to that at the the end but there was another question there related to accreditations yeah um the accreditations of the providing institutions is one of the one of the items that is to be uploaded onto the virtual biobank to describe you know the collection and the institution there is no shortage of accreditations uh there is of course the new biobanking accreditation um there will be some who are accredited are certified i should say to iso 9001 there will be some who are accredited to 17025 there will be others who are accredited to whatever it is 15089 i think it is um all these should be available should be announced by the uh the collection within the information that they put onto the virtual buyback so that the requester can can select based on the information available and last point is that obviously when you when we're looking for perspective collections we have the opportunity here to determine just those points and one of the areas where it turns out that um that i myself and my colleagues and joseph and fein have been working on is the determination of collection protocols and data collection protocols to ensure that the the samples really are fit for specific purpose so it's easier for perspective but of course the perspective is out in the future it's not in the biobank today thank you for that answer i know a lot of these questions are ending up with dominic i think and that's absolutely fine um there's a question again on terms of quality of the sample so quite specifically on the samples again and their data actually uh dr martin van franken hoisin from the itm in antwerp do you have a means to guarantee the quality of the samples and their data in the virtual biobank yeah it's a little bit back to what i was saying just a moment ago that the short answer is no um the biobank is a place is a platform it's a meeting place between collections and researchers and the determination as to to the quality of the samples and the data is part of the discussion between those two parties and at the moment find is is not active if you like in doing things like we don't do audits of collections um now your question is one that comes up a lot and it is something that i think it would be really useful for the community to think of is is it the role of i find or anybody else within the community to be doing such quality assessment and i'm not i'm not loading the question either to say that it's right or wrong but it's it's an important strategic question concerning the role of the platform and we won't we won't be able to find the right answer here but i'd be really interested in carrying on that discussion because it is a real question that at a very legitimate question which has been posed by many potential users yeah i think and doctor there's a continuation of this to you the manpower all the external catalogs up to date so i don't know if you'll find the same issues there or not but it's certainly an issue there for the potential users that they'd like to discuss with is that that's great um i'm just trying to scan through in terms of questions for aubry um or we really we've been talking about you as a potential user as a potential collaborator if you have the collaborators hat on i know you you know we ourselves were made an external partner uh as one of the one of the many external partners on last friday off the digital diagnostics for africa network networks we're very very uh happy and honored to be um on that but as a potential collaborator and in that network why i just mentioned that in that network it's a massive kind of breadth and depth different kind of disciplines involved from that perspective what do you think you'd be able to contribute or be as the digital diagnostics network there are issues on collection processing storage those kind of issues is that somewhere that you can see contributions coming in from your network from the network or where do you see the kind of collaborator network interface does it work thanks cameron so i think um the in terms of potentially being able t