00:00:00:00 - 00:00:43:15 Welcome to this fourteenth episode of the BBMRI-ERIC Podcast. My name is Mariangela Masiello, Media Relations Specialist at BBMRI. This is a two-part episode which shares success stories from across BBMRI-ERIC’s Member States and communities. They were presented at the BBMRI-ERIC 10th anniversary workshop. Each story demonstrates the wide-ranging expertise and impact of the research infrastructure that our community both shapes and benefits from. 00:00:43:17 - 00:01:09:05 The anniversary event was held at the Permanent Representation of Austria to the European Union, Brussels on 29 February 2024 and brought together key members of the biobanking community to explore BBMRI-ERIC’s impact as a research infrastructure over the last ten years and look to the future. Let’s start with stories from BBMRI-ERIC’s IT service which forms the backbone of the community’s interconnectivity. 00:01:09:07 - 00:01:18:24 Petr Holub, is BBMRI-ERIC’s Chief Information Officer and leads the IT team that brings together expertise from across Europe. 00:01:18:24 - 00:01:43:21 BBMRI-ERIC has transformed biobanking and biomolecular research by creating an IT ecosystem that enables valuable resources to be easily discoverable, accessible, interoperable and of the highest quality. The pioneering BBMRI-ERIC Directory and Federated Platform have streamlined the connection between biobanks and researchers to promote secure data discovery and privacy-preserving federated analysis. 00:01:43:23 - 00:02:16:22 This is underpinned by BBMRI-ERIC’s strong commitment to FAIR-Health data as part of the European Open Science Cloud (EOSC) initiative. BBMRI-ERIC Negotiator facilitates access and communication between researchers and service/data providers. All three together - Directory, Federated Platform and Negotiator - constitute an interconnected IT ecosystem that offers our stakeholders a single entry point to BBMRI-ERIC’s samples, data and biomolecular services. 00:02:16:24 - 00:02:49:04 We have two examples that illustrate successful stories, each showcasing different aspects. The Estonian Biobank project, that was headed up by Professor Andres Metspalu, is a population-based biobank of the Estonian Genome Centre. It gathered a pioneering cohort of over 210,000 participants reflecting the demographic distribution of the Estonian adult population. The project involved genomic analyses for research that includes cancer. 00:02:49:06 - 00:03:13:17 Estonia serves as a prime example of a national system where visionary approaches have enabled the mobilisation of data in ways that larger or more decentralised countries may find challenging. It allows the implementation of innovative initiatives that might otherwise be difficult to achieve. Andres will explain that journey. 00:03:13:17 - 00:03:15:18 Unknown Thank you very much and I'm really happy to be here. 00:03:15:22 - 00:03:43:22 After 25 years of doing biobanking. So I see that in our case, actually the new generation will take over. But from the very beginning 1999, it was clear that we want to do a biobank for two good reasons. One is research and the other one is healthcare. And just to be sure that people are confident that we keep the data and we save the samples very well and nothing bad happens. 00:03:43:22 - 00:04:07:03 So it was clear that we needed a law and we started a law, biobanking law. We called it human Gene Research Act and it assured that for 25 years now I guess it needs to be a little bit changed because of new regulations from Europe. And the law is pretty good. That's very good. We went through the economic collapse, but law come and testified the money. 00:04:07:09 - 00:04:32:13 And finally they put into the law that they are supporting the maintenance of biobank from the state budget. So we have to provide one a for every year and as a for the end of year. And so it has been the last 15 years. So I don't have to worry about we cannot touch it on anything. So basically we have to recruit people to do research and provide the data and the knowledge to the healthcare. 00:04:32:15 - 00:04:56:06 Last year, I would say it was a very good year. University hospital started a new clinic called Genetics and Personalised Medicine. We've got a big grant from the European Commission, together with the University and the Erasmus Medical University, from Rotterdam 30 million for small country. Big thing. And also we have already second time as a center of excellence in Estonia. 00:04:56:08 - 00:05:16:07 But I remember when we started, we were pretty much like alone. UK had a biobank and IARC had a biobank, a big biobank called Epic, and I spent one year in Lyon. Very nice anyway, but I learned how to do the biobank. I also am a medical doctor, so never did any biobank before. So these are story and I was really happy. 00:05:16:09 - 00:05:39:02 And then i followed the accord that look on the service a new activity called Biobanking BBMRI. And the preparatory phase is going to happen. So please join us. And it was really good. You just join the community and you make sure that everything that we are doing there. Long way from here. 00:05:39:03 - 00:06:02:14 You know, I don't know how many of you have been there, but we are now in the far east, northern corner of European Union and from Tartu is 100 km to come at the Syriza border and after the border, you know what happens. So basically, we are really safe now and in many ways, also in biobanking way. 00:06:02:15 - 00:06:22:20 We are part of the family, but we are doing here what we know is that what we are doing at home, we can benchmark and we are working together. So IT is central issue. And, you know, Estonia is very much of a country and we started from the IT immediately,. Everything was on IT. So we got set by law. 00:06:22:20 - 00:06:53:08 We get the updated information from the hospitals databases, registries and also now we made it all available through IT solutions like findability discovery for BBMRI. So people actually can use BBMRI window and go into data what we have and they say interested. So you can get to data. Now of course at the beginning we provided data, but now the tools have to come to the data. 00:06:53:08 - 00:07:15:22 Data is so big. We have two petabytes of data. You can't move them anymore. So the tools have to come to data. You can do whatever, but you leave with your own results. You leave everything behind which belong to you. So I would say that being in BBMRI it's a good thing. 00:07:15:22 - 00:07:38:19 It's very good thing. It makes you sure that you are doing the right thing and you are going along with other countries which are much bigger, more resources, more scientist, everything more. But in some places small is beautiful. We can do a proof of principle things because one medical university, one large biobank which is supported by the government. 00:07:38:21 - 00:07:45:01 Unknown Thank you very much. 00:07:45:03 - 00:08:16:16 Andres and the team connected their genomic data to Finder to make it available to researchers across Europe. This next story links to another aspect of BBMRI’s Federated Platform. BBMRI Germany developed an IT solution that preserves the sovereignty of biobanks while allowing easy access to their information. The ‘Sample Locator’ is an openly accessible online tool based on a federated search. 00:08:16:18 - 00:08:42:13 That means data is kept at source with the biobank, where privacy is preserved. Germany’s success story highlights how national initiatives for discovering bio-specimen data have been integrated into BBMRI’s portfolio, connecting and supplying researchers in Europe and beyond. 00:08:42:13 - 00:08:44:09 thank you very much. 00:08:44:11 - 00:09:13:02 The second IT success story from Germany I think we already heard BBMRI is a family, family with a lot of child, the Biobanks and a family with mother and father, national nodes and the headquarters. And it's really necessary that we support each other. We are not always of the same opinion. That's very good because it raises a lot of discussion, but also a lot of interaction. 00:09:13:04 - 00:09:40:00 On the other side, we need harmonisation. And when we started ten years ago, also in Germany, was too structured biobanking, boosted by BBMRI-ERIC, it was a new situation. We have now started with 1011 Biobanks in Germany. How to integrate those biobanks in an alliance not only to see single biobanks isolated, but to bring everything together to make it visible. 00:09:40:06 - 00:10:07:08 What is the potential of those biobanks? And so we started to think about the possibility to make the bio samples available, to make it visible, accessible. And it was starting point with 11 biobanks. And now you can see it's more than 11 dots here on the map. We are now 37 Biobanks in Germany, which are intact. 00:10:07:10 - 00:10:37:22 And I think it's very important to make available what is present, what is available in these biobanks. And for this purpose, we initiated a large and good and sometimes emotional cooperation with IT people from Germany and had a lot of concept. And these days in order to allow a federated search platform that was new and we do not want to establish a central biobank. 00:10:37:22 - 00:11:24:09 So the data should be kept locally. That was very clear. But how to organise this? And after a while we initiated the sample locator. That was Jens you might remember Lubeck Euro Biobank week. I was standing in front of a large audience launching our Sample Locator. What is a Sample Locator? You have the possibility to type in a web interface search terms, and within one minute it will receive results from the connected Biobanks, not detailed patient information, but the number of samples or donors linked to this search criteria is highlighted. 00:11:24:11 - 00:11:59:09 That is GDPR compliant to huge extent. And if you log in, you can see which biobank contributed to this search. And that was what you can see. You can see after log in which Biobanks contributed samples and donors which fulfilled your criteria. That is our German solution. That's good. Interesting. But thanks also the initiative of Jens, Federated Search, in addition to the catalog to the directory was initiated as a European platform. 00:11:59:11 - 00:12:27:07 And believe me, I'm more than happy that Germany that our IT colleagues that the biobanks can contribute to the federated search platform of BBMRI-ERIC to a I think significant extent and also not only the biobanks but also the IT people involved in that development. More than happy that this has initiated. It's not ready. I'm sure there is space for the next ten years to contribute to develop further. 00:12:27:13 - 00:12:58:07 Also to have more data in the Sample Locator it's limited. That's good as a first step for feasibility studies. But now that is the situation we have. And I thank you very much for your attention. 00:12:58:09 - 00:13:26:24 You just heard from Petr, Michael and Andres from the IT teams. Next, let’s meet Michaela Mayrhofer, who is Head of BBMRI ELSI Service and Research. The ELSI team of experts tackle the thorny ethical, legal and societal issues related to biobanking. She will introduce two examples of Pan-European ELSI collaboration and their impact, focusing on biobanking with children and the practical implementation of biobank legislation and standards. 00:13:27:01 - 00:14:04:22 Thank you Mari. Over the last 10 years of contributing to major biomolecular research initiatives, BBMRI-ERIC’s network of ethical, legal and societal implications (ELSI) experts delivered reliable, practical and sustainable services based on state-of-the-art research for the immediate benefit of the life sciences community. The ELSI experts provide case-by-case guidance, promoting best practices, while enabling a sustainable platform for internal and public knowledge exchange. 00:14:04:24 - 00:14:45:21 To date, ELSI expertise has been requested in more than 30 projects and we responded to hundreds of ELSI Helpdesk requests. By teaming up with patient representatives and life science researchers, we have actively contributed to shaping guidelines and legislation, including General Data Protection Regulation, European Health Data Space, and Council of Europe initiatives. It’s my pleasure to introduce two success stories that showcase how tackling ethical, legal and societal aspects, enables responsible research innovation through collaboration. 00:14:45:23 - 00:14:53:02 The first is told by Annelies Debucquoy, National Node Director for BBMRI Belgium. 00:14:53:02 - 00:15:13:01 I'm very happy to be here today. to give you an example of how the ELSI code and services of BBMRI-ERIC have had an impact on the Belgian biobanking landscape. Our ELSI experts on the Belgian level have been very active working with the ELSI team at the headquarters, but also with the ELSI experts of the other nations of BBMRI-ERIC. 00:15:13:01 - 00:15:37:17 Either in common European projects through the ELSI help desk, or by attending or giving trainings in the framework of the ELSI Common Service. And in my five minutes , I would like to go into one aspect, particularly where we had a very good collaboration on the national and on the European level, and this is about the implementation of the Belgium Biobank law and the alignment with the regulations on the European level. 00:15:37:19 - 00:16:04:08 So, as you might know, there is no harmonised European law on biobanking, and therefore all member States have to take their own decision about it. So, some member States do not have any specific rules or regulations dedicated to Biobanks. Some have implemented soft law and also some countries have a dedicated national biobank law. In Belgium that has actually been a law on the acquisition and use of human body material, both for medical applications and for research. 00:16:04:08 - 00:16:35:19 Since 2008, however, the part on biobanking so the use of samples for research has only been enforced ten years later in 2018, because only then the royal decree about this part of the law has been published. The publication of this law was a big opportunity for the Belgian Biobanks, because it showed the necessity of biobanks for research, and it also ensured that the only biobanks that are recognised by federal authorities could store and give samples to the researchers, which assured the high quality of samples in the data. 00:16:35:21 - 00:16:58:21 However, it has also been a very bumpy road with a lot of uncertainties and questions, both from the biobank side and from the researcher side And one of the questions that came up immediately after publication of our law was how should we deal with European regulations and how should we align our law with this? And as a storage and provision of samples goes, of course, hence and hance the storage and provision of data. 00:16:58:23 - 00:17:23:00 The GDPR was the first one that came up and gave a lot of questions. And for this, the collaboration between the ELSI experts at BBMRI-ERIC and at the national level has been really crucial. The common service, of BBMRI-ERIC has set up a lot of trainings, webinars, discussions, sessions about hot topics on the GDPR. They developed supporting documents, frequently asked questions about the GDPR really a lot of things. 00:17:23:00 - 00:17:45:03 And this really gives us a very good insight in what the GDPR is about, and especially also what the possibilities are within the GDPR and how we can fit this to our Belgian Biobank law. And so by their support, we were able to come up with a Belgium Biobank law that is aligned with the GDPR. And that is also acceptable both for the Biobanks and for the researchers. 00:17:45:05 - 00:18:14:18 And then to make the story full circle our ELSI experts have then at the end of last year, I think, given a webinar within the ELSI common service about our Belgian Biobank legislation and how this was aligned with the GDPR as a showcase for the other nodes of BBMRI-ERIC, because we know that also a lot of other national nodes are struggling with the same issues at this moment, and our story could help them to get things sorted also in their country. 00:18:14:20 - 00:18:37:07 So now that we have those two laws aligned, I don't think the story ends because of course we have a lot of other upcoming regulations. We have the European Health Data Space in the pipeline, the proposed AI act and I'm sure many others will follow. So I am quite sure that the ELSI journey, will continue and I am looking forward to extend our collaboration with the ELSI team of the BBMRI-ERIC for the next ten years. 00:18:37:10 - 00:18:42:20 Thank you. 00:18:42:22 - 00:19:07:21 That was Annelies from our National Node in Belgium. Zisis Kozlakidis is National Node Director for BBMRI IARC/WHO. He gives an example of collaboration between BBMRI-ERIC and IARC/WHO on biobanking with children that led to the publication of “The European Paediatric Biobanking recommendations”. 00:19:07:21 - 00:19:13:07 Thank you. So I thought since BBMRI is turning ten and it's still a child, 00:19:13:07 - 00:19:47:24 I would give an example about working with children and then keep it within the theme. So when we started talking about biobanking with children or samples from children, we had to respond to three main questions, three on the side of the legislation laws and guidelines across Europe. Many children remain children and then suddenly they become adults, which is not really the way biology or the capacity of development throughout the first years of their life goes. 00:19:48:01 - 00:20:12:19 So legally, we cannot reflect the processes that happen naturally. The second question that we had was what does happen when the child becomes an adult? And then they have to decide for the samples that have been biobanked for themselves on their behalf. And the third question, well, of course, the question then is when children, teenagers, they don't really care much. 00:20:12:19 - 00:20:40:22 But in any case, we have to provide that solution. And the third question was, when we find something on those childhood samples that has an impact on the adult life, how do we deal with it as biobanks? So with a lot of help and support with the ELSI team and Marialuisa, with a lot of the Italian colleagues, because Italy is very active in the paediatric research space. 00:20:40:24 - 00:21:09:22 We sat down and had a look at the landscape of Europe, which unsurprisingly, it's fragmented at that point and we didn't try to defragment it, but we try to bring together a lot of these differing opinions into something that is workable. And we've published a series of recommendations on how to work with paediatric samples across Europe. Now, why is this important? 00:21:09:22 - 00:21:38:00 Because I come from the World Health Organization, so why do we care? The reason is because what happens in Europe this year has funded seed funding, received seed funding by the Netherlands and by foundation in Spain to promote the creation of multinational studies in childhood and cancer in low and middle income countries, based on the recommendations that we developed in Europe. 00:21:38:02 - 00:21:56:12 So what happens here is something that we care about, because we can then take it and extend it as a blueprint across the world and addressing these problems. I'll stop here more than happy to talk about this studies. Thank you. 00:21:56:14 - 00:22:25:17 BBMRI-ERIC exists to represent and support the biobanking and biomolecular resources community. The innovations you’ve heard today are driven by BBMRI community experts who possess great dedication and passion. You can hear this in their enthusiasm so it has been a delight to share these stories of biobanking impact from across Europe. Listen to part two of this podcast to hear 10th anniversary impact stories from Quality Management and Biobanking Development. 00:22:25:19 - 00:22:55:21 To learn more about how we work, and read stories from our National Nodes visit the BBMRI-ERIC website – bbmri-eric.eu and browse the ‘’news’ section. We regularly share National Node news from across the biobanking community via the BBMRI-ERIC newsletter; you can sign up on our website. If you enjoyed this podcast, do share it with interested friends and colleagues, and leave us a review on whichever platform you listened via. 00:22:55:23 - 00:23:23:08 It helps us to reach new listeners. Watch out for our next podcast episode via our @BBMRI-ERIC socials on Twitter and LinkedIn.