00:00:00:00 - 00:00:45:08 Welcome to this fifteenth episode of the BBMRI-ERIC Podcast. My name is Mariangela Masiello, Media Relations Specialist at BBMRI. This is part two of a two-part podcast which shares impact 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. 00:00:45:10 - 00:01:11:09 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. The first episode contains stories from IT and our ethical, legal and societal issues experts. 00:01:11:11 - 00:01:35:21 If you haven't heard it already, I suggest you to listen to part one first. This episode features impact stories from Quality Management and Biobanking Development. Andrea Wutte, Head of BBMRI QM, and Saba Abdulghani, Head of BBMRI Biobanking Development, will help give you some context. It’s my pleasure to hand over to Andrea. 00:01:35:23 - 00:02:09:09 Thank you Mari. BBMRI-ERIC has dedicated significant efforts to ensuring that the quality of samples and data provided by biobanks for biomedical research meets the highest quality and research standards. BBMRI-ERIC Quality Management has developed, in collaboration with the experts from our community, with international and European standardisation organisations, more than 20 recognised international standards, setting the highest benchmark for the operation of biobanks, not only in Europe but globally. 00:02:09:11 - 00:02:39:15 We also have developed a numerous targeted training program, and we are providing biobanks with an extensive audit and peer review scheme for assessing sampling data quality that not only leads to a harmonised and standardised research output, but also to a BBMRI-ERIC quality label that indicates that the biobank operates and is set up and maintained according to these international standards. 00:02:39:17 - 00:03:23:23 We selected two impact stories to showcase member country representative examples for the successful implementation of quality assurance and quality control measures, along with the positive impact on both basic and applied research. First is Lila Kallio with us, who is the Aria Biobank director in Finland. The Aurora Biobank was not only the first biobank who has achieved a quality label by BBMRI in 2017, but they continued their effort of improvement, and that has led to a third party accreditation by its national accreditation body two years ago. 00:03:24:00 - 00:03:53:22 Thank you. Good afternoon everybody. I'm going to give you a short introduction about quality management at Auria Biobank. But here you can see first the biobanking scene in Finland. Obviously we are part of the BBMRI-ERIC family and National Node Coordinator is the Finnish Biobank cooperative. We have 11 biobanks in Finland. We have cohort biobanks nationwide, population biobanks, blood donor biobanks. 00:03:53:24 - 00:04:25:06 And then we have six hospital integrated biobanks which cover the whole area in Finland. And Auria Biobank got the permission to operate 2014, ten years ago, right after the Biobank Act was accepted in Finland. Quality Management has always been very important for Auria and we have had a full time quality manager since the beginning. First, we have followed the OECD best practice guidelines. 00:04:25:08 - 00:05:04:16 We did self assessment surveys developed by BBMRI-ERIC and obtained the quality label, later on in 2017. We started to prepare for the accreditation very shortly after the Biobank specific ISO standard was published and finally achieved the accreditation for Human Material BiobankIing in 2022 from FINAS, which is the Finnish accreditation service. And of course, we do internal audits and external sample quality testing routinely in the Biobank. 00:05:04:18 - 00:05:31:23 So there are some key factors which have enabled successful biobanking in Finland. One is the broad consent, which is the collection of the consent is in the credit in the hospital routines and also the sample collection and data. Clinical data from the electronic health records in hospital that can be linked to the samples and that provides biobank with high quality samples and data. 00:05:31:23 - 00:06:15:05 Already in the beginning. So the quality management thoughts when the samples are received at the Biobank, the accreditation covers the receiver processing, storing and donation of the biobank samples for research purposes. And during the ten years of operation, we have donated samples and data for nearly 300 biomedical studies. And I think the impact comes here that biomedical studies provide basic scientific knowledge, for example, about disease mechanisms or discovery of potential new drug targets, which can lead to development of new treatments and treatment practices for personalised medicine, for example. 00:06:15:07 - 00:06:49:11 And very importantly, the new data generated in the Biobank studies So it is returned back to the Biobanks, for example, sequencing data. And that can be used in the future biobank studies. And the samples don't need to be sequenced again. And finally, the biobank studies don't normally benefit the donor himself. But, if there have been some findings in the biobank studies, which can be of clinical significance, those can be returned to the donors if they have been consented for that. 00:06:49:13 - 00:07:13:12 And we have recently piloted that in the hospital biobanks in Finland very successfully by returning genomic data of certain pathogenic breast cancer variants to donors. And if the donor's consented for receiving that information, the data was then returned to them by the hospital, by professional from the health care. So I think that is shortly what I had. 00:07:13:14 - 00:07:19:06 But I thank you very much. 00:07:19:08 - 00:07:53:24 BBMRI Italy features more than 46 quality certified biobanks that annually offer services to more than 290 research groups. The concerted quality efforts significantly contribute to progress in biobanking and biomolecular research, not only benefiting Italy but also establishing fruitful collaborations within the broader scope of BBMRI-ERIC. The person to tell you about this success story is Marialuisa Lavitrano who is National Node Director of BBMRI Italy. 00:07:54:01 - 00:08:31:18 Thank you very much. I must say that I am full of emotion today, full of emotion. This is ten years and even more of my life. As you all know, maybe. So now I'm very pleased to present the case of Italy. You have to know that in the last 4 or 5 decades in Italy, biobanks that store human bio specimens and data, of course, were proliferated in private and also and in public institutions. 00:08:31:20 - 00:09:19:14 And when the BBMRI started its journey for BBMRI, for the participation in BBMRI the national strategy was to establish an inclusive network with all the biobanks present in Italy, and to support them to reach the required quality level. Currently we have 97 Biobanks, lots: disease oriented, population archive tissues biobank that are part of BBMRI Italy, the National Node. 47 of them are compliant with the quality and Elsi requirements, and therefore signed the partner charter for the participation in BBMRI-ERIC. 00:09:21:00 - 00:10:05:22 Our Biobanks are located in almost all the regions in Italy and are hosted in 19 universities, plus the CNR, 45 hospitals and 33 IRCCS. IRCCS are special hospitals, research hospitals, often linked to academic institutions. Identify high to perform translational research and therefore allowing a continuous exchange between clinic and research. You have heard from Jens how important is the exchange between clinical and research and what does it mean 00:10:05:24 - 00:10:46:05 Healthcare Integrated Biobanking. In the 51 IRCCS in Italy, they are participating in networks focus on cancer, neuroscience, cardiovascular, paediatric and aging. And with more than 15,000 scientists clinicians, they perform cutting edge research, fundamental, translational and clinical research and provide care to about 350,000 patient annually admitted to the hospitals and more than 5 million outpatients. In the IRCCS, BBMRI 00:10:46:07 - 00:11:25:07 Italy promoted the Health Care Integrated Biobank. Why? Because in the IRCCS, in these research hospitals, the virus pathologies are followed up from the prevention phase to diagnosis to therapy, thus making it possible to sampling and biobanking of biological material in the different phases of the natural history of the diseases. Implementing the Healthcare Integrated Biobank, each patient visiting a research hospitals has now biomedical and health data included in their biobank after consent. 00:11:25:07 - 00:12:03:14 Of course, by default, without any further extra burden. The healthcare biobanking and the healthcare biobanks are playing an increasingly important role, not only in the biomedical research, but also in transferring knowledge to the health system. Science has a wealth of knowledge and technologies that has not yet been transferred into patient care, and the commitment in the IRCCS is to bring innovation to clinical practice so that patients can look to the future with more confidence. 00:12:03:16 - 00:12:42:19 I strongly believe we all strongly believe that the research process itself can have a beneficial effect on the delivery of high quality healthcare. And BBMRI Italy is planning that Biobanks will become integral part of the national healthcare structures, thus supporting not only research but also the healthcare. Thank you. 00:12:42:21 - 00:13:04:20 You just heard from Andrea, Lila and Marialuisa. Next, let’s meet Saba Abdulghani who is Head of BBMRI Biobanking Development. She is here to introduce this new BBMRI department and two impact stories from innovators in the community. 00:13:04:22 - 00:13:31:00 Thanks Mari. The Biobanking Development department is a recent addition to the Core Services at BBMRI-ERIC. We help new National Nodes and their networks to integrate into our community and we strive towards long-term sustainable growth. We support our community by enhancing the visibility through facilitating the access to samples, data and biomolecular resources, as well as integrating our community into EU funded projects where the Biobanks are instrumental in advancing medical research, such as in the fields of cancer and infectious diseases. 00:13:31:02 - 00:14:02:07 Furthermore, we foster community engagement activities with multiple stakeholders, leverage novel technologies, and facilitate knowledge exchange for the benefit of our wider community. We are also leading a collaboration with our community towards a greener, more sustainable, biobanking future that is focused on climate friendly practices and education. Facilitating the link between researchers and biobanks for the benefit of society is a core Biobanking Development priority and is showcased in two impact stories. The first is from Judit Molnar, National Node Director of BBMRI Hungary who will tell you about the initiative to advance data sharing in healthcare. 00:14:13:12 - 00:14:35:21 It's a real big honor for me to be here and to introduce you the Hungarian node. We are a relatively new member of the BBMRI-ERIC. And I can tell you that to join BBMRI-ERIC had a huge impact on our development at the Hungarian Node consist of seven, different biobanks. 00:14:35:21 - 00:15:12:13 We have four universities owning medical faculties, and we have a large hospital, which is actually a national center for hematology and infectious diseases. we have a pediatric oncology network, and we have a family pharmaceutical company, which is the digital guardian. And we have population based biobank. This is Biobanks and, data repositories. And when we were joining BBMRI-ERIC, the first thing was that that we were mapping what we had, and then we realised that our data are really diverse, fragmented and not interoperable. 00:15:12:15 - 00:15:39:03 And that's why we decided that we have to do something and to create such an ecosystem which can integrate these fragmented data sets. And we would like to harmonise the data and prioritise plans of interoperability through the BBMRI standard and align. Because we have so many clinical data, we have to align with the OMOP data, model for the clinical data. 00:15:39:05 - 00:16:05:08 And then of course, we have to map, what we have very detailed to be. So we have done it. So we started with this mapping and the first goal was how can we, changing the structure of these data sets. And the first we had to create a common data model because there were so diverse in the structure of the data that our biobanks were collected. 00:16:05:10 - 00:16:31:03 So it was not an easy we have no the common data model, and we harmonised the local databases. And we are now in the phase of the federation. So, to, implement in Hungary, it's a new method how to share the data ,that the data stays at the local biobanks, but we can share it, to protect the privacy. 00:16:31:05 - 00:17:00:11 For us it was not a very easy, job. And the second that we wanted to have such type of federated data sharing that we are able to implement varied and complex queries because we have not only the clinical data, we have so many genomic data as well. And I think it's a brilliant thing when we can see the data from the different patients without knowing all the data and to be able to do the statistics. 00:17:00:13 - 00:17:26:14 Why is it important for us? Because we can reevaluate all this sensitive data and, we can support the expansion of these rich data sets, and we can really integrate the patient data. And what is the impact for us, the first impact that at first we will do it within one university. It's a pilot project. The second, I hope we can start next year within the Hungarian Node. 00:17:26:16 - 00:17:49:12 And the third will be a very important. Then we can come to the European platform and we can share this way the data with BBMRI-ERIC as well. And the main benefit for us, we are living, we are starting the precision medicine, the data driven medicine. So all these data are extremely important in the patient care. I can identify patients with different mutation. 00:17:49:14 - 00:18:17:11 I can offer them, I can identify patients who are good for different clinical trials. And then I can also support the reverse translation. I think it is also very important if I have to go data. And finally we can improve not only the health of an individual citizen or patients, but also the health of the society. Thank you very much. 00:18:17:13 - 00:18:42:09 Now let’s hear from Katerina Novakova who represents BBMRI Czech Republic. It’s not often we get to hear about research that is facilitated by samples provided from our biobanks, let alone studies that have gone to clinical trial. Katerina will share one of these rare stories on how a life may be saved from a single drop of blood. Ladies and gentlemen, I'm really honored to be here and present 00:18:42:09 - 00:19:19:09 You our Czech by banking story. It's, a little bit different point of view, because everything starts with patient, and everything should end with the practice, availability of methods or some kits or some practical outcomes to the patient again. So I choose one based on the research of Professor Holčapek and his team, from University of Pardubice to his researcher who developed a new innovative method how to detect pancreatic cancer from drop of the blood. 00:19:19:11 - 00:19:59:02 So it's really interesting. And I will tell you more why they chose pancreatic carcinoma. The incident of this cancer is, really high and the mortality is following in timeline since 70s from the source of Czech Republic. You can see this, this cancer is spread around the Europe, of course. And I can say that the survival of, this cancer is really low because after treatment, only 10% of patients survive for five years. 00:19:59:04 - 00:20:30:16 So why is this mortality so high? It can be caused by severe circumstances, such as asymptomatic course of this disease. Or it can be because of problematic detection, because the pancreas is covered by other organs. And also the detection of this disease is really late in advanced stages of cancer. So this is why professor Holčapek focused on this cancer. 00:20:30:18 - 00:21:09:13 And I would like to show you why I chose it, because he starts around the establishing of BBMRI-ERIC, in 2013. And during his research, he asked several times our Biobanks, check biobanks, for samples and also for other associated services such as biochemical analysis, sequencing, and so on. So we collaborate together for several years. And after that, during 2022, was pilot study done atmospheric memory or cancer Institute. 00:21:09:15 - 00:21:38:03 And it was done for the patient with high potential of, pancreatic cancer. And, now we are running some national multicenter clinical trials which are focused on evaluation and validation of the methods on national level. So now we are starting in this year, and hopefully in the future, it will be possible to make this method available internationally. 00:21:38:04 - 00:22:11:11 And I would like to mention three important things from my speech that biobank and participate on the research. More than once, we provided to Professor Holčapek over 1000 samples and about 300 analysis. Is good to know that the practical outcomes from research takes time. So it was decade. Then we start together and to get to the national level, and it is still running. 00:22:11:13 - 00:22:52:24 But the impact can be really high. And it's also good to know that this clinical trials cannot be done without any coordination with other infrastructures, because this clinical trial were coordinated by this and the collaboration of both are really helpful for the researcher and I would like to mention that, this method can save life because of this detection is, really over 90% in early stages. 00:22:53:01 - 00:23:13:23 So if you imagine that the patient is detected, retained in the hospital, also the accuracy, quality life and also for the society input, impacts of the patient can be much higher than it is now. Thank you. 00:23:14:00 - 00:23:53:23 Thank you, Katerina, Judit and Saba and thanks to all the impact storytellers over the last few episodes. BBMRI-ERIC exists to represent and support the biobanking and biomolecular resources community. Such is the pace of work at local biobank, national and EU project level, it’s not often we get to capture examples of innovation like this, so it’s been a pleasure to bring these to you. 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. 00:23:54:00 - 00:24:21:21 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 – it helps us to reach new listeners. Watch out for our next podcast episode via our @BBMRI-ERIC socials on Twitter and LinkedIn. 00:24:22:00 - 00:24:27:07 And thank you for listening.