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ESBB Interactive LIMS Workshop
Thursday 13th & Friday 14th March, 2014
REGE Hotel Via Milano 2,
20097 San Donato Milanese (MI), Italy Tel +39 (0)2 51628184
Fax +39 (0)2 516282216 [email protected]
http://www.regehotel.it
Contents
Pg.
A. Welcome and Introduction .................. 1.
B. Programme Diagram ........................... 2.
C. Programme Schedule ......................... 3.
D. Speaker Abstracts ............................... 7.
E. Speaker Biographies ........................... 13.
F. Corporate Profiles ............................... 18.
G. Participants ......................................... 21.
H. Notes ................................................... 25.
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A. Welcome & Introduction
Welcome to this 2 day Interactive LIMS workshop, with an emphasis on the word "Interactive". The goal of this workshop is to share and discuss the typical biobank data-management requirements and to encourage discussion with and between experts, both biobank users and vendor representatives.
As you can see from the Programme Diagram, we have a total of 12 half-hour sessions where biobank users and other experts give a 20 minute talk followed by 10 minutes of questions (light green shading). There are sessions for general discussion (yellow shading) and sessions where vendor-representatives will describe their products (light purple shading). In addition there are a number of opportunities for networking and discussion over coffee, lunch and dinner.
So that you can stay in contact with people you meet after the workshop, a list of email addresses will be sent to all participants directly after the conference.
We hope that you have a very productive and enjoyable 2 days and if you have any questions, please feel free to contact the three organisers either during or after the conference. Our contact details are:
Pasquale De Blasio ... [email protected]
Erik Steinfelder ... [email protected]
Robert Hewitt ... [email protected]
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B. Programme Diagram
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C. Programme Schedule
Thursday 13th March
08:00am Registration
09:00am Welcome & Introduction
09:30am MBioLIMS implementation for 1) an institutional cancer-oriented biobank and 2) a national biobank network dedicated to an orphan disease. Boris Calmels Paoli-Calmettes Institute, Marseille, France
10:00am Maintaining and verifying sample integrity Slee Mbhele University of Cape Town, South Africa
10:30am Coffee
11:00am Attendee Requirements: Open Discussion
12:30pm Lunch
01:30pm BBMRI-IT the Italian Node of BBMRI-ERIC Marialuisa Lavitrano University of Milano-Bicocca, Milano, Italy
02:00pm The BBMRI-IT Informatics Infrastructure Luciano Milanesi Institute for Biomedical Technologies, Milan, Italy
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02:30pm Comprehensive Bioprocessing and Biobanking: Enterprise level requirements for global success Andy Brooks RUCDR Infinite Biologics, 170 Frelinghuysen Rd., EOHSI, Rm 236, Piscataway, New Jersey 08854 USA
03:00pm Biobank management platform for standardizing IDIBGI collections
Aina Rodriguez Vilarrupla IDIBGI, Girona, Spain
03:30pm Coffee
04:00pm Freezerworks Presentation Cheryl Michels, Rick Michels
04:15pm Modulbio Presentation Laurent Jacotot, Sonia Mraihi
04:30pm NorayBio Presentation Micael Noguero, Daniela Pistillo
04:45pm LabVantage Presentation Matt Rogers, Graham Wilson, Vitale Ambrosini
05:00pm Synergistic data integration in the age of personalized medicine: the OPID system network Pierluigi Scalia, P. & Giacomo Lo Presti Somatogenics, Inc., 714 Oceanview, Los Angeles, California 91016, USA
05:30pm General Discussion for up to 1 hour
07:00pm Workshop Dinner at REGE Hotel
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Friday 14th March
08:30am Qatar Biobank LIMS Hadi Abderrahim Qatar Biobank, Doha, Qatar
09:00am Regional biobank activity: getting started Mariagrazia Daidone Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy
09:30am RURO Presentation Vlad Lebedev, Vera Terekhina
09:45am Thermo Scientific Presentation Philippe Gameiro, Roberto Tecco
10:00am Technidata Presentation Christophe Guitart Arnau
10:15am Soventec Presentation Kai Diercks, Christina Bober
10:30am Coffee
11:00am Vendor-Neutral Guide Eric Steinfelder ESBB Vendor Committee Chair
12:00nn General Discussion
12:30pm Lunch
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01:30pm Promote scientific collaboration and maximize the value of stored specimens Annick Barthelaix1 and Christophe Guitart Arnau2 1Angers University, Angers, France; 2Technidata SAS, Montbonnot, France
02:00pm Everything around Nautilus software for an accurate management of Biobank. Giuseppina Bonizzi European Institute of Oncology, Via Ripamonti, 435 Milano, Italy
02:30pm Biobanking Information System Requirements with regional focus Rita Lawlor ARC-Net Applied Research on Cancer Centre, University of Verona, Verona, Italy
03:00pm Coffee
03:30pm General Discussion & Wrap-Up
04:30pm Farewell
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D. Speaker Abstracts Promote scientific collaboration and maximize the value of stored specimens Barthelaix, A.1, Guitart Arnau, C.2 1Angers University, Angers, France; 2Technidata SAS, Montbonnot, France Biobanking is now a € 5.7 billion industry, according to VisionGain, a London-based business information company. Demand for specimens is skyrocketing. Biobanking is going big time! Moreover, researchers and pharmaceutical companies have an enormous need for access to large quantities of well annotated samples, especially if they can be pre-screened for specific disorders and diseases. For example, many research studies would benefit from having access to as many as 2,000 tissue samples from men and women diagnosed with the same type of cancer according to specific bio-clinical annotations. Biobanks need to manage their process using a robust and complete data management solution, including the following features: Promotion of scientific collaboration
• Networks of biobanks
• Interoperability Increasing the value of stored specimens
• Traceability and biobanking process flow management
• Dedicated bio-clinical annotation forms Value is in both nitrogen tanks and the database … Take as much care of your data as you do of your biological specimens. Everything around Nautilus software for an accurate management of Biobank. Bonizzi, G., Monturano, M., Capra, M., Milani, A., Magon, G., Dapra, P., Zilioli, P., Renne, G., Pece e Pier Paolo di Fiore, S. European Institute of Oncology, Via Ripamonti, 435 Milano, Italy
The Biobank of the European Institute of Oncology (IEO Biobank and Biomololecular Infrastructure, IBBRI) was born as an institutional infrastructure within the broader scenario of the Molecular Medicine Program (MMP) of IEO. In this context, IBBRI mission is to support biomedical research working. We collect and store biological specimens only from patients who have signed our specially designed informed consent form for research purposes. All patients are offered the choice of samples being held anonymously or of being anonymized with encryption. Audio-visual materials have also been prepared to explain the main features of the informed consent and to help patients make fully informed decisions to participate to our
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research programs by donating biological samples. We are using Thermo Scientific’s Nautilus software for the accurate management and analysis of biospecimens stored in our Biobank. This software is specifically designed to simplify the tracking of biosamples, and the management of biospecimen collection, localization, and patient demographics. Each sample can be integrated with the clinical and pathological data of each patient, thanks to the capacity of Nautilus to manage and integrate (via web services) the information coming from the existing three software systems in use at IEO: VHospital (VH), a management system of medical records that contains demographic information, administrative episodes and patient informed consent; Armonia, a database of all diagnostic pathological results; BAC, the IEO central registry from which Nautilus retrieves patient demographic information. Comprehensive Bioprocessing and Biobanking: Enterprise level requirements for global success Brooks, A.I. RUCDR Infinite Biologics, 170 Frelinghuysen Rd., EOHSI, Rm 236, Piscataway, New Jersey 08854 USA Biobanking and biosample processing create unique operational challenges. The diversity of sample types, the choice for processing technologies, the variety of sample storage conditions and complexity of customization around biosample distribution requires a truly integrated approach to information management. The addition of quality assurance, quality control and regulatory oversight further defines the need for an enterprise level solution for sample and process management in a biobank setting. As more biorepositories transition to playing a larger role in the biobanking process and don’t just limit their contribution at the level of sample management the implementation of a laboratory information management system is critical for operational success and fiscal viability. This presentation will discuss the critical components of an enterprise level approach to managing, operating and expanding a full service biorepository program. Additionally, workflows, automation, data formats and integrated quality control will be described using real world biobanking scenarios that describe the utility of an enterprise level LIMS system. MBioLIMS implementation for 1) an institutional cancer-oriented biobank and 2) a national biobank network dedicated to an orphan disease Calmels, B., Chabannon, C., Peffault de Latour, R., Bechlian, D., and Fontenille, C. 1) Biological Ressources Center, Paoli-Calmettes Institute, Marseille, France 2) CryoStem, Société Française de Greffe de Moelle et de Thérapie Cellulaire
We will first describe the implementation of a Lims software for an institutional cancer biobank handling more than 4,300 patient’s samples per year. 23,000 samples issued from various neoplasms have been processed in 2013,
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including automated DNA and RNA extraction. Processing, labelling, pre-analytical treatment and storage of more than 440,000 samples are managed by the Lims software. We will also report on CryoStem, a unique national network of biobank storing biological material for a rare disease, i.e. Graft versus Host Disease (GvHD). CryoStem is an initiative of the French Society for Bone Marrow Transplantation and Cellular Therapy and has been funded by the French Government Investissements d’Avenir program to the extent of 5,5 millions €. More than 20 french Biological Ressources Centers are processing blood samples into various pre-analytical samples using harmonized procedures as well as common reagents and labels. Modul-Bio's LIMS software allows the registration of patients and samples collected across 30 transplantation centers. Others features include automatic e-mailing for blood harvests management and barcode labels editing. So far 32,000 samples have been processed, issued from more than 2,600 blood samples. Regional biobank activity: getting started Daidone, M.G., Veneroni, S., Milione, M., Barisella, M., Torresani, M., Pierotti, M.A. Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy Biobanking is often conceived as non-core by other units which are focused on primary processes like surgical operation, and daily pathological diagnostics, even in research institutes. However, a process like tissue sampling crosses different care departments and has a number of stakeholders, often carrying different objectives. So far, considering only issues related to the sampling process (an “internal” point of view) can provide a limited vision of biobanking potential . Additionally, at least two more considerations must be added: 1) nowadays the majority of institutions do not get enough biosamples to carry out their own project or to justify the costs of a state-of-the-art infrastructure; 2) research projects and large-scale clinical studies need a certain amount of samples with specific characteristics, that are usually provided swapping materials with other centers. These examples highlight a second key dimension of analysis (“external” point of view): a biobank should be networked to other similar organizations in order to pursue economies of scope and gain synergies on research and investments. Questionnaires on biobanking distributed within Hospitals and Research Institutions participating in the oncologic network of Lombardy Region highlighted critical points and unfulfilled needs, in terms of highly fragmentation with poor support for activities and low overall effectiveness. A pilot project was supported by Lombardy Region and Fondazione CARIPLO and initially focused on colon cancers to implement a virtual Regional Oncologic Biobank as a network of local BioBanks. Key challenges have been identified and addressed through the activity of Working Groups to assure the quality of specimens: § organization: institutionalization of the biobanking process within the
organization, and commitment of the clinical staff; § quality assurance and overall process control: SOPs and traceability of
time- and temperature-sensitive specimens;
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§ completeness of information: creation of complete case profiles merging data from clinical subsystems;
§ adequate investments in laboratory instrumentation and storage sites; networking and research to exploit the value of local biological assets through shared knowledge and joined research projects. BBMRI-IT the Italian Node of BBMRI-ERIC Lavitrano, M. University of Milano-Bicocca, Milano, Italy BBMRI IT - The Italian node of BBMRI has been established with a joint effort by the Ministry of Health and the Ministry of University & Research and it involves ISS (National Institute of Health), CNR, 18 Universities, 23 IRCCS, institute of health care and research, and 8 patient associations. BBMRI-IT main goals are i) to take Italian collections of biological resources, BBs and networks to a new level of coordination and efficiency, ii) to supply new common services for the community of the Italian biobanks, iii) to provide better access for users from public and private sector, iv) to contribute to the pan-European research infrastructure BBMRI-ERIC. A path has been designed for BBMRI-IT membership to assess and select well established Italian biobanks in terms of quality and richness in samples and data. BBMRI-IT now includes 90 biobanks / biological resource centres / collections organized in thematic networks and regional networks with a matrix architecture. Population biobanks and pathology, genetic or disease- oriented biobanks are characterized by a collection of biological samples, such as blood, tissues or DNA, plus associated epidemiological, clinical, and research data, which may be important research tools for identification of new targets for therapy and may help in drug discovery and development. BioBank Specimen Archives have large collections of well-documented, up-to-date clinical and biological information samples, supplied with the molecular genomic resources and with links to epidemiological and health care information, which can support retrospective studies and accelerate research progress. Biobanking Information System Requirements with regional focus Lawlor, R.T. ARC-Net Applied Research on Cancer Centre, University of Verona, Verona, Italy As the biobanking discipline evolves, biobanking information management systems must also evolve to meet the developing requirements. Reseach biobanks IT requirements extend beyond standard LIMS functionality to include the need to address document management of informed consent and MTA conditions. Furthermore in the arena of stratified medicine, the changing landscape requires a more precise selection of samples to validate potential markers. The biobank management system needs to provide the possibility to register this detailed description that can then be used as parameters for
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selection. This requirement for more precisley defined samples has created the need for networks to accumulate the required statisically valid numbers, networks based on project collaboration, geographical functionality or disease based. As such, LIMS systems need to be able to harmonize and catalgoue information for access and use by members in the network who can sometimes be physically separated or collecting according to different processes while sharing similar procedures. Biobank IT LIMS need to mirror the biobank process in place. Requirements must be developed by the biobank before deciding on an IT system, in terms of functionality of sample registration and tracking, processes used for sample collection, processing and use, type of samples to be processed and the information that is required to define not only the sample itself but also the necessary information the defines the sample for selection. Biobank IT systems should also provide analytic capabilities to assist the biobank in analyzing the procedures used in the biobanking process. Maintaining and verifying sample integrity Mbhele, S. Division of Medical Microbiology, Room 5.23, Falmouth Building, University of Cape Town Medical School, Anzio Road Observatory 7925, South Africa
Sample storage and cataloguing aren’t especially glamorous job duties, but thankfully Freezerworks can do it for us! In the Division of Medical Microbiology at the University of Cape Town in South Africa, we have up to 12 concurrent, clinical trials taking place at multiple study sites and with many partners. When the samples come back to the lab, it is of paramount importance that they are each assigned a unique barcode to catalogue the type and amount of biological specimen, the study to which it belongs, and where it will be stored. Keeping track of this information and ensuring its accuracy is the grease that keeps the study wheels turning! With a breakdown in sample integrity or when samples go missing, our lab literally comes to a screeching halt! Funders and partners pull out of collaborations, time and energy is shifted toward damage control and productivity declines. It’s a terrible snowball effect that can be prevented by using an adaptable, reliable, and user-friendly system. For our lab, Freezerworks has been the answer and we have confidence that each sample is uniquely labelled, accurately inventoried, and securely tracked. Freezerworks takes the headache out of sample reception and storage, and allows the focus to remain on clinical diagnosis and scientific discovery. Biobank management platform for standardizing IDIBGI collections Rodriguez Vilarrupla, A. Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta (IDIBGI), Avinguda de França, s/n - planta 9B, 17007 Girona, Spain
IDIBGI Biobank is the reference Biobank of the region of Girona which has a population of 800 000 people and 7 hospitals. The major hospital of this region is the University Hospital of Girona Dr. Josep Trueta. In this hospital,
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as well as in others in the region, different samples have been collected for years. The nature of these collections is very diverse; adipose tissue samples, samples of the Spanish hematopoietic Transplantation Group, dementia, digestive diseases, paediatric metabolism… All these samples were managed in very different ways without any standardization: a tailored software, Excel templates and even Access databases. In order to integrate all these collections in a Biobank it was necessary to standardize and define the structure and functioning of the Biobank. IDIBGI thought it was necessary to acquire specialized software for the management of Biobanks. This software has made it possible to configure the structure of the Biobank, collections and its linked variables, sample types, the processes that are carried out and the storage structure, among others. This application is a modular web tool that allows collecting information of samples and all the associated clinical data in different colleting nodes. The system always keeps the traceability of the sample and the related information inside the Biobank and even when samples are sent to meet the requirements of researchers. After taking other necessary steps, in October 2013 the Conselleria de Salut de la Generalitat authorized the constitution of the Biobanc del Institut d'Investigació Biomèdica de Girona (IDIBGI). The main objective is to collect and store biological human samples to facilitate research projects. Synergistic data integration in the age of personalized medicine: the OPID system network Scalia, P. & Lo Presti, G. Somatogenics, Inc., 714 Oceanview, Los Angeles, California 91016, USA
The systematic collection and preservation of biologic specimen along with constant organization and integration of biologic and clinical data from the same subject are an intrinsic paradigm of personalized medicine and a powerful goal to speed up research in most areas of biomedical sciences. This aspect has become even more critical since the advent of clinical genomics. In order to process, interpret and use all data generated in a same individual and to reach higher levels of virtual integration, a novel web based tool called OPID (Onco-Path-ID) has been designed and is an active object of collaborative multidisciplinary efforts. This system allows the virtual centralization of multi-format data generated from the same patient and allows remote experts and professionals to add value to the information conveyed in this platform. The system is meant to be used in combination and synergy with biobank LIMS, eMRs, Image management software and Patient Data management systems. The hierarchy of the system, the target users and the operational models chosen for this multi-target tool will be discussed.
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E. Speaker Biographies Barthelaix , Annick Annick Barthelaix MD, Professor of Cellular Biology, Medical School, Angers University. Until September 2013 in charge of a clinical neurobiology and neuropathology laboratory specialized in neurodegenerative diseases and of the human samples Biobank of the University Hospital of Angers. Scientific coordination of several biocollections in the fields of neurodegenerative diseases and working in research on Alzheimer 's disease. Bonizzi, Giuseppina Degrees awarded
• 1992: Graduate in Biology, University of Pavia (Pavia, Italy), Biochemistry (Prof. G.Cetta and C.Balduini)
• 1993: Board of Biology, University of Pavia (Pavia, Italy)
• 1999: PhD degree of Docteur en Science, University of Liège (Liège, Belgium) Molecular Biology (Prof. Bours V and Piette J).
Professional charge
• 1996-1999: PhD student in the Laboratory of Medical Oncology / Clinical Chemistry, University of Liège (Liège, Belgium)
• 2000-2003: Post-Doc in the Laboratory of Gene Regulation and Signal Transduction Department of Pharmacology, UCSD (San Diego, CA)
• Staff scientific in the Laboratory of Prof. Pelicci PG. on Breast Stem Cell and Breast Cancer Stem Cell at the European Oncology Institute, Milan (Italy).
• Coordinator of IEO Biobank: IEO Biobank Biomolecular Resource Infrastructure (IBBRI)
Honors / Prizes and Fellowship
• 1996: Prize Nicole, University of Liège, Belgium
• 1996-1997: Research Fellowship from the Centre Anti Cancéreux, University of Liège, Belgium.
• 1998-1999: Research training grant in the framework of Biotechnology from European Commission (Marie Curie).
• 2000: Fellow from European Institute of Oncology Milan.
• 2000-2003: Research Fellowship from Human Frontier Science.
• 2003-2006: Research Fellow from American Italian Cancer Foundation
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Publications 1. Bonizzi G. et al. Cell 18 September, 2009 Volume 138, Issue 6 pp. 1035-
1248 2. Pasi CE, Bonizzi G, Pelicci P. Cell Cycle. 2010 Jun 15;9(12):2265-6. Epub
2010 Jun 15. 3. Bonizzi G, et al. Trends Mol Med. 2012 Jan;18(1):6-12. Epub 2011 Sep 7. 4. Giuseppina Bonizzi, et al. A trusted-based pact in research biobanks.
From theory to practice. Submit: Bioethics Brooks, Andy Dr. Brooks is currently Chief Operating Officer of RUCDR Infinite Biologics and the Director of the Bionomics Research and Technology Center (BRTC) at Rutgers University. He is also one of the founding members of the Bioprocessing Solutions Alliance (BSA). He is an Associate Professor of Genetics at Rutgers University. Dr. Brooks is a molecular neuroscientist whose research focuses on deciphering the molecular mechanisms that underlie memory and learning. These studies investigate gene-environment interactions in the context of aging, neurodegenerative disease and neurotoxicant exposure. Dr. Brooks is a well-recognized genomicist and has been involved in the development and implementation of cutting edge molecular based technologies for nucleic acid and protein analyses. He has worked to automate many biobanking workflows and build a service entity that provides high throughput sample management and analysis for DNA, RNA and protein based technologies. Calmels, Boris B Calmels is in charge of the Paoli-Calmettes Institute Cell Therapy production unit; he is coordinating the Biological Ressources Centers for the CryoStem project that he launched together with Dr Peffault de Latour in 2010. He is vice-president of the Société Française de Greffe de Moelle et de Thérapie Cellulaire. Daidone, Maria Grazia Graduated in Biological Sciences and Certified Board in Biostatistics at the University of Milan. She started her scientific career at Istituto Nazionale Tumori in Milan, where she is currently Head of the Biomarkers Research Unit and Director of the Department of Experimental Oncology and Molecular Medicine Dr. Daidone’s authorship includes 190 articles published in peer-reviewed journals. Moreover, she acts as ad hoc-reviewer for several international scientific journals and research Foundations. Her scientific interests are dealing with: a) biomolecular characterization of human preneoplastic and neoplastic lesions; b) identification and validation of
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biomarkers associated with cell proliferation, apoptosis and cell survival; c) relationship between gene expression profiles and clinical progression and/or treatment resistance in breast cancer; d) isolation, characterization and propagation of tumor-initiating cells obtained from human solid tumors; e) coordination of quality control studies for cancer biomarkers and proposition of guidelines for the clinical use of biomarkers; f) biobanking research. Lavitrano, Marialuisa Marialuisa Lavitrano is professor of Pathology, director of Molecular Medicine Lab and director of the School of Oncology at the Milano-Bicocca University. She participated to the preparatory phase of the European Biobanking and Biomolecular Resource Research Infrastructure (BBMRI) as Italian member state representative and she has been appointed BBMRI-IT Node Coordinator. For four years she developed the international strategies for the Ministry of Health and coordinated the Italian participation in the BioMedical Sciences ESFRI roadmap. Prof. Lavitrano is actively involved in research in molecular medicine with a translational approach for the transfer of the scientific results to the clinical practice. She also founded a university spin off for the development of tumour markers and of modulator compounds of drug resistance in epithelial tumours. Moreover, she is interested in bioethical aspect of science and research and participated at Bioethics Committees of the Council of Europe, of the Vatican and of the Italian government. Lawlor, Rita Rita Lawlor is a Computer Science graduate of Trinity College Dublin but works in Verona where she was the co-founder and project manager of the ARC-Net (www.arc-net.it) cancer research centre at the University of Verona, Italy. She runs the ARC-Net biobank and coordinates the biobank activties for the AIRC 5X1000 funded project on early diagnosis and risk assessment of pancreas cancer, novel molecular diagnostic markers (http://www.moldiagpaca.eu/), therapeutic targets (http://epcnet.eu), and epidemiological studies in cancer (pangen-eu). She also project manages the Italian effort within the International Cancer Genome Consortium (www.icgc.org) and the Italian-Australian-Canadian collaboration for pancreas cancer. She is is part of the working group to define the standards for Research Biobanks of the Veneto Regional Government of Italy where the University heads the regional project to create a research biobank network. She has participated in the joint AIOM-SIAPEC working group, scientific italian societies of Oncology and Pathology, commission to define biobanking for cancer research and is part of the coordinating group to create a regional biobank network and is a part of the IT/LIMS working group of BC-NET ( Biobank Cohort Network of Low Middle Income Countries) of IARC (International Association for Research on Cancer). She is past president of ESBB, the European, Middle Eastern and African Society for Biopreservation and Biobanking (www.esbb.org). Her current research interests are in molecular diagnostic markers and therapeutic targets and the role of cancer
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heterogeneity and molecular characterization of samples in the application of individualized medicine. Lo Presti, Giacomo Giacomo Lo Presti is an Electronic Engineer with majors in Bio-Informatics (Univ.Bologna Italy), robotics and artificial intelligence (Univ.Stanford, USA). Giacomo currently holds the position of chief informatic officer at Somatogenics and is a co-designer of the OPID system. Mbhele, Slee I'm a proud South African, Zulu woman! I grew up in Durban, Kwa-Zulu Natal and studied psychology in the USA while I au paired for two families with autistic teenage boys. Upon returning to South Africa, I began working at a local hospital and captured results for PEPFAR studies (HIV testing). Over the ensuing years I took on more responsibilities as a data capturer and for the past 4+ years as a data manager in the Division of Medical Microbiology at the University of Cape Town. In my current position I manage a team of three data capturers and liaise with seven graduate students and four post-docs. At any given time, we have up to 12 ongoing clinical trials, many of which are with international partners. I am the gatekeeper for all the data and sample reception involved for these studies. We have over 200,000 teeny-tiny precious tubes of biological specimens- and this doesn't include the many processed samples (extracted DNA, purified isolates, etc.)! Recently, I have begun studying for my Masters in Clinical Research Administration. I am interested in the problems surrounding multiple TB data registries and how patients that default on treatment and eventually retest undergo the gamut of testing all over again! A single, on-line, TB registry has the potential to reduce costs, speed up recovery, decrease resistance and reduce transmission rates – at least, that’s what I hope to argue in my thesis!
Rodríguez Vilarrupla, Aina Aina Rodríguez was born in Mataró (Barcelona) in 1973. She obtained her degree in Biology from Universitat de Barcelona and her PhD in Cellular Biology from the Universitat de Barcelona in 2003. Aina joined the Hepatic Hemodynamic Laboratory at Hospital Clínic in Barcelona and worked as a postdoctoral researcher from 2003 to 2013. The Barcelona Hepatic Hemodynamic Laboratory is a world leader research team in liver vascular disorders, including cirrhotic and non cirrhotic portal hypertension and hepatic endothelial dysfunction. She was involved in the study of new mechanisms of hepatic vascular tone de-regulation and the design of new therapeutic approaches using molecular, cellular and physiological techniques. She joined IDIBGI in 2013 as a biobank coordinator. IDIBGI Biobank is a recently authorized Biobank that actively participates participates in the Spanish National Hospital-based Biobanks Network – Red Temática de Biobancos Hospitalarios- ISCIII, and also in international societies involved in biobanking.
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Scalia, Pierluigi Pierluigi Scalia is a biomedical scientist (MD, PhD, MB/MP-ASCP) whose main research focuses on the molecular pathology and cancer genomics. He carries extensive experience in multidisciplinary projects management and entrepreneurship. He isa co-founder and director of Somatogenics, inc., a Delaware c-corp operating in the areas of Biobanking, Genomic support services and Patient data management solutions with current interests and collaborations both in the US and Europe.
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F. Corporate Profiles (1) Freezerworks (Dataworks Development, Inc) Freezerworks has been providing quality sample management for clinical and research labs in highly regulated environ¬ments since 1992. Track samples and products across freezers while managing laboratory workflow, shipping, and testing. Recoup storage costs with the billing module. Safeguard data with comprehensive security features, audit trail for regulatory compliance, chain of custody, and cryogenic-safe bar code labeling. Written and validated according to FDA guidelines. Freezerworks integrates with clinical software, iPods, hardware and robotics using a secure web service module. Its world renowned configurability features provide flexible and timely data and freezer storage management for multiple groups and users. http://www.freezerworks.com
(2) Labvantage Solutions LABVANTAGE, the most configurable, web-based LIMS in the market, is trusted by industry leaders worldwide. We help customers run their labs more efficiently and with fewer errors by automating tasks and integrating with instruments and systems. Our vast experience allows us to minimize risk of project delays or failures. Our system can adapt to changing business needs after initial implementation. LABVANTAGE comes standard with features essential to laboratory operations. Built on a platform that is widely recognized as the best in the industry, LABVANTAGE can support hundreds of concurrent users as well as interface with most instruments. With over 30 years of experience, LABVANTAGE powers hundreds of laboratories, large and small, worldwide. LABVANTAGE is the best choice for industries ranging from pharmaceuticals and consumer goods to molecular diagnostics and biobanking. http://www.labvantage.com (3) Modulbio Modul-Bio’s products portfolio includes :
• MBioLABEL®: biological samples identification solutions for long term storage, from labelling to scanning.
• MBioLIMS® BioBanking: a flexible Laboratory Information Management System based on MBioLIMS Core and Plug-in modules.Specially designed for biobanks and cohorts projects, main functionnalities include patients management, samples collection, processing and distribution.
• eMBioBANK® : a centralized biospecimen inventory web portal for sharing biorepositories sample collections with researchers
http://www.modul-bio.com
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(4) Noraybio NorayBio is the leading Spanish Bioinformatics company developing software for bioscience. Leading product: NorayBanks, software for managing biobanks and biorepositories. Other software for biobanking: BrainBanks; software for managing brain biobanks and SpecBank; software for specimen repositories. We have large number of customers in biobanks of hospitals, research centres, universities and private companies. Based in the north of Spain, with offices in Italy, France and United Kingdom. We specialise in software for biobanks, animal facilities and biotechnology laboratories. http://www.noraybio.com (5) Ruro Inc. RURO laboratory information software and RFID solutions are used around the world. RURO is best known for its sample management system, FreezerPro, and full scale laboratory information management system, LIMS 24/7. RURO’s comprehensively integrated solutions allow users to grow the scale of their information management suite within the same RURO framework as needed. http://www.ruro.com (6) soventec soventec is a software engineering company with processes certified according ISO 13485 and 15 years experiences in the field of research and medical devices automation. GxP (21CFRPart11, 820) compliant processes can be implemented. The software Lab OS® - developed and provided by soventec – documents laboratory processes in medical and research application fields (ELN, electronical laboratory notebook), manages samples in biobanks and repositories with high quality documentation and can automate laboratory devices. soventec is also providing software development services in the field of laboratory data management, laboratory device integration, automation and scheduling for companies and institutions in life sciences, biotechnology, pharma and medicine. http://www.soventec.com (7) Technidata With over 40 years’ experience in the field of lab management, TECHNIDATA has become one of the leading global software suppliers for clinical and anatomic-pathology laboratory information systems (LIS), and biobank management systems. Developed in full compliance with the ISO 9001/ISO 13485 quality standards, TECHNIDATA software products are distributed in more than 25 countries and cover all the clinical laboratory disciplines. Our solutions help the laboratory and biobank accreditation process. Disciplines: Biochemistry, Hematology, Immunology, Serology, Virology, Microbiology, Histology/Cytology, Genetics, Blood Banking Management,
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Biobanking. Products & services:
• Laboratory Information Systems (TD-Synergy® suite) • Middleware Solutions (TD-Harmony® suite) • Instrument workstations • Point of Care Testing • Web-based requests and results module • Services: consulting, development, support, training activities
www.technidata-‐web.com
(8) Thermo Scientific Thermo Scientific has the world’s largest breadth of offerings for Biobanks, from biospecimen collection, processing, analysis and storage to sample and data management. The end-to-end portfolio includes the centrifuges, concentrators, freezers, robotics, 2-d bar coded tubes, scanners, microplate readers, mass spectrometers and comprehensive services to enable turn-key biobanking solutions http://www.thermoscientific.com
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G. Participants Abderrahim, Hadi Qatar Biobank, Hamad Medical City, 5825, Doha, Qatar Ambrosini, Vitale Labvantage Solutions Baccheschi, Gianluca INPECO, Via San Gottardo, 10, 6900, Lugano, Switzerland Bacchi, Fabrizio TwinHelix, Via f. Borromeo 4, 20017, Rho, Italy Badia, Mercè Biokit, Can Malé s/n, 08186, LLiçà d’ Amunt, Spain Barthelaix, Annick Angers University, Angers, France Betti, Martina A.O.U. Careggi Largo Brambilla, 3, 50134, Firenze, Italy Bober, Christina Soventec, Hauptstraße 49, D-24867 Dannewerk, Germany Bonizzi, Giuseppina European Institute of Oncology, Via Ripamonti, 435 Milano, Italy Brooks, Andy RUCDR Infinite Biologics 170 Frelinghuysen Rd., EOHSI, Rm 236, Piscataway, New Jersey 08854 USA Calmels, Boris Biological Ressources Center, Paoli-Calmettes Institute, Marseille, France Cloquet, Benoît B&C Group, Rue Granbonpré 11, 1435 Mont Saint Guibert, Belgium Coulthurst, Gary Brooks Life Science Systems, Northbank, Irlam, M44 5AY, Manchester, UK Daidone, Mariagrazia Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy De Blasio, Pasquale Integrated Systems Engineering s.r.l., Via Fantoli 16/15, 20138 Milano, Italy Diercks, Kai Soventec, Hauptstraße 49, D-24867 Dannewerk, Germany
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Digito, Maura University of Padova, Via Gattamelata 64, via Giustiniani 2, 35128, Padova, Italy Dober, Julia NCCR Kidney.CH, Hirslanden Klinik St. Anna, Innere Medizin, St. Anna Strasse 32, 6006, Lucerene, Switzerland Fröhlich, Tanja Inselspital, Freiburgstrasse, 3010, Bern, Switzerland Gabrielsen, Kjerski Marbank, Institute of Marine Research, PO Box 6404, Tromso, Norway Gameiro, Philippe Thermo Scientific Guitart Arnau, Christophe Technidata Hewitt, Robert ESBB, 20 Boulevard du Roi René, 13100 Aix-en-Provence, France Jacotot, Laurent Modulbio, Parc Scientifique Luminy Biotech II, 163 avenue de Luminy - case postale 935, 13288 Marseille cedex 09, France Kikuha, Norbert KEMRI-Wellcome Trust, PO Box 230, 80108, Kilifi, Kenya Klykens, Johan Activity Centre Biobanking University Hospital Leuven, Herestraat 49, 3000, Leuven, Belgium Knuuttila, Juha National Institute for Health and Welfare, Mannerheimintie 166, 00271, Helsinki, Finland Künzli, Michel Inselspital, Freiburgstrasse, 3010, Bern, Switzerland Lavitrano, Maria Luisa University of Milano-Bicocca, Milano, Italy Lawlor, Rita ARC-Net Applied Research on Cancer Centre University of Verona, Verona, Italy
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Lebedev, Vlad Ruro Inc, 321 Ballenger Center Drive, Suite 102, Frederick, MD 21703 USA Lo Presti, Giacomo Somatogenics, Inc., 714 Oceanview, Los Angeles, California 91016, USA Meier, Mattias Winterthurerstrasse 190, CH-8057 Zürich, Switzerland Mhbele, Slee University of Cape Town Division of Medical Microbiology, Room 5.23, Falmouth Building, University of Cape Town Medical School, Anzio Road Observatory 7925, South Africa Michels, Cheryl Freezerworks (Dataworks Development, Inc) Michels, Rick Freezerworks (Dataworks Development, Inc) Milanesi, Luciano Institute for Biomedical Technologies, Milan, Italy Mraihi, Sonia Modulbio, Parc Scientifique Luminy Biotech II, 163 avenue de Luminy - case postale 935, 13288 Marseille cedex 09, France Nannetti, Genni A.O.U. Careggi, Largo Brambilla, 3, 50134, Firenze, Italy Nocentini, Davide Linde Healthcare, Seitnerstrasse, 70, 82049, Pullach, Germany Noguero, Micael Noray Bioinformatics, S.L.U., Parque Tecnológico 801 A, 2º, 48160 Derio, Bizkaia, Spain Pistillo, Daniela Noray Bioinformatics, S.L.U., Parque Tecnológico 801 A, 2º, 48160 Derio, Bizkaia, Spain Qafoud, Fatima Qatar Biobank, Hamad Medical City, 5825, Doha, Qatar Rodriguez, Felipe Andalusian Public Health System Biobank, Fundación Pública Andaluza Progreso Y Salud, , Avda. Américo Vespucio 5, Bloque 2, 41092, Seville, Spain Rodriguez Vilarrupla, Aina
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Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta (IDIBGI), Avinguda de França, s/n - Planta 9B, 17007 Girona, Spain Rogers, Matt Labvantage Solutions Scalia, Pierluigi Somatogenics, Inc., 714 Oceanview, Los Angeles, California 91016, USA Steinfelder, Erik Thermo Scientific Tecco, Roberto Thermo Scientific Terekhina, Vera Ruro Inc, 321 Ballenger Center Drive, Suite 102, Frederick, MD 21703 USA Welkenhuysen, Joris UZ Leuven, Herestraat 49, 3000, Leuven, Belgium Wilson, Graham Labvantage Solutions Wolf, Corinna Merck KGaA, Frankfurter Str. 250, Postcode: A031/202, 64293, Darmstadt, Germany
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H. Notes
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