Biobanking Global Congress 2014 Europe
Biobanking Global Congress 2014 Europe
Don’t miss this opportunity – Reason to register today and – Why Attend?
• The most up-to-date information on Sample Storage and Tracking Issues
• Review the development and implementation of a tissue repository
• Hear the latest on the Stem Cell Banking
• Discuss the changing approaches to target-finding, drug development and patient treatment
• Gain a clearer insight on Green Banking
• Understanding the regulatory social and ethical frameworks
• Examine the quality concerns for existing biospecimen collections
• Recognise the importance of biobanking in rare disorders
• Analyse major challenges for biorepository management and implementation
• Get the latest update on the application
Worldwide Biobanking market is to increase by 30% to reach an estimated $183 Billion by 2015.
A “Must attend??? Biobanking Conference for 2014 for:
VPs, Directors, Heads, Managers of:
• Tissue bank
• Biorepository / Biosample
• Translational Medicine
• Personalised Medicine
• Biomarkers Development
• Compound Management
• Digital Pathology
• Laboratory Automation
• Oncology Clinical Research
• Liquid Handling
• DNA Methylation
• Laboratory and Inventory
• Molecular Diagnostics
• Clinical Genetics, Pathology
• Scientific and Quality
• Privacy / Protections / Security
• R & D
• Quality Control
• Strategic Outsourcing
• Clinical Research
• Bioanlytical Chemistry
• Business Development
• Strategic Alliances
• Non-clinical Biosample
• Health Science Policy
• Toxicology, Clinical Chemistry
• Clinical trials and Non-clinical R & D
• Procurement and Strategic Sourcing
Consultants, Academics, Regulatory bodies, Researchers, Biorepository Vendors, Government Officials[/tab]
Paul Whittaker, Direstor and Unit Head for Pre-Clinical Biomarkers, Respiratory Disease Area, Novartis
Fourteen years research experience in academia working on DNA methylation, chromosome structure and function, Duchenne muscular dystrophy and cancer metastasis. Sixteen years research experience in drug discovery. PhD in molecular biology (DNA methylation) from the University of Aberdeen. Seven years postdoctoral research at the Universities of Edinburgh and Oxford. Seven years as a lecturer in the Medical School at Southampton University. Employed in a variety of scientific and managerial roles at Novartis in the Respiratory Disease Area. Currently running a Research Unit in the Respiratory Disease Area dedicated to identifying, characterising and developing biomarkers and targets for respiratory disease. Designated Individual for Human Tissue Authority licence.
Amelia Wall Warner, PharmD, President and CEO, Gentris
Amelia Wall Warner, PharmD joined Gentris in 2013 as President. Dr. Warner oversees the U.S. operations, leads the development of new service offerings, and develops scientific education and training programs for biobanking and pharmacogenomics. As a key member of the management team, she works with Gentris leaders to set the strategic vision for the company and to ensure it continues to be on the cutting-edge of genomic medicine. Dr. Warner was most recently the Head of Clinical Pharmacogenomics and Clinical Specimen Management for Merck Research Laboratories (MRL). In her position, she oversaw all clinical pharmacogenomics projects, oversaw policies and procedures for biosample collection and storage for clinical trial samples, and was the MRL Pharmacogenomics Expert for the Translational Science Research Network. Amelia was the MRL key expert for global regulation for genetic research and human specimen usage regulation/law. Amelia is the CEO and Founder of Global Specimen Solutions, Inc., a past chair of the Industry Pharmacogenomics Working Group (I-PWG), and a PhRMA representative to ICH E16- Genomic Biomarkers Related to Drug Response. As an industry expert, she has participated in numerous meetings and conferences as a key opinion leader on applying pharmacogenomics in drug development, best practices for collecting, maintaining, and maximizing return-on-investment for clinical sample biobanks in all phases of clinical trials, and appropriate informed consent to enable future use and testing. Dr. Warner completed a residency in Pediatric Pharmacotherapy at St. Jude Children’s Research Hospital with John Rodman, PharmD and a fellowship in Clinical Pharmacology/ Pharmacogenomics at St. Jude Children’s Research Hospital with William Evans, PharmD. Amelia holds a PharmD from the University of North Carolina at Chapel Hill and a Bachelor of Science in Biology from Wake Forest University.
Ing. Pasquale De Blasio, Founding President of ESBB
CEO and Managing Director of Integrated Systems Engineering Srl. (ISENET)
Pasquale De Blasio, is an international manager with more than 35 years experience in industrial and academic positions. He is the founder and Managing Director of Integrated Systems Engineering srl (www.isenet.it) an Italian SME specialized in biomedical instrumentation design and biobanking. ISENET manufactures and distributes world wide the Galileo Tissue Microarrayer and participates in several Research Projects on Stem Cell Banking (including iPS).
Pasquale De Blasio, is also the founder and CEO (from 2003 to 2011) of BioRep srl, a “Global Biorepository Service Provider??? which operates in partnership with Coriell Institute for Medical Research USA (www.coriell.org), serving the CHDI Foundation (for the European Huntington Disease Project, Enroll-HD), The Michael J. Fox Foundation and other important Foundations.
International Organizations Participations:
- Founder President of the ESBB (European, Middle-Eastern and African Society for Biopreservation and Biobanking – www.esbb.org)
- Member of MAWG (Marble Arch International Working Group of Biobanking Experts).
- Member of ISBER (International Society of Biological and Environmental Biorepositories – www.isber.org)
- Scientific Committee member of SASA (Society for the Advancement of Science in Africa – www.sasascience.org)
Ida Biunno, Senior researcher at National Research Council of Italy (IRGB-CNR) in Milano- Italy and Scientific Director of ISENET Stem Cell Banking activities.
She acquired the Bachelor Degree in Biology and Psychology from Temple University in 1976 and PhD in Molecular Biology from the University of Pennsylvania in 1980. In 1982 she received the Doctoral Degree in Molecular Biology from the University of Milan-Italy.
She has been the Scientific Director of BioRep (Milano-Italy) from 2005-2010 and member of the Steering Committee for the EHDN-Registry and Enroll HD Projects in addition to PPMI for the MJFox foundation.
She has been PI in several National and EU financed projects dealing with stem cells biobanking and quality controls.
She is Adjunct Associate Professor of Biology at the Biotechnology Center of Temple University Philadelphia-USA and
Assistant contract Professor of Biochemical Oncology at PhD School of Molecular Oncology. Univesity of Chieti (Italy)
She has published close to 100 peer reviewed papers in oncology and stem cell biology
Dr. Kimberly Myers is a Manager in the Federal Health Practice at Deloitte Consulting LLP.
She has experience managing large, complex biomedical science and translational research programs with successful results. Dr. Myers joined the firm in August 2011, providing leadership and program management support to comparative effectiveness research and translational medicine programs, including the development of strategies and research agendas, the support of stakeholder engagement activities, the development of performance metrics, and the support of dissemination research and activities. Prior to joining Deloitte, Dr. Myers worked at the National Cancer Institute’s Office of Biorepositories and Biospecimen Research (OBBR) where she led biobanking efforts in support of personalized medicine and translational science. As a member of the OBBR, she led the Partnerships Management Business Unit of the Cancer Human Biobank (caHUB), building domestic and international partnerships and leading the development of plans, policies, funding opportunities, and procedures on behalf of national biobanking efforts. Additionally, while at NCI, she aided in the development of novel small business funding opportunities and led the organization of Congressional briefings and activities. In addition to her interests in personalized medicine, patient-centered outcomes research, and biospecimen resources, Dr. Myers has broad interests in science policy, communicating science to lay audiences, mobile health and technologies, and scientific strategic planning. Dr. Myers earned her B.S. in Microbiology from Middle Tennessee State University and her Ph.D. from Harvard University’s Program in Virology in the Division of Medical Sciences.
Dan Cooper advises clients on information technology regulatory issues, particularly data protection, e-commerce and data security matters. Mr. Cooper has successfully represented clients in the pharmaceutical research, biotech, sports and financial services sectors, among others, before national data protection regulators and EU-level authorities, including European Union and Council of Europe institutions. According to the latest edition of Chambers UK (2014), clients note that he “is extremely knowledgeable and provides practical and comprehensive advice.” The guide describes him as “outstanding. He is practical, responsive and smart.” Mr. Cooper also regularly assists leading bio-tech and e-health companies on their European and global compliance strategies. Mr. Cooper is dual-qualified in the United States and United Kingdom, and also has been appointed to the advisory and expert boards of privacy NGOs and agencies, such as Privacy International and the European security agency, ENISA.
Dr. Shannon J. McCall, M.D., Director, Duke Biospecimen Repository and Processing Core, Pathology, Duke University School of Medicine
Dr. McCall completed degrees in chemical engineering and biochemistry at North Carolina State University before attending medical school at Duke University in Durham, North Carolina. She stayed at Duke to pursue Anatomic and Clinical Pathology training followed by a fellowship in gastrointestinal surgical pathology. She practices GI pathology and serves on the faculty of the School of Medicine at Duke University. She serves on the Biorepository Accreditation Committee of the College of American Pathologists. Dr. McCall is the director of the Biospecimen Repository and Processing Core at Duke.
Dr Morag McFarlane, Chief Scientific Officer, Tissue Solutions Ltd
Morag is the Chief Scientific Officer and one of the founding directors of Tissue Solutions, a specialist tissue procurement and management service based in Glasgow. Tissue Solutions (www.tissue-solutions.com) works with a virtual model to supply ethically acquired and fully consented quality human tissue to pharma, biotech and CROs worldwide. They specialise in ‘hard to source’ tissues such as fresh samples or those with specific inclusion and exclusion criteria. Formal alliances with specialist companies allow us to offer tissue related services including IHC/histology, human primary cell line establishment plus pancreatic islet and biomarker studies. Morag has extensive experience in the preclinical research and development arena. Morag previously worked as the Principal Scientist for a pre-clinical drug discovery services company. She led a team producing detailed project proposals through specific scientific discussion and contract negotiations with clients (directly responsible for the scientific content of over £20 million of contracts). Previously she worked for one of the world’s largest specialist providers of contrsafety testing, GMP manufacturing, and pre-clinical and clinical testing services. This was initially as their Development Scientist then as the Study Director for molecular biology. Her first industrial position was as a Development Scientist carrying out R&D on DNA extractions kits.She has a First class honours degree in molecular biology and a PhD in molecular virology, both from the University of Glasgow.
Dr Kirstin Goldring, UCL Biobank and BioResource Coordinator, UCL School of Life and Medical Sciences
Dr Goldring graduated in Physiology and Pharmacology (BSc) in 1991 and studied for her PhD on asthma research at Southampton University.
She moved to London in 1994 to undertake Post-Doctoral research in to Muscular Dystrophy at King’s College and Imperial College. Dr Goldring then managed the UK Parkinson’s Disease Society Tissue Bank when it moved to Imperial College in August 2002, until June 2009. Dr Goldring has been working at UCL since 2009 as the Biobank facilitator. The role has involved in developing biobank infrastructure and support, dissemination of information to researchers on biobanking and providing advice on protocols, ethics and regulations for use of human. Since 2012, Dr Goldring has expanded her role to co-ordinate the UCL BioResource, part of the NIHR BioResource, which aims to develop a panel of healthy volunteers and patients consent for recall to future research studies.
Dr. Brian Thomson, Director of R&D, Nottingham Integrated Clinical Research Centre, Nottingham University Hospital NHS Trust
Dr Brian Thomson qualified in Medicine from the University of Edinburgh and trained in medicine in Edinburgh, London and Cambridge before being appointed an Associate Professor and Honorary Consultant Physician in Nottingham in 1997. He has held MRC Training and Clinician Scientist Fellowships in London and Cambridge and was awarded a PhD in 1992. Dr Thomson has been Director of Research and Innovation at Nottingham University Hospitals NHS Trust since 2007. Dr Thomson is the founder and Director of the Nottingham Health Science Biobank (NHSB). The NHSB is the only NHS led Biobank in the UK and brings together a centralised quality assured tissue resource and an innovative patient informatics and e-records strategy to provide a unique platform for research.
Irene Schlünder, Scientific Consultant, TMF (Technology, Methods and Infrastructure for Networked Medical Research), Berlin
She advises and supports a variety of projects within TMF with a focus on data protection. TMF is the German platform for interdisciplinary exchange as well as cross-project and international cooperation in order to identify and solve the organizational, legal/ethical and technological problems of modern medical research. TMF hosts the German Biobank Register and maintains a Biobanking Working Group. Due to her expertise in data protection on the European level, Ms. Schlünder represents TMF in two major European research projects: EHR4CR (Electronic Health Records for Clinical Research) and BioMedBridges, both aiming to enhance translational and transnational medical research while maintaining a high data protection standard. She graduated in law at the University of Heidelberg and worked several years as a researcher at the University of Potsdam, focusing and publishing on human rights. She has also long experience as attorney at law with a focus on privacy law and on IP law.
Dr. Glyn Stacey, Head, Division of Cell Biology and Imaging, NIBSC, an operating centre of UK regular MHRA
Glyn Stacey leads to Division of Cell Biology and Imaging at NIBSC an operating centre of the UK regulator MHRA. The work of his group addresses issues relating to the suitability of cell substrates used in the manufacture of biological medicines and diagnostic reference materials including delivery of seed stocks of cells for vaccine manufacture and cell therapy. This involves coordination of international programmes such as the International Stem Cell Banking Initiative, PI on several large EC research consortia and advisor on several other research consortia. The research is focussed on qualification of new techniques for characterisation, culture and differentiation of human stem cell lines for applications in product safety testing and supply of cells for therapy.
Balwir Matharoo-Ball, Operations Manager for Translational Research Biobank, Nottingham Health Science Biobank
Dr Balwir Matharoo-Ball was appointed as the Operational Manager for Translational Research and Nottingham Health Science Biobank (NHSB) in January 2011. She leads a team of 15 staff. The NHSB is sited within Nottingham University Hospitals Trust (NUH), which is the fourth largest NHS Trust in the UK, and works closely with the University of Nottingham to deliver biobanking services to the wider scientific community. The NHSB is constructed on the principles of partnership, outreach and sustainability and has developed a series of innovative models to underpin these key concepts. A particular feature of the NHSB is a focus on the automatic linkage of biosamples to high quality clinical data and we have designed and implemented a novel clinical informatics strategy to create a uniquely powerful resource of particular value to stratified and personalised medicine. The NHSB has a policy for Biobanking-related training, education and motivation of clinical staff to participate in the sample collection process and to ensure that Biobanking becomes an integral part of the NUH culture.
Prior to this Bal was a Senior Post Doctoral Research Fellow for 12 years both at Nottingham Trent University and University of Nottingham. After gaining her PhD in 1994 from Keele University Bal became Head of Biomedical Sciences in Oman for 4 years. Prior worked as a Clinical Chemist in the NHS for 15 years
Dr. Beate Kamlage, Senior Scientist, Data Interpretation Health, Metanomics GmbH – A BASF Plant Science Company
Beate Kamlage is a biologist and obtained her PhD in the area of microbiology from the University of Göttingen, Germany. She joined metanomics GmbH – a BASF Plant Science Company – in 2000 working for several years in the metabolomics data analysis, result interpretation and project management in various indications in the fields of biomedical research, nutritional intervention as well as plant biotechnology and plant protection. Her current focus of interest is within the comprehensive clinical biomarker program of Metanomics Health GmbH the identification and validation of metabolic biomarkers related to the quality assurance and quality control of biobank specimens.
Day 1 – 27th March 2014
08:00-08:50 – Registration & Coffee – Exhibitors Hall
08:50-09:00 – Chair’s welcome –
09:00-09:40 – The role of Biobanks: Bridges research and healthcare
- Archiving of biological samples for research
- Cross – fertilisation of ideas and technologies
- How to overcome challenges in collecting sample
Dr Kirstin Goldring, Coordinator, UCL Biobank and NIHR BioResource
09:40-10:20 – International Biobanking regulations and Policies : Implication on Global Research involving Collection of Samples
- Rules, principles and guidelines governing the collection , storage and use of samples for clinical trials
- Differences in global regulations and law for human sample research
- Impacts on collection of samples and research
- Challenges and latest strategies for successful samples collection.
Amelia Wall Warner, PharmD, President and CEO, Gentris
10:20-11:00 – Networking Refreshments Break (Exhibitors Lounge)
11:00-11:40 – Ethical issues for research Biobanking
- What are the ethical issues in conducting research?
- Updates on ethical policies and guidelines
- Protection of human subject
- Privacy issues
Dr. Morag McFarlane PhD, Chief Scientific Officer, Tissue Solutions
11:40-12:20 – Privacy / data protection regulation of Biobanks
- Recent developments in the EU data protection framework as may impacts biobank research (this is a big development and probably worth half the time)
- Common privacy regulatory compliance pitfalls for biobank companies
- Rules relating to notice and consent; and how to comply
- Contracts with vendors, the dos and don’ts
- Data transfers, data security and breach notification.
Daniel Cooper, Partner, Covington & Burling LLP
12:20-13:00 – Sponsor Spotlight Presentation – Take this unique opportunity to be a part of the conference theme, network, share ideas and provide an overview of your services to the audience. For more information contact: email@example.com
13:00-14:00 – Networking Lunch – Exhibitors Lounge
14:00-14:40 – International Stem – cell banking collaborations
- Potential impact of preservation and suboptimal storage on stem-cell cultures
- International coordination in stem – cell banking
- An International concensus on developing seed stocks for clinical application
Dr. Glyn Stacey, Head, Division of Cell Biology and Imaging, NIBSC, an operating centre of UK regulator MHRA
14:40-15:20 – Banking of Human iPS Cells Lines for research and Pharmaceutical applications
- The necessity to build an iPSCs bank
- Quality controlled iPS in disease model, toxicology and pharmaceutical studies
- Regulatory issues on storing iPS cell lines
Ida Biunno, Senior researcher, National Research Council of Italy (IRGB – CNR) Scientific Director, ISENET Stem Cell Banking
15:20-16:00 – Networking Refreshment Break (Exhibitors Lounge)
16:00-16:40 – Biobanking for personalised Medicine
- Ethics Concern for genetic testing
- Specimen Processing & Management
- Genotyping & Data Management infrastructure
- Foresting Growth
Pasquale De Blasio, Founding President of ESBB, CEO and Managing Director, Integrated Systems Engineering Srl. (ISENET)
16:40-17:20 – PANEL: ETHICS AND INFORMED CONSENTS
A panel discusses the ethical issues and informed consents relating to biobanking.
17:20-17:30 – Chairman’s comments and end of day one.
17:30-19:00 – Networking Drinks Reception (Exhibitors Lounge)
Day 2 – 28th March 2014
08:00-08:50 – Registration & Coffee – Exhibitors Hall
08:50-09:00 – Chairman’s opening comments
09:00-09:40 – From bench to Clinic: the importance of healthy and diseased human tissue in discovering new therapeutics for respiratory disease
- Human tissue is a crucial element in the discovery and validation of new targets and biomarkers
- Human tissue is a key link between animal model experiments and clinical studies
- Human tissue from well-phenotyped patients is necessary for efficient biomarker qualification
Paul Whittaker Ph.D, Director and Unit head for preclinical Biomarkers, Respiratory Disease Area, Novartis
09:40-10:20 – Novel Governance Model for a Pathology-Based Biobank at Duke
- Truly centralized tissue biobanking at large academic centers is difficult
- Pathology centralization works best if governance model is accepted
- Health system advantages: improved patient safety, improved regulatory compliance
- Researcher advantages: larger cohorts, high sample quality, improved collaboration
Shannon J. McCall, M.D., Director, Duke Biospecimen Repository and Processing Core, Pathology, Duke University School of Medicine
10:20-11:00 – Networking Refreshments Break – Exhibitors lounge
11:00-11:40 – Sample acquisition and sample management
- Regulatory challenges
- How to meet demands for supply
- Good storage practices and sample management procedures
Dr. Balwir Matharoo – Ball, Operations Manager for Translational Research and Biobank, Nottingham Health Science Biobank
11:40-12:20 – Novel Metabolic Assay Enabling Pre -Analytical Quality Control of Human Plasma Samples
- Quality of biobank and prospective clinical study biospecimens can be impacted by pre-analytical processing steps that confound the analytical results and decrease the reproducibility and value of the research outcomes. Highest sample quality is particularly important in all projects which involve studies of the metabolome or a systems biology approach.
- Metanomics Health GmbH has developed an assay for quantitative analysis of quality markers in human EDTA plasma. The quality control assay detects plasma samples of a poor pre-analytical quality due to prolonged storage of blood or plasma or incubation at improper temperatures with a high sensitivity and specificity. Additionally, a sample type check allows distinguishing EDTA plasma from citrate/heparin plasma or serum.
- The clinical use cases include monitoring of clinical sample quality which is particularly relevant in multicentre studies and selecting high quality samples from biobanks, both with the objective to enable reproducible and meaningful biomarker and other clinical research.
- Metanomics Health GmbH is now offering the quality control assay for EDTA plasma samples in two business models: Fee-for-service or outlicensing.
Dr. Beate Kamlage, Senior Scientist, Data Interpretation Health, Metanomics GmbH – A BASF Plant Science Company
12:20-13:00 – PANEL: QUALITY MANAGEMENT AND ASSURANCE
The panel discusses issues and strategies for quality management in biobanks
13:00-14:00 – Networking Lunch – Exhibitors lounge
14:00-14:40 – Sustainability in Biobanking
- Defining sustainability
- Models of sustainability
- The Nottingham experience – a case study
Dr. Brian Thomson, Nottingham University Hospital NHS Trust
14:40-15:20 – Multi-stakeholder Collaborations: Biobank Relationships with Outside Institutions
- The types and role of partnerships in successful biobanking operations
- The lifecycle of biobanking partnerships: from inception to evaluation
- Keys to successful biobanking partnerships
Kimberly Myers PhD, Manager, Deloitte Consulting Strategy
15:20-16:00 – Networking Refreshment Break (Exhibitors Lounge)
16:00-16:40 – International harmonization and collaboration of National repositories
- Reasons and obstacles for collaboration of biobanks
- International Regulations
- Different approaches to developing legal and contractual standards
- Recent developments against the background of rapid technological progress regarding DNA sequencing
- Data access surrounding the use of biobanks
- The role of ethics committees
- Establishing an European Governance Model for Biobanks
Irene Schlünder, Scientific Consultant, TMF, Berlin
16:40-17:20 Information management: how to conquer complexities in Biobanking
- Effective data infrastructure system
- Integration of data informatics
- Drilling down into data for validation
- Techniques for Data management
17:20-17:30 Chairman’s closing comments and end of conference
Sponsors & Exhibitors
Metanomics Health GmbH
Metanomics Health GmbH – a BASF Group company – applies comprehensive Metabolite Profiling (metabolomics) with biomedical data interpretation. Metabolite Profiling is defined as the parallel analysis of multiple endogenous and xenobiotic metabolites in biological systems. The core expertise of Metanomics Health resides in discovery and validation of biomarkers.
- Metabolite Profiling platform with > 75 GC-MS and LC-MS/MS instruments
- Wide metabolite coverage via combination of unbiased and targeted platforms
- Holistic quality concept including validated quality control markers
- Excellence in systems biology analysees of complex gene function relationships
- Unique toxicity mode-of-action prediction through MetaMap®Tox database
In cooperation with academic institutes and clinical experts Metanomics Health is running a large-scale clinical biomarker program. Areas include metabolic syndrome, heart failure, prostate cancer and pancreatic cancer to mention a few.
Metanomics Health provides its services to pharmaceutical, diagnostics and nutrition companies.
Technology applications include:
- Mechanism-of-action studies
- Mechanism-of-toxicity studies
- Translational and clinical biomarker development (e.g. surrogate efficacy and safety markers)
- Companion diagnostic development (prognostic response markers)
- Cancer cell line profiling
- Bioprocessing optimization
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