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7 November 2016EMA/707605/2016Inspections, Human Medicines Pharmacovigilance and Committees DivisionWorkshop final programme
Background and objectivesRapid developments in technology have resulted in the generation of vast volumes of data, creatingnew evidence which has the potential to add significantly to the way the benefit-risk of medicinalproducts is assessed over their entire life cycle.While creating huge opportunities, it is recognised there are also significant challenges in theexploitation of these data. For example there is a fundamental need to establish appropriate access tothe data, to understand their strengths and limitations and to apply new analytical methods tointegrate and analyse the heterogeneous datasets in order to generate conclusions which contribute toregulatory decision making. Importantly, compliance with data protection legislation ensuring robustmechanisms to protect patient confidentiality is critical for securing patient trust.It is important for the European Medicines Agency and the European Union Medicines RegulatoryNetwork to gather information on the latest developments in the field of big data from the perspectiveof different stakeholders. This will begin to clarify how and when the multitude of data sources maycontribute to medicinal product development, authorisation and surveillance.This meeting brings together a group of individuals who can inform on the advances being made in thisfield and the opportunities for the application of big data in medicine.ScopeThis workshop will be of interest to all stakeholders involved in medicines development and regulatoryscience: health authorities; healthcare professionals; patient associations; regulators; pharmaceuticalindustry; academics; civil-society organisations; corporate decision-makers.SessionsSession 1 The Big Data LandscapeSession 2 Big Data meets Medicines Regulation: Which data and When?Session 3 How do we transform Data into Knowledge to support decision making?Session 4 Reconciling Big Data and Privacy: Legal safeguards for unleashing technological innovationSession 5 Panel discussion: Brainstorming Big DataOutputsThe workshop is being broadcast live via the website. Both a recording of the workshop and a writtensynopsis will be made publicly available.Workshop Draft programmeEMA/707605/2016Page 2/10
Workshop venue: CCT Venue Plus, 195 Marsh Wall, South Quay, London14 November 2016 – 1st floor, Spice Room12:30RegistrationCoffee and biscuits13:30Welcome and IntroductionGuido Rasi, Executive Director, European Medicines Agency (EMA)13:40Session 1: The Big Data LandscapeChair:Jean Georges, Alzheimer EuropeCo-chair:Fergus Sweeny, EMAsetting the scene10’5’The Age of Big Data and the Power of WatsonLisa Latts, IBM Watson Health25’Data Management in the Cloud - Lessons learned fromInside GoogleNico Gaviola, Google Cloud Platform25’Delivering Better Transport through Big Data Innovation25’Lauren Sager Weinstein, Transport for LondonDiscussion10’15:10Session 2: Big Data Meets Medicines Regulation: Which Data andWhen?Chair:Luca Pani, Italian Medicines AgencyCo-chair:Alison Cave, EMAsetting the sceneBiomedical Discovery through Data Mining and Data Science5’25’Nicolas Tatonetti, University of Columbia15:40Coffee break16:10Session 2: Big Data Meets Medicines Regulation: Which Data andWhen?Enabling Precision Medicine and the Transformation of HealthcareSystems: Thoughts on Data and Technology Strategies30’25’Brian Kelly, Association of Clinical Research Organizations (ACRO)Workshop Draft programmeEMA/707605/2016Page 3/10
Integrating Pharmacogenomics into Decision Making25’Munir Pirmohamed, University of LiverpoolIdentifying the Future Needs for Big Data in Medicines Regulation25’Hans Hillege, EMA Committee for Medicinal Products for Human UseThe Future: partly FAIR, partly Cloudy25’Barend Mons, European Science Cloud, Leiden UniversityBig Data: Current and Future Initiatives of the EuropeanCommissionRoger Lim, European Commission DG SANTELeveraging Big Data for Better Health Outcomes:The Need for a Collaborative Space and Common SolutionsRichard Bergstrom, European Federation of PharmaceuticalIndustries and Associations (EFPIA)18:30End of day 118:30Reception and dinner (venue restaurant)Workshop Draft programmeEMA/707605/201625’15’Page 4/10
Workshop venue: CCT Venue Plus, 195 Marsh Wall, South Quay, London15 November 2016 – 1st floor, Spice Room08:15RegistrationCoffee and biscuits08:45Session 3: How do we Transform Data into Knowledge to SupportDecision Making?Chair:Thomas Senderovitz, Danish Medicines AgencyCo-chair:Paolo Alcini, EMAsetting the sceneKeynote:FDA Approaches to Analytical Challenges Posed by Big DataDavid Martin, Food and Drug AdministrationCase study: Large scale analytics for Electronic Health Records- OHDSI: Observational Health Data Sciences and InformaticsPatrick Ryan, Observational Health Data Sciences and InformaticsCase study: Specific Challenges around data analytics forSocial Media Data5’30’25’25’Marcel Salathé, École Polytechnique Fédérale de LausanneAn Industry Perspective on Big DataBart Vannieuwenhuyse, European Federation of PharmaceuticalIndustries and Associations (EFPIA)25’Discussion15’10:50Coffee break25’11:15Session 4: Reconciling Big Data and Privacy: legal safeguards forunleashing technological innovationChair:Jon Snaedal, World Medical AssociationCo-chair:Alessandro Spina, EMAsetting the sceneBig Data and the New EU Data Protection Regulation (GDPR)5’25’Sophie Louveaux, European Data Protection SupervisorMechanisms to Meet Privacy Requirements for Clinical DataManagement in Large Observational and Experimental Studies25’Ronald Brand, University of LeidenEthical and Governance Aspects of Research Data:Experience from UK Biobank25’Helene Hayman, House of Lords, UK Biobank Ethics and Governance CouncilWorkshop Draft programmeEMA/707605/2016Page 5/10
Wacean. A patient-driven innovative tool for data capture25’Julian Isla, Dravet Syndrome FoundationDiscussion15’13:15Lunch (venue restaurant)45’14:00Session 5: Panel discussion: Brainstorming Big DataModerator/Chair: Pierre Meulien, Innovative Medicines Initiative (IMI)105’This session will debate the key questions raised during the meetingspecifically in the context of medicines development and regulationPanellists:Ian Hudson, Medicines Healthcare and Product Regulatory AgencyAndrew Leach, European Bioinformatics InstituteMiriam Sturkenboom, Erasmus University Medical CenterRob Hemmings, Medicines Healthcare and Product Regulatory AgencyOlaf Klungel, University of UtrechtStephen Evans, London School of Hygiene and Tropical MedicineThomas Senderovitz, Danish Medicines AgencyHugo Hurts, Medicines Evaluation BoardBart Vannieuwenhuyse, European Federation of Pharmaceutical Industries andAssociations (EFPIA)Lisa Latts, IBM Watson Health15:45Closing remarksGuido Rasi, EMA16:00End of workshopWorkshop Draft programmeEMA/707605/201615’Page 6/10
List of speakers, co-chairs and panellistsPaolo AlciniEuropean Medicines AgencyRonald BrandLeiden University, NetherlandsAlison CaveEuropean Medicines AgencyStephen EvansLondon School of Hygiene and Tropical Medicine, United KingdomNico GaviolaGoogle Cloud Platform, United KingdomJean GeorgesAlzheimer Europe, LuxembourgHelene HaymanHouse of Lords, UK Biobank Ethics and Governance Council, UnitedKingdomRobert HemmingsMedicines and Healthcare products Regulatory Agency, United KingdomHans HillegeEMA Committee for Medicinal Products for Human Use, College terBeoordeling van Geneesmiddelen, NetherlandsIan HudsonMedicines and Healthcare products Regulatory Agency, United KingdomHugo HurtsMedicines Evaluation Board, NetherlandsJulian IslaDravet Syndrome Foundation, SpainBrian KellyAssociation of Clinical Research Organizations (ACRO) representative,United States of AmericaOlaf KlungelUniversity of Utrecht, NetherlandsLisa LattsIBM Watson Health, United States of AmericaAndrew LeachEuropean Bioinformatics Institute, United KingdomRoger LimEuropean Commission DG SANTE, BelgiumSophie LouveauxEuropean Data Protection Supervisor (EDPS), BelgiumDavid MartinFood and Drug Administration, United States of AmericaPierre MeulienInnovative Medicines Initiative, BelgiumBarend MonsEuropean Science Cloud, Leiden University, NetherlandsLuca PaniItalian Medicines Agency, ItalyMunir PirmohamedUniversity of Liverpool, United KingdomPatrick RyanObservational Health Data Sciences and Informatics, United States ofAmericaRichard BergströmEuropean Federation of Pharmaceutical Industries and Associations(EFPIA) representative, BelgiumWorkshop Draft programmeEMA/707605/2016Page 7/10
Lauren Sager WeinsteinTransport for London, United KingdomMarcel SalathéÉcole Polytechnique Fédérale de Lausanne, SwitzerlandThomas SenderovitzDanish Medicines Agency, DenmarkJón SnædalWorld Medical Association, IcelandAlessandro SpinaEuropean Medicines AgencyMiriam SturkenboomErasmus University Medical Center, NetherlandsFergus SweeneyEuropean Medicines AgencyNicholas TatonettiColumbia University, United States of AmericaBart VannieuwenhuyseEuropean Federation of Pharmaceutical Industries and Associations(EFPIA) representative, BelgiumWorkshop Draft programmeEMA/707605/2016Page 8/10
Practical informationVenueThe workshop venue is the CCT Venue Plus, 195 Marsh Wall, South Quay, London, E14 9SG.Lunch and dinner will also be served at this location By Docklands Light Railway (DLR)The workshop venue is a short walk from South Quay station on the DLR. Services run from Bank,Tower Gateway, Lewisham, Stratford, King George V and Beckton. By UndergroundThe nearest stop for the venue is Canary Wharf station on the Jubilee Line. By busThe venue is serviced by local bus numbers D6, D7, D8, 135 and 277. Plan your journey on TfL websiteEntering the buildingUpon arrival at the ground-floor reception, you will be guided to the 1st floor. Please make sure youhave an ID or a bank card with your name for identification at registration.Physical disabilityLet us know if you would like any specific help or information that would make your stay morecomfortable. We will be very happy to help.Workshop Draft programmeEMA/707605/2016Page 9/10
RegistrationWe advise you to arrive up to one hour before the start of the workshop (i.e. at 12:30) to allowsufficient time for registration and settling down. Registration will take place in the foyer on the 1stfloor.Meeting roomThere is no seating plan in the room except for a number of reserved seats for the speakers, panellistsand chairs of the workshop.PresentationsWe will not circulate printouts of speakers' presentations beforehand. However, you will be able todownload the presentations from the workshop website approximately one week after the event.CateringBeverages and dinner will be provided on the 14th November and beverages and lunch on the 15thNovember for all delegates free of charge to allow opportunities for discussion and networking.Media disclaimerThe Agency records or broadcasts a number of its meetings, including some virtual meetings. This ispart of the Agency's commitment to the principle of transparency as enshrined in the Treaty on theEuropean Union. By attending this meeting you consent to any recording or broadcast.Live broadcastThe workshop will be live streamed. Please follow the link in Multimedia tab on the event page. Noregistration or password is required.Individuals interested to tweet on this event are invited to use the hashtag #bigdata4medicines.Workshop venueCCT Venue Plus195 Marsh Wall, South QuayLondon, E14 9SGWebsite th-quayWorkshop Draft programmeEMA/707605/2016Page 10/10
The Age of Big Data and the Power of Watson 25' Lisa Latts, IBM Watson Health . Data Management in the Cloud -Lessons learned from 25' Inside Google . Nico Gaviola, Google Cloud Platform . Delivering Better Transport through Big Data Innovation 25' Lauren Sager Weinstein, Transport for London . Discussion 10'
