Enabling Technologies for Collaborative Research in Health. Ann Martin BigData2015 Munsbach, Luxembourg

Transcription

1 Enabling Technologies for Collaborative Research in Health Ann Martin BigData2015 Munsbach, Luxembourg

2 IMI Europe s partnership for health > 5 bn 2.5 bn Partnership bn

3 IMI key concepts Focus on unmet needs Non-competitive collaborative research Competitive Calls for proposals Open collaboration in public-private consortia Data sharing, dissemination of results Industry contribution is in kind

4 IMI Knowledge Management IMI 2 Data and Knowledge Management SGG Enabling Platforms New project ideas: SGG Strategy or ad hoc proposals Research Informatics Translational Informatics Real World Data Adaptive Informatics Digital Business IMI IMI-2 RADAR Patient Hub BD4BO 4

5 Enabling Technologies & Tools Some Examples

6 etox Searchable in a database Publically available toxicology data OH HO N O N N OH Predictive in-silico models Reports from companies

7 Compound Target Pathway Disease data ü Created the Open PHACTS Discovery Platform linking information and facts from multiple public databases ü Created an API for drug discovery with an ecosystem of apps ü ü ü Methodology for delivery business-relevant solutions Use by bench and computational scientists Established itself as a a unique forum for partners ü the Open PHACTS Foundation support the existing infrastructure and widen scientific scope

8 Model Based Drug Development Clinical Trial Simulator - Prototype v.2 Adap>ve Op>mal Designs prototype V.1

9 Efforts to Automate clinical research 1 DESIGN Feasibility Study Protocol (CDISC PRM SDM) 2 EXECUTION Pa?ent Recruitment 3 EXECUTION Data Collec?on Case Report Form (CDISC ODM) FDA- EMA SUBMISSION Regulators XML XML XML Trial Registry Document Management System Clinical Trial Management System (CTMS) Clinical Data Management System (CDMS) XML

10 Ø Supports collaborative projects Ø Analysis needs of translational data Ø Deploys open-source transmart Ø Service with public data Ø Ethics / data protection Ø Standards research Ø transmart Foundation o 35 transmart implementations o multiple development teams o commercial services European Translational and Knowledge Management Services Abirisk Oncotrack UBIOPRED Predict- TB RA- MAP... studies including omics images clinical assessment data 22 transla?onal, 1400 gene expression studies J&J etriks TraIT TheHyve IDBS Sanofi Pfizer Takeda RecombinantbyDeloiPe Thomson Reuters Michigan Harvard

11 EMIF European Medical Information Framework Research topics provide focus Platform Make data available for browsing and analysis in multiple ways Alzheimers Disease Identification and validation of markers that predict Alzheimer s progression Metabolics Discovery of predictors of the metabolic complications of adult and paediatric obesity

12 Accelerated development of vaccine benefit-risk collaboration in Europe Review, develop, test methods, data sources & procedures Feed blueprint sustainable pan-european framework Deliver robust quantitative data to assess benefits & risks marketed vaccines Fast informed decisions regulators/health authorities

13 Incorporating real-life clinical data into drug development HTA assessment è value new drug for given healthcare system. need data to assess relative effectiveness guidance on generating real world data during drug development analyse existing processes and methodologies network of regulators, HTA, companies, academics, healthcare professionals, patients etc

14 Recognising Adverse Drug Reactions Mobile app: report ADRs info on meds Social media: explore identification safety signals Recommendations safety monitoring

15 ND4BB Infocentre Infocentre accross antimicrobial projects Electronic lab notebooks Transmart Code of practice secondary use medical data

16 Reinforce Data & Knowledge Management

17 General conditions for proposals Open Publications (gold or green) Data Management Plan (H2020 guidance) Adopt data standards e.g. CDISC Adapt or develop standards with SDO Dessiminate description resources using standards e.g. Dublin Core (ISO15836)

18 Results/Data dissemination Guidelines on Open Access to Scientific Publications and Research Data in Horizon 2020 Guidelines on Data Management in Horizon 2020

19 Data Management Plan template 1 page template covering Data set reference and name Data set description Standards and metadata Data sharing Archiving and preservation (including storage and back-up)

20 Data Standards & Other MOU with CDISC Extends IMI membership to beneficiaries Adopt, adapt, develop standards eg CDISC CFAST therapeutic area standards etriks starter pack Code of practice for secondary use of medical data

21 Standards facilitate regulatory submissions collaborative research in networdked R&D in & out licensing mergers & acquisitions è adoption is difficult to measure

22 Disseminate results Article 29.1 General obligation to disseminate results Make resources discoverable for metrics & re-use Describe resources using e.g. Dublin Core (ISO15836) Examples of Resources are (a collection of) biosamples, datasets, images, publications etc.

23 Under Evaluation

24 Remote Assessment of Disease and Relapse (RADAR) Caregiver Reports Literature Patents Epidemiology Predict and Preempt: Ø relapse in depression Multi-Platform Biomarker Data from Controlled Studies Physician Notes Patient Hospital Records Data Ø exacerbation in MS Ø epileptic fit Ø Onset of mania Ø Psychotic break etc. Vision of Tomorrow: Next Generation Patient Centric Data MOVE FROM DIAGNOSE AND TREAT TO PREDICT AND PREEMPT 24 Continuous Real-Time Patient Data Home Monitoring. Remote Sensing. (Actigraphy, Physiological) 24

25 Challenges in Managing Chronic Disease Today Physician visits are time-limited evaluations based on subjective observations of both the patient and the physician or psychiatrist Changes in disease state for each of these diseases can occur on timescales much shorter than the interval between physician visits Through technological advances over the last decade it is now possible to objectively, remotely, and continuously measure aspects of patient physiology, behavior and symptoms 25

26 Knowledge repository to enable patient-focus medicine Future development Pharma Pharma Pharma Knowledge Repository Patients Advocacy Groups Regulators

27 Patient input into drug development Today Pharma 1 Pharma 2 Pharma 3 Patients Advocacy Groups Regulators

28 Big Data for Better Outcomes Program

29 CSA DDN TA projects Consistency & quality policy/direc?on, objec?ves, call texts facilitate interac?ons and learnings between projects Standards for data and knowledge Implementa?on Data protection & integrity Legal & ethical standards Code of prac?ce Common ethics Board Templates/guidance Technical data security and privacy solu?ons Common minimum data standards Opera?onal interac?ons with competent authori?es Knowledge integration Policy principles (programme level) Gap analysis and recommenda?ons for projects TA specific recommenda?ons Engagement with HC stakeholders & communication Branding (templates, guidance) Programme comms material Programme website Stakeholders engagement Recommenda?ons on data formats and standards TA specific interac?ons with stakeholders (+repor?ng to CSA) Communica?on (project level) Data sustainability & growth of networks Data sustainability mechanisms (including quality of data and adequate use) Knowledge repository/ platform Processes for collec?on, use and exploita?on of knowledge and ac?ve process management Repository infrastructure Generate and manage TA specific contents IMIProgramBD4BOUpdatesv 30 July 2015.pptx 29

30 Call 6: BD4BO launched Topic 3:Real World Outcomes Across the AD Spectrum (ROADS) to Better Care Topic 4:Development of an outcomes-focused data platform to empower policy makers and clinicians to optimize care for patients with hematologic malignancies

31 Call Topics in preparation (DKM) BD4BO Coordination and Support Action European Distributed Data Network Cardiovascular Multiple Sclerosis RADAR - PAIN

32 Conclusion

33 What do we need? X1, Network of containers with services transmart / etriks Data management Data Management Plan Adopt (adapt, develop) standards CDISC, etriks starter pack Access data incl governance Code of practice

34 Thank you Ann Martin Principal Scientific Manager