Building an Intelligent Biobank to Power Research Decision-Making



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Building an Intelligent Biobank to Power Research Decision-Making Lori Ball, Chief Operating Officer, President of Integrated Client Solutions, BioStorage Technologies, Inc. Brian J. Brunner, Senior Manager, Clinical Practice, LabAnswer Suresh Chandrasekaran, Senior Vice President, Denodo Technologies

Agenda 1:00 1:05 pm Workshop Introduction by ISBER 1:05 1:15 pm Research Sample Intelligence: The Growing Need for Global Data Integration Lori Ball, Chief Operating Officer, President of Integrated Client Solutions, BioStorage Technologies, Inc. 1:15-1:25 pm Building a Research Data Integration Plan and Cloud Sourcing Strategy Brian J. Brunner, Senior Manager Clinical Practice, LabAnswer 1:25-1:35 pm How Data Virtualization Works and the Value it Delivers Suresh Chandrasekaran, Senior Vice President, Denodo Technologies 1:35-2:00 pm Panel led Workshop Questions 2:00-2:15 pm Panel Solution Discussion 2:20 2:30 pm Participant Q&A

Lori Ball Research Sample Intelligence: The Growing Need for Global Data Integration Lori Ball, MBA Chief Operating Officer, President of Integrated Client Solutions BioStorage Technologies, Inc.

Biobank Sample and Data Stakeholders Patients and Physicians Collect samples from patients to utilize for testing, diagnosis and therapy decisions Research Scientists and Organizations Require samples to support translational science, biomarker development and research studies (ex. Industry, Academia, Foundations, Government, Hospitals, Research Institutes) Biobank Inventory Managers Manage sample inventories at biobanks to support research scientist requests Biobank Operations Personnel Support biobank managers in day-to-day management of sample storage, logistics, retrieval, materials and data management.

Personalized Medicine requires Samples and Data Researchers and doctors both rely heavily on biorepositories to provide them with highquality samples that they need to advance personalized medicine and to treat patients. 1 Analysis of sample data enables us to detect genetic differences in individuals which can improve therapy decisions and success. 30% of patients over-express the HER2 protein and are unresponsive to standard therapy 60% of melanoma patients who have the B-Raf protein were not effectively treated for skin cancer until vemurafenib was developed in 2011 Development of effective data management systems is the #1 challenge to individuals managing biobanks today. 1 Academics Hospitals Biopharma Laboratories Non-Profits Research Institutions The most important part of data management Source: 1 IQPC Global Biobanking Study, February 2015

Global Sample Data Integration Considerations As cloud computing extends its reach into clinical trials, data analysis, analytics and visualization are becoming key areas demanded by trial managers 1 Sample and Data Types Range of complexity Data Sources - >25B connected devices today and >50B estimated by 2020 Data Virtualization (Data Integration) Broad virtual data access with open APIs Data Visualization Intuitive, flexible decision-support Data Devices / Tools Need for standards Data Analytics / Analysis Tools 1 Centerwatch, Cloud Computing Expanding into All Areas of Clinical Trial Conduct, August 2014

Value of Global Sample Data Integration Virtualization Visualization Valorization Consolidate global sample inventory data Virtually connect global sample data to relevant research data Access sample data anytime from the cloud from anywhere in the world. Create visual dashboards and reports of sample data to support analytics and deliver business insights Assess the quality and value of samples stored for future research Select the best samples that are consented for research Dispose of samples not needed or compromised Determine which sample data and assets to utilize or share with research partners

Global Sample Data Integration Opportunities / Challenges Development of effective data management systems is the #1 challenge facing individuals managing biobanks today. 1 Data Integration (physical & virtual) Laboratory Data LIMS Cloud Storage Virtualization Researcher Data SDMS Hospital/Clinic Data SDMS SAS SQL Oracle ERP Visualization Consolidated Data Center / Logical Data Warehouse Biorepository Data SMS Clinical Trial Data CTMS Biobank Data SMS Valorization Consent Technology promises to deliver more value to clinical trials as it enables a real-time view of the patient experience and collects data that had previously gone uncaptured. 2 Sources: 1 PharmaVoice, The Internet of Things, March 2015

Brian J. Brunner Building a Research Data Integration Plan and Cloud Sourcing Strategy Brian J. Brunner Senior Manager, Clinical Practice LabAnswer

Global Sample Data Integration Opportunities / Challenges Development of effective data management systems is the #1 challenge facing individuals managing biobanks today. 1 There are 3 primary strategies in the market today for Sample Data Integration: 1. Systems Consolidation 2. Systems Integration 3. Systems Externalization All of these strategies include an Integration Platform, Harmonized Data Store and Visualization to enable a single view into Sample Data. These options will be discussed in the context of cost, complexity and maintenance On a scale of 1 5 with 5 being the highest Technology promises to deliver more value to clinical trials as it enables a real-time view of the patient experience and collects data that had previously gone uncaptured. 2 Sources: 1 PharmaVoice, The Internet of Things, March 2015

Global Sample Data Integration Data Aggregation & Visualization Model Laboratory Data Researcher Data SDMS LIMS Hospital/Clinic Data SDMS Biorepository Data SMS Clinical Trial Data CTMS Biobank Data SMS Consent Operational Data Stores Integration Platform Analytics/Decision Support Create a single, consolidated and integrated view to all sample data Integration can be either traditional ETL, ESB or Virtualized Database Integration requires interfaces with a wide range of systems Client and External source data is integrated as required

Internal Data Global Sample Data Integration Opportunities / Challenges Systems Consolidation External Data Internal Data External Data Visualization Harmonized Data Store Integration Assume: Mass Systems Consolidation, ETL/ESB Integration, Internal Infrastructure Cost: 5 - Cost to transition all systems - Infrastructure - SW Costs Complexity: 4 - Challenge to harmonize and standardize during development - Challenge for single platform Maintenance: 2 - Lower integration cost ongoing - Internal System Dependencies considered for system changes

Internal Data Global Sample Data Integration Opportunities / Challenges Systems Integration External Data Internal Data External Data Visualization Harmonized Data Store Integration Integration Assume: ETL/ESB Integration, Complex Master Data Management (MDM), Internal Infrastructure Cost: 4 - Cost to integrate all systems - Infrastructure Costs - SW Costs Complexity: 3 - Need harmonize internal data through integration platform - Need to integrate ext data Maintenance: 3 - Integration cost ongoing - Ongoing Infrastructure and SW maintenance cost

Internal Data Global Sample Data Integration Opportunities / Challenges Systems Externalization External Data Internal Data External Data Visualization Harmonized Data Store Integration Assume: Data Virtualization & Integration Platform, Complex MDM, Cloud Infrastructure Cost: 2 - Cost to integrate systems - SW & Infra costs are leased - Data Virt lowers integrate cost Complexity: 3 - Need to harmonize internal data through integration platform - Need to integrate ext. data Maintenance: 2 - Integration cost reduced - SW & Infra are elastic with demand and growth

Cloud Sourcing Discussion The Cloud Security Alliance defines cloud computing as: Cloud computing ( cloud ) is an evolving term that describes the development of many existing technologies and approaches to computing into something different. Cloud separates application and information resources from the underlying infrastructure, and the mechanisms used to deliver them. Other perspectives: Cloud computing is processing and storing of data as a service outside of the traditional processing that takes place inside an organization Enables organizations to treat data as a commodity that can be processed, transformed and delivered by outside organizations in a secure, compliant manner Amazon Web Services approved by U.S. DoD as a Service Provider http://www.informationweek.com/government/cloud-computing/amazon-cloud-services-wins-dod-authorization/d/d-id/1141529 Other Resources: EU Agency for Network and Information Security Risk Assessment Tool http://www.enisa.europa.eu/activities/risk-management/files/deliverables/cloud-computing-risk-assessment DoD Guidance on Cloud Computing

Data Integration Strategy Summary Selecting the Right Data Integration Strategy Laboratory Data Researcher Data SDMS LIMS Hospital/Clinic Data SDMS Biorepository Data SMS Clinical Trial Data CTMS Biobank Data SMS Consent Operational Data Stores Integration Layer Analytics/Decision Support Consolidate Duplicative Systems, utilize COTS Platforms as basis for Core Systems Cloud Platform used for secure processing and storage; elastic based on need Data Virtualization enables agile, flexible data integration External Service providers can be used to process, harmonize and visualize data

Suresh Chandrasekaran How Data Virtualization Works and the Value it Delivers Suresh Chandrasekaran Senior Vice President, Denodo

What is Data Virtualization? Data Virtualization combines disparate data sources into a single virtual data abstraction layer (aka information fabric) that provides unified access and integrated data services to consuming applications in real-time (right-time). Derived View Data Service (SQL, SOAP, REST, Widgets ) Connect & Virtualize Combine & Integrate Publish as a Data Service Base View Base View Base View

DV Enables Agile Info Architecture Many to Many Agile BI & Apps Faster Solution BI /Reporting Analytics Visualization Application Data Sharing Data Services Optimized Performance Integrate New Sources Any Data, Anywhere

Data Virtualization in Life Sciences Business Solutions Access Informationas-a-Service Data Virtualization Right Information at the Right Time Disparate Data Any Source Any Format

Bio Sample and Research Intelligence Business Need (Canonical Views) Data Virtualization Functions Samples Consent Access heterogeneous data sources Clients Create logical abstraction layer CRO Data Virtualization Layer Trial Deliver canonical business views Data services access anywhere Real World (Source Data Views) Researcher Data SDMS Laboratory Data LIMS Hospital/Clinic Data SDMS Agile data integration and quality Minimize replication (cost, time) Biorepository Data SMS Clinical Trial Data CTMS Biobank Data SMS Enterprise to cloud scalable, secure Consent

Major Companies Find Compelling Benefits NNSA's Product Realization Integrated Digital Enterprise (PRIDE) program is built on a data virtualization fabric Accessing and aggregating data from different NNSA sites would not be possible without Data Virtualization. It expedites projects by enabling fast and secure movement of data through different facilities. - Stephanie Elsea, Pantex Plant, NNSA

Top CIOs in Life Sciences Use Agile Data & Cloud Intelligence Amgen, a $17.3 billion pharmaceutical company uses statistical analysis of data points collected in real time. The analytics system includes virtualized data warehousing tools from Denodo. Amgen can draw conclusions much faster than in the past, says CIO Diana McKenzie. Now You Can Too!

WORKSHOP SESSION

WORKSHOP QUESTION #1 What is your current state of sample data integration? Take 2 minutes and discuss as a table Write down common issues on note cards

WORKSHOP QUESTION #2 What does an intelligent biobank look like to you? Take 2 minutes and discuss as a table Write down common issues on note cards

WORKSHOP QUESTION #3 What obstacles are preventing your success? Take 2 minutes and discuss as a table Write down common issues on note cards

Speaker Panel - Solutions Discussion

Q&A Audience - Q&A Session