SLAS 2017 - "Multiple Research Platforms: One Single Data Sharing Portal"
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The document presents a strategic approach to implementing a unified electronic laboratory notebook (ELN) system to enhance data management across multiple research platforms in biopharmaceutical settings. It discusses the needs of scientists regarding data capturing, analysis, sharing, and the challenges of managing workflows among different research groups. The summary emphasizes the importance of a collaborative template design that facilitates efficient user workflows and integrates lab data management with document management.
SLAS 2017 - "Multiple Research Platforms: One Single Data Sharing Portal"
- 1. Premier Laboratory Informatics Experts Strategic Planning Implementation Validation Multiple Research Platforms: One Single Data Sharing Portal Farid A. Said ELN Consultant
- 2. © 2017 CSols, Inc. Speaker Introduction Farid A. Said ELN Consultant Biopharmaceutical Experience: 20 years interdisciplinary experience in medical sciences, scientific research, scientific informatics computing with good understanding of scientists' requirements Laboratory Informatics Experience: Leader and project manager for R&D Enterprise Electronic Laboratory Notebook (ELN) implementations Specialization in strategic planning for laboratory informatics projects
- 3. © 2017 CSols, Inc. Agenda High Level Architecture & Science Intelligence Strategic Role of Unified Platform in R&D Example of Collaborative Science Data Platform What do the Scientists Want? Use Case: ELN Template Design that Provides a “Hub” application for user workflows Summary Q&A
- 4. © 2017 CSols, Inc. High Level Architecture & Science Intelligence What Scientists Are Looking For… • Creating Data • Processing Data • Analyzing Data • Finding & Visualizing data • Validating Data • Sharing Data Unified Corporate Portals and Third Party Integration Technologies ERP/SAP MRP/MES P L M Integration& Connections
- 5. © 2017 CSols, Inc. Strategic Role of Unified Platform in R&D Chemistry Informatics Chemical Structure Drawing Tools 3 D Modeling SAR Compound Registration (IP) Biology Informatics Cell Biology Efficacy Assays Bioanalytical DMPK Biochemistry HTS In Vivo Clinical Informatics PK / PD Studies Patient Samples Management Pre-clinical Tox studies Enterprise Scientific Search Instruments & Equipment Systems: SAP, ERP,LIMS, ELN, CDS etc..
- 6. © 2017 CSols, Inc. Experiment Results Chemical Registration QC/Analytical Synthesis of Product Track Product Suppliers Decide what to make Chemical DB Explore Libraries Literature & References Inventory Manager Procurement Order Reagents Instruments Systems Methods & SOPs Instruments (NMR/HPLC) Systems (LIMS/EDMS) CoA etc.… Compound Registration (IP) Container Inventory Structure Search Reports Level 1: Simple Capture of Experiment Results Example of Collaborative Science Data Platform ELN EDMS SDMS
- 7. © 2017 CSols, Inc. Experiment Results Chemical Registration QC/Analytical Synthesis of Product Track Product Suppliers Decide what to make Chemical DB Explore Libraries Literature & References Inventory Manager Procurement Order Reagents Instruments Systems Methods & SOPs Instruments (NMR/HPLC) Systems (LIMS/EDMS) CoA etc.… Compound Registration (IP) Container Inventory Structure Search Reports Level 2: Capture of Experiment Results Compound Registration System Integration for IP Protection Inventory Manager Integration Chemical structure (including sub-structure) Search ELN EDMS SDMS Example of Collaborative Science Data Platform. Cont.
- 8. © 2017 CSols, Inc. Experiment Results Chemical Registration QC/Analytical Synthesis of Product Track Product Suppliers Decide what to make Chemical DB Explore Libraries Literature & References Inventory Manager Procurement Order Reagents Instruments Systems Methods & SOPs Instruments (NMR/HPLC) Systems (LIMS/EDMS) CoA etc.… Compound Registration (IP) Container Inventory Structure Search Reports Level 3: Capture of Experiment Results Compound Registration System Integration for IP Protection Chemical structure (including sub-structure) Search Instruments & Systems Integration Document Manager (QA/QC) ELN EDMS SDMS Example of Collaborative Science Data Platform. Cont.
- 9. © 2017 CSols, Inc. Experiment Results Chemical Registration QC/Analytical Synthesis of Product Track Product Suppliers Decide what to make Chemical DB Explore Libraries Literature & References Inventory Manager Procurement Order Reagents Instruments Systems Methods & SOPs Instruments (NMR/HPLC) Systems (LIMS/EDMS) CoA etc.… Compound Registration (IP) Container Inventory Structure Search Reports Level 4: Full Capture Of Data Workflow and Decision Across Project ELN, EDMS and SDMS Example of Collaborative Science Data Platform. Cont.
- 10. © 2017 CSols, Inc. What do the Scientists want? Workflow Support Complex experimental design and setup Sample materials tracking Data sharing Data Support Import instrument data Capture subjective data and observations Statistical analysis Data Searching and Reporting Example Departments ADME DMPK Toxicology
- 11. © 2017 CSols, Inc. Use Case: Collaborative Template Design that Provides a “Hub” application for user workflows Phase I: Strategy The Evaluation Results of detailed requirements review from different contributing groups: Chemistry Formulation In vivo Bio-analytical Requirements Gathering As-Is Workflow Stakeholders Interview process Each group uses a single specific ELN interface To-Be Workflow Create/Design a common template that can be used by all groups Benefits Analysis Qualitative: Workflow Support, Easy tracking and sharing with high user compliance Quantitative: Time saving
- 12. © 2017 CSols, Inc. Use Case: Collaborative Template Design that Provides a “Hub” application for user workflows. Phase I: Strategy Cont. Issue: One project, multiple groups, multiple templates Study Director Study Coordinators Study Request Study Design Chemistry Formulation In Vivo Bioanalytical Template 1 Template 2 Template 3 Template 4 Template 5 Template 6 Consultation Dpt. Heads PTL, authorization etc...
- 13. © 2017 CSols, Inc. Solution: One Project, Multiple Groups One Single User Friendly Interface Use Case: Collaborative Template Design that Provides a “Hub” application for user workflows. Phase II: Strategy Cont.
- 14. © 2017 CSols, Inc. Solution: One Project, Multiple Groups One Single User Friendly Interface Use Case: Collaborative Template Design that Provides a “Hub” application for user workflows. Phase II: Strategy Cont.
- 15. © 2017 CSols, Inc. Solution: One Project, Multiple Groups One Single User Friendly Interface Use Case: Collaborative Template Design that Provides a “Hub” application for user workflows. Phase II: Strategy Cont.
- 16. © 2017 CSols, Inc. Solution: One Project, Multiple Groups One Single User Friendly Interface Use Case: Collaborative Template Design that Provides a “Hub” application for user workflows. Phase II: Strategy Cont.
- 17. © 2017 CSols, Inc. Solution: One Project, Multiple Groups One Single User Friendly Interface Use Case: Collaborative Template Design that Provides a “Hub” application for user workflows. Phase II: Strategy Cont.
- 18. © 2017 CSols, Inc. Solution: One Project, Multiple Groups One Single User Friendly Interface Use Case: Collaborative Template Design that Provides a “Hub” application for user workflows. Phase II: Strategy Cont.
- 19. © 2017 CSols, Inc. Solution: One Project, Multiple Groups One Single User Friendly Interface Use Case: Collaborative Template Design that Provides a “Hub” application for user workflows. Phase II: Strategy Cont.
- 20. © 2017 CSols, Inc. Summary Unify lab data management and document management workflow Automatic integration of lab systems and instrumentation Improve legibility for audit trail and patent purposes Coordinating efforts of different groups Handling large quantities of screening data Locating/tracking products/supplies Maintaining adequate security
- 21. © 2017 CSols, Inc. Thank you Farid A. Said ELN Consultant www.csolsinc.com Questions?
Editor's Notes
- #3: Talk about your relevant experience Add Your Picture Strategy: Knowing what questions to ask and when to ask them?
- #4: To solve the problems I just mentioned, I’m going to cover …. We’ll see the value that understanding your processes can add to your ELN via process improvements and template creation I’ll discuss how metadata can improve search results and facilitate collaboration I’ll cover a few of the systems that can be interfaced with your ELN to streamline processes and increase efficiency Finally I’ll explain why user adoption—and its relative, stakeholder input—are important to a successful ELN: if no one is using the system today, then we want to involve the end users this time around so you can get the most value out of the system
- #11: Each of these different types of research will require a different type of template with differing levels of detail and process enforcement If you are developing completely new synthesis methods, you might need a relatively blank template that includes only a place for safety information and an area for e-signatures However, if you’re doing experiments to find a new raw material, you might need to replicate a QC process with different raw materials and would therefore need to have a fairly detailed template with some process enforcement built in