Alfresco Day Vienna 2015 - Alfresco im Einsatz - AFFiRiS AG
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Alfresco Day Vienna 2015 - Alfresco im Einsatz - AFFiRiS AG, Dr. Oleksandr Otava, MBA, Scientific IT Head
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Alfresco Day Vienna 2015 - Alfresco im Einsatz - AFFiRiS AG
- 2. FEW WORDS ABOUT AFFIRIS WHO WE ARE AND WHAT IS OUR BUSINESS ABOUT 2
- 3. 3 Company Facts • Founded in November 2003 • Located at the Vienna Biotech Cluster • 57 employees (June 2004 ‐ only 8) • Seven clinical trials in Phase I and Phase II ongoing or completed • Strategic investors – Strüngmann family office (Santo Holding) – MIG AG
- 4. 4 AFFiRiS Profoundly Impacts Lives of Patients First‐in‐class vaccines for therapy AND prevention of chronic diseases • Cardio metabolic • Neurodegeneration • Allergy AFFITOPE® products shall induce an antibody response • Specific (on target) • Sustained (reactivation) • Substantial (functional titers)
- 5. 5 Pipeline Overview Target Indication Discovery Preclinical Phase I Phase II Cardio metabolic PCSK9 Lipid lowering PCSK9 bi‐epitopic Lipid lowering undisclosed Diabetes type II Neurodegeneration -Syn (PD01/PD03) Parkinson‘s -Syn (PD01/PD03) Multiple System Atrophy -Syn (PD04) Parkinson‘s A (AD05) Alzheimer‘s HTT Huntington‘s Allergy IgE Allergic Rhinitis
- 6. 6 AFFITOME® Technology ‐ Knowhow Peptide conjugate vaccines • Peptide antigens • Carrier proteins • Adjuvants Target Selection AFFITOPE®s Formulation knowledge Knowhow Blocks to Vaccine Development Vaccinable targets • Soluble vs. Aggregated vs. Intracellular Selective peptide engineering
- 7. 7 AFFITOME® VACCINE System Adaptable system for rational vaccine design Defines cross- reactivity Defines absolute immunogenicity • TT, VLP, PADRE as alternative carriers • Expansion to additional carrier and adjuvant/systems AFFITOPE® Mimotope VARIOTOPE® Linker Carrier Peptide Adjuvant KLH CRM Alum
- 8. 8 AFFITOPE®: Technology Evolution Mimotopes AFFITOPEs® 2004 2006 2008 2015 PD04AT04/06PD01AAD01/AD02 Safety Immuno‐ genicity Safety Immuno‐ genicity SafetyImmuno‐ genicity 2016 Peptide Selection with commercial Abs Peptide Selection with in‐house Abs Iterative peptide selection in single animal model Iterative selection in various animal models Additional carrier backboneCRM – carrier alternative
- 11. 11 Historically growing storage structures and related problems • All important, fundamental information the company generates daily, our knowledge ‐ our data – Word, Excel, PDF, Laboratory data, … • since 2004 continuously growing amount of data was stored and managed on the fileserver • There was no defined way of storage or structures at that time • Every scientist and every team had its own art of data management (folders and file naming etc.) • There was no common way of versioning, especially by reviewing different kinds of reports • Communication with the experts in the field, emails Slowly we started to realize that we need to bring everything in order!
- 12. 12 Demands to DMS • Structured data depositing concept … … in contrast to chaotic document depositing on the file server • To assure that nothing from data is lost • To secure confidentiality • User friendly and quick search option • To preserve the knowledge when an employee leaves the company • To support important company activities: – “Due Diligence“ – Project management, planning und progress overview – Collaboration projects
- 13. 13 Our way to Enterprise Content Management step 3 • Alfresco step 2 • Evaluation step 1 • Open Text
- 14. 14 DMS – step 1 ‐ OpenText • There was no evaluation • Recommendation • Document management und Project management with OpenText • IT‐costs for implementation and service ‐ not defined • Project was stopped
- 15. 15 DMS – Step 2 ‐ Evaluation • Evaluation • http://www.capterra.com/document‐management‐ software • Shortlist – SharePoint • www.microsoft.com – Alfresco • www.alfresco.com – OpenKM • www.openkm.com
- 16. 16 Step 3 – Decision We decided for Alfresco ! Alfresco® Advantages • Open Source • Single repository • Versioning, Check in & out • drag and drop and upload • Preview of documents • Can be used like a network‐drive • MS Office integration • Workflow • No client installations • Claims to be easily set up • Full audit logs • Dashboard for every project • Project wiki Alfresco® Disadvantages • Annual Subscription • No direct office integration
- 17. 17 Starting the project and implementation planning • The discussion about „out of box“ content – Intense orientation on standards of Alfresco • Compilation of the functional specifications • Implementation and adjustments – Project und Experiment folder‐template – Metadata for documents
- 18. 18 Start Setup ‐ Implementation • Departments were selected • Key – user from the departments were defined • Main rule ‐ all data should be stored in Alfresco • Every department had a Site • a group of the department = R&D • all active projects were migrated – Structures were built – Migrated data was taken over by users: • aim: structuring and cleaning • The old data from the files server was integrated into Alfresco as Archive
- 19. 19 Setting the right permissions • Active directory synchronization • We try to keep , where possible, inherited rights for the sites and structures • we have also set some special access rights to some folders and documents
- 21. 21 Alfresco structures at AFFiRiS Every user has also individual Alfresco Home QA/QC Administration R&D Clinical Department Board / management Project Management Business Development Scientific IT Finance Alliances Clinical finances AFFIRIS INTRANET FAW trainingVIERER‐RAT Due diligence a site in Alfresco for R&D with the separate folders =spaces for each Department every single project within each R&D department created from Project template
- 22. 22 DMS STRUCTURE R&D R&D IGDG NG PG Project A Project B Project C Info Experiments ReportsPresentations Diverse (for info not fitting well into other folders) Miscellaneous (for info not fitting to single projects but to the whole department); e.g. Group meetings ServicesAnimal Works USERS CAN NOT ADD ANY FOLDERS ON THE BLUE LEVEL INSIDE BLUE FOLDERS USERS CAN CREATE SIMPLE FOLDERS AND TEMPLATE BASED FOLDERS (PROJECT) INSIDE EXPERIMENT FOLDER USERS CAN CREATE SIMPLE FOLDERS AND FOLDERS BASED ON THE TEMPLATE (EXPERIMENT)
- 28. 28 Categories tree Categories allow quickly and easily organize and later to retrieve the content
- 30. 30 Lessons learned • Collaboration instead of workflows • Plan initial structures • Peer support over classroom‐courses • Be aware of path length‐issue • Do not use WEBDAV, CIFS, Share Point‐ Protocol • Use ezuno© instead Enjoy Alfresco!
- 31. 31 The future plans • Migration to Alfresco 5 – Q1 2016 • Improve search
- 33. 33 Evaluiation ‐ OpenText • + pro – Browser based – Central repository – Support for big number of data types – Metadata – Graphical Workflow‐Tool – Drag & Drop – Permissions system – Versioning • ‐ contra – Price – Fokus on big organisations
- 34. 34 Evaluiation – SharePoint • + pro – Collaboration, for example tagging – Dependence on Ofice and Windows – Workflow – Working spaces for teams – Sites – Metadata • ‐ contra – Rigid and unflexible – Adjustments ‐ expensive – License model – To switch to the other system afterwrds might be complex
- 35. 35 Evaluation ‐ Alfresco • + pro – Open source – Central repository – Drag & Drop – Document preview – Access throught the connected drives – Office integration as in SharePoint – Dashboards und Sites • ‐ contra – Annual subscription
- 36. 36 Evaluation ‐ OpenKM • + pro – Browser user interface – Drag & Drop – Addins for the programs access, for example Office – Workflow tools – Digital signature of the documents – Wikis, Chats, Forens • ‐ contra – Limitation in the data size – Support time
- 37. 37 DMS Structure Clinical Department Clinical Department VACCINE General Admin AFFiTOPE ID A Project A Project B Project C QA related Study related PV Audit SOP Budget Contracts Test scales AFFiTOPE ID B Project D Project E
- 38. 38 DMS Structure Clinical Department Example for VACCINE Folder Clinical Department VACCINE AD01 Study AFF001 Study AFF003 AD02 Study AFF006 Study AFF002 ... (all other folders as described in figure above) „Create new AFFiTOPE ID“ (without Meta‐Data) PD01 Study AFF008 AFFiTOPE ID X Project X„Create new Project‐Folder“ (with Meta‐Data) 28 folders + subfolders 28 folders + subfolders 28 folders + subfolders 28 folders + subfolders 28 folders + subfolders 28 folders + subfolders
- 39. 39 DMS Structure Clinical Department Clinical Department VACCINE AD01 Study 1 Study 2 Study 3 Study 4 Study 5 Study 6 F1 F2 F5 F6 F7 F8 F9 F10 F11 F12 F13 F14 F15 F16 F17 F18 F19 F20 F21F3 F4 F22 F23 F24 F25 F27 F26 Other