Alfresco Day Vienna 2015 - Alfresco im Einsatz - AFFiRiS AG
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Transcript of Alfresco Day Vienna 2015 - Alfresco im Einsatz - AFFiRiS AG
BRINGING VACCINES TO CHRONIC DISEASE
01 December 2015
Alfresco at AFFiRiS AGOleksandr Otava
FEWWORDS ABOUT AFFIRISWHOWE ARE AND WHAT IS OUR BUSINESS ABOUT
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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
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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)
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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
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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
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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®MimotopeVARIOTOPE®
Linker
Carrier
Peptide
Adjuvant
KLHCRM
Alum
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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
WHY DO WE NEED DMS AND HOW WE DECIDED FOR ALFRESCO IMPLEMENTATION AT
AFFIRIS
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Assets of AFFiRiS
Secure IP position
Data
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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!
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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
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Our way to Enterprise Content Management
step 3• Alfresco
step 2• Evaluation
step 1• Open Text
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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
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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
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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
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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
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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
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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
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Alfresco architecture at AFFiRiS
Management and search using Alfresco Share
Solr
MetadataData Archive Data
Alfresco Application Server
Users should have a possibility to work with the documents using Windows Explorer
WEBDAV or CIFS
MyShare (ezuno)
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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
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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)
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Metadata and Folder ‐ Template „Project“
Unfortunately, without filling up metadata it is difficult to find the right files!
Name:TITLE:DISCRIPTION:Author: Tags: Categories: Project FolderProject Title:* Project Acronym: Cost Unit: Indication: Affitopes ID: Vaccines ID: Start: DD/MM/YYYY End: DD/MM/YYYY Actual End: DD/MM/YYYY PreclinicalProject ID: Partner: Sponsor: Functional Management: Project Management: Clinical Development Management: Connecting Projects: ClinicalStudy Title: CRO: Principal Investigator: Clinical Management:
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Project folder structure for R&D
Project X
Info Experiments ReportsPresentations
Templates
Literature
Materials & Methods
Folders for single experiments
Internal Presentations
External Presentations
Papers by AFFiRiS
Internal Reports
External Reports
Audit Reports
Diverse (for info not fitting well into other folders)
Folders for TOX experiments
?Patents?
Competitors
Congress Reports
Mouse ordering
Protein expression
Immunohisto‐chemistry
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Metadata Folder Template „Experiment“
As previous template, It was a long discussion but not in real use until today!
Title: Description: Author: Tags: Categories:Experiment FolderExperiment Title:*Start of Experiment: DD/MM/YYYY CooperationNo Cooperation Internal Cooperation External Cooperation OrganismMouse Rat Guinea Pig Hamster Rabbit Other Carrier/AdjuvantKLH ALUM etc.No adjuvant Other Experiment detailsIn vitro In vivo POC study Other
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Tags and Categories
Aspects such as categories (effectively used by PM department) and tags are important for success in search
Tags and categories should be added manually, however we apply some automatization for adding/removing categories where possible
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One way to autoapply categories in Alfresco
Folders with rules (every file get‘s/loose a category getting in/out this folder)
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Categories tree
Categories allow quickly and easily organize and later to retrieve the content
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Tags
Might be helpful for searching if used with rational!
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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!
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The future plans
• Migration to Alfresco 5 – Q1 2016
• Improve search
THANK YOU FOR YOUR ATTENTION!
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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
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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
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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
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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
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DMS Structure Clinical Department
Clinical Department
VACCINE
General AdminAFFiTOPE 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
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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 newAFFiTOPE ID“(without Meta‐Data)
PD01
Study AFF008
AFFiTOPE ID X
Project X„Create newProject‐Folder“(with Meta‐Data)
28 folders + subfolders
28 folders + subfolders
28 folders + subfolders
28 folders + subfolders
28 folders + subfolders
28 folders + subfolders
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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