Alfresco Day Vienna 2015 - Alfresco im Einsatz - AFFiRiS AG

BRINGING VACCINES TO CHRONIC DISEASE

01 December 2015

Alfresco at AFFiRiS AGOleksandr Otava

[email protected]

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






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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