[PPT] - Presentation & Discussion: Integrate and accelerate Knowledge PowerPoint Presentation

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Presentation & Discussion: Integrate and accelerate Knowledge Management to seek Intelligence across the life science industry

Delphine Delaunay & Marc-Antoine Perrissin-Fabert 26 November 2015

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Content

Context Methodology In Practice

Why a company should develop and strengthen KM Different ways to enhance KM and seek for Intelligence Key steps to put in place robust and collaborative KM in your company

Definition (KM standard,

ICHQ10 & ISO)

Data & information

management issues and challenges

Open discussion on

benefit inside & outside Life cycle industry, survey etc...

KM platform and Wow,

use of ontology and innovative semantic in data treatment, external environment monitoring

Implementation in drug

development center

Let 'us know what have

you developed

KM maturity assessment
Build KM strategy and

implementation plan

Roll-out pilot
Enlarge to company

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Content

Context Methodology In Practice

Why a company should develop and strengthen KM Different ways to enhance KM and seek for Intelligence Key steps to put in place robust and collaborative KM in your company

Definition (KM standard,

ICHQ10 & ISO)

Data & information

management issues and challenges

Open discussion on

benefit inside & outside Life cycle industry, survey etc...

KM platform and Wow,

use of ontology and innovative semantic in data treatment, external environment monitoring

Implementation in drug

development center

Let 'us know what have

you developed

KM maturity assessment
Build KM strategy and

implementation plan

Roll-out pilot
Enlarge to company

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WHY A COMPANY SHOULD DEVELOP AND STRENGTHEN KM

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What is knowledge ? KEY MESSAGES “ Knowledge is a fluid mix of framed experience, values, contextual information, expert insight, and grounded intuition that provides an environment and framework for evaluating and incorporating new experiences and information” Gamble and Blackwell (2001)

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What is knowledge ? KNOWLKEDGE IN CONTEXT

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What is knowledge ? QUALITY EXPECTATION

“Knowledge management is a systematic approach to acquiring,

analyzing, storing, and disseminating information related to products, manufacturing processes, and components. Sources of knowledge include, but are not limited to, prior knowledge (public domain

r

internally documented); pharmaceutical development studies; technology transfer activities; process validation studies over the product lifecycle; manufacturing experience; innovation; continual improvement; and change management activities.”

ICH Q10 2009. Pharmaceutical Quality System

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Clause 7.1.6. Knowledge

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"Determine the knowledge necessary for the operation of its processes and to achieve conformity of products and services.

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"This knowledge shall be maintained and made available to the extent necessary.

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"When addressing changing needs and trends, the organization shall consider its current knowledge and determine how to acquire or access any necessary additional knowledge and required updates.

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"NOTE 1: Organizational knowledge is knowledge specific to the

rganization; it is generally gained by experience. It is information

that is used and shared to achieve the organization's objectives.

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"NOTE 2: Organizational knowledge can be based on:

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a) Internal Sources (e.g., intellectual property, knowledge gained from experience, lessons learned from failures and successful projects, capturing and sharing undocumented knowledge and experience; the results

f

improvements in processes, products and services);

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b) External Sources (e.g., standards, academia, conferences, gathering knowledge from customers or external providers).

ISO 9001:2015

What is knowledge ? QUALITY EXPECTATION

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Knowledge Management Strategy and Processes

Sources of knowledge include, but are not limited to : prior knowledge (public domain or internally documented) pharmaceutical development studies technology transfer activities process validation studies over the product lifecycle manufacturing experience innovation continual improvement change management activities. Collaborative knowledge management allows employees to more easily collaborate across geographical and organizational boundaries and help companies respond more efficiently to new and changing market trends. Collaborative networks as well, give companies the potential to drive processes much faster than traditional methods. Knowledge management is A systematic approach to acquiring, analyzing, storing, and disseminating information The information is related to products, manufacturing processes, and components.

“Use of knowledge management and quality risk management will enable a company to implement ICH Q10 effectively and successfully.” (ICH Q10)

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http://www.knoco.com/knowledge-management-video.htm

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KNOWLEDGE, DOCUMENT & RECORDS WHY CARE?

INTRODUCTION TO THE RELEVANCE OF DOCUMENT AND RECORDS MANAGEMENT IN THE CONTEXT OF QUALITY ASSURANCE

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CONTEXT & STAKES

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Thanks Google! You’re so fast… But how am I going to read all this, or make sense of all of this information ? For example :

Understand the subject of

medical devices

What are general sub topics ?
Who are the companies active

in each of these topics ?

What are the most relevant

document in my domain of interest ?

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CONTEXT & STAKES

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UNSTRUCTURED DATA PROBLEMATIC

+ =

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Ho do we retrieve unstructured information? UNSTRUCTURED DATA PROBLEMATIC

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KNOWLEDGE EXPERIENCE

Your experience and What return of investment

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Open discussion

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ROI of KM

Siemens ShareNet system

 Addition of $122 in sales for an investment of $7,8 million  ROI of 15000%

Shell International Exploration and

Production

 Annual cost of $200 million direct cost saved and additional income in 2002 for an annual cost of about $5 million  ROI

f 4000%

 Cisco Internet Business Solutions Group

 Cost reduction of $251 million; profit margin $142 million and time saving $380 million  ROI of 840%

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http://www.knoco.com/Knoco%20newsletter%20october%202012.pdf

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BQG strategy : use all innovative technology Document, Records & Content Management Ontologies & Controlled Vocabularies Text Mining

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Controlled vocabularies

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ex:animals rdf:type skos:Concept; skos:prefLabel "animals"@en; skos:altLabel "creatures"@en; skos:prefLabel "animaux"@fr; skos:altLabel "créatures"@fr. ex:animals rdf:type skos:Concept; skos:prefLabel "animals"@en; skos:narrower ex:mammals. ex:mammals rdf:type skos:Concept; skos:prefLabel "mammals"@en; skos:broader ex:animals.

Ontologies

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Terminology Extraction

Fuzzy matching

Clustering Naïve bayes classifier Similarity detection Etc.

T ext Mining

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SLIDE 31 *note : not being describe in this presentation

 With the thesaurus, the information will be organized by an automated labelling.  An algorithm scans the documents (PDF, Word, Excel, etc.) entrants in Kortex and detects the concepts of thesaurus they contain.  The documents are labeled (or tagged) with the concepts found in the scan.  The information is grouped in an index file, which is stored in a database, and which will serve downstream, in the phase of information retrieval.  The concepts of thesaurus will serve to users wishing to find documents in Kortex  The user selects one or more concepts.  KORTEX will propose a series of documents containing selected concepts, as well as the concepts usually associated with the latter.  If the results are too broad or too specific, the user can add or remove concepts at his request.  Macros preconfigured can 'shoot' the documents with combinations of concepts.

MGT SOFTWARE

Modeling target doc and content mgmt. system

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Our Thesaurus Management System

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Automated Labelling Example :

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Automated Labelling Example :

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BQG Web crawler prototype

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Knowledge Management in Solvay - KMIO

 KMIO manage the knowledge processes

in order to provide the Right Knowledge to the Right people at the Right time, which leads to higher performance by taking the right actions

r decisions. To do so it integrates, in a

systematic, way:

 people,  tools  and process/methodologies.

Note that two knowledge processes are considered:

the pyramid “from data to

knowledge”

and the “Knowledge cycle”

Knowledge Management & Innovation (KMIO)

Better Use of tools Embed Best practices Align practices & tools People Methods Tools 11/26/2015 36

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The key questions regarding the management

f our explicit knowledge in our environment

Explicit Knowledge management Work Streams CoP’s Topic teams

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Abbott Knowledge Mapping Orientation August 2nd – 3rd, 2011

Why a Knowledge inventory ?

 Some tools enable

effective mapping of the knowledge necessary to make efficient:

Product Support
Transfer of responsibility

 Knowledge that needs

to be mapped:

What knowledge do we

need for what action?

How important this

knowledge ?

Who has it ? Who needs it?
Where are the knowledge

gaps?

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Knowledge maps – some metaphors

Product knowledge map

Knowledge categories
Knowledge items
You could become sick if you do not take medicines with you in countries where

there are no pharmacies.

You could be in difficult situation at the North Pole if you only pack tee-shirts.
You can try to manage each situation but preparation and experience can help you

better understand what you need to have in your suitcase. Our current template is based on past experience but we also recognize that each knowledge map will be different just as each trip is different.

Rationale is that you can travel with few things but experience shows that you may be taking risks if you don’t adequately prepare:

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From Why to how

Designed Process (incl. QbD, DtC) Earn Money in a sustainable way Create Value Maintain Value People (incl. mind set) Tools & Technologies (incl. PAT) Share & Spread Identify Collect Codify Organise & store Build Use Capture Structure KM cycle Designed Process (incl. QbD, DtC) Earn Money in a sustainable way Create Value Maintain Value People (incl. mind set) Tools & Technologies (incl. PAT) Share & Spread Identify Collect Codify Organise & store Build Use Capture Structure Share & Spread Identify Collect Codify Organise & store Build Use Capture Structure KM cycle

To achieve one of its main goal, earn money in a sustainable way (profitable growth), the company has to create and maintain value. To achieve these objectives the company uses designed processes. These processes are supported and designed by people combining their knowledge with tools and technologies. Hence, knowledge is a real company asset that has to be efficiently managed taking into account these three critical components: people, processes and tools and technologies. To manage knowledge, a cyclic process known as the knowledge management (KM) cycle can be used. Using the KM cycle consist in applying (connecting) it to the processes it should support from a knowledge perspective. Applying the knowledge cycle to a process includes providing people with tools and technologies required to manage the knowledge inputs to achieve the process outputs 11/26/2015 40

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What do you do ?

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Content

Context Methodology In Practice

Why a company should develop and strengthen KM Different ways to enhance KM and seek for Intelligence Key steps to put in place robust and collaborative KM in your company

Definition (KM standard,

ICHQ10 & ISO)

Data & information

management issues and challenges

Open discussion on

benefit inside & outside Life cycle industry, survey etc...

KM platform and Wow,

use of ontology and innovative semantic in data treatment, external environment monitoring

Implementation in drug

development center

Let 'us know what have

you developed

KM maturity assessment
Build KM strategy and

implementation plan

Roll-out pilot
Enlarge to company

11/26/2015

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The maturity model anchors range from reactive, when knowledge management (content and context, process and

rganization, etc.) are in their infancy, to optimum, when knowledge management are in the most advanced stage of

development. When focusing on knowledge management, following topics are assessed in BQG maturity model: strategic & tactics, Organization/ competencies and governance, process & technology. 43

Collaborative knowledge management

maturity model BQG - Introduction

The tools and technical resources required to support knowledge management.

Technology

The knowledge and materials that need to be shared to ensure employees are successful in

performing their work and adding value in their jobs.

The techniques, activities and infrastructure required to systematically identify, manage, share

and apply our knowledge and intellectual capital. Process

Senior management support of knowledge management, and the oversight to ensure that KM

activities are funded, approved, integrated and meet business objectives.

Resources required are defined and trained according to systematically identify, manage, share

and apply our knowledge and intellectual capital. Organization, competencies & governance

Close alignment of knowledge management strategies with business strategies, along with visible

leadership support to reinforce the importance of KM to the success of the organization.

The behaviors, beliefs, interactions and cultural factors required to support knowledge management.

Strategic & tactics

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APQC’s Road Map to KM Results: Stages of Implementation

Stage 1 Getting Started Stage 2 Explore and Experiment Stage 3 Pilots and KM Initiatives Stage 4 Expand and Support Stage 5 Institutionalize KM

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Maturity stage & potential gains for the company

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BQG benchmarked the maturity improvement model from other industries to design an approach dedicated to the Life science industry: the Apollo Maturity

TM 11/26/2015 46

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4/29/2015 49

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