Presentation & Discussion: Integrate and accelerate Knowledge Management to seek Intelligence across the life science industry Delphine Delaunay & Marc-Antoine Perrissin-Fabert 26 November 2015 11/26/2015 1
Content Context Methodology In Practice Key steps to put in Why a company should Different ways to place robust and develop and strengthen enhance KM and seek collaborative KM in KM for Intelligence your company Definition (KM standard, KM platform and Wow, KM maturity assessment • • • ICHQ10 & ISO) use of ontology and innovative semantic in • Build KM strategy and • Data & information data treatment, external implementation plan management issues and environment monitoring challenges Roll-out pilot • • Implementation in drug • Open discussion on • Enlarge to company development center benefit inside & outside Life cycle industry, • Let 'us know what have survey etc... you developed 11/26/2015 2
Content Context Methodology In Practice Key steps to put in Why a company should Different ways to place robust and develop and strengthen enhance KM and seek collaborative KM in KM for Intelligence your company Definition (KM standard, KM platform and Wow, KM maturity assessment • • • ICHQ10 & ISO) use of ontology and innovative semantic in • Build KM strategy and • Data & information data treatment, external implementation plan management issues and environment monitoring challenges Roll-out pilot • • Implementation in drug • Open discussion on • Enlarge to company development center benefit inside & outside Life cycle industry, • Let 'us know what have survey etc... you developed 11/26/2015 3
WHY A COMPANY SHOULD DEVELOP AND STRENGTHEN KM 11/26/2015 4
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) 11/26/2015 5
What is knowledge ? KNOWLKEDGE IN CONTEXT 11/26/2015 6
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 or 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 11/26/2015 7
What is knowledge ? QUALITY EXPECTATION Clause 7.1.6. Knowledge "Determine the knowledge necessary for the operation of its processes and to achieve conformity of products and services. "This knowledge shall be maintained and made available to the extent necessary. "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. "NOTE 1: Organizational knowledge is knowledge specific to the organization; it is generally gained by experience. It is information that is used and shared to achieve the organization's objectives. "NOTE 2: Organizational knowledge can be based on: 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 of improvements in processes, products and services); b) External Sources (e.g., standards, academia, conferences, gathering knowledge from customers or external providers). ISO 9001:2015 11/26/2015 8
Knowledge Management Strategy and Processes Collaborative knowledge Sources of knowledge include, but are management allows employees to not limited to : more easily collaborate across prior knowledge (public domain or internally geographical and organizational documented) boundaries and help companies pharmaceutical development studies respond more efficiently to new and technology transfer activities changing market trends. process validation studies over the product Collaborative networks as well, give lifecycle companies the potential to drive manufacturing experience processes much faster than innovation traditional methods. continual improvement change management activities. “Use of knowledge management and quality Knowledge risk management will enable a company to management is implement ICH Q10 effectively and successfully.” (ICH Q10) A systematic approach to acquiring, analyzing, storing, and disseminating information The information is related to products, manufacturing processes, and components. 11/26/2015 9
http://www.knoco.com/knowledge-management-video.htm 11/26/2015 10
KNOWLEDGE, DOCUMENT & RECORDS WHY CARE? INTRODUCTION TO THE RELEVANCE OF DOCUMENT AND RECORDS MANAGEMENT IN THE CONTEXT OF QUALITY ASSURANCE 11/26/2015 11
CONTEXT & STAKES 12 11/26/2015
13 11/26/2015
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 ? 11/26/2015 14
CONTEXT & STAKES 11/26/2015 15
UNSTRUCTURED DATA PROBLEMATIC + = 11/26/2015 16
UNSTRUCTURED DATA PROBLEMATIC Ho do we retrieve unstructured information? 11/26/2015 17
KNOWLEDGE EXPERIENCE Your experience and What return of investment 11/26/2015 18
Open discussion 11/26/2015 19
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 of 4000% Cisco Internet Business Solutions Group Cost reduction of $251 million; profit margin $142 million and time saving $380 million ROI of 840% http://www.knoco.com/Knoco%20newsletter%20october%202012.pdf 11/26/2015 20
Other Success Stories Hoffmann-Roche Saving of about $1 million per day Hewlett-Packard Reduction of average call times by two- thirds cost per call has fallen by 50 percent Chevron Corporation Initial saving of $150 million yearly saving of $20 million http://www.tlainc.com/articl69.htm 11/26/2015 21
KM potential – CEO views Top line impact ◦ Consultants ◦ Advisors ◦ Public Affairs Bottom line ◦ High tech ◦ Industry ◦ … 11/26/2015 22
Knowledge is also a skill - learning Learning Faster Than Your Competition Is periods of the Only discontinuous or disruptive Sustainable change the duration of a business model Competitive Advantage the duration of a person’s career ... create change… or be changed ... 11/26/2015 23
Content Context Methodology In Practice Key steps to put in Why a company should Different ways to place robust and develop and strengthen enhance KM and seek collaborative KM in KM for Intelligence your company Definition (KM standard, KM platform and Wow, KM maturity assessment • • • ICHQ10 & ISO) use of ontology and innovative semantic in • Build KM strategy and • Data & information data treatment, external implementation plan management issues and environment monitoring challenges Roll-out pilot • • Implementation in drug • Open discussion on • Enlarge to company development center benefit inside & outside Life cycle industry, • Let 'us know what have survey etc... you developed 11/26/2015 24
What we mean when we talk about Knowledge Management BQG vision & strategy Decision & Learning INTELLIGENCE A r e a s c o v e r e d b y t h e Your m a p p i n g o f Knowledg dge Interpret y o u r c r i t i c a l Management i n f o r m a t i o n KNOWLEDGE strat ategy y transf sform rms s Technology hard d & soft Synthesise Regulatory DATA A into and share INFORMATION Market INTELLIGE IGENCE NCE to suppo port rt Product effe fect ctive ive Filter and …. decisio ision n organize I nternal/External making and Hard & Soft DATA learn rning ing curve’s KM Process, Organization and Technology 11/26/2015 25
What we mean when we talk about Knowledge Management Focus on technology 11/26/2015 26
TECHNOLOGICAL SOLUTIONS + Ontologies & Controlled Vocabularies Document, Records & Content + Management Text Mining BQG strategy : use all innovative technology 11/26/2015 27
Controlled vocabularies 11/26/2015 28
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