Professional Documents
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Data Strategy
Donna Burbank
Managing Director, Global Data Strategy Ltd.
Enterprise DATAVERSITY, November 4th, 2015
Donna Burbank consulting company that specializes in She has worked with dozens of Fortune
the alignment of business drivers with 500 companies worldwide in the
data-centric technology. In past roles, Americas, Europe, Asia, and Africa and
she has served in key brand strategy and speaks regularly at industry
product management roles at CA conferences. She has co-authored two
Technologies and Embarcadero books: Data Modeling for the
Technologies for several of the leading Business and Data Modeling Made
data management products in the Simple with CA ERwin Data Modeler r8.
market. She can be reached at
donna.burbank@globaldatastrategy.com
Donna is a recognized industry expert in As an active contributor to the data
Donna is based in Boulder, Colorado,
information management with over 20 management community, she is a long
USA.
years of experience in data time DAMA International member and is
management, metadata management, the President of the DAMA Rocky
and enterprise architecture. Her Mountain chapter. She was also on the
background is multi-faceted across review committee for the Object
consulting, product development, Management Group’s Information
product management, brand strategy, Management Metamodel (IMM) and a
marketing, and business leadership. member of the OMG’s Finalization
Taskforce for the Business Process
She is currently the Managing Director at Modeling Notation (BPMN).
Global Data Strategy, Ltd., an
international information management
Follow on Twitter @donnaburbank
Global Data Strategy, Ltd. 2015 2
Agenda
What we’ll cover today
• Aligning with Business Motivations & Drivers
• Components of a Global Data Strategy
• Case Studies
• International Telcom company
• International Pharmaceutical company
• Consumer Energy company
• Professional Development & Certification organization
4
How can we Transform the Business through Data?
• Optimization: Becoming a Data-Driven Company
• Making the Business More Efficient
• Better Marketing Campaigns
• Higher quality customer data, 360 view of customer, competitive info, etc.
• Better Products
• Data-Driven product development, Customer usage monitoring, etc.
• Better Customer Support
• Linking customer data with support logs, network outages, etc.
• Transformative: Becoming a Data Company
• Changing the Business Model via Data – data becomes the product
• Monetization of Information: examples across multiple industries including:
• Telcom: location information, usage & search data, etc.
• Retail: Click-stream data, purchasing patterns
• Social Media: social & family connections, purchasing trends &
recommendations, etc.
• Energy: Sensor data, consumer usage patterns, smart metering, etc.
10
DAMA DMBOK Framework
Industry Best-Practices & Guidelines
• The DAMA Data Management Body of Knowledge DATA
ARCHITECTURE
(DMBOK) is a helpful guideline to follow for industry MANAGEMENT
best practices DATA DATA
13
The Importance of “Right-Sizing” your Data Strategy
The Right Data Strategy Depends on a Number of Factors
Sentiment Analysis
(Social Media)
Family Identification
... Etc.
Alignment
• Architects network requirements for the Hadoop service (latency, • Networking architecture
Network Architect
capacity, availability, etc.) • Networking engineering
• Implements Hadoop components within the framework • Hadoop framework & components (e.g. MapReduce, Pig, Hive, etc.)
Hadoop Developer • Writes MapReduce code for analysis, data movement scripts, etc. • Linux
• Java or related programming skills
• Statistical analysis
• Builds statistical models
• Programmatic knowledge in MapReduce coding
Data Scientist • Understands business requirements
• Business knowledge of data
• Discovers new patterns & insights from data
New
Insights
Target to Start of Chemistry to Candidate selection to First Time in Human to Proof Proof of Concept to Commit File ( Approval, Life Cycle
Target identification Start of Chemistry Candidate Selection First Time in Human of Concept (Phase I & IIa) to Phase III (Phase IIb) Phase III Reimbursement & Launch) Management
Selection of technology
Biomarkers assay
development
Manufacturing process
scale-up strategy defined,
incl. waste treatment &
Initial design development for new
manufacturing plant initiated (if required)
product & manufacture
process validation batches Ongoing Change
and Risk
Discover the molecule constraints and possibilities platforms for biomarkers in recycling measures Management
BP: Finalise & transfer
predictive medicine manufacturing process, Design and preparation of packaging
Develop route to provide dose ranging & 28 day toxicology compatibility and Change and Late-stage Risk materials Distribution of
Technical supplies
Line extension
Disease Make the medicine toxicology
animal and early clinical trial
species Chronic toxicity – repeat opportunities
BP: Manufacturing campaign
Opportunity BP: 1st Molecular Design to evaluate Developability administration (long term)
for Phase III materials using Reproductive
PRECLINICAL DEVELOPMENT Dose range finding toxicology studies PHASE IV
Assessment Long-term toxicity studies
final process in final site.
Continuing animal - peri-postnatal
toxicology Formal repeat Confirm supply chain Advance predictive
Preliminary metabolism pharmacology studies PHASE IIIB
Identifying, defining and
valuing disease areas Safety Assay development
Screening toxicity
Preliminary
genotoxicity
dose toxicity studies
(medium duration) in two
species
Reproductive toxicology
studies
- fertility & embryo foetal
CLINICAL TRIALS PHASE III
(1000+ volunteers)
New Indications
medicine
Utilization of
5 - 15 year horizon Test the medicine Further comparative trials pharmacogenetics
in vivo toxicology Detailed safety CLINICAL TRIALS International large-scale multi-centre Demonstration of
High throughput screening with competitor products
selection studies pharmacology studies trials with different patient populations to therapeutic advantage,
Opportunity mapping genotoxicity PHASE II Phase IV commitments
(CVS, CNS and other demonstrate proof of safety and efficacy
Healthcare Outcomes
Trials in support of
Marketing Pharmacovigilence &
post-marketing
Perform clinical trials Genotoxicity studies to establish proof of concept - Expand disease and product knowledge - Quality of Life
Initial profile identification Medical development strategy VOLUNTEER New line extensions Surveillance
indication of efficacy & clinical - Use of predictive medicine agents in - pharmacoeconomics
Opportunities to change - differentiation STUDIES PHASE I
Pharmacokinetics: benefit prognosis and diagnosis
medical practice through Initiate long-term
Integration of research - evidence based absorption, distribution, (20+ volunteers) - Validation of surrogate markers and
use of Develop communications safety/health outcomes
investment with long-term pharmacogenetics and metabolism & elimination Safety and tolerability in Confirmation of safety pharmacogenetic tests publication strategy (e.g.
commercial goals studies Answering questions on
applied diagnostics Definition of clinical options for (ADME) healthy volunteers bioavailability & bioequivalence congresses & workshops)
progression to proof of concept Evaluation of surrogates for - highest tolerable dose of different formulations Establishment of the therapeutic submissions New Line Extension
Potential for predictive early clinical trials BP: Tissue cross reactivity, - smallest effective dose profile/product labelling claims: approvals
Knowledge transfer to
medicine in disease diagnosis
Regulatory Evaluation of potential
biomarkers for use in predictive
Presentation
repeat
assay
of data
dose tox
safetydevelopment,
studies,
review prior toPK/PD
clinical evaluation
studies
- mode of action
- dose/effect relationship
- duration of effect
Development of clinical genetics
databases
- indications
- dosage and routes of administration
- contra-indications
operating companies
Preparation for Advisory
meetings
- new formulations
- new indications
- label changes
Register the medicine medicine Evaluation of biomarkers for - side effects
- side effects
Select (genetic) - QTc drug interaction study pharmacogenetics and applied - precautionary measures Annual safety
Outline Clinical Development biomarker for diagnostics reporting to
development in
REGISTRATION WITH GOVERNMENT
Plan Pharmacokinetics in man Paediatric development plans Regulators
predictive medicine Evaluation of surrogates (or waivers)
LICENSING AUTHORITIES
Summary of product License renewal
Risk management
processes
• Motivation Model • High-Level Process Models • Conceptual Data Models • Process to Data Mapping
• Business Capability Models • Detailed Process Models • Business Glossary • Process to System & Data Mapping
• Solution Planning • Logical Data Models
• Physical Data Models
Global Data Strategy, Ltd. 2015 Architecture a stage gate for every project 26
Roles & Culture
• Business Acceptance: Clinical Scientists • Architecture team had clear direction
had data models on their office walls • “Who we are and what we do” clearly
• “Blueprints” describing their clinical articulated to the business
development • Best Practices for data management made
processes more efficient
• Governance driving architecture as a “must-
have” for each new initiative.
Traditional Business Model More Efficient Business Model New Business Model
• Usage-based billing • More efficient billing • Consumer-Driven Smart
• Issue-driven customer service • Faster customer service Metering
response • Connected Devices, IoT
• More consumer information • Proactive service monitoring
re: energy efficiency, etc. • Monetization of usage data
Metadata Management
Group related Socialize with key Conduct full impact Notify all
Definitions stakeholders assessment stakeholders
Retail
Data Quality
Drives the need for What is Data Quality?
• Email: donna.burbank@globaldatastrategy.com
• Twitter: @donnaburbank
• Website: www.globaldatastrategy.com
• Linkedin: https://www.linkedin.com/in/donnaburbank