Transcript Presentation Title Goes Here

SAS and the Life Sciences:
New Solutions and Capabilities
Dave Handelsman
Global Strategist / Clinical Research and Development
Worldwide Strategy
Copyright © 2005, SAS Institute Inc. All rights reserved.
Trends in Life Sciences
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Changing R&D Process
Changing Regulatory Environment
Changing Business Environment
Rise in Number of Mergers & Acquisitions
Growth in e-submissions
Decreasing Top Line Revenue
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Trends in Life Sciences
 Changing R&D Process
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Rising costs and length of R&D process
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Emphasis on focused drugs, personalized medicine
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Biological process (versus a chemical process)
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More collaborative development; more outsourcing;
more inlicensing
 Changing Regulatory Environment
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FDA likely to get more conservative regarding
approvals
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FDA likely to require more research before approvals
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Trends in Life Sciences
 Changing Business Environment
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Decrease in public trust and shareholder confidence
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Requirements for transparency, open data sources,
price control
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Strategic shift away from developing drugs for chronic
illnesses
 Rise in Number of Mergers & Acquisitions
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Weak financing and patents nearing expiration
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Expand product portfolios and cut losses
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Trends in Life Sciences
 Growth in e-submissions
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New rule requires e-submission of product labeling
data.
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Technology and systems have recognized role in
improving time to market
 Decreasing Top Line Revenue
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Focus on maintaining a healthy product pipeline
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Improve sales force effectiveness
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5
Trends in Life Sciences
Rise in Mergers & Acquisitions
"During the first six months of 2004, 315 biotech and
life sciences acquisitions occurred…. Weak
financing paired with patents nearing expiration have
driven companies to look for quick ways to expand
their product portfolios and cut losses.”
Life Sciences Industry Watch, 15 September 2004
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Trends in Life Sciences
Growth in e-submissions
"FDA may require that drug companies to submit
clinical trial data for new drug applications using an
electronic format called the Study Data Tabulation
Model (SDTM), according to FDA chief Lester
Crawford.“
FDA Week, 3 September 2004
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Trends in Life Sciences
Changing Regulatory Environment
"FDA Code of Federal Regulations Title 21 Part 11
(21 CFR 11), covering electronic records and
electronic signatures, supplemented these rules with
additional guidance evolved in response to the
recognized role technology and systems play in
improving time to market for medicines and medical
devices.“
IDC, December 2004
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Trends in Life Sciences
Growth in e-submissions
"This new initiative builds on more than a decade of
FDA efforts to facilitate electronic submission of data
and documents… At first, e-filing was voluntary. But
that changed last December, when a new rule
required electronic submission of product labeling
data.”
Life Sciences Executive, 1 August 2004
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Trends in Life Sciences
Decreasing Top Line Revenue
"The current year is unlikely to mark a return of
robust health for the drug sector… estimates
showing sales rising 9%. But it's hardly a stellar
performance: The industry hadn't posted single-digit
growth since 1994.“
Businessweek, 10 January 2005
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Issues & Initiatives in Life Sciences
 Bring Safe & Effective Drugs to Market More
Quickly and at Lower Cost
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Innovations in R&D: Therapies and Processes
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Improvements in Manufacturing
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Increase Sales & Marketing Effectiveness
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FDA’s Critical Path Initiative
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Leverage the Information Explosion
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Issues & Initiatives in Life Sciences
Leverage the Information Explosion
What are the most
pressing technology
issues facing life
sciences?
Better data
integration tools
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Development of
data standards
Data storage
and archiving
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entions
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# Mentions
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Issues & Initiatives in Life Sciences
 Restore Consumer/Investor Confidence and
Perception
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Industry “Black Eye”
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Risk Management
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Generating Better Risk/Benefits Assessment and
Testing
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Role of Compliance
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Clinical Trial Registries
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Issues & Initiatives in Life Sciences
 Optimize Product Portfolio to Patient Population
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Right Drug to the Right Patient
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Knowing the Patient Population
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Differentiating Products
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Increasing Competition
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Addressing the Issues & Initiatives
 Life Sciences is Evolving with Many Business
Process Areas Playing Key Roles
 You Must Effectively Manage…..
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Customers
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Operations
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Research & Development
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Risk & Compliance
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SAS’ History in the Life Sciences
 29 year partnership with life sciences
companies
 >600 life sciences customers
• Top 50 Pharmaceuticals
• Top 15 Devices & Diagnostics
• Top 10 Biotechs
 Dedicated industry user groups and advisory
committees
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What else is the life sciences industries
using SAS for?
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Automated safety reporting
Pharmaceutical SAS Users
Group 2005: > 90
Producing patient profiles
presentations
Building clinical data management systems
Developing EDC systems
Range-checking an entire database
Implementing CDISC models
Finding the right level of tolerance for clinical data
acceptance
 Randomization
 SUGI pharmaceutical track (66 presentations –
exceeded only by the beginner track)
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SAS Industry Framework
Life Sciences
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SAS Industry Framework
Life Sciences
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SAS Industry Framework
Life Sciences
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SAS Industry Framework
Life Sciences
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Customer Intelligence
 Campaign Management and Marketing
Optimization
 Segmentation & Profiling
 Sales Force Effectiveness
 Market Analysis
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SAS Marketing Optimization
 Planning and prioritization of all outbound
customer communication
 Maximizing economic outcomes
 Balancing capacity to deliver and likeliness to
respond.
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SAS Industry Framework
Life Sciences
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Operational Intelligence
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Planning & Financial Reporting
Scorecarding & KPIs
IT Management
Patent Analysis
Quality
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SAS Innovation Analysis
 Analyze global patent data using concepts rather
than simple keywords
• Automatically find uncited documents that keyword
search systems fail to identify
• Review hundreds of patents at a time
 Provides patent intelligence to power business
decisions in:
• Merger & Acquisition
• Patent Portfolio management and Patent Licensing
• R&D
• Patent enforcement
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SAS Innovation Analysis
 R&D business issues
• Are there patents that put my new research projects at
risk?
• Should I buy the technology or can I produce it inhouse?
• Where are the holes in the patent landscape?
• Can I license the patent rights I need?
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SAS IT Management Solutions
 Use IT organizational intelligence to:
• Optimize operational resource management processes
• Enhance existing IT investments
• Provide an enterprise view of IT infrastructure
• Aid in effective planning of resources
• Accurately analyze IT costs
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SAS Industry Framework
Life Sciences
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Risk & Compliance Intelligence
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Corporate Compliance & Governance
Pharmacovigilance
GXPs
Validation
Pre-Approval Safety Assessment
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Validation
 Utilizing SAS services to monitor information
about SAS defects and issues
 Evaluating known defects and maintenance
fixes; determining how they may affect you and
their associated risks
 Applying and testing SAS maintenance fixes
 Managing the effect of other software/hardware
changes to SAS
 Migrating to current releases of SAS
 Using the IQ/OQ tools to perform ongoing
testing.
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SAS Industry Framework
Life Sciences
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Research & Development
Intelligence
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Compliance & Standards
Clinical Trial Data Management & Analysis
e-submissions
Genomics Research
Safety
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SAS Scientific Discovery
Analysis management for scientific research
Data
prep
Expressionidentify significant genes
Biomarkersfind associations
Analyses
SAS
Microarray
SAS
Proteomics
Genotypingassess variability
SAS Genetic
Marker
SAS Research Data Management
SAS Research
Data Management
Client
Java Application
JMP
Server
SAS Technologies (WA)
 Centralized analytical resource enables improved
productivity
• Extendable, modular, customizable
 Capabilities geared for business and technical users
 Flexibility and breadth ideal for molecular discovery and
biomarker research
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CDISC
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XML Engine ODM Native mode (SAS 9)
XML Engine and XMLMap Extensions
PROC CDISC
New base SAS formats/informats for ISO-8601
SAS CDISC Viewer
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CDISC
 Proc CDISC
• ODM read/write capability (Production)
• SDTM content validation (New: March 2005)
• define.xml (Currently under development)
• Lab, SEND, ADaM (pending)
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SAS Drug Development
 Enables regulatory compliance for data
extraction, transformation and statistical analysis
processes.
 Provides a centralized, controlled, repository for
source data, derived data, analyses, reports,
programs, logs, templates, documents and other
research content.
 Integrates with existing systems to provide
information management and compliance across
the research value chain.
 Allows non-technical users to interactively
explore research data as appropriate.
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SAS Drug Development
 Easily extended to work with other industry
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technologies
Actively supporting open standards
Integrated analysis
Integrated exploration
Integrated compliance
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SAS Industry Framework
Life Sciences
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SAS Presents…
Life Sciences Presentations
Title
A Regulatory Compliant Process for
Developing SAS-Based Reports
R&D Connections: SAS Software
for the Life Sciences
Maintaining a Validated SAS®
System
Building onto SAS® Scientific
Discovery Solutions: New Modules
and SAS®9
Investigational Data in XML
according to the CDISC Operational
Data Model
SAS Corporate Compliance – A
Case Study for Developing
Reusable J2EE Applications
Copyright © 2005, SAS Institute Inc. All rights reserved.
Time
Presenter(s)
Monday
10:30
Monday
2:00
Monday
3:30
Tuesday
8:00
Chuck Reap
Tuesday
1:30
Ed Helton
Andrew Fagan
Sue Carroll, Patricia
Halley, Ed Helton
Susan Flood
Wednesday Zhiyong Li
10:00
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SAS Presents…
Demonstration Stations
 SAS Scientific Discovery
 SAS Drug Development
 CDISC
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SAS and the Life Sciences
 Capabilities
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Integrated and comprehensive platform
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Advanced analytics -- unmatched in the industry
 Customer Focus
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Commitment to innovation
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Customer-centric business model
 Company & People
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Financial strength and stability
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Global reach & local presence
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Industry knowledge and expertise
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