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

 Changing R&D Process

 Changing Regulatory Environment
 Changing Business Environment
 Rise in Number of Mergers & Acquisitions
 Growth in e-submissions
 Decreasing Top Line Revenue

Copyright © 2005, SAS Institute Inc. All rights reserved. 2

 Trends in Life Sciences

 Changing R&D Process

• Rising costs and length of R&D process
• Emphasis on focused drugs, personalized medicine
• Biological process (versus a chemical process)
• More collaborative development; more outsourcing;
more inlicensing
 Changing Regulatory Environment
• FDA likely to get more conservative regarding
approvals
• FDA likely to require more research before approvals

Copyright © 2005, SAS Institute Inc. All rights reserved. 3

 Trends in Life Sciences

 Changing Business Environment

• Decrease in public trust and shareholder confidence
• Requirements for transparency, open data sources,
price control
• Strategic shift away from developing drugs for chronic
illnesses
 Rise in Number of Mergers & Acquisitions
• Weak financing and patents nearing expiration
• Expand product portfolios and cut losses

Copyright © 2005, SAS Institute Inc. All rights reserved. 4

 Trends in Life Sciences

 Growth in e-submissions
• New rule requires e-submission of product labeling
data.
• Technology and systems have recognized role in
improving time to market
 Decreasing Top Line Revenue
• Focus on maintaining a healthy product pipeline
• Improve sales force effectiveness

Copyright © 2005, SAS Institute Inc. All rights reserved. 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

Copyright © 2005, SAS Institute Inc. All rights reserved. 6

 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

Copyright © 2005, SAS Institute Inc. All rights reserved. 7

 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
Copyright © 2005, SAS Institute Inc. All rights reserved. 8
 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

Copyright © 2005, SAS Institute Inc. All rights reserved. 9

 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

Copyright © 2005, SAS Institute Inc. All rights reserved. 10

 Issues & Initiatives in Life
Sciences
 Bring Safe & Effective Drugs to Market More
Quickly and at Lower Cost
• Innovations in R&D: Therapies and Processes
• Improvements in Manufacturing
• Increase Sales & Marketing Effectiveness
• FDA’s Critical Path Initiative
• Leverage the Information Explosion

Copyright © 2005, SAS Institute Inc. All rights reserved.Version 1.4 11

 Issues & Initiatives in Life
Sciences
Leverage the Information Explosion
Better data
integration
What are the most 35
tools
pressing technology 30

issues facing life 25 Developme

sciences? 20
nt of data
standardsData
15 storage
10 and
archiving
5

entions #Mentions

Copyright © 2005, SAS Institute Inc. All rights reserved.Version 1.4 12

 Issues & Initiatives in Life
Sciences
 Restore Consumer/Investor Confidence and
Perception
• Industry “Black Eye”
• Risk Management
• Generating Better Risk/Benefits Assessment and
Testing
• Role of Compliance
• Clinical Trial Registries

Copyright © 2005, SAS Institute Inc. All rights reserved.Version 1.4 13

 Issues & Initiatives in Life
Sciences
 Optimize Product Portfolio to Patient Population
• Right Drug to the Right Patient
• Knowing the Patient Population
• Differentiating Products
• Increasing Competition

Copyright © 2005, SAS Institute Inc. All rights reserved.Version 1.4 14

 Addressing the Issues &
Initiatives
 Life Sciences is Evolving with Many Business
Process Areas Playing Key Roles
 You Must Effectively Manage…..
• Customers
• Operations
• Research & Development
• Risk & Compliance

Copyright © 2005, SAS Institute Inc. All rights reserved.Version 1.4 15

 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

Copyright © 2005, SAS Institute Inc. All rights reserved.Version 1.4 16

 What else is the life sciences
industries using SAS for?
 Automated safety reporting Pharmaceutical SAS
 Producing patient profiles Users Group 2005: >
90 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)
Copyright © 2005, SAS Institute Inc. All rights reserved.Version 1.4 17
 SAS Industry Framework
Life Sciences

Copyright © 2005, SAS Institute Inc. All rights reserved.Version 1.4 18

 SAS Industry Framework
Life Sciences

Copyright © 2005, SAS Institute Inc. All rights reserved.Version 1.4 19

 SAS Industry Framework
Life Sciences

Copyright © 2005, SAS Institute Inc. All rights reserved.Version 1.4 20

 SAS Industry Framework
Life Sciences

Copyright © 2005, SAS Institute Inc. All rights reserved. 21

 Customer Intelligence

 Campaign Management and Marketing

Optimization
 Segmentation & Profiling
 Sales Force Effectiveness
 Market Analysis

Copyright © 2005, SAS Institute Inc. All rights reserved.Version 1.4 22

 SAS Marketing Optimization

 Planning and prioritization of all outbound

customer communication
 Maximizing economic outcomes
 Balancing capacity to deliver and likeliness to
respond.

Copyright © 2005, SAS Institute Inc. All rights reserved.Version 1.4 23

 SAS Industry Framework
Life Sciences

Copyright © 2005, SAS Institute Inc. All rights reserved.Version 1.4 24

 Operational Intelligence

 Planning & Financial Reporting

 Scorecarding & KPIs
 IT Management
 Patent Analysis
 Quality

Copyright © 2005, SAS Institute Inc. All rights reserved.Version 1.4 25

 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

Copyright © 2005, SAS Institute Inc. All rights reserved.Version 1.4 26

 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 in-
house?
• Where are the holes in the patent landscape?
• Can I license the patent rights I need?

Copyright © 2005, SAS Institute Inc. All rights reserved.Version 1.4 27

 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

Copyright © 2005, SAS Institute Inc. All rights reserved.Version 1.4 28

 SAS Industry Framework
Life Sciences

Copyright © 2005, SAS Institute Inc. All rights reserved. 29

 Risk & Compliance Intelligence

 Corporate Compliance & Governance

 Pharmacovigilance
 GXPs
 Validation
 Pre-Approval Safety Assessment

Copyright © 2005, SAS Institute Inc. All rights reserved.Version 1.4 30

 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.
Copyright © 2005, SAS Institute Inc. All rights reserved.Version 1.4 31
 SAS Industry Framework
Life Sciences

Copyright © 2005, SAS Institute Inc. All rights reserved. 32

 Research & Development
Intelligence
 Compliance & Standards
 Clinical Trial Data Management & Analysis
 e-submissions
 Genomics Research
 Safety

Copyright © 2005, SAS Institute Inc. All rights reserved.Version 1.4 33

 SAS Scientific Discovery
Analysis management for scientific
research
Data
Expression- prep Biomarkers- Genotyping-
dentify significant genes assess variability
find associations
Analyses
SAS
Microarray SAS SAS Genetic
Proteomics Marker

SAS Research Data Management

SAS Research
Client Data Management
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
Copyright © 2005, SAS Institute Inc. All rights reserved. 34
 CDISC

 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

Copyright © 2005, SAS Institute Inc. All rights reserved.Version 1.4 35

 CDISC

 Proc CDISC
• ODM read/write capability (Production)
• SDTM content validation (New: March 2005)
• define.xml (Currently under development)
• Lab, SEND, ADaM (pending)

Copyright © 2005, SAS Institute Inc. All rights reserved.Version 1.4 36

 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.
Copyright © 2005, SAS Institute Inc. All rights reserved.Version 1.4 37
 SAS Drug Development
 Easily extended to work with other industry
technologies
 Actively supporting open standards
 Integrated analysis
 Integrated exploration
 Integrated compliance

Copyright © 2005, SAS Institute Inc. All rights reserved.Version 1.4 38

 SAS Industry Framework
Life Sciences

Copyright © 2005, SAS Institute Inc. All rights reserved.Version 1.4 39

 SAS Presents…
Life Sciences Presentations
Title Time Presenter(s)
A Regulatory Compliant Process for Monday Chuck Reap
Developing SAS-Based Reports 10:30
R&D Connections: SAS Software Monday Andrew Fagan
for the Life Sciences 2:00
Maintaining a Validated SAS® Monday Sue Carroll, Patricia
System 3:30 Halley, Ed Helton
Building onto SAS® Scientific Tuesday Susan Flood
Discovery Solutions: New Modules 8:00
and SAS®9
Investigational Data in XML Tuesday Ed Helton
according to the CDISC Operational 1:30
Data Model
SAS Corporate Compliance – A Wednesday Zhiyong Li
Case Study for Developing 10:00
Reusable J2EE Applications
Copyright © 2005, SAS Institute Inc. All rights reserved. 40
 SAS Presents…
Demonstration Stations

 SAS Scientific Discovery

 SAS Drug Development
 CDISC

Copyright © 2005, SAS Institute Inc. All rights reserved. 41

 SAS and the Life Sciences

 Capabilities
• Integrated and comprehensive platform
• Advanced analytics -- unmatched in the industry
 Customer Focus
• Commitment to innovation
• Customer-centric business model
 Company & People
• Financial strength and stability
• Global reach & local presence
• Industry knowledge and expertise

Copyright © 2005, SAS Institute Inc. All rights reserved. 42

Copyright © 2005, SAS Institute Inc. All rights reserved. 43