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

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.

2

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.

3

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.

4

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.

5

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.

6

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.

7

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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8

"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

Trends in Life Sciences

Changing Regulatory Environment


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9

"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

Trends in Life Sciences

Growth in e
-
submissions


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

10

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.

11

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

Version 1.4

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12

Issues & Initiatives in Life Sciences

Leverage the Information Explosion

Version 1.4

0
5
10
15
20
25
30
35
# Mentions
0
5
10
15
20
25
# Mentions
Better data
integration tools

Development of
data standards

Data storage
and archiving

What are the most
pressing technology
issues facing life
sciences?


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

13

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

Version 1.4

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14

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

Version 1.4

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15

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


Version 1.4

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16

SAS’ History in the Life Sciences

Version 1.4


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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17

What else is the life sciences industries
using SAS for?

Version 1.4


Automated safety reporting


Producing patient profiles


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)

Pharmaceutical SAS Users
Group 2005: > 90
presentations

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

18

SAS Industry Framework

Life Sciences

Version 1.4

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19

SAS Industry Framework

Life Sciences

Version 1.4

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

20

SAS Industry Framework

Life Sciences

Version 1.4

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

21

SAS Industry Framework

Life Sciences

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22

Customer Intelligence


Campaign Management and Marketing
Optimization


Segmentation & Profiling


Sales Force Effectiveness


Market Analysis

Version 1.4

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23

SAS Marketing Optimization


Planning and prioritization of all outbound
customer communication


Maximizing economic outcomes


Balancing capacity to deliver and likeliness to
respond.

Version 1.4

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

24

SAS Industry Framework

Life Sciences

Version 1.4

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25

Operational Intelligence


Planning & Financial Reporting


Scorecarding & KPIs


IT Management


Patent Analysis


Quality

Version 1.4

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26

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

Version 1.4

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27

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?


Version 1.4

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

28

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


Version 1.4

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

29

SAS Industry Framework

Life Sciences

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30

Risk & Compliance Intelligence


Corporate Compliance & Governance


Pharmacovigilance


GXPs


Validation


Pre
-
Approval Safety Assessment

Version 1.4

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31

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.

Version 1.4

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

32

SAS Industry Framework

Life Sciences

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33

Research & Development

Intelligence


Compliance & Standards


Clinical Trial Data Management & Analysis


e
-
submissions


Genomics Research


Safety

Version 1.4

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34


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

SAS Research Data Management

SAS

Microarray



Analyses

Data

prep

Server

Client

SAS Technologies (WA)

Java Application

JMP

SAS

Proteomics

SAS Genetic

Marker

SAS Research Data Management

Expression
-

identify significant genes

Genotyping
-


assess variability

Biomarkers
-


find associations

SAS Scientific Discovery

Analysis management for scientific research

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35

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

Version 1.4

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36

CDISC


Proc CDISC


ODM read/write capability (Production)


SDTM content validation (New: March 2005)


define.xml (Currently under development)


Lab, SEND, ADaM (pending)

Version 1.4

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37

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.

Version 1.4

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38

SAS Drug Development


Easily extended to work with other industry
technologies


Actively supporting open standards


Integrated analysis


Integrated exploration


Integrated compliance

Version 1.4

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39

SAS Industry Framework

Life Sciences

Version 1.4

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40

SAS Presents…

Life Sciences Presentations

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

Title

Time

Presenter(s)

A Regulatory Compliant Process for
Developing SAS
-
Based Reports

Monday

10:30

Chuck Reap

R&D Connections: SAS Software
for the Life Sciences

Monday

2:00

Andrew Fagan

Maintaining a Validated SAS®
System

Monday
3:30

Sue Carroll, Patricia
Halley, Ed Helton

Building onto SAS® Scientific
Discovery Solutions: New Modules
and SAS®9

Tuesday
8:00


Susan Flood

Investigational Data in XML
according to the CDISC Operational
Data Model

Tuesday

1:30

Ed Helton

SAS Corporate Compliance


A
Case Study for Developing
Reusable J2EE Applications

Wednesday

10:00

Zhiyong Li

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41

SAS Presents…

Demonstration Stations

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


SAS Scientific Discovery


SAS Drug Development


CDISC



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42

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.

43

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

43