Sas Life Science

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

SAS and the Life Sciences:New Solutions and CapabilitiesDave HandelsmanGlobal Strategist / Clinical Research and DevelopmentWorldwide 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



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



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



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


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


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


"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


"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


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


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

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Issues & Initiatives in Life SciencesLeverage the Information Explosion

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Better data integration tools

Development of data standards

Data storage and archiving

What are the most pressing technology issues facing 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

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Optimize Product Portfolio to Patient Population• Right Drug to the Right Patient

• Knowing the Patient Population

• Differentiating Products

• 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…..• Customers

• Operations

• Research & Development

• Risk & Compliance

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SAS’ History in the Life Sciences

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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


What else is the life sciences industries using SAS for?

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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


SAS Industry FrameworkLife 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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Operational Intelligence

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 in-house?

• 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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Risk & Compliance Intelligence

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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Research & DevelopmentIntelligence

Compliance & Standards

Clinical Trial Data Management & Analysis

e-submissions

Genomics Research

Safety

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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 SAS MicroarrayMicroarray

AnalysesAnalyses

Data Data prepprep

ServerClient

SAS Technologies (WA)Java Application JMP

SASSASProteomicsProteomics

SAS GeneticSAS GeneticMarkerMarker

SAS Research Data ManagementSAS Research Data Management

Expression-identify significant genes

Genotyping- assess variability

Biomarkers- find associations

SAS Scientific DiscoveryAnalysis management for scientific research


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

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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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Easily extended to work with other industry technologies

Actively supporting open standards Integrated analysis Integrated exploration Integrated compliance

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SAS Presents…Life Sciences Presentations


Title Time Presenter(s)A Regulatory Compliant Process for Developing SAS-Based Reports

Monday10:30

Chuck Reap

R&D Connections: SAS Software for the Life Sciences

Monday2:00

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

Tuesday1:30

Ed Helton

SAS Corporate Compliance – A Case Study for Developing Reusable J2EE Applications

Wednesday10:00

Zhiyong Li


SAS Presents…Demonstration Stations


SAS Scientific Discovery


CDISC


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

Sas Life Science

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