Sas Life Science

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

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Trends in Life Sciences  Changing R&D Process •

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 •

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 •

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 •

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 •

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 •

Focus on maintaining a healthy product pipeline

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Improve sales force effectiveness

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

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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 •

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?

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Better data integration tools

30 25 20 15 10 5

Developme nt of data Data standards storage and archiving

0

entions

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Issues & Initiatives in Life Sciences  Restore Consumer/Investor Confidence and Perception •

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 •

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….. •

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?       

Automated safety reporting

Pharmaceutical SAS Users Group 2005: > Producing patient profiles 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)

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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     

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

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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     

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     

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 Expressiondentify significant genes Analyses

GenotypingBiomarkersassess variability find associations

SAS Microarray

SAS Proteomics

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     

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    

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 40

SAS Presents…

Demonstration Stations

 SAS Scientific Discovery  SAS Drug Development  CDISC

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SAS and the Life Sciences  Capabilities •

Integrated and comprehensive platform

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Advanced analytics -- unmatched in the industry

 Customer Focus •

Commitment to innovation

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Customer-centric business model

 Company & People •

Financial strength and stability

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Global reach & local presence

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Industry knowledge and expertise

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