sas life science
TRANSCRIPT
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
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
Copyright © 2005, SAS Institute Inc. All rights reserved. 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
Copyright © 2005, SAS Institute Inc. All rights reserved. 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
Copyright © 2005, SAS Institute Inc. All rights reserved. 12
Issues & Initiatives in Life SciencesLeverage the Information Explosion
Version 1.4
0
5
10
15
20
25
30
35
# 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
Copyright © 2005, SAS Institute Inc. All rights reserved. 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
Copyright © 2005, SAS Institute Inc. All rights reserved. 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
Copyright © 2005, SAS Institute Inc. All rights reserved. 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
Copyright © 2005, SAS Institute Inc. All rights reserved. 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 FrameworkLife Sciences
Version 1.4
Copyright © 2005, SAS Institute Inc. All rights reserved. 19
SAS Industry FrameworkLife Sciences
Version 1.4
Copyright © 2005, SAS Institute Inc. All rights reserved. 20
SAS Industry FrameworkLife Sciences
Version 1.4
Copyright © 2005, SAS Institute Inc. All rights reserved. 21
SAS Industry FrameworkLife Sciences
Copyright © 2005, SAS Institute Inc. All rights reserved. 22
Customer Intelligence
Campaign Management and Marketing Optimization
Segmentation & Profiling
Sales Force Effectiveness
Market Analysis
Version 1.4
Copyright © 2005, SAS Institute Inc. All rights reserved. 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 FrameworkLife Sciences
Version 1.4
Copyright © 2005, SAS Institute Inc. All rights reserved. 25
Operational Intelligence
Planning & Financial Reporting
Scorecarding & KPIs
IT Management
Patent Analysis
Quality
Version 1.4
Copyright © 2005, SAS Institute Inc. All rights reserved. 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
Copyright © 2005, SAS Institute Inc. All rights reserved. 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 FrameworkLife Sciences
Copyright © 2005, SAS Institute Inc. All rights reserved. 30
Risk & Compliance Intelligence
Corporate Compliance & Governance
Pharmacovigilance
GXPs
Validation
Pre-Approval Safety Assessment
Version 1.4
Copyright © 2005, SAS Institute Inc. All rights reserved. 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 FrameworkLife Sciences
Copyright © 2005, SAS Institute Inc. All rights reserved. 33
Research & DevelopmentIntelligence
Compliance & Standards
Clinical Trial Data Management & Analysis
e-submissions
Genomics Research
Safety
Version 1.4
Copyright © 2005, SAS Institute Inc. All rights reserved. 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 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
Copyright © 2005, SAS Institute Inc. All rights reserved. 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
Copyright © 2005, SAS Institute Inc. All rights reserved. 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
Copyright © 2005, SAS Institute Inc. All rights reserved. 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
Copyright © 2005, SAS Institute Inc. All rights reserved. 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
Copyright © 2005, SAS Institute Inc. All rights reserved. 39
SAS Industry FrameworkLife Sciences
Version 1.4
Copyright © 2005, SAS Institute Inc. All rights reserved. 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
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
Copyright © 2005, SAS Institute Inc. All rights reserved. 41
SAS Presents…Demonstration Stations
Copyright © 2005, SAS Institute Inc. All rights reserved.
SAS Scientific Discovery
SAS Drug Development
CDISC
Copyright © 2005, SAS Institute Inc. All rights reserved. 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. 43Copyright © 2005, SAS Institute Inc. All rights reserved. 43