Paper FC11

Critical Success Factors in Pharmaceutical Innovation
Thomas H. Burger, Eli Lilly and Company, Indianapolis, IN
Michael S. Lajiness, Eli Lilly and Company, Indianapolis, IN
ABSTRACT
Technology is one of the most important factors that will influence which pharmaceutical companies prevail in the information age. Effective, efficient and timely implementation of tools that speed information delivery is a primary driver of competitive advantage. However, difficulty often arises in determining how to adopt tools and integrate them into the business. Interruptions to the business and failures in software acquisition are frequently costly, in terms of money, resources, and lost opportunities necessitating an innovation-based approach. We discuss strategy and considerations essential to matching SAS technologies with key business drivers at the corporate scale. In addition, we will discuss our vision for future software opportunities that would significantly enhance pharmaceutical research. Below is an outline summary of this paper. The final paper will be distributed at the presentation.

INTRODUCTION
Pharmaceutical companies are in an ever-increasing contention for innovation, revenue and market share.
Competitive advantage in this environment requires the ability to exploit information vertically and horizontally throughout the organization so that sound, timely decisions can be made. While current SAS software tools are integrated into various points in the discovery, development and sales of new therapeutic agents, there is currently no integrated platform to service informatics needs across the whole corporation.
We present a brief review of some of the SAS tools that exist today and the impact they have in pharmaceutical use.
In addition, a vision will be discussed for what kinds of integrated solutions could be provided to optimize the drug discovery and development process so that pharmaceutical companies can provide better, more cost effective solutions to unmet medical needs.

UNDERSTAND THE BUSINESS
This section will discuss the importance of a holistic view of the business and the considerations necessary to innovate. Key issues in pharmaceutical research:
Strategy
Technological efficiencies
R&D
•Pharmacogenomics
•Predictive Modelling (In silico)
Critical Success Factors:
Identify drivers
Recognize needs
•Assess context
•Prioritize importance
•Determine magnitude
Understand Infrastructure
Evaluate constraints
Project needs
Envision solution
Research candidates
Build the case
•Decision Makers
•Practitioners
Involve stakeholders
Secure advocates
Broadcast concept

1

INTEGRATE ENABLING TECHNOLOGIES
This section will describe the pharma process with a schematic of various current solutions/tools at appropriate points in the pharmaceutical development lifecycle and the impacts they have. See figure 1. We will discuss:
SAS Scientific Discovery:
SAS Research Data Management
Data accessibility/management
Legacy system Integration
Regulatory Compliance
SAS MicroArray Solution
Target Identification/Lead Optimization
Standardizing Microarray Processes
Data Sharing
Analysis
Visualization
Integration with JMP-nice feature
SAS/Genetics
Relationship identification
SAS Drug Development:
Data Integration
Warehousing, Analysis, Reporting
21 CFR 11 compliance
SAS CRM for Pharma
Campaign Design
Targeting Channels
Customer Identification
SAS Intellivisor for Pharma
Optimize DTC marketing
Marketing effectiveness
SAS Patent Portfolio Management for Pharma
Regulatory Compliance
Validate Financial Reports
Manage Acquisition Risk
Manage Litigation Risk
Identify R&D Opportunities

INNOVATION
This section will begin with a discussion of what defines innovation, how it is incorporated into the business and describes some critical success factors for tool adoption.
Companies often strive to acquire the latest tools and technologies but if