1. “The Special Compliance Challenges of Biopharmaceutical Enterprises”
The Fifth Annual Pharmaceutical Regulatory and Compliance Congress and Best Practices Forum November 15, 2004
“The Special Compliance Challenges of Biopharmaceutical Enterprises”
Liz Lewis,
Associate General Counsel, Commercial
Millennium Pharmaceuticals, Inc.

2. Challenge 1: Focus on Innovation
Do the impossible/change the world
Innovators of life saving technology
Commitment to doing the right thing
Reward “out of the box” thinking/acting
Disdain of rigidity and inflexibility
Resistance to process and formality

3. Challenge 2: “Rip Van Winkle Syndrome”
Pre-marketed products “bubble”
Outdated information
Lack of understanding of legal and regulatory environments
Getting new challenges
Increased responsibility
Broader role
Making a difference

4. Challenge 3: Resources Funding Personnel External pressures
Internal pressures
Trade-offs (pipeline, personnel)
Personnel
Head count limitations
Flexible & fluid job descriptions; Everyone is a “Jack of all trades”

5. Meeting the Challenges
Capitalize on culture of making the world a better place
Recognize and address resistance to process
Flexibility
Matrix approach
Become a strategic partner: know your employees and your products