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“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.

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“The Special Compliance Challenges of Biopharmaceutical Enterprises”

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  1. The Fifth Annual Pharmaceutical Regulatory and Compliance Congress and Best Practices ForumNovember 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 Challenge 2:“Rip Van Winkle Syndrome” • Pre-marketed products “bubble” • Outdated information • Lack of understanding of legal and regulatory environments • Getting new challenges • Increased responsibility • Broader role • Making a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 • 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

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