January 26-27, 2004 � Renaissance Washington, D.C.
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2004 Agenda > Track 5 � Pharmaceutical and Biotech CEO/CFO Summit
 
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- M O N D A Y , J A N U A R Y 2 6 , 2 0 0 4 -
 
2:45

FDA Update in Election Year 2004

  • Major potential changes in regulatory compliance
  • Regulations in manufacturing, clinical and marketing and compliance
  • Medicare and Medicaid – Public purchaser demands and working with State and Federal contracts

Mark McClellan, MD, Commissioner, Food and Drug Administration

4:15

Strategies to Increase Output Productivity in Research Labs

  • Reasons for decrease in productivity
  • Organizational structural approaches
  • Chemical biology – A knowledge platform
  • Pre-competitive consortia

Frank Douglas, Executive Vice President for Drug Innovation and Approval, and Chief Scientific Officer, Aventis Pharmaceuticals

5:00

New Business Strategies and Models to Compete in an Era of Consumerism in Healthcare

  • Analysis of changing market conditions for utilization and access to drugs
  • Building the case for the value of pharmaceuticals and determining whether insurers will pay
  • How consumerism will impact Medicare and Medicaid populations

Moderator: Scott Hensley, Staff Reporter, The Wall Street Journal
Henry A. McKinnell, Jr., Ph.D., Chairman and CEO, Pfizer Inc

 
- T U E S D A Y , J A N U A R Y 2 7 , 2 0 0 4 -
9:15

Updates on FDA Efforts to Improve the Efficiency and
Effectiveness of Drug Development

  • New FDA initiatives to improve drug development and
    agency review processes
  • Pharmacogenomics — Guidance addressing key regulatory questions
  • Interagency Oncology Task Force activities to facilitate cancer
    drug development

Theresa M. Mullin, PhD, Assistant Commissioner, Food and Drug Administration
John Jenkins, MD, Director, Office of New Drugs, Food and Drug Administration

10:00

Evolving Customer Relationships – Partnership Strategies with PBMs

  • Maintaining high consumer satisfaction while keeping prescription drug costs down
  • Engaging consumers in their prescription benefit through more choice and incentives
  • Meeting the challenge of making new, high cost biotech drugs affordable
  • Making the use of prescription drugs safer

Sarah S. Harrison, Vice President, Customer Strategy Integration, AstraZeneca Pharmaceuticals; 2002 Healthcare Businesswoman of the Year

11:15

Challenges and Opportunities in R&D and Marketing of Targeted Therapies

  • Examples and discussion of targeted therapies
  • Difficulties of recruiting patients for trials
  • Issues of providing access to patients in the early stages and the often unrecognized need of marketing these kinds of therapies

David Epstein, President, Novartis Oncology

   
 
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