New Drug Product Development and Life Cycle Management

Drug development is an incredibly complex and risky endeavor, one that even experienced organizations will fail at more often than they succeed. This introductory course will help you understand how companies structure their efforts and utilize their resources to improve the odds of successful development and minimize the risks associated with shepherding a new drug candidate through the development process.

At the end of this course, you will be able to explain the phases, major work streams, key players, and interrelationships necessary to develop new drugs in the US and Europe and to expand the life cycle of in-line products. Interactive exercises will take you through the many decisions faced by an organization as they progress a new drug candidate through development and beyond.

• Drug development process
• Candidate identification/preclinical testing
• Phase 1
• Phase 2
• Phase 3 and regulatory review
• Phase 4 and life cycle management
  

At the conclusion of this activity, participants should be able to:

• Explain how a desired drug product label dictates the components of the drug development plan
• Identify the five major work streams that must be completed in any drug development program and describe their interactions
• Describe the key functional area players and when they contribute to the six phases of drug development
• Discuss the life cycle management process and how product line extensions are developed
• Recognize the major differences between drug, biologic, and drug device development
• Discuss the differences in the drug development process between the US and Europe
• List where to find additional information on biologic and drug device development