Drug / Device Development

Drug development begins with an idea and moves through the entire research process beginning with basic research, moving into translational (preclinical) studies, and finally resulting in a clinical trial. Then the drug must navigate through the regulatory process. This section provides a big picture snapshot about this process, including information about the economics and the various stakeholders.

In this section we will discuss:

• Review of Bench-to-Bedside Research
• Stages of Drug Development Discovery
• The Regulatory Process
• Economics of Drug Development
• Stakeholders
• Featured Stakeholders: Patient Advocacy Groups
• CISN Summary of Drug Development Challenges