| Description |
Exploratory approaches for first-in-human studies have been available through regulatory guidance in Europe and the USA for the last few years. These approaches have been employed usually with objectives to select a drug candidate for development or test a biochemical hypothesis using various endpoints designed to make a clear go/no go decision. The purpose of this workshop is to review at a very detailed level from both a regulatory and industrial perspective how these approaches have worked – successes, what worked, what did not work - focusing on the applied science and the regulatory process. The expectations are that issues/opportunities can be identified to help improve the process moving forward for small molecules as well as biologics. For those not directly involved with expCTAs, it will be a learning experience on the opportunities offered with this regulatory approach.
Highlights
• Objectives of the Project and Justification on n ‘exp’
Approach
• Pre-Clinical Programme and Issues
• Clinical Protocol
• Starting Dose Justification
• Stop Dose Justification/Experiences
• Regulatory Approach (What worked, what could be done
differently)
• Role for Biologics
• Regulatory Perspectives
• Types and Numbers of As/INDs Filed by Region
• What Industry Could Improve in the Process
• Opportunities for the Future.
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