Exploratory Phase I Clinical Trials (expCTAs) - Practical Experiences from the Industry and Regulato
Event Date/Time: Mar 27, 2009
End Date/Time: Mar 28, 2009
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 â€“ 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.
â€¢ Objectives of the Project and Justification on n â€˜expâ€™
â€¢ Pre-Clinical Programme and Issues
â€¢ Clinical Protocol
â€¢ Starting Dose Justification
â€¢ Stop Dose Justification/Experiences
â€¢ Regulatory Approach (What worked, what could be done
â€¢ Role for Biologics
â€¢ Regulatory Perspectives
â€¢ Types and Numbers of As/INDs Filed by Region
â€¢ What Industry Could Improve in the Process
â€¢ Opportunities for the Future.