2. NCI Workshop on Phase ‘0’ Trials: Rationale and Goals  Reduce the FDA’s Exploratory IND to practice: New process for investigators interested in early phase cancer therapeutics. Designed for pilot studies from Academia and Pharma. ¬When appropriate? When not? ¬How to apply it? Who can help you? ¬What are pitfalls? What has been learned? ¬Can it speed up the development timeline? GOAL: Provide primer on a new mechanism for testing novel therapeutic and imaging molecules

3. NCI Workshop on Phase ‘0’ Trials: Format  Introductory lectures and overviews in the morning. Coffee and Lunch on your own.  “Hands-On” panels and “Think-Tank” question and answer sessions in the afternoon: Will provide you with question cards that will be picked up after the morning session so that they can be addressed after lunch. Please identify yourself when speaking. Informal: Focus on providing information that will assist you in the conduct of very early phase cancer clinical trials

5. The Next Speaker is: Dr. David Jacobson-Kram