NCI Workshop on Phase ‘0’ Trials:

Rationale and Goals Reduce the FDA’s Exploratory IND Reduce the FDA’s Exploratory IND

to practice: New process for to practice: New process for investigators interested in early investigators interested in early phase cancer therapeutics. phase cancer therapeutics. Designed for pilot studies from Designed for pilot studies from Academia and Pharma.Academia and Pharma. When appropriate? When not?When appropriate? When not? How to apply it? Who can help you?How to apply it? Who can help you? What are pitfalls? What has been What are pitfalls? What has been

learned?learned? Can it speed up the development Can it speed up the development

timeline?timeline?

GOAL: Provide primer on a new GOAL: Provide primer on a new mechanism for testing novel mechanism for testing novel therapeutic and imaging moleculestherapeutic and imaging molecules

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

The Next Speaker is:

Dr. David Jacobson-Kram