TL30: First-Time-In-Human Trials - Everything but the kitchen sink?
*Jennifer LS Gauvin, GlaxoSmithKline Sharon Cornell Murray, GlaxoSmithKline
With increasing pressure to do more with less, companies are looking to answer as many questions with their First Time in Human (FTIH) trials as possible. Traditionally, FTIH trials are used to examine the safety of the compound and evaluate PK data in order select an appropriate dose. In oncology trials, they also identify the MTD. However, more and more, FTIH may be multi-part, include cohorts of healthy volunteers and patients, be used to select an appropriate biomarker identifying a subset of the population that may respond well to treatment, give an early evaluation of food effect, confirm the mechanism of action, and even provide a proof of concept. In this roundtable session, we will discuss experiences with complicated FTIH trials and the advantages and disadvantages of the multi-part FTIH strategy.
April 30 - May 22, 2013
Invited Abstract Submission Open
June 4, 2013
Online Registration Opens
August 9 - August 23, 2013
Invited Abstract Editing
August 23, 2013
Short Course materials due from Instructors
August 26, 2013
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC