FDA-NCI Workshop on Therapeutic Cancer Vaccines

FDA-NCI Workshop on Therapeutic Cancer Vaccines
Considerations for Early Phase Clinical Trials Based on Lessons Learned from Phase III
October 27, 2009

Objective and Scope:

FDA and NCI are holding a public workshop intended to facilitate the development of safe and effective cancer vaccine by optimizing early phase clinical trials based on lessons learned from completed Phase III studies.

In this workshop, the role of randomized Phase II clinical trials and adaptive study designs will be discussed. Furthermore, the workshop will emphasize the importance of monitoring immune responses in early phase trials in order to optimize immunological therapies and incorporating pretreatment biomarkers in early phase clinical studies that could predict the effect of specific treatment for patients (predictive biomarkers) in order to identify a population likely to benefit.

Location:

Lister Hill Center Auditorium
(On NIH Campus)
Bldg 38A
8600 Rockville Pike
Bethesda, MD 20894

Registration:

Register for the workshop:
http://web.ncifcrf.gov/events/cancervaccine/default.asp

Contact:
Bernadette Kawaley
Center for Biologics Evaluation and Research
Food and Drug Administration
(301) 827-2000
CBERTraining@fda.hhs.gov (Subject line: Therapeutic Cancer Vaccines Workshop)