fda-nci workshop on therapeutic cancer vaccine

I trust that Rogers et al will be attending this next week.

The transcripts/presentations should be mandatory reading for anyone interested in PRR.

Rgds

Prof

http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm175885.htm


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:

Masur Auditorium
Building 10 Clinical Center
National Institutes of Health
Bethesda, Maryland 20892

Workshops, Meetings & Conferences (Biologics)
FDA's Center for Biologics Evaluation and Research (CBER) sponsors or co-sponsors meetings, conferences and workshops about various biologics in order to educate the public and seek the opinion of interested parties. Minutes, transcripts, summaries and/or presentations for CBER sponsored or co-sponsored meetings and workshops are made available as soon after the meeting as possible.