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Untitled Document
 
Therapeutic Vaccines: Why Traditional Surrogates of Efficacy Fail
Course # W43

Webinar Course
May 18, 2010
12:00 PM to 1:30 PM
  EST
   Registration Rates:
Regular Registration Fee   $300 Register Online | Register by Fax
ACS/Gov Registration Fee   $ Register Online | Register by Fax
Group Site Registration Fee  
$ Register by Fax

Cancellation Fee: $
 
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Course Description:

Day 1: 12:00 PM - 1:30 PM

It is widely believed that the first therapeutic vaccine will be approved by the FDA by May 1, 2010. There is still much controversy about the explanation of clinical trial results showing improved survival without improved time to progression or objective responses. This webinar will focus on findings from recent randomized controlled trials clinical trials of therapeutic vaccines in cancer patients and the implications these findings have for the design and interpretation of clinical trials of immunotherapeutics in general and therapeutic vaccines in particular. The presentation will last approximately 1 hour, with ample time for questions and discussion.

Who Should Attend:
Clinical research associates, regulatory affairs professionals, product managers, statisticians, clinical data managers, marketing research staff, and anyone working in oncologic drug development or moving to this area will gain knowledge from attending this course.
Educational Objectives:

•Comprehend the differences between kinetics of response to a conventional therapy and a therapeutic vaccine
•Discuss the outcomes of recent randomized controlled studies of therapeutic vaccines in prostate cancer and lymphoma.
•Explain the potential explanations for improved survival without improved time to progression for therapeutic vaccines
•Describe the role of tumor burden may play in responses to therapeutic vaccines

Key Topics:

•Therapeutic Vaccines
•Kinetics of clinical response following immunotherapy
•Clinical trial design

Course Director(s):
James L Gulley, MD, PhD, FACP
Director, Clinical Trials Group, Laboratory of Tumor Immunology & Biology
National Cancer Institute
Contact Course Manager:
Course Manager
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