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FDA-NCI Workshop on Therapeutic Cancer Vaccines
Considerations for Early Phase Clinical Trials Based on Leasons Learned from Phase III

October 27, 2009
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General Information
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FDA-NCI Workshop on Therapeutic Cancer Vaccines


October 27, 2009

NEW LOCATION:
Masur Auditorium
Bldg. 10 -- NIH Campus

SAVE THE DATE!

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.



Using the information from clinical trial phase 3 to better design phase 2
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.


ONLINE REGISTRATION (choose one)
Note: When registering, please indicate whether you need any special accommodations. Seating is limited and registration is on a first-come, first served basis. The workshop will also be available via live videocast and podcast through the NIH videocasting service. Updated information about the workshop and live videocasting will become available to registered participants.

  • PARTICIPATION IN-PERSON

  • PARTICIPATION VIA LIVE VIDEOCASTING & PODCASTING

  • Please visit the registration page to select which to attend.


    ADDITIONAL INFORMATION

  • RECOMMENDED ACCOMMODATIONS

  • NIH VISITORS AND SECURITY

  • CAMPUS MAP AND PARKING

  • CONTACT

  • SPECIAL ACCOMMODATIONS


  • ORGANIZING COMMITTEE

    Virginia Axline (NCI)
    Ashok Batra, MD (FDA/CBER)
    Peter Bross, MD (FDA/CBER)
    Stephen Creekmore, PhD MD (NCI)
    Syed Husain, PhD (FDA/CBER)
    Bernadette Kawaley (FDA/CBER)
    Ke Liu, MD, PhD (FDA/CDER)
    Steven S. Oh, PhD (FDA/CBER)
    Raj Puri, MD PhD (FDA/CBER)
    Howard Streicher, MD (NCI)
    Celia M. Witten, PhD MD (FDA/CBER)

    PROGRAM COMMITTEE

    Peter Bross, MD (FDA/CBER) - Co-chair
    Stephen Creekmore, PhD MD (NCI)
    Bernard Fox, PhD (Earle A. Chiles Research Institute) - iSBTc Representative
    Thomas F. Gajewski, MD PhD (University of Chicago) - ASCO Representative
    Joseph Gootenberg, MD (FDA/CDER)
    Syed Husain, PhD (FDA/CBER) - Co-chair
    Hyam Levitsky, MD (Johns Hopkins University) - AACR Representative
    Ke Liu, MD, PhD (FDA/CDER)
    Steven S. Oh, PhD (FDA/CBER) - Co-chair
    Howard Streicher, MD (NCI)
    Boguang Zhen, PhD (FDA/CBER)

    For conference related questions please contact Karen Kochersberger
    301.228.4027

    Location


    NEW LOCATION:
    Masur Auditorium
    (Bld. 10 -- NIH CAMPUS)

    Masur Auditorium




    Sponsors


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    NCI logo
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    National Cancer Institute National Institutes of Health Human and Health Services