Initiatives

Since its inception in 1984, the International Society for Biological Therapy (iSBTc) has implemented several high-caliber scientific meetings with a focus on basic, clinical and translational aspects of the biological therapy of cancer. iSBTc has since come to be known as the premier venue for scientific exchange by investigators in the oncology biologics community, including members from academia, industry and regulatory agencies from the U.S. and abroad. The Society has now expanded its efforts to promote international scientific exchange by investigators through several new initiatives and collaborative efforts.

The iSBTc aims to facilitate rapid dissemination of information regarding tumor immunology and the biological therapy of cancer and to expedite the translation of both basic and applied research to the clinical setting. In an effort to achieve these goals, iSBTc is continuing its efforts to collaborate with other leading domestic and international organizations with a strong interest in biologic approaches for cancer treatment.

iSBTc initiatives are projects that have been developed beyond the annual educational programs regularly held by the Society. These initiatives are designed to promote the Society's mission of improving cancer patient outcomes by advancing the development and application of biological therapy, and include directed initiatives that are focused on issues of major importance to the field.



2008 iSBTc Initiatives/Collaborations

  • iSBTc-FDA Taskforce on Immunotherapy Biomarkers
    The iSBTc is joining the US Food and Drug Administration (FDA) and other major cancer organizations
    in evaluating the use of biomarkers in clinical trials.

    The iSBTc taskforce will focus on the unique issues related to immunologic monitoring assays as well as novel methodologies for assessing the immune landscape in cancer. Standardization of assays, assay validation, and appropriate potency assays will be the subject of one subcommittee while the other will assess the clinical utility of promising novel technologies and make recommendations on how to incorporate these into the clinical arena.

    Steering Committee

    Lisa Butterfield, PhD
    University of Pittsburgh

    Mary (Nora) Disis, MD
    University of Washington

    Bernard Fox, PhD
    Earle A. Chiles Research Institute

    Samir Khleif, MD
    National Cancer Institute

    Francesco Marincola, MD
    National Institutes of Health

    Jon Wigginton, MD
    Merck & Co. Inc.

    Topics Addressed:

    • Standardization of assays
    • Assay validation
    • Potency assays

    • Promising novel technologies
    • Incorporating technologies in clinical trials

  • iSBTc Clinical Endpoint and Response Criteria Working Group
    A working group sponsored by iSBTc has been formed to address the question of whether a different approach to tumor response is more appropriate than traditional models in trials evaluating biologic agents.

    It is widely noted within the biologic therapy field that some patients appear to have a different course following treatment with biologic or immunologic based therapies, ranging from delayed responses to dramatic regression after subsequent chemotherapy. Recognizing that biologic agents may have more subtle or complex effects on malignancies, the iSBTc has formed the Clinical Endpoint and Response Criteria Working Group to investigate whether a different approach to tumor response is more appropriate in trials evaluating biologic agents.

    The working group is exploring clinical trial design, endpoints and response criteria from a biologics perspective. Participants representing academia, NCI, the FDA, and industry will address these questions in a scientific and data driven fashion. Future plans include presentation of consensus recommendations at the iSBTc 23rd Annual Meeting in November, 2008.

    Organizers

    Thomas Davis, MD
    Celldex Therapeutics

    Jeffrey Schlom, PhD
    National Cancer Institute

    Participants

    Michael B. Atkins, MD
    Beth Israel Deaconess Medical Center

    Ashok Batra, MD
    Food and Drug Administration

    Bernard Fox, PhD
    Earle A. Chiles Research Institute

    Thomas Gajewski, MD, PhD
    University of Chicago

    Rachel Humphrey, MD, PhD
    Bristol-Myers Squibb

    Raj Puri, MD, PhD
    Food and Drug Administration

    Vernon Sondak, MD
    H. Lee Moffitt Cancer Center

    Jeffrey Weber, MD, PhD
    H. Lee Moffitt Cancer Center

    Louis Weiner, MD
    Georgetown University Medical Center

    Jon Wigginton, MD
    Merck & Co.

    James Zwiebel, MD
    National Cancer Institute

  • Global Regulatory Considerations in the Development of Oncology Biologics
    Product Development for the Treatment of Cancer
    To be held October 29, 2008 in conjunction with the iSBTc 23rd Annual Meeting & Associated Programs.

    The Global Regulatory Summit will bring together the knowledge and insight of thought-leaders at regulatory agencies from around the world to give a global perspective on regulatory considerations in the development of oncology biologics products for the treatment of cancer.

    The Summit is designed to be a highly-interactive program complete with speakers from various regions of the world and a panel discussion involving not only the program speakers, but also invited experts from additional regulatory and related agencies. Speakers will focus their presentations on their country's regulatory perspectives and requirements as well as address audience questions.

    Program Organizers:

    Raj K. Puri, MD, PhD
    U.S. Food and Drug Administration, CBER

    Ulrich Kalinke, PhD
    Paul-Ehrlich-Institut, Germany

    For more information on registration, faculty and a program outline, please visit the Global Regulatory web site.

  • iSBTc and Biotherapy Development Association (BDA)
    Held March 12-15, 2008 at the 9th International Symposium- Biological Therapy of Cancer (BTOC) in Munich.

    The joint educational session entitled, "Improving the Therapeutic Efficacy of Cancer Immunotherapy," was co-chaired by Drs. Heinz Zwierzina (Chairman, BDA) and Jon Wigginton (President, iSBTc) as a part of the BTOC program jointly sponsored by the BDA, the European Society of Medical Oncology (ESMO) and the U.S. National Cancer Institute (NCI). This collaboration represents an important component of expanded efforts by iSBTc to promote international scientific exchange and collaboration by investigators with a focus on tumor immunology and the biological therapy of cancer in the U.S., Europe and Asia-Pacific regions.



Past iSBTc Initiatives/Collaborations

  • iSBTc and Clinical Immunology Society (CIS)
    Held June 7, 2007 at the FOCIS Annual Meeting.

    This joint satellite symposia, "Damage Associated Molecular Pattern Molecules (DAMPs)" was developed to introduce the emergent understanding of the DAMPs in inflammation and clinical immunology. This satellite collaboration brought together domestic and international rheumatologists, geriatricians, infectious disease clinicians and cardiologists with an interest in the inflammatory aspects of atherosclerosis, oncologists, and basic scientists interested in the clinical issues related to inflammation and the role of damage associated molecular pattern molecules (DAMPs).

    For the program schedule, abstracts and pictures, please visit the DAMPs Satellite Symposia page.

  • iSBTc and the Cancer Vaccine Consortium (CVC)
    Held November 10, 2005 in conjunction with the iSBTc 20th Annual Meeting & Associated Programs.

    The purpose of this group was to help move cancer vaccines through the clinical development process more efficiently and expeditiously, accelerating their development and general patient access. Ultimately, the program co-chairs of this collaborative workshop provided a comprehensive scientific summary to aid in developing future guidelines for cancer vaccine clinical development supporting regulatory authorities with the aim of standardizing and governing the drug development and approval process of cancer vaccines.

    For more information on program faculty, presentation slides and manuscript, please visit the iSBTc Workshop page.

  • iSBTc Consensus Conference on Patient Specific Therapy
    Held November 2, 2003 in conjunction with the iSBTc 18th Annual Meeting & Associated Programs.

    Representatives from the National Cancer Institute (NCI) and the Food and Drug Administration (FDA), as well as industry leaders gathered at this conference to discuss key issues related to personalized medicine and to establish a better understanding of the problems and opportunities associated with Patient Specific Therapy in the context of current FDA regulations and drug development costs.

    For more information on program faculty and schedule, please visit the Consensus Conference web site.

  • iSBTc at FOCIS
    Held May 15, 2003 at the FOCIS Annual Meeting in Paris.

    As a member Society within FOCIS, iSBTc was provided the opportunity to hold the satellite symposia entitled, "Cellular Immunology and the Immunotherapy of Cancer V." With this membership, iSBTc is sharing in the mission of improving human health through immunology by fostering interdisciplinary approaches to both understand and treat immune-based diseases.

    For more information on program faculty and schedule, please visit the iSBTc Symposia page.