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iSBTc Community Update
iSBTc-FDA Taskforce on Immunotherapy BiomarkersThe 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
Samir Khleif, MD Topics Addressed:
For information on this and other iSBTc initiatives, please visit the iSBTc Initiatives page. iSBTc Clinical Endpoint and Response Criteria Working GroupA 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. Participants representing academia, NCI, the FDA, and industry will explore clinical trial design, endpoints and response criteria from a biologics perspective 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 Jeffrey Schlom, PhD For more information on this and other iSBTc initiatives, please visit the iSBTc Initiatives page.
iSBTc Summit to Feature Regulatory Agency Thought-Leaders From Around the World Providing Global Perspectives on Regulatory Considerations for the Development of Oncology BiologicsiSBTc is excited to announce a new addition to our Fall 2008 educational program lineup. The Global Regulatory Summit will be a half-day program on October 29, 2008 in conjunction with our 2008 Annual Meeting, Primer and Workshop at the Westin Horton Plaza San Diego in San Diego, CA. The purpose of the Global Regulatory Summit is to provide the audience with key information from regulatory agencies from various regions of the world in oncology biologics product development. The attendees of this program will learn about and participate in the discussion of a variety of specific regulatory considerations and requirements. The presentations will address those requirements and considerations especially pertaining to product, pre-clinical and clinical trial issues for oncology biologics products. For more information, please click here. iSBTc Oncology Biologics Development PrimeriSBTc created the Oncology Biologics Development Primer (OBDP) to meet the needs of the biological therapy community by educating physicians and researchers on the worldwide regulatory paths for biological therapy development. Through facilitating collaborative interactions between regulators, preclinical scientists, clinical investigators and industry, the OBDP helped ensure that active, innovative new therapies are rapidly and appropriately moved into clinical testing. The program was held over two full days on February 28 and 29, 2008 in Gaithersburg, MD. It was a key forum to explore and discuss best practices for worldwide biologics development. Through the expertise of the invited speakers, panel members and course attendees, this rigorous and challenging program curriculum facilitated understanding, open discussion and exploration of the development issues surrounding biologic agents for cancer. Click here for more information. iSBTc Co-Sponsors Seminar at Biotherapy Development Association MeetingThe International Society for Biological Therapy of Cancer (iSBTc) recently co-sponsored a session entitled, "Improving the Therapeutic Efficacy of Cancer Immunotherapy" in collaboration with the Biotherapy Development Association (BDA) at the 9th International Symposium- Biological Therapy of Cancer (BTOC) on March 12-15, 2008 in Munich, Germany. The session 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 initiative 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. Presentations in this session included representatives from the both the BDA and the iSBTc and included: Combining Different Modalities in Immunotherapy of Cancer Click here for more information. DAMP Symposium to be Held August 30-September 2, 2008Save the Date! The University of Pittsburgh Medical Center will be holding the Damage Associated Molecular Pattern Molecules (DAMPs), Endokines and Alarmins Symposium from August 30-September 2, 2008 in Pittsburgh, PA.
Cancer Vaccine Consortium Joins Cancer Research InstituteThe iSBTc would like to congratulate the Cancer Vaccine Collaborative, Ludwig Institute for Cancer Research and the Cancer Vaccine Consortium as they have recently formed a joint initiative administered under the Cancer Research Institute (CRI). The new CRI Cancer Vaccine Consortium will be led by Lloyd J. Old, MD, who will serve as the Director of the CRI Cancer Vaccine Consortium and will chair the Executive Committee. Axel Hoos, MD, PhD, will also co-chair the Executive Committee of the new initiative. The iSBTc looks forward to future opportunities for collaborations with the CRI/CVC and other stakeholders in the field as we all endeavor to advance the field of cancer biologics and immunotherapy. |
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