SITC initiatives

SITC and three other organizations jointly organized a Task Force on immunoscoring as a new possible approach in the classification of cancer. This SITC-led project was initiated with 17 countries, 23 centers, and includes data from over 3,000 patients. Click here to read more about the SITC Immunoscore Validation Project efforts.

The WIC is a group of 18 organizations interested in promoting the research and translation of cancer immunotherapy in an effort to facilitate effective collaboration to accelerate delivery of new immunotherapies to patients with cancer throughout the world. The goal of this group is to provide a forum to facilitate the rapid development and global dissemination of cancer immunotherapies through scientific exchange. Click here to read more about the WIC.

SITC established the Cancer Immunotherapy Guidelines Task Force to develop recommendations for the clinical application of cancer immunotherapies. This SITC initiative will result in evidence-based and consensus recommendations on FDA-approved immunotherapies with special consideration on patient eligibility, toxicity assessment and management, assessment of response and treatment termination and therapy sequencing and combination strategies. Click here to learn more about the Cancer Immunotherapy Guidelines.

The CITN partnered with SITC to establish a network of top academic immunologists to conduct multicenter research on agents that boost a patient’s own immune system to fight their cancer. Click here to read an update on the CITN/SITC efforts. Click here to visit the CITN website.

The work of this initiative continues with the offering of the Symposium on Immuno-Oncology Biomarkers, as well as an expected results publication generated as follow up to the 2009 Immunologic Biomarkers Workshop. This group published a manuscript in 2010 titled “Immuno-Oncology Biomarkers 2010 and Beyond: Perspectives from the iSBTc/SITC Biomarker Task Force.” To view this manuscript, click here. To view the SITC Immune Biomarkers Task Force and Steering Committee participants, click here.

This working group sponsored by the Society was formed to address the question of whether a different approach to tumor response was more appropriate than traditional models in trials evaluating biologic agents and to investigate whether a different approach is more appropriate in trials evaluating biologic agents.

In 2008, SITC joined forces with the FDA and other major cancer organizations in evaluating the use of biomarkers in clinical trials. This Taskforce focused on the unique issues related to immunologic monitoring assays as well as novel methodologies for assessing the immune landscape in cancer.

The Society has played vital role in the Consortium’s efforts in development and regulatory qualification of these biomarkers for use in developing effective new treatments for major diseases. Dr. Ena Wang, MD served as the official liaison to the organization and represented the Society as a member of the Consortium’s Cancer Steering Committee.

SITC and Cancer Vaccine Consortium (CVC) leaders gathered to formulate the Cancer Vaccine Clinical Trials Working Group (CVCTWG). The goal of this group was to help move cancer vaccines through the clinical development process and getting them to patients. An outcomes report of this group was given at the SITC-CVC Workshop. To view this report, click here.

This educational session gathered experts from partnering organizations that focused significant effort on biomarker development.  This meeting focused on the unique issues related to immunologic monitoring assays as well as novel methodologies for assessing the immune landscape in cancer. To view presenter slides, photos, and more information about the workshop, click here.

As a member Society within FOCIS, the Society was provided with an opportunity to host this satellite program in conjunction with the FOCIS Annual Meeting. This half-day symposium focused on the application of cell therapies and in particular the IL-1 and IL-12 extended families which appear to regulate the immune response to cancer. For more information on this symposium, click here.

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 this conference, click here.

This 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. To view presentation slides and the presentation manuscript, click here.

This program was a key forum for continuing to explore and discuss best practices for worldwide biologics development. The Society developed the OBDP to meet the needs of the biological therapy community by educating physicians and researchers on the worldwide regulatory paths for biological therapy development. To view presenter slides and download reference materials, click here.

The Society participated in this meeting to discuss important topics such as "Review of Cost Recovery Regulations and Procedures for Cell Therapy Products and Medical Devices" and "Safety Testing of Embryonic Stem Cell Lines.” The ISCT North American Legal and Regulatory Affairs Committee had representation at this program as well as 10 other participating organizations from around the United States.

This Summit brought 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. Speakers focused their presentations on their country's regulatory perspectives and requirements as well as addressing audience questions. To view presenter slides, photos, and more information about the program, click here.

This working group explored clinical trial design, endpoints and response criteria from a biologics perspective. The consensus recommendations were presented at an educational session during the Society’s 23rd Annual Meeting on October 31, 2008.

This workshop had both a scientific and clinical focus and looked at the future of cell processing. The workshop was sponsored by the NHLBI (National Heart, Lung and Blood Institute) extramural program and the PACT program (Product Assistance for Cellular Therapies). Society representatives served on the planning committee of this workshop, along with representatives from AABB, ISCT, iSBTc* and the U.S. FDA/CBER. A manuscript titled “Developments in Clinical Cell Therapy” emerged from this meeting. To view this manuscript, click here.

Each year, SITC hosts an Annual Meeting, Primer, and Workshop in the fall. The Annual Meeting & Associated Programs provides a unique environment and educational forum that fosters strategic partnerships and intimate channels of discussion on current clinical trials, methodologies, and new initiatives in tumor immunology and biological therapy between basic and clinical researchers, regulatory agencies and biotech/pharmaceutical industry representatives. To access an archive of presentation slides, award winner listings, resulting papers/manuscripts, final programs, pictures, and news releases of past Annual Meetings & Associated Programs, click here.

Participants in this summit included representatives from nine domestic and international associations, all promoting research and translation in cancer immunotherapy. The goal of this meeting was to facilitate effective collaboration to accelerate delivery of new immunotherapies to the patient population. Spearheaded by Dr. Bernard Fox, PhD, the collaborating associations prepared a joint publication titled “Defining the Critical Hurdles in Cancer Immunotherapy.” To view this paper, click here.

SITC partnered with the largest clinical oncology professional organization in China, the Chinese Society of Clinical Oncology (CSCO), for a joint symposium that covered recent developments in cancer immunotherapy and agents approved in the United States. This program was an integral part of furthering SITC’s international focus and impact. The symposium was co-chaired by Dr. Shu-Kui Qin, MD, President of CSCO, Dr. Wenru Song, MD, PhD of the Chinese American Hematologist Oncologist Network (CAHON), and Dr. Bernard Fox, PhD, Immediate Past President of SITC. For more information about CSCO, click here. For more information about CAHON, click here.

This SITC-supported meeting brought together a congress of international faculty members to discuss the recent advances in melanoma molecular biology, immunology and therapy. The primary topics that were discussed were innovative approaches in prevention, diagnosis and surgical treatment, new pathways and targets in melanoma, immunotherapy and combination strategies. To see a full summary of the meeting, click here.

The SITC Primer on Tumor Immunology and Cancer Immunotherapy™ From Biology to Treatment was a half-day program that took place leading into the 2012 ASCO Annual Meeting.  This program provided a foundation for understanding core immunology principles as they relate to the clinical application of cancer immunotherapies.  The cancer immunotherapy primer provided a framework for community oncologists working directly with patients, and other oncology health care practitioners who wished to enhance their understanding of recent advances and the biologic basis of tumor immunology and immunotherapy. To view presenter slides and more information about the SITC cancer immunotherapy primer, click here.

For the second year in a row, SITC partnered with the largest clinical oncology professional organization in China, the Chinese Society of Clinical Oncology (CSCO), and the Chinese American Hematologist Oncologist Network (CAHON), for a joint symposium that covers cell therapy regulations in the United States and Europe, exciting new immunotherapies with clinical impact and immunoscore as a predictive biomarker of response. The symposium will be co-chaired by Dr. Shu-Kui Qin, MD, President of CSCO, Dr. Wenru Song, MD, PhD of the Chinese American Hematologist Oncologist Network (CAHON), and Dr. Bernard Fox, PhD, Immediate Past President of SITC. For more information about CSCO, click here. For more information about CAHON, click here.

At the request of the International Society for Cellular Therapy (ISCT), the FDA CBER (Center for Biologics Evaluation & Research) committed to biannual liaison meetings. The meetings act as a forum to discuss important issues of mutual interest, exchange information and allow the cell therapy industry to inform CBER of specific concerns, discuss events which have occurred for products of interest, update the FDA on recent scientific and administrative developments in the cell therapy community, and obtain information on how the Center operates. David Stroncek, MD of the NIH will represent SITC at this meeting.

This meeting will bring together experts in the field to discuss molecular advances, biomarkers, combination therapies, the tumor microenvironment of melanoma, colorectal cancer and the immunoscore prognostic method. For more information on the Melanoma Bridge and World Immunoscoring Meeting, click here.