Initiatives and Collaborations
iSBTc Initiatives
Ongoing iSBTc Collaborations
Since its inception in 1984, the International Society for Biological Therapy (iSBTc) has implemented numerous 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.
iSBTc INITIATIVES
2010 iSBTc Task Force on Immunotherapy Biomarkers
2010-present
The work of the 2009 iSBTc-FDA Task Force on Immunotherapy Biomarkers continues in 2010 with the offering of the Symposium on Immuno-Oncology Biomarkers, 2010 and Beyond as well as an expected results publication generated as follow up to the 2009 Immunologic Biomarkers Workshop.
2010 Symposium on Immuno-Oncology Biomarkers, 2010 and Beyond: Perspectives from the iSBTc Biomarker Task Force
September 30, 2010
NIH Campus, Masur Auditorium
Bethesda, MD
2009 iSBTc-FDA Taskforce on Immunotherapy Biomarkers
2008-2009
In 2008, iSBTc joined the U.S. Food and Drug Administration (FDA) and other major cancer organizations in evaluating the use of biomarkers in clinical trials. The iSBTc-FDA Taskforce focused 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 were the subjects of one subcommittee while the other assessed the clinical utility of promising novel technologies and made recommendations on how to incorporate these into the clinical arena. The interim results of this taskforce were reported at the "iSBTc-FDA-NCI Workshop on Prognostic and Predictive Immunologic Biomarkers in Cancer" held in conjunction with the iSBTc 24th Annual Meeting on October 29, 2009 in Washington, D.C.
In December 2008, a summary of the Taskforce's efforts entitled "A Systematic Approach to Biomarker Discovery; Preamble to the iSBTc-FDA taskforce on Immunotherapy Biomarkers" was published in the Journal of Translational Medicine (JTM). This foreword provided an overview of the taskforce and invited feedback from readers that could be incorporated in the discussions and in the final document. To view this article, click here for the pdf document or visit the JTM website to view the open access article and provide commentary.
iSBTc-FDA-NCI Workshop on Prognostic and Predictive Immunologic Biomarkers in Cancer
October 28, 2009 part of iSBTc's 24th Annual Meeting & Associated Programs – Washington, D.C.
This iSBTc educational session gathered experts from multiple venues who focused significant effort in this area including the United States Food and Drug Administration (FDA); the National Cancer Institute (NCI); the National Institutes of Health (NIH); members from industry; and partnering organizations such as the Biotherapy Development Association (BDA), Association for Immunotherapy of Cancer (CIMT), Cancer Vaccine Consortium (CVC) a program of the Cancer Research Institute (CRI), Nordic Center for Development of Antitumour Vaccines (NCV-network), the Italian Network for Tumor Biotherapy (NIBIT), Society for Fundamental Cancer Immunology (SFCI), as well as academic experts in the field of immunologic biomarker development and standardization. The workshop was unique in that it provided for interactive exchange in addtion to didactic lectures. Attendees participated in lively discussion and shared data on biomarker development. The result of this workshop was the articulation and definition of the "state of the art" in assay and cellular product development and standardization.
iSBTc Clinical Endpoint and Response Criteria Working Group
2008-present
A working group sponsored by iSBTc 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. 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, iSBTc 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.
"Endpoints, Response Criteria for Clinical Trial Design" Session
October 31, 2008 in conjunction with iSBTc's 23rd Annual Meeting & Associated Programs
The working group explored clinical trial design, endpoints and response criteria from a biologics perspective. Participants representing academia, NCI, the FDA, and industry addressed these questions in a scientific and data driven fashion. The consensus recommendations were presented at an educational session during the iSBTc 23rd Annual Meeting on October 31, 2008. A document outlining these findings will be published soon. Click here to see the slides from the Annual Meeting Session.
iSBTc Symposium at 2nd European Congress of Immunology
September 16, 2009 - Berlin, Germany
This session titled "Tumor immunology: Mobilizing cellular immunity against cancer" held in conjunction with the highly lauded 2nd European Congress of Immunology was chaired by iSBTc Members Carmen Scheibenbogen, MD (Berlin, Germany) and Licia Rivoltini, MD (Milano, Italy). The Congress drew over 3500 abstracts from all parts of the world and will gave iSBTc exposure among many immunology leaders. The iSBTc symposium featured talks by international leaders on a variety of topics relevant to the cancer immunotherapy. For more information, click here.
NHLBI PACT Workshop - Converging Concepts in Cell Therapy
April 23-24, 2009 – Bethesda, MD
This one and a half day workshop was held in Bethesda, MD at the Natcher Auditorium on the NIH campus. The agenda had both a scientific and clinical focus and also looked at the future of cell processing. The workshop was sponsored by the NHLBI extramural program and the PACT program (Product Assistance for Cellular Therapies). The planning committee of this workshop was comprised of representatives from the AABB, ISCT, ISBTc and the U.S. FDA/CBER. A manuscript summarizing the highlights of the meeting is planned for publishing. To find out more information about the program, click here.
iSBTc Global Regulatory Summit - "Global Regulatory Considerations in the Development of Oncology Biologics Product Development for the Treatment of Cancer"
October 29, 2008 in conjunction with the iSBTc 23rd Annual Meeting & Associated Programs
The Global Regulatory 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. The Summit was 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 focused their presentations on their country's regulatory perspectives and requirements as well as addressing audience questions. For more information this program, including viewing the presenter slides and photos from the program, please visit the Global Regulatory Summit page.
Cell Therapy Liaison Meetings
The International Society for Cellular Therapy (ISCT) requested of the FDA CBER the launch of closed biannual liaison meetings for stakeholders in cellular therapy. The FDA committed to biannual meetings and the first scheduled was on November 5, 2004. iSBTc has been invited to participate in these meetings and has been identified as one of the key stakeholders. The meetings are intended to provide a forum for key stakeholders to discuss important issues of mutual interest, exchange information and to allow the cell therapy industry to inform CBER of specific concerns, to discuss events which have occurred for products of interest, to update the FDA on recent scientific and administrative developments in the cell therapy community, and to obtain information on how the Center operates.
"8th Cell Therapy/FDA Liaison Meeting"
October 17, 2008 – Bethesda, MD
iSBTc representative Laszlo G. Radvanyi, PhD served as the co-chair for this meeting along with ISCT North America Legal and Regulatory Affairs Committee representative Kurt Gunter, MD. The primary focus of this stakeholder meeting included discussions on "Review of Cost Recovery Regulations and Procedures for Cell Therapy Products and Medical Devices" and "Safety Testing of Embryonic Stem Cell Lines." Information available from the meeting includes a Final Meeting Summary as well as presentation slides.
Participating organizations: American Association of Blood Banks (AABB), Advanced Medical Technology Association (AdvaMed), American Society for Blood and Marrow Transplantation (ASBMT), Biotechnology Industry Organization (BIO), College of American Pathologists (CAP), Foundation for the Accreditation of Cellular Therapy (FACT), International Society for Biological Therapy of Cancer (iSBTc), International Society for Cellular Therapy (ISCT), Production Assistance for Cellular Therapy (PACT), United States Food and Drug Administration (US-FDA).
9th International Symposium - Biological Therapy of Cancer (BTOC)
March 12-15, 2008 – Munich, Germany
The educational session entitled "Improving the Therapeutic Efficacy of Cancer Immunotherapy" was held a part of the BTOC program jointly sponsored by the Biotherapy Development Association (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.
iSBTc Oncology Biologics Development Primer
February 28-29, 2008 – Gaithersburg, MD
The iSBTc Oncology Biologics Development Primer (OBDP) was a key forum for continuing to explore and discuss best practices for worldwide biologics development. Through the expertise of the invited speakers, panel members and attendees, this rigorous and challenging program curriculum facilitated understanding, open discussion and exploration of the development issues surrounding biologic agents for cancer. iSBTc 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. For more information this program, including viewing the presenter slides and downloading of resource materials distributed during the program, please visit the OBDP page.
iSBTc-CIS Damage Associated Molecular Pattern Molecules Symposium (DAMPs)
June 7, 2007 at the FOCIS Annual Meeting – San Diego, CA
This joint satellite symposium 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 Cancer Vaccine Clinical Trials Working Group
2004-2005
Because of the strategic initiative and focus of iSBTc, leaders from both iSBTc and the Cancer Vaccine Consortium (CVC) were gathered to formulate the Cancer Vaccine Clinical Trials Working Group (CVCTWG). The goal of this working group was to help move cancer vaccines through the clinical development process more efficiently and expeditiously, accelerating their development and general patient access. The outcomes of this group ultimately lead to the report in the iSBTc-CVC Workshop.
iSBTc-CVC Cancer Vaccine Clinical Trials Workshop
November 10, 2005 in conjunction with the iSBTc 20th Annual Meeting & Associated Programs – Alexandria, VA
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 2005 Workshop page.
iSBTc Consensus Conference on Patient Specific Therapy
November 2, 2003 in conjunction with the iSBTc 18th Annual Meeting & Associated Programs – Bethesda, MD
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 2003 Consensus Conference page.
FOCIS-iSBTc Satellite Symposium on Cellular Immunology and the Immunotherapy of Cancer V
May 15, 2003 – Paris, France
As a member Society within FOCIS, iSBTc 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. To see the complete schedule, please visit the symposium home page.
iSBTc ONGOING COLLABORATIONS
United States Government and Regulatory Agencies
Food and Drug Administration (FDA)
The iSBTc has a long-standing relationship with the FDA, including both members from the Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER) as faculty members and partners in the fight against cancer. To that end, the FDA was an active participant and organizer of the 2008 iSBTc Global Regulatory Summit and the 2009 iSBTc-FDA-NCI Workshop on Prognostic and Predictive Immunologic Biomarkers in Cancer. They were also a primary organizer of the iSBTc-FDA Taskforce on Immunotherapy Biomarkers in 2009.
National Institutes of Health (NIH)
The National Institutes of Health (NIH), a part of the U.S. Department of Health and Human Services, is the primary Federal agency for conducting and supporting medical research. Helping to lead the way toward important medical discoveries that improve people's health and save lives, NIH scientists investigate ways to prevent disease as well as the causes, treatments, and even cures for common and rare diseases. Composed of 27 Institutes and Centers, the NIH provides leadership and financial support to researchers in every state and throughout the world.
National Cancer Institute (NCI)
The NCI is the world's largest organization solely dedicated to cancer research. The NCI supports researchers at universities and hospitals across the United States and at NCI-Designated Cancer Centers, a network of facilities that not only study cancer in laboratories but also conduct research on the best ways to rapidly bring the fruits of scientific discovery to cancer patients.
The National Cancer Institute coordinates the National Cancer Program, which conducts and supports research, training, health information dissemination, and other programs with respect to the cause, diagnosis, prevention, and treatment of cancer, rehabilitation from cancer, and the continuing care of cancer patients and the families of cancer patients. Members of the NCI Cancer Therapy Evaluation Program (CTEP) are often contributors to iSBTc efforts and educational programming. The NCI worked with iSBTc and served as one of the primary organizers of the 2009 iSBTc-FDA-NCI Workshop on Prognostic and Predictive Immunologic Biomarkers in Cancer.
National Heart, Lung and Blood Institute (NHLBI)
The NHLBI provides leadership for a national program in diseases of the heart, blood vessels, lung, and blood; blood resources; and sleep disorders. The NHLBI plans and directs research in development and evaluation of interventions and devices related to prevention, treatment, and rehabilitation of patients suffering from such diseases and disorders. It also supports research on clinical use of blood and all aspects of the management of blood resources. The Institute plans, conducts, fosters, and supports an integrated and coordinated program of basic research, clinical investigations and trials, observational studies, and demonstration and education projects. Research is conducted in the Institute's own laboratories and by scientific institutions and individuals supported by research grants and contracts.
NHLBI PACT Workshop - "Converging Concepts in Cell Therapy"
April 23-24, 2009 – Bethesda, MD
The NHLBI PACT Workshop entitled "Converging Concepts in Cell Therapy" was held April 23-24, 2009 in Bethesda, MD. The workshop was sponsored by the NHBLI extramural program and the PACT program (Product Assistance for Cellular Therapies). iSBTc representatives served on the planning committee of this workshop along with representatives from the AABB, ISCT, and the U.S. FDA CBER. The agenda had both a scientific and clinical focus and examined the future of cell processing. Archived program information is available at www.pactgroup.net.
International Government and Regulatory Agencies
Department of Biotechnology (DBT), Government of India
The creation of a separate Department of Biotechnology (DBT), under the Ministry of Science and Technology in 1986 gave a new impetus to the development of the field of modern biology and biotechnology in India. In more than a decade of its existence, the department has promoted and accelerated the pace of development of biotechnology in the country. Through several R&D projects, demonstrations and creation of infrastructural facilities a clear visible impact of this field has been seen. The DBT was an active participant in the 2008 iSBTc Global Regulatory Summit.
European Medicines Agency (EMEA)
The EMEA is the regulatory body that is responsible for the scientific evaluation of applications for European marketing of medicinal products. The EMEA was an active participant in the 2008 iSBTc Global Regulatory Summit.
Health Canada
Health Canada is the federal department responsible for helping the people of Canada maintain and improve their health. Health Canada is committed to improving the lives of all of Canada's people and to making that country's population among the healthiest in the world as measured by longevity, lifestyle and effective use of the public health care system. Health Canada is the federal department responsible for helping the people of Canada maintain and improve their health and was an active participant in the 2008 iSBTc Global Regulatory Summit.
Paul-Ehrlich-Institut (PEI)
The Paul-Ehrlich-Institut is a center within the Federal Republic of Germany that is responsible for evaluation and approval of biological medicinal products such as vaccines for humans and animals, as well as medicinal products containing allergens, antibodies, blood and blood products, etc. The PEI has participated in numerous iSBTc programs and was an active participant in the 2008 iSBTc Global Regulatory Summit.
Pharmaceuticals and Medical Devices Agency (PMDA)
The PMDA is the governing body of Japan that is responsible for the aid of adverse health effect, evaluation and approval of pharmaceutical drugs, as well as maintaining safe use and promotion of pharmaceutical drugs. The PMDA was an active participant in the 2008 iSBTc Global Regulatory Summit.
Japan Science and Technology Agency (JST)
The JST has a mission of promoting science and technology in Japan by encouraging consistent research and development to the commercialization of the product, and disseminating scientific and technological information. The JST was an active participant in the 2008 iSBTc Global Regulatory Summit.
State Food and Drug Administration (SFDA)
The State Food and Drug Administration, P.R. China is the regulatory authority on the safety management of food, pharmaceuticals and cosmetics. The SFDA is directly under the State Council, is the competent authority of drug regulation in China, and was an active participant in the 2008 iSBTc Global Regulatory Summit.
Swissmedic, Swiss Agency for Therapeutic Products
Swissmedic is the central Swiss supervisory authority for therapeutic products. To protect the health of humans and animals, Swissmedic strives to ensure that medicines and medical devices in Switzerland are effective and safe. Swissmedic informs appropriate professionals and the general public about specific issues and new discoveries in the therapeutic products sector. It is a public service organization of the federal government with headquarters in Bern, Switzerland. Swissmedic was an active participant in the 2008 iSBTc Global Regulatory Summit.
International Associations and Organizations
Biotherapy Development Association (BDA)
The BDA is an international organization based in Munich, Germany that is devoted to the education, pre-clinical and clinical research and development of biological therapies for cancer. iSBTc has entered in to an ongoing collaborative effort with the BDA on meetings and initiatives such as the 2008 meeting on "Improving the Therapeutic Efficacy of Cancer Immunotherapy" at the 9th International Symposium - Biological Therapy of Cancer (BTOC) in Munich, Germany. The BDA was also an active participant in the iSBTc-FDA Taskforce on Immunotherapy Biomarkers in 2009 and is currently participating in the 2010 Symposium on Immuno-Oncology Biomarkers, 2010 and Beyond.
Association for Immunotherapy of Cancer (CIMT)
CIMT, a non-profit association in Germany, was founded in fall 2002 as an information and education platform for immunological cancer therapy. It is located at the Tumor Vaccination Center of the Johannes Gutenberg-University Mainz, and was established with the support of the "Deutsche Krebshilfe" (German Cancer Aid). CIMT was an active participant in the 2009 iSBTc-FDA-NCI Workshop on Prognostic and Predictive Immunologic Biomarkers in Cancer and is currently collaborating on the 2010 Symposium on Immuno-Oncology Biomarkers, 2010 and Beyond.
Italian Network for Tumor Biotherapy (NIBIT)
NIBIT is an Italian-based organization whose main objectives are to promote and foster a stronger scientific and operative interaction among professionals belonging to Academia, Biotech/Pharmaceutical Industry, Regulatory Bodies; to develop innovative, multi-center clinical studies of cancer bio-immunotherapy at national level; and to set-up initiatives to inform patients about potentials and limitations of cancer bio-immunotherapy and on ongoing clinical trials. NIBIT was an active participant in the 2009 iSBTc-FDA Taskforce on Immunotherapy Biomarkers.
Nordic Center for Development of Antitumour Vaccines (NCV-network)
The NCV-network was created to reach a consensus, or a common platform, for the design and execution of immunotherapeutic treatments through exchange of information and increase of knowledge especially among the junior faculty in these groups. The coordination of the immunotherapeutic efforts of the members of the network will simplify and speed up the translation of the current knowledge in the post-genomic era for improvement of health care in the Nordic countries. The NCV-network participated in the 2009 iSBTc-FDA Taskforce on Immunotherapy Biomarkers and currently collaborates on the 2010 Symposium on Immuno-Oncology Biomarkers, 2010 and Beyond.
Domestic Associations and Organizations
Cancer Immunotherapy Consortium (CIC) / Cancer Research Institute (CRI)
The Cancer Immunotherapy Consortium, a program of the Cancer Research Institute, is an international association of more than 70 pharmaceutical and biotech companies and academic institutions, who share a common goal of improving patient care by making cancer vaccines part of the standard-of-care in oncology. Through the leadership of iSBTc, leaders of both iSBTc and the CIC came together to formulate the Cancer Vaccine Clinical Trials Working Group in 2004-2005 with a resulting Cancer Vaccine Clinical Trials Workshop held as part of the iSBTc 2005 Annual Meeting & Associated Programs. The CIC/CRI was also an active participant in the 2009 iSBTc-FDA Taskforce on Immunotherapy Biomarkers and the 2009 iSBTc-FDA-NCI Workshop on Prognostic and Predictive Immunologic Biomarkers in Cancer. It is currently participating the 2010 Symposium on Immuno-Oncology Biomarkers, 2010 and Beyond. The Cancer Research Institute is an organization that is dedicated to conquering cancer through immunology. It provides funding to academic researchers at top institutions around the world.
Clinical Immunology Society (CIS)
The Clinical Immunology Society facilitates education, translational research and novel approaches to therapy in clinical immunology to promote excellence in the care of patients with immunologic/inflammatory disorders. Through a collaborative effort of the iSBTc and CIS, a joint satellite symposium was developed to introduce the emergent understanding of the DAMPs in inflammation and clinical immunology. The symposium was held on June 7, 2007 at the FOCIS Annual Meeting in San Diego, CA.
Federation of Clinical Immunology Societies (FOCIS)
iSBTc is an active "Member Society" of FOCIS, which is a federation of non-profit organizations that exists to improve human health through immunology by fostering interdisciplinary approaches to both understand and treat immune-based diseases. FOCIS has 20 Member Societies and 17 Affiliate Societies, representing roughly 40,000 clinician scientists. A Federation of this size provides a voice for clinical immunologists and ultimately strives to improve patient care. iSBTc has collaborated with FOCIS by providing input on the educational content of their programming including organizing several satellite symposium that have been held in conjunction with the FOCIS Annual Meeting.
International Society for Cellular Therapy (ISCT)
ISCT is a global forum and resource for developing and supporting innovative cellular therapies through communication, education, and training, thus furthering clinical based investigation for the benefit of patients. iSBTc is an active participant in the ISCT initiated "Cellular Therapy Liaison Meetings" held biannually with the FDA and numerous stakeholders in cellular therapy.
