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Daniel Rotrosen, M.D., Director, DAIT
Dr. Rotrosen announced the following new staff: Jane L. Halpern, Ph.D., joined the Office of Clinical Applications in June 2000 to serve as the Director of Regulatory and Industry Affairs. Dr. Halpern has worked in the area of regulatory affairs and biopharmaceutical product development for a number of years, most recently as a consultant in regulatory affairs. Prior to this, she worked for 10 years at the Center for Biologics Evaluation and Research at the FDA as a researcher/reviewer in the Office of Vaccines Research and Review. Her research studies focused on the pathogenic mechanisms of bacterial protein toxins and their evaluation as vaccine candidates.
Denise G. Wiesch, Ph.D., joined the Clinical Immunology Branch as a Program Officer in June 2000. Dr. Wiesch comes to the branch after completing a Ph.D. degree in Epidemiology from Johns Hopkins University and a post-doctoral fellowship at University of Maryland's Center for the Genetics of Asthma and Complex Diseases. Prior to graduate studies, she worked in a molecular genetics laboratory at NIMH and later as a technical information specialist for the National Library of Medicine. Her research experience includes study design and statistical analysis of genetic susceptibility, environmental exposure and gene-environment interactions in disease. Dr. Wiesch will be responsible for the Branch's immunodeficiency portfolio and a portion of the autoimmunity portfolio.
Dr. Rotrosen announced the following scientific activities:
Immune Tolerance and Islet Transplantation Highlighted on National Public Radio: NIAID Director, Dr. Anthony S. Fauci and Dr. James Shapiro, Director of the Islet Transplantation Program at the University of Alberta, Edmonton, Canada, and Ms. Deb Butterfield, founder and Executive Director of the Insulin-Free World were guests on the Diane Rehm show on National Public Radio. Their discussion focused on recent breakthroughs in research aimed at finding a cure for diabetes. Mainly, the "Edmonton Protocol" in which insulin-producing islet cells are transplanted into patients with severe and difficult to control type 1 diabetes. Ten sites in the U.S. and Europe will participate in conducting the clinical trial under the auspices of the Immune Tolerance Network. The establishment of this unique Network was spearheaded by the National Institute of Allergy and Infectious Diseases and is co-sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases and Juvenile Diabetes Foundation International.
President Clinton Announces Expansion of "Edmonton" Islet Transplantation Clinical Trial: President Clinton, in his July speech before the NAACP, announced NIH and Juvenile Diabetes Foundation International (JDFI) sponsorship of the "Edmonton" islet transplantation clinical trial through the Immune Tolerance Network. He praised NIH and JDFI for their leadership and support in efforts to find a cure for this chronic, debilitating disease.
Pathogenesis of Churg-Strauss Syndrome: NIAID in collaboration with NHLBI, NIH Office of Rare Diseases and FDA held a 2-day workshop in September, 2000 to: (a) review the detailed reports of Churg-Strauss syndrome and related cases of hypereosinophilic pulmonary syndromes, (b) evaluate the nature of the relationship between anti-leukotriene therapy and Churg-Strauss syndrome, and (c) identify possible mechanisms which explain the data. This workshop focused on identifying new priorities for research to understand the pathogenesis of Churg-Strauss syndrome and of subsets of patients with severe asthma.
Continuing Medical Education (CME) for Primary Care Physicians: NIAID has collaborated for several years with Synermed, an organization that facilitates preparation of CME material for physicians and other health care professionals. This collaboration has produced material on the latest clinical advances in allergic diseases and asthma. Now, NIAID in collaboration with NHLBI, the American Lung Association, Synermed and the American Academy of Family Practice (AAFP) is facilitating the development of CME materials for AAFP's Annual Clinical Focus 2001: "Asthma, Allergy and Respiratory Infections." This program was initiated at the AAFP's meeting in Dallas in September 2000.
Workshop on the Immature Immune System: The NIAID, in collaboration with the National Institute of Child Health and Human Development, sponsored a workshop entitled "The Developing Immune System: Frontiers of Knowledge". This meeting, held on September 20-21, 2000, focused on gaps in knowledge and research opportunities in the areas of fetal-maternal interactions, ontogeny of the innate and adaptive immune systems, requirements to develop more effective vaccines for infants, and etiologies of autoimmune and allergic diseases.
Innovative Research In Human Mucosal Immunity: Recently, NIAID with the National Institute of Dental and Craniofacial Research (NIDCR), and the Crohn's and Colitis Foundation of America (CCFA) funded 15 exploratory research grants received in response to the RFA on "Innovative Research in Human Mucosal Immunity". These innovative projects are supported for 2 years and may lead to new understandings of the human mucosal immune response.
Multiplex Autoimmune Disease Genetics Consortium (Madgc): The Multiplex Autoimmune Disease Genetics Consortium (MADGC) is a nation-wide project to establish a repository of clinical and biological materials for studying the genetics of autoimmune diseases. Identification of these genes will provide important insights into disease mechanism. The Principle Investigator, Dr. Peter Gregersen (North Shore University Hospital), and his co-investigators, Dr. Tim Behrens (University of Minnesota) and Dr. Lindsey Criswell (University of California, San Francisco) began enrolling eligible families in May 2000. As of August 2000, each site had enrolled 5 families, with the eligibility of 20 more families under investigation.
PROGRAM UPDATE: AUTOIMMUNITY
Council members, Ad hoc Council members, guests and staff participated in a highly stimulating discussion on current issues in Autoimmunity. Moderator, and discussant Susan Kirshner, Ph.D., Program Officer, Clinical Immunology Branch discussed the Multiple Autoimmune Diseases Genetics Consortium and North American Rheumatoid Arthritis Consortium; Elaine Collier, M.D., Chief, Autoimmunity Section, Clinical Immunology Branch discussed an Update on Clinical Trials in Autoimmune Diseases - Autoimmunity Centers of Excellence and Immune Tolerance Network. This was subsequently followed by a provocative discussion on Design and Ethics of Pilot Clinical Trials in Patients with Early Multiple Sclerosis (MS): Samia Khoury, M.D., Brigham & Women's Hospital; Need for Clinical Trials of Treatment Naïve Patients with MS: Fred Lublin, M.D., Mount Sinai Hospital; Report of National Multiple Sclerosis Society Task Force on Placebo Controlled Trials in MS: Henry McFarland, M.D., National Institute of Neurological Disorders and Stroke; Design of Short Pilot Trials using MRI in Early MS: Robert Levine, M.D., Yale University; Ethical Issues for Pilot Clinical Trials of New Agents in Patients for which Approved Treatments are Available.
CONCEPT REVIEW
Five concepts were presented and approved.
NIAID Tetramer Facility: The purpose of this contract initiative is to continue the NIAID Tetramer Facility to produce and supply Major Histocompatibility Complex (MHC) tetramer reagents. The Facility, established in 1998, provides ready-to-use, quality-controlled tetramer reagents to research scientists worldwide. Requests for tetramer reagents submitted through the NIAID web site are reviewed by NIAID, and approved requests are sent to the Facility. The centralized Facility has successfully supplied many qualified investigators with quality-controlled custom reagents at greatly reduced expense.
NIAID Inner-City Asthma Consortium: Immunologic Approaches to Reduce Asthma Severity: The goal of this initiative is to evaluate promising immune-based therapies to control and eventually prevent the development of asthma in inner city children. This initiative will establish a new consortium of basic scientists and clinical investigators to evaluate the safety and efficacy of a variety of promising allergen-specific and nonspecific immune-based therapies to reduce asthma severity and eventually prevent disease in inner city children, targeting the major indoor allergens that have been identified as risk factors. Studies of the underlying mechanisms of promising therapeutic approaches will be an integral component of all clinical trials.
Statistical and Clinical Coordinating Center for Stem Cell Transplantation for Autoimmune Diseases Clinical Trials (SACCC-STAD): This initiative will provide statistical support and clinical coordination for the NIAID Inner City Asthma Consortium: Immunologic Approaches to Reduce Asthma Severity. The Statistical and Clinical Coordinating Center will carry out a variety of functions to support the NIAID Inner City Asthma Consortium, including: statistical and clinical trial design expertise, assistance in protocol development, regulatory support for Investigational New Drug Applications and required FDA reporting, clinical site training and monitoring, centralized data collection, quality assurance and analysis, and publication of study findings.
Non-Human Primate Tolerance Cooperative Study Group: The goal of this initiative is to evaluate the safety and efficacy of novel tolerance-induction therapies in non-human primate models of immune-mediated diseases. Expansion of the Non-Human Primate Transplant Tolerance Cooperative Study Group (NHPCSG) will enable continuation of studies of novel tolerance induction regimens in kidney and islet transplantation and the incorporation of studies focused on autoimmune diseases and asthma. Non-human primates are superior models to rodents or other animals because the physiology and immune system of non-human primates closely approximate those of humans.
Sex and Gender Differences in the Immune Response: To identify, characterize, and define differences in the immune response between males and females, including response to exogenous and self-antigens, the innate and adaptive immune response, systemic and mucosal immune response, and regulation of the immune system by hormonal and non-hormonal sex differences. This initiative will support multidisciplinary research to identify, characterize, and define sex and gender-based differences in immune responses that may be important in autoimmune diseases, including multiple sclerosis, Sjorgren's syndrome, vasculitis, systemic lupus erythematosus, rheumatoid arthritis and other immune mediated diseases, and the underlying mechanisms and clinical significance of such differences.
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