Special Projects & Programs

CIRCLES Biorepository

CIRCLES stands for the Collaborative International Research in Clinical and Longitudinal Experience in NMO Studies. The purpose of the CIRCLES study is to create a biorepository containing longitudinally-collected data and bio samples from subjects with NMO and control subjects. The data and bio samples will be available to researchers to better understand NMO pathogenesis, clinical course, and impact of therapy. Results of these studies may identify the etiology and risk factors, biomarkers for disease progression, and treatment outcomes to guide development of novel therapies. Findings may also facilitate future research and clinical trials to investigate specific hypotheses related to NMO and to improve the lives of individuals suffering from NMO.

Program Goals

• Enroll volunteer NMO patients and controls into the CIRCLES study to collect biosamples and/or  associated clinical information donors.
• Facilitate prospective longitudinal observational studies designed to improve understanding of etiology, pathogenesis & biomarkers of NMO.
• Support industry efforts to develop improved therapeutic agents and strategies that benefit patients with NMO.

Program Details

• Expand the GJCF Biorepository in the United States and Canada
• Promote consensus-based collaboration
• Enable multiple investigation sites
• Facilitate clinical studies and accelerate industry-sponsored clinical trials

Partners

Fourteen CIRCLES IRB-approved sites currently enrolling patients and controls in the US and Canada

To be a part of CIRCLES, visit the Blood Bank.

ICC – International Clinical Consortium

Commitment

The Guthy-Jackson Charitable Foundation (GJCF) accelerates breakthrough advances that benefit NMO patients. Our International Clinical Consortium (GJCF-ICC) consists of thought leaders in over 65 institutions engaged in translational research and who practice medicine focused on Neuromyelitis Optica (NMO). These resources are coordinated by the GJCF to promote NMO research and facilitate industry-sponsored trials. GJCF is committed to improving prevention, diagnosis and treatment of NMO by engaging stakeholders through shared values of integrity and transparency.

Mission

To promote the discovery, development and delivery of improved medicines, therapeutic strategies and diagnostic tools to ultimately cure NMO. Our mission is realized through scientific, clinical, and educational programs focusing on the NMO patient and advocate community, NIH and regulatory agencies, and industry partners, as integrated through the GJCF-ICC.

Objectives

The core objective of the GJCF-ICC is to accelerate clinical breakthroughs for NMO. The GJCF-ICC facilitates research. An important goal is to provide patients access to appropriate industry-sponsored studies. The GJCF-ICC supports clinical studies by promoting standardized collection, processing, storing, and distribution of biospecimens, clinical datasets, and related resources to researchers dedicated to solving NMO.

Value-added objectives include:

1: responsible sharing of resources among NMO researchers;

2: identifying epidemiologic factors that contribute to NMO and related diseases;

3: enhancing awareness of NMO and similar autoimmune diseases;

4: standardization of specimen collection; and

5: building global consensus on diagnostic criteria and best clinical practices for NMO/NMOSD.

Scope

The GJCF-ICC focuses on the implementation of an efficient infrastructure to support mission critical research and industry-sponsored clinical trials.

Enabling Clinical Trials

The GJCF-ICC is focused on the implementation of an efficient infrastructure to support the most meaningful clinical research and industry-sponsored clinical trials.

Standardized Clinical Studies Infrastructure

Standardized infrastructure is important to efficient performance and interpretation of clinical studies. Common Data Elements (CDEs) and Case Report Forms (CRFs), Standard Operating Procedures (SOPs), and Informed Consent developed through GJCF-ICC consensus harmonize the collection and organization of clinical biospecimens and data to promote their most meaningful translational impact. The goal is to reach global consensus on therapeutic candidates and clinical studies.

Coordinate Mutual Interests of Stakeholders

In rare diseases such as NMO, the key to successful clinical trials is the optimization access of patients to study participation opportunities. The GJCF-ICC works in stride with organizations (industry, regulatory agencies, NIH), and individuals including clinicians and researchers, and of course NMO patients to meet the challenges of clinical studies. Additionally, the GJCF-ICC is designed to accommodate a growing international network to streamline global collaboration and promote efficient administration in the areas of Ethics Committee (EC) or Institutional Review Board (IRB) approvals. The present network includes North America, South America, Europe and Asia-Pacific.

IPND – International Panel for Neuromyelitis Optica Diagnosis

The IPND was comprised of the following expert members, each of whom contributed effort within one or more panel subgroups and tasks throughout the process. The Guthy-Jackson Charitable Foundation team coordinated and facilitated the IPND in this important

Members