Letter from the Chairman
November 2007
Dear Colleagues:
Welcome to the website of the International Serious Adverse Event Consortium [SAEC]. We’re delighted you chose to spend a few minutes with us.
We launched the SAEC in August of 2007, as an industrial biomedical consortium, focused on identifying and validating DNA-variants useful in predicting the risk of drug induced, rare serious adverse events [SAEs]. Drug-induced, rare SAEs can be a severe health issue; while posing significant issues for the use of approved drugs and the development of new drugs. SAEs are a significant challenge for patients, FDA, industry, and payors. However, the rarity of such drug induced SAEs and the absence of effective government surveillance/research networks, makes it extremely difficult for any one company/research entity to accrue enough SAE cases and controls to conduct effective whole genome studies. Central to the notion of the SAEC is that industry, government and health care researchers can join forces and work together to make use of a variety of biological and data resources to study the genetic basis of rare, drug induced SAEs. The challenge demands a highly coordinated, collaborative effort involving many parties. To date, twenty one agreements have been completed to give birth to the International SAE Consortium Ltd. Collaboration and team work are at the heart of our efforts to conduct this research and to serve the public good. We enthusiastically welcome researchers from around the world to collaborate with our efforts. I invite all researchers interested in contributing to our novel research efforts to contact me directly.
Although the Consortium’s scientific scope is broad in principle, it will initially focus on two projects. It will collaborate with leading scientists to identify DNA variants associated with drug-induced liver-disease [DILI] and Serious Skin Rashes [SSR]. These two projects, while critical in their own right, will also allow the SAEC to generate initial results in a relatively short time frame [due to the availability of case-control DNA sample collections]. These projects will also facilitate the development of the consortium’s informatics and data analysis/coordinating center, as well as other important operational capabilities. All “allowable” data from these efforts will be released to all qualified researchers at the same time. Simultaneously, while these Phase 1 discovery research are being executed, the SAEC will explore the feasibility of research on additional SAEs, develop hypothesis driven follow on studies, and examine the feasibility of developing additional networks to identify and obtain greater numbers of SAE cases and controls.
The Consortium was developed with the FDA and launched with the scientific, technical and financial support of eight initial founding members [ Abbott, GSK, J & J, Novartis, Pfizer, Roche, Sanofi-Aventis, and Wyeth]. The FDA and other regulatory bodies responsible for drug and medical products safety will be involved in all facets of the SAEC. The SAEC is currently in the process of adding additional research funding members as it begins to execute its Phase 1 research program and develops its future Phase 2 plans. I invite all companies interested in joining our novel research consortium to contact me directly. We must add additional funding members if we are to realize our vision to identify, validate and publish the data on genetic markers predictive of the key rare, drug induced serious adverse events.
I can be reached at . Please let me hear from you. Thank you.
Sincerely,
Arthur L. Holden
Chairman and CEO
International SAE Consortium, Ltd.
Download Letter (PDF)
For further detail please consult the following presentations:
An overview of the SAEC (PowerPoint)