Chicago (September 9, 2010) – The International Serious Adverse Events Consortium (SAEC) announced today it will collaborate with The University of Liverpool (www.liv.ac.uk/pharmacogenetics) to research the genetics of a form of serious adverse drug reaction called hypersensitivity. These are thought to involve the body's immune system, and mostly involve serious skin rashes. The SAEC is a novel, non-profit international research consortium, formed by the global pharmaceutical industry and the Wellcome Trust, to better understand the role genetics plays in drug safety. The University of Liverpool is one of the UK's top 20 research-led universities and has an impressive history of pioneering education and scientific research. The collaboration will be directed out of the university's Wolfson Center for Personalized Medicine.
The International Hypersensitivity Consortium (ITCH) will be coordinated via The University of Liverpool, and will be directed and lead by Professor Munir Pirmohamed, NHS Chair of Pharmacogenetics. ITCH will recruit patients with a range of drug induced skin and hypersensitivity reactions, through a collaborative network comprised of 20+ leading research centers from around the world. This collaboration will further the SAEC and The University of Liverpool's ground breaking research into the genetics of "drug induced immunologic SAEs," through a focus on specific causal drugs and populations groups that experience drug induced skin and hypersensitivity reactions.
"Our genetic research to date points to a strong role of the immune system in mediating these adverse responses," said Arthur L. Holden, Chairman of the SAEC. "To better understand the full genetic effects contributing to these diseases, we need to develop larger and more diverse collections of subjects, in conjunction with international researchers who share our strong interest and have experience with drug induced skin and hypersensitivity reactions. We are thrilled The University of Liverpool, and Professor Munir Pirmohamed share our commitment to such large scale international research collaboration. I can think of no better setting for the ITCH coordinating center than at The University of Liverpool. "
"This is a superb development which will ultimately benefit patients," said Prof Pirmohamed. The aim is to identify genetic predisposing factors which would allow for prospective identification of susceptible patients, and insights into the mechanisms of these serious adverse reactions, which are associated with a number of drugs. Because of the relative rarity of these reactions, a global approach with multiple partners is the only solution. Without the support and initiative of the SAEC, this would not be possible."
Founded in the fall of 2007, the SAEC is a private, global partnership of leading pharmaceutical companies, the U.S. Food and Drug Administration and academic institutions from around the world to identify and confirm genetic markers that may help predict which patients are at risk for drug-related serious adverse events. Through identifying and ultimately validating genetic markers associated with SAEs, the Consortium hopes to reduce the patient and economic costs caused by drug-related SAEs. The SAEC also hopes to improve the flow of safe and effective medical therapies by better addressing idiosyncratic safety risks of new drugs before they reach the market. It provides to qualified researchers, free access to its study data and results.
About the International SAEC
The International Serious Adverse Event Consortium (SAEC, www.saeconsortium.org) is a 501(c) 3 organization dedicated to identifying and validating DNA variants useful in predicting the risk of drug-related serious adverse events. The Consortium brings together the pharmaceutical industry, regulatory authorities, and academic centers to address clinical and scientific issues associated with drug-related serious adverse events.
SAEC members include representatives from the pharmaceutical industries, the scientific community, and the Wellcome Trust.
- Pharmaceutical industry partners are involved in all aspects of the Consortium launch, providing ongoing consultation on the development and structure of the Consortium's scientific model, contributing cohort data, and underwriting costs of the SAEC's studies.
- SAEC members include Abbott, Amgen, Daiichi Sankyo, GlaxoSmithKline, Merck, Novartis, Pfizer, Takeda, and the Wellcome Trust.
- The FDA provides consultation on the direction of the SAEC, the design and conduct of SAEC studies, and support of research data release.