Chicago (September 9, 2010) – The International Serious Adverse Events Consortium (SAEC) announced today it will collaborate with Newcastle University (www.ncl.ac.uk) to research the genetics of drug induced liver injury. 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. Newcastle University is one of the UK's top research universities and has an impressive history of pioneering education and scientific research. The collaboration will be directed from the Institute of Cellular Medicine at the university's Medical School.
The International Drug Induced Liver Injury Consortium (IDILIC) will be co-directed by Professor Ann Daly, Professor of Pharmacogenetics at Newcastle University and Dr. Guru Aithal, Deputy Director of the Digestive Diseases Center at Nottingham University (www.nottingham.ac.uk). IDILIC will recruit patients with drug induced serious liver injury reactions, through a collaborative network comprised of 20+ leading research centers from around the world. This collaboration will further the SAEC and Newcastle University's ground breaking research into the genetics of "drug induced liver injury," through a focus on specific causal drugs and populations groups that experience these adverse drug reactions.
"Our genetic research to date points to a strong role of the immune system in 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 DILI reactions. We are thrilled Newcastle University and Professor Ann Daly share our commitment to such large scale international research collaboration. I can think of no better setting for the IDILIC coordinating center than at Newcastle University. "
Professor Ann Daly said, "This is a great opportunity for the Newcastle and Nottingham teams together with colleagues at the University of Liverpool to continue our productive relationship with the SAEC while forging new links with researchers in Europe, Asia and Australia. International cooperation is vital to enable us to understand these relatively rare but very serious adverse reactions to certain prescription medicines. Our aim is to develop simple genetic tests so that treatment can be personalized and those at risk of these liver reactions prescribed other medicines instead."
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 free access to its study data and results to qualified researchers.
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.