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U.S. Department of Health and Human Services

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International Serious Adverse Events Consortium (iSAEC)

Public Health Context: 

Serious adverse drug reactions pose a public health risk and are a well recognized cause for the withdrawal of drugs from the market.  Research shows that some serious adverse events (SAEs) may be associated with variations in an individual's genetic make-up.  Because SAEs may be rare, difficulties associated with gathering the number of cases to provide meaningful results has hampered progress in this area.  International collaborations offer the opportunity to pool identified cases, needed resources, and requisite expertise to provide the scale needed to make rapid and significant progress in understanding the genetic basis of serious adverse events.  Providing a scientific basis for understanding an individual's risk for a serious adverse drug reaction is central to realizing the promise of personalized medicine.

Mission & Program Objectives:

The iSAEC disclaimer icon will identify and validate DNA-variants useful in predicting the risk of drug induced serious adverse events.  Key goals include:

  • Supporting the development of existing and new international networks to obtain well phenotyped cases and controls for pharmacogenomics (PGx) research on important drug-induced SAEs.
  • Developing effective whole genome genotyping and sequencing methods for SAE research.
  • Supporting the development of the computational methods necessary for effective genome-wide association studies (GWAS) analysis (both genotyping and sequencing).
  • Creating a timely and publicly available scientific database (raw data and genetic markers) associated with key drug-induced SAEs.
  •  Managing the intellectual property related to genetic markers associated with SAEs to ensure broad and open access to all users in all settings.

Accomplishments as of August 2010:

  • Completed serious skin rash (SSR) pilot study to establish the SAEC DACC (implementation and testing of hardware infrastructure, data management, analysis process and reporting) while identifying genetic marker(s) of potential clinical significance.
  • Assembled one of the largest drug induced liver injury (DILI) research cohorts in the world, generating significant GWAS results and three publications.
  • Filed provisional patent application to ensure a “clear date of discovery” on SSR & DILI markers in support of the 2008-2010 public data releases.
  • Established initial case cohort for pilot torsades de pointes (TdP) GWAS.
  • Created and launched a publicly available “knowledge base” to identify PGx markers for predicting key SAEs via a dedicated SAEC web-site.
  • Initiated a major SAE phenotyping standardization effort to facilitate both SAE surveillance and 3 pilots for SAE research via electronic medical records.
  • Developed/developing global academic networks for expansion of SSR, DILI, Acute Hypersensitivity Reaction, and TdP.

Operational Framework:

The Serious Adverse Event Consortium (SAEC) 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, the Wellcome Trust, regulatory authorities and academic centers to address clinical and scientific issues associated with drug-related serious adverse events.

A Scientific Management Committee provides direction for all studies and coordinates the development of manuscripts for publication in journals.  Membership includes expertise from all SAEC member organizations and expert academic advisors.


U.S. Food and Drug Administration
European Medicines Agency (EMA)
Pharmaceuticals and Medical Devices
Agency (PMDA)
U.S. Veterans Administration Center
for Drug Safety

Abbott Laboratories
Amgen, Inc.
Cerner, Inc.
Daiichi Sankyo, Inc.
Expression Analysis, Inc.
Illumina, Inc.
Johnson & Johnson
Merck and Co., Inc.
Roche Palo Alto, LLC
sanofi-aventis U.S., inc.
Broad Institute
Columbia University
Duke University
Dundee University
HMO Research Network (HMORN)
Malaga University
Marshfield Clinic Research Foundation
Newcastle University
University of Florence
Wellcome Trust

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