What is the International Serious Adverse Events Consortium (iSAEC)?

The International Serious Adverse Events Consortium (iSAEC) is a nonprofit biomedical research organization established in 2007. It comprises leading pharmaceutical companies, the Welcome Trust, and academic institutions, and receives scientific and strategic input from regulatory bodies such as the U.S. Food and Drug Administration (FDA). The consortium's primary mission is to identify genetic variants that can help understand the risk of drug-related serious adverse events (SAEs).

What are the key features of International Serious Adverse Events Consortium (iSAEC)?

• Global Collaboration: The consortium collaborates with over 50 academic and clinical groups worldwide to collect diverse data, crucial for understanding genetic factors across different populations.
• Open Access Policy: iSAEC maintains an open-access approach to its data. It regularly releases large, de-identified datasets to the public, allowing other researchers to utilize this information for further studies.
• Standardization Efforts: The consortium supports phenotype standardization initiatives to ensure consistent identification of case subjects across multiple collection sites, enhancing the reliability of research findings.
• Innovative Data Analysis: The iSAEC Data Analysis and Coordination Center at Columbia University leads statistical analyses of association studies related to drug-induced adverse reactions, contributing significantly to the understanding of genetic risks.

What is the significance of International Serious Adverse Events Consortium (iSAEC) in Pharmacovigilance?

• Enhance Patient Safety: Understanding genetic predispositions can lead to better predictions of which patients are at higher risk for adverse reactions, allowing for tailored treatment options.
• Facilitate Drug Development: Insights gained from iSAEC’s research can inform the design of safer drugs and improve the overall drug development process.
• Promote Collaborative Research: iSAEC fosters collaboration among various stakeholders, enhancing the efficiency and effectiveness of research into drug-related SAEs.

DDReg’s Capability

DDReg is dedicated to advancing pharmacovigilance and drug safety by leveraging cutting-edge methodologies to study and understand serious adverse drug reactions (ADRs) on a global scale. Our capabilities include utilizing advanced genomic and clinical data analysis to identify genetic markers and risk factors associated with ADRs, enabling personalized medicine approaches. We collaborate with key stakeholders, including regulatory authorities, healthcare providers, and industry leaders, to foster a unified strategy for addressing ADRs. With expertise in managing large-scale data and conducting multi-center studies, DDReg plays a pivotal role in enhancing drug safety profiles and supporting the development of safer therapeutics worldwide.