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We focus on sparking a positive change in our communities.
At Spark Therapeutics, patients are our North Star. We strive to understand their individual journeys and unique needs and imagine they are with us in every interaction. The resilience of patients and their families is our inspiration. Therefore, the safety of patients using our investigational and/or approved therapies is central to Team Spark’s work.
We are committed to complete and timely evaluation of the benefits and risks of our gene therapies and communicating this and other educational information to help healthcare professionals and patients make informed treatment choices.
We collect information regarding adverse events and other safety information from patients, caregivers and healthcare professionals, among others, on an ongoing basis. Employees undergo intensive training on what an adverse event is, how to recognize one and how to report adverse events. To report an adverse event or a product complaint, click here and complete the submission form or contact us by calling 1-855-SPARKTX/+1 855-772-7589.
Spark’s patient safety and pharmacovigilance team reviews safety information received for our investigational and marketed gene therapies and determines what actions, if any, may need to be taken with regard to any potential evolving safety profile of our therapies.
Our investigational gene therapies are subject to rigorous testing before they are approved by regulatory authorities, such as the U.S. Food and Drug Administration, the European Medicines Association (EMA) for EU, and local agencies from other countries. Before a medicine is initially given to patients, our findings from pre-clinical studies (before entry into humans) are carefully analyzed and discussed with regulatory authorities. The medicine then undergoes a long process of investigation using well-designed clinical trials to determine the safety and efficacy of the investigational gene therapy.
As a biotechnology company researching new therapies, it is our responsibility to keep patient safety at the core of our mission to create a world where no life is limited by disease.