Expanded access refers to the use of an investigational therapy outside a clinical trial when the primary goal is to diagnose, prevent, or treat a serious condition in a patient. This is different from a clinical trial, where more comprehensive safety and efficacy data are collected. Our goal is to provide access to our investigational therapies at the appropriate time and in the correct manner for patients
At this time, participation in one of our clinical trials is the most appropriate way to access our investigational therapies, and we do not currently offer access (including “expanded access”) outside of those trials. Consistent with our mission, we encourage awareness of and participation in our clinical trials. Clinical trials are controlled research studies in humans designed to determine if an investigational drug or device is safe and effective. You can access information on Zymeworks’ clinical trials by visiting https://www.zymeworks.com/our-pipeline/clinical-trials or https://clinicaltrials.gov/.
If you have questions about expanded access, please speak with your physician or have your physician contact email@example.com. We anticipate responding to inquiries sent to this email within five business days.
In line with the 21st Century Cures Act, Zymeworks may revise this policy at any time. Additionally, the posting of this policy shall not serve as a guarantee of access to any specific investigational drug by any individual patient.