shapes our actions and intentions.
- bluebird bio is committed to developing gene therapies for severe genetic diseases.
- Participating in a clinical trial is the most appropriate way to access our investigational therapies.
- When participating in a clinical trial is not possible, bluebird bio may consider requests for expanded access on a case-by-case basis for patients with a serious or life-threatening disease or condition when no comparable or satisfactory alternative therapy options are available.
- At this time, only requests for expanded access from a qualified treatment center in the US can be considered.
- For information about how to access an FDA-approved bluebird bio therapy, please contact my bluebird support.
- For information about how to access an investigational therapy, please speak with your physician or contact firstname.lastname@example.org. We anticipate acknowledging receipt of requests sent to this email within five business days.
- In line with the 21st Century Cures Act, bluebird bio may revise this policy at any time. This website and policy will be updated with a hyperlink or other reference to the expanded access record on clinicaltrials.gov after such record becomes active.