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access policy

bluebird bio is committed to developing safe and effective therapies to transform the lives of patients with severe genetic diseases.

At this time, we believe that participating in a clinical trial is the most appropriate way to access our investigational therapies. We also recognize that participation in a clinical trial is not always possible, and we may consider requests for expanded access on a case by case basis when:

  • a patient is judged by their physician to be at clear risk of near-term mortality due to their disease or due to a treatment that is required
  • there is no other medical option that is approved and available to the patient that is likely to meaningfully reduce or remove the risk of mortality
  • data provide bluebird and the treating physician with robust reason to believe that the therapy has a chance of meaningfully reducing the patient’s risk of near-term mortality

Due to the complex nature of gene therapy and our current phase of clinical development only requests for expanded access from a qualified treatment center in the US can be considered.

If you have additional questions, please speak with your physician or contact clinicaltrials@bluebirdbio.com. 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.