Atara Biotherapeutics, Inc. (Atara Bio) is dedicated to developing meaningful therapies for patients with severe and life-threatening diseases that have been underserved by scientific innovation.
Process for Requesting Expanded Access
Atara Bio will consider providing an individual patient with access to an Atara investigational product candidate either through an expanded access study at an active site or outside of a clinical trial. A treating physician may request information about how to apply for access to one of Atara Bio’s investigational product candidates by contacting Atara Bio at MedInfo@atarabio.com. Atara Bio will use reasonable efforts to respond and acknowledge each request within one (1) business day of submission. All physicians who receive Atara Bio’s investigational product candidate through expanded access are required to comply with all applicable laws and regulations, and contractual conditions, including those relating to safety reporting.
Review Criteria for Expanded Access Requests
Atara Bio will use the following criteria to review each request:
|1.1||The patient or patients to be treated have a serious or immediately life-threatening disease or condition, and there is no comparable or satisfactory alternative therapy to treat the disease or condition.|
|1.2||The potential patient benefit justifies the potential risks of the treatment use and those potential risks are not unreasonable in the context of the disease or condition to be treated.|
|1.3||Providing the investigational product candidate for the requested use will not interfere with the initiation, conduct, or completion of clinical investigations that could support marketing approval of the investigational product candidate for the expanded access use or otherwise compromise the potential development of the investigational product candidate for the expanded access use.|
|1.4||There is a plausible scientific rationale which suggests that the patient may benefit from treatment with the investigational product candidate.|
|1.5||The investigational product candidate must be part of an active clinical development program at Atara Bio and there must be adequate supply of such investigational product candidate. If there is a protocol under an existing IND for which the patient is eligible, then the patient should be provided the option to enroll in this protocol.|
|1.6||There is a regulatory mechanism in the country or region to support expanded access for the investigational product candidate.|
Each request must meet the all of the above criteria; otherwise, the request will be denied.
Existing Expanded Access Study Protocols
Additional information about existing expanded access study protocols for Atara Bio’s investigational product candidates can be found at the following links: